FDA Foia Fy 2022 Log

Control # Recd Date From
PharmedOut, Georgetown
2021-6475 10/01/2021 University Medical Center
2021-6476 10/01/2021 Alicia Antiri
2021-6477 10/01/2021 Alicia Antiri
2021-6478 10/01/2021 Alicia Antiri
2021-6479 10/01/2021 Alicia Antiri

2021-6480 10/01/2021 Alicia Antiri
2021-6481 10/01/2021 Alicia Antiri
2021-6482 10/01/2021 Alicia Antiri
2021-6483 10/01/2021 Alicia Antiri
2021-6484 10/01/2021 Alicia Antiri
2021-6485 10/01/2021 Alicia Antiri
2021-6486 10/01/2021 Alicia Antiri
2021-6487 10/04/2021 L, Paul

2021-6488 10/04/2021 Melton, Donavan
2021-6489 10/04/2021 Melton, Donavan
2021-6490 10/04/2021 Melton, Donavan
2021-6491 10/04/2021 Evans, Shasta
2021-6492 10/04/2021 Evans, Shasta
2021-6493 10/04/2021 Evans, Shasta
2021-6494 10/04/2021 Evans, Shasta

2021-6495 10/04/2021 Melton, Donavan
2021-6496 10/04/2021 Evans, Shasta
2021-6497 10/04/2021 Evans, Shasta
2021-6498 10/04/2021 Evans, Shasta
2021-6499 10/04/2021 Evans, Shasta
2021-6500 10/04/2021 Evans, Shasta
2021-6501 10/04/2021 Duty, Harry

2021-6502 10/04/2021 Robinson, Raymond
2021-6503 10/04/2021 Bathen, Benjamin
2021-6504 10/04/2021 FOI Services, Inc.
2021-6505 10/04/2021 FDAZILLA
2021-6506 10/04/2021 Medytox Inc.
2021-6507 10/04/2021 Medytox Inc.
2021-6508 10/04/2021 MIDI, Inc.

2021-6509 10/04/2021 ECS Global LLC
2021-6510 10/04/2021 NBC NEWS
BAYLOR UNIVERSITY MEDICAL
2021-6511 10/04/2021 CENTER
2021-6512 10/04/2021 NBC NEWS
2021-6513 10/04/2021 STAT News

2021-6514 10/04/2021 INDIANA UNIVERSITY
2021-6515 10/04/2021 Hudson, Jonathan C

EMPIRE STATE CONSUMER
2021-6516 10/04/2021 PROJECT INC
2021-6517 10/04/2021 Schmidt & Copeland LLC
2021-6518 10/04/2021 smart, tammy l
2021-6519 10/04/2021 Litzher, Paul
2021-6520 10/04/2021 Litzher, Paul
Spark Capital Advisors (I)

2021-6521 10/04/2021 Private Limited
2021-6522 10/04/2021 Mandava Associates, LLC
2021-6523 10/04/2021 John DeBeer

2021-6524 10/04/2021 Han, Hyung Tak
2021-6525 10/04/2021 Acella Pharmaceuticals, LLC

Wilbur Ellis Nutrition LLC DBA
2021-6526 10/04/2021 Rangen
2021-6527 10/04/2021 East West Engineering PLLC
2021-6528 10/04/2021 East West Engineering PLLC
2021-6529 10/04/2021 COGENCY GLOBAL INC.
2021-6530 10/04/2021 INGENIO PICHICHÍ S.A.
2021-6531 10/04/2021 FOLEY & LARDNER LLP

Long Grove Pharmaceuticals,
2021-6533 10/04/2021 LLC
2021-6534 10/04/2021 Fumizer LLC
2021-6535 10/04/2021 Pearce Legal Services, PLLC
2021-6536 10/04/2021 TORRENT PHARMA INC
2021-6537 10/04/2021 TORRENT PHARMA INC

Long Island Laparoscopic
2021-6538 10/04/2021 Group
2021-6539 10/04/2021 BloombergQuint

Physicians for Informed
2021-6540 10/04/2021 Consent
Columbia Graduate School of

2021-6541 10/04/2021 Journalism
2021-6542 10/04/2021 Safir Miranda
2021-6543 10/04/2021 Wilshire Law Firm, PLC
Capstone Development
2021-6544 10/04/2021 Services
2021-6545 10/04/2021 Berge, Beau

Philip M. Lustbader & David
2021-6546 10/04/2021 Lustbader,PA
Glenmark Pharmaceuticals
2021-6547 10/04/2021 Inc
2021-6548 10/04/2021 SCA Pharmaceuticals, LLC


2021-6557 10/04/2021 Inc
2021-6558 10/04/2021 FDAZILLA
2021-6559 10/04/2021 FDAZILLA
2021-6560 10/04/2021 FDAZILLA
2021-6561 10/04/2021 FDAZILLA
2021-6562 10/04/2021 FDAZILLA
2021-6563 10/04/2021 FDAZILLA
2021-6564 10/04/2021 FDAZILLA
Hyman Phelps & McNamara

2021-6565 10/04/2021 PC
2021-6566 10/04/2021 Fresenius Kabi USA, LLC

2021-6567 10/04/2021 Keller and Heckman LLC
2021-6568 10/04/2021 REACH24H USA INC.
2021-6569 10/04/2021 Biocomposites Ltd
2021-6570 10/04/2021 HOLLAND & KNIGHT LLP
2021-6571 10/04/2021 REACH24H USA INC.
2021-6572 10/04/2021 REACH24H USA INC.
2021-6573 10/05/2021 George W Kraus

2021-6575 10/05/2021 ECS Global LLC
Clarivate Analytics (France)

2021-6576 10/05/2021 SAS

2021-6577 10/05/2021 SAS
2021-6578 10/05/2021 IPD ANALYTICS LLC
2021-6579 10/05/2021 CLSA India Pvt Ltd
2021-6580 10/05/2021 Janssen vaccines
2021-6581 10/05/2021 FDAZILLA
2021-6582 10/05/2021 FDAZILLA
2021-6583 10/05/2021 FDAZILLA
2021-6584 10/05/2021 FDAZILLA
2021-6585 10/05/2021 FDAZILLA
2021-6586 10/05/2021 FDAZILLA

2021-6588 10/05/2021 FOI Services, Inc.
2021-6589 10/05/2021 FOI Services, Inc.
2021-6590 10/05/2021 FOI Services, Inc.

2021-6591 10/05/2021 FOI Services, Inc.
2021-6592 10/05/2021 FOI Services, Inc.
2021-6593 10/05/2021 FOI Services, Inc.
2021-6594 10/05/2021 FOI Services, Inc.
2021-6595 10/05/2021 FOI Services, Inc.

2021-6596 10/05/2021 FOI Services, Inc.
2021-6597 10/05/2021 FOI Services, Inc.

2021-6598 10/05/2021 Xpro associates, LLC
2021-6599 10/05/2021 Registrar Corp
2021-6600 10/05/2021 FOI Services, Inc.
2021-6601 10/05/2021 FOI Services, Inc.
2021-6602 10/05/2021 FOI Services, Inc.

2021-6603 10/05/2021 Spherix Consulting Group, Inc.
Zydus Pharmaceuticals USA

2021-6604 10/05/2021 Inc.
2021-6605 10/05/2021 FOI Services, Inc.
2021-6606 10/05/2021 FDAZILLA

2021-6607 10/05/2021 FDAZILLA
2021-6608 10/05/2021 FDAZILLA
2021-6609 10/05/2021 FDAZILLA
2021-6610 10/05/2021 FDAZILLA
2021-6611 10/05/2021 Nephron Research
2021-6612 10/05/2021 CBS
2021-6613 10/05/2021 POLITICO
2021-6614 10/05/2021 POLITICO
2021-6615 10/05/2021 POLITICO
Columbia University Graduate

2021-6616 10/05/2021 School of Journalism
2021-6617 10/05/2021 Bumiller, George B

Mid-Illinois Hematology &
2021-6618 10/05/2021 Oncology Associates, Ltd.
2021-6619 10/05/2021 Tanton, Marianne

2021-6620 10/05/2021 Pritzker Hageman, P.A.
2021-6621 10/05/2021 SAS
2021-6622 10/05/2021 United Safety Agents LLC

2021-6623 10/05/2021 ROPES & GRAY LLP
2021-6624 10/05/2021 NeuroField Inc.
2021-6625 10/05/2021 kaleo, Inc.
2021-6626 10/05/2021 PROPUBLICA
2021-6627 10/05/2021 PROPUBLICA
2021-6628 10/05/2021 Vong BioPharma Consultants

University of Missouri School
2021-6629 10/05/2021 of Law Library
2021-6630 10/05/2021 FDAZILLA
2021-6631 10/05/2021 The Capitol Forum

2021-6632 10/05/2021 UNIVERSITY OF UTAH
2021-6633 10/05/2021 Jimmy Tobias
VATT Institute for Economic

2021-6634 10/05/2021 Research
2021-6635 10/05/2021 LATHAM & WATKINS LLP

2021-6636 10/05/2021 Bhargav, Sanjay
2021-6637 10/05/2021 Masson, Steve
2021-6638 10/05/2021 Anderson, Derry
2021-6639 10/05/2021 Farnam Companies, Inc.
2021-6640 10/05/2021 CSL BEHRING
2021-6641 10/05/2021 Ascend Laboratories LLC
Jeanmarie Donovan
2021-6642 10/05/2021 Consulting, LLC
2021-6643 10/05/2021 Cassandra Phillips
2021-6644 10/05/2021 CAPLIN STERILES LIMITED
2021-6645 10/05/2021 Encube Ethicals, Inc.
2021-6646 10/05/2021 Praxis Medical Devices

2021-6649 10/05/2021 PROPHARMA GROUP

2021-6650 10/05/2021 Rugar, Joshua E
2021-6651 10/05/2021 Rugar, Joshua E

Viyash Life Sciences Private
2021-6652 10/05/2021 Limited
2021-6653 10/05/2021 Animal Outlook
BAXTER HEALTHCARE
2021-6654 10/06/2021 CORPORATION
Viyash Life Sciences Private
2021-6655 10/06/2021 Limited
2021-6656 10/06/2021 Registrar Corp
2021-6657 10/06/2021 Insider

2021-6658 10/06/2021 Registrar Corp
2021-6659 10/06/2021 Registrar Corp

Quattlebaum, Grooms & Tull
2021-6663 10/06/2021 PLLC
Kleinfeld, Kaplan & Becker

2021-6664 10/06/2021 LLP
2021-6665 10/06/2021 Cigna Insurance Company

2021-6666 10/06/2021 Humble Juice Co., LLC
Hyman, Phelps & McNamara,

2021-6668 10/06/2021 P.C.

2021-6669 10/06/2021 P.C.
2021-6670 10/06/2021 P.C.

2021-6671 10/06/2021 P.C.

2021-6672 10/06/2021 P.C.

2021-6673 10/06/2021 P.C.
University of Passau, Bavaria,
2021-6674 10/06/2021 Germany
2021-6675 10/06/2021 Jimmy Tobias
2021-6676 10/06/2021 Levin Simes Abrams LLP

ANIMAL LEGAL DEFENSE
2021-6677 10/06/2021 FUND
2021-6678 10/06/2021 FUND
2021-6679 10/06/2021 FUND
2021-6680 10/06/2021 Levin Simes Abrams LLP
2021-6681 10/06/2021 Services
Informed Consent Action

2021-6682 10/06/2021 Network
2021-6683 10/06/2021 DUNN SHEEHAN LLP

2021-6684 10/06/2021 Derek Ferland
UNIVERSITY OF MINNESOTA,
2021-6685 10/06/2021 TWIN CITIES CAMPUS
2021-6686 10/06/2021 Magnotta, Tracy
2021-6687 10/06/2021 GREGORATOS, GABRIEL
2021-6688 10/06/2021 Magnotta, Tracy

2021-6689 10/06/2021 MLV Pharma LLC
2021-6690 10/06/2021 Lamarco, Christian

2021-6691 10/06/2021 J LEE HOLMES
2021-6692 10/06/2021 LUXENA PHARMACEUTICALS

2021-6693 10/06/2021 MEGASTAR ADVISORS LLC
LAW OFFICE OF D. JOSHUA
2021-6695 10/06/2021 STAUB
2021-6696 10/06/2021 Inc
2021-6697 10/06/2021 Sharp Law LLP

2021-6699 10/06/2021 Robinson Fresh
2021-6700 10/06/2021 FOI Services, Inc.
2021-6701 10/06/2021 Shaun Mehra
2021-6703 10/06/2021 Registrar Corp
2021-6704 10/06/2021 MPG Operations LLC
2021-6705 10/06/2021 Blue Spark Technologies
2021-6706 10/06/2021 Registrar Corp
2021-6707 10/06/2021 Registrar Corp

2021-6708 10/06/2021 Registrar Corp
2021-6709 10/06/2021 Registrar Corp
2021-6710 10/07/2021 Sung Chun Kim, Esq.
2021-6711 10/07/2021 Sung Chun Kim, Esq.
2021-6713 10/07/2021 H New Media Law

THOMPSON HINE & FLORY
2021-6714 10/07/2021 LLP
2021-6715 10/07/2021 LLP

2021-6716 10/07/2021 LLP
2021-6717 10/07/2021 STEADMAN, HEATHER

2021-6718 10/07/2021 Joosang Kim
2021-6719 10/07/2021 SHOOK HARDY & BACON
2021-6720 10/07/2021 DATELINE NBC
2021-6721 10/07/2021 Clare, Patrick J

2021-6722 10/07/2021 Mahoney, James J
Froggy's Fog DBA SMPLY

2021-6723 10/07/2021 Brands
2021-6724 10/07/2021 Food & Water Watch
2021-6726 10/07/2021 FOI Services, Inc.

2021-6727 10/07/2021 FOI Services, Inc.
2021-6728 10/07/2021 Huntsman (Europe) BV
2021-6729 10/07/2021 BIOSERENITY INCORPORATED
2021-6730 10/07/2021 Jamieson Laboratories Ltd.
2021-6731 10/07/2021 B&H Consulting Services, Inc.
2021-6732 10/07/2021 FDAZILLA
2021-6733 10/07/2021 FDAZILLA
2021-6734 10/07/2021 FDAZILLA

2021-6735 10/07/2021 FDAZILLA
2021-6736 10/07/2021 FDAZILLA
2021-6737 10/07/2021 FDAZILLA
2021-6738 10/07/2021 FDAZILLA

2021-6739 10/07/2021 Hogan Lovells
2021-6740 10/07/2021 Hogan Lovells
2021-6741 10/07/2021 ANI Pharmaceuticals, Inc.
VARIAN MEDICAL SYSTEMS

2021-6742 10/07/2021 INC
2021-6743 10/07/2021 Everpoint Asset Management
2021-6744 10/07/2021 Ameritek USA, Inc
2021-6745 10/07/2021 Telemundo Network
2021-6746 10/07/2021 PROPUBLICA
2021-6747 10/07/2021 Sam Ravin

2021-6748 10/07/2021 Steptoe & Johnson LLP
2021-6749 10/07/2021 The Associated Press
2021-6750 10/08/2021 FOI Services, Inc.

2021-6751 10/08/2021 EAS Consulting Group, LLC
2021-6753 10/08/2021 FDA NEWS
2021-6754 10/08/2021 FDA NEWS
2021-6755 10/08/2021 FOI Services, Inc.
2021-6756 10/08/2021 FDAZILLA
2021-6757 10/08/2021 FDAZILLA
2021-6758 10/08/2021 FDAZILLA
2021-6759 10/08/2021 FDAZILLA

2021-6760 10/08/2021 FOI Services, Inc.
2021-6761 10/08/2021 FOI Services, Inc.
2021-6762 10/08/2021 FOI Services, Inc.
2021-6764 10/08/2021 Rich, Cynthia
2021-6765 10/08/2021 Environmental Health Trust
2021-6766 10/08/2021 BLOOMBERG NEWS

2021-6767 10/08/2021 BLOOMBERG NEWS
2021-6768 10/08/2021 MLV Pharma LLC
2021-6769 10/08/2021 DICKINSON, WILLIAM
2021-6770 10/08/2021 Dinwiddie, Carl
2021-6771 10/08/2021 COLOMBINA DEL CAUCA S.A.

2021-6772 10/08/2021 Carroll, Claire E
2021-6773 10/08/2021 POMERANTZ LLP
2021-6774 10/08/2021 Cooper & Larsen
2021-6775 10/08/2021 Bloodworks Northwest
2021-6777 10/08/2021 Seagen Inc.
2021-6778 10/08/2021 Seagen Inc.
2021-6779 10/08/2021 Seagen Inc.

2021-6780 10/08/2021 Seagen Inc.
2021-6783 10/08/2021 Jazz Pharmaceuticals
2021-6784 10/08/2021 Atara Biotherapeutics

Voyageur Pharmaceuticals
2021-6786 10/08/2021 Ltd.
2021-6787 10/08/2021 BioTex, Inc.
2021-6788 10/08/2021 MedEdge LLC
2021-6789 10/08/2021 Gilead Sciences, Inc.
2021-6790 10/08/2021 NORBROOK INC

UNIVERSITY OF ILLINOIS AT
2021-6791 10/08/2021 URBANA-CHAMPAIGN
2021-6792 10/08/2021 FOI Services, Inc.
2021-6793 10/08/2021 FOI Services, Inc.
2021-6794 10/08/2021 FOI Services, Inc.
2021-6795 10/08/2021 FOI Services, Inc.
2021-6796 10/08/2021 FOI Services, Inc.

2021-6797 10/08/2021 FOI Services, Inc.
2021-6798 10/08/2021 FOI Services, Inc.
IEH Laboratories & Consulting

2021-6799 10/08/2021 Group
2021-6800 10/08/2021 NOVARTIS PHARMA AG
2021-6801 10/08/2021 FOI Services, Inc.
2021-6802 10/08/2021 FOI Services, Inc.
2021-6803 10/08/2021 Jabil Inc
2021-6804 10/08/2021 FOI Services, Inc.
2021-6805 10/08/2021 FOI Services, Inc.
2021-6806 10/08/2021 FOI Services, Inc.
2021-6807 10/08/2021 FOI Services, Inc.

2021-6808 10/08/2021 FOI Services, Inc.
2021-6809 10/08/2021 FOI Services, Inc.
2021-6810 10/08/2021 FOI Services, Inc.
2021-6811 10/08/2021 FOI Services, Inc.

2021-6812 10/08/2021 MARIA PEREZ
2021-6813 10/08/2021 Federated Consultants, LLC
2021-6814 10/08/2021 FOI Services, Inc.
2021-6815 10/08/2021 FOI SERVICES, INC, *

2021-6816 10/08/2021 U.S. Right to Know
2021-6817 10/12/2021 SIRI & GLIMSTAD LLP

Weinberg, Wheeler, Hudgins,
2021-6819 10/12/2021 Gunn & Dial
2021-6820 10/12/2021 LLP
2021-6821 10/12/2021 Regunalys LLC
2021-6822 10/12/2021 Covington & Burling LLP
Geisinger Medical Center,
2021-6823 10/12/2021 Christen Mowad MD
2021-6824 10/12/2021 Freelancer - Cali Bagby

BUCHANAN INGERSOLL &
2021-6825 10/12/2021 ROONEY PC
2021-6826 10/12/2021 Clayton Trial Lawyers PLLC

2021-6827 10/12/2021 Jacob Ilany
2021-6829 10/12/2021 Grotewold, Jan L
2021-6830 10/12/2021 Adams FFI

2021-6831 10/12/2021 MED INSTITUTE INC
IEH Laboratories & Consulting

2021-6832 10/12/2021 Group
2021-6833 10/12/2021 FDA NEWS
2021-6834 10/12/2021 King & Spalding LLP
Quinn Emanuel Urquhart &

2021-6835 10/12/2021 Sullivan, LLP

2021-6837 10/12/2021 Hogan Lovells
2021-6838 10/12/2021 Hogan Lovells
2021-6839 10/12/2021 AABB

2021-6840 10/12/2021 MED INSTITUTE INC
2021-6841 10/12/2021 George Salmas
Law Offices of Andrew J.
2021-6842 10/12/2021 Carboy
2021-6843 10/12/2021 Best Automation & Robotics
2021-6844 10/12/2021 ovidio j.vides s.a de cv
2021-6845 10/12/2021 Markon Cooperative Inc.
2021-6846 10/12/2021 Best Automation & Robotics
2021-6847 10/12/2021 COLUMBIA UNIVERSITY
2021-6848 10/12/2021 ROGERS, MIKE

2021-6849 10/12/2021 Marler Clark Law Firm
2021-6850 10/12/2021 Bigtuna36, LLC
2021-6851 10/12/2021 RVAC Medicines

2021-6852 10/12/2021 American Regent Inc.
2021-6853 10/12/2021 FOI Services, Inc.

J.P. Morgan India Private
2021-6854 10/12/2021 Limited
Global Dental Science
2021-6855 10/12/2021 (Avadent.com)
2021-6856 10/12/2021 FOI Services, Inc.
Center for Pharmaceutical

Information and Engineering
2021-6857 10/12/2021 Research of Peking University
2021-6858 10/12/2021 FDAZILLA
2021-6859 10/12/2021 FDAZILLA
2021-6860 10/12/2021 FDAZILLA
2021-6861 10/12/2021 FDAZILLA
2021-6862 10/12/2021 FDAZILLA
2021-6863 10/12/2021 FDAZILLA
2021-6864 10/12/2021 eFoodAlert

2021-6865 10/12/2021 eFoodAlert
2021-6866 10/12/2021 FDAZILLA
2021-6867 10/12/2021 FDAZILLA
2021-6868 10/12/2021 FDAZILLA
2021-6869 10/12/2021 FDAZILLA
2021-6870 10/12/2021 MOTLEY RICE LLC
2021-6871 10/12/2021 SAEN
2021-6872 10/12/2021 Valle, Nathan C
SCOTT+SCOTT Attorneys at
2021-6873 10/12/2021 Law LLP
2021-6874 10/12/2021 Susan E. Loggans & Associates

2021-6875 10/12/2021 MARKETSHIELD, INC
2021-6876 10/12/2021 Civica Rx
2021-6877 10/12/2021 Sadhukha, Tanmoy
2021-6878 10/12/2021 THOMPSON HINE LLP
2021-6880 10/12/2021 mdi Consultants, Inc.

University of Michigan School
2021-6881 10/12/2021 of Public Health
2021-6882 10/12/2021 FOI Services, Inc.
2021-6883 10/12/2021 Import Compliance

2021-6884 10/12/2021 Najah Odrick
2021-6885 10/12/2021 Due Diligence Group
2021-6887 10/13/2021 SMITH, ADAM
2021-6888 10/13/2021 Capsulomics, Inc.
2021-6889 10/13/2021 REACH24H USA INC.

2021-6896 10/13/2021 Weiner, Julie
2021-6897 10/13/2021 Maesa LLC

2021-6901 10/13/2021 Point Seventy-Two

2021-6903 10/13/2021 FOI Services, Inc.
2021-6904 10/13/2021 FOI Services, Inc.
2021-6905 10/13/2021 FOI Services, Inc.
2021-6906 10/13/2021 Provepharm Inc

University of Missouri Law
2021-6907 10/13/2021 Library
2021-6909 10/13/2021 Marc Lanzar

Frost Brown Todd LLC ATTN:
2021-6910 10/13/2021 Kaitlyn Hawkins-Yokley Esq.
ENVIRONMENTAL DEFENSE
2021-6911 10/13/2021 FUND
2021-6912 10/13/2021 Schmit, Hans

2021-6913 10/13/2021 Pomerantz, LLP
2021-6914 10/13/2021 Pomerantz, LLP
2021-6915 10/13/2021 Pomerantz, LLP
2021-6916 10/13/2021 Pomerantz, LLP
2021-6917 10/13/2021 BARNES & THORNBURG LLP
2021-6918 10/13/2021 Northwestern University

2021-6919 10/13/2021 INTERTEK
2021-6920 10/13/2021 INTERTEK
2021-6921 10/13/2021 Matt Eckler
2021-6922 10/13/2021 Due Diligence Group LLC
2021-6923 10/13/2021 FOI Services, Inc.
2021-6924 10/13/2021 FOI Services, Inc.
2021-6925 10/13/2021 FOI Services, Inc.
2021-6926 10/13/2021 FOI Services, Inc.

2021-6927 10/13/2021 FOI Services, Inc.
2021-6928 10/13/2021 FOI Services, Inc.
2021-6929 10/13/2021 FOI Services, Inc.
2021-6930 10/13/2021 FOI Services, Inc.

BALYASNY ASSET
2021-6931 10/13/2021 MANAGEMENT
2021-6932 10/13/2021 FDAZILLA
2021-6933 10/13/2021 FDAZILLA
2021-6934 10/13/2021 IPDataLab.com
2021-6935 10/13/2021 Wells Fargo Securities, LLC
Watson Pharma Private

2021-6936 10/13/2021 Limited (A TEVA Company)
2021-6937 10/13/2021 FDAZILLA
2021-6938 10/13/2021 Frank Costanzo

2021-6939 10/13/2021 FDAZILLA
2021-6940 10/13/2021 FDAZILLA
2021-6941 10/13/2021 FDAZILLA
2021-6942 10/13/2021 FDAZILLA
2021-6943 10/13/2021 Oren Livnat
2021-6944 10/13/2021 RAY THOMPSON
2021-6945 10/13/2021 RAY THOMPSON
2021-6946 10/13/2021 RAY THOMPSON

2021-6948 10/13/2021 Corbly, Abigail R
2021-6949 10/13/2021 GREGORY J GALASKI
2021-6950 10/13/2021 PROPUBLICA
2021-6951 10/13/2021 TULLOS, LORI
2021-6952 10/13/2021 Busman, Sander S
2021-6953 10/13/2021 MERCK & CO., INC.
2021-6954 10/13/2021 CSL Plasma, Inc.
2021-6955 10/13/2021 bluebird bio Inc.

2021-6956 10/13/2021 Berman Tabacco
2021-6957 10/13/2021 DEERFIELD MANAGEMENT
2021-6958 10/13/2021 Michael Daniels
2021-6959 10/14/2021 Patel, Niral

2021-6960 10/14/2021 Americans for Public Trust
2021-6961 10/14/2021 Swiss American CDMO, LLC
2021-6962 10/14/2021 Collin Baker

2021-6963 10/14/2021 Reaud, Morgan & Quinn
2021-6964 10/14/2021 A Plus International Inc.
2021-6965 10/14/2021 Squire Patton Boggs (US) LLP

BALYASNY ASSET
2021-6966 10/14/2021 MANAGEMENT
BALYASNY ASSET
2021-6967 10/14/2021 MANAGEMENT
2021-6968 10/14/2021 A2A Pharma
2021-6969 10/14/2021 SurGenTec
FAVUS INSTITUTIONAL
2021-6970 10/14/2021 RESEARCH LLC
2021-6971 10/14/2021 Moore Law Firm, P.C.
2021-6972 10/14/2021 FOI Services, Inc.
2021-6973 10/14/2021 FDAZILLA
2021-6974 10/14/2021 FDAZILLA
2021-6975 10/14/2021 FDAZILLA
2021-6976 10/14/2021 FDAZILLA
2021-6977 10/14/2021 FDAZILLA

2021-6978 10/14/2021 Vein360 LLC,
2021-6979 10/14/2021 Vein360, LLC
2021-6980 10/14/2021 Vein360, LLC
2021-6981 10/14/2021 DRT Strategies, Inc.
2021-6982 10/14/2021 FOIA Professional Services
2021-6983 10/14/2021 Alex Berenson
2021-6984 10/14/2021 THE FEDERALIST SOCIETY
2021-6985 10/14/2021 Wondery
2021-6986 10/14/2021 Foley and Lardner, LLP

2021-6987 10/14/2021 Aesculap Chifa Sp. z o.o.
2021-6988 10/14/2021 FOI Services, Inc.
2021-6989 10/14/2021 FOI Services, Inc.
2021-6990 10/14/2021 FOI Services, Inc.
2021-6991 10/14/2021 FOI Services, Inc.
2021-6992 10/14/2021 FOI Services, Inc.

2021-6993 10/14/2021 FOI Services, Inc.
2021-6994 10/14/2021 FOI Services, Inc.
2021-6995 10/14/2021 FOI Services, Inc.
2021-6996 10/14/2021 Greg Glaser, Attorney at Law
2021-6997 10/14/2021 ROBERT LLOYD

2021-6998 10/15/2021 Cook Biotech Inc.
2021-6999 10/15/2021 Cook Biotech, Inc.
2021-7000 10/15/2021 FOI Services, Inc.

2021-7002 10/15/2021 Inc.
2021-7003 10/15/2021 FDAZILLA

2021-7004 10/15/2021 FDAZILLA
2021-7005 10/15/2021 FDAZILLA
2021-7006 10/15/2021 FDAZILLA
2021-7007 10/15/2021 FDAZILLA
2021-7008 10/15/2021 FDAZILLA
2021-7009 10/15/2021 FDAZILLA
2021-7010 10/15/2021 FDAZILLA
2021-7011 10/15/2021 SurGenTec LLC
2021-7012 10/15/2021 SurGenTec LLC
2021-7013 10/15/2021 SurGenTec

2021-7014 10/15/2021 ZMC
2021-7015 10/15/2021 RAI Services Company
2021-7016 10/15/2021 SurGenTec
2021-7017 10/15/2021 SurGenTec LLC
2021-7018 10/15/2021 Infrared Cameras Inc.

2021-7019 10/15/2021 Guggenheim Partners
2021-7020 10/15/2021 Cooley, LLP
2021-7021 10/15/2021 Breiding, Carmen
2021-7022 10/15/2021 Brodkin, Jesse
2021-7023 10/18/2021 FDA NEWS
2021-7024 10/18/2021 FDA NEWS
2021-7025 10/18/2021 FOIA GROUP INC
2021-7026 10/18/2021 FDA NEWS

2021-7027 10/18/2021 Butcher, Melissa
Advocate Lutheran General
2021-7028 10/18/2021 Hospital
2021-7029 10/18/2021 eFoodAlert
2021-7030 10/18/2021 TrendSetters E-Liquid LLC
2021-7031 10/18/2021 Liquid Nics LLC

2021-7032 10/18/2021 MedEdge LLC
2021-7033 10/18/2021 Derek Ferland
2021-7034 10/18/2021 Derek Ferland

2021-7035 10/18/2021 KING & SPALDING
2021-7036 10/18/2021 Baker Hostetler
2021-7037 10/18/2021 LLP
2021-7038 10/18/2021 Reuters News
2021-7039 10/18/2021 Wagstaff Law Firm
2021-7040 10/18/2021 ADISSEO FRANCE SAS
2021-7042 10/18/2021 Dassault Systemes
2021-7043 10/18/2021 Registrar Corp

2021-7046 10/18/2021 Altria Client Services LLC
2021-7047 10/18/2021 Liquid Labs LLC
International Food Protection

2021-7050 10/18/2021 Training Institute
2021-7051 10/18/2021 Guggenheim Securities, LLC
2021-7052 10/18/2021 Northwest Clinical Trials, Inc.

2021-7053 10/18/2021 FDAZILLA
2021-7054 10/18/2021 FDAZILLA
2021-7055 10/18/2021 FDAZILLA
2021-7056 10/18/2021 FDAZILLA

2021-7058 10/19/2021 Globizz Corp.
2021-7059 10/19/2021 Globizz Corp.
2021-7060 10/19/2021 Dunn Regulatory Associates
2021-7061 10/19/2021 FOI Services, Inc.

2021-7062 10/19/2021 FOI Services, Inc.
2021-7063 10/19/2021 FOI Services, Inc.
2021-7064 10/19/2021 FOI Services, Inc.
2021-7065 10/19/2021 FOI Services, Inc.
2021-7066 10/19/2021 FOI Services, Inc.
2021-7067 10/19/2021 FOI Services, Inc.
2021-7068 10/19/2021 FOI Services, Inc.
2021-7069 10/19/2021 FOI Services, Inc.
2021-7070 10/19/2021 FOI Services, Inc.
2021-7071 10/19/2021 FOI Services, Inc.
2021-7072 10/19/2021 FOI Services, Inc.
2021-7073 10/19/2021 Evergreen Research Inc.

2021-7074 10/19/2021 CSL Behring LLC
2021-7075 10/19/2021 CSL Behring LLC
2021-7076 10/19/2021 FOI Services, Inc.
2021-7077 10/19/2021 Sadhukha, Tanmoy
2021-7078 10/19/2021 Sadhukha, Tanmoy

2021-7079 10/19/2021 CARESTREAM HEALTH INC
2021-7080 10/19/2021 eFoodAlert

2021-7081 10/19/2021 FOI Services, Inc.
MUSCULOSKELETAL
2021-7082 10/19/2021 TRANSPLANT FOUNDATION
2021-7083 10/19/2021 SIDLEY AUSTIN LLP
2021-7084 10/19/2021 FOI Services, Inc.
2021-7085 10/19/2021 FDAZILLA
2021-7086 10/19/2021 FDAZILLA
2021-7087 10/19/2021 FDAZILLA

2021-7088 10/19/2021 FDAZILLA
2021-7089 10/19/2021 FDAZILLA
2021-7090 10/19/2021 FDAZILLA
2021-7091 10/19/2021 FDAZILLA
2021-7092 10/19/2021 RAY THOMPSON
2021-7093 10/19/2021 RAY THOMPSON
2021-7094 10/19/2021 RAY THOMPSON
2021-7095 10/19/2021 Treace Medical Concepts, Inc.
2021-7096 10/19/2021 Bridge Regulatory Affairs, LLC
2021-7097 10/19/2021 eFoodAlert
2021-7098 10/19/2021 UNIVERSITY OF MARYLAND
2021-7099 10/19/2021 Meitheal Pharmaceuticals Inc

2021-7100 10/19/2021 LOEB & LOEB LLP
2021-7101 10/19/2021 Harrington Films
2021-7108 10/19/2021 Duty, Harry
2021-7109 10/19/2021 Duty, Harry
2021-7110 10/19/2021 Duty, Harry
2021-7111 10/19/2021 Duty, Harry
2021-7112 10/19/2021 Duty, Harry

2021-7113 10/19/2021 Melton, Donavan
2021-7114 10/19/2021 Sung Chun Kim, Esq.
2021-7115 10/19/2021 TROUTMAN PEPPER
2021-7116 10/19/2021 Sung Chun Kim, Esq.
2021-7117 10/19/2021 Sung Chun Kim, Esq.
2021-7118 10/19/2021 Sung Chun Kim, Esq.

2021-7119 10/19/2021 Registrar Corp
2021-7120 10/19/2021 Tenessa Jordan BSN RN
2021-7121 10/19/2021 Sung Chun Kim, Esq.
2021-7122 10/19/2021 Sung Chun Kim, Esq.
2021-7123 10/19/2021 Verde, Joshua
2021-7124 10/20/2021 NVE PHARMACEUTICALS INC

2021-7125 10/20/2021 Law LLP
2021-7126 10/20/2021 ALZHEIMER'S ASSOCIATION
2021-7127 10/20/2021 Blair-Jimenez, Dawn M
2021-7128 10/20/2021 Iron Triangle Partners
2021-7129 10/20/2021 CCHR International

2021-7130 10/20/2021 Blincoe, Brianna L
2021-7131 10/20/2021 Terris, Pravlik & Millian, LLP
2021-7132 10/20/2021 US RIGHT TO KNOW

Statera BioPharma (formerly
2021-7134 10/20/2021 Cytocom, Inc.)
2021-7135 10/20/2021 Jakob and Partners
2021-7136 10/20/2021 Kline & Company, Inc.

VenatoRx Pharmaceuticals,
2021-7138 10/20/2021 Inc.
Kissei Pharmaceutical Co.,

2021-7141 10/20/2021 Ltd.
2021-7143 10/20/2021 Valiant Capital

2021-7145 10/20/2021 USA THINK INC
2021-7147 10/21/2021 Wilkins, Jacob

2021-7148 10/21/2021 ET Now
2021-7149 10/21/2021 ET Now
2021-7150 10/21/2021 CATO SMS
2021-7151 10/21/2021 Law LLP
2021-7152 10/21/2021 STERIS CORP
2021-7153 10/21/2021 Trojan Law Offices
2021-7154 10/21/2021 Ricket, Ashley
BASKETBALL FUNDAMENTALS
2021-7155 10/21/2021 WITH M.E.
2021-7156 10/21/2021 Arnold, Brad
2021-7157 10/21/2021 Crain's New York Business
2021-7158 10/21/2021 FDAZILLA
2021-7159 10/21/2021 Crain's New York Business
Bernstein Litowitz Berger &

2021-7160 10/21/2021 Grossmann LLP
2021-7161 10/21/2021 FDAZILLA
2021-7162 10/21/2021 FDAZILLA

2021-7163 10/21/2021 FDAZILLA
2021-7164 10/21/2021 RAY THOMPSON
2021-7165 10/21/2021 RAY THOMPSON
2021-7166 10/21/2021 TROUTMAN PEPPER
2021-7167 10/21/2021 FOI Services, Inc.
2021-7168 10/21/2021 FOI Services, Inc.
2021-7169 10/21/2021 FOI Services, Inc.
2021-7170 10/21/2021 FOI Services, Inc.

2021-7171 10/21/2021 Alturix
2021-7172 10/21/2021 Mankind Pharma Ltd.
2021-7173 10/21/2021 JEWELL, WILLIAM A
2021-7174 10/21/2021 POINT72

LNPLV - Ligue Nationale pour

2021-7176 10/21/2021 la Liberte des Vaccinations
2021-7180 10/22/2021 Sheehan and Associates, P.C.
2021-7182 10/22/2021 Verrill Dana

2021-7184 10/22/2021 FOI Services, Inc.
2021-7185 10/22/2021 Albemarle Management LLC
2021-7186 10/22/2021 FOI Services, Inc.
2021-7187 10/22/2021 Registrar Corp
2021-7188 10/22/2021 Notter, Michael
Contract In-House Counsel

2021-7189 10/22/2021 and Consultants LLC
2021-7190 10/22/2021 E&E News
2021-7192 10/22/2021 CENTER FOR FOOD SAFETY
2021-7193 10/22/2021 Thixton, Susan
2021-7194 10/22/2021 Grassi, Krista

2021-7196 10/22/2021 Rose, Elizabeth M
510K TECHNOLOGY GROUP
2021-7197 10/25/2021 LLC
2021-7199 10/25/2021 Brozowski, Lawrence J
2021-7200 10/25/2021 Gibbons, Joe

2021-7201 10/25/2021 Brodkin, Jesse

2021-7202 10/25/2021 Research
2021-7203 10/25/2021 OREGON STATE UNIVERSITY
2021-7204 10/25/2021 OREGON STATE UNIVERSITY

2021-7205 10/25/2021 ET Now
2021-7206 10/25/2021 Amptron Medical
2021-7207 10/25/2021 Amptron Medical
2021-7208 10/25/2021 Posada Taddeo Dietiker

2021-7209 10/25/2021 INTERSURGICAL INC
Faegre Drinker Biddle &
2021-7210 10/25/2021 Reath LLP
2021-7211 10/25/2021 Dane Thompson
2021-7212 10/25/2021 BEVERIDGE & DIAMOND

2021-7213 10/25/2021 Reath LLP

2021-7215 10/25/2021 Adams Clinical
2021-7216 10/25/2021 Reath LLP
Centaur Pharmaceuticals Pvt.

2021-7217 10/25/2021 Ltd.
2021-7218 10/25/2021 FDAZILLA
2021-7219 10/25/2021 FDAZILLA
2021-7220 10/25/2021 FDAZILLA
2021-7221 10/25/2021 FDAZILLA
2021-7222 10/25/2021 FDAZILLA

2021-7223 10/25/2021 FDAZILLA
Ohio State University Moritz
2021-7224 10/25/2021 College of Law
2021-7225 10/25/2021 truthinadvertising.org
2021-7226 10/25/2021 Pomerantz, LLP
2021-7227 10/25/2021 Pomerantz, LLP
2021-7228 10/25/2021 Pomerantz, LLP

2021-7229 10/25/2021 Reath LLP
2021-7230 10/25/2021 University of Zurich
2021-7231 10/25/2021 KITE LAKE CAPITAL
2021-7234 10/26/2021 FDAZILLA

2021-7235 10/26/2021 FOI Services, Inc.
2021-7236 10/26/2021 FOI Services, Inc.
2021-7237 10/26/2021 FOI Services, Inc.
2021-7238 10/26/2021 FOI Services, Inc.
2021-7239 10/26/2021 FOI Services, Inc.
2021-7240 10/26/2021 FOI Services, Inc.
2021-7241 10/26/2021 FOI Services, Inc.
2021-7242 10/26/2021 FOI Services, Inc.

Circularity Plastics Advisory
2021-7244 10/26/2021 Services
2021-7245 10/26/2021 FDAZILLA
2021-7246 10/26/2021 FDAZILLA

2021-7247 10/26/2021 FDAZILLA
2021-7248 10/26/2021 FDAZILLA
2021-7249 10/26/2021 FDAZILLA

2021-7250 10/26/2021 FDAZILLA
2021-7251 10/26/2021 FOI Services, Inc.
2021-7252 10/26/2021 FOI Services, Inc.
2021-7253 10/26/2021 FOI Services, Inc.
2021-7254 10/26/2021 FOI Services, Inc.

2021-7255 10/26/2021 FDAZILLA
2021-7256 10/26/2021 FDAZILLA
2021-7257 10/26/2021 FDAZILLA
2021-7258 10/26/2021 FDAZILLA
2021-7259 10/26/2021 Nivagen Pharmaceuticals, Inc.
2021-7260 10/26/2021 Netherlands Cancer Institute

2021-7261 10/26/2021 SKG Pharma Inc.
2021-7262 10/26/2021 SKG Pharma Inc.
2021-7263 10/26/2021 SKG Pharma Inc.
2021-7264 10/26/2021 Airis Pharma Inc
2021-7265 10/26/2021 Dr. Reddys Laboratories
2021-7266 10/26/2021 Mark S. Godec, MD
2021-7267 10/26/2021 Mark S. Godec, MD

2021-7268 10/26/2021 SAS

2021-7269 10/26/2021 SAS

2021-7270 10/26/2021 SAS

2021-7271 10/26/2021 SAS
2021-7274 10/26/2021 Reuters News

2021-7275 10/26/2021 Duty, Harry
2021-7276 10/26/2021 Duty, Harry
2021-7277 10/26/2021 Duty, Harry
2021-7278 10/26/2021 Duty, Harry
2021-7279 10/26/2021 Duty, Harry
2021-7280 10/26/2021 Duty, Harry
2021-7281 10/26/2021 Duty, Harry

2021-7282 10/26/2021 Jonathan Alpern
LNPLV - Ligue Nationale pour

2021-7283 10/26/2021 la Liberte des Vaccinations
2021-7284 10/26/2021 Entwistle & Cappucci LLP
2021-7285 10/26/2021 ALSTON & BIRD LLP
2021-7286 10/26/2021 Veronica Toledo
2021-7287 10/26/2021 PilieroMazza

2021-7288 10/27/2021 SAS
2021-7289 10/27/2021 SAS
2021-7290 10/27/2021 SAS
2021-7291 10/27/2021 SAS
2021-7292 10/27/2021 SAS
2021-7293 10/27/2021 SAS
2021-7294 10/27/2021 SAS
2021-7295 10/27/2021 SAS
2021-7296 10/27/2021 SAS

2021-7297 10/27/2021 SAS

2021-7298 10/27/2021 SAS

2021-7299 10/27/2021 SAS

2021-7300 10/27/2021 SAS
2021-7301 10/27/2021 SAS

2021-7302 10/27/2021 SAS

2021-7303 10/27/2021 SAS

2021-7304 10/27/2021 SAS
2021-7305 10/27/2021 FOI Services, Inc.
2021-7306 10/27/2021 FOI Services, Inc.
2021-7307 10/27/2021 FOI Services, Inc.
2021-7308 10/27/2021 FOI Services, Inc.
2021-7309 10/27/2021 Airis Pharma Inc

2021-7310 10/27/2021 Airis Pharma Inc
2021-7311 10/27/2021 Airis Pharma Inc

2021-7313 10/27/2021 SAS

2021-7314 10/27/2021 SAS

2021-7315 10/27/2021 SAS
POINT72 ASSET
2021-7316 10/27/2021 MANAGEMENT LP
2021-7317 10/27/2021 Hydrite Chemical Co.
POINT72 ASSET
2021-7318 10/27/2021 MANAGEMENT LP
2021-7319 10/27/2021 Melton, Donavan
2021-7320 10/27/2021 Library

2021-7321 10/27/2021 Library
2021-7322 10/27/2021 Library

2021-7323 10/27/2021 SAS
2021-7324 10/27/2021 SAS

2021-7325 10/27/2021 SAS

2021-7326 10/27/2021 SAS
2021-7327 10/27/2021 Tiruvattar, Chandran
2021-7328 10/27/2021 MAGNETAR CAPITAL
2021-7329 10/27/2021 DELOITTE & TOUCHE
2021-7330 10/27/2021 Albatross

2021-7331 10/27/2021 JENNIFER CRANNEY
2021-7332 10/27/2021 Summit Therapeutics
2021-7333 10/27/2021 Wilkins, Jacob
2021-7334 10/27/2021 Weitz & Luxenberg, P.C.

2021-7335 10/27/2021 Douglas Brooks
Wake Forest School of
2021-7336 10/27/2021 Medicine
2021-7337 10/27/2021 DEACONESS HOSPITAL
2021-7338 10/27/2021 The Verge
Landman Corsi Ballaine &

2021-7339 10/27/2021 Ford, P.C.
2021-7340 10/28/2021 The USVA
2021-7341 10/28/2021 The USVA
2021-7342 10/28/2021 The USVA
2021-7343 10/28/2021 The USVA
2021-7344 10/28/2021 The USVA
2021-7345 10/28/2021 The USVA
2021-7346 10/28/2021 The USVA
2021-7347 10/28/2021 The USVA
2021-7348 10/28/2021 The USVA
2021-7349 10/28/2021 The USVA

2021-7350 10/28/2021 SAS

2021-7351 10/28/2021 SAS

2021-7352 10/28/2021 SAS

2021-7353 10/28/2021 SAS

2021-7354 10/28/2021 SAS

2021-7355 10/28/2021 SAS

2021-7356 10/28/2021 SAS

2021-7357 10/28/2021 SAS
2021-7358 10/28/2021 SAS

2021-7359 10/28/2021 SAS

2021-7360 10/28/2021 SAS

2021-7361 10/28/2021 SAS

2021-7362 10/28/2021 SAS

2021-7363 10/28/2021 SAS

2021-7364 10/28/2021 SAS

2021-7365 10/28/2021 SAS
2021-7366 10/28/2021 SAS

2021-7367 10/28/2021 SAS

2021-7368 10/28/2021 SAS

2021-7369 10/28/2021 SAS

2021-7370 10/28/2021 SAS
2021-7371 10/28/2021 Evans, Shasta
2021-7372 10/28/2021 Evans, Shasta
2021-7373 10/28/2021 Evans, Shasta
2021-7374 10/28/2021 Evans, Shasta
2021-7375 10/28/2021 Evans, Shasta
2021-7376 10/28/2021 Evans, Shasta
2021-7377 10/28/2021 Evans, Shasta

2021-7378 10/28/2021 Evans, Shasta
2021-7379 10/28/2021 Duty, Harry
2021-7380 10/28/2021 Duty, Harry
2021-7381 10/28/2021 Duty, Harry
2021-7382 10/28/2021 Evans, Shasta
2021-7383 10/28/2021 Duty, Harry
2021-7384 10/28/2021 Duty, Harry
2021-7385 10/28/2021 Duty, Harry
2021-7386 10/28/2021 PresPoint Capital
J.P. Morgan India Private

2021-7387 10/28/2021 Limited
2021-7388 10/28/2021 FDAZILLA
2021-7389 10/28/2021 Evans, Shasta

2021-7390 10/28/2021 Duty, Harry
2021-7391 10/29/2021 McVicker, Lauren
2021-7392 10/29/2021 CHICAGO SUN-TIMES
2021-7393 10/29/2021 FDAZILLA
2021-7394 10/29/2021 FDAZILLA
2021-7395 10/29/2021 FDAZILLA

2021-7396 10/29/2021 FUND
2021-7398 10/29/2021 federal package

2021-7400 10/29/2021 Innolitics, LLC
2021-7401 10/29/2021 DELOITTE & TOUCHE

2021-7402 10/29/2021 BASF SE
2021-7403 10/29/2021 MULLER BRAZIL LLP
2021-7404 11/01/2021 FOI Services, Inc.
2021-7405 11/01/2021 Puma Biotechnology, Inc.

2021-7406 11/01/2021 PROPHARMA GROUP
2021-7407 11/01/2021 Harrington Films LLC

2021-7411 11/01/2021 ExodusPoint
2021-7412 11/01/2021 Riley, Ashley
2021-7413 11/01/2021 Huey-Nazareno, Elmer
2021-7414 11/01/2021 Huey-Nazareno, Elmer

2021-7415 11/01/2021 SORGI, LEONARD S
2021-7416 11/01/2021 ExodusPoint

2021-7417 11/01/2021 Yuxuan Wang
2021-7418 11/01/2021 Duty, Harry
2021-7420 11/01/2021 FDAZILLA
2021-7421 11/01/2021 FDAZILLA
2021-7422 11/01/2021 FDAZILLA
2021-7423 11/01/2021 FDAZILLA
2021-7424 11/01/2021 FDAZILLA
2021-7425 11/01/2021 COGENCY GLOBAL, INC

2021-7427 11/01/2021 Germany

2021-7428 11/01/2021 Library
2021-7429 11/01/2021 Noah Smith

2021-7430 11/01/2021 Library
2021-7431 11/01/2021 eFoodAlert
2021-7433 11/01/2021 Penny, Esther E

2021-7434 11/01/2021 Jefferies LLC

2021-7435 11/01/2021 PC
2021-7436 11/01/2021 FOI Services, Inc.
2021-7437 11/01/2021 FOI Services, Inc.
2021-7438 11/01/2021 FOI Services, Inc.
2021-7439 11/01/2021 FOI Services, Inc.
2021-7440 11/01/2021 FOI Services, Inc.
2021-7441 11/01/2021 FOI Services, Inc.
2021-7442 11/01/2021 FOI Services, Inc.
2021-7443 11/01/2021 FOI Services, Inc.
2021-7444 11/01/2021 FOI Services, Inc.

2021-7445 11/01/2021 Dr Ajay Phadke
2021-7449 11/01/2021 Mills, Kerry
2021-7450 11/01/2021 Hasman, Zach
OREGON HEALTH & SCIENCE

2021-7451 11/01/2021 UNIV
2021-7453 11/01/2021 PresPoint Capital
2021-7454 11/01/2021 FOI Services, Inc.
2021-7455 11/01/2021 FOI Services, Inc.
2021-7456 11/01/2021 FOI Services, Inc.

2021-7457 11/01/2021 FOI Services, Inc.
2021-7458 11/01/2021 FDAZILLA
2021-7460 11/01/2021 FDAZILLA
2021-7461 11/01/2021 FDAZILLA
2021-7462 11/01/2021 FDAZILLA
2021-7463 11/01/2021 FDAZILLA

2021-7464 11/01/2021 FDAZILLA
2021-7466 11/01/2021 BLOOMBERG NEWS
2021-7467 11/01/2021 Mark S. Godec, MD
2021-7468 11/01/2021 Mark S. Godec, MD
2021-7469 11/01/2021 Mark S. Godec, MD
2021-7470 11/01/2021 Mark S. Godec, MD
2021-7471 11/01/2021 FDAZILLA

2021-7472 11/01/2021 FDAZILLA
2021-7473 11/01/2021 FDAZILLA
2021-7474 11/01/2021 FDAZILLA
2021-7475 11/01/2021 FDAZILLA
2021-7476 11/02/2021 FOI Services, Inc.
2021-7477 11/02/2021 FOI Services, Inc.
2021-7478 11/02/2021 FOI Services, Inc.

2021-7479 11/02/2021 FOI Services, Inc.
2021-7480 11/02/2021 FOI Services, Inc.

2021-7481 11/02/2021 SAS

2021-7482 11/02/2021 SAS

2021-7483 11/02/2021 SAS
2021-7484 11/02/2021 PROPHARMA GROUP
2021-7485 11/02/2021 Sumbra, LLC
2021-7486 11/02/2021 ExodusPoint Capital

2021-7487 11/02/2021 FOIA GROUP INC
2021-7488 11/02/2021 DECHERT LLP
Natural Products
INSIDER/Informa Exhibitions
2021-7489 11/02/2021 LLC
Natural Products
2021-7490 11/02/2021 LLC
Natural Products
2021-7491 11/02/2021 LLC
Robbins Geller Rudman &
2021-7492 11/02/2021 Dowd LLP - Mary Blasy
2021-7493 11/02/2021 Savit, Aaron
Nomura Financial Advisory &

Securities (India) Private
2021-7495 11/02/2021 Limited

2021-7496 11/02/2021 Dowd LLP
2021-7497 11/02/2021 Hallowitz, Marilyn
2021-7498 11/02/2021 Orchid Orthopedic Solutions
Citigroup Global Markets

2021-7499 11/02/2021 India Private Limited
BALYASNY ASSET
2021-7500 11/02/2021 MANAGEMENT
2021-7501 11/02/2021 FDAZILLA

2021-7502 11/02/2021 none
2021-7503 11/02/2021 Cameron Oakes (freelance)
HSBC Securities and Capital

2021-7505 11/02/2021 Markets India Private Limited
2021-7506 11/02/2021 Riverence Provisions LLC

Landman Corsi Ballaine &
2021-7508 11/02/2021 Ford, P.C.
2021-7509 11/02/2021 Elara Capital
MEDTRONIC SOFAMOR
2021-7510 11/02/2021 DANEK
MEDTRONIC SOFAMOR
2021-7511 11/02/2021 DANEK
2021-7512 11/02/2021 Research Delta Advisors
Child Welfare League of

America/ Johns Hopkins
2021-7513 11/02/2021 University
2021-7514 11/02/2021 Barrett, Kate

2021-7515 11/02/2021 Victoria Scales
2021-7516 11/02/2021 Anderson, Derry
2021-7517 11/02/2021 MIC International Corp.
2021-7518 11/02/2021 El, Taqi
2021-7519 11/02/2021 SAMUELS, ADRIENNE

2021-7521 11/02/2021 KU Leuven
Orbicular Pharmaceutical
2021-7522 11/02/2021 Technologies Private Limited
2021-7523 11/03/2021 FDAZILLA

2021-7524 11/03/2021 Sirtex Medical Ltd.
2021-7525 11/03/2021 Sirtex Medical Ltd.
2021-7526 11/03/2021 FOI Services, Inc.

2021-7527 11/03/2021 FOI Services, Inc.
2021-7528 11/03/2021 FDAZILLA

2021-7529 11/03/2021 RAY THOMPSON
2021-7530 11/03/2021 Hogan Lovells

AceOne RS (formerly
2021-7531 11/03/2021 NutraSource, Inc)
2021-7532 11/03/2021 FDAZILLA
2021-7533 11/03/2021 FDAZILLA

Quanta Dialysis technologies
2021-7534 11/03/2021 Limited
2021-7535 11/03/2021 FDAZILLA

2021-7536 11/03/2021 Limited
2021-7537 11/03/2021 Germany
2021-7538 11/03/2021 ANDERSON, PAUL S
2021-7539 11/03/2021 History Associates, INC

2021-7543 11/03/2021 Duty, Harry

2021-7546 11/03/2021 Latrycia Bock
2021-7547 11/03/2021 Registrar Corp
Kleinfeld Kaplan and Becker

2021-7548 11/03/2021 LLP
2021-7550 11/03/2021 Relish Labs DBA Home Chef

2021-7551 11/03/2021 Registrar Corp
2021-7552 11/03/2021 Hogan Lovells

2021-7553 11/03/2021 Limited
2021-7555 11/03/2021 RAY THOMPSON

Joseph M. Still Research
2021-7557 11/03/2021 Foundation, Inc.
2021-7558 11/03/2021 MICHIGAN STATE UNIVERSITY

2021-7560 11/03/2021 McGavock, Darnell
2021-7561 11/03/2021 Woodknotconsulting

ORASURE TECHNOLOGIES,
2021-7562 11/03/2021 INC.
2021-7563 11/03/2021 HIKMA PHARMACEUTICALS

2021-7567 11/03/2021 SamanTree Medical SA

2021-7568 11/03/2021 ET Now
2021-7569 11/03/2021 Woodknotconsulting
2021-7570 11/04/2021 FOI Services, Inc.
2021-7571 11/04/2021 Virbac AH Inc.
2021-7572 11/04/2021 Foreveryoung Technology
2021-7573 11/04/2021 Morgan Law Firm, Ltd.
2021-7574 11/04/2021 Stoll, Daniel W

2021-7575 11/04/2021 JH Miles and Associates
2021-7576 11/04/2021 FOI Services, Inc.
2021-7577 11/04/2021 CSL Behring LLC
2021-7578 11/04/2021 CSL Behring LLC

2021-7579 11/04/2021 Weitz & Luxenberg, P.C.
2021-7580 11/04/2021 DAMON ELLIOTT 31034-037

2021-7581 11/04/2021 DONTZIN NAGY & FLEISSIG
2021-7582 11/04/2021 Mark S. Godec, MD
Waterstone Pharmaceuticals
2021-7583 11/04/2021 (Hubei) Co., Ltd.
2021-7584 11/04/2021 Medytox Inc.
Physicians Committee for

2021-7585 11/04/2021 Responsible Medicine (PCRM)
2021-7586 11/04/2021 Berman North LLP
2021-7587 11/04/2021 Kodiak Sciences Inc
2021-7588 11/04/2021 Axar Laboratories Inc
2021-7589 11/04/2021 Walker, Joseph
2021-7590 11/04/2021 Bowen Shi
2021-7591 11/04/2021 White Coat Waste Project
2021-7592 11/05/2021 FOI Services, Inc.
2021-7593 11/05/2021 FDAZILLA

2021-7594 11/05/2021 FOI Services, Inc.
2021-7595 11/05/2021 FDAZILLA
2021-7596 11/05/2021 FDAZILLA
2021-7597 11/05/2021 FDAZILLA
2021-7598 11/05/2021 FDAZILLA
2021-7599 11/05/2021 FDAZILLA
2021-7600 11/05/2021 Cropper, Neal
2021-7601 11/05/2021 Melton, Donavan

Ricardo Gonzalez Customs
2021-7602 11/05/2021 Broker LLC
2021-7603 11/05/2021 The Epoch Times
2021-7604 11/05/2021 Koepke, Christine
2021-7605 11/05/2021 ANDREW KENT

2021-7606 11/05/2021 BOSTON COLLEGE
2021-7607 11/05/2021 ALSTON & BIRD LLP
2021-7608 11/05/2021 Jana Antic

2021-7609 11/05/2021 Pharmalogic

2021-7611 11/05/2021 Janssen
2021-7612 11/05/2021 Sarah Chia
2021-7613 11/05/2021 Medytox Inc.

2021-7614 11/05/2021 LIPOCINE INC
2021-7615 11/05/2021 BOSTON COLLEGE
2021-7616 11/05/2021 USC
2021-7617 11/05/2021 FOI Services, Inc.

2021-7618 11/05/2021 ALLIE JOHNSTON
2021-7619 11/05/2021 Rigrodsky Law, P.A.

2021-7620 11/05/2021 PROJECT INC
2021-7621 11/05/2021 Sleater, Jessica
2021-7622 11/05/2021 PROPUBLICA

2021-7624 11/08/2021 FOI Services, Inc.
2021-7625 11/08/2021 FOI Services, Inc.
2021-7626 11/08/2021 FOI Services, Inc.
2021-7627 11/08/2021 VEIN360
2021-7628 11/08/2021 VEIN360
2021-7629 11/08/2021 VEIN360
2021-7630 11/08/2021 VEIN360
2021-7631 11/08/2021 FOI Services, Inc.
2021-7632 11/08/2021 FOI Services, Inc.
2021-7633 11/08/2021 FOI Services, Inc.
2021-7634 11/08/2021 FOI Services, Inc.

2021-7635 11/08/2021 FOI Services, Inc.
2021-7636 11/08/2021 FOI Services, Inc.
2021-7637 11/08/2021 FOI Services, Inc.

2021-7639 11/08/2021 FOI Services, Inc.
2021-7640 11/08/2021 FOI Services, Inc.
2021-7641 11/08/2021 FOI Services, Inc.
2021-7642 11/08/2021 FOI Services, Inc.

2021-7643 11/08/2021 FOI Services, Inc.
2021-7644 11/08/2021 FOI Services, Inc.
2021-7645 11/08/2021 FOI Services, Inc.
2021-7646 11/08/2021 FOI Services, Inc.
2021-7647 11/08/2021 FOI Services, Inc.
2021-7650 11/08/2021 Kreindler & Kreindler LLP
2021-7651 11/08/2021 America's Frontline Doctors

2021-7653 11/08/2021 Barry Bennett
2021-7654 11/08/2021 Intercon Chemical Company

2021-7655 11/08/2021 Lamarco, Christian
2021-7656 11/08/2021 Raymond Robinson

2021-7657 11/08/2021 Williams-Beyer, Beth
2021-7658 11/08/2021 LIBERTY MUTUAL
2021-7660 11/08/2021 Armada Nutrition
2021-7661 11/08/2021 American Regent, Inc.
IOVATE HEALTH SCIENCES

2021-7662 11/08/2021 INTERNATIONAL INC
2021-7663 11/08/2021 RAI Services Company
2021-7665 11/08/2021 Greenberg Traurig, LLP
2021-7666 11/08/2021 silverstein, lori

2021-7668 11/08/2021 Antique Stock Broking
2021-7669 11/08/2021 Nsite INC
2021-7670 11/08/2021 Abzymo Biosciences Co., Ltd
2021-7671 11/08/2021 The USVA
2021-7672 11/08/2021 The USVA
2021-7673 11/08/2021 The USVA
2021-7674 11/08/2021 The USVA
2021-7675 11/08/2021 The USVA
2021-7677 11/08/2021 FDAZILLA
2021-7678 11/08/2021 FDAZILLA

2021-7679 11/08/2021 FDAZILLA
2021-7680 11/08/2021 FDAZILLA
2021-7681 11/08/2021 FDAZILLA

2021-7682 11/08/2021 FDAZILLA
2021-7683 11/08/2021 FDAZILLA
2021-7684 11/08/2021 FDAZILLA
2021-7685 11/08/2021 FDAZILLA
2021-7686 11/08/2021 FDAZILLA
2021-7687 11/08/2021 INTERTEK
POINT72 ASSET
2021-7689 11/08/2021 MANAGEMENT LP
2021-7690 11/08/2021 Bradfield, Emily M
2021-7691 11/09/2021 FOI Services, Inc.
2021-7692 11/09/2021 FOI Services, Inc.

2021-7693 11/09/2021 FOI Services, Inc.
2021-7694 11/09/2021 The Daily Poster
2021-7695 11/09/2021 Haugabrooks, Esther

2021-7696 11/09/2021 ALGOMEDICA
Penn Neuroscience Center ,

Hospital of the University of
2021-7698 11/09/2021 Pennsylvania
2021-7700 11/09/2021 PROPUBLICA
2021-7701 11/09/2021 446 AMXS USAF
2021-7702 11/09/2021 Collins, Stephen

2021-7703 11/09/2021 Speid & Associates, Inc.
2021-7704 11/09/2021 Sprouts Farmers Market
2021-7705 11/09/2021 Notter, Michael
Kara Hadican Samuels &

2021-7706 11/09/2021 Assoc LLC
2021-7707 11/09/2021 Registrar Corp
2021-7708 11/09/2021 Registrar Corp
2021-7709 11/09/2021 Registrar Corp
2021-7710 11/09/2021 Whittingham, Claire

2021-7711 11/09/2021 Siokas, Dean
2021-7712 11/09/2021 Schuber, Paul
2021-7713 11/10/2021 EW Scripps Television

2021-7714 11/10/2021 Constellis, LLC
2021-7715 11/10/2021 FDAZILLA
2021-7716 11/10/2021 FDAZILLA
2021-7717 11/10/2021 FDAZILLA
2021-7718 11/10/2021 FDAZILLA
2021-7719 11/10/2021 FDAZILLA

2021-7720 11/10/2021 FDAZILLA
2021-7721 11/10/2021 FDAZILLA
2021-7722 11/10/2021 KTMC, LLP
2021-7723 11/10/2021 RBC CAPITAL MARKETS
2021-7724 11/10/2021 Sylvia Erickson Consulting

2021-7725 11/10/2021 ADOCIA
2021-7726 11/10/2021 Dr Ajay Phadke
Dentons US LLP counsel for

2021-7727 11/10/2021 Avante Health Solutions
2021-7728 11/10/2021 DeBeer, John
2021-7729 11/10/2021 Dowd LLP
2021-7730 11/10/2021 Stinson LLP
University of Vermont
Tobacco Center on Regulatory
2021-7731 11/10/2021 Science
2021-7732 11/10/2021 Science
2021-7733 11/10/2021 Systematix Shares and Stocks
2021-7734 11/10/2021 TAP Pharmaceuticals AG

2021-7735 11/10/2021 SSA
2021-7736 11/12/2021 Johnson, Heidi
2021-7737 11/12/2021 Duty, Harry

2021-7738 11/12/2021 Duty, Harry

The Law Offices of Donald
2021-7740 11/12/2021 Hudspeth
2021-7741 11/12/2021 Handelsbanken
2021-7742 11/12/2021 Michael Burke
2021-7743 11/12/2021 Santen Incorporated
Vanguard Regulatory
2021-7744 11/12/2021 Services, Inc.
2021-7745 11/12/2021 DUKE UNIVERSITY
Wilson Sonsini Goodrich &
2021-7746 11/12/2021 Rosati
2021-7747 11/12/2021 HOLLAND & HART LLP
2021-7748 11/12/2021 BioCryst Pharmaceuticals, Inc.
2021-7749 11/12/2021 Medline Industries, LP
2021-7750 11/12/2021 Primus Pharmaceuticals, Inc
2021-7751 11/12/2021 Capstone Nutrition, LLC
2021-7752 11/12/2021 Athenex, Inc.
2021-7753 11/12/2021 FOI Services, Inc.
2021-7754 11/12/2021 Clarivate Analytics
2021-7755 11/12/2021 EXPONENT

2021-7756 11/12/2021 THE WALL STREET JOURNAL
2021-7757 11/12/2021 Wiley LLP
2021-7758 11/12/2021 Wiley LLP

2021-7759 11/12/2021 AiPing Pharmaceutical, Inc.
2021-7760 11/12/2021 Savit, Aaron
2021-7761 11/12/2021 Sha'Tina Alridge
2021-7762 11/12/2021 Savit, Aaron
Axinn, Veltrop & Harkrider

2021-7763 11/12/2021 LLP
2021-7764 11/12/2021 MG + M
2021-7765 11/12/2021 ENVISAGE CONSULTING LLC

Center for Regulatory
2021-7766 11/12/2021 Services, Inc,
2021-7767 11/12/2021 FDA NEWS
2021-7768 11/12/2021 FDA NEWS
2021-7769 11/12/2021 FDA NEWS
2021-7770 11/12/2021 FDA NEWS
2021-7771 11/12/2021 FDA NEWS
2021-7772 11/12/2021 FOI Services, Inc.

2021-7773 11/12/2021 FOI Services, Inc.
2021-7774 11/12/2021 FOI Services, Inc.
2021-7775 11/12/2021 FOI Services, Inc.
2021-7776 11/12/2021 FOI Services, Inc.
2021-7777 11/12/2021 FOI Services, Inc.
2021-7778 11/12/2021 FOI Services, Inc.
2021-7779 11/12/2021 BLOOMBERG NEWS
2021-7780 11/12/2021 BLOOMBERG NEWS
2021-7781 11/12/2021 AMGEN
2021-7784 11/12/2021 Heron Therapeutics, Inc.
2021-7785 11/12/2021 Potrero Medical, Inc.

2021-7786 11/12/2021 Kim Wigglesworth
2021-7787 11/12/2021 FOI Services, Inc.
2021-7789 11/12/2021 FOI Services, Inc.
2021-7790 11/12/2021 FOI Services, Inc.

2021-7791 11/12/2021 FOI Services, Inc.
2021-7792 11/12/2021 FOI Services, Inc.
2021-7794 11/12/2021 FDAZILLA
2021-7795 11/12/2021 FOI Services, Inc.
2021-7796 11/12/2021 FOI Services, Inc.
2021-7797 11/12/2021 FOI Services, Inc.
2021-7798 11/12/2021 FOI Services, Inc.

2021-7799 11/12/2021 FOI Services, Inc.
2021-7800 11/12/2021 FOI Services, Inc.
2021-7801 11/12/2021 FDAZILLA

2021-7802 11/12/2021 ROPES AND GRAY
2021-7803 11/12/2021 MICHAEL MARUCA
2021-7804 11/15/2021 FOI Services, Inc.
2021-7805 11/15/2021 FOI Services, Inc.
2021-7806 11/15/2021 FOI Services, Inc.
2021-7807 11/15/2021 FDAZILLA
2021-7808 11/15/2021 FDAZILLA

2021-7809 11/15/2021 FDAZILLA
2021-7810 11/15/2021 Duty, Harry
2021-7811 11/15/2021 Jones, Andy
2021-7812 11/15/2021 Pistevo Law LLC
2021-7813 11/15/2021 ENVISAGE CONSULTING LLC

Total Resources International,
2021-7814 11/15/2021 Inc.
2021-7815 11/15/2021 ABC NEWS
2021-7816 11/15/2021 CNN

2021-7817 11/15/2021 Thomas Hodges
2021-7818 11/15/2021 LOUIS R. GIGLIOTTI, PA
2021-7819 11/15/2021 Lori A. Carr, Inc.
2021-7820 11/15/2021 Lori A. Carr, Inc.
2021-7822 11/15/2021 Colombina S.A
2021-7823 11/15/2021 Kerry Inc. /Kerry ingredients


2021-7826 11/15/2021 Daniel Lapen
2021-7827 11/15/2021 Marcela Braun
2021-7828 11/15/2021 Civica, Inc.

2021-7830 11/15/2021 Kaiser Health News
2021-7834 11/15/2021 USA TODAY
Mintzer Sarowitz Zeris Ledva

2021-7835 11/15/2021 & Meyers
2021-7836 11/15/2021 LUTHER, RYAN
2021-7837 11/15/2021 Latrycia R. Bock
Arizona Nutritional
2021-7838 11/15/2021 Supplements LLC
Sovle Consulting International
2021-7839 11/15/2021 Pty Ltd
Solve Consulting International
2021-7840 11/15/2021 Pty Ltd
2021-7841 11/15/2021 Pty Ltd
2021-7842 11/15/2021 Pty Ltd
2021-7843 11/15/2021 Pty Ltd
2021-7844 11/15/2021 Pty Ltd
2021-7845 11/15/2021 Pty Ltd
2021-7846 11/15/2021 Pty Ltd
2021-7847 11/15/2021 Pty Ltd
UNIVERSITY OF MINNESOTA,
2021-7848 11/15/2021 TWIN CITIES CAMPUS
2021-7849 11/15/2021 Matthew Zagorski
2021-7850 11/15/2021 Bengston, Amanda
2021-7851 11/15/2021 UNIVERSITY OF MISSISSIPPI

2021-7852 11/15/2021 FDAZILLA
2021-7853 11/15/2021 FDAZILLA
2021-7854 11/15/2021 FDAZILLA
2021-7855 11/15/2021 FDAZILLA
2021-7856 11/16/2021 FOI Services, Inc.
2021-7857 11/16/2021 FDA NEWS
2021-7858 11/16/2021 SSA
2021-7859 11/16/2021 SSA
2021-7860 11/16/2021 FDAZILLA
2021-7861 11/16/2021 FDAZILLA
2021-7862 11/16/2021 FDAZILLA
2021-7863 11/16/2021 FDAZILLA
2021-7864 11/16/2021 FDAZILLA
2021-7865 11/16/2021 FDAZILLA
2021-7866 11/16/2021 Sheba Medical center
2021-7867 11/16/2021 Pistevo Law LLC

2021-7868 11/16/2021 N/A
2021-7869 11/16/2021 United Health Products Inc

2021-7871 11/16/2021 Ricket Law Firm, LLC
2021-7872 11/16/2021 Sharp Law, LLP
2021-7873 11/16/2021 Judicial Watch, Inc.

CALIFORNIA DEPARTMENT OF
2021-7875 11/16/2021 FOOD AND AGRICULTURE
2021-7877 11/16/2021 TELEFLEX MEDICAL
2021-7878 11/16/2021 WINDER LABORATORIES LLC

2021-7879 11/16/2021 Sparrow Acoustics
2021-7880 11/16/2021 Calyxt, Inc.
Kono Sseisakusho Company
2021-7881 11/16/2021 Limited
2021-7882 11/16/2021 Limited
2021-7883 11/16/2021 Sung Chun Kim, Esq.

2021-7884 11/16/2021 Amy Li

2021-7885 11/16/2021 P.C.
2021-7886 11/16/2021 Hyman, Phelps, & McNamara

2021-7887 11/16/2021 Limited
2021-7888 11/16/2021 Limited
2021-7889 11/16/2021 Vega, Jeannie
2021-7890 11/16/2021 Psymposia
2021-7891 11/16/2021 Psymposia
2021-7892 11/16/2021 REED SMITH LLP
2021-7893 11/16/2021 N/A
2021-7894 11/16/2021 N/A

2021-7895 11/17/2021 FOI Services, Inc.
2021-7896 11/17/2021 PBM Capital Group, LLC

2021-7897 11/17/2021 FOI Services, Inc.
2021-7898 11/17/2021 PCCA
2021-7899 11/17/2021 HILL DERMACEUTICALS, INC
2021-7900 11/17/2021 SAGE QUALITY SERVICES
2021-7902 11/17/2021 Lyra Therapeutics
2021-7904 11/17/2021 WINDER LABORATORIES LLC
2021-7905 11/17/2021 The Horton Fruit Co., Inc.
2021-7907 11/17/2021 FOI Services, Inc.
2021-7908 11/17/2021 FDAZILLA

2021-7909 11/17/2021 FDAZILLA
2021-7910 11/17/2021 FDAZILLA
2021-7911 11/17/2021 FDAZILLA
2021-7912 11/17/2021 FDAZILLA
TARO PHARMACEUTICALS
2021-7913 11/17/2021 U.S.A., INC
2021-7914 11/17/2021 U.S.A., INC
2021-7915 11/17/2021 U.S.A., INC

MILLENNIUM MANAGEMENT
2021-7917 11/17/2021 LLC
2021-7918 11/17/2021 PROPUBLICA
2021-7919 11/17/2021 PROPUBLICA
2021-7920 11/17/2021 Psymposia
2021-7921 11/17/2021 Psymposia
2021-7922 11/17/2021 Psymposia
2021-7923 11/17/2021 Psymposia
2021-7924 11/17/2021 Psymposia

2021-7925 11/17/2021 Wirtes, Michael S
2021-7926 11/17/2021 Dwork, Jeremy
2021-7927 11/17/2021 PROPHARMA GROUP
2021-7928 11/17/2021 PROPHARMA GROUP
2021-7929 11/17/2021 Amin Talati Wasserman, LLP

2021-7930 11/17/2021 TERESA O'BRIEN
2021-7931 11/17/2021 HOGAN LOVELLS US LLP
2021-7932 11/17/2021 FDA NEWS
2021-7933 11/17/2021 FDA NEWS
2021-7934 11/17/2021 FDA NEWS
2021-7935 11/17/2021 FDA NEWS
2021-7936 11/17/2021 Education for All
2021-7938 11/18/2021 FOI Services, Inc.
2021-7939 11/18/2021 FOI Services, Inc.
2021-7940 11/18/2021 FOI Services, Inc.

2021-7941 11/18/2021 FOI Services, Inc.
2021-7942 11/18/2021 FOI Services, Inc.
2021-7943 11/18/2021 FOI Services, Inc.
2021-7944 11/18/2021 FOI Services, Inc.
2021-7945 11/18/2021 FOI Services, Inc.

2021-7946 11/18/2021 FOI Services, Inc.
2021-7947 11/18/2021 FOI Services, Inc.
2021-7949 11/18/2021 FOI Services, Inc.
2021-7950 11/18/2021 FOI Services, Inc.

Collaborative Care
2021-7951 11/18/2021 Diagnostics
2021-7952 11/18/2021 FOI Services, Inc.

2021-7953 11/18/2021 Inc.
2021-7954 11/18/2021 FOI Services, Inc.
2021-7955 11/18/2021 Sullivan, Holly
2021-7956 11/18/2021 Dustin Block
2021-7957 11/18/2021 MACHEREY-NAGEL
2021-7958 11/18/2021 MACHEREY-NAGEL
2021-7959 11/18/2021 MCGUIREWOODS LLP
2021-7960 11/18/2021 Alex jensen
2021-7961 11/18/2021 Barnett Law Office LLC
2021-7962 11/18/2021 John Sharpe

2021-7963 11/18/2021 PROPUBLICA
2021-7964 11/18/2021 PROPUBLICA

2021-7965 11/18/2021 Genentech
2021-7966 11/18/2021 Davidson, Brandon
2021-7967 11/18/2021 Analysis Group, Inc.
2021-7969 11/18/2021 NICHOLAS & TOMASEVIC LLP
2021-7970 11/18/2021 LIFE EXTENSION

2021-7971 11/18/2021 Rethink Priorities
2021-7972 11/19/2021 FDAZILLA
2021-7973 11/19/2021 FDAZILLA
2021-7974 11/19/2021 FDAZILLA
2021-7975 11/19/2021 FDAZILLA
2021-7976 11/19/2021 FDAZILLA
2021-7977 11/19/2021 FDAZILLA
2021-7978 11/19/2021 FDAZILLA

2021-7979 11/19/2021 FDAZILLA
2021-7980 11/19/2021 FDAZILLA
2021-7981 11/19/2021 Inc., USA
2021-7983 11/19/2021 Sweet Harvest Foods

2021-7984 11/19/2021 PROPHARMA GROUP
2021-7985 11/19/2021 Ferring Pharmaceuticals Inc.
2021-7986 11/19/2021 Rouviere, Jodi

2021-7987 11/19/2021 Anika Therapeutics, Inc.
2021-7988 11/19/2021 TELEFLEX MEDICAL
2021-7989 11/19/2021 BLOOMBERG NEWS
2021-7990 11/19/2021 Business Insider
2021-7991 11/19/2021 Serious Injury Law Group

2021-7992 11/19/2021 Dowd LLP
2021-7993 11/19/2021 Inka Crops S.A.

2021-7994 11/19/2021 Gonzalez, Cecilia
2021-7995 11/19/2021 Bentley InnoMed GmbH
2021-7996 11/19/2021 FDAZILLA
2021-7997 11/19/2021 FDAZILLA
2021-7998 11/19/2021 FDAZILLA
2021-7999 11/22/2021 Sievers, David
2021-8000 11/22/2021 John Sharpe
2021-8001 11/22/2021 John Sharpe
2021-8002 11/22/2021 John Sharpe

2021-8003 11/22/2021 FDA NEWS
2021-8004 11/22/2021 FDA NEWS
2021-8005 11/22/2021 FDA NEWS
2021-8006 11/22/2021 FDA NEWS
2021-8007 11/22/2021 FDA NEWS
2021-8008 11/22/2021 FDA NEWS
2021-8009 11/22/2021 FDA NEWS
2021-8010 11/22/2021 FDA NEWS
2021-8011 11/22/2021 FDA NEWS
2021-8012 11/22/2021 FOI Services, Inc.
2021-8013 11/22/2021 FDAZILLA
2021-8014 11/22/2021 FDAZILLA
2021-8015 11/22/2021 Pearce Legal Services
2021-8016 11/22/2021 THOMSON REUTERS
2021-8017 11/22/2021 eFoodAlert
2021-8018 11/22/2021 eFoodAlert
2021-8019 11/22/2021 eFoodAlert
2021-8020 11/22/2021 Caines, Charles

2021-8021 11/22/2021 Morgan, Lewis & Bockius LLP
2021-8022 11/22/2021 SKG Pharma Inc.

2021-8023 11/22/2021 Airis Pharma Inc
2021-8024 11/22/2021 Airis Pharma Inc
2021-8025 11/22/2021 Airis Pharma Inc
2021-8026 11/22/2021 Airis Pharma Inc
2021-8027 11/22/2021 eFoodAlert
Kico Knee Innovation

2021-8028 11/22/2021 Company
2021-8029 11/22/2021 Dr. Reddys Laboratories

2021-8031 11/22/2021 Medela LLC

2021-8032 11/22/2021 Bittium Biosignals Ltd.
2021-8033 11/22/2021 FDAZILLA
2021-8034 11/22/2021 Jegge, Jason

2021-8036 11/22/2021 mctlaw
2021-8037 11/22/2021 FDAZILLA
2021-8038 11/22/2021 FDAZILLA
2021-8039 11/22/2021 FDAZILLA
2021-8040 11/22/2021 FDAZILLA
2021-8041 11/22/2021 CUB FOODS
2021-8042 11/22/2021 KEYS, CLAY C
2021-8043 11/23/2021 FDAZILLA
2021-8044 11/23/2021 FDAZILLA
2021-8045 11/23/2021 FOI Services, Inc.
2021-8046 11/23/2021 FOI Services, Inc.

2021-8047 11/23/2021 SAS
2021-8048 11/23/2021 FDA NEWS
2021-8049 11/23/2021 FDA NEWS
2021-8050 11/23/2021 FDA NEWS
2021-8051 11/23/2021 FDA NEWS
2021-8052 11/23/2021 FDA NEWS
2021-8053 11/23/2021 FDA NEWS
2021-8054 11/23/2021 FDA NEWS
2021-8055 11/23/2021 FDA NEWS
2021-8056 11/23/2021 FDA NEWS
2021-8057 11/23/2021 FDA NEWS
2021-8058 11/23/2021 FOI Services, Inc.

2021-8059 11/23/2021 Novartis Pharmaceuticals
2021-8060 11/23/2021 Favus Institutional Research
2021-8066 11/23/2021 FDAZILLA
2021-8067 11/23/2021 FDAZILLA
2021-8068 11/23/2021 FDAZILLA
2021-8069 11/23/2021 Steptoe and Johnson LLP
2021-8070 11/23/2021 Acella Pharmaceuticals

2021-8073 11/23/2021 Elugen Pharmaceuticals
2021-8074 11/23/2021 Eagle Pharmaceuticals, Inc.
2021-8075 11/23/2021 Tower Laboratories Ltd
2021-8076 11/23/2021 Tower Laboratories Ltd

2021-8077 11/23/2021 Eskenazi, Daniel
2021-8078 11/23/2021 Bristows LLP
2021-8079 11/23/2021 Burt Barr & Associates, LLP
2021-8080 11/23/2021 Burt Barr & Associates, LLP
2021-8081 11/23/2021 Carnes, Kimberly A
2021-8082 11/23/2021 Amabile & Erman, P.C.
2021-8083 11/23/2021 Walker, Joseph

EASTERN MICHIGAN
2021-8084 11/23/2021 UNIVERSITY
Physicians for Informed

2021-8085 11/23/2021 Consent
2021-8086 11/23/2021 Tatiana Walk-Morris
Clark-Esposito Law Firm, P.C.,

on behalf of Axiocore
2021-8088 11/23/2021 Corporation
2021-8089 11/23/2021 Gibson, Dunn & Crutcher LLP

2021-8090 11/23/2021 Copeland, Missy
University of Texas
Southwestern Medical
2021-8091 11/23/2021 Center--Kellyn Pollard
2021-8092 11/23/2021 Jegge, Jason
2021-8093 11/23/2021 Rouviere, Jodi

Levin Papantonio Rafferty et
2021-8094 11/23/2021 al
2021-8095 11/23/2021 ROPES & GRAY

2021-8096 11/24/2021 FOX ROTHSCHILD LLP
2021-8097 11/24/2021 FOI Services, Inc.
2021-8098 11/24/2021 FOI Services, Inc.
Conservas y Congelados ¡Ya

2021-8099 11/24/2021 Está!
2021-8100 11/24/2021 CSL Behring LLC

LANDMAN CORSI BALLAINE &
2021-8101 11/24/2021 FORD PC
2021-8102 11/24/2021 SmartHealth, Inc.
2021-8103 11/24/2021 Mandes LLC
2021-8105 11/24/2021 Helmick, Diane C

2021-8106 11/24/2021 Dowd LLP
2021-8107 11/24/2021 Lupin Pharmaceuticals, Inc.

2021-8108 11/24/2021 On Point Investigations, LLC
2021-8109 11/24/2021 Montana Board of Dentistry
Shenzhen Imdk Medical

2021-8110 11/24/2021 Technology Co., Ltd.
2021-8111 11/24/2021 Advokatfirman Cederquist KB
2021-8112 11/24/2021 Vici Health Sciences

Rubicon Research Private
2021-8113 11/24/2021 Limited, INC. Research
2021-8114 11/26/2021 MVE Biological Solutions

2021-8115 11/26/2021 P.C.
2021-8116 11/26/2021 Teikoku Pharma USA, Inc.

Hyman, Phelps and
2021-8117 11/26/2021 McNamara P.C.

2021-8119 11/26/2021 Gabriel López
LANDMAN CORSI BALLAINE &
2021-8120 11/26/2021 FORD PC
2021-8121 11/26/2021 Encube Ethicals Inc.

2021-8125 11/26/2021 Abby Jeffers
2021-8126 11/26/2021 CMC Pharma GmbH

2021-8127 11/26/2021 McGinnis, Joseph F
2021-8128 11/26/2021 Law LLP
2021-8129 11/26/2021 Jeffers, Abigail

Perfect Pharmaceutical
2021-8132 11/26/2021 Consultants
2021-8133 11/26/2021 Hemerion Therapeutics SAS

2021-8134 11/26/2021 REACH24H USA INC.

2021-8135 11/29/2021 SAS
2021-8136 11/29/2021 SAS

2021-8137 11/29/2021 SAS

2021-8138 11/29/2021 SAS

2021-8139 11/29/2021 SAS

2021-8140 11/29/2021 SAS

2021-8141 11/29/2021 SAS

2021-8142 11/29/2021 SAS

2021-8143 11/29/2021 SAS
2021-8144 11/29/2021 SAS

2021-8145 11/29/2021 SAS

2021-8146 11/29/2021 SAS

2021-8147 11/29/2021 SAS

2021-8148 11/29/2021 SAS

2021-8149 11/29/2021 SAS

2021-8150 11/29/2021 SAS

2021-8151 11/29/2021 SAS
2021-8152 11/29/2021 SAS

2021-8153 11/29/2021 SAS

2021-8154 11/29/2021 SAS

2021-8155 11/29/2021 SAS

2021-8156 11/29/2021 SAS

2021-8157 11/29/2021 SAS

2021-8158 11/29/2021 SAS

2021-8159 11/29/2021 SAS
2021-8160 11/29/2021 SAS

2021-8161 11/29/2021 SAS

2021-8162 11/29/2021 SAS

2021-8163 11/29/2021 SAS

2021-8164 11/29/2021 SAS

2021-8165 11/29/2021 SAS

2021-8166 11/29/2021 SAS

2021-8167 11/29/2021 SAS
2021-8168 11/29/2021 GOODKNECHT, LEROY J

2021-8169 11/29/2021 News 5 - WEWS
2021-8170 11/29/2021 Lenehan, Justine
2021-8175 11/30/2021 DUKE UNIVERSITY

2021-8176 11/30/2021 Tom Namsavanh
2021-8177 11/30/2021 UCSF
2021-8178 11/30/2021 FOI Services, Inc.
2021-8179 11/30/2021 TSG Inc.

2021-8180 12/01/2021 John Sharpe
2021-8181 12/01/2021 John Sharpe
2021-8182 12/01/2021 John Sharpe
2021-8183 12/01/2021 John Sharpe
2021-8184 12/01/2021 John Sharpe
2021-8185 12/01/2021 John Sharpe
2021-8186 12/01/2021 John Sharpe
New World Int'l Holdings

2021-8187 12/01/2021 Corp

2021-8188 12/01/2021 Research
2021-8190 12/01/2021 Dr. Farrah Agustin-Bunch

2021-8192 12/01/2021 Island Health
2021-8193 12/01/2021 FDA NEWS
2021-8194 12/01/2021 FDA NEWS
2021-8195 12/01/2021 FDA NEWS
2021-8196 12/01/2021 FDA NEWS
2021-8197 12/01/2021 FDA NEWS
2021-8198 12/01/2021 FDA NEWS
2021-8199 12/01/2021 FDA NEWS
2021-8200 12/01/2021 VBreathe Pty Ltd

2021-8201 12/01/2021 SAS

2021-8202 12/01/2021 SAS

2021-8203 12/01/2021 SAS
Emkay Global Finanical
2021-8204 12/01/2021 Services Ltd
2021-8205 12/01/2021 FDA NEWS
2021-8206 12/01/2021 FDA NEWS
2021-8207 12/01/2021 FOI Services, Inc.
2021-8208 12/01/2021 FOI Services, Inc.

2021-8209 12/01/2021 FOI Services, Inc.
2021-8210 12/01/2021 FDAZILLA
2021-8211 12/01/2021 FOI Services, Inc.
2021-8212 12/01/2021 FOI Services, Inc.
2021-8213 12/01/2021 FOI Services, Inc.
2021-8214 12/01/2021 FOI Services, Inc.
2021-8215 12/01/2021 FOI Services, Inc.
2021-8216 12/01/2021 FOI Services, Inc.

2021-8217 12/01/2021 Adagio Therapeutics, Inc.
2021-8219 12/01/2021 CSL Behring LLC

2021-8220 12/01/2021 VALLAURIX PTE LTD
2021-8221 12/01/2021 60 Minutes, CBS News
2021-8223 12/01/2021 Qpex Biopharma, Inc.

THE UNIVERSITY OF IOWA,
2021-8225 12/01/2021 COLLEGE OF LAW
2021-8226 12/01/2021 Science
2021-8229 12/01/2021 Mizerk, Don
2021-8230 12/01/2021 Mizerk, Don

los angeles produce
2021-8231 12/01/2021 distributors
2021-8232 12/01/2021 Sundman, Emily

Greenan, Peffer, Sallander &
2021-8233 12/01/2021 Lally, LLP
2021-8234 12/01/2021 Thornhill, Jennifer

Bausch and Lomb
2021-8235 12/01/2021 Incorporated
2021-8236 12/01/2021 AndersonBrecon Inc.
2021-8237 12/01/2021 McNutt, Markey

2021-8238 12/01/2021 Assertio Therapeutics Inc
2021-8239 12/01/2021 Mark S. Godec, MD

2021-8240 12/01/2021 Bock, Latrycia
2021-8242 12/01/2021 Mark S. Godec, MD
2021-8243 12/01/2021 Psymposia

Nilo Medical Consulting
2021-8244 12/01/2021 Group
2021-8245 12/01/2021 Bock, Latrycia
2021-8246 12/01/2021 Garnett, Elizabeth
2021-8248 12/01/2021 PharmaLogic Holdings Corp

2021-8249 12/01/2021 Rouviere, Jodi
2021-8250 12/01/2021 Rouviere, Jodi
2021-8251 12/01/2021 Rouviere, Jodi
2021-8252 12/01/2021 Rouviere, Jodi

Kissei Pharmaceutical Co.,
2021-8254 12/01/2021 Ltd.
2021-8255 12/01/2021 ODIN Global Research
2021-8256 12/01/2021 Science
2021-8257 12/01/2021 FDAZILLA
2021-8258 12/01/2021 FDAZILLA
2021-8259 12/01/2021 FDAZILLA
2021-8260 12/01/2021 FDAZILLA

2021-8261 12/01/2021 FDAZILLA
2021-8262 12/01/2021 FDAZILLA
2021-8263 12/01/2021 FDAZILLA
2021-8264 12/01/2021 FDAZILLA
2021-8265 12/02/2021 Muller Brazil, LLP
2021-8266 12/02/2021 FDA NEWS
2021-8267 12/02/2021 FDA NEWS
2021-8268 12/02/2021 FDAZILLA

Axinn, Veltrop & Harkrider
2021-8269 12/02/2021 LLP
2021-8270 12/02/2021 FDA NEWS
2021-8271 12/02/2021 FDA NEWS
2021-8272 12/02/2021 FDA NEWS
2021-8273 12/02/2021 FDA NEWS
2021-8274 12/02/2021 FDA NEWS
2021-8275 12/02/2021 FDA NEWS
2021-8276 12/02/2021 FDA NEWS
2021-8277 12/02/2021 FDA NEWS
2021-8278 12/02/2021 FDA NEWS
2021-8279 12/02/2021 FDAZILLA
2021-8280 12/02/2021 FDAZILLA

2021-8281 12/02/2021 FOI Services, Inc.
2021-8282 12/02/2021 FDAZILLA

2021-8283 12/02/2021 FDA NEWS
2021-8284 12/02/2021 FDAZILLA

2021-8285 12/02/2021 FDAZILLA
2021-8287 12/02/2021 FDAZILLA
2021-8288 12/02/2021 FOX 13 Utah
2021-8289 12/02/2021 PROPHARMA GROUP
2021-8290 12/02/2021 Registrar Corp.

2021-8292 12/02/2021 Services, Inc,

2021-8293 12/02/2021 Sullivan, LLP

2021-8294 12/02/2021 Sullivan, LLP
2021-8295 12/02/2021 Sullivan, LLP

2021-8296 12/02/2021 Sullivan, LLP
Keller and Heckman LLP on

behalf of Wages & White dba
2021-8297 12/02/2021 Triton Distribution
2021-8298 12/02/2021 Conba USA Inc.

2021-8301 12/02/2021 PilieroMazza
2021-8302 12/02/2021 U.S. Donor Conceived Council

2021-8303 12/02/2021 Regunalys LLC
2021-8304 12/02/2021 Registrar Corp.
2021-8305 12/02/2021 Opertech Bio

2021-8306 12/02/2021 Young Innovations Inc
2021-8307 12/02/2021 Two Seas Cap
2021-8308 12/02/2021 CEUTICAL LABS

2021-8309 12/02/2021 Whitfield Coleman Bullock
BioMedical Strategy (2004)

2021-8311 12/02/2021 Ltd.
2021-8312 12/02/2021 FDAZILLA
2021-8313 12/02/2021 FDAZILLA
2021-8314 12/02/2021 FDAZILLA
2021-8315 12/02/2021 FDAZILLA
2021-8316 12/02/2021 FDAZILLA

2021-8317 12/03/2021 Kevin Thompson


2021-8322 12/03/2021 Rittgers & Rittgers
2021-8323 12/03/2021 PC
2021-8324 12/03/2021 PC
2021-8325 12/03/2021 Keeley Cauthen
2021-8326 12/03/2021 FOI Services, Inc.
2021-8327 12/03/2021 FOI Services, Inc.
2021-8328 12/03/2021 FOI Services, Inc.
2021-8329 12/03/2021 FOI Services, Inc.
2021-8331 12/03/2021 Beveridge & diamond, P.C.

2021-8333 12/03/2021 Triple Ring Technologies
2021-8335 12/03/2021 FOI Services, Inc.

2021-8336 12/03/2021 Meitheal Pharmaceuticals Inc.
Arent Fox LLP, Attorneys at
2021-8337 12/03/2021 Law, Washington DC
California Department of
Public Health - Radiologic
2021-8338 12/03/2021 Health Branch
2021-8339 12/06/2021 Cropper, Neal
2021-8340 12/06/2021 Cropper, Neal
2021-8341 12/06/2021 Cropper, Neal
2021-8344 12/06/2021 FOI Services, Inc.
2021-8346 12/06/2021 FOI Services, Inc.
2021-8347 12/06/2021 Ellis, Andrew
2021-8348 12/06/2021 Whiterabbit.ai Inc

Contract In-House Counsel
2021-8349 12/06/2021 and Consl. LLC
2021-8351 12/06/2021 Keller and Heckman LLP
Columbia University Irving

2021-8352 12/06/2021 Medical Center
Eastern Michigan University

2021-8353 12/06/2021 School of Health Sciences
Oregon State University

2021-8354 12/06/2021 College of Pharmacy
Warehouse Workers for
2021-8355 12/06/2021 Justice
2021-8357 12/06/2021 Center For Food Safety

2021-8358 12/06/2021 TERRY, DOROTHY
2021-8359 12/06/2021 Kahn Swick & Foti, LLC
2021-8360 12/06/2021 American Oversight
Clark-Esposito Law Firm, P.C.,

on behalf of Axiocore
2021-8361 12/06/2021 Corporation
2021-8362 12/06/2021 Cox, Dawne
2021-8363 12/06/2021 Viosera Therapeutics
2021-8364 12/06/2021 Baird

2021-8365 12/06/2021 FOI Services, Inc.
Stradling Yocca Carlson &

2021-8366 12/06/2021 Rauth, A P.C.
2021-8368 12/06/2021 510K FDA, Inc.
2021-8369 12/06/2021 Inc.
2021-8370 12/06/2021 Summit Therapeutics
2021-8371 12/07/2021 Registrar Corp.
2021-8372 12/07/2021 Santos Agency Inc
2021-8373 12/07/2021 Athenex, Inc.

2021-8374 12/07/2021 Services Company, LLC
2021-8375 12/07/2021 Robbins LLP

2021-8378 12/07/2021 Stinson LLP

2021-8379 12/07/2021 FDAZILLA
2021-8381 12/07/2021 FDAZILLA
2021-8382 12/07/2021 FDAZILLA
2021-8383 12/07/2021 FDAZILLA
2021-8384 12/07/2021 FDAZILLA
2021-8385 12/07/2021 FOI Services, Inc.
2021-8386 12/07/2021 The Pink Sheet/Informa

2021-8389 12/07/2021 CSL Plasma, Inc.
2021-8390 12/07/2021 CSL Plasma, Inc.
2021-8391 12/07/2021 CSL Plasma, Inc.

2021-8392 12/07/2021 Carestream Health, Inc.
2021-8393 12/07/2021 Hogan Lovells
2021-8394 12/07/2021 Bock, Latrycia
2021-8395 12/07/2021 Cosmetic Solutions
2021-8396 12/07/2021 FDAZILLA
2021-8397 12/07/2021 FDAZILLA
2021-8398 12/07/2021 FDAZILLA

2021-8399 12/07/2021 FDAZILLA
2021-8400 12/07/2021 FDAZILLA

2021-8401 12/07/2021 Carestream Health, Inc.
2021-8402 12/07/2021 FDAZILLA

2021-8403 12/07/2021 FOI Services, Inc.
2021-8404 12/07/2021 FDAZILLA
2021-8405 12/07/2021 FDAZILLA
2021-8406 12/07/2021 FDAZILLA

2021-8409 12/07/2021 FOI Services, Inc.
2021-8410 12/07/2021 Karrie J Sicely Inc

BALYASNY ASSET
2021-8411 12/07/2021 MANAGEMENT
2021-8412 12/07/2021 Randy Byrd LLC
Olympus Corporation of
2021-8413 12/07/2021 America
Autos Reporter, The Wall

2021-8414 12/07/2021 Street Journal
2021-8415 12/07/2021 Barrington Police Department

Jonathan Riches, Original
2021-8416 12/07/2021 Media Group
2021-8418 12/07/2021 FOI Services, Inc.

2021-8419 12/07/2021 Central Vapors
2021-8420 12/07/2021 Thompson Barney
2021-8421 12/07/2021 PROJECT INC
2021-8422 12/07/2021 Greg Scanlon

The New York Times
2021-8424 12/07/2021 Company
2021-8425 12/07/2021 National Fisheries Institute
2021-8426 12/07/2021 LifeSiteNews.com

2021-8427 12/07/2021 Hebert, Sheila A

2021-8429 12/08/2021 Johnson, Heidi
2021-8430 12/08/2021 Regunalys LLC
2021-8431 12/08/2021 Advent Services LLC
Lexington Law Group on

behalf of the Center for
2021-8432 12/08/2021 Environmental Health
ENDEMIX DOGAL MADDELER
2021-8433 12/08/2021 A.S.
2021-8434 12/08/2021 Sung Chun Kim, Esq.
2021-8435 12/08/2021 FOI Services, Inc.
2021-8436 12/08/2021 FOI Services, Inc.
2021-8437 12/08/2021 FOI Services, Inc.
2021-8438 12/08/2021 FOI Services, Inc.
2021-8439 12/08/2021 FOI Services, Inc.
2021-8440 12/08/2021 FOI Services, Inc.
2021-8441 12/08/2021 Xiromed, LLC

Roche Diagnostics
2021-8442 12/08/2021 Operations, Inc.
2021-8443 12/09/2021 CytoSorbents, Inc.
2021-8444 12/09/2021 FOI Services, Inc.
2021-8445 12/09/2021 FOI Services, Inc.
2021-8446 12/09/2021 FOI Services, Inc.

2021-8448 12/09/2021 FOI Services, Inc.
2021-8449 12/09/2021 FOI Services, Inc.
2021-8450 12/09/2021 FOI Services, Inc.
2021-8451 12/09/2021 FOI Services, Inc.

Covidien LLC (owned by
2021-8452 12/09/2021 Medtronic)
2021-8453 12/09/2021 FOI Services, Inc.

2021-8454 12/09/2021 Northside Hospital Atlanta
2021-8455 12/09/2021 Nagy, Calem M

2021-8456 12/09/2021 ROCHE DIAGNOSTICS
2021-8458 12/09/2021 FDA NEWS
CLEVELAND CLINIC
2021-8459 12/09/2021 FOUNDATION
2021-8460 12/09/2021 Innova Medical Group

Copyright Clearance Center
2021-8461 12/09/2021 on behalf of client
2021-8462 12/09/2021 Students for Life of America

2021-8463 12/09/2021 Lead by Sales, LLC
2021-8464 12/09/2021 Duke University
2021-8465 12/09/2021 Athenex, Inc.
2021-8466 12/09/2021 Karch, Trenton

2021-8467 12/09/2021 Syrnich, Samantha T
2021-8468 12/09/2021 LUTHER, RYAN
2021-8469 12/09/2021 SAP Letselschade Advocaten
2021-8470 12/09/2021 GRANT & EISENHOFER PA
2021-8471 12/09/2021 Lanier Law Firm
2021-8472 12/09/2021 Lanier Law Firm
2021-8473 12/09/2021 Lanier Law Firm
2021-8474 12/09/2021 Lanier Law Firm PLLC

2021-8475 12/09/2021 Lanier Law Firm
2021-8476 12/09/2021 Evonik Operations GbmH
2021-8477 12/09/2021 Registrar Corp.
2021-8478 12/09/2021 Tse-Ling Fong
2021-8479 12/09/2021 Lanier Law Firm PLLC
2021-8480 12/09/2021 FDAZILLA
2021-8481 12/09/2021 FDAZILLA
2021-8482 12/09/2021 FDAZILLA
2021-8483 12/09/2021 FDAZILLA
2021-8484 12/09/2021 FDAZILLA
2021-8485 12/09/2021 FDAZILLA
2021-8486 12/09/2021 Fearon, Stephen

2021-8487 12/09/2021 Fearon, Stephen
2021-8488 12/09/2021 Lin, Derrick
2021-8489 12/09/2021 Lin, Derrick
2021-8490 12/09/2021 Aylstock, Witkin, et al.

2021-8491 12/09/2021 GREGORY MORRIS
2021-8492 12/09/2021 QSITE
2021-8493 12/09/2021 JEREMY W WINTER
2021-8494 12/09/2021 FDA NEWS
2021-8495 12/09/2021 FDA NEWS
2021-8496 12/09/2021 FDA NEWS

2021-8497 12/09/2021 FDA NEWS
2021-8498 12/09/2021 FDA NEWS
2021-8499 12/09/2021 FDA NEWS
2021-8500 12/09/2021 FDA NEWS
2021-8501 12/09/2021 FDA NEWS
2021-8502 12/09/2021 FDA NEWS
2021-8503 12/09/2021 FDA NEWS
2021-8504 12/09/2021 FDA NEWS
2021-8505 12/09/2021 FDA NEWS
2021-8506 12/10/2021 Rouviere, Jodi
2021-8507 12/10/2021 Wang, Tony

2021-8508 12/10/2021 FOI Services, Inc.
2021-8509 12/10/2021 FOI Services, Inc.
2021-8510 12/10/2021 FOI Services, Inc.
2021-8511 12/10/2021 FOI Services, Inc.
2021-8513 12/10/2021 FOI Services, Inc.
2021-8514 12/10/2021 510K FDA, Inc.
2021-8515 12/10/2021 Driftless Extracts LLC
2021-8518 12/10/2021 The Rosen Law Firm, P.A.
2021-8520 12/10/2021 PERRINE, STEPHEN M

Hebrew University,
2021-8521 12/10/2021 Jerusalem, Israel

2021-8523 12/10/2021 RBC CAPITAL MARKETS
2021-8524 12/10/2021 Mandes LLC

2021-8526 12/13/2021 FOI Services, Inc.
2021-8527 12/13/2021 FOI Services, Inc.
2021-8528 12/13/2021 FOI Services, Inc.
2021-8529 12/13/2021 FOI Services, Inc.
2021-8530 12/13/2021 FOI Services, Inc.
2021-8531 12/13/2021 FDAZILLA
2021-8532 12/13/2021 FOI Services, Inc.
2021-8533 12/13/2021 Sung Chun Kim, Esq.
2021-8534 12/13/2021 FDAZILLA
2021-8535 12/13/2021 FDAZILLA
2021-8536 12/13/2021 FDAZILLA
2021-8537 12/13/2021 FDAZILLA

2021-8538 12/13/2021 FDAZILLA
2021-8539 12/13/2021 FDAZILLA
2021-8540 12/13/2021 FDAZILLA
2021-8541 12/13/2021 FDAZILLA
2021-8542 12/13/2021 Melton, Donavan
2021-8543 12/13/2021 Melton, Donavan
2021-8544 12/13/2021 Johnson, Heidi
2021-8545 12/13/2021 Abbott Laboratories, Inc
Pacific Northwest Pesticide

2021-8546 12/13/2021 Consulting
2021-8547 12/13/2021 Talusis LLC
2021-8548 12/13/2021 Greenleaf Health Inc.
Grifols Plasma Operations -

2021-8549 12/13/2021 BPC Plasma
2021-8550 12/13/2021 NaturAmericas

2021-8551 12/13/2021 FH2 Pharma L.L.C.

2021-8553 12/13/2021 Griffin Purnell LLC
2021-8554 12/13/2021 LOPEZ-BERESTEIN, GABRIEL
2021-8555 12/13/2021 Andres Perez Delgadillo

Benjamin L. England and
2021-8556 12/13/2021 Associates, LLC

2021-8557 12/13/2021 Hospital
2021-8558 12/13/2021 Orasis Pharmaceuticals Ltd
Edenbridge Pharmaceuticals
2021-8559 12/13/2021 LLC
2021-8560 12/13/2021 LLC
2021-8561 12/13/2021 FDAZILLA
2021-8562 12/13/2021 FDAZILLA
2021-8563 12/13/2021 FDAZILLA
2021-8564 12/13/2021 FDAZILLA
2021-8565 12/13/2021 FOIA GROUP INC
2021-8566 12/13/2021 FOIA GROUP INC
2021-8567 12/13/2021 MC3, Inc.
2021-8568 12/13/2021 MC3, Inc.
2021-8569 12/13/2021 Point Seventy Two
2021-8571 12/14/2021 Thompson Barney
2021-8572 12/14/2021 Zuq, Martha
2021-8573 12/14/2021 Sirthomas Snell
2021-8574 12/14/2021 Saptalis Pharmaceuticals, LLC
2021-8575 12/14/2021 LINCARE INC
2021-8576 12/14/2021 Athenex, Inc.

2021-8577 12/14/2021 FOI Services, Inc.
2021-8578 12/14/2021 Brandon Davidson
2021-8579 12/14/2021 SFL DIABETICS
2021-8580 12/14/2021 FDAZILLA
2021-8581 12/14/2021 FDAZILLA
2021-8582 12/14/2021 FDAZILLA
2021-8583 12/14/2021 FDAZILLA
2021-8584 12/14/2021 FDAZILLA
2021-8585 12/14/2021 FDAZILLA
2021-8586 12/14/2021 FDAZILLA
Axinn, Veltrop and Harkrider

2021-8587 12/14/2021 LLP
2021-8588 12/14/2021 Lehigh Valley Press
2021-8589 12/14/2021 Hospital

2021-8590 12/14/2021 Hospital
2021-8591 12/14/2021 VANITY FAIR
2021-8592 12/14/2021 The Epoch Times

2021-8593 12/14/2021 The Epoch Times
2021-8594 12/14/2021 Johnson, Heidi
2021-8595 12/14/2021 Thompson Barney
2021-8596 12/14/2021 Thompson Barney
2021-8597 12/14/2021 Thompson Barney

2021-8598 12/14/2021 Stinson LLP
2021-8600 12/14/2021 Stinson LLP
2021-8601 12/14/2021 Heidi Johnson
2021-8602 12/15/2021 FOI Services, Inc.
2021-8603 12/15/2021 MHC
2021-8604 12/15/2021 FOI Services, Inc.

2021-8605 12/15/2021 FOI Services, Inc.
2021-8606 12/15/2021 FOI Services, Inc.
2021-8607 12/15/2021 FOI Services, Inc.
2021-8608 12/15/2021 FOI Services, Inc.
2021-8609 12/15/2021 FOI Services, Inc.
2021-8610 12/15/2021 FOI Services, Inc.

2021-8611 12/15/2021 FOI Services, Inc.
2021-8612 12/15/2021 FOI Services, Inc.
2021-8613 12/15/2021 FOI Services, Inc.
2021-8614 12/15/2021 FOI Services, Inc.
2021-8615 12/15/2021 FOI Services, Inc.

2021-8616 12/15/2021 FOI Services, Inc.
2021-8617 12/15/2021 FOI Services, Inc.

2021-8618 12/15/2021 FOI Services, Inc.
2021-8619 12/15/2021 FOI Services, Inc.

2021-8620 12/15/2021 FOI Services, Inc.
2021-8621 12/15/2021 FOI Services, Inc.
2021-8622 12/15/2021 FOI Services, Inc.

2021-8624 12/15/2021 Burdock Group Consultants
2021-8625 12/15/2021 Burdock Group Consultants
2021-8626 12/15/2021 Den-Mat Holdings Inc

2021-8627 12/15/2021 NORTHSIDE HOSPITAL
2021-8628 12/15/2021 Baker Hostetler

2021-8629 12/15/2021 NORBROOK INC
2021-8630 12/15/2021 NORBROOK INC

2021-8631 12/15/2021 L.A Vegetable
2021-8632 12/15/2021 NORBROOK INC

2021-8633 12/15/2021 NORBROOK INC
2021-8634 12/15/2021 Harrang Long Gary Rudnick
2021-8635 12/15/2021 NORBROOK INC

2021-8637 12/15/2021 AngioDynamics, Inc.
2021-8638 12/15/2021 Registrar Corp.
2021-8639 12/15/2021 Wells Fargo
2021-8641 12/15/2021 KaiserDillon PLLC
2021-8642 12/15/2021 Marie Gale
2021-8644 12/16/2021 Wang, Debbie

2021-8645 12/16/2021 Bardy Diagnostics
2021-8648 12/16/2021 FOI Services, Inc.
2021-8649 12/16/2021 Odin Pharmaceuticals, LLC

2021-8650 12/16/2021 FOI Services, Inc.
BAMUNDO ZWAL
SCHERMERHORN & CAFFREY
2021-8651 12/16/2021 LLP
2021-8652 12/16/2021 Tusk Holdings
2021-8653 12/16/2021 Odin Pharmaceuticals, LLC
2021-8654 12/16/2021 FOI Services, Inc.
2021-8655 12/16/2021 FOI Services, Inc.
2021-8656 12/16/2021 FOI Services, Inc.
2021-8657 12/16/2021 FOI Services, Inc.
2021-8658 12/16/2021 FDAZILLA
2021-8659 12/16/2021 FDAZILLA
2021-8660 12/16/2021 FDAZILLA
2021-8661 12/16/2021 Medtronic Navigation, Inc.

2021-8662 12/16/2021 Parker Waichman, LLP
2021-8663 12/16/2021 FOI Services, Inc.
2021-8664 12/16/2021 FDAZILLA
2021-8665 12/16/2021 FDAZILLA
2021-8666 12/16/2021 FDAZILLA
2021-8667 12/16/2021 FDAZILLA
2021-8668 12/16/2021 RBC CAPITAL MARKETS CORP

2021-8669 12/16/2021 TULEY LAW OFFICE
2021-8670 12/16/2021 Handelsbanken
Boston University School of

2021-8671 12/16/2021 Law
POINT72 ASSET
2021-8672 12/16/2021 MANAGEMENT LP
2021-8675 12/16/2021 FOI Services, Inc.

2021-8676 12/17/2021 FOI Services, Inc.
2021-8677 12/17/2021 Cyberdontics USA, Inc.


2021-8693 12/17/2021 FOI Services, Inc.
2021-8694 12/17/2021 WELLS FARGO
2021-8695 12/17/2021 FDAZILLA
2021-8696 12/17/2021 FDAZILLA
2021-8698 12/17/2021 FDAZILLA
2021-8699 12/17/2021 FDAZILLA
2021-8700 12/17/2021 FDAZILLA

2021-8701 12/17/2021 FDAZILLA
2021-8702 12/17/2021 FDAZILLA
2021-8703 12/17/2021 FDAZILLA
2021-8704 12/17/2021 FDAZILLA
2021-8705 12/17/2021 FDAZILLA
Economic Crimes
Investigation Department of
Seoul Gangdong District
Police. Korean National
2021-8706 12/20/2021 Police Agency.
2021-8707 12/20/2021 Melton, Donavan
2021-8708 12/20/2021 Carnegie Pharmaceuticals LLC

Medtronic Sofamor Danek
2021-8709 12/20/2021 Inc.
2021-8710 12/20/2021 FOI Services, Inc.
2021-8711 12/20/2021 FOI Services, Inc.
2021-8712 12/20/2021 FOI Services, Inc.

2021-8713 12/20/2021 FOI Services, Inc.
2021-8714 12/20/2021 Inc.
2021-8715 12/20/2021 Inc.
2021-8716 12/20/2021 Adamis Pharmaceuticals
2021-8717 12/20/2021 Medical Device Academy inc.
2021-8718 12/20/2021 Monarch PCM, LLC
2021-8719 12/20/2021 INTERTEK
2021-8720 12/20/2021 Adamis Pharmaceuticals
2021-8721 12/20/2021 Medical Device Academy inc.
Pharma Conference
2021-8722 12/20/2021 Education Inc.
2021-8723 12/20/2021 Ken Reid

2021-8728 12/20/2021 Behmanesh, Jessica
2021-8729 12/20/2021 McIlwain, Colleen

Costco Wholesale, Trade and

2021-8732 12/20/2021 Customs Compliance
2021-8733 12/20/2021 Micro-Tech (Nanjing) Co., Ltd.
2021-8734 12/20/2021 FOI Services, Inc.
BALYASNY ASSET
2021-8735 12/20/2021 MANAGEMENT
BALYASNY ASSET
2021-8736 12/20/2021 MANAGEMENT

2021-8738 12/20/2021 Grossmann LLP
2021-8739 12/20/2021 BDO
2021-8740 12/20/2021 BDO

2021-8741 12/20/2021 BDO
2021-8742 12/20/2021 BDO
2021-8743 12/20/2021 SKG Pharma Inc.
2021-8746 12/20/2021 HOFFMAN, DAVID .
2021-8747 12/20/2021 McNamara, Lotte K

2021-8748 12/20/2021 Devakadaksham, Praveen
2021-8749 12/20/2021 Svadhyaya Home School

2021-8750 12/20/2021 Muller Brazil, LLP
2021-8751 12/20/2021 Gland Pharma Limited
2021-8752 12/20/2021 Shaun Mehra
2021-8753 12/20/2021 Curadel Surgical Innovations

Balyasny Europe Asset
2021-8754 12/20/2021 Management LLP

2021-8755 12/20/2021 Management LLP
2021-8756 12/20/2021 Melton, Donavan
DICKIE MCCAMEY &
2021-8757 12/20/2021 CHILCOTE
2021-8758 12/20/2021 MARLER CLARK ATTYS
2021-8759 12/20/2021 SAEN

2021-8761 12/20/2021 Universität Bonn, Germany
Universities Allied for

2021-8762 12/20/2021 Essential Medicines (UAEM)
2021-8763 12/21/2021 FDAZILLA
2021-8764 12/21/2021 FDAZILLA
2021-8765 12/21/2021 FDAZILLA
2021-8767 12/21/2021 FDAZILLA
MATRIX MEDICAL DEVICES
2021-8768 12/21/2021 LLC
2021-8769 12/21/2021 washington info source co

2021-8770 12/21/2021 FDAZILLA
2021-8771 12/21/2021 LLC
2021-8772 12/21/2021 Cleveland, Nicole

2021-8773 12/21/2021 LLC
2021-8774 12/21/2021 Doehler
Kleinfeld, Kaplan & Becker,

2021-8775 12/21/2021 LLP

2021-8778 12/21/2021 Immunovant, Inc.
2021-8780 12/21/2021 Harvard Medical School
Harvard Medical School

Department of Population
Medicine and Harvard Pilgrim
2021-8781 12/21/2021 Health Care Institute
American Institute for

2021-8782 12/21/2021 Economic Research
2021-8783 12/21/2021 Guggenheim Securities, LLC

ADAGE CAPITAL
2021-8784 12/21/2021 MANAGEMENT LP
2021-8785 12/21/2021 Aurobindo Pharma USA Inc.
2021-8786 12/21/2021 Takahashi, Ayumi
2021-8787 12/21/2021 Stinson LLP
2021-8788 12/21/2021 GC Pharma
2021-8789 12/21/2021 FDAZILLA
2021-8790 12/21/2021 FDAZILLA
2021-8791 12/21/2021 FDAZILLA
2021-8792 12/21/2021 FDAZILLA
2021-8793 12/21/2021 Tri Locum Partners

2021-8794 12/21/2021 FDAZILLA
2021-8795 12/22/2021 FOI Services, Inc.
2021-8796 12/22/2021 FOI Services, Inc.
CAPITAL GROUP COMPANIES

2021-8797 12/22/2021 INC
2021-8798 12/22/2021 UroDev Medical
2021-8799 12/22/2021 FOI Services, Inc.
2021-8800 12/22/2021 REGCON Solutions LLC

2021-8802 12/22/2021 PC

AIMETDC GROUP &
2021-8804 12/22/2021 FOUNDATION
2021-8805 12/22/2021 Hogan Lovells LLP
CENTER FOR SCIENCE IN THE

2021-8806 12/22/2021 PUBLIC INTEREST
2021-8807 12/22/2021 mietus, zachary
2021-8808 12/22/2021 Lally, LLP
2021-8809 12/22/2021 Lally, LLP
2021-8810 12/22/2021 Lally, LLP
2021-8811 12/22/2021 Leroy Rogers
2021-8812 12/22/2021 FOI Services, Inc.
2021-8813 12/22/2021 FOI Services, Inc.
2021-8814 12/22/2021 FOI Services, Inc.
2021-8815 12/22/2021 FOI Services, Inc.
2021-8816 12/22/2021 FOI Services, Inc.
2021-8817 12/22/2021 FOI Services, Inc.
2021-8818 12/22/2021 FOI Services, Inc.

2021-8819 12/22/2021 FOI Services, Inc.
2021-8820 12/22/2021 FOI Services, Inc.
2021-8821 12/22/2021 FOI Services, Inc.
2021-8822 12/22/2021 FOI Services, Inc.
2021-8823 12/22/2021 FOI Services, Inc.
2021-8824 12/22/2021 FOI Services, Inc.
2021-8825 12/22/2021 FOI Services, Inc.
2021-8826 12/22/2021 FOI Services, Inc.
2021-8827 12/23/2021 Teikoku Pharma USA, Inc.
2021-8828 12/23/2021 IQVIA

2021-8829 12/23/2021 Sullivan, LLP
2021-8830 12/23/2021 Sullivan, LLP
2021-8831 12/23/2021 Sullivan, LLP
2021-8832 12/23/2021 Sullivan, LLP
2021-8833 12/23/2021 SSA
Federal Public Defender

Office Middle District of
2021-8834 12/23/2021 Tennessee
2021-8835 12/23/2021 FDAZILLA
2021-8836 12/23/2021 FDAZILLA
2021-8837 12/23/2021 FDAZILLA
2021-8838 12/23/2021 FDAZILLA
2021-8839 12/23/2021 FDAZILLA

Ipsen Biopharmaceuticals,
2021-8840 12/23/2021 Inc.
2021-8841 12/23/2021 IQVIA
2021-8844 12/23/2021 COLUMBIA UNIVERSITY
2021-8846 12/23/2021 HAZLEHURST, ROLF
2021-8847 12/23/2021 HAZLEHURST, ROLF

2021-8848 12/23/2021 Acuta Capital Partners
2021-8849 12/23/2021 Abir Cohen Treyzon Salo, LLP

2021-8850 12/23/2021 Accenture solutions pvt ltd
2021-8851 12/23/2021 Spencer Collet
2021-8852 12/23/2021 Spencer Collet

2021-8853 12/23/2021 BAILEY GLASSER LLP
2021-8855 12/23/2021 THE MARKER GROUP
2021-8856 12/27/2021 FOI Services, Inc.
2021-8857 12/27/2021 FOI Services, Inc.
2021-8858 12/27/2021 FOI Services, Inc.
2021-8859 12/27/2021 FOI Services, Inc.
2021-8860 12/27/2021 FOI Services, Inc.
2021-8861 12/27/2021 FOI Services, Inc.
2021-8862 12/27/2021 FOI Services, Inc.
2021-8863 12/27/2021 FOI Services, Inc.

2021-8864 12/27/2021 FOI Services, Inc.
BALYASNY ASSET
2021-8865 12/27/2021 MANAGEMENT

2021-8867 12/27/2021 RBC
The Microbiome c/o Steven
2021-8868 12/27/2021 Solomon
BRIGHTVIEW MEDICAL
TECHNOLOGIES(NANJING)CO.
2021-8869 12/27/2021 ,LTD
2021-8870 12/27/2021 Connect Inc.
2021-8871 12/28/2021 Mark S. Godec, MD
2021-8872 12/28/2021 Amy's Kitchen

2021-8873 12/28/2021 Inc.
2021-8875 12/28/2021 Ingenio Pichichi S.A
2021-8876 12/28/2021 Wegmans Food Markets, Inc.
2021-8877 12/28/2021 OneSource Regulatory, LLC
2021-8878 12/29/2021 FOI Services, Inc.

2021-8879 12/29/2021 FOI Services, Inc.
2021-8880 12/29/2021 FOI Services, Inc.
2021-8881 12/29/2021 FOI Services, Inc.
2021-8882 12/29/2021 FOI Services, Inc.
2021-8883 12/29/2021 FOI Services, Inc.
2021-8884 12/29/2021 FOI Services, Inc.
2021-8885 12/29/2021 FOI Services, Inc.
2021-8886 12/29/2021 FOI Services, Inc.
2021-8887 12/29/2021 FOI Services, Inc.
2021-8888 12/29/2021 FOI Services, Inc.

2021-8889 12/29/2021 FDAZILLA
2021-8890 12/29/2021 FDAZILLA
2021-8891 12/29/2021 FDAZILLA
2021-8892 12/29/2021 FOI Services, Inc.
2021-8893 12/29/2021 FDAZILLA

2022-1 01/03/2022 Paladin Medical, Inc.
2022-2 01/03/2022 FOI Services, Inc.

2022-3 01/03/2022 Inc.
2022-4 01/03/2022 FDAZILLA

2022-5 01/03/2022 FDAZILLA
2022-6 01/03/2022 FDAZILLA
2022-7 01/03/2022 FDAZILLA

2022-8 01/03/2022 FDAZILLA
2022-9 01/03/2022 FDAZILLA
2022-10 01/03/2022 FDAZILLA
2022-11 01/03/2022 FOI Services, Inc.

2022-13 01/03/2022 FDAZILLA
2022-14 01/03/2022 Inc.
2022-15 01/03/2022 Inc., USA
2022-16 01/03/2022 SAS
2022-17 01/03/2022 IPD Analytics, LLC

2022-18 01/03/2022 SAS

2022-19 01/03/2022 SAS
2022-20 01/03/2022 FDAZILLA
2022-21 01/03/2022 FDAZILLA
2022-22 01/03/2022 FDAZILLA
2022-23 01/03/2022 FDAZILLA
2022-24 01/03/2022 FDAZILLA

2022-25 01/03/2022 FDAZILLA

2022-27 01/03/2022 Sullivan, LLP

2022-28 01/03/2022 Sullivan, LLP

2022-29 01/03/2022 Sullivan, LLP

2022-30 01/03/2022 Sullivan, LLP

2022-32 01/03/2022 Cropper, Neal
2022-33 01/03/2022 Duty, Harry
2022-34 01/03/2022 Duty, Harry

2022-35 01/03/2022 Litzher, Paul
American Dental Products
2022-36 01/03/2022 Inc.
2022-37 01/03/2022 Litzher, Paul
2022-38 01/03/2022 Charles Johnson
2022-39 01/03/2022 Germany
2022-40 01/03/2022 AED Battery Exchange, LLC
2022-41 01/03/2022 Global Seafood Alliance
2022-42 01/03/2022 Wiley LLP
University of California, San

Diego Department of
Electrical and Computer
2022-43 01/03/2022 Engineering
Program on Regulation,
2022-44 01/03/2022 Therapeutics, and Law
2022-46 01/03/2022 Hernandez Lee Martinez, LLC
2022-47 01/03/2022 CASSIDAY SCHADE LLP
2022-48 01/03/2022 Davidson, Brandon

2022-49 01/03/2022 LLP
BALYASNY ASSET
2022-50 01/03/2022 MANAGEMENT
2022-51 01/03/2022 Petersen, Mitchell

2022-53 01/03/2022 N/A
2022-54 01/03/2022 Secure Lead Solutions LLC

2022-57 01/03/2022 FDAZILLA
2022-58 01/03/2022 FDAZILLA
2022-59 01/03/2022 FDAZILLA
2022-60 01/03/2022 FDAZILLA
2022-61 01/03/2022 MacroMedics BV
2022-62 01/03/2022 FDAZILLA
2022-63 01/03/2022 Goldman Sachs & Co.
2022-64 01/03/2022 Erica W. Stump, Esq.

2022-65 01/03/2022 Jesse Brodkin
2022-66 01/03/2022 FDAZILLA
2022-67 01/03/2022 DAMON ELLIOTT 31034-037

2022-68 01/03/2022 REMINGER
American Institute for

2022-70 01/03/2022 Economic Research
2022-71 01/03/2022 FDAZILLA
2022-72 01/03/2022 FDAZILLA
2022-73 01/03/2022 FDAZILLA
2022-74 01/03/2022 FDAZILLA
2022-75 01/03/2022 FDAZILLA
2022-76 01/03/2022 Pritzker Hageman P.A.
2022-77 01/03/2022 Pritzker Hageman P.A.

2022-79 01/04/2022 Pty Ltd

2022-85 01/04/2022 Andrea Steel

2022-86 01/04/2022 Curb, Bruce
2022-87 01/04/2022 YATES, JOSEPH
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2022-93 01/04/2022 Pty Ltd
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2022-95 01/04/2022 WynnVision, LLC
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2022-96 01/04/2022 Journalism
2022-97 01/04/2022 N/A
2022-98 01/04/2022 N/A
Harvard Pilgrim Health Care
2022-99 01/04/2022 Institute
2022-100 01/04/2022 MATHIS, KATE
2022-101 01/04/2022 MATHIS, KATE
2022-103 01/04/2022 ATL Regulatory Consulting LLC
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2022-104 01/04/2022 School of Dentistry
2022-105 01/04/2022 Cosmetic Ingredient Review

2022-108 01/04/2022 Allen, Adam
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2022-118 01/05/2022 FDAZILLA
2022-119 01/05/2022 FDAZILLA
2022-120 01/05/2022 FDAZILLA
2022-121 01/05/2022 FDAZILLA
2022-122 01/05/2022 FDAZILLA
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2022-126 01/05/2022 Street Journal
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2022-129 01/05/2022 Republic Brands LP

2022-131 01/05/2022 Hospital
2022-132 01/05/2022 Street Journal

2022-133 01/05/2022 Street Journal

2022-134 01/05/2022 Street Journal
2022-135 01/05/2022 Street Journal

2022-136 01/05/2022 Street Journal
2022-137 01/05/2022 Miracle Mile Law Group
2022-138 01/05/2022 THE RECORD AND USA TODAY
2022-139 01/05/2022 Wells Fargo
2022-140 01/05/2022 Clario.

2022-141 01/05/2022 DAVID COSMETIC CO., LTD.
2022-142 01/05/2022 CAS
2022-144 01/05/2022 The Washington Examiner
2022-145 01/06/2022 SCHIFF HARDIN LLP
Florida Department of
2022-146 01/06/2022 Financial Services
2022-147 01/06/2022 Marks, Jamie

UNIVERSITY OF CALIFORNIA,
2022-148 01/06/2022 IRVINE
2022-149 01/06/2022 CoaguSense

2022-150 01/06/2022 Grossmann LLP

2022-152 01/06/2022 Fresh From Texas, LLC
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2022-166 01/07/2022 FOI Services, Inc.
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2022-178 01/07/2022 FOI Services, Inc.
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2022-188 01/07/2022 Dechra Ltd.

2022-189 01/07/2022 HEWLETT, IRIS
2022-190 01/07/2022 HEWLETT, IRIS
2022-191 01/07/2022 Bloomberg News
2022-192 01/07/2022 Wiygul, Jeremy

BTG Specialty
2022-193 01/07/2022 Pharmaceuticals
2022-195 01/07/2022 Sinocare Inc

2022-196 01/07/2022 CDC
2022-197 01/10/2022 Melton, Donavan
2022-198 01/10/2022 MCCARTHY, JOHN
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2022-200 01/10/2022 FOI Services, Inc.
2022-201 01/10/2022 FirstString Research, Inc.

EMMA International
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2022-204 01/10/2022 Capstone Nutrition, LLC
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2022-205 01/10/2022 Pharmaceuticals
2022-206 01/10/2022 FDAZILLA
2022-207 01/10/2022 FDAZILLA
2022-208 01/10/2022 FDAZILLA
2022-209 01/10/2022 FDAZILLA
2022-210 01/10/2022 FDAZILLA

2022-211 01/10/2022 Grossmann LLP

2022-213 01/10/2022 CAS
MIDWEST CENTER FOR
2022-214 01/10/2022 INVESTIGATIVE REPORTING
2022-215 01/10/2022 The Block Firm LLC
2022-216 01/10/2022 Mintz Levin

2022-217 01/10/2022 Dentsply SIrona
Krugliak Wilkins Griffiths &

2022-218 01/10/2022 Dougherty Co LPA
2022-219 01/10/2022 Ace Vision Group
2022-220 01/10/2022 OPTOVUE, INC.
2022-222 01/10/2022 FOIA GROUP INC
2022-223 01/10/2022 Hill Show Lambs
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2022-226 01/10/2022 FDAZILLA
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2022-227 01/10/2022 LLC
2022-228 01/11/2022 FOI Services, Inc.
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2022-230 01/11/2022 60 Minutes CBS News
2022-231 01/11/2022 60 Minutes CBS News
2022-232 01/11/2022 60 Minutes CBS News
2022-233 01/11/2022 60 Minutes CBS News
2022-234 01/11/2022 Triple Gate Capital
2022-235 01/11/2022 PROPHARMA GROUP
2022-236 01/11/2022 Wells Fargo Securities, LLC

2022-237 01/11/2022 INTERTEK
2022-238 01/11/2022 Inc.
2022-239 01/11/2022 FDAZILLA
2022-240 01/11/2022 FDAZILLA
2022-241 01/11/2022 FDAZILLA
2022-242 01/11/2022 FDAZILLA
2022-243 01/11/2022 FDAZILLA

2022-244 01/11/2022 FDAZILLA
2022-245 01/11/2022 FDAZILLA
2022-246 01/11/2022 FDAZILLA
2022-247 01/11/2022 FDAZILLA
2022-248 01/11/2022 FDAZILLA
KYL J. KIRBY, ATTORNEY AND

2022-249 01/11/2022 COUNSELOR AT LAW, PC
2022-250 01/11/2022 FDAZILLA
2022-251 01/11/2022 FDAZILLA
2022-252 01/11/2022 FDAZILLA
2022-253 01/11/2022 Schnuck Markets Inc

CAPITAL GROUP COMPANIES
2022-254 01/11/2022 INC
2022-255 01/11/2022 60 Minutes CBS News
2022-256 01/11/2022 60 Minutes CBS News
2022-257 01/11/2022 60 Minutes CBS News
2022-258 01/11/2022 60 Minutes CBS News
2022-259 01/11/2022 60 Minutes CBS News
2022-260 01/11/2022 60 Minutes CBS News
2022-261 01/11/2022 60 Minutes CBS News
2022-262 01/11/2022 60 Minutes CBS News
2022-263 01/11/2022 60 Minutes CBS News
2022-264 01/11/2022 60 Minutes CBS News
2022-265 01/11/2022 60 Minutes CBS News
2022-266 01/11/2022 60 Minutes CBS News
2022-267 01/11/2022 THE DALLAS MORNING NEWS
2022-268 01/11/2022 Nordea Bank Denmark
2022-269 01/11/2022 Law Office of Kevin J. Philbin
2022-271 01/11/2022 spivak, gary

2022-272 01/11/2022 IQVIA
2022-273 01/11/2022 The Fletcher Firm LLP

2022-274 01/11/2022 Papamichael, Michael
2022-275 01/11/2022 Taylor Research Group
2022-276 01/12/2022 FOI Services, Inc.
2022-278 01/12/2022 Granite Microsystems, Inc.
2022-279 01/12/2022 FDAZILLA

2022-280 01/12/2022 FDAZILLA
2022-281 01/12/2022 FDAZILLA
2022-282 01/12/2022 FDAZILLA
2022-283 01/12/2022 FDAZILLA
2022-284 01/12/2022 FDAZILLA
2022-285 01/12/2022 FDAZILLA
2022-286 01/12/2022 kaleo, Inc.
2022-287 01/12/2022 LOEB & LOEB LLP
2022-288 01/12/2022 Ouano, Jeffrey

2022-289 01/12/2022 LOEB & LOEB LLP
2022-290 01/12/2022 Stewart Smith Law

2022-291 01/12/2022 Rishi R.
2022-292 01/12/2022 Nuview Life Sciences


2022-294 01/12/2022 Rosati, P.C.
2022-295 01/12/2022 HOLLIS LAW FIRM PA

2022-296 01/12/2022 Paul Litzher
2022-297 01/13/2022 FOI Services, Inc.
2022-298 01/13/2022 Registrar Corp.
2022-299 01/13/2022 FOI Services, Inc.
2022-300 01/13/2022 FOI Services, Inc.

2022-301 01/13/2022 FOI Services, Inc.
2022-302 01/13/2022 FOI Services, Inc.
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2022-304 01/13/2022 FOI Services, Inc.
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2022-306 01/13/2022 FOI Services, Inc.
2022-307 01/13/2022 FOI Services, Inc.
2022-308 01/13/2022 Lassman Law+Policy
2022-309 01/13/2022 FOI Services, Inc.
2022-310 01/13/2022 FOI Services, Inc.

2022-311 01/13/2022 FOI Services, Inc.
2022-312 01/13/2022 FOI Services, Inc.

2022-313 01/13/2022 FOI Services, Inc.
2022-314 01/13/2022 Life Extension

Dechra Veterinary Products,
2022-315 01/13/2022 LLC
2022-316 01/13/2022 Inc.
2022-317 01/13/2022 Exponent Consultant
2022-318 01/13/2022 Exponent Consulting

2022-322 01/13/2022 Litzher, Paul
2022-323 01/13/2022 Duty, Harry
2022-324 01/13/2022 Duty, Harry

2022-325 01/13/2022 DLA Piper LLP (US)
2022-326 01/13/2022 Evonik Corporation
2022-327 01/13/2022 Evexias Health Solutions
2022-328 01/13/2022 Registrar Corp.
2022-329 01/13/2022 McKenzie & Hart LLC
2022-330 01/13/2022 jackie salter
2022-331 01/14/2022 Yang, Yang
2022-333 01/14/2022 Bloomberg News
2022-334 01/14/2022 StarKist Co.

Novocol Pharmaceutical of
2022-335 01/14/2022 Canada, Inc.
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2022-336 01/14/2022 Canada, Inc.
2022-337 01/14/2022 Miller, Jennifer
2022-338 01/14/2022 Vikram, Bhanu
2022-340 01/14/2022 FathomX Pte Ltd
2022-341 01/14/2022 FDAZILLA
2022-342 01/14/2022 FDAZILLA

2022-343 01/14/2022 FOI Services, Inc.

2022-345 01/14/2022 FOI Services, Inc.
2022-346 01/14/2022 FDAZILLA
2022-347 01/14/2022 FDAZILLA
Schubert Jonckheer & Kolbe

2022-348 01/14/2022 LLP
2022-349 01/14/2022 Sterigenics, Los Angeles

2022-350 01/14/2022 Sedwick Delegated Authority
2022-351 01/14/2022 Pistevo Law LLC
Swedish Match North

2022-352 01/14/2022 America, LLC
2022-353 01/14/2022 Stinson LLP
2022-354 01/14/2022 PilieroMazza
2022-355 01/14/2022 PilieroMazza

2022-356 01/14/2022 POINT72
Chinese American Legal
2022-357 01/14/2022 Defense Alliance
2022-358 01/14/2022 Sharla Winters

2022-359 01/14/2022 The Epoch Times
2022-360 01/14/2022 Jennifer Primeau
2022-361 01/14/2022 Linda Bonvie

2022-362 01/14/2022 Renton Prep
2022-363 01/14/2022 Linda Bonvie

2022-364 01/14/2022 Stinson LLP
2022-366 01/14/2022 Strides Pharma Inc.

2022-370 01/14/2022 Actuated Medical, Inc.
2022-371 01/14/2022 POINT72
2022-372 01/14/2022 Nolan Heimann LLP
2022-373 01/14/2022 Leading Pharma, LLC

MIT Knight Science
2022-374 01/14/2022 Journalism Program
2022-375 01/18/2022 FOI Services, Inc.
2022-376 01/18/2022 Ipsen Ltd

2022-377 01/18/2022 FOI Services, Inc.
2022-378 01/18/2022 FOI Services, Inc.
2022-379 01/18/2022 FOI Services, Inc.
2022-380 01/18/2022 FOI Services, Inc.
2022-381 01/18/2022 FOI Services, Inc.
2022-382 01/18/2022 FOI Services, Inc.
2022-383 01/18/2022 FOI Services, Inc.
2022-384 01/18/2022 FOI Services, Inc.
2022-385 01/18/2022 Registrar Corp.
2022-386 01/18/2022 AdverseEvents, Inc.

2022-388 01/18/2022 Grossmann LLP
2022-389 01/18/2022 60 Minutes CBS News
2022-390 01/18/2022 60 Minutes CBS News
2022-391 01/18/2022 60 Minutes CBS News
2022-392 01/18/2022 60 Minutes CBS News
2022-393 01/18/2022 60 Minutes CBS News
2022-394 01/18/2022 60 Minutes CBS News
2022-395 01/18/2022 60 Minutes CBS News
2022-396 01/18/2022 60 Minutes CBS News
2022-397 01/18/2022 60 Minutes CBS News
2022-398 01/18/2022 FDA NEWS
2022-399 01/18/2022 DUKE UNIVERSITY
2022-400 01/18/2022 DUKE UNIVERSITY

2022-401 01/18/2022 Washington Post
2022-402 01/18/2022 60 Minutes CBS News
2022-403 01/18/2022 60 Minutes CBS News
2022-404 01/18/2022 60 Minutes CBS News

2022-405 01/18/2022 60 Minutes CBS News
2022-406 01/18/2022 60 Minutes CBS News
2022-407 01/18/2022 60 Minutes CBS News
2022-408 01/18/2022 60 Minutes CBS News
2022-409 01/18/2022 60 Minutes CBS News
2022-410 01/18/2022 60 Minutes CBS News
2022-411 01/18/2022 60 Minutes CBS News
2022-412 01/18/2022 Walker, Joseph
2022-413 01/18/2022 BuzzFeed NEws

2022-415 01/18/2022 Omnicell IV Solutions

2022-416 01/18/2022 CASEY-BAINVILLE, KATHLEEN
2022-417 01/18/2022 Ali, Shurjo
2022-418 01/18/2022 Shekter, Jamison
Centaur Pharmaceuticals Pvt.

2022-419 01/18/2022 Ltd.

2022-422 01/18/2022 POINT72
2022-423 01/18/2022 EXPONENT

Sibas Gida Sanayi Ve Ticaret
2022-424 01/18/2022 A.S.
2022-425 01/18/2022 FDAZILLA
2022-426 01/18/2022 FDAZILLA
2022-427 01/18/2022 POINT72

2022-428 01/18/2022 FDAZILLA
2022-429 01/18/2022 FDAZILLA
2022-430 01/18/2022 FDAZILLA
2022-431 01/18/2022 N/A
INTERNATIONAL
ASSOCIATION OF COLOR
2022-432 01/18/2022 MANUFACTURERS
2022-433 01/18/2022 Pistevo Law LLC
2022-434 01/18/2022 National Foods Limited
University of Oregon School

2022-435 01/18/2022 of Law
2022-436 01/18/2022 Slayback Pharma LLC
2022-437 01/18/2022 NEWSWEEK
2022-438 01/19/2022 FDAZILLA
2022-439 01/19/2022 FDAZILLA
2022-440 01/19/2022 FDAZILLA
2022-441 01/19/2022 FDAZILLA

2022-442 01/19/2022 FDAZILLA
2022-443 01/19/2022 Walker, Joseph
2022-444 01/19/2022 FDAZILLA

2022-449 01/19/2022 Searchlight Science

2022-451 01/19/2022 Medtronic Inc, -Swinnea

2022-453 01/19/2022 PROJECT INC

2022-454 01/19/2022 PROJECT INC
2022-455 01/19/2022 Het Financieele Dagblad
2022-456 01/19/2022 Jinks Crow & Dickson, PC

2022-457 01/19/2022 Jonathan Leung
2022-458 01/19/2022 Harris Teeter LLC
2022-459 01/19/2022 Belcher Pharmaceuticals, LLC
2022-460 01/19/2022 Whole In One LLC

2022-461 01/19/2022 Patient Shield Concepts LLC
2022-462 01/20/2022 FOI Services, Inc.
2022-463 01/20/2022 FOI Services, Inc.
2022-464 01/20/2022 FOI Services, Inc.
2022-465 01/20/2022 FOI Services, Inc.
2022-466 01/20/2022 FOI Services, Inc.
2022-467 01/20/2022 FOI Services, Inc.
2022-468 01/20/2022 FOI Services, Inc.

2022-469 01/20/2022 FOI Services, Inc.
2022-470 01/20/2022 FOI Services, Inc.
2022-471 01/20/2022 FOI Services, Inc.
2022-472 01/20/2022 FOI Services, Inc.
2022-473 01/20/2022 FOI Services, Inc.
2022-474 01/20/2022 FOI Services, Inc.
2022-475 01/20/2022 FOI Services, Inc.

TAFT STETTINIUS &
2022-476 01/20/2022 HOLLISTER LLP
2022-477 01/20/2022 FDAZILLA
2022-478 01/20/2022 FDAZILLA
2022-479 01/20/2022 FDAZILLA

2022-480 01/20/2022 FDAZILLA
2022-482 01/20/2022 Hogan Lovells
2022-484 01/20/2022 Zachary Shelley
2022-485 01/20/2022 Daily Dot
Octapharma Pharmazeutika
2022-486 01/20/2022 Prod. Gmbh
2022-487 01/20/2022 Biomerica, Inc.

2022-488 01/20/2022 MIM Software Inc.
2022-489 01/20/2022 Apotex Inc.
2022-490 01/20/2022 Merck Animal Health
2022-491 01/20/2022 Gustman Law P.C.

Jeoffrey L. Burtch, Bankruptcy
Chapter 7 Trustee of EuCyt
Laboratories, LLC, Case 20-
2022-493 01/20/2022 13181-CSS, Delaware
2022-494 01/20/2022 LARKIN, LOREN

Reilly, McDevitt & Henrich,
2022-495 01/20/2022 P.C.
2022-496 01/20/2022 Walker, Joseph

2022-497 01/20/2022 Street Journal
2022-498 01/20/2022 Campfire Studios

The New York Times
2022-500 01/20/2022 Company

2022-503 01/20/2022 AI Optics
2022-504 01/20/2022 STRYKER ENDOSCOPY

2022-505 01/20/2022 POLITICO
2022-506 01/20/2022 POLITICO
2022-508 01/20/2022 Harrison.ai
2022-509 01/20/2022 Law Office of Kevin Justen
2022-510 01/20/2022 Exact Scientific Services

2022-511 01/20/2022 Hogan Lovells

2022-513 01/20/2022 MSC UK LTD
2022-514 01/20/2022 Mowry, Frank
2022-515 01/20/2022 FDAZILLA
2022-516 01/20/2022 FDAZILLA

2022-517 01/20/2022 FDAZILLA
2022-518 01/20/2022 FDAZILLA
2022-519 01/20/2022 FDAZILLA
2022-520 01/20/2022 FDAZILLA
2022-521 01/20/2022 FDAZILLA
2022-522 01/21/2022 Sus Marie

2022-524 01/21/2022 Teva Pharmaceuticals, Inc.
2022-525 01/21/2022 Holly, Caitlin

2022-526 01/21/2022 N/A
2022-527 01/21/2022 Isaac Rose
2022-528 01/21/2022 Baker Hostetler
2022-531 01/21/2022 Services Co, LLC
2022-532 01/21/2022 WHOLE FOODS MARKET, INC.


2022-535 01/21/2022 LLP
2022-536 01/21/2022 SSA
2022-537 01/21/2022 Donaldson and Weston, PA
2022-538 01/21/2022 Donaldson and Weston, PA
2022-539 01/21/2022 Miller, Tariq


2022-541 01/21/2022 Reath, LLP
2022-543 01/21/2022 MICHELLE E DOLAN
2022-544 01/21/2022 N/A
2022-545 01/21/2022 Satsuma Pharmaceuticals
2022-546 01/21/2022 BOSTON SCIENTIFIC

The New York Times
2022-547 01/24/2022 Company

2022-550 01/24/2022 PLASIL, DAVID M

2022-551 01/24/2022 AIUM
2022-552 01/24/2022 AIUM
2022-553 01/24/2022 AIUM
2022-554 01/24/2022 AIUM
2022-555 01/24/2022 AIUM
2022-556 01/24/2022 Shape Memory Medical
2022-557 01/24/2022 Sorgi, Leonardo S
2022-558 01/24/2022 Amusa, Gbolahan
2022-559 01/24/2022 Cole, Savannah C

2022-560 01/24/2022 Cole, Savannah C
2022-561 01/24/2022 Cole, Savannah C
Gordon & Rees, Scully,

2022-562 01/24/2022 Mansukhani
2022-563 01/24/2022 Mansukhani
2022-564 01/24/2022 Cole, Savannah C
2022-565 01/24/2022 Mansukhani
2022-566 01/24/2022 Mansukhani
2022-567 01/24/2022 Mansukhani
2022-568 01/24/2022 LARKIN, LOREN
2022-569 01/24/2022 Eosera Inc
2022-570 01/24/2022 Medtronic Inc. - Swinnea

2022-573 01/24/2022 Cole, Savannah C

2022-574 01/24/2022 Mansukhani
2022-575 01/24/2022 Cole, Savannah C
2022-577 01/25/2022 CBio-X
Hong Kong University of

2022-578 01/25/2022 Science and Technology
2022-579 01/25/2022 REACH24H USA INC.
2022-580 01/25/2022 May Oberfell Lorber

2022-581 01/25/2022 James Colvin
2022-582 01/25/2022 PORZIO LIFE SCIENCES
2022-583 01/25/2022 Dell & Dean
2022-584 01/25/2022 Gimopharm

2022-585 01/25/2022 Michael Best & Friedrich LLP
2022-586 01/25/2022 Northgate Gonzalez, LLC
2022-587 01/25/2022 Syprosoft Inc.
2022-588 01/25/2022 Swiss American CDMO, LLC
2022-590 01/25/2022 FDAZILLA
2022-591 01/25/2022 FDAZILLA
2022-592 01/25/2022 FDAZILLA
2022-593 01/25/2022 FDAZILLA
2022-594 01/25/2022 FDAZILLA
2022-595 01/25/2022 FDAZILLA

2022-596 01/25/2022 FDAZILLA
2022-597 01/25/2022 FDAZILLA

2022-598 01/25/2022 FDAZILLA
2022-599 01/25/2022 FDAZILLA
2022-600 01/25/2022 FDAZILLA
2022-601 01/25/2022 FDAZILLA
2022-603 01/25/2022 Schuster, Glenn

2022-604 01/25/2022 BERMAN AND COMPANY
2022-605 01/25/2022 Ropi Distribution INC
2022-606 01/25/2022 COHEN, JEFFREY M
2022-610 01/25/2022 Frier Levitt
2022-611 01/25/2022 Frier Levitt

2022-612 01/25/2022 Frier Levitt
2022-613 01/25/2022 Frier Levitt
2022-614 01/25/2022 Frier Levitt

2022-615 01/25/2022 SANDS ANDERSON PC
2022-619 01/26/2022 FOI Services, Inc.
2022-620 01/26/2022 Dowd LLP
2022-621 01/26/2022 The Epoch Times
2022-622 01/26/2022 McCray, Emanuel
2022-624 01/26/2022 Stinson LLP
2022-625 01/26/2022 The Epoch Times
2022-627 01/26/2022 FOI Services, Inc.
2022-628 01/26/2022 ProMed Molded Products

2022-629 01/26/2022 Kahle, Carla
2022-630 01/26/2022 Sullivan, LLP
2022-631 01/26/2022 The Epoch Times
Empower Oversight
2022-632 01/26/2022 Whistleblowers & Research
2022-633 01/26/2022 Hogan Lovells
2022-635 01/26/2022 TOM'S HARDWARD
2022-636 01/26/2022 TEGNA

2022-637 01/27/2022 N/A
2022-638 01/27/2022 The Flyover Report
2022-639 01/27/2022 FOIA GROUP INC

2022-640 01/27/2022 AK & MN BioFarm Co., Ltd.
2022-641 01/27/2022 Jeffrey Luck

2022-642 01/27/2022 none
CITIZENS COMMISSION ON
HUMAN RIGHTS
2022-643 01/27/2022 INTERNATIONAL
Zeiler Floyd Zadkovich (US)
2022-644 01/27/2022 LLP
Jeoffrey L. Burtch, Chapter 7

Trustee of EuCyt
Laboratories, LLC, Case 20-
13181-CSS, United States
Bankruptcy Court, District of
2022-645 01/27/2022 Delaware
2022-646 01/27/2022 PharmEng Technology
2022-647 01/27/2022 TruthCures

THE JOHNS HOPKINS
2022-648 01/27/2022 UNIVERSITY

2022-649 01/27/2022 Street Journal
2022-650 01/27/2022 Karl Nobert
2022-651 01/27/2022 Bloomberg News
2022-652 01/27/2022 Karl Nobert

2022-653 01/27/2022 US Biotest, Inc.
2022-656 01/27/2022 Evans, Shasta

2022-657 01/27/2022 Melton, Donavan
2022-658 01/27/2022 Melton, Donavan
2022-659 01/27/2022 THOMSON REUTERS
2022-660 01/27/2022 FDAZILLA
2022-662 01/27/2022 FDAZILLA
2022-663 01/27/2022 FDAZILLA

2022-664 01/27/2022 FDAZILLA
2022-665 01/27/2022 Taft Stettinius & Hollister, LLP
2022-666 01/27/2022 none
2022-667 01/27/2022 Sheffield, Jason

2022-668 01/27/2022 FOI Services, Inc.
2022-669 01/27/2022 Globizz Corp.

2022-670 01/27/2022 FDA NEWS
2022-671 01/27/2022 FDA NEWS
2022-672 01/27/2022 DAVENPORT, DONNA A
2022-673 01/27/2022 Cipla USA, Inc.
2022-674 01/27/2022 Vince Ettare
2022-676 01/27/2022 Servier Pharmaceuticals, LLC

2022-677 01/27/2022 FOI Services, Inc.
2022-678 01/27/2022 FOI Services, Inc.
2022-679 01/27/2022 FOI Services, Inc.
2022-680 01/27/2022 FOI Services, Inc.
2022-681 01/27/2022 FOI Services, Inc.
2022-682 01/27/2022 FOI Services, Inc.
2022-683 01/27/2022 FOI Services, Inc.
2022-684 01/27/2022 FOI Services, Inc.
2022-685 01/27/2022 FOI Services, Inc.
2022-686 01/27/2022 FOI Services, Inc.

2022-687 01/27/2022 FOI Services, Inc.
2022-688 01/27/2022 FOI Services, Inc.

2022-689 01/27/2022 Regulatory Mark
The New York Times

2022-690 01/28/2022 Company
2022-691 01/28/2022 Duty, Harry
2022-692 01/28/2022 Duty, Harry
2022-693 01/28/2022 HARPER, LISA M
2022-694 01/28/2022 HARPER, LISA M

2022-695 01/28/2022 Duty, Harry
2022-696 01/28/2022 Duty, Harry

2022-697 01/28/2022 Regunalys LLC
2022-698 01/28/2022 FDAZILLA
2022-699 01/28/2022 FDAZILLA

2022-700 01/28/2022 Dymedix Diagnostics, Inc.
2022-701 01/28/2022 Juice Roll-Upz, Inc.

Deerland Probiotics and
2022-703 01/28/2022 Enzymes
2022-705 01/28/2022 Magnetic Insight, Inc.
2022-706 01/28/2022 CHICAGO TRIBUNE

2022-707 01/28/2022 Magnetic Insight, Inc.


2022-712 01/28/2022 Babula, Megan
2022-713 01/28/2022 Lupetin & Unatin, LLC
2022-714 01/31/2022 FOI Services, Inc.
2022-715 01/31/2022 FOI Services, Inc.

2022-716 01/31/2022 FOI Services, Inc.
2022-717 01/31/2022 GRAS Associates, LLC.
2022-718 01/31/2022 FOI Services, Inc.
2022-719 01/31/2022 American Vapor Inc
2022-720 01/31/2022 FDAZILLA

John Dichiara & Associates
2022-722 01/31/2022 LLC
2022-723 01/31/2022 FDAZILLA
2022-724 01/31/2022 FDAZILLA

2022-725 01/31/2022 FOI Services, Inc.
2022-727 01/31/2022 FDAZILLA

2022-730 01/31/2022 Delfina Care Inc
2022-731 01/31/2022 FDAZILLA
2022-732 01/31/2022 FDAZILLA
2022-733 01/31/2022 FDAZILLA
2022-734 01/31/2022 FDAZILLA
2022-735 01/31/2022 FDAZILLA
2022-736 02/01/2022 N/A
2022-737 02/01/2022 Gleason Flynn Emig & McAfee

2022-749 02/01/2022 FDA NEWS
2022-750 02/01/2022 FDA NEWS
2022-751 02/01/2022 FDA NEWS
2022-752 02/01/2022 FDA NEWS
2022-753 02/01/2022 FDA NEWS
2022-754 02/01/2022 FDA NEWS
2022-755 02/01/2022 FDA NEWS
2022-756 02/01/2022 FDA NEWS
2022-757 02/01/2022 HEWLETT, IRIS

2022-773 02/01/2022 Mark S. Godec, MD

2022-774 02/01/2022 Taft Stettinius & Hollister, LLP
2022-775 02/01/2022 Cipla USA, Inc.

2022-776 02/01/2022 P.C. (Karla L. Palmer)
2022-777 02/01/2022 Pez Volador S.A.

Hikma Pharmaceuticals USA
2022-778 02/01/2022 Inc.
Taro Pharmaceuticals U.S.A.,

2022-780 02/01/2022 Inc.
2022-781 02/01/2022 Claudia R. Morris, MD
Therapeutics, and Law at
2022-783 02/01/2022 Bloomberg News
2022-784 02/01/2022 Engstrom, Lipscomb & Lack
2022-785 02/01/2022 Girnun, Geoffrey

2022-786 02/01/2022 Dell & Dean
2022-787 02/01/2022 Duty, Harry

2022-789 02/01/2022 Wilson, Bobbi J
2022-790 02/01/2022 MICHAEL BEST & FRIEDRICH
2022-791 02/01/2022 PETERSON, REBECCA
2022-792 02/01/2022 KNOBBE MARTENS
2022-793 02/01/2022 FOI Services, Inc.
2022-794 02/01/2022 FOI Services, Inc.
2022-795 02/01/2022 FOI Services, Inc.
2022-797 02/01/2022 FOI Services, Inc.

2022-798 02/01/2022 FDAZILLA
2022-799 02/01/2022 American Regent LLC
2022-800 02/01/2022 Baker Hostetler

2022-804 02/01/2022 Bloomberg News
2022-805 02/01/2022 BLOOMBERG NEWS

2022-806 02/01/2022 Street Journal
Department of Neurology,
2022-807 02/01/2022 Bispebjerg Hospital

2022-809 02/01/2022 Wilson Kehoe Winingham LLC
American Regent Animal

2022-812 02/01/2022 Health
2022-814 02/01/2022 MAILIS PONCET
2022-815 02/01/2022 C, Victor
2022-816 02/01/2022 Aurora

2022-817 02/01/2022 Bao, Jian
2022-818 02/01/2022 University of King's College
2022-821 02/01/2022 CLINUVEL, INC.
Jiangsu Hengrui
2022-822 02/01/2022 Pharmaceuticals Co.,Ltd
2022-824 02/02/2022 SAS
THOMSON REUTERS COURT
2022-825 02/02/2022 EXPRESS

2022-826 02/02/2022 SAS

2022-827 02/02/2022 SAS
2022-828 02/02/2022 FOI Services, Inc.
2022-829 02/02/2022 Star Therapeutics

2022-830 02/02/2022 Impel Neuropharma
2022-831 02/02/2022 Impel Neuropharma

2022-832 02/02/2022 Dr Ajay Phadke

2022-834 02/02/2022 FDAZILLA
2022-835 02/02/2022 FDAZILLA
2022-836 02/02/2022 FDAZILLA
2022-837 02/02/2022 FDAZILLA
2022-838 02/02/2022 FDAZILLA
2022-839 02/02/2022 FDAZILLA
2022-840 02/02/2022 FDAZILLA

2022-841 02/02/2022 Holub, David
2022-842 02/02/2022 Collins, Viola H
2022-844 02/02/2022 FDAZILLA

3M Company/ 3M Health
2022-845 02/02/2022 Care
2022-846 02/02/2022 EXPRESS
2022-848 02/02/2022 Delegat USA
2022-849 02/02/2022 CAS

WINTHROP UNIVERSITY
2022-850 02/02/2022 HOSPITAL
2022-851 02/02/2022 IPD Analytics, LLC

Lind Jensen Sullivan &
2022-852 02/02/2022 Peterson, P.A.
Daicel Chiral Technologies Pvt
2022-853 02/02/2022 Ltd
2022-854 02/02/2022 Aspen Surgical
2022-855 02/02/2022 Insider
2022-856 02/02/2022 Fdalytics
2022-857 02/02/2022 Sung Chun Kim, Esq.
2022-858 02/02/2022 ZUCKERMAN SPAEDER LLP
2022-859 02/02/2022 Becker Data USA, LLC

2022-860 02/02/2022 Registrar Corp.
2022-861 02/02/2022 Registrar Corp.
2022-862 02/02/2022 Regunalys LLC
2022-863 02/02/2022 FOI Services, Inc.
2022-864 02/02/2022 FOI Services, Inc.
2022-865 02/02/2022 Everpoint Asset Management
2022-866 02/02/2022 STERIS CORP
2022-867 02/02/2022 Registrar Corp.

2022-868 02/02/2022 Walker, Joseph
2022-869 02/02/2022 The Epoch Times
Shenandoah University,
Bernard J. Dunn School of
2022-870 02/02/2022 Pharmacy
Cleveland Clinic Foundation
2022-871 02/02/2022 Taussig Cancer Institute
2022-872 02/02/2022 Rocket Medical Plc
2022-873 02/02/2022 Cassidy Robinson
2022-874 02/02/2022 FDAZILLA
2022-875 02/02/2022 FDAZILLA
2022-876 02/02/2022 FDAZILLA
2022-877 02/02/2022 FDAZILLA
2022-878 02/02/2022 FDAZILLA
2022-879 02/02/2022 FDAZILLA
2022-880 02/02/2022 FDAZILLA
2022-881 02/02/2022 FDAZILLA

2022-885 02/03/2022 BETTER BUSINESS BUREAU
2022-886 02/03/2022 Eminence Capital
2022-887 02/03/2022 STERIS CORP
2022-888 02/03/2022 Jabil Inc.

Hongray (USA Medical
2022-889 02/03/2022 Products Inc.
2022-890 02/03/2022 RKW, LLC
2022-891 02/03/2022 Globizz Corp.

2022-892 02/03/2022 Globizz Corp.
2022-893 02/03/2022 Johnson & Martin, P.A.
2022-894 02/03/2022 Northwest Clinical Trials, Inc.

McGuff Compounding
2022-897 02/03/2022 Pharmaceutical Services, Inc
2022-898 02/03/2022 Zinpro Corporation
2022-900 02/03/2022 MapLight Therapeutics, Inc.
2022-904 02/03/2022 Pomerantz, LLP

2022-905 02/03/2022 Ka Lo
2022-906 02/03/2022 Levi & Korsinsky LLP

2022-907 02/03/2022 Lori Bucci
2022-908 02/03/2022 Defending the Republic
2022-909 02/03/2022 Patel, Amar

2022-910 02/04/2022 Cropper, Neal
2022-912 02/04/2022 Cropper, Neal

2022-914 02/04/2022 Grossmann LLP
2022-915 02/04/2022 Nahar, Keshav
2022-916 02/04/2022 Anderson, Derry
2022-917 02/04/2022 Anderson, Derry

2022-919 02/04/2022 Buhler UK

A. Stein - Regulatory Affairs
2022-922 02/04/2022 Consulting Ltd.
2022-923 02/04/2022 PASSY-MUIR, INC.
2022-924 02/04/2022 Chemie-Technik GmbH

2022-925 02/04/2022 Hogan Lovells
2022-926 02/04/2022 Merchant & Gould P.C.
2022-929 02/04/2022 Merchant & Gould P.C.

2022-930 02/04/2022 Onkos Surgical
2022-931 02/04/2022 Hogan Lovells
2022-932 02/04/2022 Hogan Lovells
2022-934 02/04/2022 Bloomberg News

2022-935 02/04/2022 Bloomberg News
2022-936 02/04/2022 Reuters News
Unreported Truths
2022-937 02/04/2022 (newsletter)
2022-938 02/04/2022 FITZGERALD, STEVEN
2022-939 02/04/2022 Miller, Jennifer

2022-940 02/04/2022 Covidien, LLC

2022-941 02/04/2022 Dowd LLP
2022-942 02/04/2022 Entwistle & Cappucci LLP

2022-943 02/04/2022 Dowd LLP
2022-944 02/04/2022 FOI Services, Inc.
2022-945 02/04/2022 FOI Services, Inc.
2022-946 02/04/2022 FOI Services, Inc.
2022-947 02/04/2022 FOI Services, Inc.
2022-948 02/04/2022 FOI Services, Inc.

2022-949 02/04/2022 FOI Services, Inc.
2022-950 02/04/2022 FOI Services, Inc.
2022-951 02/04/2022 FOI Services, Inc.
2022-952 02/04/2022 FOI Services, Inc.
2022-953 02/04/2022 FOI Services, Inc.
2022-954 02/04/2022 FOI Services, Inc.
2022-955 02/04/2022 FOI Services, Inc.
2022-956 02/04/2022 FOI Services, Inc.
2022-957 02/04/2022 FOI Services, Inc.
2022-958 02/04/2022 FOI Services, Inc.
2022-959 02/04/2022 FOI Services, Inc.

2022-960 02/04/2022 FOI Services, Inc.
2022-961 02/04/2022 FOI Services, Inc.
2022-962 02/04/2022 FOI Services, Inc.
2022-963 02/04/2022 FOI Services, Inc.
2022-964 02/04/2022 Incyte Corporation

2022-966 02/04/2022 THERESA VOLLMUTH
2022-967 02/04/2022 THERESA VOLLMUTH
2022-968 02/07/2022 FOI Services, Inc.
2022-969 02/07/2022 NOLA LLC

2022-973 02/07/2022 The Epoch Times
2022-974 02/07/2022 The Epoch Times

2022-975 02/07/2022 The Epoch Times
2022-976 02/07/2022 The Epoch Times
2022-977 02/07/2022 The Epoch Times

2022-978 02/07/2022 The Epoch Times
2022-979 02/07/2022 The Epoch Times
2022-980 02/07/2022 Aurora
2022-981 02/07/2022 Chartwell Scheduled, LLC
2022-982 02/07/2022 Jubilant Radiopharma

2022-983 02/07/2022 Leason Ellis LLP
2022-984 02/07/2022 Pharmavite LLC

2022-985 02/07/2022 Tracy Fischer
2022-986 02/07/2022 Monteris Medical
Costco Wholesale
2022-987 02/07/2022 Corporation
2022-988 02/07/2022 Athyna Pharma LLC
2022-989 02/07/2022 Teva Pharmaceuticals
2022-991 02/07/2022 Balzarini Jr, Edward J
2022-992 02/07/2022 Kline & Specter, PC

2022-993 02/07/2022 CLINUVEL, INC.
2022-994 02/07/2022 The Canine Review
2022-995 02/07/2022 The Canine Review

2022-996 02/07/2022 Sons of Liberty
2022-997 02/07/2022 FDAZILLA
2022-998 02/07/2022 FDAZILLA
2022-999 02/07/2022 FDAZILLA
2022-1000 02/07/2022 FDAZILLA
2022-1001 02/07/2022 FDAZILLA
2022-1002 02/07/2022 McGurrin, Theodore C
2022-1003 02/07/2022 Provepharm Inc
2022-1005 02/07/2022 McGinnis, Joseph F
2022-1006 02/07/2022 N/A

2022-1007 02/07/2022 Actalent
2022-1008 02/08/2022 FOI Services, Inc.
2022-1009 02/08/2022 FOI Services, Inc.

2022-1010 02/08/2022 Street Journal
2022-1011 02/08/2022 PROPHARMA GROUP

2022-1012 02/08/2022 Street Journal
2022-1013 02/08/2022 FDAZILLA
2022-1014 02/08/2022 FDAZILLA
2022-1015 02/08/2022 FDAZILLA
2022-1016 02/08/2022 FDAZILLA

2022-1017 02/08/2022 Antonio Johnson
2022-1018 02/08/2022 FDAZILLA
2022-1019 02/08/2022 SULLIVAN, ROBERT

The Law Firm of Michael S.
2022-1020 02/08/2022 Porter
2022-1021 02/08/2022 Aimmune Therapeutics Inc.

2022-1022 02/08/2022 Kevin Nichols
EHESS (Paris) ; University of

2022-1023 02/08/2022 Chicago
Shenzhen Jumper Medical

2022-1024 02/08/2022 Equipment Co., Ltd
2022-1025 02/08/2022 INFINITY PHARMACEUTICALS
2022-1026 02/08/2022 Provepharm Inc


2022-1032 02/08/2022 TIANNA WAYNS
2022-1033 02/09/2022 Johnson, Heidi

2022-1034 02/09/2022 Kent, Chelsea
2022-1035 02/09/2022 Johnson, Heidi
2022-1036 02/09/2022 Johnson, Heidi
2022-1037 02/09/2022 Duty, Harry

offices of Akiva M. Goldfarb
2022-1038 02/09/2022 Esq
2022-1039 02/09/2022 Umeki Funchess
2022-1040 02/09/2022 Edward Cutler
2022-1041 02/09/2022 FOI Services, Inc.

MUSCULOSKELETAL
2022-1046 02/09/2022 TRANSPLANT FOUNDATION
NACUITY PHARMACEUTICALS.
2022-1047 02/09/2022 INC.
2022-1048 02/09/2022 POLITICO
2022-1049 02/09/2022 Prinston Pharmaceutical

2022-1054 02/09/2022 Grossmann LLP
2022-1055 02/09/2022 Hogan Lovells

2022-1058 02/09/2022 Registrar Corp.

2022-1059 02/09/2022 THE NEW YORK TIMES
2022-1060 02/09/2022 AUBURN UNIVERSITY
2022-1061 02/09/2022 Daniel Piepenbring
2022-1062 02/09/2022 Cosmetic Ingredient Review
2022-1063 02/09/2022 Wake Research

2022-1064 02/09/2022 Brock, Jordan
2022-1065 02/09/2022 FIRST MANHATTAN CO

2022-1066 02/09/2022 Brock, Jordan
2022-1068 02/09/2022 POINT72

2022-1069 02/09/2022 Sustain CO2 Ltd
The Pennsylvania State
2022-1070 02/09/2022 university
2022-1071 02/09/2022 Samantha Henderson

2022-1072 02/09/2022 Lauren Davidson
2022-1073 02/09/2022 Brock, Jordan

2022-1075 02/09/2022 PcoMed LLC
2022-1076 02/09/2022 Georgetown University

2022-1077 02/09/2022 PcoMed LLC
2022-1078 02/10/2022 ET Now
Suzhou Hengrui Hongyuan
2022-1079 02/10/2022 Medical Co., Ltd
2022-1080 02/10/2022 ESCREEN

2022-1081 02/10/2022 MEDTRONIC
2022-1082 02/10/2022 MEDTRONIC
2022-1083 02/10/2022 Dowd LLP
2022-1084 02/10/2022 MEDTRONIC
2022-1085 02/10/2022 MEDTRONIC
2022-1086 02/10/2022 Casanovas, Dilan
2022-1087 02/10/2022 Sharp Law LLP

QILU PHARMACEUTICAL
2022-1088 02/10/2022 CO.,LTD.
HARE WYNN NEWELL &

2022-1089 02/10/2022 NEWTON LLP
National Council for

Prescription Drug Programs
2022-1090 02/10/2022 (NCPDP)
2022-1091 02/10/2022 knoell USA, LLC

2022-1092 02/10/2022 Damon Verial
2022-1093 02/10/2022 P.C.
2022-1094 02/10/2022 P.C.

2022-1096 02/10/2022 FOI Services, Inc.
2022-1097 02/10/2022 FDAZILLA
2022-1098 02/10/2022 FDAZILLA
2022-1100 02/10/2022 FOI Services, Inc.

2022-1102 02/10/2022 Tse-Ling Fong
2022-1103 02/10/2022 Tse-Ling Fong
2022-1104 02/10/2022 Tse-Ling Fong
2022-1105 02/10/2022 Tse-Ling Fong
2022-1106 02/10/2022 Martir, Lorenzo

WINTHROP UNIVERSITY
2022-1107 02/10/2022 HOSPITAL
2022-1108 02/10/2022 Cipla Limited
2022-1109 02/10/2022 FDAZILLA
2022-1110 02/10/2022 FDAZILLA
2022-1112 02/10/2022 HARPER'S MAGAZINE

Cohen Compagni Beckman
2022-1114 02/10/2022 Appler & Knoll, PLLC
2022-1116 02/10/2022 Walker, Joseph
French National Agency for
2022-1117 02/11/2022 Medicines (ANSM)

2022-1119 02/11/2022 PC
2022-1120 02/11/2022 LLP
2022-1121 02/11/2022 FOI Services, Inc.
2022-1122 02/11/2022 FOI Services, Inc.
2022-1123 02/11/2022 FOI Services, Inc.
2022-1124 02/11/2022 FOI Services, Inc.
2022-1125 02/11/2022 FOI Services, Inc.
2022-1126 02/11/2022 FOI Services, Inc.
2022-1127 02/11/2022 FOI Services, Inc.

2022-1128 02/11/2022 FOI Services, Inc.
2022-1129 02/11/2022 FOI Services, Inc.
2022-1130 02/11/2022 FOI Services, Inc.
2022-1131 02/11/2022 FOI Services, Inc.
2022-1132 02/11/2022 Experien Health Sciences, Inc.

Philips Medizin Systeme
2022-1133 02/11/2022 Böblingen GmbH
2022-1134 02/11/2022 John Gamberzky
2022-1135 02/11/2022 Registrar Corp
2022-1136 02/11/2022 FOI Services, Inc.
2022-1137 02/11/2022 FOI Services, Inc.

2022-1144 02/11/2022 Topco Associates, LLC
2022-1145 02/11/2022 FDAZILLA
2022-1146 02/11/2022 FDAZILLA
2022-1147 02/11/2022 FDAZILLA
2022-1148 02/11/2022 FDAZILLA

2022-1149 02/11/2022 FDAZILLA
2022-1150 02/11/2022 FDAZILLA

George Washington
2022-1151 02/11/2022 University
2022-1152 02/11/2022 Harman Finochem Limited
2022-1153 02/11/2022 NA
2022-1158 02/14/2022 The Epoch Times

2022-1159 02/14/2022 The Epoch Times
2022-1160 02/14/2022 Marquette University
2022-1161 02/14/2022 SHAPIRO HABER & URMY LLP


2022-1173 02/14/2022 AK & MN BioFarm Co., Ltd.
2022-1174 02/14/2022 FOIA GROUP INC
2022-1175 02/14/2022 FathomX Pte Ltd
2022-1176 02/14/2022 Hughes, Jennifer

2022-1178 02/14/2022 Anthony Roberts
2022-1180 02/14/2022 CUSTOMIZED BROKERS
2022-1181 02/14/2022 Owen & Owen, P.L.L.C.
2022-1182 02/14/2022 Eastman & Smith
2022-1184 02/14/2022 FOI Services, Inc.

2022-1185 02/14/2022 Services, Inc,
2022-1186 02/14/2022 FOI Services, Inc.
2022-1187 02/14/2022 FOI Services, Inc.
2022-1188 02/14/2022 FOI Services, Inc.
2022-1189 02/14/2022 FOI Services, Inc.
2022-1190 02/14/2022 FOI Services, Inc.
2022-1191 02/14/2022 FOI Services, Inc.
2022-1192 02/14/2022 FOI Services, Inc.
2022-1193 02/14/2022 FOI Services, Inc.

2022-1194 02/14/2022 FOI Services, Inc.
2022-1195 02/14/2022 KIRKLAND & ELLIS LLP
2022-1196 02/14/2022 Epiros USA LLC
2022-1198 02/14/2022 Stella Farms LLC

Fisher College of Business,
2022-1200 02/14/2022 The Ohio State University
2022-1201 02/14/2022 Anthony Roberts
2022-1202 02/14/2022 Anthony Roberts

Mirion Technologies
2022-1206 02/14/2022 (Capintec), Inc.
Bryan Cave Leighton Paisner,

2022-1207 02/14/2022 LLP
2022-1208 02/14/2022 LOUIS, RANDALL

Flier's Quality Water Systems,
2022-1209 02/14/2022 Inc.




2022-1231 02/14/2022 Kotler
2022-1234 02/14/2022 PROPHARMA GROUP
2022-1235 02/14/2022 MERCK KGAA
2022-1237 02/14/2022 FDAZILLA

2022-1238 02/14/2022 FDAZILLA
2022-1239 02/14/2022 FDAZILLA
2022-1240 02/14/2022 FDAZILLA
2022-1241 02/14/2022 Christine Stephenson
IDORSIA CLINICAL
2022-1242 02/14/2022 DEVELOPMENT US
2022-1243 02/15/2022 FDAZILLA
2022-1244 02/15/2022 FDAZILLA
2022-1245 02/15/2022 FDAZILLA
2022-1246 02/15/2022 FDAZILLA

2022-1248 02/15/2022 Melanie Burkhold
2022-1250 02/15/2022 Biological E Limited
2022-1251 02/15/2022 Borderless MedDev, LLC

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2022-1255 02/15/2022 UNIVERSITY OF IOWA

2022-1257 02/15/2022 Caribbean Appetizers
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2022-1259 02/15/2022 Mark S. Godec, MD
2022-1261 02/15/2022 FDAZILLA
2022-1262 02/15/2022 FDAZILLA
2022-1263 02/15/2022 FDAZILLA
2022-1264 02/15/2022 FDAZILLA
2022-1265 02/15/2022 FDAZILLA

2022-1266 02/15/2022 FDAZILLA

FAVUS INSTITUTIONAL
2022-1268 02/16/2022 RESEARCH LLC

FAVUS INSTITUTIONAL
2022-1270 02/16/2022 RESEARCH LLC
FAVUS INSTITUTIONAL
2022-1271 02/16/2022 RESEARCH LLC
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2022-1272 02/16/2022 RESEARCH LLC
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2022-1273 02/16/2022 LLP (shanghai)
2022-1274 02/16/2022 Bridger Healthcare

2022-1275 02/16/2022 Duty, Harry
2022-1276 02/16/2022 Duty, Harry
2022-1277 02/16/2022 The Epoch Times
2022-1278 02/16/2022 The Epoch Times
2022-1279 02/16/2022 The Epoch Times
2022-1280 02/16/2022 The Epoch Times
2022-1281 02/16/2022 The Epoch Times
2022-1282 02/16/2022 Altasciences

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UGA Regulatory Affairs
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POINT72 ASSET
2022-1303 02/16/2022 MANAGEMENT LP
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2022-1306 02/16/2022 LLC

2022-1309 02/16/2022 xiaodongjuan
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2022-1310 02/16/2022 Immunalysis Corporation



2022-1332 02/16/2022 KEYS 22458-017, CLAY
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2022-1336 02/17/2022 FOI Services, Inc.
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2022-1346 02/17/2022 FOI Services, Inc.
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2022-1351 02/17/2022 FOI Services, Inc.
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2022-1357 02/17/2022 Kite Pharma

2022-1358 02/17/2022 FDA NEWS

2022-1360 02/17/2022 LLP (shanghai)
2022-1361 02/17/2022 BLOOMBERG NEWS
2022-1362 02/17/2022 Berkeley Research Group
2022-1363 02/17/2022 Zense Life, Inc

Indiana University,
2022-1364 02/17/2022 Bloomington
2022-1365 02/17/2022 Bloomberg News
2022-1366 02/17/2022 Walker, Joseph
2022-1368 02/17/2022 Asheville Legal

2022-1369 02/17/2022 Eastman & Smith
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2022-1370 02/17/2022 Rothenberg
2022-1371 02/17/2022 Moon, Sharon
2022-1372 02/17/2022 Eastman & Smith

2022-1373 02/17/2022 Dalia Monassebian
2022-1374 02/17/2022 STERIS CORP
2022-1375 02/17/2022 Labaton Sucharow LLP
2022-1376 02/17/2022 Douglas Barasatian
2022-1377 02/17/2022 ADAM BRENNER

2022-1380 02/18/2022 FDA NEWS
2022-1381 02/18/2022 FDA NEWS
2022-1382 02/18/2022 FDA NEWS
2022-1383 02/18/2022 FDA NEWS
2022-1384 02/18/2022 FDA NEWS
2022-1385 02/18/2022 FDA NEWS
MALLINCKRODT
2022-1386 02/18/2022 PHARMACEUTICALS
2022-1387 02/18/2022 FDA NEWS
2022-1388 02/18/2022 Life Extension
2022-1389 02/18/2022 LIFE EXTENSION

2022-1390 02/18/2022 LIFE EXTENSION
2022-1391 02/18/2022 Life Extension
2022-1392 02/18/2022 LIFE EXTENSION

2022-1393 02/18/2022 FDA NEWS
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2022-1397 02/18/2022 FOI Services, Inc.
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2022-1402 02/18/2022 FDAZILLA
2022-1403 02/18/2022 FDAZILLA
2022-1404 02/18/2022 FDAZILLA

2022-1405 02/18/2022 FDAZILLA
2022-1406 02/18/2022 FDAZILLA
2022-1407 02/18/2022 FDAZILLA
2022-1408 02/18/2022 The Epoch Times

2022-1410 02/18/2022 Sonin & Genis
2022-1411 02/18/2022 PilieroMazza
2022-1412 02/18/2022 Copenhagen Businss School
2022-1413 02/18/2022 Claire McNamara
2022-1415 02/18/2022 Raley's

2022-1416 02/18/2022 Rama Rao
2022-1417 02/18/2022 Tanner, Nancy
2022-1418 02/18/2022 Tanner, Nancy

2022-1419 02/18/2022 Tanner, Nancy
2022-1420 02/22/2022 FDAZILLA
2022-1421 02/22/2022 FDAZILLA
2022-1422 02/22/2022 FDAZILLA
2022-1423 02/22/2022 FDAZILLA
2022-1424 02/22/2022 FDAZILLA
2022-1425 02/22/2022 FDAZILLA

2022-1426 02/22/2022 FDAZILLA
2022-1427 02/22/2022 FDAZILLA
2022-1428 02/22/2022 FDAZILLA
2022-1429 02/22/2022 FDAZILLA
2022-1430 02/22/2022 FDAZILLA
BIOLOGICS CONSULTING
2022-1431 02/22/2022 GROUP
2022-1432 02/22/2022 GROUP
2022-1433 02/22/2022 Fdalytics
2022-1434 02/22/2022 GROUP
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2022-1436 02/22/2022 Vascular Sciences
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2022-1438 02/22/2022 Palladio BioSciences

2022-1440 02/22/2022 MEDTRONIC
2022-1441 02/22/2022 SHEPPARD MULLIN ET AL
2022-1443 02/22/2022 GO LAW OFFICES
SURFING MEDICINE
2022-1446 02/22/2022 INTERNATIONAL 501(c)(3)
2022-1447 02/22/2022 The Epoch Times
2022-1448 02/22/2022 The Epoch Times
2022-1449 02/22/2022 The Epoch Times
2022-1450 02/22/2022 The Epoch Times



SURFING MEDICINE
2022-1455 02/22/2022 INTERNATIONAL 501(c)(3)
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2022-1461 02/22/2022 USA Today Network
2022-1462 02/22/2022 The Epoch Times
2022-1463 02/22/2022 CNN
2022-1464 02/22/2022 CNN
2022-1465 02/22/2022 CNN
2022-1466 02/22/2022 Parth Desai
2022-1467 02/22/2022 Stinson LLP
2022-1468 02/22/2022 Seave, Paul L
2022-1469 02/22/2022 Chitra Nidadavolu

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2022-1473 02/22/2022 FOX13
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2022-1477 02/22/2022 THE WASHINGTON POST
2022-1478 02/22/2022 William Brown
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2022-1479 02/22/2022 Limited
2022-1480 02/22/2022 Sanchez-Echevarria, Diana
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2022-1483 02/22/2022 FDAZILLA
2022-1484 02/22/2022 FDAZILLA
2022-1485 02/22/2022 FDAZILLA
2022-1486 02/22/2022 Huntsman Europe BV

2022-1487 02/22/2022 FDAZILLA
2022-1488 02/22/2022 FDAZILLA

2022-1489 02/22/2022 Philip W. Appel, Ph.D.,
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2022-1491 02/23/2022 FDAZILLA
2022-1492 02/23/2022 FDAZILLA
2022-1493 02/23/2022 Sheffield Pharmaceuticals LLC

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2022-1499 02/23/2022 ROONEY PC
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2022-1511 02/24/2022 PC
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2022-1515 02/24/2022 EXPRESS
2022-1516 02/24/2022 Luminate Medical Inc
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2022-1519 02/24/2022 TurtleTree
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2022-1528 02/24/2022 Ultragenyx Pharmaceutical
2022-1529 02/24/2022 Swansea University
2022-1530 02/24/2022 Consumer Reporst

2022-1531 02/24/2022 Street Journal

2022-1532 02/24/2022 Street Journal

2022-1533 02/24/2022 Street Journal
2022-1534 02/24/2022 CAS

2022-1535 02/24/2022 Levin Papantonio Rafferty
2022-1536 02/24/2022 Innovative Healthy Solutions
2022-1537 02/24/2022 DeBeer, John

US Air Force - Wright
2022-1539 02/24/2022 Patterson Medical Facility
2022-1540 02/24/2022 Calpro AS

Primus Corporation dba
2022-1541 02/24/2022 Trinity Biotech
2022-1544 02/24/2022 Pura Vida Investments
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2022-1546 02/25/2022 FOI Services, Inc.
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2022-1551 02/25/2022 FOI Services, Inc.
2022-1552 02/25/2022 FOI Services, Inc.
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2022-1554 02/25/2022 FOI Services, Inc.
2022-1555 02/25/2022 FOI Services, Inc.
2022-1556 02/25/2022 FOI Services, Inc.
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2022-1559 02/25/2022 Evans, Shasta
2022-1560 02/25/2022 Evans, Shasta

2022-1561 02/25/2022 Duty, Harry
2022-1562 02/25/2022 Kent, Chelsea
2022-1563 02/25/2022 Kent, Chelsea

2022-1564 02/25/2022 Duty, Harry
2022-1565 02/25/2022 Duty, Harry

2022-1566 02/25/2022 Kent, Chelsea
2022-1567 02/25/2022 Cropper, Neal
2022-1568 02/25/2022 Thixton, Susan
2022-1569 02/25/2022 Melton, Donavan

2022-1570 02/25/2022 Melton, Donavan
2022-1573 02/25/2022 FOI Services, Inc.

2022-1574 02/25/2022 Becker Data USA, LLC
2022-1575 02/25/2022 FDAZILLA
2022-1576 02/25/2022 FDAZILLA
2022-1577 02/25/2022 FDAZILLA
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2022-1581 02/25/2022 BioTex, Inc.
2022-1582 02/25/2022 Anushka Raut

2022-1583 02/25/2022 MPM ADVISORS
2022-1584 02/25/2022 Cocchiaraley, Christopher
2022-1585 02/25/2022 Cocchiaraley, Christopher
2022-1586 02/25/2022 Clearlab US INC

2022-1587 02/25/2022 SAS

Swedish Match North
2022-1590 02/25/2022 America, LLC
2022-1591 02/25/2022 The Epoch Times
2022-1592 02/25/2022 The Epoch Times

2022-1593 02/25/2022 The Epoch Times
2022-1594 02/25/2022 The Epoch Times
2022-1595 02/25/2022 The Epoch Times
2022-1596 02/28/2022 FOI Services, Inc.
2022-1597 02/28/2022 FOI Services, Inc.
2022-1598 02/28/2022 TurtleTree
2022-1599 02/28/2022 TurtleTree
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2022-1601 02/28/2022 FOI Services, Inc.
2022-1602 02/28/2022 TurtleTree
2022-1603 02/28/2022 Remy Stihl

2022-1604 02/28/2022 Swedish Match Company
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2022-1606 02/28/2022 FOI Services, Inc.
2022-1607 02/28/2022 FOI Services, Inc.
2022-1608 02/28/2022 FOI Services, Inc.
2022-1609 02/28/2022 Netta Hirshberg
2022-1610 02/28/2022 Netta Hirshberg
2022-1611 02/28/2022 NSF International

2022-1612 02/28/2022 porters
2022-1613 03/01/2022 Patt, Tyce A
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Professionals for
2022-1614 03/01/2022 Transparency
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2022-1615 03/01/2022 PHARMACEUTICALS INC

2022-1617 03/01/2022 Lacteossa
2022-1618 03/01/2022 FOI Services, Inc.
2022-1623 03/01/2022 The Epoch Times
2022-1624 03/01/2022 The Epoch Times

2022-1625 03/01/2022 The Epoch Times

2022-1627 03/01/2022 SAS

2022-1628 03/01/2022 SAS
2022-1629 03/01/2022 SAS

2022-1631 03/01/2022 SAS

2022-1632 03/01/2022 SAS

2022-1633 03/01/2022 SAS

2022-1634 03/01/2022 SAS

2022-1636 03/01/2022 SAS
2022-1637 03/01/2022 SAS

2022-1638 03/01/2022 SAS

2022-1639 03/01/2022 SAS

2022-1640 03/01/2022 SAS
2022-1641 03/01/2022 Regunalys LLC

2022-1642 03/01/2022 SAS

2022-1643 03/01/2022 SAS

2022-1644 03/01/2022 SAS
2022-1645 03/01/2022 SAS

2022-1646 03/01/2022 SAS

2022-1647 03/01/2022 SAS

2022-1648 03/01/2022 SAS

2022-1649 03/01/2022 SAS

2022-1650 03/01/2022 SAS

2022-1651 03/01/2022 SAS

2022-1652 03/01/2022 SAS
2022-1653 03/01/2022 SAS

2022-1654 03/01/2022 SAS

2022-1655 03/01/2022 SAS

2022-1656 03/01/2022 SAS

2022-1657 03/01/2022 SAS

2022-1658 03/01/2022 SAS

2022-1659 03/01/2022 SAS

2022-1660 03/01/2022 SAS
2022-1661 03/01/2022 SAS

2022-1662 03/01/2022 SAS
2022-1663 03/01/2022 FDAZILLA
2022-1664 03/01/2022 FDAZILLA
2022-1665 03/01/2022 FDAZILLA
2022-1666 03/01/2022 FDAZILLA
2022-1667 03/01/2022 FDAZILLA
2022-1668 03/01/2022 FDAZILLA
2022-1669 03/01/2022 FDAZILLA
2022-1670 03/01/2022 FDAZILLA

2022-1671 03/01/2022 FDAZILLA
2022-1672 03/01/2022 FDAZILLA
2022-1673 03/01/2022 FDAZILLA

2022-1674 03/01/2022 Bob Gordon
2022-1675 03/01/2022 Cuneo Gilbert & LaDuca, LLP

Gulf Coast Veterans
2022-1676 03/01/2022 Healthcare System
2022-1677 03/01/2022 ITG Brands, LLC

2022-1678 03/01/2022 LIVMOR.Inc.
AltaThera Pharmaceuticals
2022-1679 03/01/2022 LLC
California Western School of

2022-1680 03/01/2022 Law, San Diego, CA 92130

2022-1682 03/01/2022 Hospital
2022-1683 03/01/2022 judah wernick
2022-1684 03/01/2022 Rad Source Technologies
2022-1685 03/01/2022 Olshan Frome Wolosky LLP

2022-1686 03/01/2022 Rad Source Technologies

2022-1687 03/01/2022 SAS

2022-1688 03/01/2022 SAS

2022-1689 03/01/2022 SAS
2022-1690 03/01/2022 Altasciences COmpany Inc
2022-1692 03/01/2022 PROPHARMA GROUP

2022-1694 03/01/2022 INTERTEK
2022-1695 03/01/2022 FDAZILLA
2022-1696 03/01/2022 Services
2022-1697 03/01/2022 FDAZILLA
2022-1698 03/01/2022 FDAZILLA
2022-1699 03/01/2022 FDAZILLA
2022-1700 03/01/2022 Street Journal
2022-1701 03/01/2022 Adam Friedman
2022-1702 03/02/2022 FDAZILLA
2022-1703 03/02/2022 FDAZILLA
2022-1704 03/02/2022 FDAZILLA
2022-1705 03/02/2022 FDAZILLA
2022-1706 03/02/2022 FDAZILLA
2022-1707 03/02/2022 FDAZILLA

2022-1708 03/02/2022 FDAZILLA
2022-1709 03/02/2022 FDAZILLA
2022-1710 03/02/2022 FDAZILLA
2022-1711 03/02/2022 FDAZILLA
2022-1712 03/02/2022 FDAZILLA
2022-1713 03/02/2022 FDAZILLA
2022-1714 03/02/2022 FDAZILLA
2022-1715 03/02/2022 FDAZILLA
2022-1716 03/02/2022 FDAZILLA

2022-1717 03/02/2022 Hogan Lovells
2022-1718 03/02/2022 Travere Therapeutics
Beijing ADSS Development
2022-1719 03/02/2022 Co., Ltd.
2022-1720 03/02/2022 Natural Partners
2022-1721 03/02/2022 Diaz Trade Law, P.A.
2022-1722 03/02/2022 Copeland, Melissa
2022-1723 03/02/2022 PAUL KNOPF BIGGER

GARWIN GERSTEIN & FISHER
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2022-1725 03/02/2022 Bigtuna36, LLC
2022-1726 03/02/2022 Purple Rhino, LLC
2022-1727 03/02/2022 Amavon, LLC
2022-1728 03/02/2022 Sumbra, LLC
2022-1729 03/02/2022 Services

2022-1733 03/02/2022 WILEY REIN LLP

Laser Unit, Rabin Medical
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2022-1735 03/02/2022 N/A
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2022-1740 03/02/2022 LAW CENTER
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2022-1741 03/02/2022 LAW CENTER
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2022-1743 03/02/2022 Stephens & Miller, P.C.

2022-1745 03/02/2022 ICONN Orthopedics, LLC

2022-1746 03/02/2022 Hospital
2022-1747 03/02/2022 BLOOMBERG NEWS
Xenex Disinfection Services
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2022-1749 03/02/2022 CNN
2022-1750 03/02/2022 NBC News National
Moms for Liberty - Dutchess

2022-1753 03/02/2022 County, NY
2022-1754 03/03/2022 Duty, Harry

2022-1756 03/03/2022 CareSet Journal
2022-1757 03/03/2022 Akiva Packouz
2022-1758 03/03/2022 FOI Services, Inc.

Professional Compounding
2022-1759 03/03/2022 Centers of America (PCCA)
2022-1760 03/03/2022 LIFE EXTENSION
2022-1761 03/03/2022 LIFE EXTENSION
2022-1762 03/03/2022 TherapeuticsMD
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2022-1764 03/03/2022 Registrar Corp
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2022-1767 03/03/2022 Life Extension
2022-1768 03/03/2022 FOI Services, Inc.

2022-1769 03/03/2022 LIFE EXTENSION
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Brigham and Women's

Hospital, Division of Oral
2022-1771 03/03/2022 Medicine and Dentistry

2022-1772 03/03/2022 Hospital

2022-1773 03/03/2022 Hospital
2022-1775 03/03/2022 Conway Homer, PC
2022-1776 03/03/2022 DDSF
Mylan Laboratories Limited,
2022-1777 03/03/2022 India
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AKORN OPERATING
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2022-2314 03/28/2022 Hospital
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2022-2320 03/29/2022 DUKE UNIVERSITY

2022-2321 03/29/2022 Chefmaster
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2022-2336 03/30/2022 FDAZILLA
2022-2337 03/30/2022 FDAZILLA
2022-2338 03/30/2022 FDAZILLA
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2022-2342 03/30/2022 Distribution Corp.

2022-2343 03/30/2022 ROONEY PC
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2022-2394 04/01/2022 Par Sterile Products, LLC
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2022-2411 04/01/2022 SAS

2022-2412 04/01/2022 SAS
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2022-2418 04/01/2022 SAS
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2022-2420 04/01/2022 SAS
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2022-2426 04/01/2022 DAVIS LAW
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2022-2429 04/01/2022 Dr Ajay Phadke
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2022-2453 04/04/2022 FDAZILLA
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2022-2455 04/04/2022 Registrar Corp
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2022-2465 04/04/2022 Registrar Corp

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2022-2473 04/04/2022 John Gamberzky
2022-2474 04/04/2022 John Gamberzky
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2022-2487 04/04/2022 AskBio
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2022-2491 04/04/2022 EXPRESS
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2022-2504 04/04/2022 Fdalytics
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2022-2506 04/04/2022 Triskelion
2022-2507 04/04/2022 Triskelion

2022-2508 04/04/2022 Triskelion
2022-2509 04/04/2022 Triskelion
2022-2510 04/04/2022 Triskelion

2022-2511 04/04/2022 Triskelion
2022-2512 04/04/2022 JOSHUA DAVID DONALDSON
2022-2513 04/04/2022 BLOOMBERG NEWS

2022-2514 04/04/2022 FDAZILLA
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2022-2525 04/05/2022 LLP

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2022-2540 04/05/2022 PLC
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2022-2541 04/05/2022 School
2022-2542 04/05/2022 Dr Ajay Phadke
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2022-2543 04/06/2022 Intolerance & Racism
2022-2544 04/06/2022 FDAZILLA

2022-2545 04/06/2022 FDAZILLA

2022-2546 04/06/2022 SAS
UNIVERSITY OF CALIFORNIA
2022-2547 04/06/2022 SAN FRANCISCO
2022-2548 04/06/2022 BIOTEX INC
2022-2549 04/06/2022 BECTON DICKINSON

Oakland University William
2022-2550 04/06/2022 Beaumont school of Medi
2022-2551 04/06/2022 UNIVERSITY OF NOTRE DAME
2022-2552 04/06/2022 Geisler, Ephraim S

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2022-2556 04/06/2022 Denise Washington
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2022-2566 04/06/2022 FDAZILLA
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2022-2567 04/06/2022 LLC
2022-2568 04/06/2022 REGENESIS BIOMEDICAL INC
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2022-2595 04/07/2022 MEAD, CHRISTOPHER B
2022-2596 04/07/2022 Kemp Jones, LLP
2022-2597 04/07/2022 FDAZILLA

2022-2598 04/07/2022 FDAZILLA
2022-2599 04/07/2022 FDAZILLA
2022-2601 04/07/2022 BBC
2022-2602 04/07/2022 ShamRock LLC

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2022-2606 04/07/2022 Jennifer Bruno
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2022-2607 04/07/2022 Project, Inc
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2022-2609 04/07/2022 Smith
2022-2610 04/07/2022 Zoetis Inc.

2022-2612 04/08/2022 FOI Services, Inc.
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2022-2616 04/08/2022 Duty, Harry
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2022-2619 04/08/2022 The Epoch Times
2022-2620 04/08/2022 Duty, Harry
2022-2621 04/08/2022 Duty, Harry
2022-2622 04/08/2022 Duty, Harry
2022-2623 04/08/2022 Duty, Harry
2022-2624 04/08/2022 FDA NEWS


2022-2629 04/08/2022 Exits & Outcomes
2022-2630 04/08/2022 ZEUS SCIENTIFIC
2022-2631 04/08/2022 ETHYPHARM
Logic Technology
2022-2633 04/08/2022 Development, LLC
2022-2634 04/08/2022 LIFE EXTENSION
2022-2635 04/08/2022 Daily American

2022-2637 04/08/2022 Abbott
2022-2640 04/08/2022 Swanson, AnnMarie

2022-2641 04/11/2022 Press Trust of India (PTI)
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2022-2647 04/11/2022 LLP
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2022-2676 04/12/2022 GxpCode

2022-2677 04/12/2022 ILLINOIS STATE UNIVERSITY
2022-2678 04/12/2022 GxpCode

2022-2679 04/12/2022 FDAZILLA
2022-2680 04/12/2022 FDAZILLA
2022-2681 04/12/2022 FDAZILLA
2022-2682 04/12/2022 FDAZILLA
2022-2683 04/12/2022 Braeburn Inc.
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2022-2685 04/12/2022 FOI Services, Inc.
2022-2686 04/12/2022 Richardson, Scott
2022-2687 04/12/2022 TUCKER ELLIS LLP

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2022-2690 04/12/2022 KING & SPALDING
2022-2691 04/12/2022 KING & SPALDING
2022-2692 04/12/2022 KING & SPALDING
2022-2693 04/12/2022 KING & SPALDING
2022-2694 04/12/2022 KING & SPALDING
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2022-2713 04/12/2022 FOI Services, Inc.
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2022-2715 04/12/2022 FDAZILLA
2022-2716 04/12/2022 FDAZILLA
2022-2717 04/13/2022 FDAZILLA
2022-2718 04/13/2022 FOI Services, Inc.
2022-2719 04/13/2022 FDAZILLA
2022-2720 04/13/2022 FOI Services, Inc.
2022-2721 04/13/2022 FDAZILLA

2022-2726 04/14/2022 Brock, Ronald
2022-2727 04/14/2022 Brock, Ronald

2022-2728 04/14/2022 Regunalys LLC
2022-2729 04/14/2022 BOOTH LLP ATTORNEYS
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2022-2737 04/14/2022 CONSULTANTS LTD
2022-2738 04/14/2022 Registrar Corp
2022-2741 04/14/2022 ITG Brands, LLC
2022-2743 04/14/2022 KAHN SWICK & FOTI LLC
2022-2744 04/14/2022 BLOOMBERG NEWS
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2022-2752 04/14/2022 Phlow Corporation

2022-2754 04/14/2022 SORGI, LEONARD S
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2022-2756 04/14/2022 FDAZILLA
2022-2757 04/14/2022 FDAZILLA
2022-2758 04/14/2022 FDAZILLA

2022-2759 04/14/2022 FDAZILLA
2022-2760 04/14/2022 FDAZILLA

2022-2762 04/14/2022 FDAZILLA
2022-2764 04/14/2022 REACH24H USA INC.
2022-2765 04/14/2022 DeBeer, John
2022-2766 04/14/2022 Faruqi & Faruqi, LLP

2022-2768 04/14/2022 Colvin, Michael S
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Padagis Israel
2022-2772 04/14/2022 Pharmaceuticals Ltd.
2022-2773 04/14/2022 Caribou Biosciences
2022-2774 04/14/2022 Klarquist
2022-2775 04/14/2022 Klarquist
2022-2776 04/14/2022 Bloomberg News
2022-2778 04/15/2022 Kerensta Blacken

2022-2779 04/15/2022 Marsee, Shawn
2022-2781 04/15/2022 Jerzy Jarzabek
2022-2782 04/15/2022 FOI Services, Inc.
2022-2783 04/15/2022 THERMOFISHER SCIENTIFIC

2022-2784 04/15/2022 Beatrice Lee
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2022-2785 04/15/2022 Sanders LLP
2022-2786 04/15/2022 Pharmaceutical Specialties Inc

2022-2787 04/15/2022 Allan Bobadilla
2022-2788 04/15/2022 Odom & Des Roches LLC
2022-2789 04/15/2022 Odom & Des Roches LLC
2022-2790 04/15/2022 Johnson Fistel LLP

NATURAL PRODUCTS
2022-2791 04/15/2022 ASSOCIATION
2022-2793 04/15/2022 APOTEX CORP.

2022-2794 04/15/2022 Sanders LLP

2022-2795 04/15/2022 Inc
2022-2796 04/15/2022 Aliment, Ruby K
2022-2797 04/15/2022 Sung Chun Kim, Esq.

2022-2799 04/15/2022 WILEY REIN LLP
2022-2800 04/15/2022 Nguyen, Nick
2022-2801 04/15/2022 University of Cologne
2022-2802 04/15/2022 PilieroMazza

2022-2803 04/15/2022 PilieroMazza
MISSOURI STATE PUBLIC
2022-2804 04/15/2022 DEFENDER SYSTEM
2022-2805 04/15/2022 Hailey Weaver
2022-2806 04/15/2022 INTERTEK
2022-2807 04/18/2022 Melton, Donavan

Kurt Wallace, Professionals
2022-2808 04/18/2022 PMA
2022-2809 04/18/2022 POLITICO
2022-2810 04/18/2022 POLITICO

2022-2811 04/18/2022 POLITICO
2022-2812 04/18/2022 Norton Rose Fulbright US LLP
2022-2814 04/18/2022 BIOCENTURY
QUINTAIROS PRIETO WOOD

2022-2815 04/18/2022 & BOYER PA
2022-2816 04/18/2022 Preuss Foster
2022-2817 04/18/2022 Globizz Corp.

2022-2818 04/18/2022 Marianna Industries, Inc.
2022-2819 04/18/2022 Globizz Corp.
2022-2820 04/18/2022 Globizz Corp.
2022-2822 04/18/2022 Poly Pharmaceuticals Inc

2022-2824 04/19/2022 FDAZILLA
2022-2825 04/19/2022 FDAZILLA
2022-2826 04/19/2022 FDAZILLA
2022-2827 04/19/2022 Tuohy, Kristen L
2022-2828 04/19/2022 Hugel Aesthetics

2022-2831 04/19/2022 Larussa Pharma Consulting
2022-2832 04/19/2022 eFoodAlert
2022-2833 04/19/2022 Osypka Medtec
2022-2835 04/19/2022 DeBeer, John
2022-2836 04/19/2022 Greyscaling LLC, Diane Shoda
2022-2837 04/19/2022 Greyscaling LLC, Diane Shoda

TAKEDA PHARMACEUTICALS
2022-2838 04/19/2022 NA INC
TAKEDA PHARMACEUTICALS
2022-2839 04/19/2022 NA INC
2022-2840 04/19/2022 ShamRock Pharma LLC
2022-2841 04/19/2022 Christie Farrell Lee & Bell, P.C.
2022-2842 04/19/2022 The Levensten Law Firm, PC
2022-2843 04/19/2022 The Post and Courier

2022-2844 04/19/2022 The Post and Courier
2022-2845 04/19/2022 HELEN SANTORO
2022-2846 04/20/2022 GOULD, CARTER
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2022-2849 04/20/2022 OssDsign

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2022-2854 04/20/2022 RAY THOMPSON
2022-2855 04/20/2022 RAY THOMPSON
2022-2856 04/20/2022 RAY THOMPSON
2022-2857 04/20/2022 RAY THOMPSON
2022-2858 04/20/2022 RAY THOMPSON

2022-2859 04/20/2022 RAY THOMPSON
2022-2860 04/20/2022 Ka Lo
2022-2861 04/20/2022 RAY THOMPSON
2022-2862 04/20/2022 RAY THOMPSON
2022-2863 04/20/2022 KING & SPALDING
2022-2864 04/20/2022 KING & SPALDING
2022-2865 04/20/2022 KING & SPALDING
2022-2866 04/20/2022 KING & SPALDING
2022-2867 04/20/2022 RAY THOMPSON
2022-2868 04/20/2022 Induction Therapies, LLC
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2022-2869 04/20/2022 Methvin, Portis & Miles, P.C.

2022-2877 04/21/2022 KING & SPALDING
2022-2878 04/21/2022 Tom Sidebottom
2022-2879 04/21/2022 DIGESTIVE CARE, INC.

2022-2881 04/21/2022 Street Journal

2022-2882 04/21/2022 P.C.
2022-2884 04/21/2022 eFoodAlert
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2022-2886 04/21/2022 Biotech Square
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2022-2895 04/21/2022 Zennova LLC
2022-2896 04/21/2022 AuroMedics Pharma LLC

2022-2897 04/21/2022 Zennova LLC
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2022-2899 04/21/2022 Street Journal
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2022-2901 04/21/2022 Inc.
2022-2902 04/21/2022 FDAZILLA
2022-2903 04/21/2022 FDAZILLA
2022-2904 04/21/2022 FDAZILLA
2022-2905 04/21/2022 FDAZILLA
2022-2906 04/21/2022 FDAZILLA

2022-2908 04/21/2022 Mark S. Godec, MD
2022-2909 04/21/2022 Amavon, LLC
2022-2910 04/21/2022 FOIA GROUP INC
2022-2911 04/21/2022 FOIA GROUP INC
2022-2912 04/21/2022 FOIA GROUP INC
2022-2913 04/21/2022 FOIA GROUP INC
2022-2914 04/21/2022 FOIA GROUP INC

2022-2915 04/21/2022 FOIA GROUP INC
2022-2916 04/21/2022 Paladin Medical, Inc.
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2022-2917 04/21/2022 Équilibre Biopharmaceuticals
2022-2918 04/21/2022 STRATEC SE
2022-2919 04/21/2022 Jessica Canty

2022-2920 04/22/2022 Victor Cosentini
2022-2921 04/22/2022 Mayo Clinic

Distribuidora de Productos
2022-2922 04/22/2022 del Lago, C. A.
2022-2923 04/22/2022 Allison Herrity
2022-2924 04/22/2022 Richardson Koudelka
2022-2925 04/22/2022 Robert Coston

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2022-2926 04/22/2022 MANAGEMENT
2022-2927 04/22/2022 Walker, Joseph
2022-2928 04/22/2022 India Private Limited
2022-2929 04/22/2022 SPBMCC
2022-2930 04/22/2022 FOI Services, Inc.
2022-2931 04/22/2022 FOI Services, Inc.

2022-2932 04/22/2022 Marek, Jonathan
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2022-2934 04/22/2022 Medtrdonic
2022-2935 04/22/2022 Lupin Pharmaceuticals,Inc.

2022-2936 04/22/2022 Xttrium Laboratories, Inc.
2022-2937 04/22/2022 Ka Lo
2022-2938 04/22/2022 FOI Services, Inc.
2022-2939 04/22/2022 Kao, Owen
2022-2940 04/22/2022 OncoZenge AB
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2022-2942 04/22/2022 Goldman, PC
2022-2944 04/25/2022 Evans, Shasta
2022-2945 04/25/2022 Evans, Shasta

2022-2946 04/25/2022 N/A
2022-2948 04/25/2022 Center for Health Innovation
2022-2949 04/25/2022 Par Pharmaceuticals Inc.
2022-2950 04/25/2022 Par Pharmaceuticals Inc.
2022-2951 04/25/2022 FOI Services, Inc.
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2022-2955 04/25/2022 FOI Services, Inc.
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2022-2957 04/25/2022 FOI Services, Inc.
2022-2958 04/25/2022 FOI Services, Inc.
2022-2959 04/25/2022 FOI Services, Inc.
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2022-2961 04/25/2022 FOI Services, Inc.
2022-2962 04/25/2022 FOI Services, Inc.
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2022-2966 04/25/2022 FOI Services, Inc.
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2022-2969 04/25/2022 FOI Services, Inc.
2022-2970 04/25/2022 McDermott Will & Emery LLP
2022-2971 04/25/2022 Sumbra, LLC
2022-2972 04/25/2022 Amavon, LLC

2022-2973 04/25/2022 Bigtuna36, LLC
2022-2974 04/25/2022 Purple Rhino, LLC
2022-2975 04/25/2022 Bright Lightbulb, LLC
2022-2977 04/25/2022 Mariana Trench, LLC
2022-2979 04/25/2022 Dragon's Mouth, LLC
2022-2981 04/25/2022 Jessica Canty

2022-2982 04/25/2022 Jennifer Kubin
2022-2983 04/25/2022 DeBeer, John

2022-2984 04/25/2022 KONICA MINOLTA INC.
2022-2986 04/25/2022 emerson college
2022-2987 04/25/2022 KEYS, CLAY C
2022-2988 04/25/2022 VAPOR STOCKROOM LLC
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2022-2989 04/25/2022 KENDRICK LLP
2022-2990 04/25/2022 Jacob Thomas
2022-2991 04/26/2022 FDAZILLA
2022-2992 04/26/2022 FDAZILLA
2022-2993 04/26/2022 FDAZILLA
2022-2994 04/26/2022 FOI Services, Inc.
2022-2995 04/26/2022 RAY THOMPSON
2022-2996 04/26/2022 RAY THOMPSON
2022-2997 04/26/2022 FDAZILLA
2022-2998 04/26/2022 RAY THOMPSON
2022-2999 04/26/2022 RAY THOMPSON
2022-3000 04/26/2022 RAY THOMPSON

2022-3001 04/26/2022 RAY THOMPSON
2022-3002 04/26/2022 RAY THOMPSON
2022-3003 04/26/2022 RAY THOMPSON
2022-3004 04/26/2022 RAY THOMPSON
2022-3005 04/26/2022 RAY THOMPSON

2022-3006 04/26/2022 Felix Vega

2022-3010 04/26/2022 Spotlight on America
2022-3011 04/26/2022 Dana Allen

2022-3013 04/26/2022 BEDFONT SCIENTIFIC LTD
2022-3014 04/26/2022 Gerresheimer
2022-3015 04/26/2022 SORGI, LEONARD S
Sullivan Papain Block

McGrath Coffinas & Cannavo
2022-3016 04/26/2022 P.C.
Williams Parker Harrison
2022-3017 04/26/2022 Dietz & Getzen
2022-3018 04/26/2022 Nostrum Laboratories, Inc.

NOVEN PHARMACEUTICALS
2022-3019 04/26/2022 INC
2022-3020 04/26/2022 Regulatory Mark

2022-3021 04/26/2022 Biltmore Vape Company
2022-3022 04/26/2022 TOM SCHOSSAU
2022-3023 04/26/2022 The Washington Examiner
2022-3024 04/27/2022 Brock, Ronald
2022-3025 04/27/2022 Evans, Shasta


2022-3027 04/27/2022 SAS

2022-3028 04/27/2022 SAS
2022-3029 04/27/2022 SAS

2022-3030 04/27/2022 SAS

2022-3031 04/27/2022 SAS

2022-3032 04/27/2022 SAS

2022-3033 04/27/2022 SAS
2022-3034 04/27/2022 The American Prospect

2022-3035 04/27/2022 LLC
2022-3036 04/27/2022 LLC
2022-3037 04/27/2022 LLC
2022-3038 04/27/2022 Eclipse Design Innovation

Novus Management Group
2022-3039 04/27/2022 LLC

2022-3040 04/27/2022 Sanders LLP
2022-3041 04/27/2022 FOI Services, Inc.

2022-3043 04/27/2022 MERCHANT & GOULD
Sun Pharmaceutical
2022-3044 04/27/2022 Industries, Inc.

2022-3045 04/27/2022 SAS
2022-3046 04/27/2022 FOI Services, Inc.
2022-3047 04/27/2022 PMC Biogenix, Inc.

2022-3049 04/27/2022 MERCHANT & GOULD
2022-3050 04/27/2022 The Lange Law Firm PLLC

2022-3051 04/27/2022 The Lange Law Firm PLLC
Jiangsu Baining Yingchuang
2022-3052 04/27/2022 Technology Co., Ltd.

2022-3053 04/27/2022 SAS

2022-3054 04/27/2022 SAS

2022-3055 04/27/2022 SAS

2022-3056 04/27/2022 SAS
2022-3057 04/27/2022 BRANT A. TAYLOR 284383
2022-3058 04/27/2022 SAS

2022-3059 04/27/2022 SAS

2022-3060 04/27/2022 SAS

2022-3061 04/27/2022 SAS
Trans-Border Global Freight
2022-3062 04/27/2022 Systems
2022-3063 04/27/2022 FUND
2022-3064 04/27/2022 BROWN & CROUPPEN PC

2022-3066 04/28/2022 Eclipse Design Innovation
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2022-3068 04/28/2022 FOI Services, Inc.
2022-3069 04/28/2022 FOI Services, Inc.
2022-3071 04/28/2022 Banner & Witcoff, Ltd.

2022-3072 04/28/2022 SAS

2022-3073 04/28/2022 SAS
2022-3074 04/28/2022 SAS

2022-3075 04/28/2022 SAS

2022-3076 04/28/2022 SAS

2022-3077 04/28/2022 SAS

2022-3078 04/28/2022 SAS
2022-3079 04/28/2022 SAS

2022-3080 04/28/2022 SAS

2022-3081 04/28/2022 SAS

2022-3082 04/28/2022 SAS

2022-3083 04/28/2022 SAS
2022-3084 04/28/2022 Bloomage Biotech. Inc.

2022-3085 04/28/2022 Focus Ventures, Inc.
2022-3086 04/29/2022 FDAZILLA
2022-3087 04/29/2022 FDAZILLA

2022-3088 04/29/2022 Diane Horwitz
2022-3089 04/29/2022 eFoodAlert
2022-3090 04/29/2022 FOI Services, Inc.
2022-3091 04/29/2022 Berquist, Darron E

2022-3092 05/02/2022 FDAZILLA
2022-3096 05/02/2022 Perry, Rachel

2022-3097 05/02/2022 Services Co, LLC
2022-3098 05/02/2022 Agios Pharmaceuticals, Inc.
2022-3099 05/02/2022 Duty, Harry
2022-3100 05/02/2022 Melton, Donavan
2022-3101 05/02/2022 Oakes Group Global Ltd.
2022-3102 05/02/2022 Beausay & Nichols Law Firm
2022-3104 05/02/2022 Duty, Harry
2022-3105 05/02/2022 The Epoch Times

2022-3106 05/02/2022 SAS

2022-3107 05/02/2022 SAS
2022-3108 05/02/2022 India Limited
2022-3109 05/02/2022 WILEY REIN LLP

2022-3111 05/02/2022 FOI Services, Inc.
2022-3112 05/02/2022 Katz, Tim
2022-3113 05/02/2022 Jonathan Leung
Conventus Biomedical
2022-3116 05/02/2022 Solutions, Inc.
2022-3118 05/02/2022 OFT Law, PLLC

2022-3120 05/02/2022 EXPRESS

2022-3122 05/02/2022 Inc
2022-3123 05/02/2022 Dell Federal Systems LP
2022-3124 05/02/2022 etnow
2022-3125 05/02/2022 Servier Pharmaceutics
2022-3126 05/02/2022 FOI Services, Inc.

2022-3128 05/02/2022 FOI Services, Inc.
2022-3129 05/02/2022 FOI Services, Inc.
2022-3130 05/02/2022 FOI Services, Inc.
2022-3131 05/02/2022 FOI Services, Inc.
2022-3132 05/02/2022 FOI Services, Inc.
2022-3133 05/02/2022 FOI Services, Inc.
2022-3134 05/02/2022 FOI Services, Inc.
2022-3136 05/02/2022 ZUCKERMAN SPAEDER LLP
2022-3137 05/02/2022 BANKS B17963, RANDY

2022-3138 05/02/2022 ET Now
2022-3139 05/02/2022 Sellers, Teresa M
2022-3140 05/02/2022 Foundling Pharma LLC
Padagis Israel
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2022-3143 05/02/2022 Law Office of Tricia Desmarais
2022-3144 05/02/2022 FOI Services, Inc.
2022-3145 05/02/2022 FOI Services, Inc.
2022-3146 05/02/2022 FOI Services, Inc.
2022-3147 05/02/2022 FOI Services, Inc.
2022-3148 05/02/2022 FOI Services, Inc.
2022-3149 05/02/2022 FOI Services, Inc.
2022-3150 05/02/2022 FOI Services, Inc.
2022-3151 05/02/2022 FOI Services, Inc.
2022-3152 05/02/2022 FOI Services, Inc.

2022-3153 05/02/2022 FOI Services, Inc.
2022-3154 05/02/2022 FOI Services, Inc.

2022-3156 05/02/2022 FDAZILLA
2022-3157 05/02/2022 FDAZILLA
2022-3158 05/02/2022 FDAZILLA
2022-3159 05/02/2022 FDAZILLA
2022-3160 05/02/2022 FDAZILLA
2022-3161 05/02/2022 FDAZILLA

2022-3162 05/02/2022 FDAZILLA
2022-3163 05/02/2022 FDAZILLA
2022-3164 05/02/2022 Dieudonne, Darline

2022-3166 05/02/2022 BLOOMBERG NEWS
2022-3167 05/03/2022 FOI Services, Inc.
2022-3168 05/03/2022 FOI Services, Inc.
2022-3169 05/03/2022 Registrar Corp
2022-3170 05/03/2022 Registrar Corp

Partnership for Safe
2022-3172 05/03/2022 Medicines
2022-3173 05/03/2022 Crystal Burton
BALYASNY ASSET
2022-3174 05/03/2022 MANAGEMENT
BALYASNY ASSET
2022-3175 05/03/2022 MANAGEMENT
2022-3176 05/03/2022 Clark, Josephine M
BALYASNY ASSET
2022-3177 05/03/2022 MANAGEMENT
BALYASNY ASSET
2022-3178 05/03/2022 MANAGEMENT
2022-3179 05/03/2022 BLOOMBERG NEWS
2022-3180 05/03/2022 Paresh Patel
2022-3181 05/03/2022 Exits & Outcomes
2022-3182 05/03/2022 Ellen Chang
2022-3184 05/03/2022 BLOOMBERG NEWS
2022-3185 05/03/2022 FDAZILLA
2022-3186 05/03/2022 FDAZILLA
2022-3187 05/03/2022 FDAZILLA

2022-3188 05/03/2022 FDAZILLA
2022-3192 05/03/2022 Katherine Eban
2022-3193 05/03/2022 Canyon Labs
2022-3195 05/04/2022 Dr Ajay Phadke
2022-3196 05/04/2022 Miller Nash LLP

2022-3197 05/04/2022 Kohout, Jennifer
2022-3198 05/04/2022 Magnetic Insight Inc
2022-3199 05/04/2022 Solaris Pharma Corporation
BJKB inc. dba Pain & Stress

2022-3200 05/04/2022 Center
2022-3201 05/04/2022 FDAZILLA
2022-3202 05/04/2022 FDAZILLA

2022-3203 05/04/2022 FDAZILLA
2022-3204 05/04/2022 FDAZILLA
Susan E. Loggans &

2022-3206 05/04/2022 Associates, P.C.
2022-3207 05/04/2022 Magnetic Insight Inc
2022-3208 05/04/2022 Registrar Corp
2022-3209 05/04/2022 BLOOMBERG NEWS

2022-3210 05/04/2022 Charles Taylor Adjusting
2022-3211 05/04/2022 FDAZILLA
2022-3212 05/04/2022 FDAZILLA
2022-3213 05/04/2022 FDAZILLA

2022-3214 05/04/2022 FDAZILLA
2022-3215 05/04/2022 FDAZILLA
2022-3216 05/04/2022 FDAZILLA
2022-3217 05/04/2022 FDAZILLA

2022-3218 05/05/2022 Melton, Donavan
2022-3221 05/05/2022 Brock, Ronald
2022-3222 05/05/2022 Brock, Ronald
2022-3223 05/05/2022 Duty, Harry
2022-3224 05/05/2022 Janaina Saad
2022-3225 05/05/2022 Melton, Donavan

2022-3226 05/05/2022 Brock, Ronald
2022-3227 05/05/2022 Melton, Donavan
2022-3228 05/05/2022 Logli, Maria

2022-3229 05/05/2022 The Epoch Times
2022-3230 05/05/2022 The Epoch Times
2022-3231 05/05/2022 The Epoch Times
2022-3232 05/05/2022 The Epoch Times

2022-3233 05/05/2022 P.C.
2022-3234 05/05/2022 Paresh Patel
2022-3235 05/05/2022 FOI Services, Inc.
2022-3236 05/05/2022 PilieroMazza

2022-3239 05/05/2022 FOI Services, Inc.
2022-3240 05/05/2022 FOI Services, Inc.
2022-3241 05/05/2022 FOI Services, Inc.
2022-3242 05/05/2022 FOI Services, Inc.

2022-3243 05/05/2022 Vizcocho, Andre
2022-3244 05/05/2022 FOI Services, Inc.
2022-3245 05/05/2022 FOI Services, Inc.
2022-3246 05/05/2022 FOI Services, Inc.
2022-3247 05/05/2022 FOI Services, Inc.
2022-3248 05/05/2022 FOI Services, Inc.
2022-3250 05/05/2022 FOI Services, Inc.
2022-3251 05/05/2022 FOI Services, Inc.

2022-3252 05/05/2022 Poly Pharmaceuticals Inc
2022-3253 05/05/2022 FOI Services, Inc.

2022-3254 05/05/2022 Coleman, Dee A
2022-3255 05/05/2022 CHILDREN'S HEALTH DEFENSE

2022-3256 05/06/2022 FOI Services, Inc.
2022-3257 05/06/2022 FDAZILLA
2022-3258 05/06/2022 FDAZILLA
2022-3259 05/06/2022 FDAZILLA
2022-3260 05/06/2022 Author, Cole Everette Chavez
2022-3261 05/06/2022 120 Capital
2022-3262 05/06/2022 Brown, Krista

2022-3264 05/06/2022 FOI Services, Inc.

2022-3266 05/06/2022 ClearCorrect
2022-3267 05/06/2022 Bausch & Lomb Incorporated
2022-3268 05/06/2022 Dunlop, Jake
2022-3269 05/06/2022 Dunlop, Jake
2022-3270 05/06/2022 Dunlop, Jake
2022-3271 05/06/2022 FDAZILLA
2022-3272 05/06/2022 FDAZILLA
2022-3273 05/06/2022 FOI Services, Inc.
2022-3274 05/06/2022 Asefzadeh, Baharak

BALYASNY ASSET
2022-3276 05/06/2022 MANAGEMENT
Newby Lewis Kaminski &
2022-3277 05/06/2022 Jones, LLP
2022-3278 05/06/2022 Munoz, Lorraine
2022-3279 05/06/2022 Munoz, Lorraine

2022-3280 05/09/2022 ET Now
State of Wisconsin,
2022-3281 05/09/2022 Department of Revenue
2022-3282 05/09/2022 Smith & Associates
2022-3283 05/09/2022 Saptalis Pharmaceuticals
SUFFOLK UNIVERSITY LAW

2022-3284 05/09/2022 SCHOOL
2022-3285 05/09/2022 ArentFox Schiff LLP
2022-3286 05/09/2022 Thorpe North & Western, LLP
2022-3287 05/09/2022 Novartis Pharmaceuticals
Edouard Mullarky /
2022-3288 05/09/2022 Guggenheim Securities
2022-3289 05/09/2022 Brookline Capital Markets
Teva Pharmaceuticals USA,
2022-3290 05/09/2022 Inc.
2022-3291 05/09/2022 Petersen, Mitchell
2022-3292 05/09/2022 Inc., USA
2022-3293 05/09/2022 Devakadaksham, Praveen

2022-3294 05/09/2022 ET Now
SUFFOLK UNIVERSITY LAW

2022-3295 05/09/2022 SCHOOL
2022-3296 05/09/2022 Ketryx
2022-3297 05/09/2022 PilieroMazza
2022-3298 05/09/2022 PilieroMazza
2022-3299 05/09/2022 FDAZILLA
2022-3300 05/09/2022 FDAZILLA
2022-3301 05/09/2022 FDAZILLA
2022-3302 05/09/2022 FDAZILLA
2022-3303 05/09/2022 FDAZILLA

2022-3304 05/09/2022 FDAZILLA
2022-3305 05/09/2022 FDAZILLA
2022-3307 05/09/2022 The Epoch Times
Tamara Lea Spira, PhD;

2022-3308 05/09/2022 Protect Their Future
2022-3309 05/09/2022 The Epoch Times
2022-3310 05/09/2022 The Epoch Times
2022-3311 05/09/2022 The Epoch Times

CONSUMER FEDERATION OF
2022-3312 05/09/2022 AMERICA
2022-3313 05/09/2022 Johnson Fistel, LLP
2022-3314 05/09/2022 Brown, Krista
2022-3315 05/09/2022 O'Doherty, Matthew
2022-3316 05/10/2022 Credit Suisse First Boston

Macquarie capital securities

2022-3318 05/10/2022 (India) Private limited
2022-3319 05/10/2022 Evans, Shasta
2022-3320 05/10/2022 Melton, Donavan
2022-3321 05/10/2022 Melton, Donavan
2022-3322 05/10/2022 FDAZILLA
2022-3323 05/10/2022 FDAZILLA
2022-3324 05/10/2022 FDAZILLA
2022-3325 05/10/2022 FDAZILLA
2022-3326 05/10/2022 FDAZILLA
2022-3327 05/10/2022 FDAZILLA

2022-3328 05/10/2022 FDAZILLA
2022-3329 05/10/2022 N/A
2022-3330 05/10/2022 KING & SPALDING
2022-3331 05/10/2022 KING & SPALDING

2022-3332 05/10/2022 FDAZILLA
2022-3333 05/10/2022 Teva Pharmaceuticals Inc
2022-3334 05/10/2022 Dentonics, Inc.
2022-3335 05/10/2022 Danielle Cyr
2022-3336 05/10/2022 Fresenius Kabi USA,LLC
2022-3337 05/10/2022 Kevin A Phelan LLC
2022-3338 05/10/2022 BLOOMBERG NEWS
2022-3339 05/10/2022 FOI Services, Inc.
2022-3340 05/10/2022 FOI Services, Inc.

Government and Civil
2022-3342 05/10/2022 Employee Services
2022-3344 05/10/2022 BioLife Plasma Services, L.P.

2022-3348 05/10/2022 FOI Services, Inc.
2022-3349 05/10/2022 LOS ANGELES TIMES
2022-3350 05/10/2022 Kirby, Stacey K

2022-3352 05/10/2022 KING & SPALDING

Motilal oswal financial
2022-3354 05/10/2022 services
2022-3355 05/10/2022 Dr Ajay Phadke

2022-3357 05/10/2022 India Limited
2022-3358 05/10/2022 eFoodAlert

2022-3359 05/10/2022 Bank of America Securities
2022-3360 05/10/2022 Bagrecha, Naman
2022-3361 05/10/2022 BQ Prime
2022-3362 05/10/2022 FDAZILLA
2022-3363 05/10/2022 FDAZILLA
2022-3364 05/10/2022 FDAZILLA
2022-3365 05/10/2022 Commonwealth Brands, Inc.

2022-3366 05/10/2022 ColubrisMX, Inc.
2022-3367 05/10/2022 FDAZILLA

2022-3368 05/10/2022 FDAZILLA
2022-3369 05/10/2022 FDAZILLA
2022-3370 05/10/2022 FDAZILLA
2022-3371 05/10/2022 FDAZILLA
2022-3372 05/10/2022 BLOOMBERG NEWS
2022-3373 05/11/2022 Cahill Consultants, Inc.
2022-3374 05/11/2022 Epstein Becker & Green, P.C.

2022-3375 05/11/2022 PROPHARMA GROUP
2022-3376 05/11/2022 Bain Capital Life Sciences
2022-3377 05/11/2022 BQ Prime
2022-3378 05/11/2022 WREG-TV
2022-3379 05/11/2022 NCM-USA

2022-3380 05/11/2022 FOI Services, Inc.
BALYASNY ASSET
2022-3381 05/11/2022 MANAGEMENT
2022-3382 05/11/2022 OLYMPUS AMERICA INC
2022-3384 05/11/2022 Central Garden & Pet
2022-3385 05/11/2022 Central Garden & Pet
Aleon Pharma International,

2022-3386 05/11/2022 Inc.
2022-3387 05/11/2022 Robert Camponovo
2022-3388 05/11/2022 Jeffrey Stone
2022-3389 05/11/2022 personal
Sheppard, Mullin, Richter&

2022-3390 05/11/2022 Hampton LLP
2022-3391 05/11/2022 BofA Securities India Limited
2022-3392 05/11/2022 Wilmar International

2022-3393 05/11/2022 N/A
2022-3394 05/11/2022 HonorHealth
2022-3395 05/11/2022 Elara Capital
2022-3396 05/11/2022 Elara Capital
2022-3397 05/11/2022 Elara Capital
2022-3398 05/11/2022 Mehta, Abhishek
2022-3399 05/11/2022 BLOOMBERG NEWS

2022-3400 05/11/2022 Dr Ajay Phadke
2022-3401 05/11/2022 Bhavarth Desai
2022-3402 05/11/2022 FDAZILLA
2022-3403 05/11/2022 FDAZILLA
2022-3404 05/11/2022 MSC Nordics
2022-3405 05/11/2022 FDAZILLA

2022-3406 05/11/2022 FDAZILLA
2022-3407 05/11/2022 FDAZILLA
2022-3408 05/11/2022 FDAZILLA
2022-3409 05/11/2022 FDAZILLA
2022-3410 05/11/2022 FDAZILLA
2022-3412 05/12/2022 Anderson, Derry

2022-3413 05/12/2022 CLIAWaived, Inc.
Agri-Pulse Communications,
2022-3414 05/12/2022 Inc.
LUPIN PHARMACEUTICALS,
2022-3416 05/12/2022 INC
2022-3417 05/12/2022 FOI Services, Inc.

2022-3418 05/12/2022 FOI Services, Inc.
Soterius, Inc on behalf of

2022-3419 05/12/2022 Equilibre Biopharmaceuticals
2022-3420 05/12/2022 Brynlawn Design
Philadelphia Inquirer /
2022-3421 05/12/2022 inquirer.com
2022-3422 05/12/2022 RQM+
2022-3423 05/12/2022 FOI Services, Inc.
2022-3424 05/12/2022 FOI Services, Inc.
2022-3425 05/12/2022 FOI Services, Inc.
ASTRAZENECA
2022-3426 05/12/2022 PHARMACEUTICALS LP
2022-3428 05/12/2022 Lilja, Patrick
2022-3429 05/12/2022 BERG & ANDROPHY

2022-3430 05/12/2022 FoodREG Consult
2022-3431 05/12/2022 BERG & ANDROPHY
2022-3432 05/12/2022 GlaxoSmithKline

2022-3433 05/12/2022 Ajanta Pharma USA Inc.
2022-3434 05/12/2022 Shaikh, Saad
GUANGZHOU HEYGEARS
2022-3435 05/12/2022 IMC.INC
Functional Government
2022-3436 05/12/2022 Initiative
2022-3437 05/12/2022 The Epoch Times
2022-3438 05/13/2022 Rhodes Pharmaceuticals L.P.
2022-3441 05/13/2022 Clarkson Law Firm, P.C.
2022-3442 05/13/2022 Richard Palmer
2022-3443 05/13/2022 Essenlix Corporation

2022-3444 05/13/2022 PC
2022-3445 05/13/2022 Helander, Jonathan
2022-3446 05/13/2022 Pharmalex

Ahlstrom Munksjo
2022-3447 05/13/2022 Nonwovens
2022-3448 05/13/2022 MYOLYN, INC
2022-3449 05/13/2022 Sanofi Consumer Healthcare

2022-3454 05/13/2022 Ingenio La Union
2022-3456 05/13/2022 McClatchy Newspapers
2022-3457 05/13/2022 ACADIA Pharmaceuticals Inc.
2022-3460 05/13/2022 TIME MAGAZINE

FISHER WALLACE
2022-3461 05/13/2022 LABORATORIES LLC
2022-3462 05/13/2022 FDAZILLA
2022-3463 05/13/2022 FDAZILLA
2022-3464 05/13/2022 FDAZILLA
2022-3465 05/13/2022 FDAZILLA
2022-3466 05/13/2022 FDAZILLA
2022-3467 05/13/2022 FDAZILLA
2022-3468 05/13/2022 FDAZILLA
2022-3469 05/13/2022 FDAZILLA
2022-3470 05/13/2022 J.P. Morgan Securities LLC
2022-3471 05/13/2022 Press Trust of India (PTI)

2022-3472 05/13/2022 Nomura
2022-3473 05/13/2022 Cowen
2022-3474 05/13/2022 Reuters News

2022-3476 05/13/2022 NJOY, LLC
Guggenheim Securities/
2022-3477 05/13/2022 Edouard Mullarky
2022-3479 05/16/2022 Brock, Ronald
2022-3480 05/16/2022 Duty, Harry

2022-3481 05/16/2022 N/A
AKIN GUMP STRAUSS HAUER

2022-3482 05/16/2022 & FELD LLP
2022-3483 05/16/2022 BROWN & CROUPPEN PC
2022-3484 05/16/2022 CHARTWELL RX SCIENCES LLC

2022-3485 05/16/2022 P.C.

2022-3486 05/16/2022 P.C.
2022-3487 05/16/2022 Cowen & Company

2022-3488 05/16/2022 FOI Services, Inc.
2022-3489 05/16/2022 Young Innovations Inc
2022-3490 05/16/2022 AIBMR Life Sciences, Inc.
2022-3491 05/16/2022 UCSF
2022-3492 05/16/2022 UCSF
Belgian Business Television

2022-3493 05/16/2022 NV
2022-3497 05/16/2022 Stinson LLP

2022-3498 05/16/2022 FOI Services, Inc.
2022-3499 05/16/2022 FOI Services, Inc.
2022-3500 05/16/2022 FOI Services, Inc.
2022-3501 05/16/2022 FOI Services, Inc.
2022-3502 05/16/2022 Clarkson Law Firm, P.C.

2022-3503 05/16/2022 Lally, LLP
2022-3504 05/16/2022 C-REG MEDICAL
2022-3505 05/16/2022 Centers of America dba PCCA
2022-3507 05/16/2022 AURITEC PHARMACEUTICALS

2022-3508 05/16/2022 Mulligan, Kyan
2022-3509 05/16/2022 Kevin Kong
2022-3510 05/16/2022 FDAZILLA
2022-3511 05/16/2022 FDAZILLA
2022-3512 05/16/2022 FDAZILLA
2022-3513 05/16/2022 FDAZILLA
2022-3514 05/16/2022 FDAZILLA
2022-3515 05/16/2022 FDAZILLA
2022-3516 05/16/2022 FDAZILLA

PEOPLE FOR THE ETHICAL
2022-3517 05/16/2022 TREATMENT OF ANIMALS
2022-3518 05/16/2022 FDAZILLA
2022-3519 05/16/2022 FDAZILLA
2022-3520 05/17/2022 FDA NEWS
2022-3521 05/17/2022 FDA NEWS
2022-3522 05/17/2022 FDA NEWS
2022-3523 05/17/2022 FDA NEWS
2022-3524 05/17/2022 FDA NEWS
2022-3525 05/17/2022 FDA NEWS
2022-3526 05/17/2022 FDA NEWS
2022-3527 05/17/2022 FDA NEWS
2022-3528 05/17/2022 FDA NEWS
2022-3529 05/17/2022 FDA NEWS
2022-3530 05/17/2022 FDA NEWS
2022-3531 05/17/2022 FDA NEWS
2022-3532 05/17/2022 FDA NEWS
2022-3533 05/17/2022 FDAZILLA
2022-3534 05/17/2022 FOI Services, Inc.
2022-3535 05/17/2022 FDA NEWS
2022-3536 05/17/2022 FOI Services, Inc.
2022-3537 05/17/2022 FOI Services, Inc.

2022-3538 05/17/2022 Stinson LLP
2022-3539 05/17/2022 Stinson LLP
2022-3540 05/17/2022 Stinson LLP
2022-3541 05/17/2022 Stinson LLP
2022-3542 05/17/2022 Stinson LLP
2022-3543 05/17/2022 Stinson LLP
Grand Rapids Police
2022-3544 05/17/2022 Department
NBC Network News c/o
2022-3545 05/17/2022 Chiara Sottile
2022-3546 05/17/2022 Anderson, Derry

2022-3549 05/17/2022 SteriPack USA

2022-3551 05/17/2022 ABC NEWS
2022-3552 05/17/2022 Mewburn Ellis LLP
2022-3554 05/17/2022 Paragon Medical Inc.
2022-3556 05/17/2022 Patel, Amar

2022-3557 05/17/2022 Inc

2022-3558 05/17/2022 Inc
2022-3560 05/17/2022 Stanford University
2022-3561 05/17/2022 Tandem Diabetes Care, Inc.

2022-3563 05/17/2022 Reuters News
2022-3564 05/17/2022 FDAZILLA
2022-3565 05/17/2022 FDAZILLA
2022-3566 05/17/2022 FDAZILLA
2022-3567 05/17/2022 FDAZILLA
2022-3568 05/17/2022 FDAZILLA

2022-3569 05/17/2022 Custodio & Dubey LLP
2022-3570 05/17/2022 FOI Services, Inc.

2022-3571 05/17/2022 Sandoz.Inc.
2022-3572 05/17/2022 FOI Services, Inc.
2022-3573 05/17/2022 FOI Services, Inc.

2022-3574 05/17/2022 FOI Services, Inc.
2022-3575 05/17/2022 FOI Services, Inc.
2022-3576 05/17/2022 FOI Services, Inc.
2022-3577 05/17/2022 FOI Services, Inc.
2022-3578 05/17/2022 FOI Services, Inc.
2022-3579 05/17/2022 Jesse Brodkin
2022-3580 05/17/2022 FOI Services, Inc.
2022-3581 05/17/2022 FOI Services, Inc.
2022-3582 05/17/2022 FOI Services, Inc.
2022-3583 05/17/2022 FOI Services, Inc.
2022-3584 05/17/2022 FOI Services, Inc.

2022-3586 05/17/2022 TriviumVet DAC

2022-3587 05/18/2022 Malmö University
2022-3588 05/18/2022 FOI Services, Inc.
2022-3589 05/18/2022 FOI Services, Inc.
2022-3590 05/18/2022 FOI Services, Inc.
2022-3591 05/18/2022 Reuters News
2022-3593 05/18/2022 BLOOMBERG NEWS
2022-3594 05/18/2022 RAY THOMPSON
2022-3595 05/18/2022 RAY THOMPSON
2022-3596 05/18/2022 RAY THOMPSON
2022-3597 05/18/2022 RAY THOMPSON
2022-3598 05/18/2022 RAY THOMPSON

2022-3600 05/18/2022 RAY THOMPSON
2022-3601 05/18/2022 RAY THOMPSON
2022-3602 05/18/2022 RAY THOMPSON

AKORN OPERATING
2022-3603 05/18/2022 COMPANY LLC
2022-3606 05/18/2022 RAISIO STAEST US INC
2022-3607 05/18/2022 CRAIN'S CHICAGO BUSINESS
2022-3609 05/18/2022 KING & SPALDING
2022-3610 05/18/2022 Jason Sager and Associates
2022-3611 05/18/2022 Minaris Medical America Inc.
2022-3612 05/18/2022 Minaris Medical America Inc.
2022-3613 05/18/2022 CSL Plasma, Inc.
2022-3614 05/18/2022 CSL Plasma, Inc.
2022-3615 05/18/2022 CSL Plasma, Inc.

2022-3616 05/18/2022 PHILADELPHIA INQUIRER
2022-3617 05/18/2022 Scientia Vascular

2022-3620 05/18/2022 Cinctive Capital
MASSACHUSETTS INSTITUTE
2022-3621 05/18/2022 OF TECHNOLOGY
2022-3622 05/18/2022 Rowan University
Democracy Forward
2022-3628 05/18/2022 Foundation
2022-3629 05/18/2022 CARTER SYMMONS

2022-3630 05/18/2022 EXPRESS
2022-3631 05/18/2022 FDAZILLA
2022-3632 05/18/2022 FDAZILLA
2022-3633 05/18/2022 FDAZILLA
2022-3634 05/18/2022 FDAZILLA
2022-3635 05/18/2022 FDAZILLA
2022-3636 05/18/2022 FDAZILLA
2022-3637 05/18/2022 FDAZILLA
2022-3638 05/18/2022 Lupin Pharmaceutical, Inc

2022-3639 05/18/2022 Skudlarek, William
2022-3640 05/18/2022 Trio Management
2022-3641 05/18/2022 STRYKER CORPORATION
University of Oregon School

2022-3642 05/19/2022 of Law
2022-3643 05/19/2022 THE ASSOCIATED PRESS
2022-3644 05/19/2022 Jack Stein
2022-3645 05/19/2022 Robert Ross
2022-3646 05/19/2022 David Fraterrigo
2022-3647 05/19/2022 Virginia Veterinary Centers
BALYASNY ASSET
2022-3648 05/19/2022 MANAGEMENT
2022-3649 05/19/2022 Moderna

2022-3650 05/19/2022 RQM+
2022-3651 05/19/2022 Alexander H. Schmidt, Esq.

2022-3655 05/19/2022 Hernandez, Jane
2022-3656 05/19/2022 Markon Cooperative Inc.


America First Legal
2022-3669 05/19/2022 Foundation
2022-3670 05/19/2022 FDAZILLA
2022-3671 05/19/2022 FDAZILLA
2022-3672 05/19/2022 FDAZILLA
2022-3673 05/19/2022 FDAZILLA
2022-3674 05/19/2022 FDAZILLA
2022-3675 05/19/2022 FDAZILLA
2022-3676 05/19/2022 FDAZILLA

BALYASNY ASSET
2022-3677 05/19/2022 MANAGEMENT
Tremeau Pharmaceuticals,
2022-3678 05/19/2022 Inc.
2022-3679 05/19/2022 Reuters News
2022-3680 05/19/2022 Jacob Miller

Stong Garner Bauer Trial
2022-3681 05/19/2022 Attorneys
2022-3682 05/20/2022 The Epoch Times

2022-3683 05/20/2022 The Epoch Times
2022-3684 05/20/2022 The Epoch Times
2022-3685 05/20/2022 The Epoch Times

2022-3687 05/20/2022 General Mills - FSQ
2022-3693 05/20/2022 Rosie Turner
2022-3695 05/20/2022 Zentiva, k.s.

2022-3696 05/20/2022 Registrar Corp

2022-3698 05/20/2022 Pharmalex
GUANGZHOU HEYGEARS
2022-3699 05/20/2022 IMC.INC
2022-3700 05/20/2022 Glancy Prongay & Murray LLP
2022-3701 05/20/2022 True North Consulting
2022-3702 05/20/2022 True North Consulting
2022-3703 05/20/2022 TriMed Bonalive
2022-3705 05/20/2022 BC Cancer
2022-3706 05/20/2022 BC Cancer

Millstone Medical
2022-3709 05/20/2022 Outsourcing, LLC
2022-3711 05/20/2022 eFoodAlert
2022-3712 05/20/2022 eFoodAlert

2022-3713 05/20/2022 JOHN D. PALMER
2022-3714 05/20/2022 PERRY HAMPTON R73679

2022-3716 05/20/2022 GOTTFRIED MEDICAL INC
2022-3717 05/20/2022 CHARLES LESLIE
2022-3718 05/20/2022 TEDDY LEWIS 79-B-0528
2022-3719 05/20/2022 FDAZILLA
2022-3720 05/20/2022 FDAZILLA
2022-3721 05/20/2022 Thomson Reuters Inc.

2022-3722 05/20/2022 FDAZILLA
2022-3723 05/20/2022 FDAZILLA
2022-3724 05/20/2022 FDAZILLA
2022-3726 05/20/2022 FDAZILLA
McCamy Phillips Tuggle &

2022-3729 05/20/2022 Fordham, LLP
2022-3730 05/20/2022 ROMEO JACKSON B43511
2022-3731 05/20/2022 EDWARD TOLBERT
2022-3733 05/20/2022 JOSEPH LAGANA 346-048

2022-3735 05/23/2022 GILEAD SCIENCES
2022-3736 05/23/2022 GILEAD SCIENCES
AMERICAN BRIDGE 21ST

2022-3737 05/23/2022 CENTURY
2022-3738 05/23/2022 Breitbart News


PHYSICIANS COMMITTEE FOR

2022-3753 05/23/2022 RESPONSIBLE MEDICINE

2022-3759 05/23/2022 eFoodAlert
2022-3761 05/23/2022 Francis Charat
2022-3763 05/23/2022 PHILADELPHIA INQUIRER
The Sherwin-Williams
2022-3764 05/23/2022 Company; c/o Judith Negley
2022-3765 05/23/2022 LLC
2022-3766 05/23/2022 Tarrant Eye Resources

2022-3767 05/23/2022 CVS Health
2022-3769 05/23/2022 Abraham Payton

2022-3771 05/23/2022 Hospital
2022-3772 05/23/2022 eFoodAlert

2022-3774 05/23/2022 FDAZILLA
2022-3775 05/23/2022 FDAZILLA
2022-3776 05/23/2022 J.P. Morgan
2022-3777 05/23/2022 Butterfly Network Inc.
2022-3778 05/23/2022 eFoodAlert

2022-3779 05/23/2022 Copexis S.A.
2022-3780 05/23/2022 eFoodAlert
2022-3781 05/23/2022 eFoodAlert
2022-3782 05/23/2022 eFoodAlert
2022-3783 05/23/2022 eFoodAlert

2022-3784 05/23/2022 Francis, Susan M
2022-3785 05/23/2022 CNBC TV18
Spark Capital Advisors (INDIA)
2022-3786 05/23/2022 Pvt Ltd
2022-3787 05/23/2022 Pvt Ltd
2022-3788 05/23/2022 Kevin Kong
2022-3789 05/23/2022 PETA
2022-3790 05/23/2022 FDAZILLA
2022-3791 05/23/2022 FDAZILLA
2022-3792 05/23/2022 FDAZILLA
2022-3793 05/23/2022 FDAZILLA
2022-3794 05/23/2022 FDAZILLA

2022-3795 05/23/2022 FDAZILLA
2022-3796 05/23/2022 FDAZILLA
2022-3797 05/23/2022 Butterfly Network Inc.
2022-3798 05/23/2022 Morrison, Rebecca
2022-3799 05/23/2022 Morrison, Rebecca
Wicker Smith O'Hara McCoy

2022-3800 05/23/2022 & Ford, P.A.
2022-3801 05/24/2022 FOI Services, Inc.
2022-3802 05/24/2022 PilieroMazza
2022-3804 05/24/2022 FITSNews
2022-3805 05/24/2022 Steptoe and Johnson, LLP
2022-3806 05/24/2022 eFoodAlert.com
2022-3807 05/24/2022 FOI Services, Inc.

2022-3809 05/24/2022 TISPORT, LLC
2022-3813 05/24/2022 eFoodAlert.com

2022-3814 05/24/2022 MHC
2022-3816 05/24/2022 Alexandra Constantinou
2022-3817 05/24/2022 CNN
2022-3818 05/24/2022 CNN
2022-3820 05/24/2022 CNN
2022-3822 05/24/2022 The Epoch Times
Daicel Chiral Technologies Pvt
2022-3824 05/24/2022 Ltd
2022-3825 05/24/2022 WBBM-TV
2022-3826 05/24/2022 Melton, Donavan

2022-3828 05/24/2022 Melton, Donavan
2022-3829 05/24/2022 Research Professional News
2022-3830 05/25/2022 Richard Parkes
2022-3831 05/25/2022 Reuters News
2022-3832 05/25/2022 Sperling & Slater P.C.
2022-3833 05/25/2022 FOI Services, Inc.

2022-3834 05/25/2022 A. L. Smith
2022-3835 05/25/2022 Duty, Harry
2022-3836 05/25/2022 Duty, Harry

2022-3837 05/25/2022 Duty, Harry
2022-3838 05/25/2022 PROPUBLICA
2022-3839 05/25/2022 Breitbart News
Functional Government
2022-3840 05/25/2022 Initiative
American Society for

2022-3841 05/25/2022 Investigative Pathology
2022-3842 05/25/2022 Hogan Lovells

2022-3843 05/25/2022 Krishna arikatla
2022-3844 05/25/2022 Robin Hanson
2022-3845 05/25/2022 Harvest Sensations

Distribuidora de Productos
2022-3846 05/25/2022 del Lago, C.A.
2022-3847 05/25/2022 FDAZILLA
2022-3848 05/25/2022 FDAZILLA
2022-3849 05/25/2022 FDAZILLA
2022-3850 05/25/2022 FDAZILLA
2022-3851 05/25/2022 FDAZILLA
2022-3852 05/25/2022 FDAZILLA
2022-3853 05/25/2022 Foley & Lardner, LLP
2022-3855 05/25/2022 TARGET CORPORATION
2022-3856 05/25/2022 Cipla Limited
2022-3857 05/25/2022 FDAZILLA

Fairmount Funds
2022-3858 05/25/2022 Management LLC
2022-3859 05/25/2022 Urgo Medical North America
2022-3860 05/25/2022 Urgo Medical North America
Fairmount Funds
2022-3861 05/25/2022 Management LLC
2022-3862 05/25/2022 Law Offices of Leah V. Duratn

Fairmount Funds
2022-3867 05/25/2022 Management LLC
2022-3869 05/25/2022 Mizerk, Don J

2022-3871 05/25/2022 Axios
Delpharm Boucherville
2022-3872 05/25/2022 Canada Inc.
2022-3873 05/25/2022 Canada Inc.
2022-3874 05/25/2022 Canada Inc.
2022-3875 05/25/2022 Canada Inc.
2022-3878 05/25/2022 Renaissance Lakewood LLC
2022-3880 05/25/2022 Wexler Boley & Elgersma

2022-3882 05/25/2022 TROUTMAN PEPPER
2022-3883 05/25/2022 Owchariw, Sonia

Law Office of Kendrick L.
2022-3884 05/26/2022 Moxon
2022-3885 05/26/2022 Alliance Recruiting Resources
2022-3886 05/26/2022 Levi and Korsinsky LLP
2022-3887 05/26/2022 Ophirex, Inc
2022-3888 05/26/2022 FDAZILLA
2022-3889 05/26/2022 FDAZILLA
2022-3890 05/26/2022 FDAZILLA
2022-3891 05/26/2022 FDAZILLA
2022-3892 05/26/2022 FDAZILLA
2022-3893 05/26/2022 FDAZILLA
2022-3894 05/26/2022 FDAZILLA

2022-3895 05/26/2022 FDAZILLA
2022-3896 05/26/2022 Lyons & Clark, Inc.
2022-3897 05/26/2022 CSL Plasma, Inc.

2022-3898 05/26/2022 FOI Services, Inc.
2022-3899 05/26/2022 Simon, Steven M
2022-3900 05/26/2022 Simon, Steven M
2022-3901 05/26/2022 FOI Services, Inc.

2022-3903 05/26/2022 BAKER DONELSON ET AL
YANTAI T.FULL BIOTECH

2022-3904 05/27/2022 CO.,LTD.
2022-3906 05/27/2022 RisCassi & Davis, P.C.
2022-3907 05/27/2022 KELLOGG COMPANY
2022-3908 05/27/2022 NS Immunology
2022-3909 05/27/2022 FOI Services, Inc.
2022-3910 05/27/2022 knoell USA, LLC

2022-3911 05/27/2022 FOI Services, Inc.
2022-3912 05/27/2022 Brynlawn Design
2022-3913 05/27/2022 Lally LLP
2022-3914 05/27/2022 Services, Inc.
2022-3915 05/31/2022 FOI Services, Inc.

The New York Times
2022-3916 05/31/2022 Company
2022-3917 05/31/2022 Asefzadeh, Baharak
2022-3918 05/31/2022 FOI Services, Inc.
2022-3919 05/31/2022 FOI Services, Inc.
2022-3920 05/31/2022 FOI Services, Inc.
2022-3921 05/31/2022 FOI Services, Inc.
2022-3922 05/31/2022 FOI Services, Inc.
2022-3923 05/31/2022 FDAZILLA

2022-3924 05/31/2022 FOI Services, Inc.
2022-3925 05/31/2022 FOI Services, Inc.

2022-3926 05/31/2022 Mnozil, Lukas
2022-3927 05/31/2022 Simon, Steven M

2022-3928 05/31/2022 FOI Services, Inc.
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2022-3930 05/31/2022 Beyeonics Vision
2022-3931 05/31/2022 Jointechlabs, Inc.
2022-3933 05/31/2022 FDAZILLA

2022-3934 05/31/2022 Respironics Inc.
2022-3935 05/31/2022 Respironics, Inc
2022-3936 05/31/2022 FDAZILLA
2022-3937 05/31/2022 FDAZILLA
2022-3938 05/31/2022 FDAZILLA

2022-3939 05/31/2022 FOI Services, Inc.
2022-3940 05/31/2022 REGENESIS BIOMEDICAL INC
2022-3941 05/31/2022 FDAZILLA
2022-3942 06/01/2022 Duty, Harry
Investigative Journalism
2022-3943 06/01/2022 Bureau, University of Toronto
2022-3944 06/01/2022 Melton, Donavan
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and writer working on a book
2022-3945 06/01/2022 project.
Katie Bo Lillis, CNN reporter

and writer working on a book
2022-3946 06/01/2022 project.
ONCONOVA THERAPEUTICS
2022-3947 06/01/2022 INC
2022-3948 06/01/2022 Liquidia Corporation
2022-3949 06/01/2022 Lupin Pharmceuticals, Inc.

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2022-3950 06/01/2022 MANAGEMENT
2022-3951 06/01/2022 Robins Kaplan LLP

2022-3952 06/01/2022 Grato Holdings, Inc.
2022-3953 06/01/2022 Garrison PharmaTech LLC
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2022-3954 06/01/2022 Family Foundation
2022-3955 06/01/2022 N/A
2022-3956 06/01/2022 N/A
2022-3957 06/01/2022 N/A
Cohen Milstein Sellers & Toll

2022-3958 06/01/2022 PLLC
2022-3959 06/01/2022 COOLEY LLP

AKORN OPERATING
2022-3960 06/01/2022 COMPANY LLC
2022-3961 06/01/2022 Apnar Pharma LP

2022-3962 06/01/2022 Pistevo Law LLC
2022-3963 06/01/2022 Cowen
2022-3964 06/01/2022 Cowen
2022-3965 06/01/2022 Cowen
2022-3966 06/01/2022 Cowen
2022-3969 06/01/2022 McCoy Leavitt Laskey LLC
2022-3971 06/01/2022 CNN
2022-3972 06/01/2022 FOI Services, Inc.
2022-3973 06/01/2022 FOI Services, Inc.
2022-3974 06/01/2022 FOI Services, Inc.
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2022-3977 06/01/2022 FOI Services, Inc.
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2022-3980 06/01/2022 FOI Services, Inc.
2022-3983 06/01/2022 FDAZILLA

2022-3986 06/01/2022 Rouviere, Jodi
2022-3987 06/01/2022 Rouviere, Jodi
2022-3988 06/01/2022 Gwendolyn Murray

2022-3989 06/01/2022 SAS

2022-3990 06/01/2022 SAS
2022-3991 06/01/2022 SAS

2022-3992 06/01/2022 SAS
2022-3993 06/01/2022 ET Now
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2022-3994 06/01/2022 cost center 4010004
2022-3995 06/01/2022 Rouviere, Jodi
2022-3996 06/01/2022 FDAZILLA
2022-3997 06/01/2022 FDAZILLA

2022-3998 06/01/2022 Rama Rao
2022-3999 06/01/2022 FDAZILLA
2022-4000 06/01/2022 FDAZILLA
2022-4001 06/01/2022 FDAZILLA

2022-4002 06/01/2022 FDAZILLA
2022-4003 06/01/2022 FDAZILLA
2022-4004 06/01/2022 FDAZILLA

2022-4005 06/01/2022 FDAZILLA
2022-4006 06/01/2022 FDAZILLA
2022-4007 06/01/2022 Jodi Rouviere
2022-4008 06/01/2022 Rouviere, Jodi
2022-4009 06/01/2022 Rouviere, Jodi
2022-4010 06/01/2022 Rouviere, Jodi

2022-4011 06/01/2022 FOI Services, Inc.

2022-4013 06/01/2022 FOI Services, Inc.
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2022-4014 06/01/2022 FREE KIDS
2022-4015 06/01/2022 FOI Services, Inc.

2022-4016 06/01/2022 Inc
2022-4017 06/01/2022 Bao, Jian

2022-4018 06/01/2022 Seven Days

2022-4019 06/01/2022 SAS
2022-4020 06/01/2022 ALCOR Scientific LLC

2022-4021 06/01/2022 SAS

2022-4022 06/01/2022 SAS
ORTHOMERICA PRODUCTS
2022-4023 06/01/2022 INC
2022-4024 06/01/2022 Zoetis Inc.

2022-4025 06/01/2022 SI-TECHNOLOGY, LLC

2022-4026 06/01/2022 SAS
BALYASNY ASSET
2022-4027 06/01/2022 MANAGEMENT
2022-4028 06/01/2022 Nussbaum Law Group, P.C.
BALYASNY ASSET
2022-4029 06/01/2022 MANAGEMENT
2022-4030 06/01/2022 Solaire Medical
2022-4032 06/01/2022 Dunlop, Jake

2022-4033 06/01/2022 SAS

2022-4034 06/01/2022 SAS

2022-4035 06/01/2022 SAS
Homer Bonner Jacobs Ortiz
2022-4036 06/01/2022 P.A.
2022-4037 06/01/2022 Rocket Pharmaceuticals
2022-4043 06/01/2022 CNN
2022-4045 06/02/2022 Abraham Payton
BOSTON SCIENTIFIC
2022-4046 06/02/2022 CORPORATION
2022-4047 06/02/2022 Nick Bauer
2022-4048 06/02/2022 Registrar Corp
2022-4049 06/02/2022 Registrar Corp
2022-4050 06/02/2022 Registrar Corp
2022-4051 06/02/2022 USA TODAY

2022-4052 06/02/2022 BLOOMBERG NEWS
2022-4053 06/02/2022 Grey Manor Consulting, LLC

Chartwell Molecular Holdings,
2022-4055 06/02/2022 LLC
Chartwell Molecular Holdings,
2022-4056 06/02/2022 LLC
2022-4057 06/02/2022 Martha Hudson
2022-4059 06/02/2022 Pistevo Law LLC
2022-4060 06/02/2022 Pistevo Law LLC
2022-4061 06/02/2022 garofalo, joseph p

2022-4062 06/02/2022 BARCLAYS
2022-4063 06/02/2022 FOI Services, Inc.
2022-4064 06/02/2022 Osteolife Biomedical, LLC
2022-4065 06/02/2022 Borys Reshetniak
2022-4066 06/02/2022 FDAZILLA
2022-4067 06/02/2022 FDAZILLA
2022-4068 06/02/2022 FDAZILLA
2022-4069 06/02/2022 FDAZILLA
2022-4070 06/02/2022 FDAZILLA
Swedish Match North

2022-4071 06/02/2022 America LLC
2022-4072 06/02/2022 Alucent Biomedical Inc.
2022-4073 06/02/2022 FDAZILLA
Seltzer Caplan McMahon

2022-4074 06/02/2022 Vitek, Attn: Vivian Keneally
2022-4075 06/02/2022 Sirnaomics, Inc.
2022-4077 06/02/2022 FDAZILLA
2022-4078 06/02/2022 BAXTER INTERNATIONAL
2022-4079 06/02/2022 FDAZILLA
2022-4080 06/02/2022 FDAZILLA
2022-4081 06/02/2022 FDAZILLA
THE HUMANE SOCIETY OF

2022-4082 06/02/2022 THE UNITED STATES
2022-4083 06/03/2022 Hong, Min
2022-4084 06/03/2022 Medytox Inc.
2022-4085 06/03/2022 Alucent Biomedical Inc.
2022-4086 06/03/2022 KELLEY DRYE & WARREN LLP
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2022-4088 06/03/2022 MANAGEMENT
2022-4089 06/03/2022 RAY THOMPSON
Lachman Consultant Services

2022-4090 06/03/2022 Inc.
2022-4091 06/03/2022 Sidley Austin LLP / Jeff Bosh
2022-4094 06/03/2022 N/A
2022-4095 06/03/2022 N/A
2022-4096 06/03/2022 N/A

2022-4097 06/03/2022 N/A
2022-4102 06/06/2022 Duty, Harry
2022-4103 06/06/2022 Duty, Harry
2022-4104 06/06/2022 Duty, Harry

2022-4105 06/06/2022 Duty, Harry
2022-4106 06/06/2022 Duty, Harry
2022-4107 06/06/2022 Duty, Harry
2022-4108 06/06/2022 Brock, Ronald
2022-4109 06/06/2022 Brock, Ronald
2022-4110 06/06/2022 BLOOMBERG NEWS
2022-4111 06/06/2022 FDAZILLA

2022-4112 06/06/2022 FDAZILLA
2022-4113 06/06/2022 FDAZILLA
2022-4114 06/06/2022 FDAZILLA
2022-4115 06/06/2022 Newry Corporation

Aleon Pharma International,
2022-4116 06/06/2022 Inc.
2022-4117 06/06/2022 THOMSON REUTERS

Alliance Medical Products dba
2022-4119 06/06/2022 Siegried
2022-4120 06/06/2022 Van De Riet, Josh A
McGuff Compounding
2022-4121 06/06/2022 Pharmacy Services, Inc.
2022-4123 06/06/2022 PCCA

2022-4124 06/06/2022 Washington Free Beacon
2022-4125 06/06/2022 FOI Services, Inc.
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2022-4126 06/06/2022 Systems
2022-4127 06/06/2022 Aneuryst, Inc.
2022-4128 06/06/2022 FOI Services, Inc.
2022-4129 06/06/2022 FOI Services, Inc.
2022-4130 06/06/2022 FOI Services, Inc.
2022-4131 06/06/2022 FOI Services, Inc.
2022-4132 06/06/2022 FOI Services, Inc.
2022-4133 06/06/2022 FOI Services, Inc.

2022-4134 06/06/2022 FOI Services, Inc.
2022-4135 06/06/2022 FOI Services, Inc.
2022-4136 06/06/2022 FOI Services, Inc.
2022-4137 06/06/2022 FOI Services, Inc.
2022-4138 06/06/2022 FOI Services, Inc.
2022-4139 06/06/2022 FOI Services, Inc.
2022-4140 06/06/2022 FOI Services, Inc.
2022-4141 06/06/2022 FOI Services, Inc.
2022-4142 06/06/2022 FOI Services, Inc.
2022-4143 06/06/2022 FOI Services, Inc.

2022-4144 06/06/2022 FOI Services, Inc.
2022-4145 06/06/2022 SKG Pharma Inc.

2022-4147 06/06/2022 FDAZILLA

2022-4148 06/06/2022 Associates, LLC
2022-4155 06/06/2022 BLOOMBERG NEWS

2022-4156 06/06/2022 Regunalys LLC
2022-4157 06/06/2022 Regunalys LLC
GREGORY HOFFMAN 84958-
2022-4158 06/06/2022 054
2022-4159 06/06/2022 MINNETRONIX
2022-4160 06/06/2022 Michigan Rising Action
2022-4163 06/06/2022 THOMSON REUTERS
2022-4164 06/06/2022 Rouviere, Jodi

2022-4166 06/07/2022 PerfusionMap
2022-4167 06/07/2022 LEVY, SARI
2022-4168 06/07/2022 LEVENTHAL PUGA BRALEY PC

2022-4169 06/07/2022 KEMMELCAL INC
2022-4170 06/07/2022 FOI Services, Inc.
2022-4171 06/07/2022 FOI Services, Inc.
2022-4172 06/07/2022 FOI Services, Inc.

2022-4173 06/07/2022 FOI Services, Inc.
2022-4174 06/07/2022 FOI Services, Inc.

2022-4175 06/07/2022 FOI Services, Inc.
2022-4176 06/07/2022 FOI Services, Inc.
2022-4177 06/07/2022 FOI Services, Inc.
2022-4178 06/07/2022 FOI Services, Inc.
2022-4179 06/07/2022 FOI Services, Inc.
2022-4180 06/07/2022 FOI Services, Inc.
2022-4181 06/07/2022 FOI Services, Inc.
2022-4184 06/07/2022 FOI Services, Inc.

2022-4185 06/07/2022 FOI Services, Inc.
2022-4186 06/07/2022 CNN
2022-4187 06/07/2022 FDAZILLA
2022-4188 06/07/2022 FDAZILLA
2022-4189 06/07/2022 FDAZILLA
2022-4190 06/07/2022 FDAZILLA
2022-4191 06/07/2022 FDAZILLA
2022-4192 06/07/2022 FOI Services, Inc.
2022-4193 06/07/2022 FOI Services, Inc.
2022-4194 06/07/2022 FOI Services, Inc.

2022-4195 06/07/2022 FOI Services, Inc.
2022-4196 06/07/2022 FOI Services, Inc.
2022-4197 06/07/2022 FOI Services, Inc.
2022-4198 06/07/2022 LeBonheur Children's Hospital
2022-4199 06/07/2022 Swanson, Martin & Bell, LLP
2022-4200 06/07/2022 PROPUBLICA
2022-4201 06/07/2022 The Epoch Times

2022-4203 06/07/2022 Dunlop, Jake
2022-4205 06/07/2022 Dalton, Ian
2022-4206 06/08/2022 Markson, Thomas R

2022-4208 06/08/2022 WILEY REIN LLP
McKee, Voorhees & Sease

2022-4209 06/08/2022 PLC
2022-4210 06/08/2022 Nelken, Colette
2022-4212 06/08/2022 The Epoch Times
2022-4213 06/08/2022 Susan Francis
2022-4214 06/08/2022 The Epoch Times
2022-4215 06/08/2022 FDA NEWS

2022-4216 06/08/2022 SET POINT INC
2022-4217 06/08/2022 Zi-medical Inc
2022-4218 06/08/2022 Abraham Payton
2022-4219 06/08/2022 Solaire Medical

2022-4221 06/08/2022 Globizz Corporation
2022-4222 06/08/2022 FOI Services, Inc.
2022-4223 06/08/2022 APOTEX CORP.
2022-4226 06/08/2022 BD
2022-4227 06/08/2022 FDAZILLA
2022-4228 06/08/2022 Cozzi, Judith
2022-4229 06/08/2022 washington info source co
2022-4230 06/08/2022 FDAZILLA
2022-4231 06/08/2022 FDAZILLA
2022-4232 06/08/2022 FDAZILLA
2022-4233 06/08/2022 FDAZILLA

Global Health Reporting
2022-4234 06/08/2022 Center
2022-4235 06/08/2022 Viant Upland Inc.
2022-4236 06/08/2022 Premera Blue Cross

2022-4237 06/08/2022 Qualifyze GmbH
2022-4238 06/09/2022 Sullivan IP Solutions
2022-4239 06/09/2022 FOI Services, Inc.
2022-4240 06/09/2022 Scherer Construction
2022-4243 06/09/2022 FDAZILLA
2022-4244 06/09/2022 Scilucent, LLC
2022-4246 06/09/2022 American Vi-Tech, LLC


2022-4253 06/09/2022 Solaire Medical

2022-4256 06/09/2022 FOI Services, Inc.
2022-4257 06/09/2022 Philips Respironics's
2022-4258 06/09/2022 KIRKLAND & ELLIS LLP
2022-4259 06/09/2022 TBD

2022-4264 06/09/2022 Rouviere, Jodi
2022-4266 06/09/2022 Nelken, Colette

2022-4267 06/09/2022 Rouviere, Jodi
2022-4268 06/09/2022 Jodi Rouviere
2022-4269 06/09/2022 Rouviere, Jodi
2022-4270 06/10/2022 Excellus Holdings, LLC
2022-4271 06/10/2022 NEW YORK TIMES
2022-4272 06/10/2022 NEW YORK TIMES

LABORIE MEDICAL
2022-4273 06/10/2022 TECHNOLOGIES
2022-4274 06/10/2022 Eran Feinstein
2022-4277 06/10/2022 University of Groningen

2022-4278 06/10/2022 Forma Therapeutics, Inc.

Galephar Pharmaceutical
2022-4280 06/10/2022 Research Inc.
2022-4281 06/10/2022 Granite Ridge Farm
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2022-4282 06/10/2022 MANAGEMENT
BALYASNY ASSET
2022-4283 06/10/2022 MANAGEMENT
2022-4284 06/10/2022 Trident Seafoods Corporation
BALYASNY ASSET
2022-4285 06/10/2022 MANAGEMENT
2022-4286 06/10/2022 APPCO PHARMA LLC
2022-4287 06/10/2022 Markson, Thomas R
2022-4289 06/10/2022 Fortanbary, David
2022-4290 06/10/2022 Lally, LLP
2022-4291 06/10/2022 Coherus BioSciences Inc.

Logic Technology
2022-4293 06/10/2022 Development, LLC
2022-4294 06/10/2022 Montanez, Stephen

2022-4295 06/10/2022 Hall Booth Smith, P.C.
2022-4296 06/10/2022 FOI Services, Inc.
2022-4297 06/10/2022 COMEXPROM
2022-4298 06/10/2022 Vascular Integrity

KEAN MILLER HAWTHORNE
D'ARMOND MCCOWAN &
2022-4299 06/10/2022 JARMAN

Benesch, Friedlander, Coplan
2022-4301 06/13/2022 & Aronoff LLP
Fisher College of Business,

2022-4302 06/13/2022 The Ohio State University
2022-4303 06/13/2022 BLOOMBERG NEWS
2022-4305 06/13/2022 Galvanize Therapeutics
2022-4306 06/13/2022 Galvanize Therapeutics
2022-4307 06/13/2022 PROMEDOSS INC
2022-4308 06/13/2022 FDAZILLA
2022-4309 06/13/2022 FDAZILLA
2022-4310 06/13/2022 FDAZILLA
2022-4311 06/13/2022 FDAZILLA

2022-4312 06/13/2022 FDAZILLA
2022-4313 06/13/2022 FDAZILLA
2022-4314 06/13/2022 FDAZILLA
2022-4315 06/13/2022 FOI Services, Inc.
2022-4316 06/13/2022 FOI Services, Inc.
BALYASNY ASSET
2022-4317 06/13/2022 MANAGEMENT
2022-4318 06/13/2022 FDAZILLA
2022-4319 06/13/2022 FOI Services, Inc.

2022-4320 06/13/2022 FOI Services, Inc.
2022-4321 06/13/2022 FOI Services, Inc.
2022-4322 06/13/2022 FOI Services, Inc.
2022-4323 06/13/2022 FOI Services, Inc.
2022-4324 06/13/2022 FOI Services, Inc.
2022-4325 06/13/2022 FOI Services, Inc.
2022-4326 06/13/2022 POLITICO
Sheppard, Mullin, Richter &

2022-4327 06/13/2022 Hampton LLP
2022-4328 06/13/2022 CNBC TV18
2022-4329 06/13/2022 FDAZILLA
FLORIDA DEPARTMENT OF
2022-4330 06/13/2022 HEALTH
2022-4331 06/13/2022 FDAZILLA
2022-4332 06/13/2022 CAPLIN STERILES LIMITED
2022-4333 06/13/2022 Z&Z Associates
2022-4334 06/13/2022 ABC News, Sasha Pezenik

The Ohio State University
2022-4335 06/13/2022 Fisher College of Business
2022-4336 06/13/2022 THOMSON REUTERS

2022-4339 06/14/2022 Brock, Ronald
2022-4340 06/14/2022 Melton, Donavan
2022-4341 06/14/2022 Melton, Donavan
2022-4342 06/14/2022 Melton, Donavan
2022-4343 06/14/2022 Melton, Donavan

2022-4344 06/14/2022 Melton, Donavan
2022-4345 06/14/2022 Melton, Donavan
2022-4346 06/14/2022 Melton, Donavan
2022-4347 06/14/2022 Melton, Donavan

2022-4348 06/14/2022 Melton, Donavan
2022-4349 06/14/2022 Evans, Shasta
2022-4350 06/14/2022 Evans, Shasta
2022-4351 06/14/2022 none
2022-4352 06/14/2022 FOIA GROUP INC

2022-4353 06/14/2022 FOIA GROUP INC
2022-4354 06/14/2022 FOIA GROUP INC
2022-4355 06/14/2022 Miller, Jennifer

2022-4356 06/14/2022 FOIA GROUP INC
2022-4357 06/14/2022 Levate LLC
2022-4358 06/14/2022 FDAZILLA
2022-4359 06/14/2022 FDAZILLA

2022-4360 06/14/2022 FDAZILLA
2022-4361 06/14/2022 FDAZILLA

2022-4362 06/14/2022 Inc.

2022-4364 06/14/2022 FOIA GROUP INC

2022-4366 06/14/2022 Reath LLP
2022-4369 06/14/2022 ABC News, Sasha Pezenik
2022-4370 06/14/2022 BLOOMBERG NEWS
2022-4372 06/14/2022 Stephanie Roberts

2022-4381 06/14/2022 National Observer
2022-4382 06/14/2022 Bohn, Carolyn
2022-4383 06/14/2022 Cosmedent, Inc
2022-4384 06/14/2022 Stifel
2022-4386 06/15/2022 PilieroMazza
2022-4387 06/15/2022 FEDinform LLC
2022-4390 06/15/2022 KING & SPALDING
2022-4391 06/15/2022 Pistevo Law LLC
2022-4392 06/15/2022 Pistevo Law LLC
2022-4393 06/15/2022 Nichole Geary

2022-4394 06/15/2022 Sperling & Slater P.C.
Sun Pharmaceutical
2022-4395 06/15/2022 Industries, Inc.
2022-4396 06/15/2022 FDA NEWS
2022-4397 06/15/2022 POINT72

2022-4402 06/15/2022 Smouse & Mason, LLC
2022-4404 06/15/2022 FDAZILLA
2022-4405 06/15/2022 FDAZILLA

2022-4406 06/15/2022 TYPENEX MEDICAL
2022-4407 06/15/2022 FDAZILLA
2022-4408 06/15/2022 FDAZILLA

2022-4409 06/15/2022 FDAZILLA
2022-4410 06/15/2022 FDAZILLA

2022-4411 06/15/2022 Mark Genovesi
2022-4412 06/15/2022 LLP
2022-4413 06/15/2022 FDAZILLA

2022-4416 06/15/2022 POINT72

2022-4417 06/15/2022 FDA NEWS
2022-4418 06/15/2022 FDA NEWS
2022-4419 06/15/2022 FDA NEWS
2022-4420 06/15/2022 FDA NEWS
2022-4421 06/15/2022 FDA NEWS
2022-4422 06/15/2022 FDA NEWS
2022-4423 06/15/2022 FDA NEWS
2022-4424 06/15/2022 FDA NEWS
2022-4425 06/15/2022 FDA NEWS
2022-4426 06/15/2022 BLOOMBERG NEWS
Parents Against Vaping

2022-4427 06/15/2022 eCigarettes
2022-4428 06/15/2022 Insmed Incorporated
2022-4429 06/16/2022 Rama Rao
2022-4430 06/16/2022 philosys co., ltd
2022-4431 06/16/2022 Jeffrey L. Berhold, P.C.
2022-4432 06/16/2022 David Price

2022-4433 06/16/2022 VivaQuant, Inc
2022-4434 06/16/2022 Brynlawn Design
2022-4435 06/16/2022 Grant, David
2022-4436 06/16/2022 FOI Services, Inc.
2022-4437 06/16/2022 FDAZILLA

2022-4439 06/16/2022 FDAZILLA
2022-4440 06/16/2022 FDAZILLA
2022-4441 06/16/2022 FDAZILLA
2022-4442 06/16/2022 FDAZILLA

2022-4443 06/16/2022 FDAZILLA
2022-4444 06/16/2022 FDAZILLA
2022-4445 06/16/2022 FDAZILLA
2022-4446 06/16/2022 FDAZILLA
2022-4447 06/16/2022 Hecyk, Angela
2022-4448 06/16/2022 FOI Services, Inc.
2022-4449 06/16/2022 Dr. Reddy's Laboratories Inc.
2022-4450 06/16/2022 ALLTECH, INC.
2022-4453 06/16/2022 ALLTECH, INC.
2022-4454 06/16/2022 KLEINFELD KAPLAN & BECKER

LAW OFFICE OF JASON
2022-4455 06/16/2022 TURCHIN
2022-4456 06/16/2022 Galenicum Health SL
Alfred E Mann Institute for

Biomedical Engineering at
University of Southern
2022-4460 06/17/2022 California

2022-4463 06/17/2022 Carter Gould
2022-4464 06/17/2022 PROPHARMA GROUP

2022-4466 06/17/2022 INTERTEK

WIlentz Goldman & Spitzer,
2022-4468 06/17/2022 P.A.
2022-4469 06/17/2022 FOI Services, Inc.
Hall Prangle & Schoonveld

2022-4471 06/17/2022 LLC
2022-4472 06/17/2022 Bridger Healthcare
2022-4473 06/17/2022 FOI Services, Inc.
2022-4474 06/17/2022 Watts Guerra LLP
2022-4475 06/17/2022 Bloomberg Businessweek
2022-4477 06/17/2022 FDAZILLA

2022-4478 06/17/2022 Melton, Donavan
2022-4479 06/17/2022 Melton, Donavan
2022-4480 06/17/2022 FDAZILLA
2022-4481 06/17/2022 FDAZILLA
2022-4482 06/17/2022 FDAZILLA
2022-4483 06/17/2022 FDAZILLA
2022-4484 06/17/2022 Brock, Ronald
2022-4485 06/17/2022 FDAZILLA
Sullivan & Cromwell LLP -

2022-4486 06/17/2022 New York, NY
2022-4487 06/17/2022 Cannabis Wire

TAFT STETTINIUS &
2022-4488 06/17/2022 HOLLISTER LLP
2022-4489 06/17/2022 FDAZILLA
2022-4490 06/17/2022 BLOOMBERG NEWS
2022-4491 06/17/2022 Clairity, Inc.
2022-4492 06/17/2022 BLOOMBERG NEWS
2022-4495 06/21/2022 Duty, Harry
2022-4496 06/21/2022 Duty, Harry
2022-4497 06/21/2022 Duty, Harry
2022-4498 06/21/2022 Kara Meintassis
2022-4499 06/21/2022 The Epoch Times
2022-4500 06/21/2022 The Epoch Times
2022-4501 06/21/2022 The Epoch Times

2022-4502 06/21/2022 Greenleaf Health
2022-4503 06/21/2022 Per Os Biosciences
2022-4504 06/21/2022 Greenleaf Health

2022-4505 06/21/2022 FOIA Request Services
2022-4506 06/21/2022 DEERFIELD INSTITUTE
2022-4507 06/21/2022 The Block Firm
2022-4508 06/21/2022 National Public Radio (NPR)

2022-4509 06/21/2022 Inc
2022-4510 06/21/2022 Verona Pharma plc
2022-4511 06/21/2022 FOI Services, Inc.
2022-4512 06/21/2022 NEW YORK TIMES

2022-4513 06/21/2022 FOI Services, Inc.
2022-4514 06/21/2022 FOI Services, Inc.
2022-4515 06/21/2022 FDAZILLA

2022-4516 06/21/2022 FDAZILLA
2022-4517 06/21/2022 FDAZILLA
2022-4518 06/21/2022 FDAZILLA
2022-4519 06/21/2022 FDAZILLA
2022-4520 06/21/2022 FDAZILLA
2022-4521 06/21/2022 FDAZILLA
2022-4522 06/21/2022 FDAZILLA

2022-4524 06/21/2022 DALMEX LTD
2022-4525 06/21/2022 FDAZILLA

2022-4526 06/21/2022 FDAZILLA
2022-4527 06/21/2022 FDAZILLA
2022-4528 06/21/2022 FDAZILLA
2022-4529 06/21/2022 FDAZILLA
2022-4530 06/21/2022 INC
2022-4531 06/21/2022 FDAZILLA
2022-4532 06/21/2022 FDAZILLA
2022-4533 06/21/2022 FDAZILLA
2022-4534 06/21/2022 FDAZILLA
Rakoczy Molino Mazzochi

2022-4535 06/21/2022 Siwik LLP

2022-4536 06/21/2022 Siwik LLP

2022-4537 06/21/2022 Siwik LLP
2022-4538 06/21/2022 Siwik LLP

2022-4539 06/21/2022 Siwik LLP

2022-4540 06/21/2022 Siwik LLP

2022-4541 06/21/2022 Siwik LLP

2022-4543 06/21/2022 Siwik LLP

2022-4544 06/21/2022 Siwik LLP
2022-4545 06/21/2022 INTERTEK

2022-4546 06/21/2022 Auld, Michael D
2022-4547 06/21/2022 FOI Services, Inc.

2022-4550 06/21/2022 Fresh Test, LLC
2022-4551 06/21/2022 MEDTRONIC, INC.
2022-4552 06/21/2022 FDAZILLA
2022-4553 06/21/2022 FDAZILLA
2022-4554 06/21/2022 QIAGEN SCIENCES

2022-4557 06/22/2022 Lally, LLP
2022-4558 06/22/2022 Brown Emergency Medicine
2022-4560 06/22/2022 SpecGx LLC
2022-4561 06/22/2022 Vox Media

BETH ISRAEL DEACONESS
2022-4562 06/22/2022 MEDICAL CENTER
2022-4564 06/22/2022 Nierhoff, Brandon J
2022-4566 06/22/2022 FDAAWARE

2022-4567 06/22/2022 Hospital
Invitron Advanced Analytics
2022-4568 06/22/2022 Private limited
2022-4569 06/22/2022 WAT Medical Technology Inc.
2022-4570 06/22/2022 FDAZILLA
2022-4571 06/22/2022 FDAZILLA
2022-4573 06/22/2022 Osborne & Francis, PLLC

2022-4574 06/22/2022 ZPX LLC
2022-4575 06/22/2022 Sterigenics
2022-4576 06/23/2022 FDAZILLA
2022-4577 06/23/2022 FOI Services, Inc.

2022-4578 06/23/2022 FDA NEWS
2022-4579 06/23/2022 FDAZILLA
2022-4580 06/23/2022 BQ Prime

2022-4581 06/23/2022 ET Now
2022-4583 06/23/2022 RayzeBio, Inc.
2022-4584 06/23/2022 Registrar Corp
2022-4585 06/23/2022 ARTHREX INC.
2022-4586 06/23/2022 Cropper, Neal

2022-4587 06/23/2022 Cropper, Neal
2022-4589 06/23/2022 N/A
2022-4590 06/23/2022 Abramson, Steven J
2022-4592 06/23/2022 Justin Hayes

2022-4594 06/23/2022 al
2022-4595 06/23/2022 IVERIC bio

2022-4596 06/23/2022 ENDO PHARMACEUTICALS
2022-4597 06/23/2022 Inc
2022-4598 06/23/2022 BioTex, Inc.

2022-4599 06/23/2022 P.C.
2022-4600 06/23/2022 STERIS CORP

2022-4601 06/23/2022 Anthony Lee
University of Washington,
2022-4602 06/23/2022 Information School
2022-4603 06/23/2022 Advancing American Freedom
2022-4604 06/23/2022 BLOOMBERG NEWS
2022-4606 06/23/2022 Mirch Law Firm LLP
Foundation for Individual

2022-4607 06/23/2022 Rights and Education
2022-4609 06/23/2022 Teva Pharmaceuticals Inc
2022-4610 06/24/2022 Singla, Jayant

2022-4612 06/24/2022 Siwik LLP
2022-4614 06/24/2022 Registrar Corp
Veterinary Research and
2022-4616 06/24/2022 Consulting Services, LLC
Kevin Kong (HEC Pharm USA
2022-4618 06/24/2022 Inc.)
2022-4619 06/24/2022 PhaemEng Technology
2022-4621 06/24/2022 JUUL Labs Inc.
2022-4622 06/24/2022 UCSF
2022-4623 06/24/2022 Dickerson Oxton, LLC
2022-4624 06/24/2022 KLEINFELD KAPLAN & BECKER

2022-4625 06/24/2022 JUUL Labs Inc.
2022-4626 06/24/2022 Eric Gaskill
2022-4627 06/27/2022 Duty, Harry
2022-4628 06/27/2022 UNIVERSITY OF EDINBURGH

2022-4629 06/27/2022 Private limited
2022-4630 06/27/2022 EyePoint Pharmaceuticals

2022-4631 06/27/2022 LLP
2022-4632 06/27/2022 Baebies Inc
2022-4633 06/27/2022 RayzeBio, Inc.
2022-4634 06/27/2022 FOI Services, Inc.
2022-4635 06/27/2022 RayzeBio, Inc.

2022-4636 06/27/2022 TROUTMAN PEPPER
2022-4638 06/27/2022 PROPHARMA GROUP

2022-4639 06/27/2022 Lally, LLP
2022-4640 06/27/2022 Minwoo Kim
2022-4642 06/27/2022 KING & SPALDING
2022-4643 06/27/2022 UCSF
2022-4644 06/27/2022 Source Nutraceutical Inc.

Long Grove Pharmaceuticals,
2022-4645 06/27/2022 LLC
2022-4646 06/27/2022 Panagos, Sarah L
2022-4647 06/27/2022 FOI Services, Inc.

2022-4648 06/27/2022 FOI Services, Inc.
2022-4649 06/27/2022 FOI Services, Inc.
2022-4650 06/27/2022 FOI Services, Inc.
2022-4651 06/27/2022 FOI Services, Inc.
2022-4652 06/27/2022 FOI Services, Inc.
2022-4653 06/27/2022 FOI Services, Inc.
2022-4654 06/27/2022 FOI Services, Inc.
2022-4655 06/27/2022 FOI Services, Inc.
2022-4656 06/27/2022 ANDERSON, EVAN
2022-4657 06/27/2022 Altadis U.S.A. LLC
2022-4658 06/27/2022 Altadis U.S.A. LLC

2022-4659 06/27/2022 Marc Roman
2022-4661 06/27/2022 Jazz Pharmaceuticals

2022-4662 06/27/2022 Sechrist Industries, Inc.
2022-4663 06/27/2022 Sechrist Industries, Inc.
2022-4664 06/27/2022 TIME MAGAZINE

2022-4665 06/27/2022 Alicia Antiri
2022-4666 06/27/2022 Altadis U.S.A. LLC
2022-4667 06/27/2022 Altadis U.S.A. LLC
2022-4668 06/27/2022 Altadis U.S.A. LLC
2022-4670 06/27/2022 Altadis U.S.A. LLC

2022-4671 06/27/2022 Alston & Bird, LLP
2022-4672 06/27/2022 Altadis U.S.A. LLC
2022-4673 06/27/2022 Altadis U.S.A. LLC
2022-4674 06/27/2022 FOI Services, Inc.
2022-4675 06/27/2022 FOI Services, Inc.
2022-4676 06/27/2022 Perry, Rachel

2022-4677 06/27/2022 Frantz Law Group
HEATHER H. HORTON, MD,
2022-4678 06/27/2022 PHD, JD
CLARENCE S. GREGORY
2022-4679 06/27/2022 227394
2022-4680 06/27/2022 MS. AMEE DESAI

2022-4683 06/28/2022 FDAZILLA
2022-4684 06/28/2022 FDAZILLA
2022-4685 06/28/2022 FDAZILLA
2022-4686 06/28/2022 FOI Services, Inc.
2022-4687 06/28/2022 FOI Services, Inc.
2022-4688 06/28/2022 FOI Services, Inc.
2022-4689 06/28/2022 FOI Services, Inc.
2022-4690 06/28/2022 FOI Services, Inc.
2022-4691 06/28/2022 FOI Services, Inc.
2022-4692 06/28/2022 FDAZILLA
2022-4693 06/28/2022 FDAZILLA
2022-4694 06/28/2022 FDAZILLA
2022-4695 06/28/2022 FOI Services, Inc.
2022-4696 06/28/2022 FOI Services, Inc.

2022-4697 06/28/2022 FOI Services, Inc.
2022-4698 06/28/2022 FOI Services, Inc.
2022-4699 06/28/2022 FOI Services, Inc.
2022-4700 06/28/2022 FOI Services, Inc.
2022-4701 06/28/2022 Moms Across America

2022-4705 06/28/2022 Mayo Clinic
2022-4706 06/28/2022 James Leggett

2022-4707 06/28/2022 McBrinn, Brian
2022-4708 06/28/2022 Philips Respironics, Inc.

2022-4712 06/28/2022 Giroux Trial Attorneys
SafetyCall International on
2022-4713 06/28/2022 behalf of Celltrion
2022-4715 06/28/2022 SPILLER, ROBERT M
2022-4717 06/28/2022 The University of Melbourne

2022-4718 06/28/2022 John Gamberzky
2022-4719 06/28/2022 Bonacci, Antonia
2022-4720 06/28/2022 Productos Marinos C.A
2022-4721 06/28/2022 Ruiz, Rosa
2022-4722 06/29/2022 AngioDynamics, Inc.
2022-4724 06/29/2022 FOI Services, Inc.

2022-4726 06/29/2022 FOI Services, Inc.
2022-4727 06/29/2022 FDAZILLA
2022-4730 06/29/2022 FDAZILLA
2022-4731 06/29/2022 NEW YORK TIMES

2022-4733 06/29/2022 FDAZILLA
2022-4734 06/29/2022 FDAZILLA
2022-4735 06/29/2022 FDAZILLA
2022-4736 06/29/2022 FDAZILLA
2022-4737 06/29/2022 Bonacci, Antonia
2022-4738 06/29/2022 Bates, Jeremy

2022-4739 06/29/2022 FOI Services, Inc.
2022-4740 06/29/2022 FOI Services, Inc.
2022-4741 06/30/2022 FDAZILLA
2022-4743 06/30/2022 Advalight ApS

2022-4745 06/30/2022 FOI Services, Inc.
2022-4746 06/30/2022 John Gamberzky

2022-4747 06/30/2022 Visterra Incorporated
2022-4748 06/30/2022 FDAZILLA
2022-4749 06/30/2022 The Capitol Forum

2022-4750 06/30/2022 Grossmann LLP
2022-4751 06/30/2022 COOPERVISION
2022-4752 06/30/2022 CIRCUIT CLINICAL
2022-4753 06/30/2022 FDAZILLA
2022-4754 06/30/2022 FDAZILLA
2022-4755 06/30/2022 The Epoch Times
2022-4756 07/01/2022 BLOOMBERG NEWS

2022-4757 07/01/2022 Harrington, Kohl
2022-4758 07/01/2022 Brock, Ronald
2022-4759 07/01/2022 Brock, Ronald
2022-4760 07/01/2022 Duty, Harry
2022-4761 07/01/2022 Melton, Donavan
2022-4762 07/01/2022 Alicia Antiri

2022-4763 07/01/2022 Alicia Antiri
2022-4764 07/01/2022 Alicia Antiri


2022-4769 07/01/2022 Duty, Harry

2022-4774 07/01/2022 Private limited
2022-4777 07/01/2022 FOI Services, Inc.
2022-4778 07/01/2022 Recordati Rare Diseases, Inc.

2022-4780 07/01/2022 P.C.
2022-4781 07/01/2022 Kao, Owen
2022-4782 07/01/2022 Brown, Paola
2022-4783 07/01/2022 Marijuana Moment

2022-4784 07/01/2022 Rosati
2022-4785 07/01/2022 Pinnacle Biologics, Inc.

2022-4787 07/01/2022 SAS

2022-4788 07/01/2022 SAS

2022-4789 07/01/2022 SAS
2022-4790 07/01/2022 CMC Quality
2022-4791 07/01/2022 Minwoo Kim
BALYASNY ASSET
2022-4794 07/01/2022 MANAGEMENT
2022-4795 07/01/2022 Ascendis Pharma Inc.
2022-4796 07/01/2022 Almin Extrusion

Reporters Committee for
2022-4797 07/01/2022 Freedom of the Press
Heshan Zhanli Sinda Foods
2022-4798 07/01/2022 Co., Ltd.
2022-4799 07/01/2022 Daniel Guda

2022-4800 07/01/2022 SAS

2022-4801 07/01/2022 SAS
2022-4802 07/01/2022 Kingchem Laboratories, Inc.
2022-4803 07/01/2022 KWAN WINSTON 09540-040
2022-4805 07/05/2022 Duty, Harry

2022-4806 07/05/2022 SAS

2022-4807 07/05/2022 SAS
2022-4808 07/05/2022 SAS

2022-4809 07/05/2022 SAS

2022-4810 07/05/2022 SAS

2022-4811 07/05/2022 SAS

2022-4812 07/05/2022 SAS

2022-4813 07/05/2022 SAS

2022-4814 07/05/2022 SAS
2022-4815 07/05/2022 SAS

2022-4816 07/05/2022 SAS


2022-4818 07/05/2022 SAS

2022-4819 07/05/2022 SAS

2022-4820 07/05/2022 SAS
2022-4822 07/05/2022 Yield10 Bioscience

2022-4823 07/05/2022 REASON FOUNDATION
2022-4827 07/05/2022 WIS-TV

2022-4828 07/05/2022 Wondfo USA Co., Ltd.
2022-4829 07/05/2022 LLC
2022-4830 07/05/2022 LLC
2022-4831 07/05/2022 Martin, Lauren
2022-4832 07/05/2022 Michael Nelson
2022-4833 07/05/2022 FDAZILLA
2022-4834 07/05/2022 N/A

2022-4836 07/05/2022 AltaThera Phamaceuticals

New Jersey Department of
2022-4837 07/05/2022 Environmental Protection
2022-4838 07/05/2022 BQ Prime
Swedish Orphan Biovitrum AB

2022-4839 07/05/2022 (publ)
2022-4840 07/05/2022 Diaz Trade Law
Sartorius Korea Biotech Co.,
2022-4841 07/05/2022 Ltd.
2022-4843 07/05/2022 CBS
Tanoury, Nauts, McKinney &

2022-4844 07/05/2022 Dwaihy, PLLC
2022-4845 07/05/2022 eFoodAlert

2022-4846 07/05/2022 Inventiv Foundation Inc.
2022-4847 07/05/2022 Inventiv.org
2022-4848 07/05/2022 Inventiv.org
2022-4849 07/05/2022 Inventiv.org
2022-4850 07/05/2022 Inventiv.org
2022-4851 07/05/2022 Inventiv.org
2022-4852 07/05/2022 Inventiv.org
2022-4853 07/05/2022 Inventiv.org

2022-4863 07/06/2022 FOI Services, Inc.

2022-4864 07/06/2022 SAS

2022-4865 07/06/2022 SAS

2022-4866 07/06/2022 SAS

2022-4867 07/06/2022 SAS
2022-4868 07/06/2022 SAS

2022-4869 07/06/2022 SAS
2022-4870 07/06/2022 FOI Services, Inc.
2022-4871 07/06/2022 FOI Services, Inc.
2022-4872 07/06/2022 FOI Services, Inc.
2022-4873 07/06/2022 BQ Prime

2022-4874 07/06/2022 FDAZILLA
2022-4875 07/06/2022 FDAZILLA

2022-4876 07/06/2022 SAS

2022-4877 07/06/2022 SAS
2022-4878 07/06/2022 FOI Services, Inc.
2022-4879 07/06/2022 FOI Services, Inc.
2022-4880 07/06/2022 Registrar Corp
2022-4881 07/06/2022 Registrar Corp
2022-4882 07/06/2022 Registrar Corp
2022-4883 07/06/2022 Registrar Corp

2022-4884 07/06/2022 Registrar Corp
2022-4885 07/06/2022 Registrar Corp
2022-4886 07/06/2022 Registrar Corp
2022-4887 07/06/2022 Registrar Corp
2022-4888 07/06/2022 Registrar Corp
2022-4889 07/07/2022 FDAZILLA

Motilal oswal financial
2022-4890 07/07/2022 services
2022-4891 07/07/2022 INTERTEK
2022-4892 07/07/2022 Becker Data USA LLC
2022-4896 07/07/2022 Falcon Laser
2022-4897 07/07/2022 BLOOMBERG
2022-4898 07/07/2022 BLOOMBERG
2022-4901 07/07/2022 Shaun Mehra

Psychiatry Residency
2022-4902 07/07/2022 Spokane, Kelly Wurzel
2022-4903 07/07/2022 EISAI INC

2022-4904 07/07/2022 Taylor Research Group
2022-4905 07/07/2022 VENABLE LLP

2022-4907 07/07/2022 Registrar Corp
2022-4908 07/07/2022 NEW YORK TIMES

Florida Agency for Health

2022-4910 07/07/2022 Care Administration
2022-4911 07/07/2022 UNIVERSITY OF TORONTO
2022-4912 07/07/2022 Toroa Management
University of Pittsburgh -
2022-4913 07/07/2022 Department of Surgery
2022-4914 07/07/2022 Plakas Mannos
2022-4915 07/07/2022 HUSCH BLACKWELL LLP

2022-4918 07/07/2022 FOI Services, Inc.
2022-4919 07/07/2022 Philips
2022-4920 07/07/2022 Dentsply SIrona
McGuff Compounding
2022-4921 07/07/2022 Pharmaceutical Services, Inc
2022-4922 07/07/2022 FDA NEWS
2022-4923 07/07/2022 FDAZILLA
2022-4924 07/07/2022 FDAZILLA

KINGSFORD CAPITAL
2022-4925 07/07/2022 MANAGEMENT
2022-4926 07/08/2022 FDAZILLA
2022-4928 07/08/2022 FDAZILLA
2022-4929 07/08/2022 FDA NEWS

2022-4930 07/08/2022 FDA NEWS
2022-4931 07/08/2022 FDA NEWS
2022-4932 07/08/2022 FDA NEWS
2022-4933 07/08/2022 FDA NEWS
2022-4934 07/08/2022 FDA NEWS
2022-4935 07/08/2022 FDA NEWS
2022-4936 07/08/2022 FDA NEWS
2022-4937 07/08/2022 FDA NEWS
2022-4938 07/08/2022 FDA NEWS
2022-4939 07/08/2022 FDA NEWS
2022-4940 07/08/2022 FDA NEWS
2022-4941 07/08/2022 Registrar Corp
2022-4942 07/08/2022 FOI Services, Inc.
2022-4943 07/08/2022 FOI Services, Inc.
2022-4944 07/08/2022 K1C Consulting LLC
2022-4945 07/08/2022 FOI Services, Inc.
2022-4946 07/08/2022 FOI Services, Inc.
2022-4947 07/08/2022 FOI Services, Inc.
2022-4948 07/08/2022 FOI Services, Inc.
2022-4949 07/08/2022 FOI Services, Inc.
2022-4950 07/08/2022 FOI Services, Inc.

2022-4951 07/08/2022 FOI Services, Inc.
2022-4952 07/08/2022 FOI Services, Inc.
2022-4953 07/08/2022 FOI Services, Inc.

2022-4954 07/08/2022 INC
2022-4955 07/08/2022 FOI Services, Inc.

2022-4956 07/08/2022 FOI Services, Inc.
2022-4957 07/08/2022 SSA
2022-4958 07/08/2022 FIDJ, PLLC
2022-4959 07/11/2022 The Epoch Times
2022-4960 07/11/2022 FOI Services, Inc.
2022-4961 07/11/2022 FOI Services, Inc.
2022-4962 07/11/2022 Travis Miller
2022-4963 07/11/2022 FOI Services, Inc.

2022-4964 07/11/2022 London Business School
2022-4965 07/11/2022 LINCARE INC
2022-4966 07/11/2022 Dunlop, Jake

2022-4969 07/11/2022 Kent, Chelsea

2022-4970 07/11/2022 ROONEY PC
2022-4971 07/11/2022 Matthew Zorn
2022-4973 07/11/2022 Cowper Law LLP
2022-4974 07/11/2022 Givaudan
2022-4975 07/11/2022 Medtronic Inc. - Swinnea

2022-4976 07/11/2022 Dowd LLP
2022-4977 07/11/2022 Outliers, Inc. (dba Thesis)

2022-4979 07/11/2022 Johnson & Johnson Medtech
2022-4980 07/11/2022 IPS HEART
2022-4981 07/11/2022 Pistevo Law LLC
2022-4985 07/11/2022 Perry, Rachel
2022-4986 07/11/2022 Perry, Rachel
2022-4988 07/11/2022 BQ Prime
2022-4989 07/11/2022 BNP Paribas

2022-4990 07/11/2022 BNP Paribas
2022-4991 07/11/2022 MARKSANSPHARMA LTD
2022-4992 07/11/2022 St. Cloud State Unviersity
2022-4994 07/11/2022 INTERTEK
2022-4995 07/11/2022 Perry, Rachel
2022-4996 07/11/2022 FDAZILLA
2022-4997 07/11/2022 FDAZILLA
BALYASNY ASSET
2022-4998 07/11/2022 MANAGEMENT
2022-4999 07/11/2022 FDAZILLA

2022-5000 07/11/2022 FDAZILLA
2022-5001 07/11/2022 FDAZILLA
2022-5002 07/11/2022 Perry, Rachel

Office of the Illinois Attorney
2022-5003 07/11/2022 General
2022-5004 07/11/2022 CLYDE & CO US LLP

NORC at the University of
2022-5005 07/11/2022 Chicago
2022-5006 07/11/2022 FDAZILLA

2022-5007 07/11/2022 Fdalytics
2022-5008 07/11/2022 FDAZILLA
2022-5009 07/11/2022 FDAZILLA
2022-5010 07/11/2022 FDAZILLA
2022-5011 07/11/2022 CNBC TV18
2022-5012 07/11/2022 C-REG MEDICAL
2022-5013 07/11/2022 Verona Pharma plc
2022-5014 07/11/2022 Sprouts Farmers Market

2022-5015 07/11/2022 C-REG MEDICAL
2022-5016 07/11/2022 UNIVERSITY OF CALIFORNIA
2022-5017 07/11/2022 Wheeler, Mitchell A

2022-5018 07/11/2022 KUHN FAMILY
2022-5019 07/11/2022 BANKS B17963, RANDY
2022-5020 07/11/2022 BU SCHOOL OF LAW

2022-5021 07/11/2022 OFT Law, PLLC
2022-5022 07/11/2022 JERRY DOFFING
2022-5024 07/12/2022 Perry, Rachel

CTI Clinical Trial and
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2022-5052 07/12/2022 FDAZILLA

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2022-5110 07/14/2022 ASSOCIATED PRESS
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2022-5126 07/14/2022 FDAZILLA
2022-5127 07/14/2022 FDAZILLA
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2022-5131 07/15/2022 Robins Kaplan LLP
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2022-5188 07/15/2022 FDAZILLA
2022-5189 07/15/2022 FDAZILLA
2022-5190 07/15/2022 FDAZILLA

2022-5191 07/15/2022 INTERSCOPE INC
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2022-5227 07/18/2022 ALSTON & BIRD
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2022-5236 07/18/2022 FOIA GROUP INC
2022-5237 07/18/2022 FOIA GROUP INC
2022-5238 07/18/2022 FOIA GROUP INC
2022-5239 07/18/2022 FOIA GROUP INC
2022-5240 07/18/2022 FDAZILLA

2022-5241 07/18/2022 FDAZILLA
2022-5242 07/18/2022 FDAZILLA
2022-5243 07/18/2022 FDAZILLA
2022-5244 07/18/2022 FDAZILLA
2022-5245 07/18/2022 CBS
2022-5246 07/18/2022 IPVM
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2022-5269 07/20/2022 The Epoch Times
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2022-5273 07/20/2022 Supernus Pharmaceutical Inc
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2022-5292 07/20/2022 FDAZILLA
2022-5293 07/20/2022 FDAZILLA
2022-5294 07/20/2022 FDAZILLA
2022-5295 07/20/2022 FDAZILLA
2022-5296 07/20/2022 FDAZILLA

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2022-5308 07/21/2022 FDAZILLA
2022-5309 07/21/2022 FDAZILLA
2022-5310 07/21/2022 FDAZILLA

2022-5311 07/21/2022 FDAZILLA
2022-5312 07/21/2022 FDAZILLA
2022-5313 07/21/2022 FDAZILLA
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2022-5315 07/22/2022 FOI Services, Inc.
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2022-5330 07/22/2022 Brock, Ronald
2022-5331 07/22/2022 Americans for Prosperity
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2022-5333 07/22/2022 Manuel Bautista
2022-5334 07/22/2022 Manuel Bautista
2022-5335 07/22/2022 Manuel Bautista
2022-5336 07/22/2022 MEXICAN PRODUCTS MDJ LLC
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2022-5339 07/22/2022 Sullivan, LLP
2022-5340 07/22/2022 Dilan Casanovas
2022-5341 07/22/2022 UNIVERSITY OF ALBERTA
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2022-5343 07/22/2022 TORF LAW FIRM
2022-5344 07/22/2022 Springborne Life Sciences
2022-5345 07/22/2022 Springborne Life Sciences


2022-5348 07/22/2022 Conway Homer, PC
2022-5349 07/22/2022 Conway Homer, PC
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2022-5350 07/22/2022 MANAGEMENT LLC
2022-5351 07/22/2022 SCILUCENT LLC
2022-5352 07/22/2022 EGIS PHARMACEUTICALS PLC

2022-5353 07/22/2022 CNBC TV18
2022-5354 07/22/2022 Rolnick Kramer Sadighi LLP
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2022-5358 07/25/2022 FOI Services, Inc.
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2022-5360 07/25/2022 FOI Services, Inc.
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2022-5372 07/25/2022 FDAZILLA
2022-5373 07/25/2022 FDAZILLA
2022-5374 07/25/2022 FDAZILLA
2022-5375 07/25/2022 FDAZILLA
2022-5376 07/25/2022 FDAZILLA
2022-5377 07/25/2022 FOI Services, Inc.
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2022-5382 07/25/2022 DUNN SHEEHAN LLP
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2022-5384 07/25/2022 FDAZILLA

2022-5386 07/25/2022 Snyder, Amy M
2022-5387 07/25/2022 MEDPAGE TODAY
2022-5388 07/25/2022 TNV Ventures LLC
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2022-5398 07/25/2022 FOI Services, Inc.
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2022-5400 07/25/2022 FDAZILLA
2022-5403 07/25/2022 FDAZILLA
2022-5404 07/25/2022 FDAZILLA
2022-5407 07/26/2022 MicroPort Prophecy, Ltd.
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2022-5408 07/26/2022 dba Stryker Orthopaedics
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2022-5411 07/26/2022 Test Squadron One
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2022-5418 07/26/2022 Allergy Therapeutics (UK) Ltd
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2022-5420 07/26/2022 FDAZILLA
2022-5422 07/26/2022 argenx BV
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2022-5429 07/27/2022 Stryker
2022-5430 07/27/2022 Stryker
2022-5431 07/27/2022 FDAZILLA

2022-5432 07/27/2022 FDAZILLA
2022-5433 07/27/2022 Stryker
2022-5434 07/27/2022 Stryker
2022-5435 07/27/2022 Stryker
2022-5437 07/27/2022 Stryker
2022-5438 07/27/2022 Stryker
2022-5439 07/27/2022 Stryker
2022-5440 07/27/2022 Stryker
2022-5441 07/27/2022 Stryker
2022-5442 07/27/2022 Stryker
2022-5443 07/27/2022 Brown Emergency Medicine
2022-5444 07/27/2022 Stryker

2022-5445 07/27/2022 INTERTEK
The Bureau of Investigative

2022-5446 07/27/2022 Journalism
2022-5447 07/27/2022 AS2 Bio

2022-5448 07/27/2022 POINT72
2022-5450 07/27/2022 TurtleTree
2022-5451 07/27/2022 FDAZILLA
2022-5452 07/27/2022 FDAZILLA
2022-5453 07/27/2022 FDAZILLA
2022-5454 07/27/2022 FDAZILLA
2022-5455 07/27/2022 CSL BEHRING
Penn State University Smeal

2022-5456 07/27/2022 College of Business
Arizona Nutritional
2022-5457 07/28/2022 Supplements
2022-5458 07/28/2022 WIS-TV

2022-5459 07/28/2022 STRYKER CORPORATION
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2022-5462 07/28/2022 FOI Services, Inc.
2022-5463 07/28/2022 JONES, GLEN
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2022-5464 07/28/2022 PACKAGING
2022-5465 07/28/2022 Raydiant Oximetry
2022-5466 07/28/2022 HARVEY P. SHORT QN8934
2022-5467 07/28/2022 HARVEY P. SHORT QN8934
2022-5468 07/29/2022 ALLWAYS FRESH PRODUCTS
2022-5470 07/29/2022 C-REG MEDICAL
2022-5471 07/29/2022 Drew Thornton
IMAGE INTERNATIONAL
MANUFACTURING, LLC DBA
2022-5472 07/29/2022 Image Skincare
IMAGE INTERNATIONAL
MANUFACTURING, LLC DBA
2022-5473 07/29/2022 Image Skincare
2022-5474 07/29/2022 eFoodAlert

SCHNEIDER SMELTZ SPIETH
2022-5475 07/29/2022 BELL
2022-5476 07/29/2022 FDAZILLA
2022-5477 07/29/2022 Stryker
2022-5478 07/29/2022 Stryker

2022-5479 07/29/2022 Stryker
2022-5480 07/29/2022 Stryker
2022-5481 07/29/2022 Stryker

2022-5482 07/29/2022 Stryker
2022-5483 07/29/2022 Stryker
2022-5484 07/29/2022 Stryker
2022-5485 07/29/2022 Stryker
2022-5486 07/29/2022 Stryker
2022-5487 07/29/2022 FDAZILLA
2022-5488 07/29/2022 FDAZILLA

2022-5489 07/29/2022 FDAZILLA
2022-5490 07/29/2022 FDAZILLA
2022-5491 07/29/2022 FDAZILLA
2022-5492 07/29/2022 FDAZILLA
2022-5494 07/29/2022 FDAZILLA
2022-5495 07/29/2022 ITG Brands, LLC
2022-5496 08/01/2022 Morgan Stanley

2022-5498 08/01/2022 Brynlawn Design
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2022-5514 08/01/2022 Bloomberg Industry Group
2022-5515 08/01/2022 Grant & Eisenhofer P.A.
2022-5516 08/01/2022 Duty, Harry

2022-5517 08/01/2022 ET Now
2022-5519 08/01/2022 Hoffmann, Caroline

COLGATE-PALMOLIVE
2022-5520 08/01/2022 COMPANY
2022-5521 08/01/2022 INC
2022-5522 08/01/2022 FOI Services, Inc.
2022-5523 08/01/2022 New U Life Corp.
2022-5524 08/01/2022 Nussbaum Law Group, P.C.
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2022-5528 08/01/2022 LLP
2022-5529 08/01/2022 Bonacci, Antonia

2022-5530 08/01/2022 WASSEF, NAGY A
2022-5531 08/01/2022 Lauren Tochacek
2022-5532 08/01/2022 FDAZILLA
2022-5533 08/01/2022 FDAZILLA
2022-5534 08/01/2022 FDAZILLA
2022-5535 08/01/2022 FDAZILLA
2022-5536 08/01/2022 FDAZILLA
2022-5537 08/01/2022 FDAZILLA

2022-5538 08/01/2022 FDAZILLA

2022-5539 08/01/2022 SAS

2022-5540 08/01/2022 SAS

2022-5541 08/01/2022 SAS

2022-5542 08/01/2022 SAS

2022-5543 08/01/2022 SAS

2022-5544 08/01/2022 SAS
2022-5545 08/01/2022 SAS

2022-5546 08/01/2022 SAS

2022-5547 08/01/2022 SAS

2022-5548 08/01/2022 SAS

2022-5549 08/01/2022 SAS

2022-5550 08/01/2022 SAS

2022-5551 08/01/2022 SAS
2022-5552 08/01/2022 SAS

2022-5553 08/01/2022 SAS

2022-5554 08/01/2022 SAS

2022-5555 08/01/2022 SAS

2022-5556 08/01/2022 SAS
OREGON HEALTH & SCIENCE
2022-5558 08/01/2022 UNIV
2022-5559 08/01/2022 Registrar Corp

2022-5560 08/01/2022 The Epoch Times
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2022-5562 08/01/2022 FDAZILLA
2022-5563 08/01/2022 FDAZILLA
2022-5564 08/01/2022 FOI Services, Inc.
2022-5565 08/01/2022 FOI Services, Inc.

2022-5566 08/01/2022 FDAZILLA
2022-5567 08/01/2022 FDAZILLA
2022-5568 08/01/2022 FDAZILLA
2022-5570 08/01/2022 POINT72
2022-5571 08/01/2022 FDAZILLA

2022-5572 08/01/2022 FOI Services, Inc.
2022-5573 08/01/2022 FOI Services, Inc.
2022-5574 08/01/2022 FOI Services, Inc.
2022-5575 08/01/2022 FOI Services, Inc.
2022-5576 08/01/2022 FDAZILLA
2022-5577 08/01/2022 FOI Services, Inc.
2022-5578 08/01/2022 FDAZILLA
2022-5579 08/01/2022 FDAZILLA
2022-5580 08/01/2022 FDAZILLA
2022-5581 08/01/2022 FOI Services, Inc.

2022-5582 08/01/2022 FDAZILLA
2022-5583 08/01/2022 FDAZILLA
2022-5584 08/01/2022 FDAZILLA
2022-5585 08/02/2022 THE HERITAGE FOUNDATION
2022-5586 08/02/2022 THE HERITAGE FOUNDATION
2022-5588 08/02/2022 Intertek Health Sciences Inc.

Penn State University Smeal
2022-5589 08/02/2022 College of Business
2022-5590 08/02/2022 LifeVac, LLC
2022-5591 08/02/2022 Gabriel Mckee

Berkshire Sterile
2022-5592 08/02/2022 Manufacturing, Inc.
2022-5593 08/02/2022 Kennedys
WILSON ELSER MOSKOWITZ

2022-5594 08/02/2022 EDELMAN & DICKER LLP
2022-5595 08/02/2022 Granata Bio

2022-5596 08/02/2022 G-SURG GmbH
2022-5597 08/02/2022 Radice Law Firm PC

2022-5598 08/02/2022 POINT72
2022-5599 08/02/2022 POINT72
2022-5600 08/02/2022 POINT72
2022-5601 08/02/2022 POINT72
2022-5602 08/02/2022 POINT72
2022-5603 08/02/2022 POINT72
Feinberg Jackson Worthman

2022-5604 08/02/2022 & Wasow
ACELLA PHARMACEUTICALS
2022-5605 08/02/2022 LLC
2022-5606 08/02/2022 STAQ Pharma, Inc.
2022-5607 08/02/2022 Two Seas Cap
2022-5608 08/02/2022 Two Seas Cap

Ascendant Manufacturing
2022-5609 08/02/2022 Solutions LLC
2022-5610 08/02/2022 Registrar Corp
2022-5611 08/02/2022 Registrar Corp
Brigham & Women's

Hospital/Harvard Medical
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2022-5612 08/02/2022 Law (PORTAL)
2022-5614 08/02/2022 FOI Services, Inc.
2022-5615 08/02/2022 Reuters News

2022-5616 08/02/2022 P.C.
2022-5617 08/02/2022 LLP (shanghai)
2022-5618 08/02/2022 SSA, SSA
2022-5619 08/02/2022 BQ Prime
2022-5620 08/02/2022 Wexler Boley & Elgersma

2022-5621 08/02/2022 Jin Services Co.
2022-5622 08/02/2022 SPILLER, ROBERT M

2022-5626 08/03/2022 Insight Service Group, Inc.

2022-5628 08/03/2022 P.C.
2022-5629 08/03/2022 eFoodAlert
2022-5630 08/03/2022 Kiesel Law LLP
2022-5631 08/03/2022 FOI Services, Inc.
2022-5632 08/03/2022 Agios Pharmaceuticals
2022-5633 08/03/2022 Newsy/E.W. Scripps Networks
2022-5634 08/03/2022 Kinard, Madris
2022-5636 08/03/2022 TIME
2022-5637 08/03/2022 REUTERS

2022-5638 08/03/2022 Kao, Owen

2022-5640 08/03/2022 Fdalytics
2022-5642 08/03/2022 Parav Nagarsheth
2022-5643 08/03/2022 Hoffmann, Caroline
2022-5644 08/04/2022 FDAZILLA
2022-5645 08/04/2022 FOIA GROUP INC
2022-5646 08/04/2022 FOIA GROUP INC
2022-5647 08/04/2022 FOIA GROUP INC
2022-5648 08/04/2022 FOIA GROUP INC
2022-5649 08/04/2022 FDAZILLA
2022-5650 08/04/2022 K.C. Pharmaceuticals, Inc.

2022-5651 08/04/2022 FDAZILLA
2022-5652 08/04/2022 FDAZILLA
2022-5653 08/04/2022 FDAZILLA
2022-5654 08/04/2022 FDAZILLA
2022-5656 08/04/2022 Waitze, Jacob
2022-5657 08/04/2022 Torigen Pharmaceuticals, Inc.

2022-5658 08/04/2022 RayzeBio, Inc.
2022-5659 08/04/2022 RayzeBio, Inc.
2022-5660 08/04/2022 RayzeBio, Inc.
2022-5661 08/04/2022 RayzeBio, Inc.
2022-5662 08/04/2022 RayzeBio, Inc.
2022-5663 08/04/2022 RayzeBio, Inc.
2022-5664 08/04/2022 RayzeBio, Inc.

2022-5667 08/04/2022 Recipharm Laboratories Inc

2022-5670 08/04/2022 Baker Hostetler
2022-5671 08/04/2022 Baker Hostetler
2022-5672 08/04/2022 Baker Hostetler
2022-5673 08/04/2022 Baker Hostetler
2022-5674 08/04/2022 ELANCO ANIMAL HEALTH

2022-5675 08/04/2022 Akin Gump
Dickie, McCamey & Chilcote,
2022-5676 08/04/2022 P.C.
2022-5678 08/04/2022 Wayne Rohde
2022-5679 08/04/2022 Miller, Denis

Grand River Aseptic
2022-5683 08/04/2022 Manufacturing
2022-5684 08/04/2022 KEMMELCAL INC

2022-5686 08/05/2022 ET Now
2022-5687 08/05/2022 Ajay Phadke
2022-5689 08/05/2022 Chen, Effie
2022-5694 08/05/2022 David Tukey
2022-5695 08/05/2022 FOI Services, Inc.

MEDTRONIC SOFAMOR
2022-5696 08/05/2022 DANEK
2022-5697 08/05/2022 ConMed Corporation
2022-5701 08/05/2022 CONMED ANDOVER MEDICAL

2022-5703 08/05/2022 Keating, Zachary
MEDTRONIC SOFAMOR
2022-5704 08/05/2022 DANEK
MEDTRONIC SOFAMOR
2022-5705 08/05/2022 DANEK
2022-5707 08/05/2022 FDAZILLA
2022-5708 08/05/2022 FDAZILLA
2022-5709 08/05/2022 FDAZILLA
2022-5710 08/05/2022 FDAZILLA
2022-5711 08/05/2022 CONMED ANDOVER MEDICAL
2022-5712 08/05/2022 FDAZILLA

BALYASNY ASSET
2022-5713 08/05/2022 MANAGEMENT
2022-5714 08/05/2022 Catherine Brisson
2022-5715 08/05/2022 FDAZILLA

2022-5716 08/05/2022 FDAZILLA
2022-5717 08/05/2022 FDAZILLA

2022-5718 08/05/2022 Check, LLP
2022-5720 08/05/2022 Ellison Sadri, LLC
2022-5721 08/05/2022 CIPLA LTD

2022-5722 08/05/2022 Inc
BALYASNY ASSET
2022-5724 08/05/2022 MANAGEMENT

2022-5726 08/05/2022 Daniel Kenney
RAPOPORT WEISBERG & SIMS
2022-5727 08/05/2022 P.C.
2022-5728 08/05/2022 CONMED
2022-5729 08/05/2022 BOOKER, NICHOLE
2022-5730 08/05/2022 THOMAS BRYAN

2022-5731 08/05/2022 shimane, takumi

2022-5733 08/08/2022 Jonesing Labs, LLC
2022-5735 08/08/2022 Engineering System Co., Ltd.

2022-5736 08/08/2022 Marketing Group USA, Inc
2022-5737 08/08/2022 Melton, Donavan

2022-5738 08/08/2022 Melton, Donavan
2022-5739 08/08/2022 Melton, Donavan
2022-5740 08/08/2022 Melton, Donavan
2022-5741 08/08/2022 Melton, Donavan

UNIVERSITY OF SOUTH
2022-5742 08/08/2022 CAROLINA
2022-5743 08/08/2022 The Epoch Times
2022-5744 08/08/2022 The Epoch Times
2022-5745 08/08/2022 N/A


Ajinomoto Health & Nutrition
2022-5752 08/08/2022 North America

2022-5754 08/08/2022 Brian Communications
OLSSON FRANK WEEDA

2022-5755 08/08/2022 TERMAN MATZ PC
2022-5756 08/08/2022 FOI Services, Inc.
2022-5757 08/08/2022 FOI Services, Inc.

BALYASNY ASSET
2022-5758 08/08/2022 MANAGEMENT
2022-5759 08/08/2022 TAP Pharmaceuticals AG
2022-5760 08/08/2022 FDAZILLA
2022-5761 08/08/2022 FDAZILLA
2022-5762 08/08/2022 FDAZILLA
2022-5763 08/09/2022 Domaoal, Gina
2022-5764 08/09/2022 Amavon, LLC

2022-5765 08/09/2022 B&D Dental Corporation
HAGENS BERMAN SOBOL

2022-5768 08/09/2022 SHAPIRO LLP
2022-5769 08/09/2022 UCSF
2022-5770 08/09/2022 Montanez, Stephen
2022-5771 08/09/2022 PROPHARMA GROUP

2022-5772 08/09/2022 AskBio
2022-5773 08/09/2022 AMGEN INC.

2022-5774 08/09/2022 INC
2022-5775 08/09/2022 Inc

Singin' River Brewing
2022-5778 08/09/2022 Company, LLC
2022-5779 08/09/2022 Newry Corporation

2022-5786 08/09/2022 FDAZILLA
2022-5787 08/09/2022 FDAZILLA
2022-5788 08/09/2022 NEWSWEEK
2022-5789 08/09/2022 Johns Hopkins University
2022-5790 08/09/2022 McDermott Will & Emery, LLP
2022-5791 08/09/2022 Magic Feathers Corp.
2022-5792 08/09/2022 Waitze, Jacob
2022-5793 08/09/2022 FDAZILLA
2022-5794 08/09/2022 FDAZILLA

2022-5795 08/09/2022 FDAZILLA
2022-5796 08/09/2022 FDAZILLA
2022-5797 08/09/2022 FDAZILLA

2022-5798 08/09/2022 Fdalytics
2022-5799 08/09/2022 FDAZILLA
2022-5800 08/09/2022 FDAZILLA
2022-5801 08/09/2022 FDAZILLA
2022-5802 08/09/2022 FDAZILLA
2022-5803 08/09/2022 FDAZILLA
2022-5804 08/09/2022 FDAZILLA
2022-5805 08/09/2022 FDAZILLA

2022-5806 08/09/2022 FDAZILLA
2022-5807 08/10/2022 Evans, Shasta
2022-5808 08/10/2022 Cropper, Neal
2022-5809 08/10/2022 Cropper, Neal

2022-5810 08/10/2022 ScottHulse, PC
2022-5811 08/10/2022 ScottHulse, PC
2022-5813 08/10/2022 PROPHARMA GROUP
2022-5817 08/10/2022 Charnas Law Firm, P.C.

2022-5819 08/10/2022 argenx BV
2022-5822 08/10/2022 FOI Services, Inc.

2022-5824 08/10/2022 InBios International, Inc.
2022-5825 08/10/2022 CLYDE & CO US LLP
2022-5826 08/10/2022 NOVARTIS
2022-5827 08/10/2022 FOI Services, Inc.
2022-5828 08/10/2022 FOI Services, Inc.
2022-5829 08/10/2022 FOI Services, Inc.
2022-5830 08/10/2022 FOI Services, Inc.

2022-5831 08/10/2022 FOI Services, Inc.
2022-5832 08/10/2022 FOI Services, Inc.
BALYASNY ASSET
2022-5834 08/10/2022 MANAGEMENT
2022-5836 08/10/2022 Marketing Group USA, Inc
2022-5837 08/10/2022 FDAZILLA
2022-5838 08/10/2022 FDAZILLA
2022-5839 08/10/2022 FDAZILLA
2022-5840 08/10/2022 FDAZILLA
2022-5841 08/10/2022 FDAZILLA
2022-5842 08/10/2022 FDAZILLA

2022-5843 08/10/2022 Management LLP
2022-5844 08/11/2022 Pty Ltd
2022-5845 08/11/2022 Pty Ltd
2022-5846 08/11/2022 Pty Ltd
2022-5847 08/11/2022 Pty Ltd
2022-5848 08/11/2022 Pty Ltd
2022-5849 08/11/2022 Hart Zhao

2022-5851 08/11/2022 Kelley, Debbe
2022-5852 08/11/2022 Par Sterile Products, LLC
2022-5853 08/11/2022 FDA NEWS
2022-5854 08/11/2022 Mohamed Dimbil
2022-5855 08/11/2022 Foster & Eldridge

2022-5857 08/11/2022 Pharmalex
2022-5858 08/11/2022 Pharmalex

2022-5861 08/11/2022 VOUK, SYDNEY
America First Legal

2022-5862 08/11/2022 Foundation
Neon Hum Media and
2022-5863 08/11/2022 Bloomberg
2022-5864 08/11/2022 Reuters News

2022-5865 08/11/2022 Pharmalex
2022-5867 08/11/2022 OFT Law, PLLC

2022-5868 08/11/2022 SimBioSys
2022-5869 08/11/2022 MEDTRONIC
2022-5870 08/11/2022 UCSF


2022-5876 08/11/2022 Pty Ltd
2022-5877 08/11/2022 Pty Ltd
2022-5878 08/11/2022 Pty Ltd
2022-5879 08/11/2022 Pty Ltd
2022-5880 08/11/2022 Pty Ltd
ASSISTANCE PUBLIQUE
HOPITAUX DE PARIS
2022-5881 08/11/2022 DERMATOLOGIE
2022-5882 08/11/2022 FDAZILLA
2022-5883 08/11/2022 FDAZILLA
2022-5884 08/11/2022 FDAZILLA
2022-5885 08/11/2022 FDAZILLA
2022-5886 08/11/2022 FDAZILLA
2022-5887 08/11/2022 FOIA Request Services, LLC

2022-5888 08/11/2022 Brock, Ronald
2022-5889 08/11/2022 Brock, Ronald
2022-5890 08/11/2022 Brock, Ronald

2022-5891 08/11/2022 Duty, Harry

2022-5897 08/12/2022 Merck Sharp and ohme LLC
2022-5898 08/12/2022 Riaan & Rishaan LP

2022-5900 08/12/2022 Senzime AB
2022-5901 08/12/2022 REACH24H USA INC.

2022-5902 08/12/2022 Pty Ltd
2022-5903 08/12/2022 Pty Ltd
2022-5904 08/12/2022 Pty Ltd
2022-5905 08/12/2022 Pty Ltd
2022-5906 08/12/2022 Pty Ltd
2022-5907 08/12/2022 Pty Ltd
2022-5908 08/12/2022 ResusRight Pty Ltd

2022-5909 08/12/2022 Pty Ltd
2022-5910 08/12/2022 Pty Ltd
2022-5911 08/12/2022 Pty Ltd
BALYASNY ASSET
2022-5912 08/12/2022 MANAGEMENT

2022-5914 08/12/2022 AVAcore Technologies, Inc
2022-5915 08/12/2022 The Los Angeles Times

2022-5918 08/12/2022 DSC Meridian Capital
2022-5919 08/15/2022 FDAZILLA
2022-5920 08/15/2022 FDAZILLA
2022-5921 08/15/2022 FDAZILLA
2022-5922 08/15/2022 FDAZILLA

2022-5923 08/15/2022 FDAZILLA
2022-5924 08/15/2022 FDAZILLA
2022-5925 08/15/2022 FDAZILLA
2022-5926 08/15/2022 FDAZILLA

2022-5927 08/15/2022 FDAZILLA
2022-5928 08/15/2022 FDAZILLA
2022-5929 08/15/2022 ET Now

2022-5930 08/15/2022 ARTHREX, INC.
2022-5931 08/15/2022 Servier Pharmaceuticals LLC

2022-5934 08/15/2022 ARTHREX, INC.
2022-5935 08/15/2022 ARTHREX INC

2022-5937 08/15/2022 ARTHREX INC
2022-5938 08/15/2022 ARTHREX INC

2022-5941 08/15/2022 Nicholas Kastilahn

2022-5942 08/15/2022 Pate, Mike
2022-5943 08/15/2022 BOEHRINGER INGELHEIM
2022-5944 08/15/2022 INDIANA UNIVERSITY
2022-5945 08/15/2022 PROPHARMA GROUP
2022-5946 08/15/2022 eFoodAlert
2022-5947 08/15/2022 eFoodAlert

BALYASNY ASSET
2022-5948 08/15/2022 MANAGEMENT
2022-5950 08/15/2022 Wolff, Kristi
2022-5951 08/15/2022 Coppin, Chad
2022-5952 08/15/2022 Youabian, Kambiz
2022-5953 08/15/2022 Youabian, Kambiz
2022-5954 08/15/2022 PROPHARMA GROUP
2022-5955 08/15/2022 FDAZILLA
2022-5956 08/15/2022 FDAZILLA

2022-5957 08/15/2022 Sooren Thathiah, PLLC
2022-5958 08/15/2022 Kim Lewis
2022-5959 08/16/2022 BQ Prime

2022-5960 08/16/2022 CytoChip Inc.
2022-5961 08/16/2022 CytoChip Inc.
2022-5962 08/16/2022 Nomura
2022-5963 08/16/2022 Shamansky Law Office

2022-5964 08/16/2022 Pty Ltd
2022-5966 08/16/2022 Devenish Nutrition
2022-5968 08/16/2022 FOI Services, Inc.

2022-5969 08/16/2022 FDA NEWS
2022-5970 08/16/2022 FDA NEWS
2022-5971 08/16/2022 FDA NEWS
2022-5972 08/16/2022 FDA NEWS
2022-5973 08/16/2022 FDA NEWS
2022-5974 08/16/2022 FDA NEWS
2022-5975 08/16/2022 FDA NEWS
2022-5976 08/16/2022 FDA NEWS
2022-5977 08/16/2022 FDA NEWS
2022-5978 08/16/2022 FDA NEWS
2022-5979 08/16/2022 FDA NEWS
Hikma Pharmaceuticals USA

2022-5980 08/16/2022 Inc.
2022-5981 08/16/2022 P.C.
2022-5982 08/16/2022 FDAZILLA
2022-5983 08/16/2022 BioView ltd.
2022-5984 08/16/2022 PHILIPS MEDICAL SYSTEMS
Schneider Smeltz Speith Bell,

2022-5985 08/16/2022 LLP

2022-5987 08/16/2022 CARPENTER, JOCELYN
2022-5988 08/16/2022 Proscia, Inc.
2022-5989 08/16/2022 Oceana, Inc.
2022-5991 08/16/2022 Call to Action, Inc. (CTADHL)
2022-5992 08/16/2022 FDAZILLA
2022-5993 08/16/2022 FDAZILLA
2022-5994 08/16/2022 FDAZILLA
2022-5995 08/16/2022 FDAZILLA

2022-5996 08/16/2022 Chamberlain, Richard
2022-5997 08/16/2022 Silversmith, William M
2022-5998 08/16/2022 Cosette Pharmaceuticals, Inc.
2022-6000 08/16/2022 Correa, Jacqueline
2022-6001 08/17/2022 FOI Services, Inc.

2022-6002 08/17/2022 Puma Biotechnology, Inc.
2022-6003 08/17/2022 P.C.
2022-6004 08/17/2022 FOI Services, Inc.
2022-6005 08/17/2022 KANSAS STATE UNIVERSITY
2022-6006 08/17/2022 NORGINE LTD
Berkshire Sterile
2022-6007 08/17/2022 Manufacturing, Inc.
2022-6009 08/17/2022 FOI Services, Inc.

2022-6010 08/17/2022 CARDIACASSIST INC
2022-6011 08/17/2022 Inc., USA

2022-6013 08/17/2022 FOI Services, Inc.
2022-6014 08/17/2022 FDAZILLA

2022-6015 08/17/2022 FDAZILLA
2022-6016 08/17/2022 FDAZILLA
2022-6017 08/17/2022 FDAZILLA
2022-6018 08/17/2022 FDAZILLA
2022-6019 08/17/2022 FDAZILLA
2022-6020 08/17/2022 Soft Lights Foundation
2022-6021 08/17/2022 Fontem US, LLC
2022-6023 08/17/2022 Alicia Antiri
2022-6024 08/17/2022 Alicia Antiri
2022-6025 08/17/2022 Alicia Antiri

2022-6026 08/17/2022 ByHeart
2022-6027 08/17/2022 ByHeart
2022-6028 08/17/2022 Dunlop, Jake
2022-6029 08/17/2022 mctlaw
2022-6030 08/18/2022 STERIS CORP
2022-6031 08/18/2022 STERIS CORP
2022-6032 08/18/2022 FDAZILLA
2022-6033 08/18/2022 FDAZILLA
2022-6034 08/18/2022 FDAZILLA
2022-6035 08/18/2022 FDAZILLA
2022-6036 08/18/2022 FDAZILLA

2022-6037 08/18/2022 FDAZILLA
2022-6038 08/18/2022 FDAZILLA

2022-6039 08/18/2022 al
2022-6040 08/18/2022 NiKang Therapeutics, Inc.
2022-6042 08/18/2022 White Labs, Inc
UTILITY WORKERS UNION OF

2022-6043 08/19/2022 AMERICA

2022-6044 08/19/2022 AMERICA

2022-6045 08/19/2022 AMERICA
2022-6046 08/19/2022 AMERICA

2022-6047 08/19/2022 AMERICA

2022-6048 08/19/2022 AMERICA

2022-6049 08/19/2022 AMERICA
2022-6050 08/19/2022 Medical Device Academy, Inc.

2022-6051 08/19/2022 AMERICA

2022-6052 08/19/2022 AMERICA
2022-6053 08/19/2022 AMERICA

2022-6054 08/19/2022 AMERICA

2022-6055 08/19/2022 AMERICA

2022-6056 08/19/2022 AMERICA
2022-6057 08/19/2022 Jodi Rouviere
2022-6058 08/19/2022 Sauber Regulatory Consulting
2022-6059 08/19/2022 Xtract Medical

2022-6060 08/19/2022 K&L GATES
2022-6063 08/19/2022 WALL STREET JOURNAL
2022-6067 08/19/2022 WALL STREET JOURNAL
2022-6068 08/19/2022 Johnstone Partners
2022-6069 08/19/2022 Granata Bio

2022-6070 08/19/2022 Michael, Brittany
2022-6072 08/19/2022 Bowersox Law Firm, P.C.

2022-6073 08/19/2022 MARKETSHIELD, INC
Agri-Pulse Communications,
2022-6074 08/19/2022 Inc.

2022-6075 08/19/2022 PC
2022-6076 08/19/2022 Forbes Media LLC
2022-6078 08/19/2022 FDAZILLA
2022-6079 08/19/2022 FDAZILLA
2022-6080 08/19/2022 FDAZILLA
2022-6081 08/19/2022 FDAZILLA
2022-6082 08/19/2022 FDAZILLA

2022-6083 08/19/2022 FDAZILLA
2022-6084 08/22/2022 Duty, Harry

2022-6085 08/22/2022 of Law Library
2022-6087 08/22/2022 Regunalys LLC

2022-6090 08/22/2022 COMEXPROM
2022-6094 08/22/2022 Zhang, Leon

2022-6096 08/22/2022 Santa Clara University

Zymtronix Catalytic Systems
2022-6099 08/22/2022 Inc.
2022-6101 08/22/2022 SACHS, STEPHEN
2022-6102 08/22/2022 Second Bite Foods, Inc.
2022-6103 08/22/2022 Second Bite Foods, Inc.
2022-6104 08/22/2022 Law LLP
2022-6105 08/22/2022 Klarquist
2022-6106 08/22/2022 NBC 5 Chicago (WMAQ-TV)
2022-6107 08/22/2022 Broughton Life Sciences

2022-6110 08/22/2022 APOTEX CORP.

2022-6113 08/22/2022 FDAZILLA
2022-6114 08/22/2022 FDAZILLA
2022-6115 08/22/2022 FDAZILLA
WENDE CORRECTIONAL
2022-6116 08/22/2022 FACILITY
Becton Dickinson Medical
2022-6117 08/23/2022 Pharmaceutical Systems
2022-6118 08/23/2022 Cipla Limited
2022-6120 08/23/2022 Karen Beckman
2022-6121 08/23/2022 NMD Healthcare
THE HUMANE SOCIETY OF

2022-6122 08/23/2022 THE UNITED STATES
2022-6123 08/23/2022 Plymouth University

2022-6126 08/23/2022 Penn Law Group
2022-6127 08/23/2022 Schmukler, Louis S
Informa Natural Products

2022-6128 08/23/2022 Insider

2022-6130 08/23/2022 StimLabs
2022-6134 08/23/2022 CytoChip Inc.

2022-6135 08/23/2022 CytoChip Inc.
2022-6136 08/23/2022 CytoChip Inc.
2022-6137 08/23/2022 CytoChip Inc.

2022-6139 08/23/2022 AbbVie, Inc.
2022-6140 08/23/2022 Ventora Medical

2022-6141 08/23/2022 Self (Requester)
Inside Out Quality Consulting

LLC, University of South
2022-6142 08/23/2022 Dakota
2022-6143 08/23/2022 FDAZILLA
2022-6144 08/23/2022 FDAZILLA
2022-6145 08/23/2022 FDAZILLA
2022-6146 08/23/2022 FDAZILLA
2022-6147 08/23/2022 FDAZILLA
2022-6148 08/23/2022 FDAZILLA

2022-6149 08/23/2022 Indianapolis Fruit, LLC
2022-6150 08/23/2022 FDAZILLA

ULMER & BERNE LLP

2022-6152 08/23/2022 ATTORNEYS AT LAW
2022-6154 08/23/2022 Garden Cut, LLC
2022-6155 08/24/2022 Philip Morris International

2022-6156 08/24/2022 Adam Detsky
ULMER & BERNE LLP

2022-6158 08/24/2022 ATTORNEYS AT LAW
2022-6160 08/24/2022 Bulk Chemical Services, LLC
2022-6163 08/24/2022 Nikki Grace

2022-6164 08/24/2022 FOI Services, Inc.
2022-6165 08/24/2022 BLOOMBERG LP

2022-6166 08/24/2022 BLOOMBERG NEWS
2022-6167 08/24/2022 BLOOMBERG NEWS
2022-6168 08/24/2022 BLOOMBERG NEWS
2022-6169 08/24/2022 BLOOMBERG NEWS
2022-6171 08/24/2022 BLOOMBERG NEWS

2022-6172 08/24/2022 Waitze, Jake
2022-6173 08/24/2022 FOI Services, Inc.
2022-6174 08/24/2022 FOI Services, Inc.
2022-6175 08/24/2022 LivaNova USA, Inc.
2022-6176 08/24/2022 Susan Francis
2022-6177 08/25/2022 FOI Services, Inc.

2022-6178 08/25/2022 Nikki Grace
2022-6179 08/25/2022 Nikki Grace
2022-6180 08/25/2022 Nikki Grace
2022-6181 08/25/2022 Alpenglow Biosciences, Inc.

2022-6183 08/25/2022 Kao, Owen
2022-6184 08/25/2022 Swiss-American CDMO, LLC
2022-6186 08/25/2022 BTR
2022-6187 08/25/2022 The Epoch Times
2022-6188 08/25/2022 Birth Tissue Recovery
2022-6189 08/25/2022 Birth Tissue Recovery

2022-6190 08/25/2022 Cytokinetics, Inc.
2022-6191 08/25/2022 ET Now
2022-6192 08/25/2022 Ronald Maddix

2022-6194 08/25/2022 Sparrow Acoustics Inc.
2022-6195 08/25/2022 PROPHARMA GROUP

2022-6198 08/25/2022 Houssiere Durant & Houssiere

2022-6200 08/25/2022 MINNEAPOLIS STAR TRIBUNE

2022-6201 08/25/2022 PUBLIC INTEREST

2022-6203 08/25/2022 KEYS 22458017, CLAY
2022-6204 08/25/2022 BOWERSOX LAW FIRM
DP DISTRIBUTION &
2022-6205 08/25/2022 CONSULTING LLP
2022-6206 08/25/2022 FDAZILLA

2022-6207 08/25/2022 FDAZILLA
2022-6208 08/25/2022 FDAZILLA
2022-6209 08/25/2022 FDAZILLA
2022-6210 08/25/2022 FDAZILLA
2022-6211 08/25/2022 FDAZILLA
2022-6212 08/25/2022 FDAZILLA
2022-6214 08/25/2022 FDAZILLA
2022-6215 08/25/2022 FDAZILLA

University College Cork,
2022-6216 08/26/2022 Ireland
2022-6217 08/26/2022 Sung Chun Kim, Esq.

2022-6218 08/26/2022 FOI Services, Inc.
2022-6219 08/26/2022 BQ Prime

2022-6220 08/26/2022 Hunt, Brittain
2022-6221 08/26/2022 Walsworth - WFBM, LLP
2022-6222 08/26/2022 Detsky, Adam

2022-6224 08/26/2022 Reath LLP
2022-6225 08/26/2022 FOI Services, Inc.

2022-6226 08/26/2022 Reath LLP
This Machine Filmworks and

2022-6227 08/26/2022 Showtime

2022-6228 08/26/2022 Reath LLP
2022-6229 08/26/2022 INC
2022-6230 08/29/2022 AMBIT CAPITAL

2022-6231 08/29/2022 FDAZILLA
2022-6232 08/29/2022 FDAZILLA
2022-6233 08/29/2022 Melton, Donavan
2022-6234 08/29/2022 Ark Pharmacy

2022-6235 08/29/2022 Melton, Donavan
2022-6236 08/29/2022 Melton, Donavan
2022-6238 08/29/2022 Triplett, Donald

NATURAL PRODUCTS
2022-6239 08/29/2022 ASSOCIATION
2022-6240 08/29/2022 Triplett, Donald

2022-6242 08/29/2022 DUPREE, HYLTON
2022-6243 08/29/2022 FDAZILLA
2022-6244 08/29/2022 FDAZILLA
2022-6245 08/29/2022 FDAZILLA
2022-6246 08/29/2022 FDAZILLA

2022-6247 08/29/2022 FDAZILLA
2022-6248 08/29/2022 FDAZILLA
2022-6249 08/29/2022 FDAZILLA
2022-6250 08/29/2022 FDAZILLA
2022-6251 08/29/2022 FDAZILLA
2022-6252 08/29/2022 FDAZILLA

2022-6253 08/29/2022 Rohrbach, Jennifer
2022-6254 08/29/2022 LLP
2022-6255 08/29/2022 MetaPhase Consulting
2022-6256 08/30/2022 PROPUBLICA

2022-6258 08/30/2022 ALSTON & BIRD
2022-6259 08/30/2022 FOI Services, Inc.
2022-6260 08/30/2022 FOI Services, Inc.

2022-6261 08/30/2022 FOI Services, Inc.
2022-6262 08/30/2022 FOI Services, Inc.
2022-6263 08/30/2022 FOI Services, Inc.
2022-6264 08/30/2022 FOI Services, Inc.
2022-6265 08/30/2022 FOI Services, Inc.
2022-6266 08/30/2022 FOI Services, Inc.
2022-6267 08/30/2022 FOI Services, Inc.
2022-6268 08/30/2022 FDAZILLA
American Optometric
2022-6269 08/30/2022 Association
2022-6270 08/30/2022 FDAZILLA

2022-6271 08/30/2022 FDAZILLA
2022-6272 08/30/2022 FDAZILLA
2022-6273 08/30/2022 FDAZILLA
2022-6274 08/30/2022 POINT72
2022-6275 08/30/2022 FDAZILLA
2022-6276 08/30/2022 FDAZILLA
2022-6277 08/30/2022 FDAZILLA
Technologies Sciences Group

2022-6278 08/31/2022 Inc
2022-6279 08/31/2022 OFT Law, PLLC

2022-6280 08/31/2022 Ethicon
2022-6282 08/31/2022 Duong, Kim
2022-6283 08/31/2022 FOI Services, Inc.
2022-6284 08/31/2022 Stimlabs, LLC

Rapid Reboot Recovery
2022-6285 08/31/2022 Products LLC
2022-6286 08/31/2022 FOI Services, Inc.
2022-6287 08/31/2022 Howry Breen & Herman, LLP
2022-6288 08/31/2022 Guild Associates, Inc
2022-6289 08/31/2022 Guild Associates, Inc

2022-6291 09/01/2022 Myriam Pham
2022-6292 09/01/2022 ET Now
2022-6293 09/01/2022 PLC
2022-6294 09/01/2022 BQ Prime

2022-6295 09/01/2022 Pvt Ltd

2022-6299 09/01/2022 PROCTER & GAMBLE
2022-6302 09/01/2022 Satsuma Pharmaceuticals

2022-6305 09/01/2022 DUANE MORRIS LLP
Sichuan Jinxin Women and
2022-6307 09/01/2022 Children's Hospital
Swedish Orphan Biovitrum AB
2022-6308 09/01/2022 (publ)
2022-6309 09/01/2022 Citeline
2022-6310 09/01/2022 Citeline
2022-6311 09/01/2022 Citeline

2022-6312 09/01/2022 SAS

2022-6313 09/01/2022 SAS
2022-6314 09/01/2022 Stimlabs, LLC

2022-6315 09/01/2022 SAS
2022-6316 09/01/2022 FOI Services, Inc.
2022-6317 09/01/2022 FOI Services, Inc.
2022-6318 09/01/2022 Ikuta Hemesath LLP
2022-6319 09/01/2022 FOI Services, Inc.
2022-6320 09/01/2022 FOI Services, Inc.

2022-6321 09/01/2022 SAS

2022-6322 09/01/2022 SAS

2022-6323 09/01/2022 SAS
2022-6324 09/01/2022 SAS

2022-6325 09/01/2022 SAS

2022-6326 09/01/2022 SAS

2022-6327 09/01/2022 SAS
Satsuma Pharmaceuticals,
2022-6328 09/01/2022 Inc.
2022-6330 09/01/2022 Granata Bio
2022-6331 09/01/2022 Granata Bio

2022-6332 09/01/2022 WON TECH Co., Ltd.
2022-6333 09/01/2022 FOLEY HOAG LLP
2022-6334 09/01/2022 etnow
2022-6338 09/01/2022 BQ Prime
2022-6339 09/01/2022 FDAZILLA
Humanwell PuraCap
Pharmaceuticals (Wuhan) Co
2022-6340 09/01/2022 Ltd.
2022-6341 09/01/2022 IBSA Institut BiochImique SA

2022-6342 09/01/2022 Pvt Ltd

2022-6343 09/01/2022 Pvt Ltd
2022-6344 09/01/2022 BQ Prime
2022-6345 09/01/2022 FDAZILLA
2022-6346 09/01/2022 FDAZILLA
MORGAN LEWIS & BOCKIUS

2022-6347 09/01/2022 LLP
Midwest Sterilization
2022-6348 09/01/2022 Corporation
2022-6350 09/01/2022 DUNN SHEEHAN LLP
2022-6351 09/01/2022 DiCello Levitt
2022-6352 09/01/2022 Swedish Match Company
2022-6354 09/01/2022 FOI Services, Inc.

2022-6356 09/01/2022 PROPHARMA GROUP
2022-6357 09/01/2022 Kurt Weber
2022-6358 09/01/2022 FDAZILLA
Bridge that Gap - SYNGAP

Research and Education Fnd;
2022-6359 09/01/2022 DBA SYNGAP1 Foundation
Assistance Publique Hopitaux

2022-6360 09/01/2022 de Paris - Hopital Bichat
2022-6361 09/01/2022 none
2022-6362 09/02/2022 CLIANTHA RESEARCH LTD
2022-6363 09/02/2022 FOI Services, Inc.
2022-6364 09/02/2022 FOI Services, Inc.

West Pharmaceutical
2022-6365 09/02/2022 Services, Inc.
2022-6366 09/02/2022 FOI Services, Inc.

Minnesota State University
2022-6367 09/02/2022 Mankato
2022-6368 09/02/2022 THE NEWS & OBSERVER
2022-6369 09/02/2022 CAREier
2022-6370 09/02/2022 Martin, Vincent
2022-6371 09/02/2022 THE NEWS & OBSERVER
2022-6372 09/02/2022 Bigtuna36, LLC

2022-6373 09/02/2022 KING & SPALDING
U.S. Army Institute of Surgical
2022-6374 09/02/2022 Research

2022-6381 09/02/2022 FOI Services, Inc.
Baylor College of
Medicine/Texas Children's
2022-6382 09/02/2022 Hospital
2022-6383 09/02/2022 JONES, GLEN
2022-6384 09/02/2022 PITTSBURGH POST-GAZETTE
2022-6385 09/02/2022 Reuters News
2022-6386 09/02/2022 J Canavati & Co LLC

Informa Natural Products
2022-6387 09/02/2022 Insider
Copyright Clearance Center

(on behalf of Dexcel Ltd and
Dexcel Pharma Technologies
2022-6388 09/02/2022 Ltd)
2022-6389 09/02/2022 Pharmavite LLC

2022-6390 09/02/2022 BioTex Inc.
2022-6391 09/02/2022 BioTex Inc.
2022-6392 09/02/2022 BioTex Inc.
2022-6393 09/02/2022 BioTex Inc.
2022-6394 09/02/2022 FOI Services, Inc.

2022-6395 09/02/2022 FOI Services, Inc.
2022-6396 09/02/2022 FOI Services, Inc.
2022-6397 09/02/2022 FOI Services, Inc.

2022-6398 09/06/2022 Fdalytics
2022-6399 09/06/2022 Evans, Shasta
2022-6400 09/06/2022 Evans, Shasta
2022-6401 09/06/2022 Kent, Chelsea

2022-6402 09/06/2022 Linda Bonvie
2022-6403 09/06/2022 Linda Bonvie
2022-6404 09/06/2022 Penn Law Group

2022-6405 09/06/2022 Dr Ajay Phadke
2022-6406 09/06/2022 Melton, Donavan
2022-6407 09/06/2022 Anapol Weiss

2022-6408 09/06/2022 Anapol Weiss
2022-6409 09/06/2022 Anapol Weiss
2022-6410 09/06/2022 Anapol Weiss
2022-6411 09/06/2022 Anapol Weiss

2022-6412 09/06/2022 Anapol Weiss
2022-6413 09/06/2022 BLOOMBERG NEWS
2022-6414 09/06/2022 FDAZILLA
2022-6415 09/06/2022 FDAZILLA
2022-6416 09/06/2022 FDAZILLA
2022-6417 09/06/2022 FDAZILLA

2022-6419 09/06/2022 Inc.
2022-6420 09/06/2022 RGRD
2022-6421 09/06/2022 Dr. Reddy’s Laboratories, Inc.
2022-6422 09/06/2022 Dr. Reddy’s Laboratories, Inc.

2022-6423 09/06/2022 FOI Services, Inc.
2022-6424 09/06/2022 FOI Services, Inc.
BALYASNY ASSET
2022-6425 09/06/2022 MANAGEMENT

2022-6427 09/06/2022 Wondfo USA Co., Ltd.
2022-6429 09/06/2022 Zhang, Wei
2022-6430 09/06/2022 Premkumar, Prashant

2022-6431 09/06/2022 FDAZILLA
2022-6432 09/06/2022 FDAZILLA
2022-6433 09/06/2022 FDAZILLA
2022-6440 09/06/2022 C.A. Goldberg, PLLC

BUCHALTER, A PROFESSIONAL
2022-6441 09/06/2022 CORP
2022-6442 09/06/2022 Morgan Stanley
2022-6443 09/06/2022 CSL Plasma, Inc.

2022-6444 09/07/2022 Lally, LLP
UCLA Health (David Geffen

School of Medicine at the
University of California, Los
2022-6445 09/07/2022 Angeles)
Dupree, Kimbrough, Carl &
2022-6447 09/07/2022 Reilly, LLP
2022-6449 09/07/2022 Associates, LLC
2022-6451 09/07/2022 Alnylam Pharmaceuticals

2022-6454 09/07/2022 BigHat Biosciences
2022-6455 09/07/2022 FOI Services, Inc.

2022-6456 09/07/2022 FOI Services, Inc.
2022-6457 09/07/2022 Penn Law Group

2022-6459 09/07/2022 FUND
2022-6460 09/07/2022 Promising Goods LLC.
2022-6461 09/07/2022 Anapol Weiss
2022-6462 09/07/2022 NBC UNIVERSAL

2022-6465 09/07/2022 CSL Plasma, Inc.

2022-6466 09/07/2022 LANDRUM & SHOUSE LLP
Indiana University,
2022-6467 09/07/2022 Bloomington
2022-6469 09/07/2022 Robinson, Raymond
2022-6470 09/07/2022 Inc., USA
2022-6472 09/07/2022 TARGET CORPORATION
2022-6473 09/07/2022 Citi Research
2022-6474 09/07/2022 HTI Plastics
2022-6475 09/07/2022 FOI Services, Inc.

2022-6476 09/07/2022 Feds4MedFreedom.org
ASSISTANCE PUBLIQUE
HOPITAUX DE PARIS
2022-6477 09/08/2022 DERMATOLOGIE
2022-6478 09/08/2022 SFSU
2022-6479 09/08/2022 Bezad Deboo
2022-6480 09/08/2022 BQ Prime

2022-6482 09/08/2022 The Epoch Times
2022-6483 09/08/2022 Engineering Systems Inc

2022-6484 09/08/2022 BOSTON SCIENTIFIC
2022-6486 09/08/2022 RADICE LAW FIRM
2022-6487 09/08/2022 Martin, Mitch
2022-6488 09/08/2022 NBC UNIVERSAL

2022-6490 09/08/2022 BofA Biotech Equity Research

2022-6491 09/08/2022 LINDA SCHAEDLER
2022-6492 09/08/2022 USWM, LLC
2022-6493 09/08/2022 Chemeca Drugs Pvt Ltd

2022-6495 09/09/2022 Biohaven Pharmaceuticals
2022-6496 09/09/2022 ARQA Consulting
2022-6497 09/09/2022 KING & SPALDING
2022-6499 09/09/2022 Topco Associates LLC
2022-6500 09/09/2022 U.S. Food Imports LLC

2022-6501 09/09/2022 GAVIPLAS SL
2022-6503 09/09/2022 Registrar Corp

2022-6504 09/09/2022 Registrar Corp
2022-6505 09/09/2022 Registrar Corp
2022-6506 09/09/2022 Registrar Corp
2022-6507 09/09/2022 Registrar Corp
2022-6508 09/09/2022 Registrar Corp
2022-6509 09/09/2022 THERMO FISHER SCIENTIFIC
2022-6510 09/09/2022 POINT72
2022-6511 09/09/2022 Martir, Lorenzo
2022-6512 09/09/2022 BofA Biotech Equity Research
2022-6513 09/09/2022 Registrar Corp

Kevin Kong (HEC Pharm USA
2022-6514 09/09/2022 Inc.)
Humanwell PuraCap
Pharmaceuticals (Wuhan) Co.,
2022-6515 09/09/2022 Ltd
2022-6517 09/09/2022 Meyers & Flowers LLC
2022-6518 09/09/2022 Shady Grove Fertility Center
2022-6519 09/09/2022 Raymond James
2022-6520 09/09/2022 CRCM Venture

2022-6524 09/09/2022 INREX, LLC
2022-6525 09/09/2022 mctlaw

2022-6526 09/12/2022 FOI Services, Inc.
SCIEGEN PHARMACEUTICALS
2022-6527 09/12/2022 INC
Fairmount Funds
2022-6529 09/12/2022 Management LLC
2022-6530 09/12/2022 FOI Services, Inc.

Padagis Israel
2022-6537 09/12/2022 FDAZILLA
2022-6538 09/12/2022 FDAZILLA
2022-6539 09/12/2022 SURVE, SATISH
Foshan RuiTong Consulting
2022-6540 09/12/2022 Co.,Ltd.
2022-6541 09/12/2022 CNBC
2022-6542 09/12/2022 N/A
2022-6545 09/12/2022 Sheehan & Associates, P.C.

2022-6546 09/12/2022 Burch, Tyler
2022-6547 09/12/2022 Burch, Tyler
Aztech Regulatory and
2022-6548 09/13/2022 Quality LLC
2022-6549 09/13/2022 FDA NEWS
2022-6550 09/13/2022 FDA NEWS
2022-6551 09/13/2022 FDAZILLA

2022-6552 09/13/2022 FDA NEWS
2022-6553 09/13/2022 FDA NEWS
2022-6554 09/13/2022 FDAZILLA

2022-6555 09/13/2022 FDA NEWS
2022-6556 09/13/2022 FDA NEWS
2022-6557 09/13/2022 FDA NEWS
2022-6558 09/13/2022 FDA NEWS
2022-6559 09/13/2022 FDA NEWS
2022-6560 09/13/2022 FDAZILLA

2022-6561 09/13/2022 FDA NEWS
2022-6562 09/13/2022 FDA NEWS
2022-6563 09/13/2022 FDA NEWS
2022-6564 09/13/2022 FDAZILLA
2022-6565 09/13/2022 FDAZILLA

2022-6566 09/13/2022 MEDTRONIC
2022-6567 09/13/2022 FOI Services, Inc.

2022-6568 09/13/2022 FOI Services, Inc.
2022-6569 09/13/2022 FOI Services, Inc.

2022-6570 09/13/2022 FOI Services, Inc.
North American Science

2022-6572 09/13/2022 Associates, LLC (NAMSA)

2022-6573 09/13/2022 SAS
2022-6574 09/13/2022 Susan Francis
2022-6575 09/13/2022 LBT Innovations Ltd

2022-6576 09/13/2022 Myriam Pham
2022-6577 09/13/2022 FEDinform LLC
SCIEGEN PHARMACEUTICALS
2022-6578 09/13/2022 INC
2022-6579 09/13/2022 Clark-Esposito Law Firm, P.C.

2022-6580 09/13/2022 Beckman Coulter Inc.
2022-6581 09/13/2022 MicroPort NaviBot

2022-6582 09/13/2022 Maicon, James
2022-6584 09/13/2022 Heather Hourihan

2022-6585 09/13/2022 FDA NEWS
2022-6586 09/13/2022 X-Dimensions, LLC

2022-6587 09/13/2022 Brock, Ronald
2022-6588 09/13/2022 BASF Corporation
2022-6589 09/13/2022 of Law Library

2022-6591 09/13/2022 Regunalys LLC
2022-6592 09/13/2022 Regunalys LLC

2022-6594 09/13/2022 Althea Medical Ltd.

2022-6596 09/14/2022 Inventia Healthcare limited
2022-6597 09/14/2022 Averell, Allyson

2022-6599 09/14/2022 Regunalys LLC
2022-6600 09/14/2022 Ravi Garg

2022-6601 09/14/2022 FOI Services, Inc.
HAGENS BERMAN SOBOL

2022-6603 09/14/2022 SHAPIRO LLP
2022-6604 09/14/2022 ALLSTATE INSURANCE CO
2022-6605 09/14/2022 Parker, Hayley D
WELLINGTON MANAGEMENT
2022-6606 09/14/2022 CO LLP
2022-6607 09/14/2022 Daniele Franceschini
Soterius Inc. on behalf of

2022-6609 09/14/2022 NEW YORK UNIVERSITY
OLSSON FRANK WEEDA

2022-6611 09/15/2022 TERMAN MATZ PC
2022-6612 09/15/2022 BQ Prime

2022-6613 09/15/2022 WJLA TV
2022-6614 09/15/2022 Jacobson, Michael F

2022-6615 09/15/2022 Regunalys LLC
2022-6618 09/15/2022 Kao, Owen
VMX-1, Marine Operational

2022-6619 09/15/2022 Test Squadron One
2022-6622 09/15/2022 Marsala, Daniel G

Olympus Corporation of
2022-6623 09/15/2022 America
Carlson School of
Management, University of
2022-6624 09/15/2022 Minnesota
2022-6625 09/15/2022 Intuitive Surgical, Inc.
2022-6626 09/15/2022 LSU Law School

2022-6629 09/15/2022 PPTA
2022-6630 09/15/2022 Revive Rx

2022-6631 09/15/2022 Check, LLP
2022-6632 09/15/2022 THE PINK SHEET
2022-6633 09/15/2022 THE PINK SHEET
2022-6634 09/15/2022 PetVivo Holdings, Inc.
2022-6635 09/15/2022 Kimberly Esteve
2022-6637 09/15/2022 Morgan Stanley
2022-6638 09/15/2022 Virbac Corporation

2022-6641 09/15/2022 SFSU
2022-6642 09/15/2022 Erin Jensen
Humanwell PuraCap
2022-6643 09/16/2022 Ltd
Humanwell PuraCap
2022-6644 09/16/2022 Ltd
2022-6645 09/16/2022 Juan Maldonado
2022-6647 09/16/2022 Pharma Intelligence | Informa
2022-6649 09/16/2022 Schlesinger Law Offices, P.A.
2022-6650 09/16/2022 Varana Capital, LLC
2022-6651 09/16/2022 Alison Schneiderman

Neon Hum Media and
2022-6653 09/16/2022 Bloomberg
2022-6654 09/16/2022 HOWARD DIBBERN K-88439
2022-6655 09/19/2022 FDAZILLA
2022-6656 09/19/2022 FDAZILLA
2022-6657 09/19/2022 FDAZILLA
2022-6658 09/19/2022 FDAZILLA
2022-6659 09/19/2022 FDAZILLA
2022-6660 09/19/2022 FDAZILLA
2022-6661 09/19/2022 FDAZILLA
2022-6662 09/19/2022 FDAZILLA
2022-6663 09/19/2022 FDAZILLA

2022-6664 09/19/2022 FDAZILLA
2022-6665 09/19/2022 FOI Services, Inc.
2022-6666 09/19/2022 FOI Services, Inc.
2022-6667 09/19/2022 FOI Services, Inc.
2022-6668 09/19/2022 FOI Services, Inc.
2022-6669 09/19/2022 FOI Services, Inc.
2022-6670 09/19/2022 FOI Services, Inc.
2022-6671 09/19/2022 FOI Services, Inc.
2022-6672 09/19/2022 FOI Services, Inc.

2022-6673 09/19/2022 Inventia Healthcare limited
2022-6674 09/19/2022 FDAZILLA
2022-6675 09/19/2022 FDAZILLA
2022-6676 09/19/2022 FDAZILLA
2022-6677 09/19/2022 PathAI
2022-6678 09/19/2022 PathAI
Applied Medical Resources
2022-6679 09/19/2022 Corporation
2022-6680 09/19/2022 ET Now
2022-6681 09/19/2022 Corporation
2022-6682 09/19/2022 Corporation
2022-6683 09/19/2022 Corporation
BALYASNY ASSET
2022-6684 09/19/2022 MANAGEMENT
Poulin Willey Anastopoulo

2022-6685 09/19/2022 Law Firm LLC
2022-6687 09/19/2022 Inyang, Nelisa

AMERICA FIRST LEGAL
2022-6688 09/19/2022 SERVICES, INC.
Howmedica Osteonics Corp
2022-6689 09/19/2022 aka Stryker Orthopaedics
2022-6695 09/19/2022 Linda Bonvie
2022-6696 09/19/2022 Sung Chun Kim, Esq.

Bestchrom (Shanghai)
2022-6698 09/19/2022 Bioscience Ltd.
Fairmount Funds
2022-6699 09/19/2022 Management LLC
2022-6700 09/19/2022 Francis, Susan M

2022-6701 09/19/2022 SAS

2022-6702 09/19/2022 SAS
2022-6703 09/19/2022 FDAZILLA
2022-6704 09/19/2022 FDAZILLA
2022-6705 09/19/2022 FDAZILLA
2022-6706 09/19/2022 FDAZILLA

2022-6707 09/19/2022 FDAZILLA
2022-6708 09/19/2022 FDAZILLA
2022-6709 09/19/2022 FDAZILLA
2022-6710 09/19/2022 FDAZILLA
2022-6711 09/19/2022 FDAZILLA
2022-6712 09/19/2022 FDAZILLA

2022-6716 09/19/2022 TERARECON, INC
2022-6718 09/20/2022 FOIA GROUP INC
Lowey Ent. DBA Sunrise

2022-6723 09/20/2022 Produce Co.
2022-6724 09/20/2022 MG Solutech Inc.

2022-6725 09/20/2022 CNBC
2022-6728 09/20/2022 Encision, Inc.
BALYASNY ASSET
2022-6729 09/20/2022 MANAGEMENT

2022-6731 09/20/2022 PROPHARMA GROUP
2022-6733 09/20/2022 Joywell Foods
2022-6734 09/20/2022 Designs for Health
2022-6736 09/20/2022 FOI Services, Inc.
2022-6737 09/20/2022 LSU Law School
2022-6738 09/20/2022 PharmaEssentia

HAGENS BERMAN SOBOL
2022-6739 09/20/2022 SHAPIRO LLP
2022-6741 09/20/2022 RAY THOMPSON
2022-6742 09/20/2022 FOI Services, Inc.
2022-6743 09/20/2022 FOI Services, Inc.

2022-6744 09/20/2022 CANEY AGRI SERVICE LLC
UNIVERSITY OF CALIFORNIA,
2022-6746 09/20/2022 IRVINE
2022-6747 09/21/2022 Analysis Group, Inc.
CALIFORNIA DEPARTMENT OF
2022-6748 09/21/2022 FOOD AND AGRICULTURE
2022-6749 09/21/2022 Linda Bonvie
BALYASNY ASSET
2022-6750 09/21/2022 MANAGEMENT
2022-6751 09/21/2022 Raymond Robinson

2022-6753 09/21/2022 SAS
2022-6754 09/21/2022 Ashby, Drew
German Patent and

2022-6755 09/21/2022 Trademark Office
2022-6756 09/21/2022 BALYASNY
2022-6757 09/21/2022 Secura Bio Inc.
2022-6758 09/21/2022 Seagen Inc.
2022-6759 09/21/2022 Rogers, Kylee
2022-6760 09/21/2022 Lannett Company, Inc.
FAVUS INSTITUTIONAL
2022-6761 09/21/2022 RESEARCH LLC
2022-6762 09/21/2022 Citrine Med Spa
2022-6763 09/21/2022 Forbes Advisor

NEPHRON
2022-6764 09/21/2022 PHARMACEUTICALS CORP.
2022-6765 09/21/2022 FOI Services, Inc.

2022-6766 09/21/2022 STAT News
FARALLON CAPITAL
2022-6768 09/21/2022 MANAGEMENT LLC
2022-6769 09/21/2022 BROWN CHIARI LLP
2022-6771 09/22/2022 Rodriguez, Jacob N

2022-6772 09/22/2022 Michael Telliard
FAVUS INSTITUTIONAL
2022-6773 09/22/2022 RESEARCH LLC
2022-6774 09/22/2022 Adakin Capital
2022-6779 09/22/2022 The Epoch Times
2022-6780 09/22/2022 Hogan Lovells
BALYASNY ASSET
2022-6781 09/22/2022 MANAGEMENT
BALYASNY ASSET
2022-6782 09/22/2022 MANAGEMENT
2022-6786 09/22/2022 FDAZILLA
2022-6787 09/22/2022 FDAZILLA
2022-6788 09/22/2022 FDAZILLA
2022-6789 09/22/2022 FDAZILLA
2022-6790 09/22/2022 FDAZILLA
2022-6791 09/22/2022 FDAZILLA
BALYASNY ASSET
2022-6792 09/22/2022 MANAGEMENT

2022-6794 09/22/2022 Highside Capital Mangement
2022-6796 09/22/2022 ARCH PHARMALABS LIMITED
PAI holdings dba

Pharmaceutical Associates
2022-6797 09/22/2022 Inc.
2022-6798 09/22/2022 eFoodAlert
2022-6799 09/22/2022 Two Seas Cap

2022-6800 09/22/2022 Elliot Favus, MD
2022-6801 09/22/2022 FOI Services, Inc.

2022-6802 09/22/2022 Hogan Lovells
Spinal Analytics &

2022-6803 09/22/2022 Geometrical Implant Co, LLC
2022-6804 09/22/2022 The Epoch Times
2022-6805 09/22/2022 FOI Services, Inc.
2022-6806 09/22/2022 Bleichmar Fonti & Auld LLP

2022-6807 09/22/2022 SAS
2022-6808 09/22/2022 SAS
2022-6810 09/22/2022 FDAZILLA
2022-6811 09/22/2022 FDAZILLA
2022-6812 09/22/2022 FDAZILLA
2022-6813 09/22/2022 FDAZILLA
2022-6814 09/22/2022 FDAZILLA
2022-6815 09/22/2022 FDAZILLA
2022-6816 09/22/2022 FDAZILLA
2022-6817 09/22/2022 FDAZILLA
2022-6818 09/22/2022 FDAZILLA

2022-6819 09/22/2022 FDAZILLA
2022-6820 09/22/2022 Bleichmar Fonti & Auld

2022-6823 09/23/2022 CNBC
Regulatory Consulting
2022-6824 09/23/2022 Services, Inc.
BAYADA Home Health Care

2022-6825 09/23/2022 Inc.
2022-6826 09/23/2022 Jake Waitze
reveal from the center for

2022-6827 09/23/2022 investigative reporting
2022-6828 09/23/2022 PFM Health Sciences
Southern Institute for Medical

2022-6829 09/23/2022 and Legal Affairs, LLC
Southern Institute for Medical

2022-6830 09/23/2022 and Legal Affairs, LLC
2022-6831 09/23/2022 ACADIA Pharmaceuticals Inc.

GARWIN GERSTEIN & FISHER
2022-6832 09/23/2022 LLP
2022-6833 09/23/2022 eFoodAlert
2022-6834 09/23/2022 Christina Chow
2022-6835 09/23/2022 CNN

2022-6839 09/23/2022 EMINENCE GROUP LLC
2022-6840 09/23/2022 CNN
2022-6841 09/23/2022 CNN
2022-6842 09/23/2022 The Epoch Times

Cochlear - Lone Tree
2022-6844 09/23/2022 Colorado - Medical Device
2022-6845 09/23/2022 Webster Law Office, PLLC
Bestchrom (Shanghai)
2022-6846 09/23/2022 Bioscience Ltd.
2022-6847 09/23/2022 Strong Garner Bauer
2022-6848 09/23/2022 Registrar Corp
2022-6850 09/23/2022 DEEP TRACK CAPITAL
2022-6851 09/23/2022 Registrar Corp
2022-6852 09/23/2022 Clark Lee
2022-6853 09/23/2022 CNN

2022-6854 09/23/2022 CNN
2022-6855 09/26/2022 FOI Services, Inc.
2022-6856 09/26/2022 FOI Services, Inc.
2022-6857 09/26/2022 PCCA
2022-6858 09/26/2022 PCCA
2022-6859 09/26/2022 FOI Services, Inc.
2022-6860 09/26/2022 FOI Services, Inc.
2022-6861 09/26/2022 FOI Services, Inc.
2022-6862 09/26/2022 FOI Services, Inc.
2022-6863 09/26/2022 FOI Services, Inc.
2022-6864 09/26/2022 FOI Services, Inc.

2022-6865 09/26/2022 FOI Services, Inc.
2022-6866 09/26/2022 FOI Services, Inc.
2022-6867 09/26/2022 PCCA
2022-6868 09/26/2022 FOI Services, Inc.
2022-6869 09/26/2022 FOI Services, Inc.
2022-6870 09/26/2022 Gates, Brian
2022-6871 09/26/2022 FOIA GROUP INC
2022-6872 09/26/2022 FOIA GROUP INC
2022-6873 09/26/2022 FOIA GROUP INC
2022-6875 09/26/2022 Pettit-Pokora, Kevin A

Glenn Robinson Cathey
2022-6876 09/26/2022 Memmer & Skaff
2022-6877 09/26/2022 Pepper Source
2022-6878 09/26/2022 Adakin Capital
2022-6880 09/26/2022 Brincor Associates, LLC

2022-6881 09/26/2022 SAS

2022-6882 09/26/2022 SAS

2022-6883 09/26/2022 SAS

2022-6884 09/26/2022 SAS
2022-6885 09/26/2022 FDAZILLA
2022-6886 09/26/2022 FDAZILLA

2022-6887 09/26/2022 FDAZILLA
2022-6888 09/26/2022 FDAZILLA
2022-6889 09/26/2022 FDAZILLA
2022-6890 09/26/2022 FDAZILLA
2022-6891 09/26/2022 FDAZILLA

2022-6892 09/27/2022 FDAZILLA
2022-6893 09/27/2022 FDAZILLA
2022-6894 09/27/2022 FDAZILLA
2022-6895 09/27/2022 FDAZILLA
2022-6896 09/27/2022 FDAZILLA
2022-6897 09/27/2022 RAY THOMPSON

2022-6898 09/27/2022 Shamrock Foods Company
2022-6899 09/27/2022 FOI Services, Inc.

2022-6900 09/27/2022 RAY THOMPSON
2022-6901 09/27/2022 RAY THOMPSON
2022-6902 09/27/2022 RAY THOMPSON
2022-6903 09/27/2022 RAY THOMPSON
2022-6904 09/27/2022 RAY THOMPSON
2022-6905 09/27/2022 RAY THOMPSON
2022-6906 09/27/2022 RAY THOMPSON
2022-6907 09/27/2022 RAY THOMPSON
2022-6908 09/27/2022 RAY THOMPSON

2022-6909 09/27/2022 Morgan Stanley
2022-6910 09/27/2022 Keys, Clay
2022-6911 09/28/2022 Ashler Capital
2022-6912 09/28/2022 Bezad Deboo

2022-6913 09/28/2022 CNBC
2022-6914 09/29/2022 BECTON DIKINSON
Subject
records reflecting correspondence between employees of the Alzheimer’s Association and FDA personnel
OHCM Customer Experience All Staff Survey results to the OHCM Senior Leadership Team
Docs for an Agency wide Leave Bank program
Mtg invites "Welcome and Transition to the OHCM Immediate Office"
All guidance sent to OHCM staff on the topic of the new HHS performance elements "Customer Experience" and
"Leadership" for performance year 2022.
PD's for employees assigned to the OHCM Division of Performance Management and Awards.
PD's of employees assigned to the Office of Human Capital Immediate Office.
List of Special Projects within the FDA Office of Human Capital Management
Listing of all reassignments within the FDA Office of Human Resources.
Listing of all reassignments within the Office of Human Capital Management.
Listing of approving officials responsible for FDA level vetting for the CXO Fellow Program FY 22 Cohort through GSA.
plans by OHCM to address the OHCM result of the 2017, 2018, 2019, 2020 Federal Employee Viewpoint survey
I request a copy of the file trees for the following servers/system of records: Document Archiving, Reporting &
Regulatory Tracking System (DARRTS) Documentum - AIMS Documentum – CMS (Compliance Management System)
Documentum - ECMS Electronic Document Room (EDR) FAERS CDER Informatics Platform – Integrity CDER
Informatics Platform - Mercado CDER Informatics Platform - Panorama
All calendar records for FDA CVM employee Charlotte Conway 01.01.2020-12.31.2020
All calendar records for FDA CVM employee Eric Nelson 01.01.2020-12.31.2020
All calendar records for FDA CVM employee Isabel Pocurull 01.01.2020-12.31.2020
All e-mail records for FDA employee Darla Bracy containing the key terms; Small Batch, Michael Vogel [OHAF-West
Division 5] 05.15.2017, 05.16.2017, 05.17.2017
All e-mail records for FDA employee Miriam Burbach containing the key terms; AAFCO, Association Of Feed Control
Officials [she works at /DHHS/FDA/ORA/ORA/OHAFO/OHAFOW/DHAFOWVI] 07.01.2021-07.31.2021
All e-mail records for FDA employee Robin Rivers containing the key terms; AAFCO, Association Of Feed Control Officials
[she works at /DHHS/FDA/ORA/ORA/OHAFO/OHAFOE/DHAFOEII/HAFCB] 05.01.2021-05.31.2021
All email records for FDA CVM employee Charlotte Conway containing the key search term: AAFCO 07.01.2021-
07.31.2021
All email records for FDA CVM employee Charlotte Conway containing the key search term: AAFCO. (Date range for
records search is: 10.01.2021-10.30.2021)
All email records for FDA CVM employee David Edwards containing the key search term: AAFCO 07.01.2021-07.31.2021
All email records for FDA CVM employee Steven Solomon containing the key search term: AAFCO 07.01.2021-
07.31.2021
All email records for FDA CVM employee Tim Schell containing the key search term: AAFCO 07.01.2021-07.31.2021
All email records for FDA CVM employee Tracey Forfa containing the key search term: AAFCO 07.01.2021-07.31.2021
All reports of adverse events and/or reactions dog and/or cats have had to dog and cat food and dog and cat treats
from 08.01.2021-09.30.2021.
Records requested are definitions of all feed/pet food ingredients, which includes the common ingredient name,
description, and any appropriate limitations for its use. These records are published in the AAFCO 2017 Official
Publication under a Memorandum of Understanding agreement between FDA and AAFCO.
All information on Pharmacyte Biotech cell in the box submissions to FDA.
documents that discuss or describe adverse event reactions to Escitalopram, Escitalopram Oxalate, or Lexapro that
have listed as a reaction "Gun Shot Wound”, “Homicide”, “Suicide” or other associations with violence.
Copy of the disclosable portions of the PREA Post-Marketing Study Committments for NDA 21290, Naproxen sodium, by
Banner Pharmacaps, for the 02/17/2006 approval. We believe the final report was due 02/18/2009. We are looking for
the final report or a PREA waiver, if one was submitted.
CVs Karen A Spencer, Sandra K Wangen, Naseem S Jouhari, Andrea L Williams-Jones, Haley H Seymour, Sierra M
Shockley, Jacob M Dyer, Christopher J Cruciotti, Debra L Boyd Seale, Jayne E Holcomb, Shirshendu K Deb, Amos C Epps,
etc
Product Area: Biologics Request record: Form 483 (Notice of Inspectional Observations) - Year 2021 Company: Hugel,
Inc. (FEI 3012163998) Address: 23, Geodudanji 1-gil, Dongnae-myeon, Chuncheon-si, Gangwon-do 24398, Korea, South
(KOR)
Product Area: Biologics Request record: Form 483 (Notice of Inspectional Observations) - Year 2021 Company: Revance
Therapeutics (FEI 3007772056) Address: 7555 Gateway Blvd. Newark CA 94560 US
We are seeking written documents, such as emails, text messages, memos and letters that pertain to MIDI, Inc., that
originated from the following FDA personnel: 1. Acting Commissioner, Janet Woodcock 2. Director of CFSAN, Susan
Mayne 3. Director of CFSAN-ODSP, Cara Welch 4. Chief Scientist, RADM Denise Hinton
TECHNICAL LEAD PRODUCT REVIEW SUMMARY
Copies of emails sent between "michael.young@fda.hhs.gov" and email correspondents using the email address domain
“@google.com” that include the term “warning letter” in the subject or body copy between 01/01/2019 and the date
this records requests is fulfilled. Any attachments to those emails.
I would like to request data/case reports of all aspergillosis infections associated with the drugs omalizumab,
reslizumab, mepolizumab, benralizumab, and dupilumab.
I would like to see copies of emails sent to and from "michael.young@fda.hhs.gov" and to recipients with the email
domain "@google.com" that include the term "warning letter" in the subject or body copy. This is in relation to Google
being notified directly of FDA warning letters about online pharmacies posing a risk to consumers, as reported here:
https://reason.com/volokh/2018/05/17/google-now-deindexing-some-web-pages-at/
Regarding a FOIA request with the control number 2021-6291: Copies all documents produced in response to the FOIA
request, including acknowledgement letters.
CDER pharmaceutical recalls from the years 2002 to 2020.
All ingredients in comirnaty vaccine, including any and all ingredients that have been redacted (b4) in publicly disclosed
documents. Failure to provide this is against the law of informed consent. You are not allowed to redact an ingredient.
Any and all voluntary and mandatory adverse event reports for polyethylene glycol 3350 products for pediatric and
adult use, sorted by age.
Copies of submissions from Perrigo Pharmaceuticals regarding hypoallergenic infant formula products containing
extensively hydrolyzed protein.
I am requesting UN-redacted ingredients list for the following covid vaccines. Pfizer-bioNTech, Moderna, and Johnson&
Johnson Janssen.
I request a copy of all small business PDUFA fee waiver requests. Please search as far back as FDA maintains records.
I request a copy of the server logs from the FDA data API over the past 5 years. See
https://open.fda.gov/about/statistics/. In order to comply with Exemption 6 of the FOIA please redact or remove the
final octet of the IP addresses (ex: 191.211.209.XXX) in the server logs.
Kindly provide the form 483 issued by USFDA at Biocon Sdn. Bhd’s insulin manufacturing facility at Iskandar Puteri,
Johor, Malaysia. The inspection was completed on 24rd Sep 2021. FEI number for the facility is 3011248248.
Mandava Associates is requesting data on dipentene, DL-Limonene, and/or L-limonene, such as toxicology data,
chemistry data, full GRAS petition documents, etc.
Reason for recall for recall event 29597, F-175-5 .House of Smoke recalled Hickory Smoked Atlantic Salmon Sides in
various sized consumer packages.
User Manual for K182372 iCAD PowerLook Tomo Detection V2 Software Product Code QDQ Device Classification Class II
Classification Name/Regulation: Radiological Computer Assisted Detection and Diagnosis Software 21 CFR 892.2090
ALL FORM 483, EIR, RESPONSE LETTERS, AND ANY OTHER COMMUNICATIONS WITH THE FDA BY/FOR CMP PHARMA
LOCATED AT 8026 US Highway 264A Farmville, NC 27828.
Any and all documents contained in MF 5234.

Facility Inspection records for Clinipad Corporation in Norwich, Connecticut
Facility inspection records for Clinipad Corporation at 243 Vergason Ave., Norwich, Connecticut
2017-9705
Good afternoon. We had a Foreign Remote Regulation Assessment (FRRA) to our company Ingenio Pichichí S.A. (ID
3004321433), executed by the inspector Edith González from September 20 to 24 of this year. We request the
evaluation report or memorandum please.
Hello, I need to access the following drug master files: 1) DMF #34308 by Oak Ridge National Laboratory for ACTINIUM-
225 Nitrate (Accelerator-Produced) and 2) DMF #35378 by Oak Ridge National Laboratory for ACTINIUM-225 Nitrate
(Thorium 229 Decay Product).
Labeling for NDA 020475 (Retin-A Tretinoin Gel Microsphere), including current prescribing information, patient
information, pump labels, tube labels, and carton labels.
Records pertaining to Fumizer LLC PMTA (STN: PM0002557 & STN: PM0002432)
Records related to cases involving the use of Xifaxan/Rifaximin in association with hepatic encephalopathy, with the
following Case ID numbers requested: 12403687 12473851 12483032 12491196 12528993 12543896 12551501
12562700 12608572 12623910 12646038 12675204
Torrent Pharma Inc. is requesting Agency to provide the following discipline documents from drug approval package of
ANDA 210799 1) Chemistry Review(s) 2) Pharmacology Review(s) 3) Statistical Review(s) 4) Clinical Pharmacology
Biopharmaceutics Review(s) 5) Other Review(s) 6) Administrative Document(s) & Correspondence
Torrent Pharma Inc. is requesting Agency to provide the following discipline documents from drug approval package of
ANDA 211050 1) Chemistry Review(s) 2) Pharmacology Review(s) 3) Statistical Review(s) 4) Clinical Pharmacology
Biopharmaceutics Review(s) 5) Other Review(s) 6) Administrative Document(s) & Correspondence
Request MAUDE Database inquiry of Surgical Intuitive Da Vinci Adverse Effects from jan 3, 2000 to jan 1, 2021
Biocon Biologics Insulin Manufacturing plant in Malaysia, Biocon Sdn Bhd received 6 observations on completion of
inspection on 24 Sept 2021. Requesting a copy of these observations made.
Copies of meeting minutes, and participant notes, for the October 22 and December 10 meetings referenced in section
9 ("Advisory Committee Meetings") on pages 26-27 of the following document:
https://www.fda.gov/media/151733/download
I request that a copy of the following documents be provided to me: every Adverse Health Report made by or about
Ideal Saline Breast Implants, Mentor Saline Breast Implants, Inamed Saline Breast Implants, and Allergen Saline Breast
Implants from 1964 to the present. Each of these reports should include the patient problem, device problem, adverse
event date(s), responsible manufacturer, report date, and testimony.
I would like all adverse case reports, narratives, associated with Propanol.
All documents, including email communications, between the Food and Drug Administration (FDA) or the Federal Trade
Commission (FTC) and GOJO Industries, Inc. pertaining to the investigation resulting in the January 17, 2020 Warning
Letter issued to GOJO Industries, Inc. (MARCS-CMS 599132, Case No. 599132) and the corresponding November 30,
2020 Closeout Letter.
Pertaining to NDA 022038 for Divigel gel, 0.1% Please provide the tube and carton label since the last Annual Report
Please provide the last patient information since the last annual report Please provide the most recently approved CMC
CBE-0 cover letter and patient information.
PharmChek Drug Sweat Test and or any other document that may pertain to the susceptibilities of any kind of the
PharmChek Sweat Drug Test used in relation PharmChek Drug Detection Sweat Patches used by the United States
Department of Justice.
salmonella outbreak in prepared fruit sold by Tailor Cut Produce, Inc, North Brunswick, NJ
ANDA 090590
Request all documents from and/or related to the Regulatory Meeting held 11/20/2020 with QuVa Pharma, Inc.,
Temple, Tx.
Request all documents from and/or related to the Regulatory Meeting held 11/20/2020 with QuVa Pharma, Sugar Land,
Tx.
Request all documents from and/or related to the Regulatory Meeting held 4-9-2021 with US Compounding, Inc,
Conway, AR.
Request all documents from and/or related to the Regulatory Meeting held 6-7-2021 with US Specialty Formulations
LLC, Bethlehem, PA.
Request all documents from and/or related to the Regulatory Meeting held on 11/20/2020 with QuVa Pharma, Inc,
Bloomsbury, NJ.
Request all documents from and/or related to the Regulatory Meeting held on 11/3/2020 with Complete Pharmacy and
Medical Solutions, LLC, Miami Lakes, FL.
Request all documents from and/or related to the Regulatory Meeting held on 7-30-2021 with KRS Global
Biotechnology, Inc., Boca Raton, FL.
Request all documents from and/or related to the Regulatory Meeting held on 9-12-2019 with Olympia Compounding
Pharmacy, Orlando, FL.
Request all documents from and/or related to the Regulatory meeting held on 3-5-2019 with SCA Pharmaceuticals.
ANDA 087859
Please provide the following 1 inspection-related documents in electronic PDF format: The 483 (in electronic format)
for Human Drugs inspection of Abid H. Khan MD ending 07/02/2021 at the location in Ontario CA, United States. Please
send documents as email attachments.
for Medical Devices & Rad Health inspection of CellEra LLC ending 07/08/2021 at the location in Monroe OH, United
States. Please send documents as email attachments.
for Medical Devices & Rad Health inspection of Gauss Surgical, Inc. ending 07/18/2019 at the location in Los Altos CA,
United States. Please send documents as email attachments.
for Medical Devices & Rad Health inspection of Premium Plus Dental Supplies Inc. ending 10/18/2019 at the location in
Brooklyn NY, United States. Please send documents as email attachments.
for Medical Devices & Rad Health inspection of Retro & R-Med Molding, LLC ending 07/22/2021 at the location in
Constantine MI, United States. Please send documents as email attachments.
for Medical Devices & Rad Health inspection of Scanlan International, Inc. ending 08/20/2020 at the location in Saint
Paul MN, United States. Please send documents as email attachments.
for Biologics inspection of Albert Einstein College of Medicine Inc. IRB #1 ending 12/13/2018 at the location in Bronx NY,
United States. ETC
All readily available documents concerning FDA Responses to Citizen Petitions for Docket number FDA-1986-P-0044
(previous docket number 1986P-0033); Docket number FDA-1986-P-0042 (previous docket number 1986P-0034) and
Docket number FDA-1986-P-0015 (previous docket number 1986P-0235).
Please provide Summary Basis of Approval for NDA 018316 SORBITOL-MANNITOL IN PLASTIC CONTAINER held by ICU
Medical Inc Approved Prior to January 1, 1982
We are requesting a copy of the redacted version of Food Contact Notification (FCN) 2130.
We are seeking for full FCN information of FCN No.1926. The language can be in English.
Please could we request the summary basis of approval for the following drug products Toradol (IV and oral ketorolac)
Marcaine (bupivacaine)
Electrostim Medical Services, Inc. d/b/a EMSI, , including but not limited to: Establishment Registration documents,
Labeler Code Forms, Product Listings, Renewal Forms, Professional Licenses, Applications for Licensure, Log of
Complaints, correspondence (including all e-mails), and any other materials that relate to this entity. The time period for
each is from inception to the present.
I am seeking for the full information of the following 4 voluntary submissions dossiers in the Submissions on PCR Plastics
for Food-Contact Articles Database: Recycle Number 76 Recycle Number 161 Recycle Number 178 Recycle Number 243
And the full information here refers to the full submission from the company along with FDA’s review memoranda of
that submission and the subsequent letter of no objection. The language can be in English
I am seeking for the full information of the following 4 voluntary submissions dossiers in the Submissions on PCR Plastics
for Food-Contact Articles Database: Recycle Number 76 Recycle Number 161 Recycle Number 178 Recycle Number 243
And the full information here refers to the full submission from the company along with FDA’s review memoranda of
that submission and the subsequent letter of no objection. The language can be in English
Please send me the laboratory report from FDA's Winchester Engineering Analytical Center (WEAC) for the Ultraviolet
wand tested pursuant to the Defect Warning Letter issued by the FDA on June 17, 2021 . The content of the defect
letter is here ( https://www.fda.gov/media/152505/download )
We are requesting a copy of the publicly available information contained in the submissions that led to FDA’s issuance
of No Objection Letter (NOL) No. 229 and any related communications associated with NOL 229, including all releasable
correspondence and FDA review memoranda.
TECHNICAL PROJECT LEAD REVIEW SUMMARY
As permitted by the Freedom of Information Act (FOIA), I am hereby requesting the following document: Form FDA 483:
I confirm that Clarivate Analytics will be charged accordingly by FOI for this request, how ever please contact me if the
charges exceed $ 200. Bieffe Medital, S.A. Senegue, Spain End Dates of inspection: 22 April 2021 FDA District Office:
Center for Drug Evaluation and Research
As permitted by the Freedom of Information Act (FOIA), I am hereby requesting the following document: I confirm that
Clarivate Analytics will be charged accordingly by FOI for this request, how ever please contact me if the charges exceed
$ 200. Senegue, Spain End Dates of inspection: 16 June 2021 FDA District Office: Center for Drug Evaluation and
Research Form FDA 483: Sterling Pharma Solutions Ltd. .
9/1/21 tentative approval letter for ANDA No. 211195 for Macitentan
Form 483 for Biocon Sdn Bhd (FEI NO 3011248248) inspected between 9/13 to 9/24
Janssen Vaccines requests VAERS reports of confirmed cases of Thrombosis with thrombocytopenia syndrome, acute
motor axonal neuropathy, acute motor-sensory axonal neuropathy, Bickerstaff's encephalitis, chronic inflammatory
demyelinating polyradiculoneuropathy ETC
LIST OF INSPECTIONS
for Biologics inspection of The New York Fertility Center ending 06/15/2021 at the location in Flushing NY, United
Please provide the following 1 inspection-related documents in electronic PDF format: The EIR (in electronic format)
for Biologics inspection of Joseph McCready, MD ending 05/09/2017 at the location in Tucson AZ, United States. Please
for Human Drugs inspection of Honest Globe, Inc. ending 10/08/2019 at the location in Santa Ana CA, United States.
Please send documents as email attachments.
The 483 (in electronic format) for Human Drugs inspection of Acino Products, LLC ending 07/01/2021 at the location in
Hamilton NJ, United States. The EIR (in electronic format) for Human Drugs inspection of Acino Products, LLC ending
07/01/2021 at the location in Hamilton NJ, United States. The EIR (in electronic format) for Human Drugs inspection of
Health Pharma USA LLC ending 06/03/2019 at the location in Rahway NJ, United States. Please send documents as
email attachments.
for Human Drugs inspection of Grunenthal Gmbh ending 07/12/2000 at the location in Aachen, Germany. The EIR (in
electronic format) for Human Drugs inspection of Henan Lihua Pharmaceutical Co., Ltd. ending 12/14/2017 at the
location in Anyang, China. The EIR (in electronic format) for Human Drugs inspection of Macleods Pharmaeuticals
Limited, Baddi ending 11/24/2017 at the location in Tehsil Baddi, District Solan, India. Please send documents as email
attachments.
FDA FOIA Response (2021-2155)
Copy of the 483 for the Nov 15, 2011 - Dec 7, 2011 (23 days) inspection of Jenis, Louis G., M.D. located at Wellesley /
United States of America] 25 Washington St #1b, Wellesley, MA 02481, USA. This inspection pertains to Medical
Devices.
Copy of the Company Response for the Nov 15, 2011 - Dec 7, 2011 (23 days) inspection of Jenis, Louis G., M.D. located
at Wellesley / United States of America] 25 Washington St #1b, Wellesley, MA 02481, USA. This inspection pertains to
Medical Devices.
Copy of the EIR for the Jun 27, 2018 - Jun 27, 2018 (1 day) inspection of Faro Ted Owiesy located at Corona / United
States of America] 802 Magnolia Ave, Corona, CA 92879, USA. This inspection pertains to Human Drugs.
Copy of the EIR for the Nov 15, 2011 - Dec 7, 2011 (23 days) inspection of Jenis, Louis G., M.D. located at Wellesley /
United States of America] 25 Washington St #1b, Wellesley, MA 02481, USA. This inspection pertains to Medical
Devices.
Copy of the disclosable inspectional documentation such as the MDSAP Medical Device Regulatory Audit Report (AU)
Report and/or the MDSAP Noncomformity Grading and Exchange Form (NC) for the inspection of Boston Scientific
Corporation, Los Gatos, CA , end date 08-17-2017. FEI# 3003882783. This inspection pertains to medical devices.
Report and/or the MDSAP Noncomformity Grading and Exchange Form (NC) for the inspection of Boston Scientific,
Menlo Park, CA , end date 08-17-2017. FEI# 3013658545. This inspection pertains to medical devices.
Report and/or the MDSAP Noncomformity Grading and Exchange Form (NC) for the inspection of Philips Ultrasound Inc,
Bothell, WA , end date 08-17-2017. FEI# 3019216. This inspection pertains to medical devices.
Copy of the disclosable portions of all correspondence between FDA and Pharmaceutics International, Inc (PII) following
the April 16, 2021 and May 19, 2021 letters from PII to FDA regarding Update on Qualification Activities Related to an
ANDA (attached). This information may be part of the files for the October 2020 inspections of PII's Hunt Valley, MD and
Cockeysville, MD facilities.
2021-1480
CTP Correspondence Regarding Efficacy of ENDS Devices for Smoking Cessation 01/01/2013 - 09/30/2021. Please see
attached.
483 issued to Yuki Gosei Kogyo at Iwaki, Japan :on CDER inspection
Pursuant to the FSVP regulation under 805(g) of the Federal Food, Drug, and Cosmetic Act, FDA provided a link to a list
of FSVP importers that have been identified at entry.
Copy of the 483 for the Mar 23, 2012 - May 15, 2012 (54 days) inspection of John Joseph Hewett, M.D. located at
Newport Beach / United States of America] 4501 Birch St, Newport Beach, CA 92660, USA. This inspection pertains to
Medical Devices.
Copy of the 483 for the Sep 7, 2011 - Sep 22, 2011 (16 days) inspection of Satyaprakash N. Makam, MD located at
Munster / United States of America] 10010 Donald S Powers Dr, Munster, IN 46321, USA. This inspection pertains to
Medical Devices.
Copy of the Company Response for the Mar 23, 2012 - May 15, 2012 (54 days) inspection of John Joseph Hewett, M.D.
located at Newport Beach / United States of America] 4501 Birch St, Newport Beach, CA 92660, USA. This inspection
pertains to Medical Devices
All of the correspondence between FDA and the notifier of GRN 876, Hydroxytyrosol, Nova Mentis Ltd.
Please provide Summary Basis of Approval of SODIUM BICARBONATE IN PLASTIC CONTAINER (SODIUM BICARBONATE
INJECTION) 0.9MEQ/ML and 1MEQ/ML for the Applicant ABBOTT LABORATORIES PHARMACEUTICAL PRODUCTS DIV-
N019443
Copy of the EIR for the Mar 23, 2012 - May 15, 2012 (54 days) inspection of John Joseph Hewett, M.D. located at
Newport Beach / United States of America] 4501 Birch St, Newport Beach, CA 92660, USA. This inspection pertains to
Medical Devices.
The 483 (in electronic format) for Medical Devices & Rad Health inspection of AMCO International Manufacturing &
Design, Inc. ending 05/27/2021 at the location in Brooklyn NY, United States. The 483 (in electronic format) for Medical
Devices & Rad Health inspection of ALC Enterprises Inc. ending 02/13/2019 at the location in Brooklyn NY, United
States. ETC
2021-2215, 2021-2514, 2021-4386, 2021-4395, 2021-4397.
2021-3540, 2021-3555, 2021-3556, 2021-3559, 2021-2213.
2021-4559, 2021-4565, 2021-4580, 2021-4588, 2021-4644.
2021-4688, 2021-4689, 2021-4693, 2021-4795, 2021-5342.
2020-2475, 2020-2511, 2020-5004, 2021-5725, 2021-5860, 2021-6027
Emails exchanged between FDA or HHS addresses and either Marion Gruber and/or Philip Krause regarding booster
shots or additional doses of COVID-19 vaccines.
I request all records of communication between acting Commissioner Janet Woodcock, CBER Director Peter Marks and
CDC Director Rochelle Walensky on deliberations over Covid-19 booster shots by the FDA's Vaccines and Related
Biological Products Advisory Committee (VRBPAC), the FDA, the CDC's Advisory Committee on Immunization Practices
(ACIP) and the CDC.
Moderna regarding the company's EUA application for use of its Covid-19 vaccine in adolescents. Please include emails,
documentation of any phone calls and in-person meetings, as well as lists of participants in any of those calls and
meetings.
Pfizer regarding booster Covid-19 shots.
Vaping related illnesses
1. copy of the FDA notice or letter providing "FDA Breakthrough Device" status for the Neuroem Therapeutics device for
Alzheimer's patients. The neuroem.com website has the Neuroem press release of FDA Breakthrough which is dated
October 28, 2020. etc
clinical investigator agreement
I would like to request a copy of premarket submission 510(k) K203155 for the BreatheSuite MDI V1 device. Thank you,
Marianne
RECS RE HEGGIE'S PIZZA
Center for Drug Evaluation and Research Form FDA 483: Jiangsu Sihuan Bioengineering Pharmaceutical Co., Ltd..
We request all entry-line records that contain any of the following data points in reference to an entry’s FSVP Importer,
Importer of Record (IOR), or Consignee; for entry-lines with submission or arrival dates between September 01 and
September 30, 2021: 1) DUNS Number / Unique Facility Identifier (UFI) of 080801169 2) FDA Establishment Identifier
(FEI) of 3014302990 ETC
FDA Docket Number 77A-0307, all records
Inspection Audit Report for NeuroField Inc. .
Summary Basis of Approval documents for KLOXXADO (naloxone HCl) nasal spray, 8 mg/spray
All email communications to/from Dr. Timothy Stenzel and any email addresses registered at the domain name
abbott.com between March 1, 2020 and March 31, 2021.
All email communications to/from Dr. Timothy Stenzel and any email addresses registered at the domain name
quidel.com between March 1, 2020 and March 31, 2021.
Records related to investigation, inspection, 483s, and communication for FUJIFILM Diosynth Biotechnologies, 100
Discovery Dr. suite 200, College Station Texas LLC,
Docket FDA-1998-P-0114.
Please provide disclosable, redacted 483s, 483 Responses, and EIRs in electronic format (.pdf) that have been released
since Monday, August 30, 2021.
Dear FDA FOIA Officer: Any and all documents pertaining to considered and completed inspections of the company
Organogensis between the dates of Jan. 1, 2019 and the date of the fulfillment of this request.
Full set of FOIA Logs List of all FOIA requests by outsiders to the FDA between 1995 to 2021
The final memos, summaries and/or reports from all closed internal investigations into misconduct among FDA staff
and officials.
We request the scans of 8 ANDA approval letters. Four of these ANDAs were approved by FDA in 2007 (#76520, #76749,
#77050, #77559), one in 2008 (#79028), one in 2010 (#78352), one in 2011 (#90957), and finally one in 2013 (#78970).
Any documents, correspondence, memoranda, or other communications received by the U.S. Food and Drug
Administration (“FDA”) from any third party related to Avadel CNS Pharmaceuticals, LLC’s (“Avadel’s”) product FT218
(sodium oxybate) for extended release oral suspension ETC
BIOEQUIVALENCY/BIOAVAILABILITY STUDY DATA FOR TERAZOSIN HYDROCHLORIDE CAPSULES (Ref. ANDA#A074823)
FDA Form 3926 Received with approval status if known for Experiment GBA1 gene therapy called PR001 from Eli Lilly or
Prevail Therapeutics (acquired by Eli Lilly).
I am requesting a copy of the application and pertinent data for: 510(K) application K874752 Device Name GAMOW
HYPERBARIC BAG Applicant HYPERBARIC AEROBICS, LTD. P.O. BOX 17696 Boulder, CO 80308 Applicant Contact Igor
Gamow
NADA drug file 031-555 for Trypzyme Aerosol. This a drug file owned by Farnam Companies, Inc. but has since been lost.
Please see attached letter.
Dear Sir/Madam: Pursuant to the Freedom of Information Act, CSL Behring would like to request the following 19
Adverse Event reports for Privigen®, Immune Globulin Intravenous (Human), 10% Liquid that were submitted to the FDA
Adverse Event Reporting System (FAERS)
FOI (freedom of Information) for CLINDAMYCIN PHOSPHATE (CLINDAMYCIN PHOSPHATE) | ANDA #214526 |
LOTION;TOPICAL | Prescription | TARO PHARMS · Summary Review(s) · Chemistry Review(s) · Pharmacology
Review(s) · Statistical Review(s) · Clinical Pharmacology Biopharmaceutics Review(s)
FDA Form 483 warning letters, any corrective actions and responses related to Form 483s issued to CoreRX two sites:
14205 Myerlake Cir, Clearwater, FL 33760 and 27 Jordan St. San Rafael, CA 94901 There are probably only warning
letters for the Clearwater site. Thank you. --JD
all material regarding the submission of: - 510(k) Premarket Notification of #K945062 by Kinetics Concepts Inc. - 510(k)
Premarket Notification of #K992448 by Kinetics Concepts Inc.
Summary details of manufacturing (CMC) supplements for the RLD CELESTON SOLUSPAN (NDA 014602) involving SUPPL-
9 to SUPPL-57.
Summary basis of approval documents for METROGEL-VAGINAL (N020208) application held by BAUSCH. Information
related to quality review covering Chemistry, manufacturing and control.
I am requesting the full 510(k) of the following medical devices: ViziShot 2 Flex (K193517), ViziShot Single Use Aspiration
Needle NA-201SX -4022 (K050503), Expect Pulmonary EBUS TBNA (K151895) , Echotip Procore (K160229), Spectra Soft
Tissue Biopsy Needles (K142791)
Request to provide additional information and copy of VAERS report for VAERS ID is 1689442
FOI (freedom of Information) for CLINDAMYCIN PHOSPHATE (CLINDAMYCIN PHOSPHATE) | ANDA #214604 |
LOTION;TOPICAL | Prescription | PADAGIS ISRAEL . · Summary Review(s) · Chemistry Review(s) · Pharmacology
Review(s) · Statistical Review(s) · Clinical Pharmacology Biopharmaceutics Review(s)
Human adverse event drug MedWatch reports for the following Case IDS: 14442031 14650306 14800123 14821352
14080329 14136774 14244797 13966338 13947063 15161129 15229141 15298453
I’m requesting documents describing the isolation of the COVID-19 aka SARS-CoV-2 virus In human beings, directly from
a sample taken from a diseased patient, where the patient sample was not first combined with any other source of
genetic material.
I’m requesting documents where the FDA (Food and Drug Administration) granted FDA-approved or FDA-authorized for
any COVID-19 aka SARS-CoV-2 vaccines (Pfizer-BioNTech, Moderna, Janssen, or any other manufacture) that are
authorized by the FDA to be administered on human patients over the age of 18 years old to treat and prevent COCID-
19 aka SARS-CoV-2.
Viyash Life Sciences Private Limited EIR October 2018

RECS RE BRAVO PACKING
Dear Sir or Madam, Pursuant to the FOIA, Baxter Healthcare Corporation respectfully requests that the unredacted EIR
from the June 23 – July 1, 2021 inspection of Baxter Healthcare Round Lake facility located at 65 Pitts Station Rd.,
Marion, NC 28752 (FEI: 1025114), be sent in either email or hard copy form to the point of contact listed below.
Vindhya Organics Pvt. Ltd. EIR

Enforcement Reports
Copies of all customer complaints about Walmart and Target's grocery, pharmacy, and other food produce that were
submitted since September 2018.
FSVP importers that have been identified at entry
We request a list of companies found in violation found during FSVP inspections, as well as the various types of
violation and the frequency in which they were observed between December 20, 2017 and September 30, 2021 (or the
most recently available date for 2021).
All internal FDA reviewer guidance, manuals, templates, etc
PMTA APPLICATION
PMTA APPLICATION
Any Parent’s Choice brand baby food product, including but not limited to Sample 1145091 of Parent’s Choice infant
rice cereal; and Consideration of any Parent’s Choice baby food recalls.
Review for Flavored ENDS PMTAs” associated with

the September 14, 2021, denial order issued for TPB’s Premarket Tobacco Product Application
assigned submission tracking number PM0001093 by the Center for Tobacco Products.
Please verify whether Sports Drug Testing Laboratory has had or applied for an Emergency Use Authorization for their
lab developed covid test, during the time frame indicated above.
Review for Flavored ENDS PMTAs” associated with the Premarket Tobacco Product Application (“PMTA”) submitted
September 3, 2020, and the September 15, 2021, denial order issued for the Company’s PMTA, assigned submission
tracking number PM0000950 by the Center for Tobacco Products.
We are requesting the U.S. Food and Drug Administration’s (FDA) copies of the following two studies related to 1,6-
hexanediol (CAS Reg. No 629-11-8): (1) Repeated dose 90-day oral toxicity study (OECD TG 408); (2) Prenatal
developmental study (OECD TG 414).
A copy of the Orphan Drug Designation file for tisagenlecleucel (Kymriah), designated on January 31, 2014, and
approved on August 30, 2017 (BL 125646/0) for the treatment of patients up to 25 years of age with B-cell precursor
acute lymphoblastic leukemia (ALL) that is refractory or in second or later relapse.
A copy of the Orphan Drug Designation file for tisagenlecleucel (Kymriah), designated on February 3, 2015, and
approved on May 1, 2018 (BL 125646/76) for the treatment of adult patients with relapsed or refractory (r/r) diffuse
large B-cell lymphoma after two or more lines of systemic therapy.
A copy of the Orphan Drug Designation file for axicabtagene ciloleucel (YESCARTA), designated on March 27, 2014, and
approved on October 18, 2017 (BL 125643) etc
A copy of the Orphan Drug Designation file for axicabtagene ciloleucel (YESCARTA), designated on April 25, 2016, and
approved on March 5, 2021 (BL 125643) for the treatment of adult patients with relapsed or refractory follicular
lymphoma after two or more lines of systemic therapy.
A copy of the Orphan Drug Designation file for axicabtagene ciloleucel (YESCARTA), designated on April 20, 2016, and
approved on October 18, 2017 (BL 125643) for the treatment of adult patients with relapsed or refractory follicular
lymphoma after two or more lines of systemic therapy.
A copy of any Orphan Drug Exclusivity decisions/determinations for REVCOVI (elapegademase-lvlr) Injection. FDA
designated REVCOVI as an orphan drug on 03/19/2015, and approved the product on 10/05/2018 (BLA 761092) for the
treatment of Adenosine Deaminase-Severe Combined Immunodeficiency (ADA-SCID). FDA granted orphan drug
exclusivity based on a determination that RECOVI is clinically superior to ADAGEN based on greater effectiveness.
Dear Sir or Madam, I kindly ask you to provide the data for all product recalls listed in the weekly enforcement reports
with Center Classification Dates between 15 July 2010 and 31 December 2020.
organizational chart available that lists the current top staff and officials at the FDA
All adverse event reports received between June 1, 2013 and the present related to R.J. Reynolds and Reynolds
American Inc. VUSE electronic nicotine delivery system (ENDS) as well as the records requested in the accompanying
attachment.
Animal Legal Defense Fund seeks copies of records, from 1/1/2006 to date request is filled, held by FDA regarding the
animal feed additive sold under the trade name Agolin.
Animal Legal Defense Fund seeks records held by FDA , from 1/1/2006 to the date this request is filled, regarding the
feed additives given to farmed animals with the intention of reducing methane emissions, including but not limited to
trade names Yea-Sacc, Enogen, Mootral, and Fortis.
Animal Legal Defense Fund seeks records, from 1/1/2016 to the date this request is filled, held by FDA regarding the
New Animal Drug with the trade name Bovaer.
INDIVIDUAL RECS
NDA 209354 Summary Basis of Approval.
Please provide a copy of the entire email chain for any email between any FDA official and any representative of Lead
Stories on September 22, 2021, including the entire email chain between the FDA and a representative of Lead Stories
on September 22, 2021
Request for Documents and Information Relating to the pharmaceutical drug Zyloprim (generic name, Allopurinol) as
listed on the attached letter.
Hi, I am looking for the full ingredients list for Pfizer, Moderna, AstraZeneca and Johnson & Johnson.
Approved Genetic and Genomic-Based In Vitro Diagnostics (IVD).
All documents related to 1) TSI 1781; 2) OSE RCM #s 2018-2725 and 2018-62; 3) NISS (SSID/TSI): 392 (1001781/1781); 4)
Documents related to a review by Dr. Fanti PPI review (DPV-I) dated 4/17/2020 (referenced in 5-14-2020 Memo of Joyce
Korvick reference ID 4615031); 5) documents of the PPI Working Group for the review of TSI 1781; 6) a complete copy
of any FOIA productions that have been produced to anyone relating to Proton Pump Inhibitors (PPIs), or Nexium, or
Prilosec, or Prevacid, or Dexilant, or Protonix from 1/1/2019 until present.
Any communication concerning FDA FOIA Request 2021-3326 to include initial request, response, and any related
correspondence.
All reports, evaluations, memoranda, and presentations conducted by CDER staff regarding the tracked safety issue data
in DARRTS that was presented to senior leadership in April 2013, October 2014 and March 2015 and CDER's evaluation
of postmarket study data in DARRTS presented to senior leadership in February 2013 and October 2014; ETC
Fully Copy of ANDA Records for 070274 Betamethasone Dipropionate Lotion USP, 0.05%.
Respectfully requesting information regarding FDA FOIA Request Number 2021-266, including the original request
letters, the responses, and any related memorandum.
ADVERSE EVENTS ALBUTEROL, RHINOCORT, ASACOL, ETC
REVIEWS FOR ZOFRAN

EMPLOYEES CURRENTLY ENROLLED IN FEDERAL RETIREMENT SYSTEM
COMMUNICATIONS WITH STRYKER CORPORATION RE AXSOS EXTREMITY PLATING SYSTEM, ETC
ANDA 090440
1. All documents and correspondence related to the invitation in 2019 for the FDA to join the Baby Food Council
Advisory Stakeholder Group; 2. All documents and correspondence related to the FDA’s decision to accept the
invitation to join the Baby Food Council Advisory Stakeholder Group in 2019; ETV
All documents from and/or related to the Listening Session with SCA Pharmaceuticals, LLC on April 21, 2021.
C.H. Robinson Worldwide, Inc. requests a spreadsheet which includes the 23 publicly available data points for all FSVP
importer declarations.
Copy of the disclosable portions of the Statement of Work and the final report (or, if the final report does not yet exist,
the most recent progress report) for the following research contract: ID number: E07682.01, awarded 10/01/2018 by
the National Center for Toxicological Research, for the Development of a Multi-pathway Physiologically Based
Pharmacokinetic (PBPK) model for Nicotine in Humans.
I am seeking the MONTHLY adverse event tally reports for the period April to September 2021 for the following branded
drugs (i.e., counts for each adverse event type by month for every drug): Orladeyo, Takhzyro, Orgovyx, Myfembree,
Lupkynis, Ingrezza, Austedo, Tepezza, ETC
demyelinating polyradiculoneuropathy, ETC
On the publicly available FDA site: https://www.fda.gov/media/119312/download, FDA provides a list of companies
participating in the FDA Foreign Supplier Verification Programs from approximately March 4 2019 - June 3 2019. We
request a modified version of this same list to include the Firm's FDA FEI Number.
Product area: Drugs Would like all the 4 case reports of cancer in the PTG-300 development program, I have included
theclinicaltrials.gov NCT numbers below as reference: NCT04767802 NCT04202965 NCT03802201 NCT04054921
Summary Report for Blue Spark Technologies TempTraq Medical Device Remote Regulatory Assessment conducted
08/03/2021 – 08/06-2021 conducted by Talmane Fisher FDA
We request a spreadsheet which includes the 23 publicly available data points for all entries that led to the inclusion of
the following companies in this list in 2019: Nestle USA, Inc (DUNS number 00-825-6224), Nestle Professional (DUNS
number 07-678-0409), Dreyer's Grand Ice Cream Holdings, Inc. (DUNS number 06-656-3859), Nestle Puerto Rico (DUNS
number 09-014-5707), Payco Foods Corp (DUNS number 36-295-4588), ETC
the companies listed in the attached document.
We request a modified version of FDA's publicly available Inspection Classifications spreadsheet to include the FEI,
Address (Line 1), and Address (Line 2) for each inspection that occurred between October 1, 2011 and September 30,
2021 (or the most recent available date). We request 3 additional columns to include classification, project area, and
end date. This request is the same request as our previous FOI request with control number 2019-454, but with a
different date range.
We request a spreadsheet identifying the firms that received FDA Warning Letters between October 1, 2011, and
September 30, 2021 or the most recently available date
The report for the CBER CMC Final Review for the approval of Bristol Myers-Squibb's ABECMA product (Idecabtagene
vicleucel). I believe it is also called a BLA Review Memo, BLA # STN 125736. I am seeking a non-redacted copy of this
document.
CBE-30 forms from Bristol Myers-Squibb/Celgene regarding capacity expansions for ABECMA at the S12 facility in
Summit, NJ since March 2021 and related correspondence.
We are requesting all submitted documents and internal review documents relating to FDA Grandfather Submissions
GF1804302 (submitted February 20, 2018 and determined December 27, 2019 and GF2012251 (submitted May 20, 2020
and determined September 11, 2020). The documents are needed in order to insure internal data integrity.
Thompson Hine is submitting this FOIA request for the document "Review for Flavored ENDS PMTAs" for MVO’s PMTA,
STN: PM0000964.
Thompson Hine is submitting this FOIA request for the "Review for Flavored ENDS PMTAs" for Magellan Technology
Inc.’s PMTAs, STN: PM0001594.
Thompson Hine is submitting this FOIA request for all internal: correspondence; communications; meeting transcripts;
notes; analysis; files; and other documents related to the review of MVO’s PMTA, STN: PM0000964, and subsequent
denial of a marketing granted order for products referenced in that application.
Results of criminal investigation by FDA Agent Williams of CSL Plasma/Behring of counterfeit masks, forged authenticity
mask documents occurring at McKeesport Center (PA 15132), and all related material.
Warning letter for Korea Organized by year Drug Quality Only (Finished product)
Request for certified copies of previously disclosed records
We are requesting more information related an FDA “Warning Letter” sent to Mr. Michael Lamboy, Gaia’s Whole
Healing Essentials, LLC dated April 1, 2020. (Attached) We are requesting any screengrabs or reports related to claims by
Mr. Michael Lamboy and Gaia’s Whole Healing Essentials, LLC. that colloidal silver was a cure for COVID-19.
Any and all documents, including but not limited to, inspection reports of and directives to Torrent Pharma (150 Basking
Ridge, New Jersey) that relate to black box warnings on the Ambien medication "insert" and pill bottle labels, and
sanctions against Torrent Pharma for failure to include black box warnings on medication inserts and pill bottle labels
that are the subject of Consumer Complaint Number: 168087
Full name, title, and mailing address for the FDA executive responsible for regulation of the supporting documents that
pharmacies must provide with each prescription filled. Data include pharmacy name and contact information, drug
name, common names, prescribed dosage, possible side effects, warnings, and other consumer information deemed
appropriate for legal or consumer purposes.
Hello, I represent the manufacturer, Froggy's Fog. We recently participated in an FDA inspection where sample
materials were taken. I am looking to receive/review the results of the OTC product samples taken from this inspection
on 9/15/21. (5) 2oz bottles of sanitizer were retrieved by the auditor.
I hereby request that FDA’s Center for Food Safety and Applied Nutrition send me all agency records that detail the
data, analysis, and calculations employed by the agency to reach its final conclusion, as stated in the fourth paragraph
on Page 2 of the attached letter from Dr. Conrad Choiniere, that “for the most sensitive populations (children 0-6 years
and females of childbearing age 16-49 years), estimated exposures to lead from these vinegar products do not exceed
FDA’s Interim Reference Level for dietary lead."
Copy of the releasable FDA health hazard evaluation and all releasable related documents and correspondence
regarding the recall classification for recall numbers D-0844-2021 and D-0845-2021, for the time period January 1, 2021
to present.
Documents regarding TOR 2013-001.
Freedom of Information Act Request for Chemistry and Toxicology Review Memoranda from Food Contact Notifications
2028, 2097, 2123 and 2124.
K182181 SUMMARY
I request copies of all documents in the possession of FDA, from July 1, 2021 – September 30, 2021, regarding products
sold under the brand name: Jamieson including any: a) Form FDA 3500 Voluntary Reporting, b) Form FDA 3500B
Voluntary Reporting for Consumer and, c) Form FDA 3500A Mandatory Reporting.
IND 055195, Serial No. 0002 and Serial No. 0006. B&H Consulting Services, Inc. is the US Agent for the IND Sponsor
(EVER Neuro). Agent Designation attached.
for Biologics inspection of FUJIFILM Diosynth Biotechnologies Texas, LLC ending 08/31/2021 at the location in College
Station TX, United States.
for Biologics inspection of PAR Sterile Products LLC ending 07/20/2021 at the location in Rochester MI, United States.
for Biologics inspection of Vitalant ending 08/12/2016 at the location in Casper WY, United States. Please send
documents as email attachments.
for Human Drugs inspection of Frontage Laboratories, Inc. ending 11/01/2019 at the location in Exton PA, United States.
for Human Drugs inspection of Maha Ahmad, M.D. ending 08/13/2021 at the location in New York NY, United States.
The EIR (in electronic format) for Human Drugs inspection of Amgen Manufacturing Ltd ending 02/27/2020 at the
location in Juncos PR, United States. The Response (in electronic format) for Human Drugs inspection of Amgen
Manufacturing Ltd ending 02/27/2020 at the location in Juncos PR, United States.
The 483 (in electronic format) for Human Drugs inspection of Teva Parenteral Manufacturing ending 08/20/2021 at the
location in Irvine CA, United States. The EIR (in electronic format) for Human Drugs inspection of Teva Parenteral
Manufacturing ending 08/20/2021 at the location in Irvine CA, United States. The Response (in electronic format) for
Human Drugs inspection of Teva Parenteral Manufacturing ending 08/20/2021 etc
NDA 018865, for Betamethasone Valerate (betamethasone valerate) topical ointment
NDA 008453, for Anectine (succinylcholine chloride) injection
Provide a list of all drug applications with their respective application numbers and/or drug products where the TE code
has been changed from AB to BX in the FDA’s Orange Book as a result of the FDA’s findings for data integrity concerns
for two clinical / bioanalytical companies: Panexcell Clinical Lab and Synchron Research (reference FDA Safety Notice
dated Sept 16, 2021).
Seeking any Report resulting from Remote Regulatory Assessment (RRA) of Varian Medical Systems, Inc. located at 3290
Northside Parkway NW, Suite 400, Atlanta, GA 30327. Conducted 12 April 2021 through 23 April 2021.
Updated cases data for Lupkynis (P) - I'm looking for all types of cases related to Lupkynis
the report for the Remote Regulatory Assessment of our company performed around Jun.15,2021 by Jenny McCardell.
A record with a list and description of all the inspections where a Form 483 was issued to Clinical Trial Sites, in Phase 1,
in the years 2016, 2017, 2018, 2019, 2020 and 2021.
All EIR reports and 483 reports related to inspections of any HeartWare facilities conducted this year. Addresses include,
but not limited to: - 14400 NW 60th Ave, Hialeah, FL - 500 Old Connecticut Path Framingham, MA
original approval package of KETALAR (ketamine hydrochloride, NDA 016812, was originally approved 02/19/1970)
Documents concerning infant formula or infant nutrition.
To collect the requested public records, please search the accounts specified above for the
following terms: “walters”, “fauci”,“biegun”, “coronavirus”, “covid”, “pending”, “quarantine”,
“passenger”, “test”, “sick”, ”evacuee”, “evacuate”, “plane”, “diamond”, “princess”, “cruise”
and “ship”.
11/22/1999 FDA Meeting Minutes Regarding Zeneca's Request that the Agency withdraw the approval of the original
formulation of Diprivan (propofol)
A copy of the FDA’s response to FOI Request Control Number: 2019-4566
A copy of the FDA’s response to FOI Request Control Number: 2020-5217
A listing of all FDA Form 483 Notices of Inspectional Observations for: • Pharmaceutical, biologics and medical device
manufacturing facilities, including premarket approval inspections, AND • Clinical research facilities, investigators and
IRBs both in the United States and outside the United States that received such notices dated from August 1 to 31,
2021. In addition, please provide any 483’s released to the public.
IRBs both in the United States and outside the United States that received such notices dated from September 1 to 30,
Copy of the disclosable portions of the original request letter and complete FDA response for File Number 2021-6362
and File Number 2021-6112.
The 483 (in electronic format) for Animal Drugs & Feeds inspection of Missouri Analytical Laboratories Inc ending
04/06/2017 at the location in Saint Louis MO, United States. The EIR (in electronic format) for Animal Drugs & Feeds
inspection of Missouri Analytical Laboratories Inc ending 04/06/2017 at the location in Saint Louis MO, United States.
: The 483 (in electronic format) for Human Drugs inspection of Fosun Pharma USA Inc. ending 08/17/2021 at the
location in Princeton NJ, United States. The EIR (in electronic format) for Human Drugs inspection of Fosun Pharma USA
Inc. ending 08/17/2021 at the location in Princeton NJ, United States. etc
The 483 (in electronic format) for Human Drugs inspection of AGGARWAL, CHARU ending 03/16/2017 at the location
in PHILADELPHIA PA, United States. The EIR (in electronic format) for Human Drugs inspection of AGGARWAL, CHARU
ending 03/16/2017 at the location in PHILADELPHIA PA, United States.
The 483 (in electronic format) for Human Drugs inspection of Actavis Laboratories UT, a wholly owned subsidiary of
Teva P ending 08/20/2021 at the location in Salt Lake City UT, United States. The EIR (in electronic format) for Human
Drugs inspection of Actavis Laboratories UT, a wholly owned subsidiary of Teva P ending 08/20/2021 at the location in
Salt Lake City UT, United States. etc
K180152
K061079
K182811
Mirror Request 2021-6409
DVD/CD of the Aldurazyme Advisory committee meeting recording from January 15th, 2001
All records, emails with attachments related to discussions, meetings and scope of work or anything related to 1. the
FDA literature review on cell phone radiation and/or 2. radiofrequency radiation that are in the records for FDA's
Jeffrey Shuren and FDAs Edward Margerrison.
Form 483 or any documents listing observations related to an inspection or site visit at any Ellume factory in the last
year
Hi. Can you please send the adverse events file from the last year for the Ellume COVID-19 Home Test?
Full copy of ANDA records for 088045 Fluocinilone Acetonide Cream, 0.025% (all original ANDA submission records, all
amendments, all supplements, all annual reports, all correspondences etc., until January 23, 2019)
I am requesting access to and copies of all documents, including but not limited to correspondence and/or inter-
departmental investigations related to the billing practices of Natera, Inc., Invitae Corp. and Myriad Genetics, Corp.
between September 30, 2018 to September 30, 2021.
I am requesting copies of the signed/approval document(s) which the FDA approved the Pfizer COVID-19 vaccine for
use.
Informe de Evaluación FRRA (Foreing Remote REgulatory Assessment) realizado a la Fabrica COLOMBINA DEL CAUCA
desde el 20 de Sept. hasta el 24 de Sept. 2021, por la funcionaria Tressa T. Lewis, MPH, REHS Dedicated Foreign Food
Cadre Investigator.
Please provide me a copy of the Warning Letter to Owlet dated 10/1/2021.
Orphazyme’s NDA for arimoclomol that was accepted by the FDA in September 2020
We are seeking copies of the complete file for our client, Maag Prescription & Medical Supply, Pocatello, Idaho to
include all FDA inspections of the pharmacy facility.
exemptions requested by CSL Plasma for plasma. Any communications or requests made by CSL Plasma, Inc to the FDA
for plasma or blood products for the year beginning on Jan. 1 2021 through October 5, 2021.
exemptions requested by CSL Plasma for plasma. Any communications or requests made by CSLPlasma, Inc to the FDA
for plasma or blood products for the year beginning on Jan. 1 2020 through Dec. 31. 2020
A Summary Basis of Approval for Avastin (bevacizumab), BLA 125085/S-0331, approved by CDER on 20 June 2019. As of
06 October 2021, the Summary Basis of Approval for this supplement has not been posted on the Drugs@FDA page at
https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm
A Summary Basis of Approval for COMETRIQ (cabozantinib), NDA 203756/S-008, approved by CDER on 31 January 2020.
As of 06 October 2021, the supplemental Summary Basis of Approval has not been posted on the Drugs@FDA page at
A Summary Basis of Approval for PERJETA (pertuzumab), BLA 125409/S-109, approved by CDER on 22 March 2016. As of
06 October 2021, the Summary Basis of Approval for this supplement has not been posted on the Drugs@FDA page at
A Summary Basis of Approval for Yervoy (ipilimumab), BLA 125377/S-106, approved by CDER on 29 June 2020. As of 06
October 2021, the Summary Basis of Approval for this supplement has not been posted on the Drugs@FDA page at
A copy of the Medical Officers Review, Statistical Review and COA Staff for: Taltz (ixekizumab), BLA 125521/S-009
approved on 5/17/2018
A copy of the disclosable portions of the supplemental drug approval information for BLA 761055/S16, Dupixent,
approved 06/14/2021.
Any documents relating to inspections of Porton Biopharma Limited, Manor Farm Road, Porton Down, Salisbury,
Wiltshire, United Kingdom manufacturing site, from June 2021-present.
Establishment Inspection Report (s) for Mylan, Teoranta, Inverin, last known FDA audit date 06/22/2018. If more recent
FDA inspection EIR available, I request a copy of that EIR also. Mylan, Teoranta, Inverin Newenham Court Maladhide
Road Dublin, 17 Ireland
Establishment Inspection Report, Last documented audit on FDA website: 7/12/2019 Novartis Klybeckstrasse Basel
4057 Switzerland Corporate address Novartis AG Lichstrasse 35 Basel 4056 Swtizerland
Copies of 510(k) submissions: K800840, K800843, K800839, K800844, K800841, K800842, K800459, K760736.
K152665 K203024
Requesting a redacted copy of the original 510(k): K203547, Nalu Neurostimulation System.
Trodelvy - BLA 761115 - We request the following unredacted documents: • Product Quality Review(s) • Multi-
discipline Review • Other Review(s) • Risk Assessment and Mitigations Review(s)
We are requesting the analytical tissue residue method for swine for Nuflor-S (NADA 141-063) related to August 19,
2021 approval of additional swine claims to product label. Note, if changes have been made to the cattle method to
accommodate swine, we request the updated cattle method.
drug relabeling information during 2008-2016
Copy of the FDA response only to the following file numbers: 2020-4271 2020-4628 2021-948 2021-949 2021-951
Report and/or the MDSAP Noncomformity Grading and Exchange Form (NC) for the inspection of Abbott Laboratories
Inc. (St Jude Medical), Saint Paul, MN , end date 07-27-2017. FEI# 1000139754. This inspection pertains to medical
devices.
Report and/or the MDSAP Noncomformity Grading and Exchange Form (NC) for the inspection of Illumina, Inc.,
Hayward, CA , end date 08-03-2017. FEI# 3005095756. This inspection pertains to medical devices.
All documents related to the testing of baby food products for heavy metals and toxic elements by the U.S. Food and
Drug Administration and any U.S. states (including copies of test or lab reports) from the last six years.
Summary Basis for Approval of Opzelura (ruxolitinib) approved in Atopic Dermatitis in September 21st, 2021.
Report and/or the MDSAP Noncomformity Grading and Exchange Form (NC) for the inspection of MEDTRONIC CARE
MANAGEMENT SERVICES, Chanhassen, MN , end date 07-20-2017. FEI# 3004594267. This inspection pertains to medical
devices.
Report and/or the MDSAP Noncomformity Grading and Exchange Form (NC) for the inspection of Medtronic Xomed,
Inc., Minneapolis, MN , end date 07-27-2017. FEI# 1045254. This inspection pertains to medical devices.
Remote Regulatory Assessment (RRA) of Jabil Inc. Benicia facility lead by Aliza Chalapong started Feb 4, 2021, ended
March 2, 2021. The RRA was in regards to the Fontem U.S. PMTA. We would like a copy of the final report.
Copy of the disclosable portions of the report prepared by FDA investigator(s) at the conclusion of the Remote
Regulatory Assessment of Strides Pharma, Inc. Located at Riviera Beach FL United States FEI Number: 2000027140 held
on 05/25/2021. This inspection pertains to drug products.
Regulatory Assessment of Pharmacia & Upjohn Company, LLC Located at Kalamazoo MI United States FEI Number:
1810189 held on 03/31/2021. This inspection pertains to drug products.
Regulatory Assessment of Pfizer Inc. Located at Parsippany NJ United States FEI Number: 3003836868 held on
03/31/2021. This inspection pertains to drug products.
Regulatory Assessment of Mylan Institutional, Inc. Located at Sugar Land TX United States FEI Number: 1610608 held on
04/19/2021.This inspection pertains to drug products.
Regulatory Assessment of Gilead Sciences, Inc. Located at Foster City CA United States FEI Number: 1000523075 held on
Regulatory Assessment of Eli Lilly & Company Located at Indianapolis IN United States FEI Number: 1819470 held on
04/07/2021.This inspection pertains to drug products.
Regulatory Assessment of Anika Therapeutics, Inc. Located at Bedford MA United States FEI Number: 3007093114 held
Regulatory Assessment of Ajinomoto Althea, Inc. Located at San Diego CA United States FEI Number: 3004575449 held
on 05/21/2021.This inspection pertains to drug products.
EMAILS BETWEEN CHRISTOPHER BROWN AND CDC
CORR BETWEEN GOTTLIEB AND SUNUNU
RECS RE REGENERON EUA CASIRIVIMAB AND IMDEVIMAB FOR TREATMENT OF COVID
RECS RE ELI LILLY EUA BAMLANIVIMAB AND ETESEVIMAB FOR TREATMENT OF COVID
CDC EMAILS
Any and all documents sufficient to identify any solvents or substances acting as solvents for any COMIRNATY
components, including but not limited to any lipid components, prior to and during the product preparation process.
Please provide unredacted copies of Table 22, Table 25, and Table 26 in the document titled CMC Review Memorandum
dated August 21, 2021. For the avoidance of doubt, the redactions that this request seeks to lift are as follows (see
Table 22 in attached letter)
2019 E. coli O103 outbreak linked to the consumption of ground beef

Copies of all Sanofi’s Allerlife structure/function claim notifications found at FDA-2020-S-0024-0064, FDA-2020-S-0024-
0065, and FDA-2020-S-0066.
LIST OF INSPECTIONS
Vaccine Adverse Event Reporting System (“VAERS”) reports relating to VAERS ID 1187918.
I am interested in the number of products registered in the VCRP database as well as the preservative usage data
indicating what preservatives are in use and in how many products.
I request that a copy of the following documents or documents containing the following information be provided to me:
any and all documents involving or regarding DevaCurl products.
A copy of any and all FDA 483 Observations issued to ECI Pharmaceuticals following inspection of the company’s facility
located at 5311 N.W. 35th Terrace, Ft. Lauderdale, FL 33309, issued during the time period January 1, 2015 to present.
All telephone call logs relating to RCBA Nutraceuticals LLC and/or Ronnie Coleman Signature Series All emails
referencing, mentioning, discussing, and/or identifying RCBA Nutraceuticals LLC and/or Ronnie Coleman Signature
Series All letters referencing, mentioning, discussing, and/or identifying RCBA Nutraceuticals LLC and/or Ronnie
Coleman Signature Series All inspection records of RCBA Nutraceuticals LLC located at 635 Century Point Suite 121, Lake
Mary, Florida 32746
I would like to get data from studies regarding renal effect of SGLT2 inhibitors.
Please provide an unredacted copy of the document available at https://www.fda.gov/media/151710/download, a copy
of which is attached hereto as Exhibit A.
Plural effusion with Repatha use. Your website states 22 reported cases of adverse reaction. Interested in see these.
Addition information including the case narratives is being requested.
Requesting Shipments on which Adams Flavors, Foods & Ingredients LLC was listed as the FSVP Importer or for which
shipment our brokerage firm transmitted UNK in place of the FSVP Importers DUNS number. Adams DUNS Number is
12-411-5986
K043143
All test results and lab reports involving infant rice cereal, and any associated documentation, from the State of Alaska
and New Hampshire over the last two years that are in the U.S. Food and Drug Administration’s possession.
Copies of Form 483s issued for Novartis International AG Pharmaceutical Company since June 1, 2015.
Data and information described in 21 C.F.R. 314.430(e)-(f) related to ANDA #204305.
Form 483 Inspectional Observations and Establishment Inspection Reports For Pharmaceutics International Inc. at 10819
Gilroy Road, Hunt Valley, MD 21031 and/or 103 Beaver Court, Cockeysville, MD 21030. Inspection dates 7/26/2021
through 9/29/2021
ETC
NDA 050592
NDA 050616
The document we are requesting is the current version of “Infectious Disease Testing, Lookback, Donor Deferral and Re-
entry” used by FDA Center for Biologics Evaluation and Research Inspections and Compliance Programs staff.
K962158
Inspection Location: 390 Swift Avenue, Suite # 7, South San Francisco, CA 94080 Current Firm Name (name may have
been different in the past): Modesto Food Distributors, Inc. Current Firm Establishment Identifier: 3001452589
Documents Requested: All Forms 483 (Notice of Inspectional Observations) and all Establishment Inspection Reports
STATISTICAL REVIEW AND EVALUATION ANTIEPILEPTIC DRUGS AND SUICIDALITY
Traditional 510(k) for Vesticon Epley Omniax. Device Classification Name : Apparatus, Vestibular Analysis, 510(k)
number: K071973, device name: Epley omniax, classification product code: LXV, Classification Advisory Committee: Ear
Nose & Throat.
We are requesting the report of the asesment FRRA related too dietary suplement guide line that was from 20 of
september 2021 to 25 of september 2021 to Ovidio J. Vides S.A de C.V. in el Salvador.
Would like more information regarding entries for which Markon Shamrock Arizona and Gordons Springfield/O Markon
Cooperative was declared as FSVP importer between June 4, 2021 and Sept. 3, 2021.
510(k) submission for Proprietary Name: BRUTM - Balance Rehabilitation Unit Common ETC
I would like to request all the FDA filin Aduhelm gs for Aduhelm by BioGen Pharma. I specifically request the drug trial
snapshots, the initial filings from BioGen in 2019 and the approval on June, 2021. This is for a school assignment. Please
feel free to contact me at 269-532-5110, if you have any questions
1. All communications to or from FDA Media Affairs Leadership (including Michael Felderbaum, Daniel Hetlage,
Stephanie Caccomo, Shannon P. Hatch, and their predecessors) and Center for Tobacco Products Press Officers
(including Alison Hunt, Courtney Rhodes and their predecessors) pertaining to the following topics: a. Premarket
Tobacco Product Applications (PMTAs) ETC
OUTBREAK RECS RE MUSHROOMS
Please provide the Establishment Inspection Report (EIR) associated with the FDA's inspection of Allergan Sales LLC's
Cincinnati, OH facility that occurred between 5/25/2021 to 6/24/2021. Facility address: 5000 Brotherton Rd, Cincinnati,
OH 45209-1105.
Any and all inspection Form 483 and EIR records, issued to Ajinomoto Althea, Inc. (FEI # 3004575449) at the facility in
11040 Roselle St, San Diego, CA. The product types are 1) human drug, 2) BIologics.
Bioequivalence Review for ANDA # 201835 (Methylprednisolone Acetate) from Sagent
Copy of the disclosable portions of the following documents: (1) Mead Johnson Enfinitas New Infant Formula
Notification submitted on or about 10/03/2014; (2) Memo from Jeremy Mihalov (OFAS) to Linda Tonucci (and others)
dated 03/19/2015 relating to the use of lactoferrin in infant formula (we believe this is also related to Enfinitas); ETC
I am requesting any Form 483s issued to Mannkind for a facility inspection at the Danbury, CT site that was conducted
sometime between June 1-October 8 2021. Also requesting any related reports regarding the company having resolved
the 483 observation(s).
I would like to see the 510K submission for K182422.

K083300
Pursuant to the Freedom of Information Act (FOIA), I hereby request all records for FOIA request 2021-1940, 2021-
4261, 2021-4566, 2021-4601, 2021-4814, 2021-5018, 2021-5129, 2021-5183, 2021-5204, 2021-5307, 2021-5365, 2021-
5366, 2021-5381, 2021-5482, 2021-5599 2021-5600 2021-5601 2021-5603 2021-5607 2021-5610 2021-5612 2021-
5614 2021-5616
2021-2692, 2021-5792, 2021-5812, 2021-5813, 2021-5843.
for Human Drugs inspection of Accu Bio-Chem Laboratories ending 08/31/2021 at the location in Glendale CA, United
for Human Drugs inspection of Amsino Healthcare (USA) Inc ending 09/20/2021 at the location in Vernon Hills IL, United
The EIR (in electronic format) for Human Drugs inspection of Integrated Commercialization Solutions, Inc. ending
01/18/2018 at the location in Reno NV, United States. The Response (in electronic format) for Human Drugs inspection
of Integrated Commercialization Solutions, Inc. ending 01/18/2018 at the location in Reno NV, United States. Please
The 483 (in electronic format) for Animal Drugs & Feeds inspection of UFAG Laboratorien AG ending 10/09/2006 at
the location in Sursee, Switzerland. The EIR (in electronic format) for Animal Drugs & Feeds inspection of UFAG
Laboratorien AG ending 10/09/2006 at the location in Sursee, Switzerland. The Response (in electronic format) for
Animal Drugs & Feeds inspection of UFAG Laboratorien AG ending 10/09/2006 at the location in Sursee, Switzerland.
The 483 (in electronic format) for Human Drugs inspection of Brigham and Women's Hospital ending 09/16/2021 at
the location in Boston MA, United States. The EIR (in electronic format) for Human Drugs inspection of Brigham and
Women's Hospital ending 09/16/2021 at the location in Boston MA, United States. The Response (in electronic format)
ETC
RE: Diamond Pet Foods, Gaston, SC. Please supply Form 483, EIR (including attachments and appendices), any Warning
Letters and Untitled Letters, sanmple test results and any correspondence relating to the 2012 inspections of this facility
(completion dates 04/20/2012 and 09/19/2012).
RE: Diamond Pet Foods, Gaston, SC. Please supply all records relating to the 2005 investigation of aflatoxin
contamination in products manufactured at this location, including all inspection records (Form 483 & EIR), Warning
Letter and/or Untitled Letter (if issued), consumer complaint summaries, sample test results, and any correspondence
pursuant to the investigation.
CVs Heather M Roach, Davia K Arnold, Tracy A Holloman, etc
2021-5875, 2021-5884, 2021-5913, 2021-5916, 2021-5956.
2021-5987, 2021-6107, 2021-6149, 2021-6151, 2021-6203.
2021-6221, 2021-6276, 2021-6378, 2021-6419, 2021-6421.
OPIOID RECS
CORR BETWEEN OLAW AND MARYLAND INSTITUTIONS
Any and all lot releases granted for Comirnaty vaccine for COVID-19 pursuant to BLA STN: 125742/0.
Document Requests: 1. For the July 2019 and September 2020 inspections of Athenex’s Buffalo, New York facility, any
and all: a. 483 Letters; b. Establishment Inspection Reports; c. Untitled Letters; d. Decisional Letters; e. Warning Letters;
and f. any prior and/or subsequent correspondence and/or communication between Athenex and the FDA relating to
the inspections.
I am requesting an opportunity to inspect or obtain copies of public records that pertain to and/or reference the 2008T
BlueStar Hemodialysis Machine, Product Code KDI.
I need the record of entries, in which I have been placed as importer for the month of August and september.
Requesting Reference-Listed Drug Labeling for the following drugs: - Versed (Midazolam Injection), N018654, HLR
Technology - Apresolene (Hydralazine Injection), N008303, Novartis Pharmaceuticals Corp The labels for these drugs
are not available on drugs@FDA website or the FDA labeling repository
SBOA for NDA # 017808 (Miacalcin) from Mylan. Chemistry Review for NDA # 017808 (Miacalcin) from Mylan.
Administrative and Correspondence Documents for NDA # 017808 (Miacalcin) from Mylan
Thompson Hine is submitting this FOIA request for the Review for Flavored ENDS PMTAs for Avail Vapor LLC’s PMTAs,
STN: PM0001233
Thompson Hine is submitting this FOIA request for the Technical Project Lead (TPL) Review and Review for Flavored
ENDS PMTAs for BMF Labs PMTAs, STNs: PM0003884 and PM0003523.
510(k) # K170660 for Endosee Hysteroscope With Disposable Diagnostic (Dx) Cannula 510(k) Holder: Cooper
Surgical, Inc.
Voluntary Cosmetic Registration Program Data on PFAS concentrations in cosmetic products.

K896622, Visitec Vitrectomy Unit.
I am Requesting all FDA records related to import alert 99-41 published on September 21, 2021, including but not
limited to: -- details about detentions without physical examination of Products imported; and communications
between FDA staff about reasons for targeting PROMEX Distribution LLC.
QUESTIONS RE PFIZER VACCINE
Correspondence with the FDA Commissioner Gottlieb: I am requesting copies of incoming-and-outgoing correspondence
between FDA Commissioner Scott Gottlieb of the Food and Drug Administration and the following public figures listed
below (with current titles and home included) from May 11, 2017, to September 30, 2021: • Gov. Chris Sununu (NH)
Under the Freedom of Information Act, I am requesting 3 documents related to Myriad Genetics. 1) Correspondence
from the FDA to Myriad Genetics on April 28, 2019. The correspondence is related to the company's GeneSight test. 2)
A letter from Mark Capone (Myriad) to Irene Tebbs (FDA) dated May 31, 2019. etc
I am seeking records regarding Dr Farrah Agustin Bunch and DRF LLC. I am able to access the public record from 21 April
2021. I would like to request her reply following this letter and the future correspondence from your team that was sent
to her.
Documents, submissions, and responses to Capnostics and transcripts related to the 510k clearance of the Esophacap
(K203450), as well as the transfer of the 510k cleared device to Pavmed.
I am seeking for full FCN information of the following 5 FCN dossiers: FCN1227 FCN964 FCN595 FCN512 FCN439 I’d
also like to request technical review memoranda or other pertinent documents associated with these FCNs.
for Foods & Cosmetics inspection of Barcel SA de CV, Carretera Mexico - Toluca Km. 54, Lerma Pueblo Infonavit Lerma,
Mexico 52000 Mexico. FEI 2000042497¿ ending 10/26/2018 Please send documents as email attachments.
We request all entry-line records (in CSV file format) that contain any of the following data points in reference to an
entry’s FSVP Importer, Importer of Record (IOR), or Consignee; for entry-lines with submission or arrival dates between
August 01 and August 31, 2021: 1) DUNS Number / Unique Facility Identifier (UFI) of: 080801169 2) FDA Establishment
Identifier (FEI) of: 3014302990 etc
We request entry / import compliance records be submitted for or on behalf of PRODUCTOS RICOLINO S.A.P.I. DE C.V.
PLANTA DULCES VERO TLAJOMULCO This includes all records of the validation of certification status confirmed by the
"FDA Color Certification Database system".
We request import compliance records / documents submitted for or on behalf of PRODUCTOS RICOLINO SAPI DE CV
PLANTA TOLUCA, Blvd Anillo Periferico S/N, Col. San Lorenzo Tepaltitlan Centro, Toluca, Mexico. FEI 3017561643.
Please provide all entry-related documents, ITACS Submitted documents, and Certificate of Analysis demonstrating
compliance with Color additives subject for certification for import admissibility,¿ of all products ¿made in the¿ foreign¿
¿facility: BARCEL PLANTA LAGUNA (Street Address: Acatita de Bajan 291 Parque Industrial Lagunero City: Gomez Palacio
State: Durango Country: Mexico DUNS:82-363-9760 FEI: 1000414086.
1) Listing of all INSPECTIONS since Tuesday, September 1, 2020 (in CSV format) with the following fields: FEI Number,
Inspection Start Date, Inspection End Date, Legal Name, Address, City Name, State Code, Zip Code, Country Name,
FDA483, Full Name, District, Center, INSPECTION REASON etc
Recs re "Currently available data do not show ivermectin is effective against COVID-19," published in FDA Consumer
Update current as of 9/3/2021, "Why You Should Not Use Ivermectin to Treat or Prevent COVID-19."
Date Range: 01/01/2019 - 10/01/2021. Forms 483 (Notice of Inspectional Observation), Establishment Inspection
Reports, and Response to Form 483 for Emilia Resources, LLC located in De Kalb, Mississippi.
Establishment Inspection Report for FDA Inspection, 5/29/2015: Miltenyi Biotec Gmbh Bergisch, Gladbach Germany
Establishment Inspection Report: FDA Inspection, Feb 4 - 9 , 2019 Aurobindo Pharma Limited, Unit XI Sy No. 61066
Pydibhimayaram Ranasthalam (Mandal) Srikakulum District Ab India
Establishment Inspection Reports: FDA Inspections 2/20/2018, 12/14/2018 Aurobindo Pharma Ltd, Unit IV Medak
District, Hyderabad India
Baxter Healthcare Corporation inspection recs
motor axonal neuropathy, acute motor-sensory axonal neuropathy, Bickerstaff's encephalitis, etc
K053052 Medela Freestyle
K113664, Tommy Tipee Closer to Nature
K200406, Evolve.
Tanexamic Acid Injection reported errors to the Agency for at least the last 10 years from January 2011 until current
date caused due to wrongly picked vials with same color stoppers or caps.
I am requesting on behalf of one of our law professors, Erika Lietzan. We need the following FDA dockets: Docket No.
FDA-1979-P-0356 FDA Docket No. 84N–0014
DRUG RECALLS
Warning Letter: 320-19-04 issued to Zhejiang Huahai Pharmaceutical Co., Ltd. I am looking for the response document
to the Warning Letter issued to Zhejiang Huahai Pharmaceutical Co., Ltd.: 320-19-04
A copy of the FDA Warning Letter sent to Owlet, Inc. on October 1, 2021.
EDF requests any correspondence between FDA and companies for 37 effective food contact substance notifications
(enclosed in the attached request letter) as well as any toxicology, chemistry, exposure or environmental assessment
reports prepared by FDA in its evaluation of the notices.
Seeking information on Sabizabulin trials, and human injuries during trials. Also interested in Zuclomiphene citrate and
Veru-100.
Bayer Healthcare Pharmaceuticals’ NDA (“NDA”) for Ciprofloxacin, a dry powder inhaler
BioMarin Pharmaceutical’s NDA for Kyndrisa (drisapersen)
Clovis Oncology’s NDA (“NDA”) for Xegafri (rociletinib, CO-1686
Novartis’s BLA (“BLA”) for Serelaxin (RLX030
The premarket approval application for the VISX Excimer Laser System (Models B and C) (P930016).
Warning Letter with response of closeout if available issued for Nationwide Children's Hospital or Sarepta Therapeutics.
All materials from FAP 0A3500, filed by American Cyanamid on July 21, 1981 and effective on August 19, 1983
All materials from FAP 7B3265, filed by Dow on May 6, 1977 and effective on December 9, 1977.
Form 483s or Form 483 Responses issued to Revance Therapeutics from Jan 1 2020 to present.
Congressional Correspondence Logs: I am requesting copies of the Congressional Correspondence logs maintained for
the members of Congress (listed below) by the Office of Legislation. • Rep. Don Bacon (2017-present) • Rep.
Steve Chabot (2011-present) • Rep. Brian Fitzpatrick (2017-present) • Rep. Andrew Garbarino (2021-present) •
Rep. Mike Garcia (2020-present) • etc
Copy of the 483 for the Jun 17, 2013 - Jul 12, 2013 (26 days) inspection of AMKS TIME RELEASE LAB, LLC located at
Paterson / United States of America] 470 Chamberlain Ave, Paterson, NJ 07522, USA. This inspection pertains to Human
Drugs.
Copy of the Company Response for the Jun 17, 2013 - Jul 12, 2013 (26 days) inspection of AMKS TIME RELEASE LAB, LLC
located at Paterson / United States of America] 470 Chamberlain Ave, Paterson, NJ 07522, USA. This inspection pertains
to Human Drugs.
Regulatory Assessment of Baxalta Incorporated Located at Los Angeles CA United States FEI Number: 2011021 held on
Regulatory Assessment of BioLife Plasma Services, L.P. Located at Great Falls MT United States FEI Number: 3004459766
held on 06/29/2021. This inspection pertains to drug products.
Copy of the EIR for the Jul 25, 2012 - Jul 25, 2012 (1 day) inspection of Singing River Hospital located at Pascagoula /
United States of America] 2809 Denny Ave, Pascagoula, MS 39581, USA. This inspection pertains to Medical Devices.
Copy of the EIR for the Jun 17, 2013 - Jul 12, 2013 (26 days) inspection of AMKS TIME RELEASE LAB, LLC located at
Paterson / United States of America] 470 Chamberlain Ave, Paterson, NJ 07522, USA. This inspection pertains to Human
Drugs.
Regulatory Assessment of Boehringer Ingelheim Vetmedica Inc Located at Saint Joseph MO United States FEI Number:
Regulatory Assessment of Genentech Inc Located at South San Francisco CA United States FEI Number: 2917293 held on
483s issued to one facility for Legend Biotech located in Raritan, NJ, from Jan 2021-present.
for Human Drugs inspection of Juan M. Ruiz-Unger, M.D. ending 09/22/2021 at the location in Palmetto Bay FL, United
for Medical Devices & Rad Health inspection of CardioQuip, LLC ending 09/17/2021 at the location in College Station TX,
I am researching about Orange Book patent listings and would like to request a complete list of delisted patents of
Orange Book.
Looking for a copy of the Form 483 Response submitted by Revance Therapeutic, Inc. in response to a Form 483 issued
to the company on 07/02/2021 (FEI #: 3007772056). The inspection in question took place on June 21-25, 28-30, and
July 1-2, 2021.
PHARMACOLOGY REVIEW, CLINICAL PHARMACOLOGY BIOPHARMACEUTICS REVIEW(S) & CHEMISTRY REVIEW for the
NDA's 1. PROCHLORPERAZINE EDISYLATE INJECTION (NDA 010742) 2. PROCHLORPERAZINE EDISYLATE ORAL
CONCENTRATE (NDA 011276) etc
for Medical Devices & Rad Health inspection of Fedex Supply Chain, Inc. ending 07/23/2021 at the location in Memphis
TN, United States. Please send documents as email attachments.
Banner Smoked Fish, Inc. Emails, phone transcripts, written correspondence including processing and regulatory
compliance records, written responses to inspectional observations.
for Human Drugs inspection of Avadel Pharmaceuticals (USA) Inc. ending 04/24/2019 at the location in Chesterfield MO,
for Medical Devices & Rad Health inspection of Avadel Pharmaceuticals (USA) Inc. ending 10/11/2018 at the location in
Chesterfield MO, United States. Please send documents as email attachments.
for Biologics inspection of FUJIFILM Diosynth Biotechnologies Texas, LLC ending 08/31/2021 at the location in College
Station TX, United States. The Response (in electronic format) for Biologics inspection of FUJIFILM Diosynth
Biotechnologies Texas, LLC ending 08/31/2021 at the location in College Station TX, United States. Please send
The 483 (in electronic format) for Medical Devices & Rad Health inspection of Avadel Pharmaceuticals (USA) Inc.
ending 10/06/2017 at the location in Chesterfield MO, United States. The EIR (in electronic format) for Medical Devices
& Rad Health inspection of Avadel Pharmaceuticals (USA) Inc. ending 10/06/2017 at the location in Chesterfield MO,
United States. The Response (in electronic format) for Medical Devices & Rad Health inspection of Avadel
Pharmaceuticals (USA) Inc. ending 10/06/2017 at the location in Chesterfield MO, United States. Please send
Please provide the inspection-related documents in electronic PDF format: Form 483's (in electronic format) for FDA
drug inspection in May, 2021 at: 1) Sterling Pharmaceutical Services, FEI 3011531531, 102 Coulter Rd. East Carondelet,
IL, United States, and 2) Sterling Pharmaceutical Services, FEI 3009705561, 109 South Second St., Dupo, IL, United
States. Please send documents as email attachments. Thank you.
The FDA-483 documents for 2 firms in New York: YFS Pharma, Inc. 485 Cayuga Rd. Buffalo, NY 14225 dated:
5/17/2021-5/21/2021 and J.M. Murray Center, Inc. 823 State Route 13 Cortland, NY 13045 dated: 4/28/2021-
4/30/2021
The FDA-483 documents for 2 firms: International Trading Pharm Lab. Inc. 470 Chamberlain Ave. Ste 12 Paterson, NJ
07522 dated:10/15/2019 - 10/29/2019; Lingraphicare America, Inc. 103 Carnegie Ctr, Ste 104 Princeton NJ 08540
dated:11/5/2019 - 11/15/2019
The FDA-483 documents for 3 firms: Edlaw Pharmaceutical, Inc. 195 Central Ave. Ste B Farmingdale, NY 11735 dated:
11/25/2019-11/27/2019; Regeneron Pharmaceuticals, Inc. 81 Columbia Tpk. Rensselaer, NY 12144 dated: 10/9/2019-
10/18/2019; and Time-Cap Laboratories, Inc. 7 Michael Ave. Farmingdale, NY 1735 dated: 12/5/2019 - 12/18/2019
We are requesting unredacted copies of the following two Chemours’ Drug Master Files (DMF): DMF 16074 for
TOPCOAT 3200-100 and DMF 28036 for 320G-201 ONE COAT CLEAR.
Any and all Adverse Event Reports referencing Chanel No. 5 Bath Powder, Chanel No. 5 Talc, Chanel No. 19 Bath
Powder, Chanel No. 19 Talc, Coco Mademoiselle Bath Powder, Coco Mademoiselle Talc, Chanel Bath Powder, and/or
Chanel Talc.
RECS RE COVID VACCINE
I hereby request a copy of all calendar entries for Tim Stenzel, director of the Office of In Vitro Diagnostics and
Radiological Health, from October 1, 2020 until September 30, 2021, inclusive of those dates.
Documents describing the isolation of the Covid-19/SARS-CoV-2 virus, and any other variants of the virus in human
beings. etc
I would like to receive the FDA Complete Response Letter or Deficiency Letter to SESEN BIO, INC. and any responses
from them to the FDA and any responses from the FDA to them.
I'm looking for a brief summary of the file submitted for "Denarase", a product manufactured by the company C-Lecta.
Requesting a copy of the FDA EIR from an FDA Inspection that was conducted in our CSL Plasma, Inc. - Lansing MI
location (3011385614) October 15, 2018 - October 19, 2018.
Request: Form 483s, EIRs, or any inspection records for the following facility: Lonza (14905 Kirby Dr Houston, TX 77047)
for the specified date range
2021-3085, 2021-3701, 2021-3738, 2021-4361
Revance Therapeutics, Inc response to 483, FMD 145 letter
Department of Health and Human Services U.S. License No. 2229, issued to BioNTech Manufacturing GmbH.
FDA’s Inspections of any manufacturing facility used by Medronics, Inc. to manufacture
pacemakers from January 1, 2015- June 1, 2019 etc
EMAILS RE GUIDANCE ON BOOSTER SHOTS WOODCOCK, MARKS, GRUBER, KRAUSE
Please provide EIR and 483 for Sunstar Americas inspections at the Schaumberg, IL Facility during the date range
provided.
Package insert, prescribing information, medication guide and any other labeling information for sermorelin (INN) also
known by the trade name Geref(R)
ADVERSE EVENT RECS
1. Remote Regulatory Assessment (RRA) Report for A Plus International Inc. (FDA Registration Number: 2083545) for
the RRA of the firm that took place from March 8 to March 12 of 2021. 2. Meeting Note for the Regulatory Meeting via
Zoom to discuss the result of the RRA between FDA CDRH Officials and A Plus International Representative that took
place on Wednesday, September 29, 2021 at 10 am (PST).
Any and all documents, communications, materials or content relating to, concerning, or regarding "CPT2001556".
Hi, I am an investment professional for an asset management firm and am looking to request all 483s issued from Jan
2021-present for: - Lonza facilities located in Slough, UK (FEIN: 1000583959) and Singapore (FEIN: 3009725845) -
Vetter Pharma facilities located in Germany with FEINs 3005987757, 3009560142, 3002270322 and 3002808846
“Agenda and meeting minutes of the 8/11/21 meeting with Mark Raza and others, subject: “Heron Therapeutis
Marketing Plan” - https://www.fda.gov/news-events/public-calendar-meetings-fda-officials/public-calendar-august-8-
14-2021”.
I would like to request the FEI and/or the Establishment DUNS per NDC and per Drug@FDA.
K180818
all FDA investigation memos related to Novavax COVID-19 vaccine NVX-CoV2373 at these two manufacturing plants: 1.
FUJIFILM Diosynth Biotechnologies, 3939 Bio-Medical Way, College Station, TX 77845 2. FUJIFILM Diosynth
Biotechnologies, 100 Discovery Dr #200, College Station, TX 77845
List of all recalls issued by ConAgra Brands, Inc. and ConAgra Foods from January 1, 2000, to date.
Reviews for PM0000551, PM0000553 and PM0000560, Vuse Solo, by RJ Reynolds.
for Human Drugs inspection of The W.S. Badger Company, Inc. ending 09/14/2021 at the location in Gilsum NH, United
for Biologics inspection of Melamed, Isaac R. , M.D. ending 04/01/2015 at the location in Centennial CO, United States.
The EIR (in electronic format) for Biologics inspection of Melamed, Isaac R. , M.D. ending 11/08/2018 at the location in
Centennial CO, United States.
for Human Drugs inspection of Particle Sciences Inc ending 06/24/2021 at the location in Bethlehem PA, United States.
The Response (in electronic format) for Human Drugs inspection of Particle Sciences Inc ending 06/24/2021 at the
location in Bethlehem PA, United States.
Please provide the following 2 inspection-related documents in electronic PDF format: The Response (in electronic
format) for Human Drugs inspection of Amgen, Incorporated ending 02/11/2015 at the location in Longmont CO, United
States. The 483 (in electronic format) for Human Drugs inspection of SnugZ USA, Inc. ending 09/17/2021 at the location
in West Jordan UT, United States.
The 483 (in electronic format) for Medical Devices & Rad Health inspection of Threshold NeuroDiagnostics Llc ending
09/14/2021 at the location in Minoa NY, United States. The 483 (in electronic format) for Human Drugs inspection of
ULTRAtab Laboratories, Inc. ending 09/14/2021 at the location in Highland NY, United States. etc
Vein360 is requesting the entire 510(k) for Penumbra numbered K161506.
Vein360 is requesting the entire 510(k) for Shockwave numbered K161384.
Vein360 is requesting the entire 510(k) for VenClose numbered K160754.
HHSF223201700023B, HHSF223201810005B, HHSF223201510027B, and HHSF223201510028B.
We request information on the Yale-Mayo Clinic FDA Center of Excellence in Regulatory Science and Innovation (CERSI)
FAIN U01FD005938-03
1) Any documents, including emails or other documents that include Alex Berenson or merely "Berenson" - or
references to me, my Twitter account, my public appearances on Fox News or elsewhere regarding my views on Covid,
Sars-Cov-2, lockdowns and other non-pharmaceutical interventions to slow the spread of Covid, or Covid vaccines. etc
Dear FDA officials, I would like to request a copy of all internal and external FDA documents related in whole or in part
to FDA regulations or guidance on European brands of infant formula such as HiPP or Holle.
I'd like to see any/all records (including complaints of adverse effects) from 1/1/2018 - 9/30/2020 pertaining to the
following products: - F-Factor 20/20 Fiber/Protein Powder – Vanilla Flavor - F-Factor 20/20 Fiber/Protein Powder –
Chocolate Flavor - F-Factor 20/20 Plant-Based Fiber/Protein – Unflavored - F-Factor 20/20 Fiber/Protein Powder –
Unflavored - F-Factor Fiber/Protein Bar – Chocolate Brownie - F-Factor Fiber/Protein Bar – Peanut Butter
Three (3) Freedom of Information (“FOIA”) Requests: Request to Transfer the Responses to the New ANDA Owner,
Picket Pharmaceuticals, Inc. • ANDA 079049 Alendronate Sodium Tablets, FOIA Control Number 2021-5978 • ANDA
090732 Anastrozole Tablets, FOIA Control Number 2021-5982 • ANDA 203161 Irbesartan Tablets, FOIA Control
Number 2021-6003
RRA report.
Report and/or the MDSAP Noncomformity Grading and Exchange Form (NC) for the inspection of 3M Company - Health
Care Business, Saint Paul, MN , end date 06-16-2017. FEI# 2110898. This inspection pertains to medical devices.
Neuromodulation Corporation, Valencia, CA , end date 07-20-2017. FEI# 3006630150. This inspection pertains to
medical devices.
Report and/or the MDSAP Noncomformity Grading and Exchange Form (NC) for the inspection of Hologic, Inc,
Marlborough, MA , end date 06-29-2017. FEI# 1000120743. This inspection pertains to medical devices.
Report and/or the MDSAP Noncomformity Grading and Exchange Form (NC) for the inspection of Philips North
America, LLC, Andover, MA , end date 07-14-2017. FEI# 1218950. This inspection pertains to medical devices.
Copies of any recommendations or guidance for communication including minutes of

online meetings to State and County Departments of Health or similar organizations, or to
commercial test manufacturers with respect to the qRT-PCR cycle threshold number that
might be optimal for the use of qRT-PCR in the detection of the SARS-CoV-2 in human
clinical specimens, etc (referral from CDC)
I request all records involving the decision by CDC to establish the threshold for considering a
COVID-19 virus test to be positive. Specifically, provide records showing the CDC decision to
set the RT-PCR (Reverse Transcriptase – Polymerase Chain Reaction) test results at a cycle
threshold of 40 cycles for a positive test
K012025
K200918
Copy of the disclosable portions of the PMTA applications for PM0000551, PM0000553, and PM0000560, for Vuse Solo
products by RJ Reynolds.
Please Provide RS-PI for DEXAMETHASONE TABLET ORAL for the Applicant HIKMA PHARMACEUTICALS USA INC for the
following strengths and ANDA No's: 0.5 mg- A084611 0.75 mg- A084613 1 mg- A088306 1.5 mg- A084610 2 mg-
A087916 4 mg- A084612 6 mg- A088316
for Biologics inspection of BioLab Sciences, Inc. ending 09/03/2021 at the location in Scottsdale AZ, United States.
for Biologics inspection of Empire Medical Practice, PC d.b.a Kindbody ending 09/03/2021 at the location in New York
NY, United States. Please send documents as email attachments.
for Biologics inspection of Family Fertility Center ending 09/14/2021 at the location in Bethlehem PA, United States.
for Biologics inspection of Octapharma Plasma Inc ending 09/10/2021 at the location in Columbus OH, United States.
for Biologics inspection of Tacoma-Pierce County Blood Bank ending 09/09/2021 at the location in Tacoma WA, United
for Biologics inspection of ADMA Biologics Inc. ending 08/12/2021 at the location in Boca Raton FL, United States.
for Human Drugs inspection of Goodier Cosmetics, Lp ending 09/05/2014 at the location in Dallas TX, United States.
for Human Drugs inspection of Revance Therapeutics Inc ending 07/02/2021 at the location in Newark CA, United
States. The Response (in electronic format) for Human Drugs inspection of Revance Therapeutics Inc ending
07/02/2021 at the location in Newark CA, United States. Please send documents as email attachments.
Request the following 510k - Only Sections 11 Device Description and 18 Performance Testing - Bench K180818
Trade/Device Name: Catamaran Sacroiliac Joint Fixation System (CAT SIJ Fixation System) Regulation Number: 21 CFR
888.3040 Regulation Name: Smooth ne fixation fastener Regulatory Class: Class II
Requesting 510k K110472 Requesting Only Sections 11 Device Description and 18 Performance Testing - Bench
Company: Medtronic Sofamor Danek, Inc.h 1800 Pyramid Place Memphis, Tennessee 38132 (901) 396-3133 Contact:
Lee Grant Senior Principal, Regulatory Affairs Product Name: MSB Sacroiliac Joint Fusion Device Regulation Name:
Smooth or Threaded Metallic Bone Fastener Classification: 21 CFR 888.3040 - Product Code: OUR
Requesting 510k K021932 Only Requesting Sections 11 Device Description and 18 Performance Testing - Bench Synthes
Synthes 6.5mm Cannulated Screw
PMA submission P200037.
Request for Technical Project Lead (TPL) Memorandum and Scientific Discipline Review Memoranda Relating to
Reynolds’ PMTAs (PM0000551, PM0000553, PM0000555-PM0000559, PM0000560, PM0000562-PM0000566) subject
to Marketing Orders Granted and Marketing Denial Orders issued on October 12, 2021—Expedited Treatment
Requested
Requesting 510k K131405 Requesting only Sections 11 Device Description 19 Performance Testing - Bench SI-BONE,
Inc. 3055 Olin Avenue, Suite 2200 San Jose, CA 95128 (408) 207-0700 Date Prepared: October 4, 2013 Trade Name of
Device: iFuse Implant System®D Common or Usual Name: Orthopedic Rod Classification Name: 21 C.F.R. 888.3040 -
Smooth or threaded metallic bone fastener; Product Code OUR
Requesting 510k K161210 - Only Sections 11 Device Description and 18 Performance Testing - Bench K161210
Trade/Device Name: RIALTO™ SI Fusion System, MEDTRONIC RESUSABLE INSTRUMENTS FOR USE WITH IPC™
POWEREASE™ SYSTEM, MEDTRONIC NAVIGATED MANUAK REUSABLE INSTRUMENTS FOR USE WITH THE
STEALTHSTATION™ AND IPC™ POWEREASE™SYSTEMS Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth
or threaded metallic bone fixation fastener
Company Name: Wello; Location: Addison, Texas; Device Name: welloStationX Types of Record: 1. Facility Inspection
Records for FDA registration and/or Medical Device Approval 2. Medical Device Approval Records, including PMAs,
510Ks, and De Novo Classifications
REVANCE 483, RESPONSE
I would like to request the following materials: IDE submissions, and any correspondence, communications, and/or
accompanying documents for: (1) Synchron’s Stentrode (2) BrainGate™ System (approved by FDA in 2004) (3) IDE No.
G120096 (4) IDE No. G120287 Feel free to reach out to me if you have any questions. Thank you!
Request FDA's regulatory expertise on mRNA therapies, to include all personnel (experts in this matter) including the
CBER organization, and timeframe in expertise.
Warning Letters to Cassava Sciences Inc. Adverse event data from NCT04079803 and NCT04388254 (Cassava clinical
trials) Documents released in response to a FOIA to 3rd party regarding Cassava Sciences Inc. Inspection documents of:
Rhode Island Mood & Memory Research Institute, East Providence, RI 02914
Documents related to inspections of the following CLINICAL INVESTIGATOR on the indicated date. Please include 483;
response to 483; warning letter response, if any; and closeout letter, if any.
Documents related to inspections of the following DEVICE companies on the indicated dates. Please include 483;
[Reference FGI#21-75306] relevant to Contract 75F40121C00134 with applicable SOW/PWS, Labor rates/categories,
winning Proposal, all Task/Delivery/Purchase Orders (if any) and agency source selection memorandum including
evaluation and scoring notes
Documents related to inspections of the following DRUG companies on the indicated dates. Please include 483;
Pursuant to the Freedom Of Information Act I am requesting records documenting when the covid-19 vaccine
Comirnaty will be available for consumers in the United States.
We are requesting all available written reports for case ID 16425864. We are seeking the medical reports for the case
and any additional information available.
RE: Cargill Animal Nutrition, Lecompte, Louisiana (FEI #2313775). Please supply Establishment Inspection Reports, FDA
Form 483s (if issued), lab results, and any correspondence (including Warning Letter and/or Untitled Letter, if issued)
pursuant to Inspection ID #681556 (Completion date August 2010) and Inspection ID #798699 (Completion date
September 2012).
I am requesting any all communications regarding an inspection that took place on or about Sunday, September 19th,
2021 at TrendSetters E-Liquid LLC 7070 Miller Lane Suite 102 Dayton, Ohio
I am requesting any all communications regarding an inspection that took place on or about Sunday, September 19th,
2021 at Liquid Nics LLC 7070 Miller Lane Suite 102 Dayton, Ohio
Requesting a redacted copy of the original 510(k): K202781, Neuspera Neurostimulation System (NNS)
Hi, Vanessa Gelman at Pfizer stated that fetal cells were being used in the vaccines, or in the creation of said vaccines, I
am just looking to confirm that information, as all ingredients should be disclosed to the public so they can make
informed decisions on whether to get the vaccine, or recommend it.
Hi, I am looking for a full ingredients list for FDA approved COVID-19 Pfizer vaccine, and any emergency authorized
COVID-19 Vaccines. I am also looking for dose amounts and the purpose of each ingredient (what they do, and how they
interact with eachother)
K201456 - Entire Approval Package
Letter dated December 13, 2007 sent from the FDA to McGuff Pharmaceuticals, Inc.
TOBACCO PRODUCT MASTER FILE REVIEW CHECKLIST MF0000474

Any and all records regarding an FDA inspection of Eli Lilly facility in Indianapolis, FEI Number 1819470, excluding
documents already provided in response to our previous FOIA number 2021-2514.
All documents, correspondence, meeting minutes, clinical and nonclinical studies, reports and memos between FDA
and Camber concerning: Lorsatan Montelukast Sodium Tablets -lot number MON17384 Montelukast Sodium Tablets –
lot number MON17355
Then, Adisseo is requesting a copy of the filing containing the data and safety information that supported the
definition use of chitosan as a flocculating agent.
BK120002 Letter & BK120002 Summary 04/24/2012 I would like the complete records for Haemonetics, Software
Solutions - Logic 3.0. Your web site says it should be available on Wayback Machine, but it's not
In October 2021, FDA sent an email to Food Facilities who missed the 12/31/2020 renewal deadline with subject
"Important Notice – U.S. FDA Food Facility Registration - Failed to Renew 2020." We request a list of all email addresses
that received this email.
PMTA Applications
PMTA Approvals
Reviewer notes regarding EX0001824-PD1
Unredacted copy of any and all documents, checklists or notes used in connection with the Technical Project Lead
Review Summary Memorandum associated with the 9.16.2021 denial order issued for PM0003413 and PM0000984 by
the Center for Tobacco Products or the Office of Science.
We are requesting the U.S. Food and Drug Administration’s (FDA) unredacted review memoranda and correspondence
relating to Mister-E-Liquid’s Premarket Tobacco Product Applications (“PMTAs”) for Open-System E-Liquid Products
under Submission Tracking Number (STN) PM0003500 (for 13 products).
- A record with a list of complaints reported to the FDA’s offices of: Biologics Studies, Clinical and preclinical studies
involving products regulated by the Center for Food Safety and Applied Nutrition (CFSAN), and Drug Studies, in the years
2016, 2017, 2018, 2019, 2020 and 2021.
We are requesting all of the materials associated with FD123 Seafood HACCP. This is to include all course materials such
as PowerPoint decks, Instructor Guide, Participant Guide, Activity Guide and Handouts.
Dear Officer: Under the Freedom of Information Act, 5 U.S.C. subsection 552, I am requesting access to the Complete
Response Letter issued regarding Revance Therapeutics’s DaxibotulinumtoxinA.
All records pertaining to FDA Inspection of Dr. Nancy Krywonis, Isabel Arnold, RN, and/or Horizons Clinical Research
Center in Denver, Colorado. This includes inspection reports, inspection findings, any enforcement actions, and any
responses to findings. The inspection(s) was related to Human Drug trials.
2021-2357, 2021-3138, 2021-3475, 2021-3536, 2021-1940.
2021-3776, 2021-5129, 2021-5204, 2021-5307, 2021-5380.
2021-5381, 2021-5628, 2021-5629, 2021-5661, 2021-5704.
2021-5721, 2021-5735, 2021-5737, 2021-5970, 2021-6428.
Contract Number: HHSF223201700013B Contract Title: Blanket Purchase Agreement GS35F257DA-
HHSF223201700013B
All contents of K042200, Device Name: MI Paste, Manufacturer: GC America, INC.
All contents of K130223, Device Name: Pulpdent RMGI Fill (Activa BioActive Restorative), Manufacturer: Pulpdent
Corporation
All eCTD sequences for IND 145661. Sponsor is unable to receive electronic eCTD records from previous CRO/Publishing
company after several attempts. Need electronic submissions from the FDA to maintain the life cycle of the application.
Copy of the 483 for the Aug 24, 2011 - Sep 15, 2011 (23 days) inspection of Steven W. Boyce, M. D. located at
Washington / United States of America] 110 Irving St NW, Washington, DC 20010, USA. This inspection pertains to
Human Drugs.
Copy of the 483 for the Jul 29, 2014 - Aug 1, 2014 (4 days) inspection of Rodo Medical, Inc. located at Sunnyvale /
United States of America] 725 San Aleso Ave #1, Sunnyvale, CA 94085, USA. This inspection pertains to Medical Devices.
Copy of the Company Response for the Aug 24, 2011 - Sep 15, 2011 (23 days) inspection of Steven W. Boyce, M. D.
located at Washington / United States of America] 110 Irving St NW, Washington, DC 20010, USA. This inspection
pertains to Human Drugs.
Copy of the EIR for the Aug 24, 2011 - Sep 15, 2011 (23 days) inspection of Steven W. Boyce, M. D. located at
Washington / United States of America] 110 Irving St NW, Washington, DC 20010, USA. This inspection pertains to
Human Drugs.
Copy of the disclosable portions of the EIRs and 483s for the following inspections of Mead Johnson (1) Evansville, IN
facility: 03/31/2017, 08/16/2017, 08/09/2018, and 08/26/2021; and (2) Zeeland, MI facility: 05/04/2018. Please note
these inspections related to Foods.
Copy of the disclosable portions of the EIRs and 483s for the following inspections of PBM Nutritionals (1) Milton, VT
facility: 08/21/2017, 08/15/2019, and 09/28/2020; and (2) Covington, OH: 09/28/2017, 09/28/2018, and 08/23/2019.
Please note these inspections relate to foods.
Copy of the disclosable portions of the Untitled Letter and 483 for the 11/18/2019 - 11/22/2019 BIMO inspection of
Drug Monitoring Research Institute, located in Navi Mumbai, India. Please note this inspection pertained to human
drugs.
Regulatory Assessment of BioLife Plasma Services, L.P. Located at Casselberry FL United States FEI Number: 3014027636
held on 10/14/2020.
Regulatory Assessment of Biomat USA, Inc. Located at Erie PA United States FEI Number: 3011035511 held on
10/14/2020.
Electronic listing (preferably csv format) of all inspections conducted by FDA since June 1, 2021. The list should cover all
FDA centers and include each FDA inspection ID number, DUNS number and reason for inspection.
Regulatory Assessment of Eli Lilly & Company Located at Indianapolis IN United States FEI Number: 1819470 held on
08/05/2020.
Regulatory Assessment of Pfizer Inc Located at Peapack NJ United States FEI Number: 3004945409 held on 08/11/2020.
De Novo classification request submission DEN200033 for the NightWare Kit (Apple iPhone, Apple Watch, Apple iPhone
Charging Cable, Apple Watch Charging Cable) from NightWare, Inc.
FAERS ID 19870903 •FAERS ID 19871373 •FAERS ID 19901300 etc
FAERS ID 19844705 •FAERS ID 19880360 •FAERS ID 19882572 •FAERS ID 19882793
FAP 4B4421. Please see attached for details.
SBOA for ANDA # 212416 (Calcitonin Salmon) from Custopharm. Chemistry Review for ANDA # 212416 (Calcitonin
Salmon) from Custopharm. Administrative and Correspondence Documents for ANDA # 212416 (Calcitonin Salmon)
from Custopharm
SBOA for NDA # 017808 (Miacalcin) from Mylan. Chemistry Review for NDA # 017808 (Miacalcin) from Mylan.
Administrative and Correspondence Documents for NDA # 017808 (Miacalcin) from Mylan
510(k) #'s K171565 and K132904
RE: Nutripack LLC (Formerly Evangers Dog & Cat Food Co), Wheeling, IL (FEI 1480280): Please supply FDA Form 483,
Establishment Inspection Report and all correspondence, including Warning Letter (if issued), Untitled Letter (if issued)
pursuant to inspection carried out from 2/19/2008 to 3/25/2008.
K181260, MiiS Horus Scope DPT 100.
FMD-145 Letter and EIR for MTF Tissue Services Rochester NY facility FEI: 3011400049 completed in May 2019 sent to
Nancy Simmons and acknowledged June 11, 2019 FMD-145 Letter and EIR for MTF Jessup PA facility FEI: 1000307092
completed July 2019 sent to Joe Yaccarino FMD-145 Letter and EIR for MTF Olyphant PA facility FEI: 3006813973
completed May 2019 sent to Joe Yaccarino August 2019
Need: Category of documents contained within Boston Scientific PMA for "Precision Spinal Cord Stimulation System"
(PM P030017) The documents we are requesting from this PMA are as follows: - The Quality System Plan - Any
documents related to design reviews - Documents relating to validation testing of related Bionic Navigator Software -
Documents related to risk/hazard assessments or analyses performed for this device
Please provide copies of the disclosable portions of the Center for Tobacco Products (CTP), Office of Science (OS), Office
of Compliance & Enforcement (OCE), and Office of Health Communication and Education (OHCE), reviewer's summaries
and any associated supporting CTP memoranda for the following STNs PM0000551, PM0000553, PM0000560.
for Medical Devices & Rad Health inspection of Guangzhou Wondfo Biotech Co., Ltd. ending 11/02/2018 at the location
in Guangzhou, China. Please send documents as email attachments.
for Medical Devices & Rad Health inspection of Hobbs Medical, Inc. ending 08/27/2021 at the location in Stafford
Springs CT, United States. Please send documents as email attachments.
for Medical Devices & Rad Health inspection of Midwest Sterilization Corp ending 09/02/2021 at the location in Jackson
MO, United States. Please send documents as email attachments.
for Medical Devices & Rad Health inspection of Theragen, Inc ending 09/10/2021 at the location in Manassas VA, United
for Human Drugs inspection of Patheon API Services Inc. ending 04/12/2019 at the location in Florence SC, United
for Medical Devices & Rad Health inspection of Oscor Inc. ending 09/10/2021 at the location in Palm Harbor FL, United
States. The 483 (in electronic format) for Medical Devices & Rad Health inspection of Technological Medical
Advancements LLC ending 09/09/2021 at the location in West Palm Beach FL, United States
for Biologics inspection of HealthOne Presbyterian/St. Luke's Medical Center ending 01/26/2017 at the location in
Denver CO, United States. The EIR (in electronic format) for Biologics inspection of HealthOne Presbyterian/St. Luke's
Medical Center ending 01/26/2017 at the location in Denver CO, United States. etc
The FDA-483 document from PRODUCT AREA of DRUGS for: Beauty Manufacturing Solutions Corp. 1250 Freeport
Pkwy, Coppell, TX, dated 3/30/2021-4/7/2021
The FDA-483 document regarding the PRODUCT AREA of FOOD Container/Closures for: Chameleon Beverage Co. Inc.
6444 E. 26th St. Commerce, CA dated: 3/29/2021-4/2/2021
The FDA-483 document with indicated PRODUCT AREA of DRUGS for: Aetna Felt Corporation 2401 W. Emaus Ave.,
Allentown, PA, dated: 5/13/2021-5/13/2021
Treace Medical Concepts, Inc. (Ponte Vedra) is requesting a copy of the Remote Regulatory Assessment report for
Treace Medical Concepts, Inc. (Ponte Vedra, Registration # 3011623994) conducted from June 7, 2021, to June 21, 2021,
by investigator Ashely Mutawakkil.
We hereby request the following documentation and appreciate your support on this: Documentation (including
establishment inspection report and 483s, if any) for the FDA inspection in 2021 on Pharmaceutics International Pii3
(FEI3006503202) in Cockeysville, MD and Pii1/4/5 (FEI 1000513101) in Hunt Valley, MD.
RE: Pro-Pet, LLC, Kansas City, KS (FEI #1912195). Please supply Establishment Inspection Report for Inspection ID 820671
(completiion date 03/01/2013)
Adverse Event reports and outcomes related to highly caffeinated energy drinks like Red Bull, Monster, 5-Hour Energy,
and Rockstar
The most recent container, carton, and prescribing information labels for NDA 083722 Phytonadione 1 mg/0.5 mL. The
most recent container, carton, and prescribing information labels for NDA 087955 Phytonadione 10 mg/mL.
Documents maintained by the Food and Drug Administration (“FDA”) regarding Bluebird Bio, Inc.’s (“Bluebird”) Biologics
License Application (“BLA”) for betibeglogene autotemcel (“beti-cel”) gene therapy, which was formerly referred to as
LentiGlobin
All email records containing the keyword “AAFCO” for FDA employee Charles Becoat for the date range of January 01,
2021-January 31, 2021. (Employee location /DHHS/FDA/ORA/ORA/OHAFO/OHAFOE)
All email records containing the keyword “AAFCO” for FDA employee Daniel Rice for the date range of January 01, 2021-
March 31, 2021. (Employee location /DHHS/FDA/ORA/ORA/ORS/OFFLO
All email records containing the keyword “AAFCO” for FDA employee Lei Tang for the date range of January 01, 2021-
March 31, 2021. (Employee location /DHHS/FDA/CVM/CVM/OSC/DAF)
All email records containing the keyword “AAFCO” for FDA employee Lourdes Andujar for the date range of January 01,
2021-January 31, 2021. (Employee location /DHHS/FDA/ORA/ORA/OHAFO/OHAFOW/DDHAFO/DHAFOB)
All email records containing the keyword “AAFCO” for FDA employee Mika Alewynse for the date range of October 1,
2021-October 31, 2021. (Employee location /DHHS/FDA/CVM/CVM/OSC/DAF)
All email records containing the keyword “AAFCO” for FDA employee Mika Alewynse for the date range of September 1,
2021-September 30, 2021. (Employee location /DHHS/FDA/CVM/CVM/OSC/DAF)
All email records for FDA CVM employee Eric Nelson containing the key search term: AAFCO 05.01.2021-06.30.2021
1. All reports of adverse events and/or reactions dog and/or cats have had to dog and cat food and dog and cat treats
from 02.01.2021-04.30.2021. a. Please include the type of animal, the reaction, the brand name and the product name
of the food item to which the dog or cat reacted, the symptoms displayed and the outcome, if available. etc
1. All e-mails from Dan McChesney (FDA-CVM) for January 01, 2018-May 31,2018 containing the keyword, AAFCO.
2. All e-mails from Dan McChesney (FDA-CVM) for January 01, 2017-December 31,2017 containing the keyword,
AAFCO. 3. All calendar records from Dan McChesney (FDA-CVM) for January 01, 2017- May 31, 2018 4. etc
2021-5951
All FDA disciplinary review documents for R.J. Reynolds Vapor Company Premarket Tobacco Product Applications
(Submission Tracking Numbers: PM0000551, PM0000553, PM0000560).
All correspondence between the FDA and the company FibroGen, headquartered in San Francisco, California, in
particular any material referencing the FDA's denial (via CRL) of FibroGen's new drug application for Roxadustat. In the
alternative, any records produced by FDA in response to FOIA request 2021-5848.
I am seeking full FDA AERS report narrative for reports made about the drug Nuplazid in the 2020 calendar year.
Inspection records, observations and reports related to inspection of FujiFilm Diosynth Biotechnologies, 100 Discovery
Drive, Suite 200 College Station TX 77845, FDA Establishment number 301198449
CFSAN LIST FDA Foreign Supplier Verification Programs from approximately December 4 2018- March 3 2019
My request is specific to requesting the "number" of Deaths/adverse events/side affects/and new onset of medical
conditions documented to date at the FDA(includes any/all adverse event and not just serious events and death), as a
result of all three (Moderna, J&J, Pfizer) Covid -19 vaccines available for EUA.
The BLA review documents for Alexion Pharmaceuticals' Eculizumab/Soliris. The application number is BLA 125166/S-
422 and BLA approval was granted on 10/23/2017. In the alternative, all documents produced in response to FDA FOIA
request 2021-84.
Emails, communications, correspondence, and/or talking points describing FDA guidance on the administration of
booster shots in response to the spread of COVID-19, during the above stated time period, in the following FDA staff
email accounts: Janet Woodcock (Acting Commissioner of Food and Drugs), Peter Marks (Director, Center for Biologics
Evaluation and Research), ETC
Each email exchanged between the FDA employees/accounts listed below and (i) another FDA employee; and/or (ii) an
external sender/recipient, that contains ANY of the following terms in the BODY or SUBJECT of the email (terms
separated by comma, without regard to capitalization): HORSE, COW, DEWORMER, DE-WORMER, IVERMECTIN, IVM.
Establishment Inspection Report for NVE Pharmaceuticals, Inc. for the FDA Inspection occurring on 12/05/2016,
12/06/2016, 12/07/2016, 12/12/2016 and 12/14/2016 conducted by the Parsippany District Office, located at 10
Waterview Blvd., 3rd Floor, Parsippany NJ 07054 NVE Pharmaceuticals, Inc. FEI #3000205552 NVE Pharmaceuticals, Inc.
located at 15 Whitehall Road, Andover, NJ 07821-2115
Document Requests: 1. Any and all prior and/or subsequent communications through the present between the FDA
and Athenex relating to the February 13, 2019 letter from the FDA’s Office of Pharmaceutical Quality Operations to
Athenex’s Clarence facility. 2. The Establishment Inspection Report from the December 2017 FDA inspection of
Athenex’s Clarence facility and any and all subsequent communications between Athenex and the FDA relating to that
inspection through the present, including Athenex’s January 4, 2018 response. etc
adverse events involving the drug Aduhelm (aducanumab) that have occurred between June 2021 through the present,
as well as any other therapies in the class of Monoclonal Antibodies Directed Against Amyloid for the Treatment of
Alzheimer’s Disease.
I am requesting records showing that SteriPack requested FDA approval to continue use of Sterile Narrow Polyester
Spun Swab-60567RevA manufactured by SteriPack LOT: 13190 MFG: 2020-10-05 for Covid19 testing purposes past it's
original expiration date of 2021-10-05.
Hi, I would like to access Revance's response to the Form 483 they received on 7/2/21
(https://www.fda.gov/media/153014/download). Thank you
1. FDA’s contact with MECTA Corporation, 19799 SW 95th Ave., Tualatin, OR 97062, or Applicant Contact Robin Nicol,
related to the MECTA Sigma (aka MECTA Sigma) electroconvulsive therapy (ECT) device, 510(K) Number: K192834 2.
Any other application or correspondence relating to MECTA Corporation where it has sought, pursuant to section 5l0
(k), clearance to market the Sigma Electroconvulsive Therapy device for indications outside existing cleared indications.
All research data in regards to the approval of the COVID-19 vaccine
1. All documents that relate to the classification of the food processing residual known as Hatgro as a fertilizer. etc
All records created and emails sent by, or received by, or copied to FDA employees Jean-Marie (John) Dimandja and/or
Jeffrey (Jeff) Archer that include one or more of the following search terms: PFAS, Per- and polyfluoroalkyl substances,
PFOA, GenX, PFOS, PFBA, PFNA and PFDA.
All course delivery materials for FD249 Conducting Seafood Inspections. We are requesting all PowerPoint decks,
Instructor Guide, Participant Guide, Activity/Exercise Guide, handouts associated with the delivery of this course
We respectfully request all submissions and letters for IND 50,987.

We are requesting the feedback to control numbers 2021-4324 and 2021-230.
To obtain Establishment Inspection Reports (EIR) along with their exhibits filed from 2017 -2021 YTD for FEI numbers
including: 3009108089, 3012123291, 3002911336, 3003981983, 3002806417.
Reviewer notes regarding PM0000470-PM0000473
NDA 206829/S-008 Prior Approval supplemental for ZERBAXA (ceftolozane and tazobactam)
ANDA 087859 Sodium Polystyrene Sulfonate Suspension USP (SPS® Suspension) owned by CMP Pharma Inc. - Please
provide a list of all supplements filed since 2011 with supplement approval dates (if approved) and the subject of each
of these supplements.
motor axonal neuropathy, acute motor-sensory axonal neuropathy, Bickerstaff's encephalitis, ETC
INSPECTION RECS 1. BioReliance, Address: 9630 Medical Center Drive Rockville, MD 20850, US Applicable period: Year
2003 to 2015 2. Quintiles, Inc., US. Address: 10245 Hickman Mills Drive Kansas City, MO 64137, US Applicable period:
Year 2003 to 2005 3. Burleson Research Technologies, Inc., Address: 120 First Flight Lane Morrisville, NC 27560, US
Applicable period: Year 2004 to 2010 ETC
A copy of the Establishment Inspection Report(s) (“EIR”) and/or any and all related documents, including any reports,
correspondence, endorsements, addenda, and exhibits, for any inspection of domestic and foreign clinical study and
manufacturing facility sites relating to U.S. Smokeless Tobacco Company LLC’s premarket tobacco product applications
for VERVE® Discs Blue Mint (PM0000470), VERVE® Chews Blue Mint (PM0000471), VERVE® Discs Green Mint
(PM0000472), and VERVE® Chews Green Mint (PM0000473).
All details related to the FDA's decision declining emergency use authorization for Lenzilumab, including 1) any letters or
correspondences to Humanigen Inc. related to the FDA's decision, 2) individuals who reviewed the EUA application, and
3) notes or comments from those individuals who reviewed the EUA application.
USA THINK INC RRA
Requesting additional information for reports under VAERS ID 1463964 and 1582506
I am seeking a copy of the current “Physician Substitute Program” approved by the Center for Biologics Evaluation and
Research (CBER) for the company CSL Behring.
form 483 for glenmark baddi unit
USFDA form 483 for Dr.REddy Duvvada facility fto 7 and fto9
We are interested in statistical and clinical reviews associated with the SBA for the supplemental approval of
abemaciclib (Verzenio) associated the supplemental NDA dated and received on 17 December 2020 and approved on 12
October 2021. NDA 208716/S-006, S-007, S-008
Product area: vaccines Record request: all inspection records of Emergent BioSolutions facilities, including 1) Lansing,
MI, 2) Winnipeg, Manitoba, Canada, 3) Gaithersburg, MD, 4) Canton, MA, 5) Baltimore, MD (Camden facility), 6)
Baltimore, MD (Bayview facility), 7) Elkridge, MD, 8) San Diego, CA, 9) Bern, Switzerland, 10) Rockville, MD
Synergy Health AST, LLC Saxonburg 7225 N. Noah Drive, Saxonburg, PA 16056 EIR
Non-redacted versions of the FDA Establishment Inspection Reports for food products for Chaparrastique Warehouse
located at 5841 S San Pedro St Ste A, Los Angeles, CA 90003-1347 (FEI No. 3004340851). The FDA Inspection Database
indicates that two inspections occurred for the Warehouse's food products, one on March 21, 2013, and the other on
January 4, 2017.
INDIVDIUAL RECS
I'd like to have the records for scientific studies done on natural immunity versus vaccine immunity in regards to COVID
19 and all variants.
Correspondence between the FDA Center for Tobacco Products and Mohammed Aamir Siddique as registered agent of
Fuma Vapor Inc. relating to Posh and Posh Plus disposal vaping devices and any documents identifying the importer or
manufacturer of Posh Plus disposable vaping devices.
I request the records provided in response to the following FOI control #s previously submitted to the FDA: #2003-4451,
#2003-6345, #2005-9407, #2006-9592. Please include all segregable portions of nonexempt material.
The 483 (in electronic format) for Foods & Cosmetics inspection of Real Water, Inc. ending 04/07/2021 at the location
in Henderson NV, United States. The Response (in electronic format) for Foods & Cosmetics inspection of Real Water,
Inc. ending 04/07/2021 at the location in Henderson NV, United States. Please send documents as email attachments.
I request any and all FDA Form 483s and warning letters during the requested date range issued to the New York Blood
Center.
Pursuant to the Freedom of Information Act (“FOIA”), 5 U.S.C. §552; and 21 C.F.R. §§20, et seq., we request access to,
and copies of, preliminary comments that the FDA sent to ChemoCentryx on March 16, 2020 pertaining to
ChemoCentryx’s drug avacopan (formerly CCX168 and now TAVNEOS).
The EIR (in electronic format) for Human Drugs inspection of Vertice Pharma Management Corp ending 08/29/2018 at
the location in Bridgewater NJ, United States. The EIR (in electronic format) for Human Drugs inspection of Janssen
Pharmaceuticals, Inc. ending 01/22/2016 at the location in Raritan NJ, United States. The EIR (in electronic format) for
Human Drugs inspection of Janssen Pharmaceuticals, Inc. ending 01/26/2017 at the location in Raritan NJ, United States.
for Human Drugs inspection of Animesh Pardanani ending 03/08/2019 at the location in Rochester MN, United States.
The Response (in electronic format) for Human Drugs inspection of Animesh Pardanani ending 03/08/2019 at the
location in Rochester MN, United States. Please send documents as email attachments.
for Biologics inspection of HealthOne Presbyterian/St. Luke's Medical Center ending 04/22/2019 at the location in
Denver CO, United States. The Response (in electronic format) for Biologics inspection of HealthOne Presbyterian/St.
Luke's Medical Center ending 04/22/2019 at the location in Denver CO, United States. Please send documents as email
attachments.
483 Cosmetic Enterprises, Ltd. 12848 Pierce St. Pacoima, CA dated: 6/7/2021-6/11/2021; Cosmetic Group USA, Inc.,
8430 Tujanga Ave., Sun Valley, CA dated: 4/5/2021-4/14/2021; Brenntag Pacific, Inc., 10747 Paterson Pl., Santa Fe
Springs, CA dated: 4/29/2021-5/6/2021; Coretex Products, Inc. 1850 Sunnyside Ct., Bakersfield, CA dated: 4/26/2021-
4/28/2021: and/ last J.M. Murray Center, Inc., 823 State Route 13, Cortland, NY dated: 4/28/2021-4/30/2021
FDA-483 Transfer Technology, 5702 Bolsa Ave, Ste 200, Huntington Beach, CA dated: 4/5/2021-4/13/2021; YFS Pharma,
Inc., 485 Cayuga Rd. Buffalo, NY dated: 5/17/2021-5/21/2021; Svelte Medical Systems, 675 Central Ave., Ste 2, New
Providence, NJ dated: 5/25/2021-6/14/2021; Life Technologies Corp., 7335 Executive Way, Frederick, MD dated:
6/7/2021-6/14/2021; and/lastly Small Beginnings, Inc. 17229 Lemon St., Ste B2, Hesperia, CA dated: 6/22/2021-
6/23/2021
(Submission Tracking Numbers: PM0000551, PM0000553, PM0000560). All documents submitted to FDA by R.J.
Reynolds Vapor Company relating to Premarket Tobacco Product Applications for Submission Tracking Numbers:
PM0000551, PM0000553, PM0000560. etc
Report and/or the MDSAP Noncomformity Grading and Exchange Form (NC) for the inspection of 3M COMPANY,
Brookings, SD , end date 06-08-2017. FEI# 1717046. This inspection pertains to medical devices.
Report and/or the MDSAP Noncomformity Grading and Exchange Form (NC) for the inspection of Medtronic Minimally
Invasive Therapies Group, Mansfield, MA , end date 05-17-2017. FEI# 1282497. This inspection pertains to medical
devices.
Report and/or the MDSAP Noncomformity Grading and Exchange Form (NC) for the inspection of Medtronic Spine LLC,
Milpitas, CA , end date 05-10-2017. FEI# 3002598640. This inspection pertains to medical devices.
Report and/or the MDSAP Noncomformity Grading and Exchange Form (NC) for the inspection of Stryker
Communications, Flower Mound, TX , end date 05-25-2017. FEI# 3002975342. This inspection pertains to medical
devices.
prescribing information, package insert and authorisation letter of Diulo 5mg (Searle) H18535 and Zaroxolyn 5mg
(Pennwalt) H17386
Request for Approved Documents of Levalbuterol Inhalation Solution ANDA No. 090297
RECS RE LITHIUM CARBONATE ER
Revance's response to the recently posted 483 issued by the FDA, which they have disclosed publicly that they respond
to in July ‘21 (original 483 posted here -https://www.fda.gov/media/153014/download) • A copy of the recently issued
CRL by the FDA to Revance Therapeutics, Inc • Establishment Inspection Report (EIR) for the facility that received the
483 above
Please provide disclosable, redacted 483s, 483 Responses, warning letter responses and EIRs in electronic format (.pdf)
that have been released since January 1st , 2018 to December 31st, 2018.The product area of these inspections are
drugs.
For the time period from 01/01/2021 through and including 1/19/2021 please disclose all statistical
results (numerical / statistical tables) and associated reports/preliminary reports owned by the
FDA or any of it’s employee and/or contractor related to the “near real-time surveillance” done on
the Medicare healthcare claims database.
Hi - I'm looking to access the Establishment Inspection Report (EIR) issued to Revance as part of their facility inspection
in late June/early July. Thanks
Hi - I'm looking to access the complete response letter issued to Revance on 10/15/21 regarding their filing for Daxi.
Thanks
demyelinating polyradiculoneuropathy, ETC
All documents, memoranda, emails, correspondence, meeting notes and minutes, presentations, i.e., powerpoint
documents relating to nutritional labeling of alcoholic beverages to the extent the FDA and not TTB was involved.
Any correspondence with any parties related to letter sent to FDA by Center for Science in the Public interest on March
15, 2021, regarding request for enforcement action against Molson Coors for the marketing of its Vizzy Hard Seltzer
with antioxidant claims, and whether enforcement action was taken or will be taken
Copies of all correspondence (including but not limited to letters, emails, text messages) between the United States
Food and Drug Administration and the United States Department of Justice relating to the criminal prosecution
(including the declination of prosecution) and/or civil enforcement of any individual or corporate entity involving the
drug “Botox” (onabotulinum toxin A) regarding potential violations of 21 U.S.C. §§331-335.
For the time period January 1, 2021 to present, the releasable FDA health hazard evaluation and all releasable related
documents and correspondence regarding the recall classification for recall numbers D-0844-2021 and D-0845-2021 of
Neutrogena Beach Defense, lots 16621E01 and 06320E26, initiated on July 14, 2021, and classified by FDA as class 1 on
9/24/2021.
I would like any records relating to analysis or sanctions for a company called Hims & Hers (formlery just called Hims)
relating to the marketing of any FDA regulated product they sell/distribute, such as Viagra, as well as the protocol for
physicians on their platform as far as barrier to prescribing a pharmaceutical
Infant Formula Submissions for (1) Enfamil Enspire; (2) ByHearts Formula; (3) Enfamil Gentlease; (4) Enfamil Premium
A2; (5) Similac Pro Sensitive; and (6) Gerber Good Start Gentlepro.
participating in the FDA Foreign Supplier Verification Programs from September 4, 2018 - December 3, 2018. We
request a modified version of this same list to include the Firm's FDA FEI Number.
Warning letter to Philips Respironics case id 433257 issued on 6/30/2014. I also need inspection citation related to
inspection id 873806 with an inspection end date of 4/15/2014
Please provide Al Khalifa’s Premarket Tobacco Product Applications (PMTAs) (assigned Submission Tracking Numbers
PM0001730; PM0002402; PM0002415; PM0002420; PM0002430). The initial budget is $350, please contact me if
additional funds are required.
communications in the food product area regarding the company Inhance Technologies LLC between Jan 1, 2021 and
Oct 1, 2021. Please use search terms: PFAS, fluorination, fluorinated, HDPE, Inhance Technologies, Fluoro-Seal.
1. Any/all STEC sampling/testing records/results conducted by the United States Food and Drug Administration and/or
in the possession of the United States Food and Drug Administration pertaining to Bernatello's Pizza Inc., from January
1, 2016, to present. ETC
All documents from November 5, 2020 to present relating to FDA’s FDCA, NEPA, and ESA assessments of AquaBounty’s
AquAdvantage salmon drug application, pursuant to the Northern District of California’s order. Specifically including
documents related to new drug production facility in Ohio.
Form 483 Inspection report for the following recalls: Simply Nourish Brand - https://www.fda.gov/safety/recalls-market-
withdrawals-safety-alerts/wet-noses-natural-dog-treat-companyr-voluntarily-recalls-simply-nourish-brand-frozen-dog-
food-due Fromm dog food - https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/fromm-family-foods-
voluntarily-recalls-four-star-shredded-entree-canned-food-dogs-due-elevated Tuffy's dog food -
https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/tuffys-pet-foods-inc-issues-voluntary-recall-
limited-quantity-pure-vita-salmon-entree-dog-food
I am trying to obtain copies of public records that COVID-19/SARS-CoV-2 virus, and any other variants of the virus, have
been isolated.
Request a copy of Premarket Notification - K012060 Modification To Hu-Friedy Brand Satin Swivel Ultrasonic Insert
Freedom of Information Act (FOIA) request for Premarket Notification for K210021, Axon Therapy by NeuroLace
Medical, Inc.
-All correspondence and other documents related to Molson-Coors’ “Vizzy” hard seltzer product line and advertising
campaign, including: -All internal correspondence between TTB officials regarding Molson-Coors’ Vizzy hard seltzer
advertisement; etc
This record request is regarding: 1) "End Of Phase Two" Meeting minutes between Cassava Sciences ($SAVA) and the
FDA. 2) "Special Protocol Assessment" for Phase three trials between Cassava Sciences ($SAVA) and the FDA. The Phase
three trial reference numbers are ( ClinicalTrials.gov Identifier: NCT04994483) and (ClinicalTrials.gov Identifier:
NCT05026177).
This record request is regarding: 1) "End Of Phase Two" Meeting minutes between Cassava Sciences ($SAVA) and the
FDA. 2) "Special Protocol Assessment" for Phase three trials between Cassava Sciences ($SAVA) and the FDA. The
Phase three trial reference numbers are ( ClinicalTrials.gov Identifier: NCT04994483) and (ClinicalTrials.gov Identifier:
NCT05026177).
FDA FIOA responses to control numbers: 2021-3861 2021-5635 2021-5877 2021-6230 2021-6232
We request the scans of 8 ANDA approval letters. Two of these ANDAs were approved by FDA in 2007(#77405, #77545),
four in 2009 (#77579, #78700, #78744, #78877), one in 2012 (#77575) and finally one in 2013 (#203059)
I am requesting the NCBI Pathogen Database Isolate numbers (PDT#) and Biosample numbers (SAMN#) for the clinical
Salmonella isolates that were used for the traceback investigation reported in Figure 1 of FDA's "Investigation Report:
Factors Potentially Contributing to the Contamination of Red Onions Implicated in the Summer 2020 Outbreak of
Salmonella Newport".
I am requesting the NCBI Pathogen Database Isolate numbers (PDT#) and Biosample numbers (SAMN#) for all of the
environmental Salmonella isolates recovered from the investigation of the Salmonella Newport outbreak in 2020 in
Table 1 in FDA's "Investigation Report: Factors Potentially Contributing to the Contamination of Red Onions Implicated
in the Summer 2020 Outbreak of Salmonella Newport".
Form 483 for mylan hyderabad unit
Device ID K180474, 510k Number K180474, Device Name: TNI SoftFlow 50, ClassificationHumidifier, Respiratory Gas,
(direct Patient Interface)
DeNovo ID DEN170001, Device Name: Precision Flow® HVNI, Classification High Flow/high Velocity Humidified
Oxygen Delivery Device,
We are seeking a copy of the Response made to the Warning Letter re: Tampa FuM Corp. MARCS-CMS 607938 -MAY 12,
2020
Remote Regulatory Assessment (RRA) closing report for Intersurgical Inc. Conducted by Gobiga Vanniyasingam, Division
1/MDRHE. Closing conducted on 10/13/2021. Intersursugical Inc. 6757 East Syracuse, NY 13057 315-451-2900
510K Submission
FDA-2021-N-1088-0001 PUBLIC COMMENTS
all FOIA requests filed with FDA’s Center for Food Safety and Applied Nutrition (“CFSAN”), including related offices,
from July 1, 2021 through July 31, 2021
510K Submission
All documents, memoranda, emails, correspondence, enforcement actions, meeting notes and minutes, presentations,
i.e., powerpoint documents relating to labeling and regulation of toothpaste products.
UNIVERSITY OF PENNSYLVANIA INSPECTION RECS
510K Submission
The RLD Halcion 0.25mg - Bottle labels of 100's and 500's pack and 0.125mg - Bottle labels of 10's, 100's and 500's pack
is not available on DailyMed or FDA label repository. If Halcion 0.125mg labeling cannot be provided, kindly arrange the
Bottle labels of 500's pack of Authorised Generic- Triazolam by Greenstone LLC
for Biologics inspection of CryoLife, Inc. ending 08/08/2018 at the location in Kennesaw GA, United States. Please send
for Foods & Cosmetics inspection of Real Water, Inc. ending 04/07/2021 at the location in Mesa AZ, United States.
format) for Human Drugs inspection of Pfizer, Inc. ending 06/18/2007 at the location in Ann Arbor MI, United States.
format) for Human Drugs inspection of QPS, LLC ending 01/16/2019 at the location in Newark DE, United States. Please
for Human Drugs inspection of Ei, LLC ending 05/08/2015 at the location in Landis NC, United States. The Response (in
electronic format) for Human Drugs inspection of Ei, LLC ending 05/08/2015 at the location in Landis NC, United States.
for Human Drugs inspection of Kadmon Corporation, LLC ending 12/08/2020 at the location in Cambridge MA, United
States. ETC
FDA, Consolidated Response to Pending Citizen Petitions on the Regulation of Ultrasound Contrast Agents, Docket No.
96P-0511, at 53 (July 25, 1997).
I am seeking all adverse health events reported to the FDA related to USANA (alternate spelling Usana) including but not
limited to its products EstroPro (alternate spelling Estropro) and Vita-Antioxidant (alternate spelling Vita Antioxidant).
1. All FDA Adverse Event Reporting System (FAERS) summaries and detailed reports concerning the drug approval
package for Trodelvy (#761115) 2. All readily available documents related to the drug approval of Trodelvy.
1. All FDA Adverse Event Reporting System FAERS summaries and detailed reports concerning the NDA (#211150) of
Wakix. 2. All readily available documents related to the NDA of Wakix.
1. All FDA Adverse Event Reporting System (FAERS) summaries and detailed reports concerning the drug approval
package for Keytruda (pembrolizumab), which received a complete response letter (CRL) on March 29, 2021, but was
later approved on July 26, 2021. 2. All readily available documents related to the drug approval of Keytruda.
510K Submission
structured dataset of when drug applications are submitted to the FDA
EIR REQUEST Hello, I would like the request the EIR for the following inspection of Dr. Frederick Locke. The details of the
inspection are below: Name: Dr. Frederick Locke Location: Moffitt Cancer Center (USA) Inspection Dates: 11-18 July
2017 Should you need anything further information, please let me know. Thank you!
EIR REQUEST Hello, I would like the request the EIR for the following inspection of Dr. Sattva Neelapu. The details of the
inspection are below: Name: Dr. Sattva Neelapu FOI Request: EIR of Investigator Site Location: MD Anderson Cancer
Center (USA) Inspection Dates: 24-28 July 2017 Should you need anything further information, please let me know.
Thank you!
demyelinating polyradiculoneuropathy, etc
for Human Drugs inspection of DPT Laboratories, Ltd ending 02/07/2020 at the location in San Antonio TX, United
Copy of the 483 for the Sep 22, 2014 - Sep 26, 2014 (5 days) inspection of AB Science located at Paris / France] 3 Avenue
George V, 75008 Paris, France. This inspection pertains to Human Drugs.
Copy of the Company Response for the Sep 22, 2014 - Sep 26, 2014 (5 days) inspection of AB Science located at Paris /
France] 3 Avenue George V, 75008 Paris, France. This inspection pertains to Human Drugs.
Copy of the EIR for the Sep 22, 2014 - Sep 26, 2014 (5 days) inspection of AB Science located at Paris / France] 3 Avenue
George V, 75008 Paris, France. This inspection pertains to Human Drugs.
Copy of the EIR for the Sep 7, 2011 - Sep 22, 2011 (16 days) inspection of Satyaprakash N. Makam, MD located at
Munster / United States of America] 10010 Donald S Powers Dr, Munster, IN 46321, USA. This inspection pertains to
Medical Devices
Regulatory Assessment of BioLife Plasma Services L.PL Located at Greenville SC United States FEI Number: 3014276902
held on 04/08/2021.
Regulatory Assessment of Biomat USA Inc Located at Shreveport LA United States FEI Number: 3006306298 held on
03/10/2021.
Regulatory Assessment of CSL Plasma Inc. Located at Akron OH United States FEI Number: 1525348 held on 04/13/2021.
Regulatory Assessment of CSL Plasma, Inc. Located at Parkersburg WV United States FEI Number: 3013402898 held on
04/09/2021.
Hello, I would like the request the EIR for the following inspection of Dr. David Miklos. The details of the inspection are
below: Name: Dr. David Miklos FOI Request: EIR of Investigator Site Location: Stanford University (USA) Inspection
Dates: 24-27 July 2017
Please provide a copy of FDA internal review memoranda regarding PNC #2565 issued on December 15, 2020 and
signed by Vanee Komolprasert.
for Human Drugs inspection of Hikma ending 11/22/2019 at the location in Columbus OH, United States. Please send
format) for Human Drugs inspection of L. Perrigo Company ending 01/17/2019 at the location in Allegan MI, United
for Biologics inspection of Vetter Pharma-Fertigung GmbH & Co. KG ending 11/10/2017 at the location in Langenargen,
Germany. The Response (in electronic format) for Biologics inspection of Vetter Pharma-Fertigung GmbH & Co. KG
ending 11/10/2017 at the location in Langenargen, Germany. Please send documents as email attachments.
for Foods & Cosmetics inspection of Be Powerful, LLC ending 09/07/2021 at the location in Fort Lauderdale FL, United
States. The EIR (in electronic format) for Foods & Cosmetics inspection of Be Powerful, LLC ending 09/07/2021 at the
location in Fort Lauderdale FL, United States. etc
for Foods & Cosmetics inspection of MYA International, Inc ending 09/10/2021 at the location in Chula Vista CA, United
States. The EIR (in electronic format) for Foods & Cosmetics inspection of MYA International, Inc ending 09/10/2021 at
the location in Chula Vista CA, United States. etc
CVs Geoffrey K Kilili, Kayler L Hudson, Patrice R Parker, Geneve M Parks, Khang K Pham, etc
2016-9770, 2016-9777, 2016-9802, 2016-9803, 2016-9810.
2016-9862, 2016-9906, 2016-9914, 2016-9922, 2016-9925.
2016-9943, 2016-9981, 2016-9982, 2016-9984, 2016-9985.
2021-2757, 2016-9621, 2016-9623, 2016-9659, 2016-9763.
Please provide us with the summary basis of approval (SBOA) for the following item: Potassium Iodide 1 gm/mL
(saturated solution), NDA# 018551. Thank you. Sincerely, Genevieve
IND filing - or any other filing which may include nonclinical safety and toxicology data - for a drug developed initially
by Eisai (E7010) and more recently by AbbVie (ABT-751).
Request to provide the Summary basis of approval (SBOA) of ANDA
Request to provide the Summary basis of approval (SBOA) of ANDA #208518
We would like to request the Complete Summary Basis of Approval (SBOA) including chemistry review and FDA Final
Reviews of the Original NDA, Furadantin Oral Suspension (NITROFURANTOIN suspension), N009175 approved Prior to
Jan 1, 1982. Dr. Reddy’s Laboratories intends to file an ANDA soon.
All documents produced under FOIA requests regarding Philips/Respironics CPAP devices and ventilators.
All documents produced under FOIA requests regarding Boston Scientific Emblem S-ICD devices.
As permitted by the Freedom of Information Act (FOIA), I am hereby requesting the following document: Form FDA
483: Baxalta US Inc Social Circle, GA End Dates of inspection: 01 July 2021 FDA District Office: Atlanta District District
Decision: VAI I confirm that Clarivate Analytics will be charged accordingly by FOI for this request, however please
contact me if the charges exceed $ 200.
483: Cardiomedix Incorporated Des Plaines, IL End Dates of inspection: 16 July 2021 FDA District Office: Chicago
District District Decision: VAI I confirm that Clarivate Analytics will be charged accordingly by FOI for this request,
however please contact me if the charges exceed $ 200.
483: Covance by Labcorp Durham, NC End Dates of inspection: 20 May 2021 FDA District Office: Atlanta District District
483: HRF, Inc Raleigh, NC End Dates of inspection: 27 July 2021 FDA District Office: Atlanta District District Decision:
VAI I confirm that Clarivate Analytics will be charged accordingly by FOI for this request, however please contact me if
the charges exceed $ 200.
1. Any/all traceback/traceforward information/documentation provided by the United States Department of Agriculture

– Food Safety and Inspection Service or the Minnesota Department of Agriculture to the FDA and/or in the possession
of the FDA concerning the 2019 E. coli outbreak associated with frozen pizza. etc
1. Any/all information/documentation pertaining to illness complaints relating the 2019 E. coli outbreak associated
with frozen pizza. 2.Any/all information/documentation pertaining to illness complaints relating to Heggie’s Pizza, LLC,
from January 1, 2016, to present. etc.
an inspection on June 28, 2021 of Access Dental Lab (ADL) in Antioch, Tennessee. ADL manufactures dental aligners, a
Class II medical device. Reuters requests the FDA-issued 483 form or notice of the agency's inspectional observations
pertaining to the above referenced inspection of ADL.
All email records for FDA CVM employee David Edwards containing the key search term: AAFCO
All email records for FDA CVM employee Eric Nelson containing the key search term: AAFCO
I'm requesting all calendar records for Tonia Bair (CVM)
I'm requesting all e-mail records for Tonia Bair (CVM) pertaining to the key words Hollis Glenn, Scott Ziehr, Ben Walther,
Mary Peck, Christi Lightcap, Laurel Hamling, Adrienne Bannister, Joshua Daniels, Rachel Jervis, Kate Greenberg, Jared
Polis
I'm requesting all e-mail records for Ying Johnston (CVM) pertaining to the key words Hollis Glenn, Scott Ziehr, Ben
Walther, Mary Peck, Christi Lightcap, Laurel Hamling, Adrienne Bannister, Joshua Daniels, Rachel Jervis, Kate Greenberg,
Jared Polis
I'm requesting all email records for Tonia Bair (CVM) containing key words; AAFCO, Answers Pet Food, Lystn LLC, Keith
Hill, Roxanne Stone, Jacqueline Hill, Derrick Hill, Scott Ziehr, Hollis Glenn, Sean Duke, Ben Walther, Mary Peck, Christi
Lightcap, Laurel Hamling, Adrienne Bannister, Joshua Daniels, Rachel Jervis, Kate Greenberg, Jared Polis, Charles
Kooyman
I'm requesting all email records for Tonia Bair (CVM) pertaining to key words; AAFCO, Answers Pet Food, Lystn LLC, Keith
Hill, Roxanne Stone, Jacqueline Hill, Derrick Hill, Scott Ziehr, Hollis Glenn, Sean Duke, Ben Walther, Mary Peck, Christi
Lightcap, Laurel Hamling, Adrienne Bannister, Joshua Daniels, Rachel Jervis, Kate Greenberg, Jared Polis, Charles
Kooyman
Annual FDA Orange Book files from 2017, 2018, 2019, and 2020
We seek information about the current pharmacovigilance related to the Covid-19 vaccines performed through the
“near real-time surveillance” method by the FDA on the Medicare healthcare claims database under the responsibility
of the FDA/CBER/OBE department
1. records regarding the application process for approval of JCAR017, lisocabtagene maraleucel (“Liso-cel”). Specifically,
we seek communications between the FDA and the applicant (Celgene and subsequently Bristol-Myers), regarding the
Biologics License Application for Liso-cel, from January 1, 2019 through June 30, 2021 etc
We request all information relating to any enforcement action conducted by FDA, or its Center for Tobacco Products,
(including inspections or investigations, warning letters, untitled letters, or other communications), and potential civil or
criminal referrals made to the U.S. Department of Justice, contemplated, underway, or taken against KT&G Corp. and its
U.S. subsidiary KT&G USA (KT&G) regarding any sales within the United States of tobacco products made without
adequate FDA authorization.
Transcripts of the meeting: Wireless Technology Research; Effects of Radiofrequency Energy on Micronucleus
Formation; Public Meeting held on August 1, 2000 and on August 2, 2000,
We request copies of the all internal and external correspondence regarding FOIA Request No. 2021-5892, including the
request itself, any acknowledgement letters, any correspondence with the requester regarding scope of the request, all
records released to the requester to date, and any other correspondence.
483: AMCO International Manufacturing & Design, Inc. Brooklyn, NY
483: Abbott Sylmar, CA End Dates of inspection: 02 August 2019
483: Absolutely Natural Melbourne, FL End Dates of inspection: 14 June 2019
483: Accord Media, LLC New York, NY End Dates of inspection: 13 May 2019
483: Accriva Diagnostics, Inc. San Diego, CA End Dates of inspection: 18 January 2019
483: Acme Monaco Corporation New Britain, CT End Dates of inspection: 17 April 2019
483: Adilia M. Hormigo, M.D. New York, NY End Dates of inspection: 08 January 2020
483: Aerolase Corp. Tarrytown, NY End Dates of inspection: 08 August 2019 FDA
483: Aetna Felt Corporation Allentown, PA End Dates of inspection: 13 May 2021
483: Agnitio Inc Appleton, WI End Dates of inspection: 04 June 2021 FDA District Office: Minneapolis District District
483: Airgas USA, LLC - Phoenix University Street Phoenix, AZ End Dates of inspection: 17 June 2021 FDA District Office:
Denver District District Decision: VAI I confirm that Clarivate Analytics will be charged accordingly by FOI for this
request, however please contact me if the charges exceed $ 200.
483: Alick's Home Medical Equipment, Inc. South Bend, IN End Dates of inspection: 03 September 2021 FDA District
Office: Denver District District Decision: VAI I confirm that Clarivate Analytics will be charged accordingly by FOI for this
483: Baxter Healthcare Corporation Medina, NY End Dates of inspection: 28 September 2021 FDA District Office: New
York District District Decision: VAI I confirm that Clarivate Analytics will be charged accordingly by FOI for this request,
483: Ampak Chemicals Incorporated Carson, CA End Dates of inspection: 09 April 2021 FDA District Office: Los Angeles
483: BioLife Plasma Services L.P. Arlington,TX End Dates of inspection: 08 June 2021 FDA District Office: Dallas District
District Decision: VAI I confirm that Clarivate Analytics will be charged accordingly by FOI for this request, however
please contact me if the charges exceed $ 200.
483: Biomat USA, Inc. Wichita Falls, TX End Dates of inspection: 07 July 2021 FDA District Office: Dallas District District
483: CSL Plasma Inc Cincinnati, OH End Dates of inspection: 11 August 2021 FDA District Office: Cincinnati District
Copy of the disclosable portions of all communications and correspondence from January 1, 2016 to present between
the FDA’s Center for Food Safety and Applied Nutrition and Qianjiang Yongan Pharmaceutical Co. Ltd. regarding the
amino acid taurine.
Copy of the disclosable portions of all establishment inspection reports, 483s, company responses, and any related
correspondence for all inspections of Qianjiang Yongan Pharmaceutical, located at No. 1 and No. 2 Guangze Avenue,
Zekou Economic Development Zone, Qianjiang City, China, from January 1, 2016 to present. Please note this request
pertains to foods.
Copy of the disclosable portions of documents submitted by Glanbia Nutritionals (NA), Inc. or Prinova US LLC to the FDA
from January 1, 2016 to present regarding Qianjiang Yongan Pharmaceutical Co. Ltd.’s compliance as a foreign supplier
under the Foreign Supplier Verification Program for Importers of Food and Humans and Animals, such as: (1) hazard
analysis records; (2) onsite audits; (3) sampling and testing of food components; (4) reviews of foreign supplier’s food
safety records.
Copy of the disclosable portions of all records from January 1, 2016 to present concerning the approval of Qianjiang
Yongan Pharmaceutical Co. Ltd. as an authorized food supplier in compliance with the Foreign Supplier Verification
Program for Importers of Food and Humans and Animals.
Request to provide the Summary basis of approval (SBOA) for Refence Standard - Bromocriptine mesylate tablets,
2.5mg, AND #077646 of Padagis US LLC
Request to provide the Summary basis of approval (SBOA) of ANDA #204735 and ANDA #077750
Request to provide the Summary basis of approval (SBOA) of ANDA 089743 and ANDA##089804
We are requesting a copy of all documents including but not limited to memos or minutes of meeting, telephone
discussions, submissions, and FDA correspondence related to brazzein sweetener or protein.
483: Charles River Laboratories Inc Spencerville, OH End Dates of inspection: 10 January 2020 FDA District Office:
Cincinnati District District Decision: VAI I confirm that Clarivate Analytics will be charged accordingly by FOI for this
483: Eric Jonasch, M.D. Houston, TX End Dates of inspection: 05 March 2021 FDA District Office: Dallas District District
483: Dentaline LLC Brooklyn, NY End Dates of inspection: 29 July 2021 FDA District Office: New York District District
Hi, I was looking for all 483s issued to the following facilities for the period April-October 2021 and was hoping you
could help? Thank you! Facility #1: Lonza, Slough, UK, 228 Bath Road, Berkshire SL1 4DX. Facility #2: Lonza Biologics Tuas
Pte Ltd, Lonza Bioscience Singapore Pte Ltd, 35 Tuas South Ave 6, Tuas 637377, Singapore.
FCN No. 1501 and all related documents submitted to FDA for FCN No. 1501.
Hi, I was looking for all 483s issued to this facility for the period April-October 2021 and was hoping you could help?
Thank you! BioMarin Pharmaceutical Inc. 46 Galli Drive Novato, CA 94949
I would like all records for the 10th production of 2019-1704.
attorney's letter/request and the FDA's reponse (the advisory opinion)
I am making this request on behalf of Prof. Erika Lietzan. She needs a copy of Position on the Concept of Solicited and
Unsolicited Requests (April 22, 1982) which was issued by what was then called the Division of Drug Advertising and
Labeling. Thank you.
CPG 7132c.02 (1976)
483: Conceptions Fertility Center Provo, UT End Dates of inspection: 13 July 2021 FDA District Office: Denver District
483: Corindus Inc Waltham, MA End Dates of inspection: 27 July 2021 FDA District Office: Minneapolis District District
483: DERMDOX CENTERS FOR DERMATOLOGY Sugarloaf, PA End Dates of inspection: 21 January 2021 FDA District
Office: Philadelphia District District Decision: VAI I confirm that Clarivate Analytics will be charged accordingly by FOI for
this request, however please contact me if the charges exceed $ 200.
483: Dental Technologies Inc. Des Plaines, IL End Dates of inspection: 20 January 2021 FDA District Office: Chicago
EIR copy of SGS India Private Limited, Health Science, Navi-Mumbai located at Plot No. A - 772/773, MIDC, TTC Industrial
Area, Koperkhairane, Navi-Mumbai - 400 701 India, FEI no.3003484180 and DUNS no. 650786127, was inspected by
USFDA in Nov 2017 (Inspection end date: 11/24/2017) and Inspection ID: 1041917
I would like to make a FOIA request on the Adma Biologics facility in Boca Raton, Florida. Could you please send
previous FOIA request number 2018-5161 to me and then send any 483, inspection reports, and any other
correspondence related the Adma Biologics in Boca Raton, FL. I would also like the latest EIR at the Adma facility in Boca
Raton, FL.
Usage of annual weight / volume of cosmetics packaging, medical product packaging, and medical product that uses
Polymethyl Methacrylate and Methyl Methacrylate Styrene Copolymer. Three pieces of information is needed,
description of cosmetics product (ie eye shadow), volume and weight of Polymethyl Methacrylate and Methyl
Methacrylate Styrene Copolymer used in year of 2020
We request the entire filings and submission history of Hetlioz (Tasimelteon), and any FDA response, review and/or
documentation of interaction with Vanda from its first application for an Orphan drug designation in 2010, until is
marketing approval by FDA in 2020.
QUESTIONS ABOUT COVID VACCINE
Seeking Anti-infective drug advisory committee meeting transcripts and video for fidaxomicin (NDA 201699) on April 5,
2011
I am seeking a copy of the current “Physician Substitute Program” approved by the Center for Biologics Evaluation and
Research (CBER) for the company CSL Behring.
All records relating to the 510(k) clearance of Philips recalled devices, especially including any recent amended
applications seeking to "remediate" (i.e. repair and replace) the recalled devices, as well as any analyses performed by
FDA or Philips and any information relating to FDA's decision to upgrade the recall from Class II to Class I (see also full
list in attached letter). Thank you very much.
1. All documents concerning a dietary supplement known as "BlackOxygen Organics." 2. All documents concerning a
company known as "11578243 Canada, Inc. d/b/a BlackOxygen Organics." 3. All documents concerning a company
known as "BlackOxygen Organics USA, Inc."
We are requesting the Center for Tobacco Products’ project report on “natural” as a modified risk claim, specifically in
regards to the brands Natural American Spirit and Nat Sherman
any reports associated muscle spasms, muscle cramping with the paragard IUD requesting specific details and location
of muscle spasms and cramps do not include pelvic cramping or abdominal cramping localized to IUD device
To Whom It May Concern: Pursuant to the Freedom of Information Act, I hereby request the following records: -
Copies of records related to Atieva's (d/b/a Lucid Motors) application for FDA approval of its light detection and ranging
(LIDAR) sensor etc
Recently, Gerald Markowitz, Ph.D. testified that either he or David Rosner, Ph.D. requested, by way of Freedom of
Information Act (“FOIA”) request, certain documents from the Food and Drug Administration (“FDA”) relating to talc and
the FDA’s regulation of talc. In this letter FOIA request, we are seeking certified copies of any all documents that the FDA
produced in response to Dr. Markowitz and/or Dr. Rosner’s FOIA request(s).
unredacted instructions to staff on decision making of the Marketing Denial Order (MDO) for Cloud House Vapor, LLC
STNs PM00003460
unredacted instructions to staff on decision making of the Marketing Denial Order (MDO) for Cloud 9 Vapor Products,
LLC STNs PM00003460_
Freedom of Information Act Request for Disclosure of unredacted instructions to staff on decision making of the
Marketing Denial Order (MDO) for Cloud Nine Vapor, LLC STNs PM00001574
Marketing Denial Order (MDO) for Cool Breeze Vapor, LLC STNs PM00003482
Marketing Denial Order (MDO) for Ecig Charleston, LLC STNs PM00002099
Marketing Denial Order (MDO) for Electric Clouds, Inc STNs PM00002099
Marketing Denial Order (MDO) for Jay Shore Eliquids, LLC STNs PM00002332
Marketing Denial Order (MDO) for Paradigm Distribution STNs PM00000968
Marketing Denial Order (MDO) for Prohibition Juice Company, LLC STNs PM00003773
Marketing Denial Order (MDO) for SWT Global Supply, Inc STNs PM00003792
483: DR. ARISTIDES MANIATIS Centennial, CO End Dates of inspection: 02 March 2021 FDA District Office: Denver
483: Dercher Enterprises, Inc., DBA Gordon Laboratories Upper Darby, PA End Dates of inspection: 04 May 2021 FDA
District Office: Philadelphia District District Decision: VAI I confirm that Clarivate Analytics will be charged accordingly by
FOI for this request, however please contact me if the charges exceed $ 200.
483: Diagnostic Automation/Cortez Diagnostics Inc Woodland Hills, CA End Dates of inspection: 15 July 2021 FDA
District Office: Los Angeles District District Decision: VAI I confirm that Clarivate Analytics will be charged accordingly by
483: Empire Medical Practice, PC d.b.a Kindbody New York, NY End Dates of inspection: 03 September 2021 FDA
District Office: New York District District Decision: VAI I confirm that Clarivate Analytics will be charged accordingly by
483: First Source, Inc. Rochester, NY End Dates of inspection: 20 July 2021 FDA District Office: New York District
483: Florida Cirtech Inc Greeley, CO End Dates of inspection: 08 June 2021 FDA District Office: Denver District District
483: Genesis Alkali LLC Green River, WY End Dates of inspection: 15 July 2021 FDA District Office: Denver District
483: Grand River Aseptic Manufacturing, Inc. Grand Rapids, MI End Dates of inspection: 02 July 2021 FDA District
Office: Detroit District District Decision: VAI I confirm that Clarivate Analytics will be charged accordingly by FOI for this
483: High Technology, Inc. North Attleboro, MA End Dates of inspection: 27 July 2021 FDA District Office: New England
483: Huron Tool & Cutter Grinding Co Farmingdale, NY End Dates of inspection: 09 July 2021 FDA District Office: New
York District District Decision: VAI I confirm that Clarivate Analytics will be charged accordingly by FOI for this request,
483: INDUCTION THERAPIES LLC Louisville, KY End Dates of inspection: 29 June 2021 FDA District Office: Cincinnati
District District Decision: OAI I confirm that Clarivate Analytics will be charged accordingly by FOI for this request,
483: Incyte Corporation Wilmington, DE End Dates of inspection: 16 April 2021 FDA District Office: Philadelphia District
483: Interstate Blood Bank Inc of Missouri Madison, WI End Dates of inspection: 02 August 2021 FDA District Office:
Minneapolis District District Decision: VAI I confirm that Clarivate Analytics will be charged accordingly by FOI for this
483: J.M Huber Micropowders, Inc La Mirada, CA End Dates of inspection: 25 June 2021 FDA District Office: Los
Angeles District District Decision: VAI I confirm that Clarivate Analytics will be charged accordingly by FOI for this
483: J.M. Murray Center, Inc. Cortland, NY End Dates of inspection: 30 April 2021 FDA District Office: New York District
483: Johnson & Johnson Consumer, Inc Lancaster, PA End Dates of inspection: 24 March 2021 FDA District Office:
Philadelphia District District Decision: VAI I confirm that Clarivate Analytics will be charged accordingly by FOI for this
483: Joseph L. Lillo, D.O. Phoenix, WY End Dates of inspection: 22 March 2021 FDA District Office: Denver District
483: Katecho Inc Des Moines, IA End Dates of inspection: 16 July 2021 FDA District Office: Kansas District District
483: Kedrion Biopharma Inc Melville, NY End Dates of inspection: 25 June 2021 FDA District Office: New York District
483: Koios Medical, Inc. New York, NY End Dates of inspection: 13 May 2021 FDA District Office: New York District
483: LabCorp Indiana Inc. South Bend, IN End Dates of inspection: 13 July 2021 FDA District Office: Detroit District
08.31.2021
All email records for FDA CVM employee Tracey Forfa containing the key search term: AAFCO 08.01.2021-08.31.2021
All records provided for 2018-7843 "I'm requesting FDA records for or relating to HPP being a kill step for pet food
and/or raw pet food"
Requesting records for: 1. All reports of adverse events and/or reactions dog and/or cats have had to dog and cat food
and dog and cat treats from 10.01.2021-10.31.2021. a. Please include the type of animal, the reaction, the brand name
and the product name of the food item to which the dog or cat reacted, the symptoms displayed and the outcome, if
available. etc
I'm requesting all calendar records for Tracey Forfa, FDA CVM
I'm requesting all e-mail records for Tracey Forfa CVM pertaining to the key words pertaining to these key words;
AAFCO, Answers Pet Food, Lystn LLC, Louisville Kentucky, zero tolerance policy, compliance policy ;
The appeals log or spreadsheet record showing appeals logged by FDA FOIA department in the month of September
2021
All e-mail records for FDA employee Darla Bracy containing the key terms; Small Batch, Michael Vogel [OHAF-West
Division 5] 05.18.2017, 05.19.2017, 05.20.2017
Date Range: 04/01/2018 - 07/17/2018; I'm requesting all e-mail records for Charles Becoat (ORA) containing key word
Kelly Larson
Date Range: 08/01/2019 - 08/15/2019; I'm requesting all e-mails from Sarah Kotler of FDA FOIA office exchanged with
Talisha.Williams@fda.hhs.gov, Ombuds@oc.fda.gov, Laurie.Lenkel@fda.hhs.gov;
I'm requesting all e-mail records for Elisa Beard ( /DHHS/FDA/ORA/ORA/OPOP/OP/DPIA/HAFB) containing key words:
Hollis Glenn, Scott Ziehr, Ben Walther, Mary Peck, Christi Lightcap, Laurel Hamling, Adrienne Bannister, Joshua Daniels,
Rachel Jervis, Kate Greenberg, Jared Polis 08.01.18-12.31.18
Hello, I am looking for communications between Zimmer Biomet and FDA in regards to (1) Form 483s, (2) Warning
letters, and (3) responses for its manufacturing facilities. Specifically, I'm looking for documents from its (1) 56 E Bell Dr,
Warsaw, Indiana site, (2) 345 E. Main Street, Warsaw, Indiana site, and (3) 1800 W Center St, Warsaw, Indiana site.
Thank you!
I am looking for any Form 483s, warning letters or inspection records related to pre-approval inspections, routine
inspections, compliance follow-up inspections, and “for cause” inspections leading to Official Action Indicated from the
above timeframe for Catalent's Madison, WI facility located at 726 Heartland Trail, Madison, WI 53717 and Catalent's
Bloomington, IN facility located at 3770 W. Jonathan Dr., Bloomington, IN 47404.
format) for Human Drugs inspection of BioMarin Pharmaceutical, Inc. ending 04/02/2021 at the location in Novato CA,
I'm requesting all email records for Isaac Carney ( /DHHS/FDA/CVM/CVM/OSC/DC) Isaac.Carney@fda.hhs.govcontaining
the key words; AAFCO, Answers Pet Food, Lystn LLC, Keith Hill, Roxanne Stone, Jacqueline Hill, Derrick Hill, Scott Ziehr,
Hollis Glenn, Sean Duke, Ben Walther, Mary Peck, Christi Lightcap, Laurel Hamling, Adrienne Bannister, Joshua Daniels,
Rachel Jervis, Kate Greenberg, Jared Polis, Charles Kooyman 08.01.2019-12.31.19
All communications with Jay Inslee or anyone acting on his behalf or in affiliation with the State of Washington
Government including but not limited to Eric Sonju, Kathryn Leathers, Dawn Cortez, David Merchant, Taylor Wonhoff,
Valerie Petrie, Jamila Thomas, Kelly Wicker, Keith Phillips, Drew Shirk, David Schumacher, Tara Lee, and Nick Streuli,
concerning approval of a COVID-19 vaccine.
Hello, I am seeking copies of any and all emails to and from anyone at the FDA and a now-former McKinsey official
named Betsy Bohlen from 2000 to 2011. I am a reporter making this request in the public interest.
format) for Human Drugs inspection of Woodstock Sterile Solutions Inc ending 05/28/2021 at the location in Woodstock
IL, United States. Please send documents as email attachments.
for Foods & Cosmetics inspection of Dynamic Nutraceuticals ending 09/03/2021 at the location in Statesville NC, United
States. The EIR (in electronic format) for Foods & Cosmetics inspection of Dynamic Nutraceuticals ending 09/03/2021 at
the location in Statesville NC, United States. etc
The Response (in electronic format) for Human Drugs inspection of Pyramid Laboratories, Inc. ending 02/03/2021 at
the location in Costa Mesa CA, United States. The Response (in electronic format) for Human Drugs inspection of Aspire
Independent Review Board LLC ending 06/13/2019 at the location in Santee CA, United States. etc
The Animal Legal Defense Fund submits this FOIA Request to the United States Food and Drug Administration regarding
records relating to FDA's social media accounts. Please see the attached request for more details.
Thompson Hine is submitting this FOIA request for the Technical Project Lead (TPL) Review and Review for Flavored
ENDS PMTAs for MH Global LLC dba Streamline Vape Co. LLC's PMTAs and subsequent denial of a marketing granted
order for products referenced in those applications.
Establishment Inspection Report for Federal Package Network, Inc., FEI No. 3003152994, 8100 Powers Blvd.,
Chanhassen, MN 55317. Inspection performed on Feb. 13-17, 2017. Inspection report dated 05/08/2017. We would like
to see the redacted copy that would be available to the public.
demyelinating polyradiculoneuropathy, demyelinating polyneuropathy, Guillain-Barre syndrome, etc
This may be a lofty thing to ask for, but I'd like to know the predicate 510(k) numbers for every 510(k) submitted since
1/1/2000. I figured the FDA has this information in an internal database of some sort.
Frequency of use data (FOU) for Methyl Methacrylate (PMMA) as collected by the FDA’s Voluntary Cosmetic
Registration Program (VCRP). I want the annual snapshots of the VCRP FOU database
US FDA CFSAN on TOXPLANET
VAERS Report
Attn: CDER. Copy of the disclosable portions of a list of all Remote Interactive Evaluations (RIEs) from 01/01/2020 to the
present. Please include the following information: firm & firm address; inspection begin and end date; investigator
name; whether a 483 was issued; and the outcome classification.
We are interested in statistical and clinical reviews associated with the SBA for the supplemental approval of
abemaciclib (Verzenio) associated with the supplemental new drug application dated 17 December 2020 and approved
on 12 October 2021. NDA 208716/S-006, S-007, S-008.
review documents for Xywav NDA 212690 Supplement-6
I would like all records for the 13th production of 2019-1704
Any and all records/transcripts of communication between Myokardia, Inc/Bristol Myers Squibb and the Food and Drug
Administration (FDA) regarding the New Drug Application for mavacamten.
I am seeking the detailed findings regarding the report on the information below: Art Naturals Scent Free Hand Sanitizer
drug product batch # G20128A contained: Acetal 459 ppm, Acetaldehyde 146 ppm, Benzene 15.4 ppm.
I would like all possible records/details for who did this testing, where the testing was done, and what method of
testing was used to determine these results. Thank you.
I would like to request a copy of the Establishment Inspection Report of the Hugel facility (FEI 3012163998) inspected
between 12AUG2021 through 20AUG2021.
I would like to request the completed Establishment Inspection Report for the Revance (FEI 3007772056) inspection
which occurred between 21JUN2021 through 02JUL2021.
NDA 202107
United Therapeutics recently announced on 10/18/21 that the FDA issued a Complete Response Letter declining to
approve the New Drug Application for Tyvaso DPI.
NDA 022150, Orginal Approval Review
all records for the 13th production of 2019-1704
Marketing Granted Orders
for Medical Devices & Rad Health inspection of Medtronic Heart Valves Division ending 10/26/2020 at the location in
Santa Ana CA, United States. Please send documents as email attachments.
format) for Human Drugs inspection of Caribe Holdings (Cayman) Co. Ltd dba PuraCap Caribe ending 07/02/2021 at the
location in Dorado PR, United States. Please send documents as email attachments.
for Medical Devices & Rad Health inspection of Abaxis Inc ending 08/22/2019 at the location in Union City CA, United
States. The Response (in electronic format) for Medical Devices & Rad Health inspection of Abaxis Inc ending
08/22/2019 at the location in Union City CA, United States.
for Foods & Cosmetics inspection of American Herbal Laboratories, Inc ending 09/10/2021 at the location in Rosemead
CA, United States. The EIR (in electronic format) for Foods & Cosmetics inspection of American Herbal Laboratories, Inc
ending 09/10/2021 at the location in Rosemead CA, United States. The Response (in electronic format) for Foods &
Cosmetics inspection of American Herbal Laboratories, Inc ending 09/10/2021 at the location in Rosemead CA, United
for Foods & Cosmetics inspection of CerBurg Products Ltd. ending 09/17/2021 at the location in South Daytona FL,
United States. The EIR (in electronic format) for Foods & Cosmetics inspection of CerBurg Products Ltd. ending
09/17/2021 at the location in South Daytona FL, United States. etc
Revance’s response to Form 483 for DAXI issued on July 2, 2021; • Complete Response Letters for DAXI issued on
October 15, 2021; and • Established Inspection Reports for DAXI.
• Please provide the number of Complete Response Letter (“CRL”) extension requests that have been submitted to
CBER pursuant to 21 CFR § 601.3(c) in the last 10 years. Please provide how many of these extension requests were
granted and denied. • Please provide the number of CRL extension requests submitted to CBER for gene therapy
products pursuant to 21 CFR § 601.3(c) in the last 5 years. etc
WARNING LETTERS
I am making this request on behalf of Prof. Erika Lietzan. We need to have a copy of CPG 7132c.02 (1976) from the
agency. The CPG is the agency's Compliance Policy Guide. I'm asking for section 7132c.02 of the Compliance Policy
Guide as it appeared in 1976. Thank you.
I am requesting the investigator-initiated IND applications for the NIHM grant-funded double-blind controlled studies
conducted at either Spring Grover State Hospital (Baltimore), or Maryland Psychiatric Research Centre, using Sandoz
Pharmaceutical Co's LSD (Lysergic Acid Diethylamide) distributed by the FDA-NIMH, dated between 01/01/1963 and
01/01/1971, ETC
(1) I am requesting the attorney’s letter/request and FDA’s response (the advisory opinion) mentioned on this page
(note: this is a request for an advisory opinion, which was probably treated by FDA as akin to a citizen petition): “On
June 3, 1986, an attorney wrote to the Food and Drug Administration ("FDA") on behalf of the publisher of a monthly
publication distributed to physicians that contains entries describing prescribing information for certain drug products.
The attorney requested an advisory opinion on whether FDA would deem the product entries labeling under section
201(m) or advertising under section 502(n) of the Federal Food, Drug, and Cosmetic Act ("the Act") for those products
that were the subject of a paid advertisement in the same publication. In response to this request, “
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/cpg-sec-400700-drug-product-entries-
periodic-publications (2) a copy of : Position on the Concept of Solicited and Unsolicited Requests (April 22, 1982)
which was issued by what was then called the Division of Drug Advertising and Labeling. Note: This was a bulletin
circulated to the public by the predecessor to OPDP/DDMAC. (3) a copy of CPG 7132c.02 (1976) from the agency.CPG
is the agency’s Compliance Policy Guide. (this is section 7132c.02 of the Compliance Policy Guide as it appeared in
1976.) Thank you.
RE: Bravo Packing, Inc., Carneys Point, NJ. Please supply all records pursuant to March 3, 2021 recall of Bravo Packing
pet foods, including: FDA form 483, Establishment Inspection Report (if available), any recall-related or inspection-
related correspondence, including but not limited to: Warning Letter (if issued), Untitle Letter (if issued), Close-out letter
(if issued) and the company's reply to any of these letters. Also, please supply any correspondence between FDA and
the organization known as Animal Outlook pursuant to Bravo Packing.
The following request is being made in accordance with the Freedom of Information Act (5 U.S.C. § 552). I am
requesting copies of the following records: Congressional Correspondence Logs: I am requesting copies of the
Congressional Correspondence logs maintained for the U.S. Senator Marco Antonio Rubio by the Office of Legislation
from October 21, 2019, to October 21, 2021.
We were given the following by the FDA to provide you in our request. The lot number is K4CG8P and we are
requesting confirming documentation for that lot number The following was provided by the FDA to assist you in our
request. Res 6533, Recall Number Z-1530-2013. Https://www.access data.Fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?
id=118570 Documentation stating which lot of product was delivered to Silver Lake Hospital Los Angeles California.
1) Job openings at the FDA in 2021, 2020, 2019, 2018 2) Number of employees at the FDA (across offices/divisions)
in 2021, 2020, 2019, 2018 3) Number of employees at the FDA in the office of neuroscience in 2021, 2020, 2019, 2018
4) Number of employees at the FDA in the division of neurology (1 and 2) in 2021, 2020, 2019, 2018 ETC
Any and all documents prepared by FDA in conjunction with FDA Docket 2021-N-0555. In addition, any and all
memoranda or analyses FDA prepared in conjunction with the proposed rule, such as, but not limited to, any
documents assessing the technical requirements for hearing aids, preemption, and the labeling of hearing aids.
Attn CBER: Copy of the disclosable portions of all FDA statements, policies, guides, and internal correspondence related
to extension requests pursuant to 21CFR601.3(c), from 01/01/2017 - Present. Please note that we are not looking for
documents related to specific products; rather, we are looking for general policy-related materials
Report and/or the MDSAP Noncomformity Grading and Exchange Form (NC) for the inspection of Medtronic Sofamor
Danek USA Inc, Memphis, TN , end date 05-03-2017. FEI# 1000477302. This inspection pertains to medical devices.
Report and/or the MDSAP Noncomformity Grading and Exchange Form (NC) for the inspection of Siemans Medial
Solutions USA, Inc, Plymouth Meeting, PA , end date 04-13-2017. FEI# 3002626007. This inspection pertains to medical
devices.
Report and/or the MDSAP Noncomformity Grading and Exchange Form (NC) for the inspection of Siemens Medical
Solutions USA Inc, Buffalo Grove, IL , end date 04-11-2017. FEI# 3006814109. This inspection pertains to medical
devices.
Solutions USA, Inc., Mountain View, CA , end date 04-06-2017. FEI# 2936884. This inspection pertains to medical
devices.
Dr Reddys FTO 7 and FTO 9 Units located at Duvvada Issued 8 observations
For certain applications JMC submitted to CTP, provide the randomly generated numbers assigned to our applications or
a listing that provides the order.
For certain applications PMUSA submitted to CTP, provide the randomly generated numbers assigned to our
applications or a listing that provides the order.
Please consider this a request for a copy of the 10/5/21 tentative approval letter for ANDA No. 213512 for Brexpiprazole
(generic drug ETC
FDA (not Pfizer supplied) Scientific testing results (laboratory and trials) for the safety and efficacy of the
Pfizer/BioNTech BNT162B2 mRNA Covid-19 vaccine as well as the same for the Pfizer Comirnaty mRNA Covid-19 vaccine
as they relate to the full approval by the FDA of each of these vaccines.
Any and all information related to OCUGEN and its drug candidate COVAXIN to treat covid 19, including but not limited
to meeting minutes, discussions, site inspections, regulatory pathway, etc.
Item 8, Volume 24, pages 1-6 from NDA 21-434 (alprazolam extended release (Xanax XR)). (Purpose: Obtain summary
statistical data on Study M/2002/0032. The medical and statistical reviews did not report these data, but the medical
review did reference the above-mentioned pages of the NDA.)
Importer of Record (IOR), or Consignee; for entry-lines with submission or arrival dates between October 1 and October
31, 2021: 1) DUNS Number / Unique Facility Identifier (UFI) of 080801169 2) Federal Tax ID Number (EIN) of
822349285 3) FDA Establishment Identifier (FEI) of 3014302990 ETC
I am looking for all correspondence between FDA and (1) Grand River Aseptic Manufactruring, Inc. and (2) Telix
Pharmaceuticals relating to its recent 483 observations and its EIR. I am not seeking the 483 report and the EIR, but am
seeking (1) any responses to the observations, (2) any meeting minutes between FDA and the companies regarding the
observations, and (3) any other documents regarding the plan to fix the observations.
Please provide copies of the disclosable portions of the Center for Tobacco Products (CTP), Office of Science, reviewer's
summaries and any associated supporting CTP memoranda for the following STNs EX0001062-EX0001065, EX0001067,
EX0001069-EX0001074, and EX0001258.
summaries and any associated supporting CTP memoranda for the following STNs EX0001327-PD1, EX0001327-PD3,
EX0001327-PDS, EX0001327-PD7, EX0001327-PD9, EX0001327-PD11, EX0001327-PD13, and EX0001327-PD15.
for Biologics inspection of Advarra IRB ending 05/27/2021 at the location in Columbia MD, United States. Please send
Please provide the following 1 inspection-related documents in electronic PDF format: The EIR (in electronic format) for
Foods & Cosmetics inspection of Barcel SA de CV, Carretera Mexico - Toluca Km. 54, Lerma Pueblo Infonavit Lerma,
Mexico 52000 Mexico. FEI 2000042497 ending 08/14/2018
for Biologics inspection of Catalent Belgium SA ending 06/19/2019 at the location in Brussels, Belgium. The Response
(in electronic format) for Biologics inspection of Catalent Belgium SA ending 06/19/2019 at the location in Brussels,
Belgium. Please send documents as email attachments.
for Biologics inspection of Merck Sharp & Dohme Corp. ending 07/27/2021 at the location in West Point PA, United
States. The Response (in electronic format) for Biologics inspection of Merck Sharp & Dohme Corp. ending 07/27/2021
at the location in West Point PA, United States. Please send documents as email attachments.
for Human Drugs inspection of New England IRB ending 07/14/2016 at the location in Needham MA, United States. The
483 (in electronic format) for Human Drugs inspection of Braintree, A part of SEBELA Pharmaceuticals ending
12/13/2013 at the location in Holbrook MA, United States. Please send documents as email attachments.
for Foods & Cosmetics inspection of Vacunda & Design ending 09/08/2021 at the location in Camuy PR, United States.
The EIR (in electronic format) for Foods & Cosmetics inspection of Vacunda & Design ending 09/08/2021 at the location
in Camuy PR, United States. The Response (in electronic format) for Foods & Cosmetics inspection of Vacunda & Design
ending 09/08/2021 at the location in Camuy PR, United States. Please send documents as email attachments.
for Human Drugs inspection of Macco Organiques Inc. ending 02/28/2020 at the location in Salaberry-De-Valleyfield,
Canada. The EIR (in electronic format) for Human Drugs inspection of Industria Farmaceutica Galenica Senese Srl ending
11/16/2018 at the location in Monteroni D'Arbia, Italy. The Response (in electronic format) for Human Drugs inspection
of Industria Farmaceutica Galenica Senese Srl ending 11/16/2018 at the location in Monteroni D'Arbia, Italy. Please
We are requesting fully unredacted copies of FDA’s chemistry and toxicology review memoranda for Food Contact
Notification (FCN) 2116.
Form 483 inspection record issued to Dr. Reddy's Laboratories Limited formulations manufacturing facilities (FTO 7 &
FTO 9) at Duwada, Visakhapatnam, Andhra Pradesh, India.
2020-7424, 2020-7425, 2020-7426, 2021-2044, 2021-2051, 2021-2175, 2021-2414, 2021-2953, 2021-2974, 2021-
11888, 2020-6774, 2020-6128, 2020-5807, 2020-5806, 2020-5780, 2020-5762, 2020-5240, 2019-409, 2018-3667, 2018-
3737, 2018-3739
I request all documents and information provided for FOIA requests 2021-3482, 2021-2254, 2018-5115 and 2018-651.
I request all documents and information provided for FOIA requests #2021-5160, #2021-5161, #2021-5431, #2021-6456
and #2021-5913.
2020-376, 2020-1875, 2020-1874, 2019-10637, 2020-3714, 2020-1881, 2019-931, 2018-9266, 2018-8936, 2018-7417,
2018-836, 2018-7744, 2018-6130, 2018-9169.
since Thursday, September 30, 2021. If the zipped files do not exceed 25 Megabytes, please send to
support@fdazilla.com, otherwise please send these on CD or DVD media to: Govzilla Inc., 9800 Dunmore Circle
Johnston, IA, 50131
2016-10170, 2016-10235, 2016-10244, 2016-10264, 2016-10357.
2016-10359, 2016-8202, 2016-9476, 2016-9478, 2016-9498.
2016-9501, 2016-9505, 2016-9519, 2016-9592, 2016-9593.
2016-9595, 2016-9597, 2016-9986, 2016-9989, 2016-9992.
Copy of the disclosable portions of Food Contact Notification 1461, including all internal FDA chemistry and toxicology
review memoranda. FCN 1461 was submitted by DSM Resins BV and relates to tricyclodecanedimethanol.
All EIRs and/or audit reports for The Blendhouse LLC, aka ByHeart, located in Reading, PA, from 09/01/2019 - Present.
The scope of this request is infant food products.
Copy of the disclosable portions of all FDA Chemistry and Toxicology review memoranda for the following 3 Food
Contact Notifications: FCN 2024 (acetic acid ethenyl ester, polymer with ethene & ethenol); FCN 1763 (EVOH
copolymers); and FCN 1198 (EVOH copolymers).
Copy of the disclosable portions of the complete FDA response for File Numbers 2020-3977, 2018-6554, 2018-7052,
2020-4353, 2020-3977.
Fie Numbers 2017-3456, 2017-5816, 2020-7059, 2018-4364, 2019-10816
Jiangsu Sihuan Bioengineering Pharmaceutical Co., Ltd. Wuxi, China End Dates of inspection: 21 May 2021 Project Area:
Drug Quality Assurance District Decision: VAI I confirm that Clarivate Analytics will be charged accordingly by FOI for this
Jubilant Generics Limited Sikanderpur Bhainswal, India End Dates of inspection: 12 March 2021 Project Area: Drug
Quality Assurance District Decision: OAI I confirm that Clarivate Analytics will be charged accordingly by FOI for this
Porton Biopharma Limited Salisbury, United Kingdom End Dates of inspection: 21 May 2021 Project Area: Drug Quality
Assurance District Decision: OAI I confirm that Clarivate Analytics will be charged accordingly by FOI for this request,
Human adverse event drug MedWatch reports for the following Case IDs: 12802076, 12935445, 13054506, 13156675,
13182227, 13308410, 13441018, 13496347, 13500013, 13657530, 13695080, 13719814
We are requesting the FDA Review documents for the Supplemental New Drug Application (NDA 202570/S-016) for
Xalkori as a new indication for the treatment of patients with non-small cell lung cancer whose tumors are ROS-1
positive.
We are seeking Biomarin's pre-NDA meeting communications for its Vosoritide NDA submission (~Feb-Aug 2020)
Additionally, we would like to see manufacturing inspection communications for its preapproval inspection at 35
Leveroni Ct, Novato, California. Lastly, we would also like to see FDA filing acceptance language at the time of its NDA
acceptance for Vosoritide (~November 2020)
HHSF223201700008B
Pursuant to 21 CFR § 20.3, we are writing to request the production of unredacted copies of certain exhibits
referenced in those two Establishment Inspection Reports.
I am requesting dietary supplement cGMP (21 C.F.R. 111) records for the last fiscal year ending Sept. 30, 2021, including
the following: (1) Number of dietary supplement firms inspected; (2) Average and median number of 'observations' per
inspection; (3) List of firms inspected, including specific observations; etc
(1) Total number of NDINs submitted in FY21; (2) Range of NDIN numbers (e.g NDINs 1058-1100) so I can review
specific notifications/responses; (3) Total number of NDINs responded to by FDA in FY21; (4) Total number of AKL
(acknowledgement) letters; etc
Of the reinspected firms based on previous OAI designation, I am requesting the following FY21 inspectional data as
well: (1) Number of firms that received Form 483; (2) Number of firms that did not receive a Form 483; (3) Average
and median number of observations per reinspected firm; (4) List of firms reinspected, including specific observations;
etc
All "comments" submitted in response to Citizen's Petition: "Requests that the FDA halt the current clinical studies of
Simufilam PTI-125 sponsored by Cassava Sciences NCT04388254 and NCT04994483, etc
All communications and documents which relate to the labeling change for Forteo (NDA 021318), as approved on or
around November 16, 2020, including but not limited to S-054 and any other relevant submissions; etc
All emails sent or received by Phil Krause, Marion Gruber, or Peter Marks between October 1, 2019 and the date of
search that include the word “deuterium” and either the word “Pfizer” or the word “Comirnaty.”
Need Form 483 with 8 observations issued to Dr. Reddy's Laboratories by USFDA for inspection of their formulations
manufacturing facilities (FTO 7 & FTO9) at Duwada, Visakhapatnam during October 2021. Please help with the same.
Thanks.
On October 20, 2021 news media reported Quality issues related to Novavax's manufacturing process. They reported
that the purity levels did not meet FDA standards. Please provide any correspondence, documents, reports, complaints
and or action taken by the FDA regarding this issue. Also please provide any correspondence between the FDA and
Novavax's contract manufacturer regarding the same issue.
OneBlood is missing Establishment Inspection Reports
I would like to get a copy of the FDA 483 issued for Viper Technologies (D.B.A. Avalign Thortex). The inspection occurred
in 2021 and the address of the manufacturer is Viper Technologies (D.B.A. Avalign Thortex) 15045 NE MASON ST.
PORTLAND, OR 97230 Registration Number: 3026776 FEI Number*: 1000135253 Thank you
Form 483 issued to Dr Reddy's Laboratories' Duvvada Manufacturing facility (FTO7). this facility has been issued a form
483 with 8 observations. This facility is located in Visakhapatnam, Andhra Pradesh, India - 530049
names and titles for individuals previously working at the Office of Cardiology, Hematology, Endocrinology and
Nephrology (OCHEN) and/or the Division of Cardiology and Nephrology (DCN) within the Office of New Drugs who have
left the office from January 2017 to present.
1) Listing of all INSPECTIONS since Sunday, November 1, 2020 (in CSV format) with the following fields: FEI
Number, Inspection Start Date, Inspection End Date, Legal Name, Address, City Name, State Code, Zip Code, Country
Name, FDA483, Full Name, District, Center, INSPECTION REASON 2) Listing of releasable inspection CITATIONS (from
FDA's FACTS database) for each company since Sunday, November 1, 2020 in CSV format with the following columns:
INSPECTION_ID, YEAR, INSPECTION_START_DATE, INSPECTION_END_DATE, FEI_NUMBER, FIRM_Name, REF_NO,
SHORT_DESC, Inspection Classification, Inspection Project Area. Please send CSV file to support@fdazilla.com
All COVID19 vaccine associated deaths reported in VAERS (specific VAERS ID's) that also completed an autopsy for cause
of death and a copy of the [anonymized] autopsy report, if available. In other words the specific VAERS ID's and
corresponding autopsy report.
All records from the Office of Criminal Investigations (including but not limited to investigative files, emails, unnamed
reports, and memos), from January 1, 2019 to the date this request is completed and closed, about counterfeit HIV
medications (including but not limited to Descovy, Symtuza, and Biktarvy) in the U.S.
For certain applications and filings that USSTC has submitted to CTP, provide the randomly generated numbers assigned
to our applications or a listing that provides the order.
Hi, Request you to share Form483 issued to Dr Reddy's manufacturing plants (FTO 7 and FTO 9) at Duvvada,
Viskhapatnam (India) issued after the FDA inspection in October 2021. Thank you
I am seeking a brief report of the FDA inspection performed on September 15, 2021 at the Riverence Provisions LLC
Processing Facility for our records. The FDA Inspection ID # is 1152574.
We write now to request a Certification for the records produced on March 31, 2021 in response to FOIA Request No.
2021-665.
Please email Form 483 issued to Dr Reddy's FTO 7 and FTO 9 situated at Duvvada India. The inspection was completed
on October 28, 2021 and 8 observations were issued.
Request for the Establishment Investigation Report evidence associated with a "For-cause Inspection around
Tuberculosis Associated with a Contaminated Bone Allograft Material Used in Surgical Procedure." Inspected Facility:
NM Donor Services 1609 University Blvd. NE, Albuquerque, NM 87102
Request for the Establishment Investigation Report evidence associated with a For-cause inspection around
Tuberculosis Associated with a Contaminated Bone Allograft Material Used in Surgical Procedure. Inspected Facility:
Aziyo 880 Harbour Way South Suite 100 Richmond, CA 94804
While individual drug's RLD is available at the drugs@fda page, can, we request the ENTIRE drug list of the Orange Book
identified with the RLD. In other words, may I request the list of ALL the ANDA approvals (and tentative approvals)
identified with their RLD? Kindly let me know from where it is available. We are ready to pay the relevant charges
towards that data. regards, Nimish Mehta
I am looking for updated adverse case reports for Phenibut which is also known as: fenibut phenigam PhGaba
Phenigamma Phenygam 4-Amino-3-phenylbutanoic acid ß-(aminomethyl)benzenepropanoic acid beta-
(Aminomethyl)hydrocinnamic acid ß-phenyl-¿-aminobutyric acid
1. All adverse event reports—from January 1, 2017 to the present-- pertaining to M. chimaera infections caused by,
arising out of, or related to LivaNova/Sorin Heater Stockert 3T Cooler machine used in hospitals in Kansas and/or
Minnesota. etc
All COVID19 vaccine (Pfizer, Moderna, J&J) associated deaths reported in VAERS (specific VAERS ID's) that also
completed an autopsy for cause of death, and a copy of the corresponding (anonymized) autopsy report, if available.
All correspondence between the FDA and Restore Hyper Wellness + Cryotherapy, Restore Hyper Wellness, or similar
spelling, including all notices of violation or warning letters.
PMA submission documents of the following PMA number: P160050 Device Name: BARRICAID ANULAR CLOSURE
DEVICE (ACD) Applicant: INTRINSIC THERAPEUTICS *The request is for the original submission only. Supplements are not
the scope of this request.
Please provide the exact first date Zantac (drugs listed below) became available for purchase over-the-counter in stores:
NDA 20520; and NDA 20745
Requested are copies of data used by the FDA for determining to give GRAS (generally recognized as safe) status to free
glutamic acid used in food. Requested also are copies of data used by the FDA for determining to give GRAS (generally
recognized as safe) status to monosodium glutamate (MSG) and other ingredients that contain free glutamic acid. ETC
Congressional Correspondence Logs: I am requesting copies of the Congressional Correspondence logs maintained for
U.S. Senator Ronald Harold Johnson by the Office of Legislation from October 21, 2019, to October 21, 2021.
K062222, K190208, K151086, K091070, K031169, K952542, K191784, K060944, K030784, K142971.
Summary Basis of Approval (SBOA) of Xylocaine (Lidocaine Hydrochloride) jelly 2% (NDA N008816) held by Akorn
Operating CO LLC
for Animal Drugs & Feeds inspection of PBM Nutritionals, LLC ending 09/26/2013 at the location in Milton VT, United
510(k) complete file - K033960 Olinda EXM
510(k) complete file - K163687 OLINDA/EXM v2.0
Copies of all records relating to any submissions regarding foods comprised of or containing cultured cells of amenable
species that have been formally accepted for review by the Office of Food Additive Safety of the Center for Food Safety
and Applied Nutrition (OFAS), as acknowledged in correspondence issued by OFAS to the submitter.
K192667
for Human Drugs inspection of PURDUE Pharmaceuticals Lp ending 08/24/2017 at the location in Wilson NC, United
A list of FDA inspections during September 1 through October 31, 2021 and whether a FDA-483 was generated. Please
see attached request.
Pursuant to the Freedom of Information Act, 5 U.S.C. § 552, and the implementing regulations under 21 C.F.R. Part 20, I
hereby request a copy of the original request letter and all responsive information for files: 2020-7212, 2020-7225, and
2020-7226
I would like to request the correspondences between the FDA and the notifier of GRN 963 (Fungal oil (=40% arachidonic
acid) from Mortierella alpina).
format) for Human Drugs inspection of PPD Development LP ending 11/18/2019 at the location in Richmond VA, United
for Medical Devices & Rad Health inspection of Western Institutional Review Board Inc ending 08/24/2018 at the
location in Puyallup WA, United States. etc
Request is for the full redacted 510(k) K190793 - Tablo Hemodialysis System, Tablo Cartridge
for Human Drugs inspection of ULTRAtab Laboratories, Inc. ending 09/14/2021 at the location in Highland NY, United
States. The Response (in electronic format) for Human Drugs inspection of ULTRAtab Laboratories, Inc. ending
09/14/2021 at the location in Highland NY, United States. etc
Request is for the full redacted 510(k) K181991 - NxStage Connected Health System
I kindly ask you to provide the complete data for all product recalls with a Center Classification date between 15 July
2010 and 14 August 2012.
Any emails between to and from FDA Center for Biologics Evaluation and Research Office of Vaccines Research and
Review Board members pertaining to decision to approve Pfizer and moderna Coronavirus vaccine boosters or approval
of pfizer vaccine for children. ETC
Specifically, I am requesting correspondence, meeting minutes, or notes created in the process of developing the
document “Guidance for Industry: Codevelopment of Two or More New Investigational Drugs for Use in Combination”
published June 2013 by the CDER.
correspondence, meeting minutes, or notes created in the process of developing the document “Guidance for
Industry: Fixed Dose Combinations, Co-Packaged Drug Products, and Single-Entity Versions of Previously Approved
Antiretrovirals for the Treatment of HIV” published October 2006 by the CDER. My research leads me to believe that
this paper was written between May 2004 and October 2006.
document “Guidance for Industry: New Chemical Entity Exclusivity Determinations for Certain Fixed-Combination Drug
Products” published October 2014 (Procedural) by the CDER.
document “Guidance for Use of Antiretroviral Agents in Adults and Adolescents Living with HIV” published December
2019 by the CDER.
The appeals log or spreadsheet record showing appeals logged by FDA FOIA department in the month of October 2021
All documents related to dose determination for the Moderna COVID-19 vaccine, including documents reflecting the
process(es) used to determine dose and the data used to support the process(es). These documents may include, but
should not be limited to, communications, meeting recordings, transcripts, or minutes wherein dose determination was
discussed and/or decided.
All documents related to dose determination for the Pfizer COVID-19 vaccine, including documents reflecting the
process(es) used to determine dose and the data used to support the process(es). These documents may include, but
should not be limited to, communications, meeting recordings, transcripts, or minutes wherein dose determination was
discussed and/or decided.
FDA-CDER-19-MP-10418359
Enforcement Reports
All versions of internal Center for Tobacco Products memoranda or other internal guidance documents relating to
review of PMTAs for electronic nicotine delivery systems (ENDS) containing non-tobacco flavored e-liquid, including
those related to evidence to demonstrate benefit of flavored ENDS to adult smokers and other related scientific issues.
Copy of the FDA response only to the following file numbers: 2021-6599, 2021-6658 2021-6659
Greetings. I will like to receive the records for all international shipments in which Relish Labs dba Home Chef has been
identified as the "FSVP Importer" (by adding my DUNS numbers at the point of entry) from 8/1/21 - 10/31/21.
FDA Foreign Supplier Verification list
Pursuant to the Freedom of Information Act, 5 U.S.C. § 552, and the implementing regulations under 21 C.F.R. Part 20, I
hereby request a copy of the original request letter and all responsive information for files:2020-8263, 2021-853, and
2021-2561
Request is for the full redacted 510(k) K200741 - Tablo Hemodialysis System
We are requesting the feedback to control numbers 2021-5547; 2020-4210; 2019-5897.
November 2, 2021 or the most recently available date
We request all FDA copies of all the Disclosable/releasable portions compliance documents, all officers
communications, opinions, findings and any and all other documents and photographs regarding determining whether
color additives of PRODUCTOS RICOLINO SAPI DE CV PLANTA TOLUCA Mexico. FEI 3017561643. are used as ingredients
in accordance with legal restrictions or tolerances in food that are consumed etc
Establishment Inspection Report (EIR) related to the inspection conducted at our site (Joseph M. Still Research
Foundation, Inc.) and Robert F. Mullins, MD / Principal Investigator.
I would like to request record #BNF000152 We consulted with Nazmul Bhuiyan (FDA) and suggested we review this
document to assist in our further consultations. Thanks!
All documents related to recommendations by Operation Warp Speed or its personnel regarding dose determination for
the Moderna COVID-19 vaccine, including documents reflecting the process(es) used to determine dose and the data
used to support the process(es). These documents may include, but should not be limited to, communications, meeting
recordings, transcripts, or minutes wherein dose determination was discussed and/or decided.
All safety tests of COVID-19 Vaccines for individuals with acromegaly.
FDA communication to DOJ that there are no risks to the public based upon the practice of Siemens Healthineers of
shipping product which are not properly protected from environmental (temperature, humidity, etc). Provide me with
communication to/from SDNY of FDA's decision that their is/was no risk for Troponin devices in both Point of Care and
in Laboratory settings. etc
PMA BP910001: OraSure Technologies is requesting the entire original PMA application for OraSure HIV-1 Oral
Specimen Collection Device.
NDA 021624
We request all disclosable/releasable portions of the Establishment Inspection Report (EIR) of Herdez S.A. de C.V Planta
Mexico -McCormick de Mexico. FEI Number 3011171597 ended 04/24/2019 with an Inspection ID: 1087348.
Additionally, all records disclosable portions of the records of Field Accomplishment and Compliance Tracking System
(FACTS) and eNSpect.
We request all disclosable/releasable portions of the Establishment Inspection Report (EIR) of JUMEX MEXICALI FEI
NUMBER 3004295602 with Inspection End Date: 04/04/2019 Inspection ID: 1097267. Additionally, all records
disclosable portions of the records of Field Accomplishment and Compliance Tracking System (FACTS) and eNSpect.
RECS RE PREGNANCY ETC WOODCOCK, GRUBER, KRAUSE ETC
Request of full 510K records/file of the following two medical devices (respective 510K numbers are referred): -
Trade/Device Name: Perimeter OTIS™ 1.0 Optical Coherence Tomography System (K160240); - Trade/Device Name:
Cellvizio® I.V.E. system with Confocal Miniprobes™ (K193416).
US FDA form 483 for Dr Reddy duvvada facility
I request records from the FDA to the DOJ (Eastern District of New York) which documents the communication that; 1.
FDA is aware of Siemens Healthineers practice of shipping adulterated devices (Troponin) to end users (both Laboratory
and Point of Care users). and, 2. That although these devices are misbranded and adulterated that their is NO risk to
patient and the devices are safe and effective for use.
All releasable communications between TurtleTree Labs and FDA-CFSAN (including any office within CFSAN or employee
of CFSAN) for the period November 1, 2019 to present, including all correspondence, meeting minutes, company
presentations, and FDA-generated memoranda related to the company.
FDA Form 483 or other records from audits of is FAREVA AMBOISE, Zone Industrielle, 29 Route des Industries, Pocé-sur-
Cisse, France 37530. Specifically interested in the FDA Inspection Records Request date 4/28/2021 and any follow ups.
We would like to see detail contents for 510K K181642, and we will use this information to perform analysis for our
predicate device to help us guide our analysis for own device.
Form 483s, Responses to Form 483s, Warning Letters, Responses to Warning Letters and Establishment Inspection
Reports for the business of Advanced Bionics Corporation and Advanced Bionics, LLC at the locations commonly known
as 28515 Westinghouse Place, Valencia, California and/or 12740 San Fernando Road, Sylmar, California or any other of
its manufacturing locations.
Any and all records pertaining to the selection of the position Supervisory Consumer Safety Officer: Announcement
number FDA-ORA-21-MP-11077979-MK
75F40121C00053
Please provide the attached 18 VAERS reports.
Pursuant to the Freedom of Information Act (FOIA), CSL Behring (CSLB) would like to request the following MedWatch
Forms for Hizentra® (Immune Globulin Intravenous (Human), 20% Liquid): • FAERS ID 19116910 • FAERS ID 19214875 •
FAERS ID 19222914 • FAERS ID 19846069 • FAERS ID 19942094 • FAERS ID 19942506 • FAERS ID 19948716 • FAERS ID
19953124 • FAERS ID 19958458 • FAERS ID 19966621 • FAERS ID 19966686 • FAERS ID 19966751
Reference is made to FDA’s urgent request to reconcile sponsor FAERS reports with FDA received reports for Privigen®
BL 125201. Pursuant to the Freedom of Information Act (FOIA), CSL Behring (CSLB) would like to request the following
MedWatch Forms for Privigen® (Immune Globulin Intravenous (Human), 10% Liquid): • FAERS ID 19870903 •
FAERS ID 19871373 • FAERS ID 19901300 • FAERS ID 19904977 • FAERS ID 19911586 • FAERS ID 19912308
• FAERS ID 19919140 • FAERS ID 19926951 • FAERS ID 19927953 • FAERS ID 19927979 • FAERS ID
19927989 • FAERS ID 19927990
PHILIPS RS NORTH AMERICA LL PMA, 510K ETC
GENTLY USED APPLIANCES ETC

NDA 202429
I request the following RES Reports - RES Report 87014, RES Report 86902, RES Report 88058, RES Report 88071.
Requesting copies of the following DMF DMF#26549 Febuxostat, DMF#27558 L-Ala-pAF-OH HCL, DMF#27872
Celecoxib, DMF#28805 Deferasirox.
Product Area: Biologics, Request record: Complete Response Letter (CRL) - Year 2021, Company: Revance Therapeutics
(FEI 3007772056), Address: 7555 Gateway Blvd. Newark CA 94560 US
Records containing information on nonclinical safety studies submitted to support approved Premarket Tobacco
Product Applications (PMTAs) for Vuse Solo Power Unit and Vuse Replacement Cartridges Original 4.8% G1 and G2—
including but not limited to records regarding in vitro cytotoxicity studies, genotoxicity studies, and in vivo subchronic
inhalation toxicity studies—from R.J. Reynolds Vapor Company.
Any and all documents submitted by, sent to, or relating to Intrivo Diagnostics, Inc. (“Intrivo”), Pure Blue Medical, Inc.
dba Intrivo Diagnostics, and/or Reeve Benaron, including without limitation, documents relating to any application, bid,
proposal, approval, review process, or contract.
FDA review documents for BLA 761197 for SUSVIMO (active ingredient: ranibizumab) approved on 10/22/2021. Label
and Letter are currently on the Drugs @ FDA website but Review documents not yet posted.
We would like to request the following for ANDA 212942 (TIMOLOL MALEATE, EQ 0.25% BASE & EQ 0.5% BASE) 1) BE
review
All Form 483 records related to the FDA inspection of Evelyn Lopez-Brignoni, M.D. at Imic, Inc., 18320 Franjo Rd
Palmetto Bay FL 33157-5503 between June 8, 2020 and June 23, 2020. https://www.fda.gov/inspections-compliance-
enforcement-and-criminal-investigations/warning-letters/evelyn-lopez-brignoni-md-612542-03022021
Requesting copies of the Environmental Assessment (EA) and Finding of No Significant Impact (FONSI) for Vuse Solo
Power Unit (PM0000551) submitted by R.J. Reynolds Vapor Company
WCW requests copies of all email communications (including emails, complete email chains, calendar invitations, and
their attachments) from any FDA staff email containing any the following keywords: • White Coat Waste •WCW •
WCWP • Anthony Bellotti • etc
Please provide a copy of the July 9, 2021 Office of Science memorandum signed by CTP’s Director of the Office of
Science, Matthew Holman, that discusses a “Fatal Flaw” review of premarket tobacco product applications not in Phase
III review for non-tobacco-flavored ENDS products.
for Human Drugs inspection of Cardinal Health 414 LLC ending 06/18/2019 at the location in East Hartford CT, United
Attn CTP: Copy of the disclosable portions of the following documents, which are referenced in the attached memo: The
Premarket Application Review Prioritization plan memo dated 08/31/2020, and the addenda dated 09/24/2020 &
05/11/2021.
for Human Drugs inspection of Cardinal Health 414, LLC ending 08/03/2018 at the location in New Orleans LA, United
for Medical Devices & Rad Health inspection of Roche Molecular Systems, Inc. ending 02/27/2017 at the location in
Pleasanton CA, United States. Please send documents as email attachments.
format) for Human Drugs inspection of Fresenius Kabi USA LLC ending 05/18/2020 at the location in Melrose Park IL,
format) for Human Drugs inspection of Lannett Company, Inc. ending 02/28/2018 at the location in Carmel NY, United
The 483 (in electronic format) for Foods & Cosmetics inspection of World Organic Corp. ending 09/14/2021 at the
location in Huntington Beach CA, United States. The EIR (in electronic format) for Foods & Cosmetics inspection of
World Organic Corp. ending 09/14/2021 at the location in Huntington Beach CA, United States. etc
All food additive petitions records submitted to FDA CVM and FDA Division of Animal Feeds, March 1 2021-October 31,
2021
RICARDO GONZALEZ CUSTOMS BROKER - EIR 06/19/2017
All records concerning complaints to the FDA about a Pfizer trial at Ventavia received between Sept. 16 and Sept. 30,
2020. -All internal correspondence regarding concerns reported to the FDA about the COVID-19 vaccine trial at Ventavia
between same dates.
All studies and/or reports in the possession, custody or control of the Food & Drug Administration (FDA) describing the
purification of any "COVID-19 virus" (including "B.1.1.7", "B.1.351", "P.1" and any other "variant") (via maceration,
filtration and use of an ultracentrifuge; also referred to at times by some people as "isolation"), directly from a sample
taken from a diseased human, ETC
Documents and communications concerning the subject matter of the complaint sent to the FDA by Ventavia Research
Group
Data set including data identifying all exclusivity periods awarded based on receiving specific types of approvals
including the exclusivity code and the date upon which the awarded exclusivity would expire.
Dates of filing (or date of request for addition of product listing to FDA's electronic registration/product listing
database), including that related to product listing, "Mask, scavenging – A&F KN95 Mask; Anhui Zhongke Duling
Commercial Kn95; Ds N95 Surgical Mask DTC3X; N95 Mask YJT Anhui Huirun Decoration Materials Gb2626-2006," made
by KL Distributing.
Detailed report of all adverse events from Caplyta (lumateperone) in the FDA Adverse Event Reporting System All
documents and correspondence regarding the approval of Caplyta (lumateperone)
Hello - I would like to request the 483 inspection citations for PETNET Solutions, Inc from 2020-2021.
Please provide the P160045/S029 Approval Order, Summary of Safety and Effectiveness (SSED) and Labeling.
13444773 13461866 14567647 14635029 15517552 15596168 16134672 17293631 17375417 17438513
Product Area: Biologics, Request record: Establishment Inspection Report (EIR) Company: Daewoong Pharmaceutical
(FEI 3012333115), Address: 35-14, Jeyakgongdan 4-Gil, Hyangnam-Eup, Hwaseong-si, Gyeonggi-Do, 18623, Republic of
Korea
Xifaxan (Rifaxamin) "Orphan Designation Request from the Sponsor" and FDA's "Approval letter of ODD".
Data set of patents publicly identified as being associated with an approved New Drug Application.
Three 510k submission dossiers are requested for a study related to dental aligners: K193622, K201104, K211010
Please provide a copy of the disclosable portions of any meeting minutes, meeting agendas, or decision logs created
between August 1, 2021 and November 1, 2021, by the “FDA Nicotine Steering Committee.”
APPROVAL OF VACCINES
All Form 483s related to FDA inspections of any Emergent BioSolutions Inc. facility from Jan 1. 2015 - March 31, 2021,
including any correspondence, notes from the inspector, responses from the company, and documents or photos. These
records have already been provided to at least three media organizations.
All voluntary and mandatory adverse events for all polyethylene glycol 3350 products for adults and children. Need FULL
DETAILED REPORT, NOT TALLY REPORT please. Need report with age, gender, date, outcome, report source, product,
role, manufacturer, route, dose and duration. Thank you.
all documents relating to the flea and tick medication Bravecto (drug name fluralaner)
All inspection reports, including but not limited to EIR and 483 reports, of Medtronic facilities related to the HeartWare
Ventricular Assist Device, PMA number P100047.
K062482
K122265
K982838
Vein360 is requesting the entire 510(k) for BD Atherectomy numbered K172315.
Vein360 is requesting the entire 510(k) for BD Atherectomy numbered K211738.
Vein360 is requesting the entire 510(k) for Medtronic Atherectomy numbered K141801.
Vein360 is requesting the entire 510(k) for Medtronic Atherectomy numbered K161361.
Copy of the 483 for the Feb 4, 2014 - Mar 14, 2014 (39 days) inspection of Brava, LLC located at Miami / United States of
America] 14221 SW 142nd St, Miami, FL 33186, USA. This inspection pertains to Medical Devices.
Copy of the Company Response for the Feb 4, 2014 - Mar 14, 2014 (39 days) inspection of Brava, LLC located at Miami /
United States of America] 14221 SW 142nd St, Miami, FL 33186, USA. This inspection pertains to Medical Devices.
Copy of the Company Response for the Sep 7, 2011 - Sep 22, 2011 (16 days) inspection of Satyaprakash N. Makam, MD
located at Munster / United States of America] 10010 Donald S Powers Dr, Munster, IN 46321, USA. This inspection
Copy of the EIR for the Feb 4, 2014 - Mar 14, 2014 (39 days) inspection of Brava, LLC located at Miami / United States of
America] 14221 SW 142nd St, Miami, FL 33186, USA. This inspection pertains to Medical Devices.
Copy of the FDA response only to the following file numbers: 2021-3299 2021-2853 2021-2981 2020-6085
FOIA requests filed with FDA’s Center for Food Safety and Applied Nutrition (“CFSAN”), including related offices, from
August 1, 2021 through August 31, 2021.
Electronic listing (preferably csv format) of all RRAs conducted since August 1, 2021
Report and/or the MDSAP Noncomformity Grading and Exchange Form (NC) for the inspection of Medtronic Sofamor
Danek USA, Inc, Memphis, TN , end date 04-27-2016. FEI# 3003120897. This inspection pertains to medical devices.
Report and/or the MDSAP Noncomformity Grading and Exchange Form (NC) for the inspection of St. Jude Medical, CATD
Westford, Westford, MA , end date 09-04-2015. FEI# 3009600098. This inspection pertains to medical devices.
Regulatory Assessment of BioLife Plasma Services, L.P. Located at Clarksburg WV United States FEI Number: 1177799
held on 03/12/2021.
Regulatory Assessment of Biomat USA Inc Located at Akron OH United States FEI Number: 3006761790 held on
03/25/2021.
Regulatory Assessment of Biomat USA Inc Located at Dayton OH United States FEI Number: 3007166152 held on
03/22/2021.
Regulatory Assessment of CSL Plasma, Inc Located at Rock Hill SC United States FEI Number: 3011015147 held on
03/22/2021.
All documents sufficient to identify each and every complaint, concern, violation, grievance, criticism, or problem
brought to the attention of the Food and Drug Administration regarding any Phase I, Phase II, and/or Phase III clinical
trial for any COVID-19 vaccine.
All emails sent or received by Peter Marks, Marion Gruber, Phillip Krause, Janet Woodcock, and/or Stephen Hahn that
include the words (Jackson or Brook) and (Ventavia or Pfizer) in the subject line, body, metadata or any other part of the
email for the time period of September 1, 2020 to the date of search.
1. All records concerning past FDA inspections of W.Y. Industries, Inc., 2500 Secaucus Road, North Bergen, New Jersey
07047, including but not limited to inspection reports, witness statements, and/or correspondence related thereto. 2.
All records concerning any FDA violations, warnings, or other sanctions and/or penalties issued to W.Y. Industries, Inc.
etc
All internal FDA communications regarding any control group for the investigational trials for Johnson & Johnson's
Janssen Covid vaccine (JNJ-78436735) from the inception of the trials to the present.
All internal FDA communications regarding any control group for the investigational trials for Moderna Covid vaccine
(mRNA-1273) from the inception of the trials to the present.
PERSONAL RECS
I hereby request copies of any FDA FORM 483 regarding Simple Science, LLC located at 5555 W 78th (or St Ste M) in
Edina MN, 55439.
Respectfully request information regarding filing of the original and subsequent revisions of "Form FDA 356h" by
"CytoDyn, Inc", "Amarex Clinical Research LLC", and/or "Kazem Kazempour, PhD" during the calendar years 2019 and
2020.
Subject: Fwd: FOIA FOR CELL IN A BOX I need ALL of the information on "cell in a box encapsulation". Austrianova is the
producer of this technology.
2021-7160
Under the Freedom of Information Act, I am requesting copies of the inspection records of the Cyclospora basil
outbreak in 2019. We are requesting these documents for legal purposes.
We are writing to request copies of any records, compiled between July 1, 2021 and December 1, 2021, on file at the
FDA regarding the investigation of this outbreak (CDC ID: 2109MLJJX-1). We specifically request: • all health department
summary reports (NORS reports) of any investigations conducted for this outbreak; • complete linelists of cases, lab
specimen, and exposures pertaining to cases in the outbreak; ETC
FDA Establishment Inspection Report and Associated sample reports from Regulatory inspection conducted Monday
10/25/2021 through Thursday 10/28/2021.
Please provide the summary review documents, bioequivalence review documents and chemistry review documents for
the recently approved isosulfan blue product under ANDA 213130.
line listing containing the following fields (Product, Manufacturer Report Number, CAERS report number, age, sex, date
received by the FDA, therapy dates, MedDRA Terms, case narrative and outcome) pertaining to the production of all
Adverse Event Reports and related documents relating or referring to Iovate products
Request for FDA’s Establishment Inspection Report for Reynolds’ Tobaccoville and Bowman Gray Technical Center in
Connection with Vuse Solo (PM0000551, PM0000553, PM0000555-PM0000560, PM0000562-PM0000566)
an electronic mail version, CD-ROM or DVD copy of any and all documents, including any reports, correspondence,
endorsements, addenda, and exhibits, related to a memorandum to file from Anne Radway, M.S., Associate Director,
Division of Regulatory Project Management, Office of Science through Matthew Holman, Ph.D., Director, Office of
Science (digitally signed by Dr. Holman on July 9, 2021) titled “ENDS Containing Non-Tobacco Flavored E-Liquid:
Approach to PMTAs not in Substantive Scientific Review (Phase III).”
FOIA request Control Number 2021-1682; FOIA request Control Number 2021-5301; FOIA request Control Number
2020-8061; any responses to prior requests.
List of Inspections conducted by Lori Silverstein, CSO Name of firm, Dates of the inspection, classification of the
inspection
PMA # P160017 for the MiniMed 670G System (approved 09/28/2016); PMA # P160017 Supplement S061 (approved
07/09/2019); PMA # P150001 for the MiniMed 630G System (approved 08/10/2016); PMA # P150001, Supplement S065
(approved 07/09/2019); reviewer’s file(s); any responses to prior requests.
Request for Form 483 Company being requested for - Dr. Reddy's Laboratories Product category manufactured - Human
drugs Plant Location - Duvvada, Visakhapatnam, India. Plant name - FTO 7 & FTO 9 Number of observations - 8
Maximum willingness to pay - USD10
Requesting the full 510K document for K011827 Ortelius 800
I need the following two files:(paper or electronic version) 1. SOP from CBER for Potency Determination for Influenza
Vaccines by Single Radial Immunodiffusion. 2. SOP from CBER for SRID image analysis (Reading of Single Radial
Immunodiffusion Gels)
FOIA Request of unredacted instructions to staff on decision making for the MDO STNs PM0001168 issued for Vaporized
Inc. Unredacted versions of staff explanation of decision and information used to come to the conclusion of issuing the
MDO. This includes all interoffice mails, notes, forms and any internal records not submitted by Vaporized Inc. Also see
attached request letter
FOIA Request of unredacted instructions to staff on decision making for the MDO STNs PM0003525 issued for Union
Street Brands, LLC. Unredacted versions of staff explaination of decision and information used to come to the conclusion
of issuing the MDO. This includes all interoffice mails, notes, forms and any internal records not submitted by Union
Street Brands, LLC. Also see attached request letter
FOIA Request of unredacted instructions to staff on decision making for the MDO STNs PM0003525 issued for Union
Street Brands, LLC. Unredacted versions of staff explanation of decision and information used to come to the conclusion
of issuing the MDO. This includes all interoffice mails, notes, forms and any internal records not submitted by Union
Street Brands, LLC. Also see attached request letter
FOIA Request of unredacted instructions to staff on decision making for the MDO STNs PM0003526 issued for
Vapornine, LLC. Unredacted versions of staff explanation of decision and information used to come to the conclusion of
issuing the MDO. This includes all interoffice mails, notes, forms and any internal records not submitted by Vapornine,
LLC Also see attached request letter
FOIA Request of unredacted instructions to staff on decision making for the MDO STNs PM0003581 issued for Vapor
Unlimited LLC. Unredacted versions of staff explaination of decision and information used to come to the conclusion of
issuing the MDO. This includes all interoffice mails, notes, forms and any internal records not submitted by Vapor
Unlimited, LLC. Also see attached request letter
Please consider this a request for a copy of the 10/5/21 supplemental approval letter for BLA No. 103772 for Remicade.
ETC
for Foods & Cosmetics inspection of Bulk Naturals LLC ending 11/26/2018 at the location in Portland OR, United States.
for Human Drugs inspection of Veeral S. Sheth, M.D. ending 10/08/2021 at the location in Oak Forest IL, United States.
for Human Drugs inspection of Coty US LLC ending 10/27/2021 at the location in Sanford NC, United States. The 483 (in
electronic format) for Medical Devices & Rad Health inspection of Deocco LLC ending 10/25/2021 at the location in
Charlotte NC, United States. Please send documents as email attachments.
for Medical Devices & Rad Health inspection of Mid South Precision, Inc. ending 10/25/2021 at the location in
Murfreesboro TN, United States. The 483 (in electronic format) for Human Drugs inspection of Aphena Pharma
Solutions - Tennessee LLC ending 10/15/2021 at the location in Cookeville TN, United States. Please send documents as
email attachments.
for Human Drugs inspection of GSK Consumer Health Inc ending 09/30/2021 at the location in Lincoln NE, United States.
The EIR (in electronic format) for Human Drugs inspection of GSK Consumer Health Inc ending 09/30/2021 at the
location in Lincoln NE, United States. The Response (in electronic format) for Human Drugs inspection of GSK Consumer
Health Inc ending 09/30/2021 at the location in Lincoln NE, United States. The 483 (in electronic format) for Human
Drugs inspection of Hillyard GMP ending 10/08/2021 at the location in Saint Joseph MO, United States. Please send
CVs Mina Ahmadi, Kevin W Necaise, Daniel T Lee, David M Wilkinson, etc
2016-8839, 2016-8840, 2016-8843, 2016-8845, 2016-8846.
2016-8964, 2016-8991, 2016-9582, 2016-9583, 2016-9585.
2021-5460, 2021-5463, 2016-8022, 2016-8023, 2016-8025.
2016-9590, 2016-9591, 2016-9598, 2016-9658, 2016-9702.
Tox Memo Only Please for: FCN 1931 Food Contact Substance: 1,2,4,5,7,8-Hexoxonane, 3,6,9-trimethyl-, 3,6,9-tris(Et
and Pr) derivs. (CAS Reg. No. 1613243-54-1). Notifier: Akzo Nobel Functional Chemicals, LLC Manufacturer/Supplier etc
483s and/or Warning Letters sent to the following facilities for the period June -November 2021 and was hoping you
could help? Thank you! Eagle Pharmaceuticals, Inc. located at 50 Tice Boulevard, Suite 315, Woodcliff Lake, NJ 07677
and 47 Moulton St. Cambridge, MA 02138.
ICU Medical, Inc. Form 483 from an FDA audit of its MedFusion syringe pumps
Attn CBER: Please send the attached information regarding IND submissions, fast track and breakthrough designations.
Please see attached.
Attn CDER: Copy of the disclosable portions of the attached information regarding number of IND submissions, fast
track, and breakthrough therapy designations for FY2021. Please see attached.
Copy of the disclosable portions of the epidemiology report prepared for use by the Office of Orphan Products
Development (OOPD), on or about June or July 2021, documenting the prevalence of IgA nephropathy in the US. This
report my have been prepared or commissioned by the Office of Surveillance and Epidemiology.
Any and all studies funded, in whole or in part, by the FDA, which form the basis of the FDA's authorization for use by
the general public of the Moderna COVID-19 Vaccine booster shot. ETC
Looking for the 3 references in the "Guidance for Industry: Channels of Trade Policy for Commodities with Methyl
Parathion Residues"
FDA 510 K FILINGS BY AIDOC SUBTLE MEDICAL MEDIC VISION
We are requesting a copy of all documents including but not limited to memos or minutes of meeting, telephone
discussions, submissions, and FDA correspondence related to brazzein sweetener or protein.
Case ID: 15915521, 15775596, 15643146, 14931174, 14126625

We are requesting copies of documents related to FDA’s review of the toxicity of triethanolamine (TEA; CAS No. 102-71-
6) when used, or present as an impurity, in food-contact applications.
*Investigative files and reports related to the FDA recall of Raws for Paws due to salmonella contamination (please
see: https://www.fda.gov/animal-veterinary/outbreaks-and-advisories/fda-investigates-outbreak-salmonella-infections-
linked-raws-paws-ground-turkey-food-pets) *The underlying complaints that led to recall of Raws for Paws due to
salmonella contamination
This request is for 1 document. Please email me a copy of the October 20th, 2021 version of the Letter of Authorization
for the Pfizer-BioNTech vaccine.
Seeking FDA Establishment Inspection Reports for Amerilab Technologies facility located in 2765 Niagara Lane North,
Plymouth, MN 55447.
DIA Meeting in 2021 in USA
All Foreign Supplier Verification Program (FSVP) records related to Sprout’s Farmers Market, Sprouts Farmers Market,
and Sprouts Farmers Market LLC Arizona Warehouse.
All records pertaing to the Philips Cpap recall dated 7/22/2021 including the philips dreamstation. The recall is related
to degredation of the pe (pur) polyeurathane foam and off gassing of certain chemicals. I am looking for all underlying
studies, data, inspections, chemical analysis and adverse events that either directly or indirectly led to the recall and any
and all data philips has turned over to the fda related to the recall.
All labeling information on the following devices that were in effect during 8/1/10 - 12/31/10: Implant: DePuy 100
Pinnacle Acetabular Cup; Size 52mm; Ref: 1217-01-052; Lot No.: E2YJH1000 Implant: DePuy Pinnacle Marathon
Acetabular Liner-Lipped; Ref: 121+-28-252; Lot No.: C16H51000 Implant: DePuy Summit Femoral Stem 12/14 Taper
Tapered with Porocoat Size: 3 STD 135 mm; Ref: 1570-01-090; Lot No.: E2HFM1; Depuy Articul/eze Femoral Head
Master File for Device (MAF) 1850
participating in the FDA Foreign Supplier Verification Programs from approximately June 4 2021 - September 3 2021.
participating in the FDA Foreign Supplier Verification Programs from approximately March 4, 2018 - June 3, 2018.
all inspection documents for FDA inspection of Answers Pet Food, Lystn LLC, located at 356 Maidencreek Rd, Fleetwood,
PA 19522
I am looking to see if 24 Clean Energy Co., Ltd and FEI Number 3017845288 imported product to the USA.
Adverse Events related to taking Skyrizi (risankizumab-rzaa)
All financial disclosure records for Timothy Stenzel, director of the Director, Office of In Vitro Diagnostics and
Radiological Health at the FDA, including forms HHS 717-2 Report of Prohibited Financial Interests reports, as well as any
other records filed to comply with § 5501.104 Prohibited financial interests applicable to employees of the Food and
Drug Administration.
Video footage
for Biologics inspection of Conceive Fertility Center ending 10/15/2021 at the location in Irving TX, United States. Please
for Biologics inspection of CorneaGen Inc ending 09/24/2021 at the location in Seattle WA, United States. Please send
for Biologics inspection of NYU Langone Reproductive Specialists of New York ending 09/30/2021 at the location in
Mineola NY, United States. Please send documents as email attachments.
for Biologics inspection of Valley Biosystems ending 10/08/2021 at the location in West Sacramento CA, United States.
for Medical Devices & Rad Health inspection of Tenderneeds Fertility LLC ending 09/29/2021 at the location in
Greenville IN, United States. Please send documents as email attachments.
for Biologics inspection of Emergent BioDefense Operations Lansing LLC ending 09/29/2021 at the location in Lansing
MI, United States. The EIR (in electronic format) for Biologics inspection of Emergent BioDefense Operations Lansing
LLC ending 09/29/2021 at the location in Lansing MI, United States. The Response (in electronic format) for Biologics
inspection of Emergent BioDefense Operations Lansing LLC ending 09/29/2021 at the location in Lansing MI, United
for Medical Devices & Rad Health inspection of Mount Sinai School of Medicine IRB #5 - Board D ending 01/31/2014 at
the location in New York NY, United States. The EIR (in electronic format) for Medical Devices & Rad Health inspection
of Mount Sinai School of Medicine IRB #5 - etc.
Documents or correspondence, whether digital or physical, between the FDA and CytoDyn, Inc. (“Cytodyn”) any of
CytoDyn’s agents, representatives, or employees, or any individual purporting to speak for CytoDyn, including Bruce
Patterson, IncellDX, and Amarex Clinical Research LLC, regarding Leronlimab, Pro-140 or Virologix (“Leronlimab”), that
occurred between the dates of November 1, 2019 and the present.
Looking for any / all available information on FAERS case #19787426. This patient was taking aducanumab, had an
adverse event of Amyloid Related Imaging Abnormality-Oedema/Effusion, and died. The event date was August 18,
2021, and was initially reported to the FDA on 03-SEP-2021.
510k submission documents for K171947, SOLOASSIST II (AKTORmed GmbH) and K200473, SOLOASSIST II, Voice Control
(AKTORmed GmbH)
I would like to have access to the most recent form 483 received by the company Biocon, Bengalore.
Form 483 for Alembic's Injectable Plant (F3) at Karkhadi Issued 10 observations
Documents confirming status and progress of matter CPT2100917 Filed June 7, 2021 filed Avante Health Solutions with
the CDRH Office of Regulatory Programs, Division of Regulatory Programs 3 (Market Intelligence), Allegation of
Regulatory Misconduct Team.
Canned tuna - subject to 21CFR161.190 - Pressed weight us used as the measure of the fill of container.
All documents in the Food and Drug Administration's ("FDA") possession relating to Iterum and its New Drug Application
for oral sulopenem etzadroxil/probenecid (the “sulopenem NDA”) during the specified time period.
(1) FEI Number 3012063246, Factory Inspection Form FDA 483 for Valisure, LLC, an analytical lab, located at 5 Science
Park, New Haven, Connecticut 06511. There were multiple dates of inspection between May 26, 2021 and July 6, 2021.
The form was issued on July 6, 2021 and is nine pages long AND (2) Valisure, LLC's response dated July 27, 2021.
Vermont Tobacco Center of Regulatory Science at the Vermont Center on Behavior and Health corr with CTP
We at the Vermont Tobacco Center of Regulatory Science at the Vermont Center on Behavior and Health IU0000079,
IU0000079-IU0000085 corr with CTP
This is a request under the Freedom of Information Act.I request a copy of the Form 483 forDr. Reddy's Duvvada,
Vishakapatnam manufacturing for human drugs.The inspection was conducted in Oct-2021.The complete address of the
plant is India Visakhapatnam, Andhra Pradesh 530049
We would like to request the following for ANDA 212942 (TIMOLOL MALEATE, EQ 0.25% BASE & EQ 0.5% BASE) 1)
Chemistry review
requesting Revance Therapeutics' Establishment Inspection Report from Newark, CA facility; FEI: 3007772056
I'm requesting a digital copy of the badge for Timothy Schmidt as well as a digital copy of an official government
employee photo for this employee. He has reported that his badge number is 13300
I am requesting all documents provided for 2018-8268
Each and every email communication between December 30, 2020 and the date of search sent or received by Janet
Woodcock, Stephen Hahn, Peter Marks, Marion Gruber, Philip Krause and/or Lorrie McNeill that includes the words
(“Maddie” or “Madeline”) and (“deGaray” or “de Garay”) in the body, subject line, or any other part of the email.
Pharmedica USA 2836 West Deer Valley Road, Suite 12 Phoenix, Arizona 85027 inspection recs
I am requesting the briefing document that FDA had put together in preparation for the ODAC meeting due October 28,
2021, to discuss the OCEAN trial regarding the drug PEPAXTO.
Please provide a list of organizations approved to use the following technologies approved under Emergency Use
Authorizations: - CRL Rapid Response by Clinical Reference Laboratory, approved 7/30/2020. - ORAcollect·RNA OR-100
and ORAcollect·RNA ORE-100 saliva collection devices by DNA Genotek Inc. approved 10/28/2020. - OMNIgene·ORAL
OM-505 and OME-505 (OMNIgene·ORAL) saliva collection devices by DNA Genotek Inc. approved 10/28/2020.
Please provide the original approval documents for PLENDIL(felodipine) in 1991. It's not available online since it's too
old. We prefer to receive it in a digital format rather than in a paper format.
The request is for a Supplement submission to GRN 000609 that was dated December 8, 2017, and is listed as
submitted December 13, 2017. The subsequent clarifying information of January 26, 2018, March 6, 2018, and May 30,
2018 is also requested. The FDA GRAS Inventory website states that "Additional correspondence is available."
I am interested in the recalls data
The tentative approval letter issued to Sandoz for ANDA #213713
1. All documents created after January 1, 2020, excluding those already published on FDA’s website, reflecting
submissions (but not limited to submissions made to FDA’s docket at regulations.gov) to FDA’s Center for Food Safety
and Applied Nutrition (”CFSAN”) advocating for (a) the exclusion or exemption of D-tagatose or D-allulose (a.k.a. D-
psicose) from the definition of “total sugars” or “added sugars” in 21 CFR § 101.9(c)(6)(ii)-(iii) or (b) the inclusion of D-
tagatose in said definition of “total sugars” or “added sugars”.ETC
AndersonBrecon Inc (dba PCI Pharma Services) Rockford, Illinois 61109, United States FEI: 1421377 Seeking FDA
Establishment Inspection Report - end date 03/23/2017, No Action Indicated (NAI), product type: drug
Complete 510(k) including all FDA correspondence and deficiencies addressed during the review and clearance of
K202208 - BeneHold Surgical Incise Drape With CHG Antimicrobial (Applicant: Avery Dennison Belgie BVBA).
All Limbrel / Flavocoxid reports associated with the Drug-induced Liver Injury Network prospective study, as well as all
MEDWATCH Drug-induced Liver Injury cases filled out by or submitted by the DILIN.
Establishment Inspection Report for Inspection on Cornerstone Research & Development, Inc. dba Capstone Nutrition at
900 S Depot Drive, Ogden, Utah 84404 on or about 11/15/2017
Form 483 from the Inspection of Spectrum Laboratory Products, Inc., 755, 769, and 777 Jersey Avenue, New Brunswick,
NJ 08901, ending on 07/14/2021.
Please provide a copy of the disclosable portions of the FDA Center for Tobacco Products Office of Science
administrative and scientific reviewer notes related to all Substantial Equivalence Reports (SE Reports) submitted by
British American Tobacco or Reynolds American (or their subsidiaries) for the product “Glo” and that received a final
determination.
Under list of all Foreign and Domestic Drug Inspections which were conducted from January 1, 2000 to the present. This
list should include CROs (Contract Research Organizations), drug manufacturers, repackers/packers, labelers/relabelers,
control laboratories and contract sterilizers that underwent a Drug GMP or PAI/PLI inspection. ETC
We kindly request all information on allulose (D-psicose), including but not limited to consultations, GRN notices
(notices filed, and any correspondence on previously filed notices), or any internal FDA communications such as
memorandum.
Seeking Moderna Inspection Records
I am requesting publicly available, non-confidential documents related to the recycling of agricultural plastic for use as a
feedstock for any type of food packaging application. More information is provided in the attached request letter.
I am requesting publicly available, non-confidential documents related to the recycling of carpet and fiber for use as a
feedstock for any type of food packaging application. More information is provided in the attached request letter.
ANDA # 076593 Sequences 0003, 0004, 0005.
Reviews and approvals of the changes to § 3 (“Dosage Forms and Strengths”) of the Forteo label (NDA 021318), as
approved on or around November 16, 2020, including but not limited to relevant sections of the approval package for
supplement S-054.
Selected candidate's qualifications for job announcement number: FDA-ORA-21-DH-11146166-KM. Starting salary
offered to selected candidate.
The review and approval package for supplement S-053, effectuating labeling changes for Forteo (NDA 021318), as
approved on or around April 6, 2020.
PharmacyChecker.com, their accredited pharmacies, and other potentially associated entities, including any Warning
Letters, It-Has-Come-To-Our-Attention Letters, Untitled Letters, and Form 483s, as well as certain documents related to
a number of criminal investigations into certain internet pharmacies.
Request any and all documents relating to the Federal Drug Administration’s sampling assignment of talc-containing
cosmetic products for the presence of asbestos as it relates to Johnson & Johnson products (hereinafter “J&J”). The
documents should include, but not be limited to, materials regarding the FDA’s retention, hiring and contract with AMA
Analytical Services, Inc. for the project regarding the analyses of J&J talc products; any written protocols concerning the
FDA’s selection of talc products for analyses and lot numbers, including specifications for utilization of testing methods,
counting criteria, or other requirements prescribed by the FDA to govern AMA’s analyses of the J&J products; any
documents assigning the “blind” identification of the J&J products; the chain of custody for J&J products Lot #22318RB
and Lot #00918RA; any communications between the FDA and AMA concerning the testing of the J & J products; and
any and all materials regarding the results of the testing (including laboratory notes/photographs and correspondence
relating to same). We request that any documents produced be certified.
510(K)s K953772 K954914 K955711

All releasable information to support the AAFFCO 36.15 Dried Fermentation Biomass , including information provided
in support of the definition and the FDA reviews and correspondence.
Copies of Form 483s issued by CDER’s International Operations Group on the indicated date:
Copies of Form 483s issued by the CDER Office on the indicated date:
Copies of Form 483s issued to the following CLINICAL INVESTIGATOR from June - September, 2021.
Copies of Form 483s issued to the following DEVICE companies from June- July, 2021.
Copies of Form 483s issued to the following DRUG companies on the indicated date.
Copy of the 483 for the Aug 8, 2014 - Sep 5, 2014 (29 days) inspection of Wakai, Ronald, Ph. D., Clinical Investigator
located at Madison / United States of America] 1111 Highland Ave #1005, Madison, WI 53705, USA. This inspection
pertains to Medical Devi
Copy of the 483 for the Mar 14, 2011 - Mar 21, 2011 (8 days) inspection of Essex Institutional Review Board, Inc located
at Lebanon / United States of America] 121 Main St, Lebanon, NJ 08833, USA. This inspection pertains to Human Drugs.
Copy of the EIR for the Aug 8, 2014 - Sep 5, 2014 (29 days) inspection of Wakai, Ronald, Ph. D., Clinical Investigator
located at Madison / United States of America] 1111 Highland Ave #1005, Madison, WI 53705, USA. This inspection
Records from inspection at Aurobindo Pharma Limited's s Unit I (API) manufacturing facility in Hyderabad, India
between August 2 to August 12, 2021 resulting in Official Action Indicated (OAI) classification.
Form 483 record of inspection at Alembic Pharmaceuticals Limited's Injectable Facility (F-3) located at Karkhadi, India
from 28th October, 2021 to 10th November, 2021.
I am requesting a copy of the Complete Response Letter issued to Spectrum Pharmaceuticals for Rolontis
(eflapegrastim), date of issue on or about 6 August 2021.
We request all disclosable/releasable portions of the Establishment Inspection Report (EIR) of Nestle Mexico, S.A. de
C.V. Lagos Polvos FEI NUMBER 3004256904 with Inspection End Date: 08/10/2017 Inspection ID: 1024412. Additionally,
all records disclosable portions of the records of Field Accomplishment and Compliance Tracking System (FACTS) and
eNSpect.
We are requesting the most recently submitted labels for Faslodex (Fulvestrant Injection) NDA 021344 so we may
develop and submit our own ANDA. Please provide the container, carton, package insert, and if applicable blister labels
that are the most current. If possible please send files via electronic email due to COVID remote working conditions.
This is a request for a copy of the full report/ Medwatch on FAERs case ID 19701548 (latest FDA receipt date per FAERs
dashboard: 14Aug2021). [Please note: aprepitant is in the list of suspect ingredients however, suspect product is
"Darzalex" only, which does not include ingredient aprepitant.]
I request that a copy of the following documents be provided to me: - K181372, premarket submission for the Argos
Monitor from Retia Medical, LLC.
I am requesting the resumes of the applicants selected for the following job vacancies: Medical Technologist, Silver
Spring MD, GS-14 announcement number: FDA-CDRH-21-MP-10972524. Open & close dates: 12/1/20-12/4/20
File Numbers 2017-7415, 2017-8504, and 2020-6737
We are requesting a copy of the U.S. Food and Drug Administration’s (FDA) unredacted review memoranda associated
with Food Contact Notification (FCN) 1754. Specifically, we are interested in receiving the chemistry and toxicology
memoranda relating to this FCN.
Report and/or the MDSAP Noncomformity Grading and Exchange Form (NC) for the inspection of 3M COMPANY,
Brookings, SD , end date 05-21-2015. FEI# 1717046. This inspection pertains to medical devices.
Report and/or the MDSAP Noncomformity Grading and Exchange Form (NC) for the inspection of Hospira Inc., A Pfizer
Company, Lake Forest, IL , end date 05-27-2015. FEI# 3005579246. This inspection pertains to medical devices.
File number 2016-9761
motor axonal neuropathy, acute motor-sensory axonal neuropathy, Bickerstaff's encephalitis, ETC
for Medical Devices & Rad Health inspection of XCATH INC ending 10/26/2021 at the location in Houston TX, United
Copy of the disclosable portions of the complete FDA response for File Numbers 2018-9139, 20206502, and 2019-1023.
Report and/or the MDSAP Noncomformity Grading and Exchange Form (NC) for the inspection of Siemans Medial
Solutions USA, Inc, Plymouth Meeting, PA , end date 05-22-2015. FEI# 3002626007. This inspection pertains to medical
devices.
Copy of the disclosable portions of the complete FDA response for the following File Numbers: 2018-3527, 2018-5018,
2018-4382, and 2018-6396.
and 2017-6601.
Solutions USA, Inc., Issaquah, WA , end date 05-19-2015. FEI# 3023245. This inspection pertains to medical devices.
Regulatory Assessment of BioLife Plasma Services L.P. Located at Riverdale Park MD United States FEI Number:
3011687629 held on 04/27/2021.
for Medical Devices & Rad Health inspection of Institute of Regenerative and Cellular Medicine ending 10/19/2021 at
the location in Santa Monica CA, United States. The 483 (in electronic format) for Medical Devices & Rad Health
inspection of Integrity United Inc ending 10/18/2021 at the location in Anaheim CA, United States. Please send
PERJETA RECS
TREATMENTS FOR COVID 19
Regulatory Assessment of CSL Plasma Inc. Located at Baltimore MD United States FEI Number: 3012614076 held on
04/21/2021.
Regulatory Assessment of CSL Plasma, Inc. Located at Chattanooga TN United States FEI Number: 1047115 held on
04/27/2021.
Regulatory Assessment of CSL Plasma, Inc. Located at Pensacola FL United States FEI Number: 1072730 held on
04/22/2021.
for Medical Devices & Rad Health inspection of Terumo (Philippines) Corporation ending 02/04/2016 at the location in
Binan, Laguna, Philippines. The EIR (in electronic format) for Medical Devices & Rad Health inspection of Terumo
(Philippines) Corporation ending 02/04/2016 at the location in Binan, Laguna, Philippines. Please send documents as
email attachments.
for Medical Devices & Rad Health inspection of Yukon Medical, LLC ending 04/06/2018 at the location in Durham NC,
United States. The EIR (in electronic format) for Medical Devices & Rad Health inspection of Yukon Medical, LLC ending
04/06/2018 at the location in Durham NC, United States. Please send documents as email attachments.
for Animal Drugs & Feeds inspection of Best Formulations Inc ending 09/30/2021 at the location in City Of Industry CA,
United States. The EIR (in electronic format) for Animal Drugs & Feeds inspection of Best Formulations Inc ending
09/30/2021 at the location in City Of Industry CA, United States. The Response (in electronic format) for Animal Drugs &
Feeds inspection of Best Formulations Inc ending 09/30/2021 at the location in City Of Industry CA, United States.
The appeals log or spreadsheet record showing appeals logged by FDA FOIA department in the month of August 2021
All documents relating to any communications and/or documents between the FDA
and Novartis Pharmaceuticals Corporation and/or Novartis International AG concerning the June
11, 2020, Beovu (brolucizumab) label update. etc
Any templates, flowcharts, decision trees, tables, checklists, algorithms and output formats used in the creation and
deployment of KASA (knowledge aided assessment and structured application) for ANDA for solid oral dosage forms.
The request covers the discipline review areas for drug substance, drug product, manufacturing facility and
biopharmaceutics.
Docket No. 78N-301 External Analgesic Effectiveness data/study data on Camphor in: OTC Volume 060008. OTC Volume
060009. OTC Volume 060029. OTC Volume 060031. OTC Volume 060040. OTC Volume 060051.
Establishment Investigation Report on Safetec of America /Safetec of America
I request a copy of any and all records related to McKinsey & Company’s disclosures of possible conflicts of interest to
the following federal awards from the Food and Drug Administration: Award ID 75F40120P00388 etc.
I would like to request any and all of the following communications between the FDA (and its various agencies) and
Global Healing Center, LLC or Infowars. *Any written warnings given to Global Healing Center and/or Infowars in
reference to their production of dietary supplements. *Any inspection records of the production sites of Global Healing
Center, specifically the warehouse in Houston, Texas or Arizona. etc
Any and all records relating to Dr. Stanislaw Burzynski, as well as the Burzynski Clinic in Houston, Texas.
All documents related to any filings Eagle River Importers from for a cigarette brand BRONCO.
2018-2164
2019-10678
Foreign Remote Regulatory Evaluation that you made of the FDA - FRRA Colombina S.A. (Colombia) - September 7 to
2021-September 13, 2021, by the researcher Tressa Lewis.
On behalf of Kerry Inc. I would like to request for expedited FOIA for all recalls and Voluntary recalls for all Kerry
facilities in the USA and any as a result of any RecaLl/VR caused by Kerry products from another company.
On behalf of Kerry Inc. I would like to request for expedited FOIA for all recalls and Voluntary recalls for all Kerry
facilities in the USA and any other recalls/VR as a result of any caused by Kerry products from another company.
On behalf of Kerry Inc. I would like to request for expedited FOIA for any and all 483 issued to Kerry facilities in the USA
and any 483’s issued to another company as a result of any Kerry products. If possible, please separate the regulatory
violations and the Food safety violations. feel fee to even use a spread sheet/excel
FDA 510K number K911831 ThinPrep processor
Hi, I would like to receive the full list of approved ingredients for cosmetic use.
Most recent approved labeling (insert, as well as container and carton labels if available) for NDA 016801, which is a
designated Reference Listed Drug for purposes of ANDA development.
Please provide all Vaccine Adverse Event Reporting System (“VAERS”) reports relating to VAERS ID 1794960.
All documents provided to National Public Radio in response to 2020-5837
All documents provided to Reuters News in response to 2021 -5299.
Copies of FDA communications with Novavax and/or Fujifilm Diosynth Biotechnologies that discuss preparation and
quality control for manufacturing covid-19 vaccine at the manufacturing facility located at 100 Discovery Drive, Suite
200, College Station, TX 77845 Establishment Number 301198449."
FDA’s pre-approval and pre-license inspection reports as well as any follow-up communication to those reports issued
for the Novavax/ Fujifilm Diosynth Biotechnologies manufacturing facility located at 100 Discovery Drive, Suite 200
College Station TX 77845. FDA Establishment number 301198449.
I am seeking all emails received by the following emails: Janet Woodcock MD, Julia Tierney and Stephen Hahn, MD sent
by Robert M. Califf, MD from March 1, 2020 to the present date. Should specific email accounts be required for the
search, Dr. Califf uses: robert.califf@duke.edu as well as a stanford.edu account, and may possibly use a private account.
All records regarding the investigation, handling,and recall of beef products from New Seasons Markets in 2019 and
2020. All records regarding the investigation into Country Natural Beef, Inc., d/b/a Oregon Country Beef and allegations
of Escherichia Coli (E. Coli).
Copies of any FOIA requests received by your office.
FDA-CDRH-19-MP-10465275
1. Establishment Inspection Report Amendment 1 with Dates of Inspection 08/10/2021 - 08/25/2021 for Arizona
Nutritional Supplements LLC located at 14700 Nw 60th Ave Miami Lakes FL 33014-2813. FDA Registration Number
13769606674, FEI Number 3014901099. AND 2. A Redacted Establishment Inspection Report with Dates of Inspection
08/10/2021 - 08/25/2021 for Arizona Nutritional Supplements LLC located at 14700 Nw 60th Ave Miami Lakes FL 33014-
2813. FDA Registration Number 13769606674, FEI Number 3014901099.
All product registration information and subsequent supplements for application N022308 as per the attached request
letter.
Product registration information and all subsequent supplements for application A062874 as per the attached request
letter
Product registration information and all subsequent supplements for application N013422 as per the attached request
letter
letter
letter
letter
letter
letter
letter
Complete record of received Form FDA 3911 (Drug Notification) from any trading partners of drug supply chains
Any documentation received from or sent to Pfizer Inc. regarding the release date of the data from the COVID-19
vaccine trial for 6-month to 4-year old children.
I am requesting any studies/information on how the FDA determined that the COVID 19 vaccine is safe for
pregnant/breastfeeding women. I'm also requesting any information on the approval of vaccination boosters despite
the vaccine injuries being reported and suppressed by media, big tech, the government etc.
I am seeking the estimated number of people affected by each approved orphan indication (estimated prevalence).
2016-8986, 2016-9068, 2016-9074, 2016-9139, 2016-9144.
2016-9165, 2016-9170, 2016-9206, 2016-9236, 2016-9258.
2016-9290, 2016-9437, 2016-9455, 2016-9460, 2016-9462.
2016-9524 2016-9548, 2016-9575, 2016-9577, 2016-9581.
IRBs both in the United States and outside the United States that received such notices dated from October 1 to 31,
Interested in documents related to control numbers: 2021-5729, 2021-5730, 2021-5792 , 2021-5937, 2021-5951,
2021-6013, 2021-6014, 2021-6028, 2021-6149, 2021-6704
Interested in documents related to control numbers: 2021-6743, 2021-6789, 2021-6901 , 2021-6970, 2021-6983,
2021-7022, 2021-7128, 2021-7174, 2021-7185, 2021-7316
for Human Drugs inspection of Greenbrier International, Inc ending 10/05/2021 at the location in Chesapeake VA,
for Human Drugs inspection of OurPharma LLC ending 09/30/2021 at the location in Fayetteville AR, United States.
for Human Drugs inspection of Signature Formulations, LLC ending 09/30/2021 at the location in Phoenix AZ, United
for Human Drugs inspection of Xcelience LLC ending 10/01/2021 at the location in Tampa FL, United States. Please send
for Biologics inspection of Nova Laboratories Limited ending 03/12/2019 at the location in Wigston, United Kingdom.
The Response (in electronic format) for Biologics inspection of Nova Laboratories Limited ending 03/12/2019 at the
location in Wigston, United Kingdom. Please send documents as email attachments.
for Human Drugs inspection of Mount Sinai School of Medicine IRB #5 - Board D ending 08/20/2003 at the location in
New York NY, United States. etc
Data from RCT of renal effect of SGLT2s. (EMPEROR, CREDENCE, CANVAS, DAPA-CKD, EMPA-REG, DECLARE-TIMI 58, )
Any document containing a written description or analysis of the FDA's statutory interpretation that a manufacturing
facility inspection must be conducted on-site by FDA personnel and that the provision in FDCA 704(a)(4) regarding
requesting documents in-lieu of an inspection cannot be read to authorize the documents in-lieu of an inspection as a
valid inspection equivalent.
Any documents, files, or records from the Food and Drug Administration's Center for Biologics Evaluation and Research,
or CBER, that may show the receipt of a complaint in September 2020 related to Ventavia Research Group's work on
Pfizer's Phase III trial for the COVID-19 vaccine
Looking for all 510K files for K112800. United Health products is rightful patent and technology owner and has a named
to file letter submitted in 2016.
all of Takeda response to 483 issued to Takeda Hikari (FEI 3004664162) on Nov.26, 2019
INVESTIGATION RECS
Form 483 regarding Philips medical company and their CPAP devices. The form concerns the use of their silicone based
foam used in the CPAP device that may degrade during the lifetime of use of the machine and become toxic.
The complete Adverse Event Reports (“AERs”) associated with the following Case Numbers, including all segregable,
non-exempt information: • 19684468 • 19484255 • 19609302 • 19519688 • 18768030 • 18542198 •
18469029 • 18240493 • 17375417 • 17293631 • 17438513 • 16134672 • 16399113 • 16265341
Investigational Drugs, Medical Devices, that applied, and were approved, for expanded access, as well as the result
reports submitted
FSIS NARMS data for California from 2013-2021 including HAACP and cecal sampling for all sampled livestock species
and the resulting antimicrobial susceptibility test results.
We are requesting a copy of Food Contact Notification (FCN) 2178 and all correspondence and FDA internal review
memoranda associated with it.
Requesting an unredacted copy of all memoranda or reports and any other documentation relevant thereto the
medical device Remote Regulatory Assessment (RRA) of Teleflex Medical, Annacotty Business Park, Annacotty Co.,
Limerick 123, Ireland
MORPHINE SULFATE ORAL SOLUTION 100 MG / 5ML NDC: 0054-0404-44 model labeling template for CARTON FOR 15
mL PACK SIZE model labeling template for CARTON FOR 30 mL PACK SIZE
K160016
BNF 138 Administrative Record
K011208
K161315
All materials (including correspondence and investigational materials) regarding Cassava Sciences and its drug
Simufilam/ PTI-125.
All documents related to on-site or virtual FDA inspections for all the subsidiaries and locations/sites of: Lonza Vetter
Pharma Cardinal Health
A copy of any checklist or similar list used by the Office of Generic Drugs when reviewing the appropriateness and
adequacy of a CBE Supplement (both a CBE-30 and CBE-0) and a Prior Approval Supplement to an ANDA for a site
transfer of an Immediate-Release drug product and for a new API supplier.
A copy of any FDA correspondence, memoranda, or determinations contained in ANDA 203976 (PAR PHARM INC.) for
Colchicine Tablets, 0.6 mg, dated between September 1, 2016 and October 31, 2016, concerning patent certification
requirements and 180-day exclusivity.
K982278
K961100
Requesting evidence of FDA approval of a Covid-19 vaccine that is administered in the United States of America.
This is a request under the Freedom of Information Act. I hereby request the following records: Any and all documents,
be they electronic or otherwise, pertaining to preliminary warnings sent to the Multidisciplinary Association for
Psychedelic Studies (MAPS) about clinical trial reports / results that were late or not submitted. etc
This is a request under the Freedom of Information Act. I hereby request the following records: Any and all email
correspondence between executives at the company Compass Pathways and the FDA about Compass Pathways clinical
trials. etc
(1) All communications* between FDA (including, but not limited to, FDA’s Center for Drug Evaluation and Research
(“CDER”)) and the United States Pharmacopeial Convention (“USP”) from January 1, 2014, to the present regarding the
following subjects: (a) compounding of human or animal drugs; (b) pharmacy compounding; or (c) proposed or potential
revisions to USP standards for compounding of human or animal drugs, etc
All reports of adverse events and/or side effects for Vimpat (aka lacosamide), including but not limited to those
submitted through the following channels: -Via the FDA's hotline (1-800-FDA-1088) -Via the FDA's MedWatch Online
Voluntary Reporting Form (https://www.accessdata.fda.gov/scripts/medwatch/) -Via physical forms submitted by health
professionals (FDA Form 3500) and consumers (FDA Form 3500B)
Any documents, files, or records from the Food and Drug Administration related to any
inspections or investigations conducted by the FDA's Office of Regulatory
Affairs—including the division's Office of Biological Products Operations—into any
complaints submitted by Ventavia Research Group employees or contractors that
pertained to Pfizer's Phase III trial for the COVID-19 vaccine in 2020.
1,106 Zepatier FAERS Case Reports. Please see attached.
All releasable documents relating to the new infant formula submission made pursuant to 21 C.F.R. 106.120 by Perrigo
Company plc to the Center for Food Safety and Applied Nutrition regarding Perrigo’s Gentle® Non-GMO Infant Formula.
FAERS case reports for Januvia, Steglatro, etc.
FDA 483 issued for the inspection conducted on 06 April 2015 and classified OAI for Valens Molecules Private Ltd (FDA
FEI 3001329340). FDA close-out letter for FDA Warning Letter 320-13-23 issued on 02 August 2013
Hill Dermaceuticals, Inc 1. Establishment Inspection Report (EIR) for the Inspection by FDA initiated on 07/26/2021
of Hill Dermaceuticals, Inc.’s facility in Sanford Florida.
Form FDA 483 / EIR and Correspondence: Cross Brands Contract Filling LLC -- Melbourne, FL End Date of inspection: July
19, 2021
Form FDA 483 and Correspondence: Oxygen Development Llc Palm Springs, FL End Date of inspection: January 17, 2018
Inspectional reports (e.g. EIR's) conducted at AccelLAB, a Charles River Company located at: 1635 Lionel-Bertrand
Boisbriand, Quebec, Canada J7H 1N8
MORPHINE SULFATE ORAL SOLUTION 10 mg / 5 mL - NDC - 0054-0237-49 - 100 mL; Pack size model labeling template
for CARTON. MORPHINE SULFATE ORAL SOLUTION 20 mg / 5 mL - NDC - 0054-0238-49 - 100 mL; Pack size model
labeling template for CARTON.
Misdeclared FSVP importer. Our DUNS# 024064040. Date range unknown but presume within last 2 months. We are
NOT an FSVP importer and never have been. We need to know who has declared us as such. Thank you for your help.
Nowcos Co., Ltd 37, Ayamok-gil Sejeong-myeon Sojeong-si, (South) Korea FDA 483, EIR, and Correspondence
documents for FDA Inspection Concluded September 06, 2019
Please provide copies of all tobacco related (including cigarette; electronic cigarette; electronic nicotine or vaping
product; or tobacco heating system) product injury/adverse event/reaction reports voluntarily reported to the FDA
Center for Tobacco Products, the FDA Safety Reporting Portal, MedWatch program, and the FDA Adverse Event
Reporting System from February 2021 – November 2021.
for Medical Devices & Rad Health inspection of Neurodynamics, Inc. ending 07/21/2021 at the location in New York NY,
for Human Drugs inspection of Grant Industries, Inc. ending 08/21/2020 at the location in Elmwood Park NJ, United
for Foods & Cosmetics inspection of New Spirit Naturals Inc. ending 08/24/2021 at the location in San Dimas CA, United
States. The 483 (in electronic format) for Foods & Cosmetics inspection of Aie Pharmacueticals, Inc. ending 09/17/2021
at the location in Ontario CA, United States. Please send documents as email attachments.
for Human Drugs inspection of Cambridge Isotope Laboratories, Inc. ending 12/09/2020 at the location in Tewksbury
MA, United States. The Response (in electronic format) for Human Drugs inspection of Cambridge Isotope Laboratories,
Inc. ending 12/09/2020 at the location in Tewksbury MA, United States. Please send documents as email attachments.
for Human Drugs inspection of Epic Pharma, LLC ending 02/01/2019 at the location in Laurelton NY, United States. The
Response (in electronic format) for Human Drugs inspection of Epic Pharma, LLC ending 02/01/2019 at the location in
Laurelton NY, United States. Please send documents as email attachments.
The Summary Basis of Approval, the Medical Officer’s Review, Chemistry Review, approved labeling and all information
concerning the studies performed by or for the Application Holder concerning the effectiveness of the product listed
below. LIDOCAINE HYDROCHLORIDE (LIDOCAINE HYDROCHLORIDE) SOLUTION; TOPICAL; 4% A088803 / Apr 3, 1985
below. LIDOCAINE HYDROCHLORIDE (LIDOCAINE HYDROCHLORIDE) SOLUTION; TOPICAL; 4% TELIGENT PHARMA INC
A204494 / Mar 12, 2014
below. LIDOCAINE HYDROCHLORIDE (XYLOCAINE 4% PRESERVATIVE FREE) SOLUTION; TOPICAL; 4% FRESENIUS KABI USA
LLC N010417 /002 / Approved Prior to Jan 1, 1982
We request all the records obtained by FDA in accordance with the FSVP regulation of the "Foreign Supplier’s Safety
Procedures, Processes and Practices Related to the Safety of the Food" for FDA product code 09CEE13
from NESTLEW MEXICO SA DE CV Street Address: Frente Estacion Ffcc, Col. Pueblo De Moya City: Lagos De Moreno
Jalisco 50071 México DUNS Number: 81-271-6819 FEI Number: 3014297337.Also, all the information relevant to this
kind of verification activities required by this rule. 21 CFR 1.510(f)
With respect to the ARx LLC manufacturing facility located at 400 Seaks Run Road, Glen Rock, PA 17327, (i) a list of all
in-person manufacturing facility inspections, including the date of the inspection, purpose of the inspection, location of
the inspection, and manufacturer name, completed from January 1, 2019 to November 30, 2021 etc
I am requesting FOIA case logs, in an electronic (spreadsheet) format, from 6/1/2020 to 11/1/2021 Typically a FOIA log
includes: The log or file number The date the request was received The name of the person or organization making the
request A description of the information sought The date the response was sent The type of response sent (granted,
denied or partial release)
Pursuant to the federal Freedom of Information Act, 5 U.S.C. § 552, I am requesting access to the following human drug
adverse events reports, associated with the drug Aduhelm/adcuanumab. The case numbers here come from the FAERS
public dashboard. 19787426 19882791 19629797 19652971 19615330 19463117 19726309 19810715 19583970
Please see attached.
Any and all email correspondence between executives at the company Atai Life Sciences and the FDA about Atai’s or
Atai’s portfolio companies’ drug clinical trials. Any and all documents, be they electronic or otherwise, relating to Atai
Life Sciences’ drug clinical trials. Any and all complaints filed to the FDA relating to Atai Life Sciences or Atai Life
Science’s drug clinical trials.
Any and all email correspondence between executives at the company Cybin and the FDA about Cybin’s drug clinical
trials. Any and all documents, be they electronic or otherwise, relating to Cybin’s drug clinical trials. Any and all
complaints filed to the FDA relating to Cybin or Cybin’s drug clinical trials. The requested documents will be made
available to the general public, and this request is not being made for commercial purposes.
Any and all email correspondence between executives at the company Field Trip Health (or just Field Trip) and the FDA
about Field Trip Health’s drug clinical trials. Any and all documents, be they electronic or otherwise, relating to Field
Trip Health’s drug clinical trials. Any and all complaints filed to the FDA relating to Field Trip Health or Field Trip Health’s
drug clinical trials.
This is a request under the Freedom of Information Act. The product area at issue is drugs and drug clinical trials. I
hereby request the following records: Any and all email correspondence between executives at the company GH
Research and the FDA about GH Research’s drug clinical trials. Any and all documents, be they electronic or otherwise,
relating to GH Research’s drug clinical trials. Any and all complaints filed to the FDA relating to GH Research or GH
Research’s drug clinical trials.
The product area at issue is drugs and drug clinical trials. I hereby request the following records: Any and all email
correspondence between executives at the company MindMed and the FDA about MindMed’s drug clinical trials. Any
and all documents, be they electronic or otherwise, relating to MindMed’s drug clinical trials. Any and all complaints
filed to the FDA relating to MindMed or MindMed’s drug clinical trials.
(1) All documents to show proof (scientific evidence) that SARS-COV-2 (COVID-19) has been isolated by testing through
the proper standards. (2) All documents in support of Natural Immunity as it relates to SARS-COV-2 (COVID-19). etc
K123975 etc
Please provide the MedWatch for FAERS Case 18917345 for the product OMADACYCLINE.
Please provide the MedWatch for FAERS Case ID19269619 for the product OMADACYCLINE.
• All investigative records, documents, and communications concerning Recall Event ID 87516, recalling The Toasted
Oat Bakehouse Blueberry Cobbler Soft Granola (6 -10 oz pouches per case); Soft Granola Crumble Bars Blueberry
Cobbler (5 - 28.3g bars per pack/6 packs per case); Macadamia Chunk Soft Granola (6 - 10oz pouches per case); Soft
Granola Crumble Bars Macadamia Chunk ( 5 - 28.3g bars per pack/6 packs per case); Cherry Streusel Soft Granola (6 -
10oz pouches per case); etc
RACE/ETHNICITY DATA FOR COVID VACCINE VAERS
NDA 017469
Copies of Form 483s issued to the following DEVICE companies from September 1-30:
Copies of Form 483s issued to the following DEVICE companies on the indicated date
Copies of Form 483s issued to the following DRUG companies from September 1-30:
483 issued to Biological E. Limited, Hyderabad, India
Pursuant to the Freedom of Information Act (FOIA), 5 U.S.C. § 552, as amended, and the regulations promulgated by
the U.S. Food and Drug Administration (“FDA”) in 21 C.F.R. Part 20, I hereby request a report of all FOIA requests filed
with FDA’s Center for Food Safety and Applied Nutrition (“CFSAN”), including related offices, from September 1, 2021
through September 30, 2021.
Corporation, Maple Grove, MN , end date 04-16-2015. FEI# 3002095335. This inspection pertains to medical devices.
Corporation, Maple Grove, MN , end date 04-16-2015. FEI# 3002095335. This inspection pertains to medical devices.
devices.
devices.
Copy of the disclosable portions of the REMS review for ANDA 209348, Lenalidomide, approved 10/14/2021.
Regulatory Assessment of BioLife Plasma Services LP Located at Ames IA United States FEI Number: 3001629960 held on
11/18/2020.
Regulatory Assessment of BioLife Plasma Services LP Located at Moorhead MN United States FEI Number: 3006769911
held on 11/18/2020.
Regulatory Assessment of Biomat USA, Inc Located at Frederick MD United States FEI Number: 3003885812 held on
11/16/2020.
Establishment Inspection Record for Collaborative Care Diagnostics LLC dba Biomedix Address 860 Blue Gentian Rd,
Suite 180 Eagan, MN 55121 Close date 10/18/2021
Regulatory Assessment of The Procter & Gamble Manufacturing Company Located at Phoenix AZ United States FEI
Number: 2021299 held on 11/18/2020.
Please provide Summary Basis of Approval of MYRBETRIQ GRANULES (mirabegron for extended-release oral suspension)
8 mg/mL for the Applicant ASTELLAS PHARMA GLOBAL DEVELOPMENT INC- N213801
Copy of the disclosable portions of the original request letter and complete FDA responses for the following File
Numbers: 2021-5002; 2021-5793.
All contents of the file labeled "Homeopathy File" as cited in footnote 131 of Suzanne White Junod's article entitled "An
Alternative Perspective: Homeopathic Drugs, Royal Copeland, and Federal Drug Regulation" from the Food and Drug
Law Journal, 200, Vol. 55, No 1 (2000), pp. 161-183. This file labeled "Homeopathy File" is referenced in the footnote to
be housed in the FDA History Office, Rockville, MD.
Please consider this a request for a copy of the Citizen Petition (CP) filed in 2020 that involves a drug called Xifaxan. This
CP was referenced in a letter dated 9/17/21 that was filed in a lawsuit that is currently pending in the U.S. District Court
for the District of Delaware (case #: 1:20-cv-00430). Please see the highlighted paragraph on page 3 of the attached
letter for the reference at issue. Thank you.
Request is related to CLIA Waiver Application of YD Diagnostics Corp. URiSCAN Optima Urine Chemistry Test System,
2ACR Urine Strips (Microalbumin/Creatinine) Document Numbers CW150013 / CR180515 .
Request is related to CLIA Waiver Application of Acon Laboratories Mission Urinalysis Reagent Strips
(Microalbumin/Creatinine) CW160010 / CR 180218
Please produce all records relating to FDA's and/or CDC's investigation of the outbreak of acute non-viral hepatitis
(starting in late 2020) that was potentially associated with consumption of the alkaline water product called "Real
Water." Please produce any data, interviews, witness statements, reports, forms, inspection records, analyses, data
analyses, or other documents associated with this "Real Water" outbreak. PHI may be redacted.
Hi, I'm writing seeking information on products tested by the Forensic Chemistry Center in the report "EVALI Vaping
Liquids Part 1: GC-MS Cannabinoids Profiles and Identification of Unnatural THC Isomers"(PMCID: PMC8499677, PMID:
34631667). Specifically, I am seeking any testing data related to any products labeled "3chi", "3 chi", "skyhio", and
"reefer's bay" during the relevant time period.
Any and all records relating to inspections, complaints, investigations, recalls, corrective or disciplinary action taken
against Producers Cooperative Association 300 E. Buffalo Girard, KS 66743, over the last 20 years.
I request under the FOIA copies of all lot release notices (the term from SOPP 8408.3) provided to the relevant
manufacturer releasing a lot or lots of Comirnaty (COVID-19 Vaccine, mRNA) pursuant to BLA license 2229 / STN
125742, the approval letter for which provides that BioNTech Manufacturing many not distribute any lots of product
until it receives a "notification of release" from Director, CBER.
Schedule for Dr. Billy Dunn from May 1, 2019 to June 30, 2021.
Any emails, memos, or other correspondence dated from May 1, 2019 to June 30, 2021 (1) sent TO or FROM Dr. Janet
Woodcock, Dr. Patrizia Cavazzoni, Dr. Billy Dunn, Dr. Kevin Krudys or Dr. Tristan Massie (2) AND containing the words
“Biogen,” “Aducanumab,” “Aduhelm,” “Study 301” OR “Study 302”
FOIA Request for MedWatch, FDA Case ID: 19576094, FDA Case ID: 19613629, FDA Case ID: 19840074
Has CBER approved Pfizer BioNTech Covid-19 vaccine EUA lots for BLA compliance and if so has there been a Dear HCP
letter issued stating BLA compliant EUA lots? Additionally if the EUA lots are considered BLA compliant are there any
legal differences between Comirnaty and EUA Pfizer BioNTech Covid-19 vaccine?
2020-7077. • Control # 2020-7078. • Control # 2020-7117. • Control # 202-7139. • Control # 2020-7140. •

Control # 2020-7141. • Control # 2020-7142. • Control # 2020-7143. • Control # 2020-7147. • Control # 2020-
7148.
RECS RE ASBESTOS IN COSMETICS
Amerilab Technologies, Inc. 2765 Niagara Lane North | Plymouth, MN 55447 Requesting any records of 482, 483
2020-86 2020-3835
for Biologics inspection of CSL Behring LLC ending 09/24/2021 at the location in Bradley IL, United States. Please send
for Biologics inspection of Fenwal International, Inc. ending 09/24/2021 at the location in Maricao PR, United States.
for Biologics inspection of Merck Sharp & Dohme Corp. ending 07/27/2021 at the location in West Point PA, United
for Biologics inspection of North Louisiana Tissue Bank ending 09/24/2021 at the location in West Monroe LA, United
for Biologics inspection of Sabine S. Hazan, M.D. ending 09/21/2021 at the location in Ventura CA, United States. Please
for Foods & Cosmetics inspection of AJES Pharmaceuticals LLC ending 10/14/2021 at the location in Copiague NY, United
for Human Drugs inspection of PLD Acquisitions LLC ending 09/21/2021 at the location in Doral FL, United States. Please
for Medical Devices & Rad Health inspection of Medtronic Inc. ending 07/07/2021 at the location in Northridge CA,
format) for Medical Devices & Rad Health inspection of Abbott Laboratories Inc. (St Jude Medical) ending 03/29/2019 at
the location in Saint Paul MN, United States. Please send documents as email attachments.
Active Ingredient: PSEUDOEPHEDRINE HYDROCHLORIDE Proprietary Name: SUDAFED 24 HOUR Dosage Form; Route
of administration: TABLET, EXTENDED RELEASE; ORAL Strength: 240MG Reference Listed Drug: Yes Label is not
available. Reference Standard: Yes TE Code: - Application Number: N020021 Product Number: 002 Approval
Date: Dec 15, 1992 Applicant Holder Full Name: JOHNSON AND JOHNSON CONSUMER INC MCNEIL CONSUMER
HEALTHCARE DIV Marketing Status: Over-the-counter
demyelinating polyradiculoneuropathy, demyelinating polyneuropathy, Guillain-Barre syndrome, Miller Fisher
syndrome, etc
We have had 7 entries of honey recently sampled. We are requesting the lab test results for the tests that were
conducted. See request letter for more information. Thanks!
Please provide the MedWatch for FAERS Case ID19860897 for the product OMADACYCLINE.
Requesting a second first party copy of the EIR for Ferring Pharmaceuticals Inc, FEI # 1000119907, NAI, 08/24/2020,
Parsippany, NJ 07054-1149 (BIMOE).
I am requesting the same information that was released for K001277 in 2018-6146 and 2018-6147 related to the
Triflange, 510K K001277. Thank you.
Cleared 510(K) K213163 whole submission and associated FDA review queries and applicant's responses.
Request for 510(k) K974793, Class II, Pro-code GEI, for Elmed 120 M/M Digital
Case reports from the adverse events reported for the drug Aduhelm.
I would like to request a copy of the case report for a 75 female who died after experiencing Amyloid-related imaging
abnormalities (ARIA) while taking Aduhelm/aducanumab. The case is listed in FAERS under the number 197874426.
I request access to and copies of the complete file, including but not limited to any and all notes, statements, reports,
supplementary reports, diagrams, and recordings relative to reported contaminated vials of Kenalog 40 40 mg, Lot
#ABF4133 and #ABF3576 from Manufacturer Bristol Myers Squibb bearing expiration date March 1, 2021.
We seek the following documents concerning Spectrum Pharmaceuticals, specifically related to the Hanmi plant
inspection in South Korea conducted in May and/or June 2021: - All Form 483s - Spectrum's responses to any 483s - Any
Establishment Inspection Reports (EIRs) - The Complete Response Letter (CRL)
We want to know all the details of these import refusal in 2018. Reviewing the information from the FDA we found
that we have registered a import refusal in 2018 (FEI Number: 3006480194) corresponding to a chili souce.
We would like to request the full audit report from the audit made on July 2015 to Global Protection Corp.
Dear Sir or Madam, in reference to the FOIA, I would like to ask if it is possible to receive the technical
documentation/design dossier (or parts of it) of the GORE VIATORR TIPS (PMA P040027).
for Human Drugs inspection of Catalent Pharma Solutions LLC ending 08/02/2021 at the location in Winchester KY,
for Human Drugs inspection of Woodstock Sterile Solutions Inc ending 05/28/2021 at the location in Woodstock IL,
for Human Drugs inspection of BioMarin Pharmaceutical, Inc. ending 12/14/2017 at the location in Novato CA, United
States. The Response (in electronic format) for Human Drugs inspection of BioMarin Pharmaceutical, Inc. ending
12/14/2017 at the location in Novato CA, United States. etc
I am requesting that this agency turnover all raw data related to Pfizer-Biotech mRNA COVID-19 vaccine safety,
Moderna mRNA COVID-19 vaccine safety, and Johnson & Johnson's Janssen COVID-19 vaccine safety.
I request under the FOIA a copy of any record or memoranda documenting the CBER/OCBQ/DBSQC discipline review for
Lot Release in the case of BLA license 2229 / STN 125742. The discipline review is referred to on page 2 of the SBRA (top
left box, last bullet).
I request under the FOIA copies of all lot release notices (the term from SOPP 8408.3) (or other equivalent document(s)
serving the same purpose) provided to the relevant manufacturer releasing a lot or lots of EUA-labeled bnt162b2
vaccine, licensed as Comirnaty (COVID-19 Vaccine, mRNA) pursuant to BLA license 2229 / STN 125742, and releasing
those lots according to the arrangement discussed in the August 23, 2021, SBRA, paragraph 10a, page 27
I request under the FOIA copies of all records submitted by the applicant for BLA license 2229 / STN 125742 addressed
or referred to by the comment in the August 23, 2021, SBRA, paragraph 10a, page 27
Copies of Form 483s issued to the following CLINICAL INVESTIGATOR from June 1-30.
Copies of Form 483s issued to the following DEVICE companies In June, 2021.
Copies of Form 483s issued to the following DEVICE companies in June, 2021.
Copies of Form 483s issued to the following DRUG companies in June, 2021.
Electronic listing (preferably csv format) of all inspections conducted by FDA since July 1, 2021. The list should cover all
format) for Biologics inspection of Allergan Pharmaceuticals Ireland ending 12/17/2019 at the location in Westport,
Ireland. Please send documents as email attachments.
for Human Drugs inspection of Adamson Analytical Laboratories, Inc. ending 03/23/2021 at the location in Corona CA,
United States. The Response (in electronic format) for Human Drugs inspection of Adamson Analytical Laboratories, Inc.
ending 03/23/2021 at the location in Corona CA, United States. Please send documents as email attachments.
Records related to the following cases involving the use of Xifaxan/Rifaximin in association with hepatic
encephalopathy. Case ID numbers: 12700575 12704401 12726338 12733415 12743874 13032980 13089923 13122285
13209263 13286430 13328293 13402349
Final FDA reviews of NDA 021318/S-054 concerning removal of the Boxed Warning regarding osteosarcoma from
FORTEO (teriparatide injection), in particular any Summary Review, Medical Review, Labeling Review, or Cross-
Disciplinary Team Leader Review.
RE: Midwestern Pet Foods, Chickasha, OK: Please supply complete Establishment Inspection Report and any subsequent
communication between the above-cited company and the FDA pursuant to the inspection of the Chickasha production
facility carried between December 31, 2020 and February 5, 2021.
RE: Midwestern Pet Foods, Evansville, IN: Please supply FDA Form 483 (if issued), complete Establishment Inspection
Report, all lab test results (if carried out), and any subsequent communication between the above-cited company and
the FDA pursuant to the inspection of the Evansville production facility carried between February 1, 2021 and March 3,
2021.
RE: Midwestern Pet Foods, Waverly: Please supply FDA Form 483 (if issued), complete Establishment Inspection Report,
all lab test results (if carried out), and any subsequent communication between the above-cited company and the FDA
pursuant to the inspection of the Waverly production facility carried between February 9, 2021 and February 23, 2021.
All information related to the Covid 19 vaccine (EAU and FDA approved) in relation to tuberculous infection and Latent
TB
All submission documents related to the 510(k) Premarket Notification K202416 that are releasable under the Freedom
of Information Act.
Provide the Product information Leaflet (PIL) for the following listed drugs 1. PROLIXIN (Fluphenazine Hydrochloride)
tablets 1mg, 2.5mg, 5mg and 10mg NDA #011751 of Apothecon Inc Div Bristol Myers Squibb. 2. PERMITIL (Fluphenazine
Hydrochloride) tablets 0.25mg, 2.5mg, 5mg and 10mg NDA #012034 of Schering Corp Sub Schering Plough Corp.
Request to provide the Summary basis of approval (SBOA) ANDA #208518
Request to provide the Summary basis of approval (SBOA) of ANDA 207004
Request to provide the Summary basis of approval (SBOA) of ANDAs
Summary basis of approval (SBOA) for ANDA #215037
Midwestern Pet Foods, Monmouth, IL: Please supply FDA Form 483 (if issued), complete Establishment Inspection
Report, all lab test results (if carried out), and any subsequent communication between the above-cited company and
the FDA pursuant to the inspection of the Monmouth production facility carried out between the dates of February 2,
2021 and April 16, 2021.
We are seeking the 510(k) submission records for the medical device named HipXpert System with 510(k) number
K200384. We are considering this device as our predicate and the documentation will be helpful to assess the
substantial equivalence. The 510(k) letter is dated January 28, 2021.
Dear Sir/Madam, We would like to request the Complete Summary Basis of Approval (SBOA) including chemistry
review, Biopharmaceutics review and FDA Final Reviews of the Original NDA, CLARITIN-D 12 hour- loratadine 5 mg and
pseudoephedrine sulphate 120mg tablet, extended release, N019670 approved on Nov 27, 2002.
Seeking inspection records for Philips Respironics
510(K) Number:- K210936 | Device Name:- Elvie Stride | Applicant:- Chiaro Technology Limited, 2nd Floor 63-66 Hatton
Garden, London, GB Ec1n 8le | Device Classification Name:- Pump, Breast, Powered | Regulation Number:- 884.5160 |
Classification Product Code: -HGX
Subject of FOIA: 510k submission records for K210805 and K191301
CV William R Chang, Decima L Thompson, Amy A Johnson, Jessica L Diliberti,etc
FDA 510(k) K210320
syndrome, subacute inflammatory demyelinating polyneuropathy, etc
Request for report related to VAERS ID# 846221. Please see the attached request and signed authorization.
2016-8873, 2016-8876, 2016-8878, 2016-8879, 2016-8910.
2016-9194, 2016-9212, 2016-9265, 2016-9288, 2016-9317.
2016-9334, 2016-9362, 2016-9413, 2016-9414, 2016-9415.
2021-6247, 2016-10169, 2016-8870, 2016-8871, 2016-8872.
CUB FOODS SAVAGE TOBACCO COMPLIANCE CHECK
BIOLOGICAL EFFECTS AND HEALTH IMPLICATIONS OF MICROWAVE RADIATIONS
for Human Drugs inspection of Johnson & Johnson Consumer, Inc ending 03/24/2021 at the location in Lancaster PA,
for Human Drugs inspection of Monarch PCM, LLC ending 08/20/2021 at the location in Fort Worth TX, United States.
483 for Pharmaceutics International (PII), Cockesysville MD for 09/29/2021. Please note this inspection pertains to
human drugs.
For the time period January 1, 2021 to present, the releasable FDA health hazard evaluation and all releasable related
documents and correspondence regarding FDA’s recall classification for the below recall numbers, which are recalls of
Lotrimin and Tinactin products initiated on October 1, 2021, and classified by FDA on November 18, 2021. Recall
numbers: D-0236-2022, D-0237-2022, D-0238-2022, D-0239-2022, etc
483: LICO Industries, LLC Mohave Valley, AZ End Dates of inspection: 08 July 2021 Project Area: Drug Quality
Assurance District Decision: VAI I confirm that Clarivate Analytics will be charged accordingly by FOI for this request,
Copies of Form 483s issued to the following CLINICAL INVESTIGATOR from July 1-31:
Copies of Form 483s issued to the DRUG company Novartis Pharmaceuticals on the indicated date.
Copies of Form 483s issued to the following DEVICE companies from July 1-31:
Copies of Form 483s issued to the following DRUG companies from July 1-31:
Copy of the disclosable portions of the Real Time Process Supplemental PMA for P040021, Supplement S047, pertaining
to approval for a modification to the sewing cuff components intended to increase valve radiopacity.
Novartis is requesting the Summary Basis of Approval document(s)for Verzenio (abemaciclib) for the recently approved
adjuvant/early breast cancer population as described in Supplements 6, 7, and 8 on November 12, 2021.
FAERS database for (lonapegsomatropin-tcgd) (brand name SKYTROFA)
FAERS database for enfortumab vedotin (brand name PADCEV).
FDA FAERS database for tucatinib (brand name TUKYSA).
FDA FAERS database for umbralisib (brand name UKONIQ).
FDA FAERS database for zanubrutinib (brand name BRUKINSA).

FDA MAUDE database for Tumor Treating Fields, also known as TTFields, NovoTTF-100L System, Optune, and Optune
Lua.
for Medical Devices & Rad Health inspection of DeVilbiss Healthcare LLC ending 08/25/2021 at the location in Somerset
PA, United States. Please send documents as email attachments.
for Medical Devices & Rad Health inspection of Respironics California LLC ending 01/10/2020 at the location in Carlsbad
CA, United States. The EIR (in electronic format) for Medical Devices & Rad Health inspection of Respironics California
LLC ending 09/10/2021 at the location in Carlsbad CA, United States. The Response (in electronic format) for Medical
Devices & Rad Health inspection of Respironics California LLC ending 09/10/2021 at the location in Carlsbad CA, United
for Human Drugs inspection of Nypro Inc. ending 03/21/2014 at the location in Clinton MA, United States. The EIR (in
electronic format) for Human Drugs inspection of Nypro Inc. ending 03/21/2014 at the location in Clinton MA, United
States. ETC
I am requesting FDA's internal review memoranda from Food Contact Notification's 513 and 2023. Additional details
are contained in the attached letters. Thank you.
ALL FORM 483, EIR, RESPONSE LETTERS, AND ANY OTHER COMMUNICATIONS WITH THE FDA BY/FOR ALLERGAN SALES,
LLC LOCATED AT 5000 BROTHERTON RD & 3941 BROTHERTON RD, CINCINNATI, OHIO 45209 AND 8301 MARS DR.
WACO, TX 76712-6578 AND 2525 DUPONT DR. IRVINE, CA 92612 AND 503 VANDELL WAY, SUITE E. CAMPBELL, CA
95008 USA.
ALL FORM 483, EIR, RESPONSE LETTERS, AND ANY OTHER COMMUNICATIONS WITH THE FDA BY/FOR AMERICAN
LABORATORIES LOCATED AT 11111 M STREET, SUITE 110 OMAHA NE 68137.
ALL FORM 483, EIR, RESPONSE LETTERS, AND ANY OTHER COMMUNICATIONS WITH THE FDA BY/FOR WESTMINSTER
PHARMACEUTICALS LOCATED AT 3450 BUSCHWOOD PARK DR SUITE 110, TAMPA, FL 33618 AND 1321 MURFREESBORO
PIKE STE 607 NASHVILLE, TENNESSEE 37217.
Dear FOIA Officer: This is a request under the Freedom of Information Act. We are requesting: 1. All ANDA's and NDA's
associated with 0.3mg Sublingual Nitroglycerin products. We are most interested in Pfizer, Alvogen, Dr. Reddy,
Ingenious, and UpJohn's (Viatris) submissions. ETC
Full EIR and FDA 483 for the inspection of Pharmaceutics International, Inc. located at 103 Beaver Court, Cockeysville,
Maryland (MD) 21030 ; FEI number 3006503102 and 10819 Gilroy Road, Hunt Valley, Maryland (MD) 21031; FEI
number 1000513101.
Establishment Inspection Report and 483s for human drug inspection, ID 1048663, ending on 03/23/2018 at Novacyl
(Thailand), FEI 3000287096, located at : 321 Moo, 4 Soi 6 Alley Mueang Samut Prakan, Samut Prakan 10280 Thailand
Establishment Inspection Report and 483s for human drug inspection, ID 1135087, ending on 03/14/2019 at Novacyl
(Thailand), FEI 3000287096, located at 321 Moo, 4 Soi 6 Alley Mueang Samut Prakan, Samut Prakan 10280 Thailand
All documents related to Consumer Complaint Number 170204
Inactive Ingredients Database file for March 2013. This is not available on the FDA site or archive page but was public at
some point.
HHE #7006 signed 5/1/2008 referred to in the CFSAN Health Hazard Evaluation, HHE 9496 RES 76602 pertaining to
Recall Classified for 76602 by Give and Go Prepared Foods Corp. under "6. PRECEDENT HHE's". No product name was
referenced. Hazard Identified was "Larvae".
HHE #7401 signed 1/4/2010 referred to in the CFSAN Health Hazard Evaluation, HHE 9496 RES 76602 pertaining to
Recall Classified for 76602 by Give and Go Prepared Foods Corp. under "6. PRECEDENT HHE's". No product name was
referenced. Hazard Identified was "Live insects/larvae in finished product".
EIR for the Fujifilm Diosynth Manufacturing Plant located in College Station, Texas for the inspection that occurred 23-31
August 2021.
I am requesting the MAUDE Adverse Event Reports as well as underlying documents for the following Report Numbers:
3005099803-2020-00816; 3005099803-2017-02114; 3005099803-2017-01293; 3005099803-2014-02943; 3005099803-
2020-05040; 3005099803-2020-04764; 2183959-2018-00001; 2183959-2018-00017; 3005099803-2018-60141;
2183959-2019-67070; 2183959-2020-00584; ETC
Please provide to me the FAERS case reports for aducanumab with the following Case IDs 19882791 19771050
19787426 19726309 19615330 19810715
Requesting FOIA from Food and drug administration FDA pertaining to health and safety oversite for the experimental
gene therapy manufacturing full spike proteins in human cells. I am requesting all emails, communications memos and
any other pertinent information and communications pertaining to decisions to allow the development, production and
distribution medical procedures that cause the production of full spike proteins in the human body. including
documents from CBER.
(1) Please provide all documents showing the number of hospitalizations and emergency room (ER) visits in the United
States that occurred in the BNT162b2 groups and placebo groups in the clinical trials relied upon for FDA-approval of
the Comirnaty vaccine. (2) For all documents produced in response to (1) above, please also provide any supporting
documentation indicating the age and gender of the participant at the hospital or ER, timing of hospitalization or ER visit
from receipt of BNT162b2 or placebo, and the attributed cause of the hospitalization or ER visit per the investigator or
per the FDA.
I'd like to request consumer complaints filed between May 7, 2020 and Nov. 22, 2021, citing adverse health effects or
misleading health claims related to COVID-19 cures against the companies that have and have not received a warning
letter for promoting false COVID-19 cures between March 6, 2020 and Nov. 1, 2021.
The records requested include, but are not limited to, any physical, or electronic, notes, comments, memoranda,
reports, investigations, examinations, interviews, advisory opinions, decisions, briefs, articles, correspondence (including
e-mail, facsimile, written, or any other method, both internal and external), and any other media related to the
PreMarket Tobacco Products Application (PMTA) Submission Tracking Number (STN) PM0002029 etc
All studies, reports, submissions, summaries, meeting minutes, correspondence, and other documents relating to post-
market studies or other post-market requirements or commitments, and negotiations and correspondence relating to
post-market commitments, applicable to the Coflex Interlaminar Technology, which was approved by the FDA on
October 17, 2012 under Premarket Approval (PMA) Application (P110008).
A complete copy of the new infant formula submission for Similac 360 Total Care.
Requesting the FDA Form 3926 associated with the Single Patient Expanded Access IND 159164 for Dr. Markey McNutt
from the University of Texas Southwestern Medical Center. Filed with the Division of Gastroenterology and Inborn
Errors Products (DGIEP).
FDA 510(k) K981095
I am requesting the complete file that the FDA has for Triflange, K001277 including the complete application for its
510k.
Copies of MedWatch reports related to Aduhelm (aducanumab) as identified by the following Case ID numbers:
19787426; 19463117; 19771050; 19583970.
•Any legal analysis or correspondence reflecting legal analysis relied on by the Department of Health and Human
Services (HHS) and the Food and Drug Administration (FDA) to support HHS Secretary Xavier Becerrra’s November 15,
2021 Statement on the Withdrawal of HHS’s Policy on Laboratory-Developed Tests
All underlying information and submissions related to SE0015386 including, but not limited to, the SE reports, deficiency
letters, responses to deficiency letters, and any other correspondent between the submitter and FDA.
Any documents, correspondence, memoranda, or other communications from Avadel CNS Pharmaceuticals to the Office
of Orphan Drug Products related to Orphan Drug Exclusivity for Xywav (NDA 212690), from 01/01/2020 to the present.
Any documents, correspondence, memoranda, or other communications received by the FDA from any party other than
Jazz Pharmaceuticals related to Xywav (NDA 212690), from 01/01/2020 to the present.
Assessment report of the Company Conservas y Congelados ¡Ya Está! Assessment conducted online from September
20 to September 24, 2021. Name of the Location: Conservas y Congelados Ya Está S.A. Location: 13 av C 3-44 zone 2
Mixco La Escuadrilla, Guatemala Type of inspection records: Assessment report
Dear Sir/Madam: Pursuant to the Freedom of Information Act (FOIA), CSL Behring (CSLB) would like to request the
following MedWatch Forms for Hizentra® (Immune Globulin Intravenous (Human), 20% Liquid): • FAERS ID 19969833
19975312 • FAERS ID 19980718 etc
Please see attached correspondence requesting a Declaration authenticating a bates-stamped version of the FDA's
documents produced in response to our FOIA Request No. 2021-7339.
Requesting records of SmartHealth Inc.'s (aka Smart Health Inc. and dba SmartPractice Inc.) FDA Remote Regulatory
Assessment (RRA) of Smart Health, Inc. located at 3400 E. McDowell Rd., Phoenix, AZ 85008. Assessor's name: Charles
Larson; Assessor's email: Charles.Larson@fda.hhs.gov; assessment dates: 4/20/2021 through 4/26/2021
Safety and effectiveness data related to the approval of Neulasta (pegfilgrastim) Onpro - BLA# 125031; STN#: 181;
Approval Date: 9/23/2015.
The following FDA Memorandum that FDA cited in its TPL for SE0015386, dated June 21, 2021: "Product quantity
changes in Substantial Equivalence Reports (SE Reports) for statutorily regulated tobacco products (December 7, 2018)"
"Addendum to February 24, 2017, Equivalence Testing for SE Evaluations Memo (February 24, 2017 and April 16,
2019)" "BCP Consult Request Memo for SE0015386 (April 29, 2021)"
Data that will back up the claim that ivermectin is ineffective and/or can have severe adverse results if prescribed (by a
medical professional) for Covid-19. 2 etc
We seek the following documents concerning Spectrum Pharmaceuticals, specifically related to the Hanmi plant
inspection in South Korea conducted in May and/or June 2021: (1) All Form 483s; and (2) Any Summaries of
Establishment Inspection Reports (Summary EIRs)
On behalf of Lupin Pharmaceuticals, Inc. I request the Agency to provide me with the latest Package Insert (approved on
11/04/2021- Suppl-51) for JANUMET (NDA 022044) owned by Merck Sharp Dohme.
• All documents concerning any communications the FDA had with Philips Respironics prior to June 14, 2021
concerning any dangers associated with the polyester-based polyurethane foam used in Philips Respironics ventilators,
continuous positive airway pressure (CPAP) and bilevel positive airway pressure (BiPAP) machines. etc
We would like official copies of the following Letters to Health Care Providers : Important Information on the Use of
Serological (Antibody) Tests for COVID-19 - Letter to Health Care Providers 04/17/2020 Certain COVID-19
Serology/Antibody Tests Should Not Be Used - Letter to Clinical Laboratory Staff and Health Care Providers etc
About Import Refusals ,And request to obtain records associated with the shipment. FEI Number 3015007456 ;Firm
Name: Shenzhen Imdk Medical Technology Co., Ltd. DISTRICT-DNBI DSEI DWCI; ENTRY_NUM-SCS-4008320-8;SCS-
1337884-1;799-9029596-4;SCS-0776686-0;799-6929931-0;SCS-0784369-3;CWL-1163077-0;AEK-7573330-0;AEK-
7581561-0;799-7352678-1;SCS-6853687-1;SCS-0610769-4;274-0262628-0;AEK-7570214-9;799-7613120-9;SCS-
0707460-4
(1) Internal memoranda, internal notes, internal white papers, consultation requests and responses, meeting minutes,
internal studies, briefing documents, or other documents generated by the FDA in connection with Atrium Medical
Corporation's ("Atrium") hernia mesh products, including FDA Form 483 Observations issued to Atrium; the Consent
Decree entered in US v. Atrium Medical Corp., 1:15-cv-00041 (D.N.H.); etc
As permitted by the Freedom of Information Act (FOIA), I am hereby requesting the following document: Latest Package
Insert for NDA 019443, Sodium Bicarbonate Injection, 8.4% (1 mEq/mL), held by Abbott Laboratories Pharmaceutical
Products Div. I confirm that vici health sciences will be charged accordingly by FOI for this request, however please
Requesting Pack Insert of Amitriptyline HCl Oral COncentrate, 40 MG/ML (ANDA #A085749)
510k number BK190401, 510k number BK100063
All written communications from FDA granting or denying a request for an exemption or alternative under 21 CFR
1271.155 with regard to the prohibition on pooling in 21 CFR 1271.220(b) as well as the underlying request from the
sponsor.
Establishment Inspection Report (EIR) for; Firm name: BASi Northwest Laboratory Firm address: 3138 NE Rivergate, Bldg
301 C, McMinnville, OR 97128 Dates of inspection: February 28th – March 4th, 2011 FEI Number: 3004634572
All written communications from FDA granting a request for an exemption or alternative under 21 CFR 1271.155.
Original NADA 135-940 Antirobe Aquadrops.
Please see the attached correspondence requesting a declaration authenticating bates-stamped versions of documents
produced by the FDA in response to our FOIA Request No. 2021-665.
Summary basis of approval documents for AZELEX ® (azelaic acid) Cream, 20% (NDA # N020428) application held by
ALMIRALL LLC. Information related to quality review covering Chemistry, manufacturing and control.
Summary basis of approval documents for Nitroglycerin Ointment USP, 2%. (ANDA# 087355) application held by
Fougera Pharmaceuticals. Information related to quality review covering Chemistry, manufacturing and control.
Summary basis of approval documents for Noritate® (metronidazole) Cream, 1% (NDA# N020743) application held by
Valeant Pharmaceuticals. Information related to quality review covering Chemistry, manufacturing and control.
Summary basis of approval documents for RECTIV (nitroglycerin ointment 0.4%) (#N021359) application held by
ALLERGAN SALES LLC. Information related to quality review covering Chemistry, manufacturing and control.
510K application for Technicare, Inc.'s MODEL 580 DIGITAL RADIOGRAPHY SYSTEM. 510K number K827501.
EIR (Establishment Inspection Report) SYNLAB Analytics & Services Germany GmbH Standort Aachen Auf der Hüls 183,
Aachen, Germany, FEI Number 3014435713 Inspector: Toni F. Bernard
FDA-483 issued on or about 10/8/21 to Biological E Limited, FEI#3008377265 located in Hyderabad, India.
1. The Complete Response Letter issued to Athenex by the FDA regarding Athenex’s New Drug Application for oral
paclitaxel plus encequidar for the treatment of metastatic breast cancer. 2. Any and all communications between the
FDA and Athenex from July 1, 2019 through November 1, 2021, regarding: a) the Complete Response Letter; and b)
oral paclitaxel plus encequidar for the treatment of metastatic breast cancer.
Requesting the PMA for Technicare's Teslacon. PMA is P830051.
This is a request under the Freedom of Information Act. I request a copy of Form 483 for Veeda Clinical Research
Shivalik facility located in Ahmedabad India for their latest inspection conducted in last 12 months
This is a request under the Freedom of Information Act. I request a copy of Form 483 for Veeda Clinical Research Vedant
facility located in Ahmedabad India for their latest inspection conducted in last 12 months
Teena Biolabs Pvt Ltd, Bachupally India Seeking Inspection Classification (VAI,NAI,OAI) ?? inspection dates 2/07/2018 -
2/9/2018 and any subsequent inspections."
Any and all records from briefing package of the pre-IND meeting PIND #110655 that held on September 22, 2014,
especially, experimental methods and results for animal pharmacology and toxicology studies of the Active
Pharmaceutical Ingredient 5-ALA. - etc
We are seeking for full FCN information of the following 2 FCN dossiers: FCN 1835 FCN 1119
483: Life Technologies Corporation Frederick, MD End Dates of inspection: 14 June 2021 Project Area: Compliance:
Devices District Decision: VAI I confirm that Clarivate Analytics will be charged accordingly by FOI for this request,
483: LightStone Medical Llc Brooklyn, NY End Dates of inspection: 25 June 2021 Project Area: Postmarket Assurance:
483: Magellan Diagnostics, Inc. North Billerica, MA End Dates of inspection: 22 June 2021 Project Area: Compliance:
483: Marine Polymer Technologies Topsfield, MA End Dates of inspection: 19 July 2021 Project Area: Compliance:
483: May T. Cho, M.D. Orange, CA End Dates of inspection: 14 April 2021 Project Area: Bioresearch Monitoring District
483: Medical Decision Network, LLC Charlottesville, MA End Dates of inspection: 25 May 2021 Project Area:
Compliance: Devices District Decision: VAI I confirm that Clarivate Analytics will be charged accordingly by FOI for this
483: Merck & Company Rahway, NJ End Dates of inspection: 20 January 2021 Project Area: Bioresearch Monitoring
483: Next Medical Products Company, LLC Branchburg, NJ End Dates of inspection: 04 October 2021 Project Area:
483: Nextremity Solutions Warsaw, IN End Dates of inspection: 03 September 2021 Project Area: Compliance: Devices
483: Novum Medical Products of NY, LLC Amherst, NY End Dates of inspection: 13 July 2021 Project Area: Compliance:
483: Octapharma Plasma Inc Columbus, OH End Dates of inspection: 10 September 2021 Project Area: Blood and
Blood Products District Decision: VAI I confirm that Clarivate Analytics will be charged accordingly by FOI for this
483: Orthodent Laboratory, Inc. Buffalo, NY End Dates of inspection: 24 March 2021 Project Area: Compliance:
483: Peter Gottlieb, MD Aurora, CO End Dates of inspection: 11 January 2021 Project Area: Bioresearch Monitoring
483: Pharmacia & Upjohn Company, LLC Kalamazoo, MI End Dates of inspection: 20 May 2021 Project Area: Blood and
Blood Products District Decision: VAI I confirm that Clarivate Analytics will be charged accordingly by FOI for this
483: Philip A. Waller, M.D. Houston, TX End Dates of inspection: 14 January 2021 Project Area: Bioresearch Monitoring
483: Polymer Technology Systems, Inc. dba PTS Diagnostics, Inc. Whitestown, IN End Dates of inspection: 07
September 2021 Project Area: Compliance: Devices District Decision: VAI I confirm that Clarivate Analytics will be
charged accordingly by FOI for this request, however please contact me if the charges exceed $ 200.
483: Retro & R-Med Molding, LLC Constantine, MI End Dates of inspection: 22 July 2021 Project Area: Compliance:
483: Sabeen Najam, MD Baytown, TX End Dates of inspection: 20 January 2021 Project Area: Bioresearch Monitoring
483: Sagar Sardesai, M.D. Columbus, OH End Dates of inspection: 12 February 2021 Project Area: Bioresearch
Monitoring District Decision: VAI I confirm that Clarivate Analytics will be charged accordingly by FOI for this request,
483: Sameek Roychowdhury, MD Columbus, OH End Dates of inspection: 22 January 2021 Project Area: Bioresearch
483: Making Cosmetics Inc Redmond, WA End Dates of inspection: 05 March 2021 Project Area: Compliance: Devices
483: McNeil Healthcare, LLC Las Piedras, PR End Dates of inspection: 31 March 2021 Project Area: Compliance: Devices
483: North Louisiana Tissue Bank West Monroe, LA End Dates of inspection: 24 September 2021 Project Area: Human
Cellular, Tissue, and Gene Therapies District Decision: VAI I confirm that Clarivate Analytics will be charged accordingly
by FOI for this request, however please contact me if the charges exceed $ 200.
483: Missouri Analytical Laboratories Inc Saint Louis, MO End Dates of inspection: 19 May 2021 Project Area:
483: Novartis Gene Therapies, Inc. Libertyville, IL End Dates of inspection: 16 June 2021 Project Area: Human Cellular,
Tissue, and Gene Therapies District Decision: VAI I confirm that Clarivate Analytics will be charged accordingly by FOI for
483: NuSil Technology LLC Bakersfield, CA End Dates of inspection: 16 July 2021 Project Area: Drug Quality Assurance
483: Olein Recovery Corp Yabucoa, PR End Dates of inspection: 18 March 2021 Project Area: Drug Quality Assurance
483: PETNET Solutions, Inc. Albany, NY End Dates of inspection: 09 July 2021 Project Area: Drug Quality Assurance
483: Roechling Medical Rochester, L.P. Rochester, NY End Dates of inspection: 02 August 2021 Project Area:
483: Sanit Technologies, LLC dba Durisan Sarasota, FL End Dates of inspection: 05 March 2021 Project Area: Drug
Quality Assurance District Decision: VAI I confirm that Clarivate Analytics will be charged accordingly by FOI for this
483: Southwest Fertility Center Phoenix, AZ End Dates of inspection: 16 March 2021 Project Area: Human Cellular,
Tissue, and Gene Therapies District Decision: VAI I confirm that Clarivate Analytics will be charged accordingly by FOI for
483: Space Maintainers Lab Chatsworth, CA End Dates of inspection: 17 September 2021 Project Area: Compliance:
483: Spartan Chemical Co Inc Maumee, OH End Dates of inspection: 26 March 2021 Project Area: Drug Quality
Assurance District Decision: OAI I confirm that Clarivate Analytics will be charged accordingly by FOI for this request,
I am requesting all information CVM can provide about adverse events reported to CVM for Claro Otic Solution
(florfenicol, terbinafine, mometasone furoate; NADA 141-440) from September 25, 2015 to present (November 25,
2021.)
Any records of FDA investigations into company named BioCorRx
DEN200040
We request all the records obtained by FDA in accordance with the FSVP regulation of the Foreign Supplier’s Safety
Procedures, Processes and Practices related to the safety of the food manufactured in Conservas La Costena, S.A. De
C.V. Calle Via Jose Maria Morelos # 268 Pueblo La Purisima Tulpetlac Ecatepec De Morelos. Mexico. FEI 3008153698.
FDA Product Code 24FEI12. Also all the information relevant to this kind of verification activities required by 21 CFR
1.510(f
Procedures, Processes and Practices related to the safety of the food manufactured in EFFEM MEXICO INC Y COMPANIA
CV Galaxias 701,Santa Catarina, Nuevo Leon. Mexico. FEI 3017980953. FDA Product Code 33SHT99. Also, all the
information relevant to this kind of verification activities required by 21 CFR 1.510(f).
We request all records obtained by FDA in accordance with the FSVP regulation of the Foreign Supplier’s Safety
Procedures, Processes and Practices related to the safety of the food manufactured in Salsa Tamazula, S.A de C.V Calle
22, No. 2583 Zona Industrial. Guadalajara, Jalisco. Mexico. FEI 3001452259. Product Code 27YCI06. Additionally, all the
information relevant to this kind of verification activities required by 21 CFR 1.510(f).
Procedures, Processes and Practices related to the safety of the food manufactured in Barcel Occidente, Calle 13 Num
440 Ampl. Valle Del Alamo, Guadalajara Jalisco, Mexico FEI 3012331453. FDA Product Code 07BGT02. Additionally, all
the information relevant to this kind of verification activities required by 21 CFR 1.510(f).
Zip file of "MedWatch Archive 1996 - 2007" as described on the following webpage:
http://wayback.archive-it.org/7993/20170110235327/http:/www.fda.gov/Safety/MedWatch/SafetyInformation/
default.htm. (The Zip file is not accessible at the link.)
Domestic and foreign 483s, responses to 483s and EIRs.
I would like the 510k summary and submission document for the following medical device: Sherpa Pak Kidney
Transport System-k143054
Please provide a copy of the disclosable portions of the FDA Center for Tobacco Products Office of Science
administrative and scientific reviewer notes related to all Substantial Equivalence Reports (SE Reports) submitted by
British American Tobacco or Reynolds American (or their subsidiaries) and authorized by the FDA, from 3/1/2019 –
10/1/2021.
FCN No. 443 (notifier: Amersham Biosciences). All materials from FCN submission, including FDA decision documents.
Request a copy of Amendments 63 and 74 to BLA STN 125742 / license no. 2229
Request a copy of the Form FDA 356h submitted to you by the sponsor/manufacturer pursuant to the instructions in the
approved BLA number 2229 dated August 23, 2021
Request a copy of the final content of labeling submitted by the sponsor/manufacturer pursuant to 21 CFR 601.14 for
Comirnaty (COVID-19 Vaccine, mRNA) pursuant to the instructions in the BLA license 2229 approval letter of August 23,
2021
Request a copy of the final labeling for Comirnaty (COVID-19 Vaccine, mRNA) submitted to you by the
sponsor/manufacturer pursuant to the instructions provided in the approved BLA dated 23 August 2021, stating as
follows: "All final labeling should be submitted as Product Correspondence to this BLA STN BL 125742 at the time of
use."
Request a copy of the final printed carton and container labels for Comirnaty (COVID-19 Vaccine, mRNA), BLA license
22291) that were submitted on August 19, 2021 by the sponsor/manufacturer as noted in the BLA approval letter on
page 3, and etc
Certificates of Analysis (CoAs), if any, submitted to the corresponding EUA file by the sponsor/manufacturer of the
Pfizer-BioNTech COVID-19 Vaccine for the following drug product lots: FD7220, FE3592, FF2587, FF2588, FF2590,
FF2593, FF8841, FH8027, FH8028.
Quarterly manufacturing reports, which should include a listing of all Drug Substance and Drug Product lots produced
after issuance of the corresponding EUA, submitted to the corresponding EUA file by the sponsor/manufacturer of the
Pfizer-BioNTech COVID-19 Vaccine. There should be two reports, because the first one was due July 2021 (so the second
should be from October 2021).
I am seeking the authorized distributors, name, address and phone numbers, as required for EUA210314 and
EUA202625, Acess Bio, Inc. relating to the Carestart Covid-19 Antigen and CareStart COVID-19 Antigen Home Test.
We request the scans of 8 ANDA approval letters. Two of these ANDAs were approved in 2009 (#77604, #79095), two in
2010 (#77135, #79226), one in 2011 (#790178), two in 2012 (#90070, #202496) and finally one in 2013 (#77488).
As permitted by the Freedom of Information Act (FOIA), I am hereby requesting the following documents for last 3 years
inspection for Solara Active Pharma Sciences Limited Kudikadu, Cuddalore, India . : Form FDA 483(s), Establishment
Inspection Report(s)EIR, observations, and 483(s)firm responses, any root cause investigation, corrective action. Also
provide details if any 483 issued to Solara Active etc
I'm seeking the complaints that were received by FDA which resulted in the warning letter MARCS-CMS 612282 — APRIL
21, 2021 addressed to my company DRF LLC.
We request all disclosable/releasable portions of the Establishment Inspection Report (EIR) of Compania Embotelladora
del Fuerte,S. de R.L. de C.V. FEI Number 3013267007 ended 8/20/2018 with an Inspection ID: 1067656. Additionally, all
records disclosable portions of the records of Field Accomplishment and Compliance Tracking System (FACTS) and
eNSpect.
Requesting Clinical Review for NDA 215256: Wegovy (Semaglutide)
Copies of Form 483s issued to the following DEVICE companies on the indicated date.
510K Summary for the following: K201220 Trade/Device Name: Aerus Medical Guardian, model F170A Regulation
Number: 21 CFR 880.6500 Regulation Name: Medical ultraviolet air purifier Regulatory Class: Class II Product Code: FRA
Dated: June 13, 2020 Received: June 16, 2020
ClinSync Clinical Research Pvt Ltd Hyderabad, India End Dates of inspection: 10 January 2020 Project Area: Bioresearch
Co-Innovation Biotect Co., Ltd. Guangzhou, China End Dates of inspection: 09 January 2020 Project Area: Compliance:
ROVI Pharma Industrial Services S.A. Madrid, Spain End Dates of inspection: 05 April 2021 Project Area: Drug Quality
Complete response letter given to Lupin limited for generic Spiriva

Copies of Form 483s issued to the following CLINICAL INVESTIGATORs on the indicated date.
Copies of Form 483s issued to the following CLINICAL INVESTIGATORs on the indicated date.
Copy of the 483 for the Apr 11, 2012 - Apr 23, 2012 (13 days) inspection of Memorial Hospital Of South Bend, IRB
located at South Bend / United States of America] 615 N Michigan St, South Bend, IN 46601, USA. This inspection
Copy of the Company Response for the Aug 8, 2014 - Sep 5, 2014 (29 days) inspection of Wakai, Ronald, Ph. D., Clinical
Investigator located at Madison / United States of America] 1111 Highland Ave #1005, Madison, WI 53705, USA. This
inspection pertains to medical devices.
Copy of the Company Response for the Jul 29, 2014 - Aug 1, 2014 (4 days) inspection of Rodo Medical, Inc. located at
Sunnyvale / United States of America] 725 San Aleso Ave #1, Sunnyvale, CA 94085, USA. This inspection pertains to
Medical Devices
for Human Drugs inspection of Pharmaceutics International, Inc. ending 09/29/2021 at the location in Cockeysville MD,
Copy of the EIR for the Apr 11, 2012 - Apr 23, 2012 (13 days) inspection of Memorial Hospital Of South Bend, IRB located
at South Bend / United States of America] 615 N Michigan St, South Bend, IN 46601, USA. This inspection pertains to
Human Drugs.
Copy of the EIR for the Jul 29, 2014 - Aug 1, 2014 (4 days) inspection of Rodo Medical, Inc. located at Sunnyvale / United
States of America] 725 San Aleso Ave #1, Sunnyvale, CA 94085, USA. This inspection pertains to Medical Devices
Regulatory Assessment of Biomat USA, Inc. Located at Altamonte Springs FL United States FEI Number: 1071839 held on
04/28/2021.
Regulatory Assessment of CSL Plasma Inc Located at Jonesboro GA United States FEI Number: 3010854409 held on
02/04/2021.
Regulatory Assessment of CSL Plasma Inc. Located at Syracuse NY United States FEI Number: 3014570107 held on
04/27/2021.
Regulatory Assessment of CSL Plasma Located at Port St Lucie FL United States FEI Number: 3009140324 held on
05/03/2021.
Forms 483/Clinical Investigator/Lydie L. Hazan/Los Angeles, California
motor axonal neuropathy, acute motor-sensory axonal neuropathy, Bickerstaff's encephalitis, chronic inflammatory etc
Reference is made to FDA’s urgent request to reconcile sponsor FAERS reports with FDA received reports for Privigen®
BL 125201. Pursuant to the Freedom of Information Act (FOIA), CSL Behring (CSLB) would like to request the following
MedWatch Forms for Privigen® (Immune Globulin Intravenous (Human), 10% Liquid): • FAERS ID 19927964 •
FAERS ID 19928004 • FAERS ID 19932417 • FAERS ID 19932424 • FAERS ID 19932430 • FAERS ID 19932435
19932504 • FAERS ID 19932511
The application document (including any appendices), all correspondence leading to and concerning, and the approval
letter regarding: FDA's decision to grant the orphan drug designation (ODD) for "(1-{2-[(3S,4R)-1-[(3R,4R)-1-cyclopentyl-
3-fluoro-4-(4-methoxyphenyl)pyrrolidine-3-carbonyl]-4-(methoxymethyl)pyrrolidin-3-yl]-5-
(trifluoromethyl)phenyl}piperidine-4-caroxylic acid-phosphoric acid" for "treatment of cutaneous variants of porphyria
(which includes treatment and prevention of cutaneous manifestations of disease)", which was designated on
06/08/2020.
All 483 records and All EIR inspection records for all Teva facilities (Teva Parenteral Manufacturing) in Irvine, CA from
2019 to present
Communications sent or received by Janet Woodcock, Philip Krause and/or Marion Gruber that include the term
“DeSantis” and/or “Florida” dated between January 1, 2020 through date of search.
Company: Allphamed PHARBIL Arzneimittel GmbH Location: Hildebrandstrasse 12, 37081 Goettingen, Germany
Request: Establishment Inspection Report, FEI 3008587095
Copies of autopsy reports concerning any VAERS-reported deaths following COVID-19 vaccination.
reports of adverse health effect records of humans exposed to Altrenogest
Response to letter from Vermont Tobacco Center for Regulatory Science at the Vermont Center on Behavior and Health
submitted a letter to the Center for Tobacco Products dated October 20, 2016
483 issued to Chugai Pharma Manufacturing, Kita-ku Tokyo Japan on CDER inspection
483 issued to Kyowa Kirin (or Kyowa Hakko Kirin) ,Takasaki Japan on CDER inspection
A copy of the Final Approval Letter and Approved Label for HEC Fingolimod 0.5 mg Capsules ANDA No. 207939 dated
11/12/2021
A copy of the Final Approval Letter and Approved Label for Teva Fingolimod 0.25 mg Capsules ANDA No. 212152 dated
11/12/2021
LOS ANGELES PRODUCE DISTRIBUTOR LIST OF CROSSINGS AS IMPORT AGENT

The original drug approval review from CDER for the Antizol (Fomepizole) Injection NDA 020696 that was originally
approved on Dec 4, 1997.
Salmonella Newport outbreak that began in the summer of 2020 and records related to the foodborne investigation.
FDA track data for FY2021, only with regard to Priority NDA and BLA Efficacy Supplements. Essentially looking for the
data or update to the FDA-Track. It hasn't been updated since Sep 30, 2020.
Request for Establishment Inspection Reports associated with inspection ID 1073462. FEI for the facility is 1032500.
This was for the follow-up inspection subsequent to the Peroxiclear recall.
Department of Health and Human Services Food and Drug Administration, Form FDA 482 Notice of Inspection dated
3/19/19, for Bellwyck Packaging Solutions Inc. dba Bellwyck Pharma Services, 8946 Global Way, West Chester, OH
45069
FDA Form 3926 associated with the Single Patient Expanded Access IND 159164 for Dr. Markey McNutt from the
University of Texas Southwestern Medical Center. Filed with the Division of Gastroenterology and Inborn Errors
Products (DGIEP).
Electronic Files for NDA 022382 and all Correspondences between Sponsor and FDA
I request all consumer complaints relating to the recent Class 1 recall of Philips/Respironics CPAP devices and ventilators
announced 6/14/2021. The Event ID's for this recall are 88071 and 88058.
FDA-OO-MP-21-110185537MC
Please provide additional information for VAERS ID#1862529
I request consumer complaints 306210645, 306220735, 10360957 and 10360958 cited in Form 483 for FEI #2518422
(inspection end date 11/9/2021) involving Philips Respironics CPAP devices and ventilators.
I hereby request the following records: Any and all documents, be they electronic or otherwise, pertaining to efficacy
trials of Spravato (or esketamine). Any and all email correspondence between executives at the companies Janssen or
Johnson & Johnson and the FDA about Spravato (or esketamine). ETC
K143114, Supplements related to K143114

FDA-OC-20-MP10706520
VAERS RECS
Importer of Record (IOR), or Consignee; for entry-lines with submission or arrival dates between November 1 and
November 30, 2021: 1) DUNS Number / Unique Facility Identifier (UFI) of: 080801169 2) Federal Tax ID Number (EIN)
of: 822349285 3) FDA Establishment Identifier (FEI) of: 3014302990 ETC
All 483 citations for Cardinal Health Cyclotron locations issued in 2020-2021. The addresses are listed in the attachment
request letter.
Seeking records disclosed in 2014-8981
2016-3176
All 483 citations for SOFIE, Inc locations issued in 2020-2021. The addresses are listed in the attachment request letter.
Established Inspection Reports for the GLP inspection on the facilities listed below; 1. BioReliance Address: 9630
Medical Center Drive Rockville, MD 20850, US Applicable inspections: 7/28/2003 Bioresearch Monitoring, CDER [NAI]
9/7/2010 Bioresearch Monitoring, CDER [VAI] 2/4/2011 Bioresearch Monitoring, CDER [VAI] 2 ETC
all communications between FDA and Axsome Therapeutics Inc. (Axsome) related to Axsome's "AXS-05" program
CTP Response to The Vermont Tobacco Center for Regulatory Science at the Vermont Center on Behavior and Health
submitted a letter to the Center for Tobacco Products dated October 20, 2016
format) for Human Drugs inspection of Dr. Reddy's Laboratories New York, Inc. ending 03/03/2021 at the location in
Middleburgh NY, United States. Please send documents as email attachments.
for Foods & Cosmetics inspection of Whitmore Family Enterprises, LLC dba Taza Chocolate ending 10/13/2014 at the
location in Somerville MA, United States. The EIR (in electronic format) for Foods & Cosmetics inspection of Whitmore
Family Enterprises, LLC dba Taza Chocolate ending 10/13/2014 at the location in Somerville MA, United States. Please
for Human Drugs inspection of Arifulla Khan MD ending 06/11/2014 at the location in Bellevue WA, United States. The
EIR (in electronic format) for Human Drugs inspection of Arifulla Khan MD ending 06/11/2014 at the location in Bellevue
WA, United States. etc
for Human Drugs inspection of WALLING, DAVID ending 04/01/2014 at the location in GARDEN GROVE CA, United
States. The EIR (in electronic format) for Human Drugs inspection of WALLING, DAVID ending 04/01/2014 at the
location in GARDEN GROVE CA, United States. etc
2021-6854, 2021-6873, 2021-6899, 2021-6900, 2021-6921.
2021-6938, 2021-6943, 2021-6945, 2021-7159, 2021-7274.
2021-7323, 2021-7324, 2021-7352, 2021-7353, 2021-7354.
2021-7355, 2021-7357, 2021-7359, 2021-7360, 2021-7361.
VAERS Report
Copies of Form 483s issued to the following CLINICAL INVESTIGATOR’S on the indicated date.
since Saturday, October 30, 2021.
The full, unredacted version of the Citizen Petition comment and all accompanying documents submitted by Eagle
Pharmaceuticals, Inc. posted on November 26, 2021 to Docket No. FDA-2021-P-1211.
Copies of Form 483s issued to the following CLINICAL INVESTIGATOR’S on the indicated date.
IRBs both in the United States and outside the United States that received such notices dated from November 1 to 30,
The following two (2) CSV files: 1) Listing of all INSPECTIONS since Tuesday, December 1, 2020 (in CSV format) with
the following fields: FEI Number, Inspection Start Date, Inspection End Date, Legal Name, Address, City Name, State
Code, Zip Code, Country Name, FDA483, Full Name, District, Center, INSPECTION REASON 2) Listing of releasable
inspection CITATIONS (from FDA's FACTS database) for each company since Tuesday, December 1, 2020 in CSV format
with the following columns: INSPECTION_ID, YEAR, INSPECTION_START_DATE, INSPECTION_END_DATE,
FEI_NUMBER, FIRM_Name, REF_NO, SHORT_DESC, Inspection Classification, Inspection Project Area. Please send CSV
file to support@fdazilla.com
for Biologics inspection of Octapharma Plasma, Inc. ending 10/24/2019 at the location in Orlando FL, United States.
N22201, Firmagon Supplements 12 & 13 approval letters and labeling
for Human Drugs inspection of ACRX Specialty Pharmacy Inc ending 07/23/2021 at the location in Las Vegas NV, United
for Biologics inspection of Hanna, Wahid T., MD ending 06/22/2001 at the location in Knoxville TN, United States. The
Response (in electronic format) for Biologics inspection of Hanna, Wahid T., MD ending 06/22/2001 at the location in
Knoxville TN, United States. Please send documents as email attachments.
for Foods & Cosmetics inspection of East West Tea Company, LLC ending 05/19/2011 at the location in Eugene OR,
United States. The Response (in electronic format) for Foods & Cosmetics inspection of East West Tea Company, LLC
ending 05/19/2011 at the location in Eugene OR, United States. Please send documents as email attachments.
ALL FORM 483, EIR, RESPONSE LETTERS, AND ANY OTHER COMMUNICATIONS WITH THE FDA BY/FOR AKRON PHARMA,
INC LOCATED AT 373 RT US 46 W Building E, Suite 117 Fairfield, NJ 07004.
for Biologics inspection of National Genetics Institute ending 01/19/2017 at the location in Los Angeles CA, United
States. The EIR (in electronic format) for Biologics inspection of National Genetics Institute ending 01/19/2017 at the
location in Los Angeles CA, United States. The EIR (in electronic format) for Biologics inspection of National Genetics
Institute ending 12/04/2018 at the location in Los Angeles CA, United States. The Response (in electronic format) for
Biologics inspection of National Genetics Institute ending 12/04/2018 at the location in Los Angeles CA, United States.
I request all documents provided to requesters in FDA FOIA requests 2017-562, 2020-1275, 2020-5892, 2021-6772, and
2021-6910.
Human adverse event drug MedWatch reports for the following case IDs: 10836059 10996114 12390182 12612596
10172732 9772973 19801207 19769801 19260129 19591773 16986559 17022020
December 1, 2021
ALL FORM 483, EIR, RESPONSE LETTERS, AND ANY OTHER COMMUNICATIONS WITH THE FDA BY/FOR AKORN
PHARMACEUTICALS LOCATED AT 150 South Wyckles Road, Decatur, Illinois (IL) 62522
Please provide the response to FDA FOI 2016-1867, which we assume will provide the analytical method for
Fenbendazole milk residues.
I write to request copies of documents, communications, and information in the FDA’s possession, custody, or control
concerning facilities located at 10381 Decatur Road, Philadelphia, Pennsylvania 19154 that are owned and/or operated
by Catalent Pharma Solutions (“Catalent”) and used for the purpose of developing, manufacturing, or commercializing
human drugs.
concerning facilities that are owned and/or operated by AGC Biologics, Inc. (“AGC Biologics”) in the United States or in
Denmark, including for facilities located at Vandtårnsvej 83, 2860 Søborg, Denmark, that are used for the purpose of
developing, manufacturing, or commercializing human drugs.
concerning facilities that are owned and/or operated by Lonza Group AG (“Lonza”) in the United States or in the United
Kingdom, including for facilities located at 228 Bath Rd, Slough SL1 4DX, United Kingdom, which are used for the
purpose of developing, manufacturing, or commercializing human drugs.
concerning facilities that are owned and/or operated by Patheon Manufacturing Services, LLC, part of Thermo Fisher
Scientific (“Patheon”), including for facilities located at 5900 M.L.K. Jr Hwy, Greenville, North Carolina 27834 or at Via
Stucchi G. Battista 110, 20052 Monza, Italy (MI), that are used for the purpose of developing, manufacturing, or
commercializing human drugs.
Review Memorandum and Correspondence related to Innevape PMTA

NDA 021797
Copies of all FOIA requests submitted to the Food and Drug Administration by Pfizer on or after November 1, 2011 and
any production made in response to each such FOIA request.
Copies of all FOIA requests submitted to the Food and Drug Administration by Pfizer on or after November 1, 2011 and
the final response made in response to each such FOIA request.
ADUHELM RECS PRODUCED BY CDER
any and all emails and/or correspondence to and/or from the FDA and/or Sean Tipton, Chief Advocacy and Policy
Officer for the American Society for Reproductive Medicine (ASRM) (email stipton@asrm.org) since 1/1/2000 that relate
to and/or concern legal, policy, and/or scientific issues related to the donation of human reproductive tissue (i.e., donor
sperm, oocytes, embryos, etc.).
FDA inspection information request from year 2010 to 2021.
RECALL DATA
Hello, We are requesting a copy of the most recent package insert of Atromid-S (Clofibrate). The NDA for Atromid-S
(Clofibrate) is 016099. Based on the FDA database, the most recent package insert may be submission SUPPL-60 made
by WYETH AYERST which has the action date 04/08/1996 or submission SUPPL-61 on 07/07/1998. Thank you for your
help.
K042828 K832654
Interested in obtaining any Form 483s related to Fennec Pharmaceuticals manufacturing at Pharmaceutics International
in Hunt Valley, MD. Please also include any additional documentation available from the PEDMARK pre-approval
inspections at this facility.
Inspection records of BPI Sports in Fort Lauderdale, Florida Please include both 483 and EIR records I understand ORA
performed an inspection on 8/12/21. Thank you to the Orlando Office for the inspection. BPI Sports 3149 SW 42nd
Street, Suite 200 Fort Lauderdale, Florida 33312-6802 Thank you, Courtland
PMA files, post-market surveillance studies, establishment inspection reports, FDA advisory committee reports. The
manufacturer is Cartiva Incorporated for the Cartiva Synthetic Cartilage Implant. The PMA number is P150017.
1) Any Form 483 issued to Laboratorios Farmacéuticos ROVI, S.A. in 2020 and 2021. 2) Any Form 483 issued to ROVI
Pharma Industrial Services in 2020 and 2021. 3) Any and all letters, emails and other communications between the
FDA and Laboratorios Farmacéuticos ROVI, S.A. in 2020 and 2021 4) Any and all letters, emails and other
communications between the FDA and ROVI Pharma Industrial Services in 2020 and 2021.
Four (4) Full Copies of Cleared 510(K) Notices # K171593, K182325, K163190 and K151793. Trade/Device Name: InMode
RF System Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and
accessories Regulatory Class: Class II Product Code: GEI Manufactured by: InMode MD Ltd Tabor Building, Shaar
Yokneam POB 44, Yokneam 20692 Israel
for Biologics inspection of LabCorp Indiana Inc. ending 07/13/2021 at the location in South Bend IN, United States.
for Foods & Cosmetics inspection of Citrus And Allied Essences Ltd. ending 06/23/2021 at the location in Belcamp MD,
for Foods & Cosmetics inspection of Whitmore Family Enterprises, LLC dba Taza Chocolate ending 03/15/2017 at the
location in Somerville MA, United States. Please send documents as email attachments.
for Human Drugs inspection of Morie A. Gertz, M.D., Clinical Investigator ending 03/09/2018 at the location in Rochester
MN, United States. The Response (in electronic format) for Human Drugs inspection of Morie A. Gertz, M.D., Clinical
Investigator ending 03/09/2018 at the location in Rochester MN, United States. Please send documents as email
attachments.
for Human Drugs inspection of Patheon Pharmaceuticals Inc ending 12/13/2019 at the location in Cincinnati OH, United
States. The EIR (in electronic format) for Human Drugs inspection of Xellia Pharmaceuticals USA LLC ending 10/13/2016
at the location in Bedford OH, United States. Please send documents as email attachments.
Recs re opioid AND McKinsey
Copies of all FOIA requests submitted to the Food and Drug Administration by Eli Lilly on or after November 1, 2011 and
Copies of all FOIA requests submitted to the Food and Drug Administration by Gilead on or after November 1, 2011 and
Copies of all FOIA requests submitted to the Food and Drug Administration by GlaxoSmithKline on or after November 1,
2011 and the final response made in response to each such FOIA request.
Copies of all FOIA requests submitted to the Food and Drug Administration by Merck on or after November 1, 2011 and
MAUDE REPORTS
A copy of the Approval Letter for ANDA 215037 for Nelarabine Injection, 250 mg/50 mL (5 mg/mL), approved on
November 17, 2021.
A copy of the Chemistry Review(s) for ANDA 215037 for Nelarabine Injection, 250 mg/50 mL (5 mg/mL), approved on
November 17, 2021.
All court and case documents regarding adverse effects of the Mirena IUD, including information regarding lawsuits on
the product.
Copy of the 483 for the inspection of A.M.G. Medical, Inc., Montreal, Canada, end date 11-16-2018. FEI# 3000171642.
This inspection pertains to medical devices.
Copy of the 483 for the inspection of Arrow International CR, a.s., Zdar Nad Sazavou 1, Czech Republic, end date 11-29-
2018. FEI# 3006425876. This inspection pertains to medical devices.
Copy of the 483 for the inspection of ESTABLISHMENT LABS SA, Coyol Free Zone, Costa Rica, end date 02-24-2017. FEI#
3012883202. This inspection pertains to medical devices.
Copy of the 483 for the inspection of Quantum Dental Technologies Inc, Toronto, Canada, end date 11-21-2018. FEI#
First party copy of Health Hazard Evaluation on Limbrel (Flavocoxid) performed and signed by the Division of Anesthesia,
Analgesia and Addiction Products (DAAAP) on CDER 12/04/2017.
FOIA requests filed with FDA’s Center for Food Safety and Applied Nutrition (“CFSAN”), including related offices, from
November 1, 2021 through November 30, 2021.
demyelinating polyradiculoneuropathy, demyelinating polyneuropathy, Guillain-Barre syndrome, ETC
complete 510(k) copies for K163457, K162741, K152967
On behalf of Lupin Pharmaceuticals, Inc. please provide me with the latest labeling for SABRIL (N022006 / SUPPL-26)
held by LUNDBECK PHARMS LLC approved on 10/20/2021.
Most recent Listing of all FDA-conducted MRA inspections, including all disclosable information including FEI, DUNS
number, company name, address, country, inspection start and end dates, type of firm, classification of outcome of
inspection, Investigator name(s), product(s) being inspected, and whether or not a 483 was issued.
Meitheal Pharmaceuticals request the most recently submitted container label for NDA 017808, MIACALIN, Calcitonin
Salmon 200 IU/mL. Please send electronically via email if possible. Thank you,
Food Contact Notification (FCN) No. 2160 (BASF)
list of certifying agencies approved by the FDA pursuant to title 21, Code of Federal Regulations, section 900.21, with
the approval date for each certified agency.
I am requesting all records and response letters provided for 2017-5356
available. b. Please include whether any of the reports of adverse events triggered any sort of follow up by the FDA. I
request the records be provided to me in electronic format.
CMS WA #200953
Copy of the disclosable portions of all communications between the FDA and any foreign regulatory authority (including,
but not limited to, regulatory authorities in the United Kingdom and Saudi Arabia) regarding any SARS-CoV-2 Antigen
Rapid Test, from 01/01/2020 - Present.
PA 19522 11.01.21-11.30.21
Copy of the disclosable portions of all internal correspondence from 01/01/2020 - Present relating to FDA's decision to
recommend the recalls conducted by Abbott related to the following products: (1) Alinity M Resp-4-Plex AMP Kit (Non-
Us Assay); (2) Alinity M SARS-CoV-2 Amp Kit (Non-US Assay): 09N78-091; (3) Alinity M SARV-CoV-2 Amp Kit (Non-US
Assay): 09N78-090; (4) Alinity M Resp-4-Plex AMP Kit (EUA, US Assay); and (5) Alinity M SARS-CoV-2 Amp Kit (EUA, US
Assay).
Product: Pivot CinchLock SS Knotless Anchor (CAT02462), manufactured by Stryker. Recall Number Z-1635-2016, Recall
Event ID 73846
Datar Cancer Genetics, A Nashik-based cancer research company - FDA submission for Breakthrough Designation for
blood test to detect early-stage breast cancer.
Please provide Al Khalifa’s Premarket Tobacco Product Applications (PMTAs) (assigned Submission Tracking Number
PM0002037).
Copies of all studies conducted by the Food and Drug Administration comparing any health outcomes, except for COVID-
19, between those who have received any COVID-19 vaccine and those that have not received any COVID-19 vaccine.
Review Memoranda and Correspondence related to DFW Vapor Holding PMT
I am writing to request additional data from the voluntary Adverse Event Reporting Forms (FDA 3500 and FDA 3500B) as
well as from the mandatory reporting required by industry that is not available publicly through the openFDA portal.
This extra information will be useful for my research into the methods used to detect and validate unknown and
unexpected adverse drug events and drug-drug interactions.
Requesting FOIA from Food and drug administration FDA pertaining to health and safety oversite for the experimental
gene therapy manufacturing full spike proteins in human cells. I am requesting all emails, communications memos and
any other pertinent information and communications pertaining to decisions to allow the development, production and
distribution medical procedures that cause the production of full spike proteins in the human body. including
documents from CBER.
Title 21 CFR §1240.61 was codified in 1949. This legislation set protocol for sales of unpasteurized cheese products. In
the previous years there was preliminary legislation and documents that helped lead to the final draft. I am looking for
any of those preliminary or supporting documents.
FURLS Food Facility Registration information for all facilities that have a currently active registration in Will County
and/or Cook County in the state of Illinois.
1) Previously released documents in response to FOIA requests control numbers: 2021-5501. 2) Any and all letters,
emails and other communications between the FDA and CorMedix in 2020 and 2021 3) Any and all letters, emails and
other communications between the FDA and CorMedix, as well as any documents, memoranda or notes concerning
communications between the FDA and CorMedix from Jan. 1, 2017 to Present, concerning: a. The manufacturing of
DefenCath, formerly known as Neutrolin b. Deficiencies identified by the FDA at any manufacturing facility CorMedix
used for making DefenCath.
Any records relating to any new genetically engineered fish (but not including AquAdvantage Salmon). Please see
attached request letter for more information.
Requesting a list of subcontractors Contract PIID HHSF223201750007A
COMMUNICATIONS WITH ALTRIA
GRUBER, KRAUSE EMAILS RE BOOSTER SHOTS
PreMarket Tobacco Products Application (PMTA) Submission Tracking Number (STN) PM0003798 and the
corresponding Marketing Denial Order (MDO) issued on September 8, 2021
Average Daily Intakes of heavy metals for foods
Adagrasib (MRTX849) FDA Pharmacokineticists' reviews and medical officers' reviews, especially data related to tissue
drug concentrations.
Adverse events reported to FAERS from June 7, 2021 through today for Aduhelm, aducanumab and/or aducanumab-
AVWA
Chemistry and Toxicology review memoranda for FCN 2142
Establishment Inspection Report for the inspection of World Nutrition, lnc. located in Scottsdale, Arizona arising from
the inspection conducted on July 26, 2018 – July 27, 2018 by Derek S. Dealy (FEI Number 3005067299).
FOIA Request for Food Contact Notification (FCN) 1157 FDA Review Memoranda; Our File No. GR12714-00001
Full text of 510(k) K925080 - TEK-LUBE device manufactured by CLINICAL TECHNOLOGY CORP.
Please provide the revised labeling Package Insert for PROCARDIA XL (NIFEDIPINE) TABLET, EXTENDED RELEASE ORAL
30MG,60MG and 90MG for the Applicant PFIZER LABORATORIES DIV PFIZER INC- N019684
Summit Therapeutics is interested in obtaining/purchasing a DVD of the April 5, 2011
Anti-Infective Drugs Advisory Committee Meeting for the product Dificid (fidaxomicin).
participating in the FDA Foreign Supplier Verification Programs from approximately December 4, 2017 - March 3, 2018.
REQUEST FOR FCE and SID NO. for FEI Number 3004281337 Nestle India Limited, Post Box No.1, Village Maulinguem
(North) Bicholim Taluka, Goa 403504 India
FDA inspection report for Intrinsic Imaging, with the specifications below: Inspection reason: Intrinsic Imaging Study
150209 – Athenex Protocol KX-ORAX-001 Inspection dates: January 4-7, 2021 Inspection location: Intrinsic Imaging LLC
580 Main Street, Suite 210, Bolton, MA
Please provide a copy of the summary basis of approval for NDA 019081
The EIR (in electronic format) for inspection of Athenex, Inc. ending 09/17/2020 at the location in Buffalo NY, United
States. FEI: 3012022182 Please send documents as email attachments.
(1) Form 483 inspection report dated March 23, 2021 relating to Adamson Analytical Laboratories (the Corona, CA,
facility); (2) Adamson Analytical Laboratories April 13, 2021 Response to the Form 483; (3) FDA's August 17, 2021
Warning letter to Adamson Analytical Laboratories
2016-9423, 2016-9433, 2016-9508, 2021-2355, 2021-3653.
I hereby request a copy of all responsive information for files 2021-1866, 2021-1868, and 2021-2445
2016-8887, 2016-8918, 2016-9298, 2016-9416, 2016-9420.
. 2016-8857, 2016-8858, 2016-8861, 2016-8862, 2016-8868.
2016-8770, 2016-8772, 2016-8807, 2016-8810, 2016-8822.
Eduardo Carbonell, Melissa M Schafer, Khunnathee Stoner, etc CVs
Copy of the disclosable portions of the Summary of Safety and Effectiveness for the Real Time Process Supplemental
PMA for P040021, Supplement S047, pertaining to approval for a modification to the sewing cuff components intended
to increase valve radiopacity. Please also include the Indications for Use Page, if applicable.
FDA's summary review and related documents on its December 1995 approval of OxyContin, and Purdue's new drug
application
I hereby request a copy of all responsive information for files 2021-2447, 2021-4256, and 2021-4257
demyelinating polyradiculoneuropathy,etc
Requesting a copy of the FDA EIR from an (FDA Inspection that was conducted in our CSL Plasma, Inc, -Indianapolis , IN
location (3013407268) June 1, 2021 - June 4, 2021
Requesting a copy of the FDA EIR from an (FDA Inspection that was conducted in our CSL Plasma, Inc, Houston , TX
location (3016665630) July 19, 2021 July 23, 2021
Requesting a copy of the FDA EIR from an FDA Inspection that was conducted in our CSL Plasma, Inc, Nampa , ID
location (3017660762) August 9, 2021 - August 11, 2021
K132904 Ziehm Vision RFD
I hereby request a copy of all responsive information for files: 2021-3852, 2021-1180, 2021-1622
Project Specialist, GS-0301-9 (FDA-CDER-20-MP-10656010).
I would like to request all the FDA site inspection reports since 2016 for a company in Taos, New Mexico- Private Label
Select- 1320 Paseo Del Pueblo Sur, Taos, New Mexico (NM) 87571, United States (USA). FEI is 3000204154 DUNS is
005415463
for Biologics inspection of Alevio, LLC ending 11/10/2021 at the location in Birmingham AL, United States. Please send
for Biologics inspection of American Cell Technology, LLC. ending 10/29/2021 at the location in Sunrise FL, United
for Biologics inspection of Rockefeller Fertility Center ending 11/05/2021 at the location in New York NY, United States.
for Biologics inspection of Virginia Center for Reproductive Medicine ending 10/29/2021 at the location in Reston VA,
for Medical Devices & Rad Health inspection of ErgoMed, Inc. ending 11/05/2021 at the location in San Antonio TX,
K171565 (OEC Elite)
for Medical Devices & Rad Health inspection of Hampton Medical Devices, LLC ending 11/08/2021 at the location in
Festus MO, United States. Please send documents as email attachments.
Electronic listing (preferably csv format) of all RRAs conducted since September 1, 2021
for Medical Devices & Rad Health inspection of Lonza Walkersville, Inc. ending 11/05/2021 at the location in
Walkersville MD, United States. Please send documents as email attachments.
for Medical Devices & Rad Health inspection of Opus KSD, Inc. ending 11/12/2021 at the location in Pembroke MA,
for Medical Devices & Rad Health inspection of Proactive Medical Products ending 11/09/2021 at the location in Mount
Vernon NY, United States. The 483 (in electronic format) for Medical Devices & Rad Health inspection of Elegant Direct
Corp ending 11/10/2021 at the location in Brooklyn NY, United States. Please send documents as email attachments.
On behalf of ModernaTX Inc., Covington & Burling LLP makes this request for the following records pursuant to the
Freedom of Information Act (“FOIA”), 5 U.S.C. § 552, and U.S. Food and Drug Administration (“FDA”) regulations at 21
C.F.R. Part 20. Please provide all Vaccine Adverse Event Reporting System (“VAERS”) reports relating to VAERS ID
1848220. If you have any questions about this request, please contact Chelsea Tisosky at ctisosky@cov.com.
I need please to get a detailed list of all the complaints or issues reported to the FDA of the drug YKP3089 of the
company SK Life Science Inc. Please include complains of all clinical trial phases and also during the years that the
medicine was approved and went to the market.
Copy of the disclosable portions of the following documents, relating to SARS-CoV-2 Antigen Rapid Qualitative Test,
from 01/01/2020 - Present: (1) All internal correspondence relating to FDA’s decision to issue Warning Letter CMS
#614819, dated June 10, 2021, to Innova Medical Group; and (2) All internal correspondence relating to the recall
conducted by Innova Medical Group (Recall 3017105091-04/02/2021-001-R Event #87682).
1. List of All vaccines that contain parasites, in any form. 2. Stats on positive parasite testing in the US for surveilled
parasites 3. Stats on how many Americans have undiagnosed parasites for year 2014, 2015, 2016, 2017, 2018, 2019,
2020, 2020
2021-8074
Establishment Inspection Report for Inspection ID 113318 end date 11/22/2019 Including form FDA 482 and FDA 483 (if
existing) and following corresondence on OK Biotech, Co., LTD, FEI 3005862821 No. 91, Sec.2, Gongdao 5th Rd
Hsinchu City, TW 30070
Olympus would like to request the full 510(k) file for K190303, cleared on 2/12/2019. The subject device is the Airseal
Insufflator, manufacturer is ConMed Corporation. Olympus would like to see the test plans for the device.
I'm requesting access to and copies of the following: - Records released in response to the following FOIA control #s
(including the original requests): 2018-1730, 2017-10046, 2019-915, 2019-6423, 2019-6456, 2021-3257, 2021-4817,
2021-6406, 2021-6633, and 2021-7730
INVESTIGATION REPORTS
All Data and Information on the Pfizer Vaccine enumerated in 21 C.F.R. 601.51(e) with the exception of publicly
available reports on the Vaccine Adverse Events Reporting System
VAERS RECS
Copy of the disclosable portions of the following information, from 01/01/2020 - Present: (1) All documents relating to
or describing any financial interest Dr. Timothy Stenzel or any of his family members may have in Abbott, Quidel, or any
other entity seeking an Emergency Use Authorization (EUA) from the FDA for any SARS-CoV-2 Antigen Rapid Test; (2)
Any financial and/or conflict of interest disclosures submitted by Dr. Timothy Stenzel regarding any products; and (3)
Any documents discussing or reflecting any recusals or other agency procedures to address any conflicts of interest
arising from items 1 and 2.
PMTA MDO decision summary
Documents provided by the FDA in response to FDA FOIA Request 2020-8420.
All voluntary and mandatory adverse event reports for all deaths for polyethylene glycol 3350 products for pediatric and
adult use. Requesting detailed event report, NOT report summary.
Any responses to FDA Import Notices of Detention and Hearings filed by Christopher J. Duncan of Stein Shostak Shostak
Pollack & O'Hara LLP since October 2019, along with any subsequent correspondence between the FDA and Duncan in
these cases, if any
Please provide disclosable, redacted 483s, 483 Responses, warning letter responses and EIRs in electronic format (.pdf)
that have been released since January 1st , 2021.The product area of these inspections are drugs. Thank you!
Please provide any and all communications between FDA staff and drug sponsors seeking to make an Rx to OTC switch
through the nonprescription drug office for oral contraceptives.
All correspondences and documents related to consumer studies associated with the naming of plant-based or vegan
substitutes for seafood, meat, and/or poultry products, including consumer understanding of the product names and/or
nutritional value for plant-based or vegan substitutes for seafood, meat, and/or poultry products.
Recs re Robert Califf’s dealings and communications with or regarding the following entities or topics in any way during
the time period of January 01, 2015 until January 20, 2017 re Danco Laboratories Limited RU-486, mifeprex,
mifepristone, and/or mifeprostol Pfizer Moderna Johnson and Johnson Astra-Zeneca Advocates for Youth Guttmacher
Institute International Planned Parenthood Federation (IPPF) etc
Findings related to my complaint against Land of Lakes
All response letters and records provided for FOIA requests, 2017-2056, 2017-2355, 2018-3307, and 2019-3362
I'm requesting calendar records for dan mcchesney, for the dates of 09.10.17 through 09.16.17
LIST OF RRAs
I am requesting: 1. the first page (i.e., Face Page) of the current contract award, and first 15 pages of the Performance
Work Statement or Statement of Work for the existing contract #GS06F0806Z / 75F40121F80218 2. for the existing
contract, who is currently assigned as: TM/POC (govt technical manager or govt owner of the requirement), COR
(Contracting Organization Representative), CO/KO (contract officer), and CS (contract specialist, if applicable) Fee
Approval: We approve fees up to $25, as we are only requesting historical PWS and contacts, so this request is likely less
than 15 pages. Email address: martelkelly@adventsvcsllc.com
Any records that discuss, explain, or are in any way related to methods “required or sanctioned” by the FDA for testing
leather products for Cr(VI); •Any records related to the ISO 17075 test protocol for testing Cr(VI) in leather products;
and • Any records reflecting whether the ISO 17075 test method is “sanctioned or required” by the FDA for
purposes of providing an affirmative defense to the enforcement of the California Safe Drinking Water and Toxic
Enforcement Act of 1986, Cal. Health & Safety Code §§ 25249.6 et seq. (also known as “Proposition 65”).
“FDA’s Foreign Food Inspection Program /Foreign Remote Regulatory Assessment”.
All records responsive to FDA FOIA requests # 2021-8065, 2021-7496, 2021-7756, 2021-7919, and 2021-7989.
CV for Wei Weng, FDA Investigator/Microbiologist
Copy of the disclosable portions of the Food Additive Petition and all FDA reviews for FAP 2B4333, regarding poly(p-
oxyphenylene poxyphenylene p-carboxyphenylene) resins as a component of food-contact articles intended for
repeated use.
Copy of the disclosable portions of the supplemental drug approval package for Symdeko, NDA 210491, supplement 3,
Copy of the disclosable portions of the supplemental drug approval package for Trikafta, NDA 212273, supplement 4,
Documents regarding pediatric rare disease designation and priority review for Symdeko, NDA 210491. Please see
attached for more details
Please provide disclosable portions of the original FOIA request letter and complete FDA response for file number 2021-
7731
Summary Basis of Approval (SBOA) for two (2) related abbreviated new drug applications (ANDAs): ANDA 203594:
Drospirenone, Ethinyl Estradiol, and Levomefolate Calcium Tablets, 3 mg/0.03 mg/0.451 mg and Levomefolate Calcium
Tablets, 0.451 mg ANDA 203593: Drospirenone, Ethinyl Estradiol, and Levomefolate Calcium Tablets, 3 mg/0.02
mg/0.451 mg and Levomefolate Calcium Tablets, 0.451 mg
De Novo submission documents and information related to DEN170019.
Complete 510(k) documentation for the clearance of K872048, the 510(k) for the Transonic Flowmeter. Request
includes all documentation included in the official file, including sponsor and FDA documentation as well as any/all
supplements or amendments to the file.
Copy of the 483 for the Apr 4, 2011 - Apr 20, 2011 (17 days) inspection of Covenant HealthCare IRB located at Saginaw /
United States of America] 700 Cooper Ave, Saginaw, MI 48602, USA. This inspection pertains to Human Drugs.
Copy of the Company Response for the Apr 11, 2012 - Apr 23, 2012 (13 days) inspection of Memorial Hospital Of South
Bend, IRB located at South Bend / United States of America] 615 N Michigan St, South Bend, IN 46601, USA. This
inspection pertains to Human drugs
Copy of the Company Response for the Mar 14, 2011 - Mar 21, 2011 (8 days) inspection of Essex Institutional Review
Board, Inc located at Lebanon / United States of America] 121 Main St, Lebanon, NJ 08833, USA. This inspection pertains
to Human Drugs.
report of all FOIA requests filed with FDA’s Center for Food Safety and Applied Nutrition (“CFSAN”), including related
offices, from November 1, 2021 through November 20, 2021
Copy of the EIR for the Mar 14, 2011 - Mar 21, 2011 (8 days) inspection of Essex Institutional Review Board, Inc located
at Lebanon / United States of America] 121 Main St, Lebanon, NJ 08833, USA. This inspection pertains to Human Drugs.
Regulatory Assessment of BioLife Plasma Services L.P. Located at Warner Robins GA United States FEI Number:
3011502561 held on 04/13/2021.
Regulatory Assessment of CSL Plasma Inc Located at Cleveland OH United States FEI Number: 1525347 held on
05/04/2021.
Regulatory Assessment of CSL Plasma Inc Located at Warren OH United States FEI Number: 3013942860 held on
05/04/2021.
All documentation relating to K200298 (ABI Instrument, Creo Electrosurgical System) - 510(k), associated attachments,
and all associated correspondence
Regulatory Assessment of CSL Plasma, Inc. Located at Warwick RI United States FEI Number: 3014436240 held on
05/03/2021.
Seeking FDA inspection records for the Blood Bank at Northside Hospital in Atlanta, GA from August 2018.
I would like to request any and all records on the Covid-19 Vaccinations. I would like inspection records of all possible
companies that have formulated vaccinations. I would like a report of any and all information and records that have
been conducted on the Covid-19 vaccinations. I am seeking records on the examination and inspection of the Covid-19
Vaccinations approval from the FDA.
De Novo submission documents and information related to DEN180030
De Novo submission documents and information related to De Novo submission DEN190028
Copies of Form 483s issued by CDER’s (complex) International Operations Group
We are seeking all case records associated with the submissions for the following adverse reactions to Rituximab Hycela
reported to the FAERS database between January 1 2017 and present: nervous system disorders (22 cases); gait
disturbance (1 case); vision blurred (2 cases); vision impairment (2 cases); and vertigo (1 case).
All documents relating to the FDA’s review and evaluation of Emergency Use Authorization (“EUA”) Request 202982
(SARS-CoV-2 Antigen Rapid Qualitative Test) submitted by Innova Medical Group.
Guidance for Industry. Bioanalytical Method Validation FDA, 2001

All adverse event cases associated with the use of Mifepristone (also called
Mifeprex or RU 486) or Misoprostol (also called Cytotec), from January 1, 2000 to the present. ETC
Internal documentation relating to the marketing denial that we received on Sept 15, 2021
All completed OOPD review templates for approved drugs with orphan designation requests
REMOTE REGULATORY ASSESSMENT 1. DEMEDICA (Site 004) 10 Calle 23 Avendida SO Casa #233 Colonia Trejo, San
Pedro Sula, Cortes, Honduras Investigator: Jorge H. Umanzor Sabillon Inspection date: November 12, 2020 Excel Medica
(Site 005) Clinica Privada, Hospital del Valle Condominios Medicos del Valle Local 318 Colonia Borgaran, Boulevard del
Norte San Pedro Sula, Cortes, Honduras Investigator: Suyapa A. Bejarano Caceres Inspection date: October 27, 2020
Instituto de Oncologia de Rosario (Site 020) Cordoba 2457 Rosario, Santa Fe, S2000KZE, Argentina Investigator Luis E.
Fein Inspection date: November 2, 2020
A 1993 Misbranding Recall issued to Arjo Corporation for claims made about their Hydrosound bathing system.
BeLive Turmeric with Curcumin 2019 FDA Recall
CORR WITH KELLY AYOTTE SINE 1/1/17
RECS RE PHILIPS DREAMSTATION 1
All communications or documents related to Sterigenics U.S., LLC, Sotera Health Holdings, LLC, Sotera Health LLC, or
Sotera Health Company’s operations in the State of New Mexico, including but not limited to communications or
documents regarding a sterilization facility at 2400 Airport Road, Santa Teresa, NM.
All correspondence and other communication from, to, by or between FDA and AMA Analytical Services, Inc. ("AMA") or
its employees or agents regarding the analytical methodologies considered, selected, excluded and employed by AMA--
including, but not limited to, NY ELAP 198.4 and modifications thereof--in relation to the following reports: "Final Report
Part 1 (02282020-1 to 02282020-12)," ETC
All correspondence and other communication from, to, by or between FDA and any manufacturer or distributor of the
products analyzed (or representatives, employees or agents thereof) by AMA Analytical Services, Inc. ("AMA") on behalf
of FDA in the reports entitled "Final Report Part 1 (02282020-1 to 02282020-12)," "Final Report Part 2A (02232021-1 to
02232921-11),"ETC
All correspondence and other communication from, to, by or between FDA and any manufacturer or distributor of the
products analyzed (or their employees or agents) regarding the analytical methodologies considered, selected, excluded
and employed by AMA--including, but not limited to, NY ELAP 198.4 and modifications thereof--in relation to the
following reports: "Final Report Part 1 (02282020-1 to 02282020-12)," ETC
All correspondence to, from, by or between FDA and AMA Analytical Services, Inc., ("AMA") regarding FDA's "2021
Testing of Talc-Containing Cosmetics for Asbestos" (https://www.fda.gov/cosmetics/cosmetic-ingredients/talc) and/or
AMA reports 02282020-1 to -12, 02232021-1 to -11, 02232021-12 to -13, 03242021-1 to 11, and 04272021-1 to -14, as
referenced on FDA's website (https://www.fda.gov/cosmetics/cosmetic-ingredients/talc).
All of the following related to the analyses conducted by AMA Analytical Services, Inc. ("AMA") on behalf of FDA
referenced as "Final Report Part 1 (02282020-1 to 02282020-12)," "Final Report Part 2A (02232021-1 to 02232921-11),"
Final Report Part 2B (02232021-12 to 02232021-13)," "Final Report Part 3 (03242021-1 to 03242021-11)," and "Final
Report Part 4 (04272021-1 to 04272021-14"): ETC
chlorhexidine digluconate, CHDG (CAS 18472-51-0) toxicity data
list of certified interstate shellfish shippers
I respectfully request data, under the Freedom of Information Act on liver (liver injury, hepatitis, jaundice, liver failure)
related adverse events related to the medication mifepristone (Mifeprex, Korlym, RU-486) that have been reported to
FDA Adverse Event Reporting System (FAERS)/MedWatch since January 1, 2010.
In relation to "AMA Analytical Services, Inc. Summary of Asbestos and Talc Analysis - Final Report Part 1 (02282020-1 to
02282020-12)" (https://www.fda.gov/cosmetics/cosmetic-ingredients/talc): 1 - All photographs, images, graphs, charts
and patterns ETC
for Human Drugs inspection of Abaco Partners, LLC ending 11/10/2021 at the location in Grand Rapids MI, United
for Human Drugs inspection of Belport Co Inc. dba Gingi-Pak ending 11/12/2021 at the location in Camarillo CA, United
for Human Drugs inspection of Ideal Specialty Apothecary, Inc. dba Ideal Pharmacy ending 11/18/2021 at the location in
Union NJ, United States. Please send documents as email attachments.
for Medical Devices & Rad Health inspection of Benchmark Electronics, Inc. ending 08/26/2020 at the location in Nashua
NH, United States. Please send documents as email attachments.
for Human Drugs inspection of Claudia R. Padilla, M.D. ending 11/12/2021 at the location in Dallas TX, United States.
The 483 (in electronic format) for Human Drugs inspection of Prasad Padala, M.D. ending 11/18/2021 at the location in
Little Rock AR, United States. Please send documents as email attachments.
for Animal Drugs & Feeds inspection of Alcami Carolinas Corporation ending 10/29/2021 at the location in Charleston
SC, United States. ETC
1. Communications between the FDA and Johnson & Johnson or Vogue International about reports of injuries, including
hair loss, associated with personal care products (such as OGX shampoo) containing DMDM. 2. Communications
between the FDA and Johnson & Johnson or Vogue International about DMDM hydantoin and/or removing DMDM from
personal care products, including shampoos and conditioners.
1. Communications between the FDA and Unilever or Conopco concerning DMDM hydantoin in personal care products
(such as shampoos and conditioners). 2. Communications between the FDA and consumers or Unilever or Conopco
about people reporting injuries after using Tresemme containing DMDM. 3. Communications between the FDA and
Unilever or Conopco about removing DMDM from personal care products.
I would like to request copies of all complaints submitted to the Office of Prescription Drug Promotion's Bad Ad program
by professionals from 2016 onwards, in electronic format. Thank you.
I would like to request copies of professional and consumer promotional materials submitted under Form 2253 for
review by the Office of Prescription Drug Promotion, in electronic format. This is for years 2016 and onward.
COMM BETWEEN EDGEWELL PERSONAL CARE BRANDS, LLC AND FDA RE BENZENE IN SUNSCREEN AND AFTER-SUN CARE
PRODUCTS, ETC
MATERIAL SAFETY DATA SHEET PFIZER, MODERNA, J&J
K172735
GUIDE TO FOIA REQUESTS; NUTRITIONAL GUIDELINES FOR ADULTS
Copies of Form 483s issued to the following CLINICAL INVESTIGATOR from September 1-30:
Copies of Form 483s issued to the following DEVICE companies from October 1-31, 2021.
Copies of Form 483s issued to the following CLINICAL INVESTIGATOR from October 1-31: Please ignore the previous
clinical request submitted with the wrong Date Range. Thanks.
Copies of Form 483s issued by the CDER Office
Copies of Form 483s issued to the following DRUG companies from October 1-31, 2021.
2002-6804
I am seeking for all regulatory actions and communications between FDA and the two companies: ASC Therapeutics Inc
located in Milpitas CA and Vigene Bioscience in Rockville MD.
Copy of the FDA response only to the following file numbers: 2021-3941 2019-622
FOIA Request for Food Contact Notification (FCN) 1120, 806 and 368
Full text of 510(k) K102456 - Intraoral BelSensor Gold
I am formally requesting company name, contact name, contact address, and phone number for all
businesses/companies registered as manufacturers of cosmetics, beverages, dietary supplements, pet supplements,
nutraceuticals, and food in the United States.
I am requesting: 1. the first page (i.e., Face Page) of the current contract award, and first 15 pages of the Performance
Work Statement or Statement of Work for the existing contract #75F40120C00011 etc
Any documents related to PolarityTE, Inc.’s drug “SkinTE”, including any trial data, as well as any communications
between the FDA and PolarityTE.
Documents related to Longeveron's drug "Lomecel-B," including any trial data and communications between the FDA
and Longeveron.
Information included in the Premarket notification submission (510k) - K201772, as per 21 CFR 807.93 Device: Nitrile
Powder Free Examination Gloves With Low Dermatitis Potential Claim And Tested For Use With Chemotherapy Drugs
And Fentanyl Citrate (Blue) Applicant: Hartalega NGC Sdn. Bhd Substantially Equivalent Determination: 25 AUG 2020
Finasteride related Psychiatric Adverse Events (anxiety, depression, suicidality or suicide)
Please provide any new records (dated June 1, 2020 to the present) relating to Edge Pharma, LLC, formerly known as
Edge Pharmacy Services, LLC, an outsourcing facility located at 856 Hercules Drive, Colchester, Vermont.
Can we please have all the AERS records for Aduhelm from September 30th (the last dashboard update) to the most
current date. Thank you.
We request the manufacturer's (Amgen Inc.'s) submission for its Supplemental Biologics License Application (sBLA)
125031/S-175, dated June 27, 2014, and additional data submissions (reports and data) from manufacturer dated on or
about October 22, 2014, in response to FDA reviewer requests concerning product quality and device information.
Copies of autopsy reports concerning any VAERS-reported
deaths following COVID-19 vaccination.
Please provide a complete list of all provisional substantial equivalence (SE) reports removed from review.
Report and/or the MDSAP Noncomformity Grading and Exchange Form (NC) for the inspection of AMICO PATIENT CARE
CORPORATION, Richmond Hill, Canada, end date 07-28-2018. FEI# 3012398026. This inspection pertains to medical
devices.
All 483s for Pharmaceutics International Inc (PII) located in Hunt Valley, MD & Cockeysville, MD from 09/30/2021 -
Present. Please note this is a human drugs firm.
Report and/or the MDSAP Noncomformity Grading and Exchange Form (NC) for the inspection of Cardiocomm
Solutions, Inc., North York, Canada, end date 06-29-2018. FEI# 3003708031. This inspection pertains to medical devices.
Report and/or the MDSAP Noncomformity Grading and Exchange Form (NC) for the inspection of LifeGlobal, Guelph,
Canada, end date 11-15-2018. FEI# 3006362813. This inspection pertains to medical devices.
for Biologics inspection of Baxalta Manufacturing Sarl ending 07/12/2013 at the location in Neuchatel, Switzerland.
Report and/or the MDSAP Noncomformity Grading and Exchange Form (NC) for the inspection of PRO-LAB, Inc,
Richmond Hill, Canada, end date 05-25-2018. FEI# 1000354384. This inspection pertains to medical devices.
All records responsive to FDA FOIA request #s 632021-5930, 2021-6013, 2021-6014, 2021-6091, 2021-6094, and 2021-
68.
for Biologics inspection of Cenexi ending 07/05/2013 at the location in Osny, France. Please send documents as email
attachments.
for Human Drugs inspection of B. Braun Medical Inc. ending 11/05/2021 at the location in Daytona Beach FL, United
for Human Drugs inspection of Carlsbad Technology, Inc ending 11/05/2021 at the location in Carlsbad CA, United
for Human Drugs inspection of Hiers Enterprises, LLC dba Northwest Compounding Pharmacy ending 11/10/2021 at the
location in Roseburg OR, United States. Please send documents as email attachments.
for Human Drugs inspection of Miami University ending 11/05/2021 at the location in Oxford OH, United States. Please
for Human Drugs inspection of Stira Pharmaceuticals LLC ending 11/05/2021 at the location in Fairfield NJ, United
for Human Drugs inspection of IMMUNOCORE, LLC ending 10/14/2021 at the location in Conshohocken PA, United
format) for Human Drugs inspection of Pace Analytical Life Sciences, LLC ending 02/07/2018 at the location in Oakdale
MN, United States. Please send documents as email attachments.
I am requesting the record or records from FDA-CVM for the definition for the ingredient "chicken meal" (for use in
animal feed and pet foods). This ingredient definition is not available on the federal register. This ingredient definition is
also not available anywhere on FDA's website.
I am requesting the record or records from FDA-CVM for the definition for the term "human grade" (for use on animal
feed and pet food packages). This term definition is not available on the federal register. This term definition is also not
available anywhere on FDA's website. FDA is required by law to provide me the records for this term.
I'm requesting all calendar records for Steven Solomon. These records may have been released under FDA FOIA request
2019-2179. Provide me the same records released for that FDA FOIA request.
1) A copy of Premarket Notification [510(k)] submission K003064; Device Name: TINA-QUANT SOLUBLE TRANSFERRIN
RECEPTOR TEST SYSTEM 2) A copy of Premarket Notification [510(k)] submission k063663; Device Name: Dimension
Vista STFR Flex Reagent Cartridge 3) A copy of Premarket Notification [510(k)] submission k080634; Device Name:
Access sTfR
Dear Sir or Madam: Under the provisions of the Freedom of Information Act, 5 U.S.C. 552, we are requesting copies of
the following documents pertaining to Food Contact Notification (“FCN”) No. 1745: 1) FCN submission documents for
FCN 1745; and, 2) FDA reviews for the FCN 1745. No copies of study data are being requested; therefore, FIFRA Section
10 (g) does not apply and no affirmation of multinational status will need to be filed. I hereby authorize the
expenditure of no more than $250 to obtain the requested documents. If the cost is expected to exceed the
aforementioned amount, please contact me for further authorizations. If you have any questions about the
aforementioned request, please contact me either by email at wmccombie@pnwpesticideconsulting.com or by
telephone at 703-924-0330. Thank you in advance for your help. Sincerely, Wendy A. McCombie
Documents pertaining to NDA 208524 (Belqiv(R); lorcaserin; specifically Module 2 and Module 4. Module 2: Section
2.4.1 (Overview of Nonclinical Testing); Section 2.4.4., Section 2.6.3, and Section 2.6.6. Module 4: Section 4.1 (Table of
Contents), Section 4.2.3.2 (Repeat Dose Toxicity)
Greenleaf Health is requesting a copy of the Multi-Discipline Review for the approval of Cyltezo (adalimumab-adbm), a
biosimilar of Humira (adalimumab). The review document is for the 10/15/2021 supplemental approval of Cyltezo.
The Establishment Inspection Report (in electronic format) for Biologics inspection of BPC Plasma, Inc., (formerly
Biotest Pharmaceuticals, Corp.) ending 04/08/2019 at the location 2501 Discovery Drive, Suite 400 Orlando, FL United
States and the EIR for the inspection ending 03/28/2019 at the location 311 N. Patterson Street, Valdosta, GA 31601.
Records of product inspection or analysis done by FDA before shipment release at the port of entry or storage facility.
Type of Product: Stevia Sweetener Country of Origin: Bolivia Name of Importer: Luis F. Covarrubias Importer No.: 229-
13-8724 Port Code: 5206 (Miami, Florida) Dates of Entry and Air Way Bill #: 05/17/17 BL or AWB: 90190330391
08/07/17 ETC
Request for EIR for LGM Pharma, Irvine Ca., FEI#3017140477
Center for Drug Evaluation and Research non-clinical reviews, including carcinogenicity study summaries, for the
following approved New Drug Applications (NDAs): • 210795 • 209627 • 212327 • 212273
•All materials related to PMA 920046 - Premarket Approval of Femcare Filshie Clip System •ETC
I need original NADA 120-161 of the product ANTIROBE Capsules.
Funding of the Food and Drug Administration. I am requesting a financial summary of donations and any money that the
Food and Drug Administration has received over the past two years.
This is a Freedom of Information Act (FOIA) request for import data relating to of Entries ES6-7001673-3, WD8-0062264-
5, KM6-1550034-5, and KM6-1555698-2.
To whom it may concern, I am studying the interaction between anti-TNF medications and ONJ. I am hoping to review
the following cases: 17809054 17804616 17754035 17517236 17498589 17089846 16974928 16970411 16911566
16838642 16880828 16543486
Summary Basis of Approval of initial NDA#018086, timolol ophthalmic solution
NDA 077510
NDA 020222
2016-8503, 2016-8793, 2016-8794, 2016-8795, 2016-8796.
2016-8798, 2021-5882, 2021-6059, 2021-6137, 2021-6262
2021-6335, 2021-6369, 2021-6436, 2021-6525, 2021-6539.
2021-6576, 2021-6622, 2021-6628, 2021-6642, 2021-6835.
[Reference FGI# 21-76152] Relevant to 75F40121C00011 we specifically request copies of the following agency records:
(1) Contract, with applicable SOW/PWS, Labor rates/categories and all Task/Delivery Orders
[Reference FGI# 21-76153] Relevant to HHSF223201710016I we specifically request copies of the following agency
records: (1) Contract, with applicable SOW/PWS, Labor rates/categories and all Task/Delivery Orders
We would like to request the performance information submitted for the 510K K191407, Fresenius Medical Care Renal
Therapies Group, Novalung System. We are interested in both the in vitro and in vivo testing submitted for review.
We would like to request the performance information submitted for the 510K K202751, Cardiac Assist Inc,
TandemHeart Pump and Escort Controller. We are interested in both the in vitro and in vivo testing submitted for
review.
I request copies of any agency documentation or communication with Smiths Medical ASD, Inc., located at 6000
Nathan Lane N. Minneapolis, Minnesota regarding FDA Warning Letter CMS #617147 since October 1, 2021 through
present day.
Documents in the possession of the FDA Office of Surveillance and Epidemiology including the words: "McKinsey" AND
"opioid"
I request a copy of all internal AveXis emails and text messages that were obtained by the FDA as part of it's
investigation into AveXis Zolgensma data manipulation.
I require a breakdown of FDA annual funding and application fees collected from pharmaceutical manufactures 1982-
2020. Thanks
METROGEL-Vaginal, 0.75% N020208.
All information concerning FDA inspections conducted at any Mendo-Lake

Home Respiratory Services, Inc. facility in the state of California for the period
January 1, 1998 through present, including, without limitation, any Form 483
Inspectional Observations, Establishment Inspection Reports and/or Warning
Letters.
I would like to request the Establishment Inspection Reports (EIRs) for three clinical sites inspected for NDA 219189
(Klisyri). Study KX01-AK-003 Site 320 Leonard Swinyer, MD 1548 East 4500 South Suite 201 Salt Lake City, UT 84117
Inspection dates: April 14-17, 2020 Study KX01-AK-003 Site 323 Michael Bukhalo, M.D. Arlington Dermatology 5301
Keystone Court Rolling Meadows, IL 60008 Inspection dates: July 13-16, 2020 etc
K172335, Bleep DreamPort
Letter sent by Pfizer notifying the FDA of the withdrawal from sale of COMIRNATY or BLA125742.
Looking for DEXCOM, INC. Medical Device Listing Number's for all products, currently really need the listing number for
510K: K191450 PRODUCT CODE: QBJ as the FDA is requesting it but I have been struggling to get in contact with
DEXCOM, INC.
for Medical Devices & Rad Health inspection of Invotec International Inc. ending 11/04/2021 at the location in
Jacksonville FL, United States. Please send documents as email attachments.
for Medical Devices & Rad Health inspection of Spinal Balance, Inc. ending 10/29/2021 at the location in Swanton OH,
for Medical Devices & Rad Health inspection of Surmodics Inc ending 11/04/2021 at the location in Eden Prairie MN,
for Medical Devices & Rad Health inspection of HTL ending 03/07/2013 at the location in Javene, France. Please send
for Human Drugs inspection of Regeneron Pharmaceuticals Inc ending 10/25/2021 at the location in Rensselaer NY,
United States. The 483 (in electronic format) for Human Drugs inspection of Unither Manufacturing LLC. ending
10/15/2021 at the location in Rochester NY, United States. Please send documents as email attachments.
for Medical Devices & Rad Health inspection of AmericanBio Inc. ending 11/04/2021 at the location in Canton MA,
United States. The 483 (in electronic format) for Medical Devices & Rad Health inspection of Synapse Dental ending
11/01/2021 at the location in Cranston RI, United States. Please send documents as email attachments.
for Foods & Cosmetics inspection of ANS Nutrition, Inc. (formerly DNE Nutraceuticals, Inc.) ending 09/04/2020 at the
location in Farmingdale NJ, United States. The Response (in electronic format) for Foods & Cosmetics inspection of ANS
Nutrition, Inc. (formerly DNE Nutraceuticals, Inc.) ending 09/04/2020 at the location in Farmingdale NJ, United States.
• All internal and external communications and analyses relating to: (1) FDA’s request for a label strength as
approved in efficacy supplement S-054, (2) FDA’s subsequent determination that the label strength as approved was in
error, and (3) FDA’s agreement of April 16, 2021 with the Reference Product Sponsor for Forteo®. ETC
Race and ethnicity information for VAERS records 902418 through 918561.
15242828 15026893 14424498
11392183 11282056 10989465
We are requesting all records, from any division of the FDA including the Center for Devices and Radiological Health,
that mention “The Living Brain Project” (LBP), also known as “a Multiscale Investigation of the Living Human Brain,” at
the Icahn School of Medicine at Mount Sinai Hospital, 1 Gustave L. Levy Place, New York, NY 10029-5674. As detailed in
the attached FOIA, these records include but are not limited to: correspondence, reports, and any analysis and review
by internal FDA staff and outside experts.
Communications from Dr. Peter Marks concerning the authorization of Pfizer COVID-19 vaccine booster doses for 16-
and 17-year-olds. Exclude spam and attachments. Thank you.
The memorandum outlining the decision to authorize COVID-19 vaccine booster doses in 16- and 17-year-olds.
All records provided for control # 2020-6396
Documents in the custody of FDA Employee Bob A. Rappaport including the words: "McKinsey" AND "opioid"
Documents in the custody of FDA employee Keith Austin containing the words: "McKinsey" AND "opioid" OR
"HHSF223201010014B"
Documents in the custody of the FDA Office of Surveillance and Epidemiology that include the words: "McKinsey" AND
"Mundipharma"
FLORIDA SUNCARE TESTING INSPECTION RECS
NDA 020551, NDA 018892
KIK CUSTOM PRODUCTS INSPECTION RECS
All records for the first production of Case No. (20cv3413), lawsuit brought against FDA for FOIA violations by a
requestor named Eric Nault, inwhich FDA has been producing records for now that the matter is in litigation directly to
Eric Nault.
Copy of the 483 for the Feb 10, 2012 - Feb 29, 2012 (20 days) inspection of Endogastric Solutions, Inc. located at
Redwood City / United States of America] 555 Twin Dolphin Dr #650, Redwood City, CA 94065, USA. This inspection
510(k) Summary for K151990 Device Name Tissue Removal System Applicant BOEHRINGER LABORATORIES LLC 510(k)
Summary for K150781 Tissue Removal Pouch Applicant BOEHRINGER LABORATORIES, LLC
Copy of the Company Response for the Apr 4, 2011 - Apr 20, 2011 (17 days) inspection of Covenant HealthCare IRB
located at Saginaw / United States of America] 700 Cooper Ave, Saginaw, MI 48602, USA. This inspection pertains to
Human Drugs.
Copy of the EIR for the Apr 4, 2011 - Apr 20, 2011 (17 days) inspection of Covenant HealthCare IRB located at Saginaw /
United States of America] 700 Cooper Ave, Saginaw, MI 48602, USA. This inspection pertains to Human Drugs.
Copy of the EIR for the Feb 10, 2012 - Feb 29, 2012 (20 days) inspection of Endogastric Solutions, Inc. located at
Redwood City / United States of America] 555 Twin Dolphin Dr #650, Redwood City, CA 94065, USA. This inspection
Report and/or the MDSAP Noncomformity Grading and Exchange Form (NC) for the inspection of AMICO PATIENT CARE
CORPORATION, Richmond Hill, Canada, end date 07-28-2018. FEI# 3012398026. This inspection pertains to medical
devices.
Report and/or the MDSAP Noncomformity Grading and Exchange Form (NC) for the inspection of Cardiocomm
Solutions, Inc., North York, Canada, end date 06-29-2018. FEI# 3003708031. This inspection pertains to medical devices.
Report and/or the MDSAP Noncomformity Grading and Exchange Form (NC) for the inspection of PRO-LAB, Inc,
Richmond Hill, Canada, end date 05-25-2018. FEI# 1000354384. This inspection pertains to medical devices.
Report and/or the MDSAP Noncomformity Grading and Exchange Form (NC) for the inspection of LifeGlobal, Guelph,
Copy of the disclosable portions of the 51(k) for K202145, Bigfoot Unity Diabetes Management System.
Copy of the disclosable portions of the 510(k) for K210561, Advisor Pro Platform, by DreaMed Diabetes.
Regulatory Assessment of BioLife Plasma Services L.P. Located at Springfield MO United States FEI Number: 3011638472
held on 10/22/2020.
Regulatory Assessment of Biolife Plasma Services, L.. P. Located at Appleton WI United States FEI Number: 3007206469
held on 10/27/2020.
Regulatory Assessment of Biomat USA, Inc. Located at Albany GA United States FEI Number: 3012978921 held on
10/26/2020.
Regulatory Assessment of Biomat USA, Inc. Located at Boise ID United States FEI Number: 3022159 held on 10/22/2020.
Regulatory Assessment of CSL PLASMA, INC Located at York PA United States FEI Number: 3011816271 held on
10/30/2020.
K153193
Regulatory Assessment of CSL Plasma Inc Located at Cincinnati OH United States FEI Number: 3013704884 held on
10/28/2020.
K161667
Regulatory Assessment of CSL Plasma, Inc. Located at Evans CO United States FEI Number: 1000117435 held on
10/23/2020.
Regulatory Assessment of CSL Plasma, Inc. Located at Las Vegas NV United States FEI Number: 3013164232 held on
10/22/2020.
all studies and communications related to said studies regarding Butterfly pea flower color additive in relation to CAP
8C03113 21 CFR 71 or other submissions, in your files and copies of the Agency’s correspondence relating to this
material
all FDA internal documents, internal emails, and safety information regarding Low erucic acid rapeseed oil (Synonyms:
canola oil) in relation to 21 CFR 184.1555 in your files and copies of the Agency’s correspondence relating to this
material
Hello, Den-Mat Holdings, LLC would like to request a copy of our 510k letter for K872510, however we are unable to
attain a copy online, nor is it available for download from the 510k database • 510k letter for K872510
EIR from last inspection on 09/06/2018 for Northside Hospital Blood Bank in Atlanta, GA
Any and all communications between the United States Food and Drug Administration (FDA), Center for Drug Evaluation
and Research, Office of Compliance, Office of Compounding Quality and Compliance and external third parties including
but not limited to the Ohio Board of Pharmacy involving discussions on the FDA’s Prohibition on Wholesaling under
Section 503B of the Federal Food, Drug and Cosmetic Act.
searching CVM's ADE database for adverse events associated with meloxicam injection in dogs and cats
Date Range: 11/30/2020 - 11/30-2021; searching CVM's ADE database for adverse events in US associated with
imidacloprid + moxidectin topical solution in all species
we are requesting FSVP import data for L.A Vegetable. We want to know who's using our duns number and is listing us
as their importer.
searching CVM's ADE database for adverse events in US associated with Previcox (firicoxib oral tablets for dogs) in all
species
searching CVM's ADE database for adverse events in US associated with enrofloxacin oral tablets in all species.
Any and all records regarding complaints, defects, recalls or adverse events involving DERMO-JET Model G
manufactured by Robbins Instruments
searching CVM's ADE database for adverse events in US associated with methimazole oral tablets (Felimazole) in all
species for date range.
Participant Guide for FD254 Preventive Controls for Human Food Regulators, the guide should include all powerpoint
slide, notes, activities, exercises and associated handouts.
K202345 Triever Catheters 510(k)
We request all documentation/information related to the shipment that resulted in Pharmaline's inclusion of FDA's
Import Alert 99-42 including, but not limited to: Notice of Action, Product Labels, Bill of Lading, Packing List, Invoice,
consignor, consignee, container number.
I would like to receive a copy of the FDA warning letter issued on December 9, 2021 for Medtronic's Northridge, CA
facility, the headquarters for its diabetes business. In addition, I would like to receive the inspection report (Form 483)
for FDA's inspection of Medtronic's Northridge, CA facility conducted in July 2021.
I request copies of any agency documentation or communication with Medtronic regarding the FDA Warning Letter
issued to their Northridge, California facility since December 1, 2021 through present day.
1. For the time period January 1, 2021 to the present, any and all FDA health hazard evaluations concerning the recalls
of Lotrimin and Tinactin products initiated on or about October 1, 2021, and classified by the FDA on or about
November 18, 2021. etc
Any correspondence to and from Fluid Chemical Company, including letter of January 25, 1978, which concern FDAs
interpretation of the phrase "generally parallel to the base on which the package rests" as used in 21 CFR 701.11(c) -
Identity Labeling and 701.13(f) - Declaration of net quantity of contents. In particular I am looking for any specification
of the angle which would be considered "generally parallel".
FDA copies of Form 3480 and corresponding attachments for the FCN 1742 for the food contact substance 2-Propenoic
acid, homopolymer, sodium salt (CAS RN 9003-04-7).
Medtronic's diabetes device manufacturing facility in Northridge, CA and the inspection that concluded in 7/2021.
K151188 full 510(k) for the BodyGuardian Remote Monitoring System
K192732 full 510(k) for the BodyGuardian Remote Monitoring System
K170565 full 510(k) for the LifeWatch Mobile Cardiac Telemetry 3 Lead LifeWatch MCT 3L
Copy of the disclosable portions of any and all documents related to Color Additive Petition (CAP) 1C0320
We request the Agency to provide the CMC (Chemistry, Manufacturing and Controls) sections and invitro
characterization section for the ANDA 212416: Calcitonin Salmon Injection USP, 400 USP units per 2 mL (200 USP units
per mL) Multi-Dose Vial held by Custopharm Inc.
K170435, Pajunk Nerveguard.
FDA prescribing guidelines for bleomycin for the year 2013
Hims & Hers Health, Inc (d/b/a “Hims” and “Hers regulatory activities conducted by Office of Regulatory Affairs (ORA),
Office of Prescription Drug Promotion (OPDP), Office of Compounding Quality and Compliance (OCQC), Center for
Devices and Radiological Health (CDRH), or Center for Drug Evaluation and Research (CDER).
We request the Agency to provide the CMC (Chemistry, Manufacturing and Controls) sections and invitro
characterization section for the ANDA 209358: Calcitonin Salmon Injection USP, 200 IU/mL held by PAR Sterile Products.
for Human Drugs inspection of National Chemical Laboratories ending 11/04/2021 at the location in Philadelphia PA,
for Human Drugs inspection of Plastikon Healthcare LLC ending 11/04/2021 at the location in Lawrence KS, United
for Foods & Cosmetics inspection of ANS Nutrition, Inc. (formerly DNE Nutraceuticals, Inc.) ending 04/24/2018 at the
location in Farmingdale NJ, United States. etc
Request for the EIR of the inspection that occurred at Medtronic Navigation, Inc. between June 9, 2021 & June 29, 2021.
Medtronic warning letter from the U.S. Food and Drug Administration (FDA) on December 9 for the company's
Northridge, California, facility
Communications between Alison Hunt, Office of Commissioner, Office of Media affairs; or (2) Gabriel Muniz, Office of
Regulatory Affairs; with public interest groups, trade groups, and educational institutions (including primary, secondary,
college – undergraduate and graduate – institutions) along with their professors and other paid researchers or
academics, on the other hand, from 9/30/2020 – 9/30/2021, regarding the efficacy of ENDS devices for smoking
cessation, excluding records (including drafts and non-email documents) related to publications and journal articles,
however, we do not want to exclude email correspondence that is associated with the publication of journal articles
relating to the efficacy of ENDS in smoking cessation.
for Human Drugs inspection of Agropharma Laboratories Inc. ending 11/03/2021 at the location in Salinas PR, United
for Human Drugs inspection of Lifequest Creations LLC ending 11/04/2021 at the location in Marietta GA, United States.
for Human Drugs inspection of RLC Labs Inc. ending 11/04/2021 at the location in Phoenix AZ, United States. Please
for Human Drugs inspection of Amsino Healthcare (USA) Inc ending 09/20/2021 at the location in Vernon Hills IL, United
States. The Response (in electronic format) for Human Drugs inspection of Amsino Healthcare (USA) Inc ending
09/20/2021 at the location in Vernon Hills IL, United States.
Hello - requesting Warning Letter on Medtronic's Northridge, California, facility, that was issued on December 9 for an
inspection that took place in July 2021.
CERTIFIED LIST OF ADVERSE EVENTS COVID VACCINE WALGREENS
A complete response letter (CRL) was issued to Braeburn Inc. on December 15th 2021 due to “manufacturing
deficiencies”, concerning the approval of Brixadi, their long-acting buprenorphine depot injection (in-licensed from
Camurus) I would like to have access to the “483 observations” documented by the FDA inspectors during the pre-
approval manufacturing site inspection of Pharmaceutics International Inc. (PII). I expect the inspection(s) to have
happened between June 26th 2021 and December 15th 2021 at PII manufacturing sites: 10819 Gilroy Rd Hunt Valley,
MD 21031-8213 and 103 Beaver Ct, Cockeysville, MD 21030-2106. However I don’t want to limit the search to these
manufacturing sites alone. A previous CRL was issued to Braeburn because of Brixadi “manufacturing deficiencies” on
the December 2nd 2020. In that case PII was the manufacturer and “483 observations” were requested. Based on those
documents the inspection dates were: 10/19/2020 – 10/30/2020 for the Cockeysville and Hunt Valley sites. The
investigator who signed off the “483 observations” was Junho Pak and the FEI number for both site inspections are:
3006503102 and 1000513101. Perhaps this information will assist in the new document search.
We request the information specified below for all applications, both funded and unfunded, for
Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR)
grants, cooperative agreements, and contracts (corresponding to National Institutes of Health
(NIH) activity codes R41-42, SB1, U43-44, UT1-2, UB1, and N43-44) submitted to the Food
and Drug Administration from 1983 to the present.
Hi, I am requesting a copy of the Warning Letter the FDA sent to Medtronic's Diabetes facility in Northridge, California
on December 9, 2021 per the below press release. Thank you. https://news.medtronic.com/2021-12-15-Medtronic-
Diabetes-receives-FDA-warning-letter,1
483 issued to Daiichi Sankyo Chemical Pharma (Onahama Plant), Iwaki, Fukushima, Japan on FDA inspection. FEI:
3002808054
483 issued to Daiichi Sankyo Chemical Pharma (Tatebayashi Plant,), Gunma, Japan on FDA inspection. FEI: 3012477651
MedWatch forms for 58 case numbers. Please see attached. If you need the case numbers in a spreadsheet, please
email rjohnson@foiservices.com and I will send them to you. The system would not let me upload a spreadsheet.
510(k) for K212456, Swoop Point-of-Care Magnetic Resonance Imaging System
All records related to 510(k) application K173402, Neocis Guidance System (Ngs) with Charside Split.
All records related to 510(k) application K182776, Neocis Guidance System.
All records related to 510(k) application K191363, Neocis Planning Software Application (NPSA) for 3rd Party PCs
All records related to 510(k) application K191369, TSolution One Total Knee Application
All records related to 510(k) application K191605, Neocis Guidance System (NGS)
All records related to 510(k) application K200348, Neocis Guidance System (Ngs) with Charside Split.
All records related to 510(k) application K200805, Neocis Guidance System (Ngs) With Patient Splints
All records related to 510(k) application K201255, TSolution® One Total Knee Application
All records related to 510(k) application K202100, Neocis Guidance System (NGS) with Clamped Chairside Patient Splint
(C-CPS)
All records related to 510(k) application K202264, Neocis Guidance System (NGS) with Yomi Plan V2.0
All records related to 510(k) application K203401 Neocis Guidance System (NGS) with Patient Splints (EPS)
All records related to 510(k) application K211129, Neocis Guidance System (NGS) With Intraoral Fiducial Array
All records related to 510(k) applications related to K161399, Neocis Guidance System.
Electronic listing (preferably csv format) of all inspections conducted by FDA since July 2021. The list should cover all
I would like a copy of Medtronic's response to the 483 they received for their Northridge, CA facility in July 2021.
for Human Drugs inspection of Geneva Laboratories, Inc ending 07/23/2021 at the location in Elkhorn WI, United States.
for Human Drugs inspection of StageBio ending 09/03/2021 at the location in Frederick MD, United States. Please send
syndrome, etc
for Human Drugs inspection of Teligent Pharma, Inc. ending 08/31/2021 at the location in Buena NJ, United States.
for Medical Devices & Rad Health inspection of Greiner Bio-One North America, Inc. ending 10/29/2021 at the location
in Monroe NC, United States. Please send documents as email attachments.
for Medical Devices & Rad Health inspection of Magna Pharmaceuticals Inc ending 10/29/2021 at the location in
Louisville KY, United States. Please send documents as email attachments.
for Medical Devices & Rad Health inspection of Medtronic Xomed, Inc. ending 10/29/2021 at the location in
Minneapolis MN, United States. Please send documents as email attachments.
for Medical Devices & Rad Health inspection of Namsa ending 09/21/2021 at the location in Minneapolis MN, United
for Medical Devices & Rad Health inspection of Viant Medical Company ending 08/22/2018 at the location in Grand
Rapids MI, United States. Please send documents as email attachments.
for Biologics inspection of Eurofins Lancaster Laboratories, Inc. ending 10/21/2021 at the location in Lancaster PA,
for Foods & Cosmetics inspection of Universal Preserv-A-Chem Inc. ending 07/22/2021 at the location in Mebane NC,
1. Whether Dream Top Co., Ltd. has actually issued an MSH code from the FDA Suspect Ki Soo Kim insists, that the
MSH code was issued to the complainant by owner/operator number (10080759) and the registration number
(3018070846). etc
all records provided for 2020-6396
All documents related to the CMC (Chemistry, Manufacturing, and Controls) for the ANDA# 065049 (Clindacin-P),
originally approved on May 25, 2000 by USFDA.
Breakthrough designation submission for SmartFuse® by Intelligent Implants LLC.
Copy of the 483 for the Feb 10, 2020 - Feb 14, 2020 (5 days) inspection of Luminex Corporation [Austin / United States
of America] 12212 Technology Blvd, Austin, TX 78727, USA. This inspection pertains to medical devices.
Copy of the 483 for the Feb 10, 2020 - Feb 19, 2020 (10 days) inspection of Wintac Limited [Nelamangala Town / India]
300 Franklin Square Dr, Somerset, NJ 08873, USA. This inspection pertains to human drugs.
Copy of the 483 for the Jan 27, 2020 - Jan 30, 2020 (4 days) inspection of Laboratorios Dentales De Zona Franca, S.A.
[San Isidro / Costa Rica] Calle 58, Provincia de Cartago, Cartago, Costa Rica. This inspection pertains to medical devices.
Copy of the 483 for the Oct 7, 2020 - Oct 28, 2020 (22 days) inspection of Syntec Pharma Corp [Farmingdale / United
States of America] 96 Gazza Blvd, Farmingdale, NY 11735, USA. This inspection pertains to human drugs.
Device De Novo submission documents for the Loadpro™ Intraoperative Rod Strain Sensor by Intellirod Spine, Inc.
related to DEN180012.
Device De Novo submission documents for the PersonaIQ® System related to DEN200064.
For ANI Pharmaceutical's approved Cortrophin Gel sNDA, we request a redacted copy of the medical review sections
(2.5 Clinical Overview; 2.6 Pharmacokinetics; 2.7 Clinical Efficacy) and CMC section (3.2 Body of Data).
I would like a copy of the following 510(k) K982577 (full copy all sections)
Monarch PCM, LLC 7333 Jack Newell Blvd N. Suite 100 Fort Worth, Texas 76118 We are requesting any information
regarding the following: -Form 483 received in the year 2021 -Establishment Inspection Report from FDA for the 483
received in 2021 -All responses to the Form 483 received in 2021 by Monarch PCM, LLC
Please provide the new infant formula notification documents and correspondence thereof for the following exempt
infant formulas: Prolact RTF 24 Human Milk-Based Premature Infant Formula Prolact RTF 26 Human Milk-Based
Premature Infant Formula Prolact RTF 28 Human Milk-Based Premature Infant Formula Prolact Plus Human Milk
Fortifiers (+4, +6, +8, and +10) Prolact CR Human Milk Caloric Fortifier
We request a copy of the Refusal to File (RTF) letter from the U.S. Food and Drug Administration (FDA) regarding its
supplemental new drug application (sNDA) for Cortrophin® Gel given to ANI Pharmaceuticals.
We would like a copy of the following 510(k) k980962 (all sections please)
1. a current list of all the Human Cell and Tissue (HCT/P) Establishments that includes each establishment’s mailing
address, E-mail address and principal contact. 2. a current list of Blood Establishments that includes each
establishment’s mailing address, E-mail address and principal contact. Please send these two lists as an Excel file with
each row as a record.
Address, phone, email for the following individuals and companies who make frequent FOIA requests to FDA.
Copies of all FOIA requests submitted to the Food and Drug Administration by Eli Lilly on or after November 1, 2011 and
Copies of all FOIA requests submitted to the Food and Drug Administration by Gilead on or after November 1, 2011 and
Copies of all FOIA requests submitted to the Food and Drug Administration by GlaxoSmithKline on or after November 1,
2011 and any production made in response to each such FOIA request.
Copies of all FOIA requests submitted to the Food and Drug Administration by Merck on or after November 1, 2011 and
A) All documents, including email communications, between the Food and Drug Administration (FDA) or the Federal
Trade Commission (FTC) and Walmart Inc. (“Walmart”) pertaining to Walmart’s “Parent’s Choice” baby foods and infant
formula. B) All documents pertaining to Walmart’s heavy metal (including, but not limited to, arsenic, inorganic arsenic,
lead, cadmium, and mercury) limits established by Walmart’s Food Safety and Compliance team for Parent’s Choice
food products.
COVID VACCINE ADVERTISING
In January through April 2020, the CDC, FDA, and state partners investigated a cluster of STEC cases linked to alfalfa
sprouts and Jimmy John’s restaurants. Marler Clark represents several clients associated with this outbreak. We are
writing to request copies of any traceback records on file at HAF 4W (DEN) of the FDA regarding this outbreak.
ANDA # 076593
We are looking for a copy of the complete lab analysis that was done on our PO 12030607488, item 1557691, from
customs entry SCS-8606898-0, Line 31/1 . Port of entry was 3801, Detroit, MI. Pepper mill & Salt Mill. Importer of
record in Costco Wholesale Corporation in An FDA Notice of FDA Action was issued on Dec 9, 2021, by Alyssa L Wenke,
Compliance Officer, US FDA.
We are seeking for the 510k submission documents for K130368. I am willing to pay fee no more than $500. We prefer
obtain the 510k submission documents by email.
Copy of the disclosable portions of the 483 for the 10/15/2021 inspection of Berkshire Sterile Manufacturing, located in
Lee, MA. Please note this inspection pertained to human drugs.
Hi, I am an investment professional for an asset management firm and would like to request the manufacturing review
package for Wegovy (NDA 215256)? Or if easier, could you please provide the full review package from the approval?
Thank you.
I am an investment professional for an asset management firm and would like to request all 483s issued to Catalent
Belgium SA, FEI number 3007647000, from 1/1/21-12/17/21. Thank you.
and copies of, the March 19, 2020 meeting minutes that the FDA sent to ChemoCentryx on April 14, 2020 pertaining to
Request for information related to inspections, responses to deficiencies, CPPs, CGMP compliance declarations, and
potential PLIs for - Patheon Italia S.p.A., Viale Gian Battista Stucchi 110, Monza, Italy (FEI 3003065803). Please refer to
attached document for detailed request.
potential PLIs for • STADA Arzneimitiel, Stadastrasse 2-18, Bad Vilbel, Germany (FEI 3010348803) Please refer to
potential PLIs for • Ypsomed AG, Weissensteinstrasse 26, Solothurn, Switzerland (FEI 3005170966) • Ypsomed,
Brunnmattstrasse 6, 3401 Burgdorf, Switzerland (FEI 3002806818) Please refer to attached document for detailed
request.
potential PLIs for: Ivers-Lee CSM, Marie-Curie-Str.8, 79539 Lorrach, Germany. Please refer to attached document for
detailed request.
Request to provide the Summary basis of approval (SBOA) for Nicardipine Hydrochloride Capsules 20 mg and 30 mg,
ANDA #074928 of Epic Pharma Inc and CARDENE (Nicardipine Hydrochloride) Capsules 20 mg and 30 mg, NDA #019488
of CHIESI USA INC
We request the Summary Basis of Approval (Approval Package) for Abbreviated New Drug Application (ANDA) No.
213914 for Sunitinib Malate that was approved on August 16, 2021 , including all FDA review materials related to the
bioequivalence review.
Request you to kindly share a copy of the 10 observations issued to Alembic Pharma Ltd after the inspection of its
Karkahadi Plant from oct 28 to nov 10 2021.
All correspondence, inspection reports, violation reports, certifications and all registrations for: Amerisal Food LLC and
Amerisal Import Export LLC 16152 Covello Street Van Nuys, CA 91406 and also prior addresses: 16153 Covello Street,
Van Nuys, CA 91406 and 14233 Halldale Avenue, Gardena, CA 90249 Thank you. David L. Hoffman, Esq. (attorney for
Amerisal)
potential PLIs for Ivers-Lee AG, Kirchbergstrasse 160, 3400 Burgdorf, Switzerland (FEI 3002420194). Please refer to
SBA- Wegovy (Semaglutide Injection) - NDA215256. Novo Nordisk.
Any and all records related to BBV152 also know as Covaxin the whole virion vaccine developed by Bharat Biotech. Any
records relating to Ocugen and their involvement with the vaccine in any capacity.
VAERS Report
Current Package insert and labels of RLD, PROTAMINE SULFATE held by ELI LILLY AND CO (Application No. N006460).
Currently, RLD is in discontinued status. We need the currently approved RLD package insert, container and carton label
to develop the generic product.
I would like to see the AE reports for the following branded drugs: Crysvita, Spinraza, Evrysdi, Oxbryta, Arikayce,
Ingrezza, Nuplazid, Lupkynis, Orladeyo, Onpattro, Givlaari, Oxlumo, Orgovyx, Myfembree, Nurtec, Wakix, Epidiolex,
Tyvaso, Tepezza, Tavneos. Thank you!
Summary Basis for Approval (SBA) for pafolacianine (Cytalux, On Target Laboratories, LLC) an imaging agent for use in
ovarian cancer patients to help identify malignant lesions during surgery. NDA approved on 29 November 2021.
I request the recent FDA Form 483 issued to the Catalent fill / finish site in Brussels, Belgium. Our understanding is that
this form 483 was issued to Catalent in late 2021 and that’s what we are requesting. The site address is: Rue Font St
Landry, 10 Parc Mercator B-1120, Neder Over Hembeek, Belgium
Please could you supply us with the pre-approval inspection records for the Novartis drug Inclisiran (brand name
Leqvio), ahead of its PDUFA date of 01-Jan-22, from the facility in Schatenau in Austria. If these records are not available
because the inspection hasn’t taken place, please let us know why the inspection is still outstanding or of any other
recent issues with the facility that have been highlighted in the FDA inspection records
ROMAINE LETTUCE LINE LISTING (REFERRAL FROM CDC)

OUTBREAK RECS (REFERRAL FROM CDC)
all correspondence in releasable format, including all related photos and videos, for the period
7/31/2021 to 10/31/2021 between the Office of Laboratory Animal Welfare, Division of Compliance Oversight and the
following
Maryland (61) institutions
syndrome, etc
QUESTION RE GRAS NOTIFICATION
REQUEST RE SECTION 2052 DATA

Please provide the results for the following CV/Resumes James K Rice, Shymetris M Allen, etc
2016-8151, 2021-6400, 2021-7367, 2021-7453, 2021-7459.
2021-7497, 2021-7498, 2021-7564, 2021-7689, 2021-7748.
2021-7751, 2021-7814, 2021-7898, 2021-7901, 2021-7970.
I would like to request the De Novo records for DEN170072 submitted by Timpel, Inc. for the Enlight 1810 device. Thank
you!
copies of the request letter, requester address, phone and email, for following control numbers 2020-8555 2020-8603
2020-8695 2021-68 2021-128 2021-364 2021-557 2021-544 2021-538 2020-8831 2021-749 2021-811 2021-1112
2021-8071, 2021-8135, 2021-8143, 2021-8150, 2021-8163.
I would like to request the following 510(k) Records from Siemens Medical Solutions USA, Inc.: - K163296 for the
SomaTom GO Up Go Now - K173632 for the SOMATOM go.Top, SOMATOM go.All, Scan&GO Thank you!
Case Events from FDA's Adverse Reporting Events database involving Wellbutrin SR and Bupropion Hydrocholoride SR
I would to request the following 510(k) Records for Hyperfine, Inc.'s Swoop Point-of-Care Magnetic Resonance Imaging
(POC MRI) Scanner Systems: K211818 and K212456. Thank you!
-Original color additive petition and appendices, and all amendments -Deficiency letters and responses -Agency’s
chemistry and toxicology reviews/memoranda
Any and all correspondence, including responses and subsequent correspondence, relating to warning letters to Honest
Globe, Inc. (dated March 15, 2021; MARCS-CMS 597177) and BioLyte Laboratories, LLC (dated March 18, 2021; MARCS-
CMS 603584).
I request copies of any agency documentation or communication with Catalent Belgium SA regarding the FDA
Warning Letter issued to their facility located at Font St Landry 10, 1120 Bruxelles, Belgium concerning vaccines as well
as WEGOVY- semaglutide injection, solution since December 1, 2021 through present day.
ANDA 211546 TENTATIVE APPROVAL LETTER
Request for Efgartigimod Summary basis of Approval for Myathania Gravis ( Including Subject matter reviews and
administrative - correspondance documentation)
Copies of any and all recall reports for RES # 89153 for a product named Veklury (remdesivir 100 mg for injection) NCS
61958-2901-02. Should include lot # 2141001-1A & #2141002-1A. Both have an expiration date of 1/2024. Distribution
to wholesalers occurred 10/25/21-10/26/2021 and 10/26/2021-11/02/2021 respectively. KHN is seeking to trace where
the lots originated.
I would like disaggregated historical data on FDA days, industry days, and total days to a MDUFA decision for all PMA
and 510(k) devices where a MDUFA decision was made between 2013 and 2020.
U.S. Food and Drug Administration: Psychopharmacologic Drugs Advisory Committee Meeting (transcript), Rockville,
Md, FDA, 2006. http://www.fda.gov/ohrms/dockets/ac/cder06.html
We request Dr. Stephen Hahn's correspondence involving emails (to and from) containing the words Great Barrington
Declaration, Great Barrington, GBD, Gbdeclaration.org, AIER, American Institute for Economic Research, Kulldorff,
Bhattacharya, Gupta, John Snow Memorandum, or Gonsalves.
Dear Officer: Under the Freedom of Information Act, 5 U.S.C. subsection 552, I am requesting access to the Form 483
letter given to the Catalent facility in Brussels, Belgium (DUNS 370696762 / FEI 3007647000) related to manufacturing of
drug products.
I am searching for 483s or Warning Letters that were issued to Catalent, specifically at their Catalent Belgium Site. The
associated product area is drugs. Could you please provide any 483s or Warning Letters related to Catalent Belgium?
Thank you very much.
Please provide the latest approved package insert and patient insert of MONUROL® (fosfomycin tromethamine)
Granules for Oral Solution (NDA # 050717).
Requesting for the August 31, 2017 letter that Douglas Balentine, the director of FDA's Office of Nutrition and Food
Labeling, Center for Food Safety, wrote to Center for Science in the Public Interest (CSPI) in response to their May 24,
2017 letter regarding the use of "No Sugar Added" on 100% Juice products.
Please produce all documents and correspondence relating to Continental Manufacturing Chemist, Inc. (“CMC”), located
at 912 South State Street, Madrid, Iowa 50156.
ORPHAN DESIGNATIONR ECS 1. Product Name: EMPAVELI® (Pegcetacoplan), Orphan designation: Treatment of
paroxysmal nocturnal hemoglobinuria (ODD date: 04/20/2014), Marketing approval date: 05/14/2021 2. Product
Name: GAMIFANT®(Emapalumab), Orphan designation: Treatment of hemophagocytic lymphohistiocytosis (ODD date:
03/26/2010), Marketing approval date: 11/20/2018 ETC
for Biologics inspection of Labcorp Bedford LLC. ending 09/14/2021 at the location in Bedford MA, United States. Please
for Human Drugs inspection of AMPLIFY BIO ending 08/05/2021 at the location in West Jefferson OH, United States.
for Foods & Cosmetics inspection of Bakehouse Bread Company LLC ending 04/23/2019 at the location in Tucson AZ,
United States. The EIR (in electronic format) for Foods & Cosmetics inspection of Bakehouse Bread Company LLC ending
04/23/2019 at the location in Tucson AZ, United States. Please send documents as email attachments.
for Medical Devices & Rad Health inspection of Lonza Walkersville, Inc. ending 11/05/2021 at the location in
Walkersville MD, United States. The Response (in electronic format) for Medical Devices & Rad Health inspection of
Lonza Walkersville, Inc. ending 11/05/2021 at the location in Walkersville MD, United States. Please send documents as
email attachments.
Requesting any Form 483s for Catalent Belgium SA, a CMO facility producing fill/finish of human drugs (including
Wegovy) in Brussels, Belgium at the following address: Rue Font St Landry 10 Parc Mercator B-1120 Neder Over
Hembeek, Belgium
for Human Drugs inspection of Hydrox Chemical Company Inc ending 06/24/2021 at the location in Elgin IL, United
States. The EIR (in electronic format) for Human Drugs inspection of Hydrox Chemical Company Inc ending 06/24/2021
at the location in Elgin IL, United States. etc
Copy of the disclosable portions of the 483 for the 11/8/2021 - 11/30/2021 inspection of Catalent, located in Chelsea,
MA. Please also send any 483s issued to Catalent's Brussels, Belgium facility, from 10/01/2021 - Present. Please note
that the scope of these inspections would be human drugs.
Copy of the disclosable portions of the Tentative Approval Letter for ANDA 211546 (amphetamine aspartate,
amphetamine sulfate, dextroamphetamine saccarate, dextroamphentamine sulfate), by SpecGx, dated 06/27/2019.
Requesting the following document in electronic PDF format: The 483 for the inspection of Catalent Massachusetts, LLC
(FEI number 3011696115) ending 11/30/2021 at the location in Chelsea, MA, United States.
1. Lotus catheter. 510(k) #K191512 cleared 5/21/20 2. Option VM catheter. 510(k) #K041983 cleared 11/17/04
Copy of the disclosable portions of the drug approval package for NDA 215395, Lanreotide injection, by InvaGen
Pharmaceuticals, approved 12/17/2021.
We are requesting the CMC and pharmacology Summary Basis of Approval for ELAVIL (Amitriptyline Hydrochloride
Tablets 10 mg,25 mg,50 mg,75 mg,100 mg and150 mg held by ASTRAZENECA PHARMACEUTICALS LP. NDA 012703
All docket entries for Docket Number 87A-0237. This docket was related to an advisory opinion issued by the Associate
Commissioner for Regulatory Affairs about fortification of juices. I doubt there will be a ton of comments or submissions
for this docket and I expect they may not be digitized yet. If there are numerous identical submissions like submitted en
masse from advocacy group, I do not need near-identical comments. If this cost of this request exceeds the amount
indicated as willing to pay, please contact me for authorization to exceed this amount prior to closing out this request.
If any clarification or narrowing of request is needed, please contact me. Thank you very much. Spencer
A copy of each Form FDA 3542 submitted by Amarin Pharma Inc. for the listing of patent information in FDA’s Orange
Book for NDA 202057 for Vascepa (icosapent ethyl) Capsules, 500 mg and 1 GM, for the following patents: 10576054,
10668042, 10786478, 10792267, 10792270, 10842766, 10842768, 10881632, 10894028, 11000499, 11103477,
11116742 and 11154526.
We are requesting the CMC and pharmacology Summary Basis of Approval for ZIAC (Bisoprolol Fumarate
&Hydrochlorothiazide Tablets) 2.5 mg/6.25 mg,5.0 mg/6.25 mg and 10 mg/ 6.25 mg held by TEVA. NDA 020186
Requesting organic or biological product records consists of all information, facts, and statistics submitted or included
through reference to any software program or written application for a biological license for the Covid-19 vaccine from
NDA 215395
full-length case reports (including full narratives) for all adverse events related to poppy seeds resulting in overdose,
dependence, death, or any other serious or medically important outcome reported to FDA between January 2019 and
December 2021
Summary basis of approval and Medical Review for Vyvgart (Efgartimod) in Myasthenia Gravis
PERSONAL RECS
PERSONAL RECS
PERSONAL RECS
MEDTRONIC WARNING LETTER
Copy of the 483 for the Sep 17, 2012 - Sep 28, 2012 (12 days) inspection of Bernard H. Doft, M.D. located at Pittsburgh /
United States of America] 3501 Forbes Ave #500, Pittsburgh, PA 15213, USA. This inspection pertains to Human Drugs.
Copy of the Company Response for the Feb 10, 2012 - Feb 29, 2012 (20 days) inspection of Endogastric Solutions, Inc.
located at Redwood City / United States of America] 555 Twin Dolphin Dr #650, Redwood City, CA 94065, USA. This
inspection pertains to Medical devices.
Copy of the Company Response for the Sep 17, 2012 - Sep 28, 2012 (12 days) inspection of Bernard H. Doft, M.D.
located at Pittsburgh / United States of America] 3501 Forbes Ave #500, Pittsburgh, PA 15213, USA. This inspection
Copy of the EIR for the Sep 17, 2012 - Sep 28, 2012 (12 days) inspection of Bernard H. Doft, M.D. located at Pittsburgh /
United States of America] 3501 Forbes Ave #500, Pittsburgh, PA 15213, USA. This inspection pertains to Human Drugs.
Report and/or the MDSAP Noncomformity Grading and Exchange Form (NC) for the inspection of BEST THERATRONICS
LTD., Kanata, Canada, end date 04-06-2018. FEI# 3006946288. This inspection pertains to medical devices.
Copy of the FDA response only to the following file numbers: 2020-5856, 2021-1463, 2021-4375, 2021-7986, 2019-
11747.
Report and/or the MDSAP Noncomformity Grading and Exchange Form (NC) for the inspection of Coroneo Inc,
Montreal, Canada, end date 03-09-2018. FEI# 3003320928. This inspection pertains to medical devices.
Report and/or the MDSAP Noncomformity Grading and Exchange Form (NC) for the inspection of Emovi Inc, Laval,
Report and/or the MDSAP Noncomformity Grading and Exchange Form (NC) for the inspection of Luminex Molecular
Diagnostics, Toronto, Canada, end date 05-04-2018. FEI# 3002777243. This inspection pertains to medical devices
Regulatory Assessment of Biolife Plasma Services, L.. P. Located at Appleton WI United States FEI Number: 3007206469
held on 10/27/2020.
Regulatory Assessment of Biomat USA, Inc. Located at Albany GA United States FEI Number: 3012978921 held on
10/26/2020.
Regulatory Assessment of CSL PLASMA, INC Located at York PA United States FEI Number: 3011816271 held on
10/30/2020.
Regulatory Assessment of CSL Plasma Inc Located at Cincinnati OH United States FEI Number: 3013704884 held on
10/28/2020.
FDA review documents for NDA Supplement S-019 for NDA 022395, Qutenza (capsaicin) 8% patch. We would like to see
how the new indication of diabetic peripheral neuropathy was approved.
I would like to request the CDER Multidiscipline Review for cemiplimab-rwlc (Libtayo) for Indication #2 - Basal cell
carcinoma. In particular, I would like to request: Section 1 (Executive Summary), Section 2 (Therapeutic Context), and
Section 8 (Statistical and Clinical Evaluation), and finally the COA Consult Review or SEALD Review, if applicable.
PREVIOUSLY RELEASED INSPECTIONS CATALENT SOLUTIONS
PREVIOUSLY RELEASED INSPECTION RECS AGC Biologics, Inc. (“AGC Biologics”) DENMARK
PREVIOUSLY RELEASED INSPECTION RECS Thermo Fisher Scientific (“Patheon
PREVIOUSLY RELEASED INSPECTION RECS Lonza Group AG (“Lonza”) located at 228 Bath Rd, Slough SL1 4DX, United
Kingdom.
Interested in all inspection related documents (483, EIR, etc) for Medtronic's Northridge, California facility. FEI Number:
3003166194. Please note this is a medical device manufacturer. Thank you
All records pertaining to FDA's inquiry, review, and decision to send Warning Letter to Bobbi Walton, Walton Marketing,
Inc. re: Allimax unapproved and misbranded products related to COVID-19. This request includes all correspondence to
and from Bobbi Walton, Walton Marketing, Inc.; as well as any and all correspondence and records pertaining to the
investigation of Bobbi Walton and Richard Marschall (Dynamic Duo / Allimax Pro) and how/when the FDA became
aware of Allimax's unapproved misbranding.
for Biologics inspection of David Miklos, MD ending 07/27/2017 at the location in Palo Alto CA, United States. Please
for Human Drugs inspection of David Miklos, MD ending 04/07/2017 at the location in Palo Alto CA, United States.
for Human Drugs inspection of Cangene BioPharma LLC ending 04/16/2021 at the location in Baltimore MD, United
States. The Response (in electronic format) for Human Drugs inspection of Cangene BioPharma LLC ending 04/16/2021
at the location in Baltimore MD, United States. Please send documents as email attachments.
for Human Drugs inspection of Janssen Cilag Manufacturing LLC ending 11/23/2021 at the location in Gurabo PR, United
States. The EIR (in electronic format) for Human Drugs inspection of Janssen Cilag Manufacturing LLC ending
11/23/2021 at the location in Gurabo PR, United States. The Response (in electronic format) for Human Drugs
inspection of Janssen Cilag Manufacturing LLC ending 11/23/2021 at the location in Gurabo PR, United States. Please
for Medical Devices & Rad Health inspection of Biosense Webster, Inc. ending 09/27/2016 at the location in Irwindale
CA, United States. The EIR (in electronic format) for Medical Devices & Rad Health inspection of Medtronic Inc. ending
07/07/2021 at the location in Northridge CA, United States. The Response (in electronic format) for Medical Devices &
Rad Health inspection of Medtronic Inc. ending 07/07/2021 at the location in Northridge CA, United States. Please send
Pursuant to the Freedom of Information Act (FOIA), 5 USC 552, and Food and Drug Administration (FDA) implementing
regulations at 21 CFR Part 20, I am writing to request the drug approval package (commonly referred to as the “review
documents”) and action package for new drug application (NDA) 215395, for Lanreotide injection, held by InvaGen
Pharmaceuticals, approved on December 17, 2021.
I would like to request the CDER Multidiscipline Review for cemiplimab-rwlc (Libtayo) for Indication #2 - Non-small cell
lung cancer. In particular, I would like to request: Section 1 (Executive Summary), Section 2 (Therapeutic Context), and
Section 8 (Statistical and Clinical Evaluation), and finally the COA Consult Review or SEALD Review, if applicable.
Copies of any and all recall reports for RES # 88154, recall number D-0661-2021 for Topotecan Injection 4 mg/4mL (1
mg/mL), Single-Dose vial. Recalling firm is Teva Pharmaceuticals USA, Inc. North Whales, PA 19454, Carton NDC# 0703-
4714-01, Vial NDC# 0703-4714-71. The lot number is 31328962B, exp. date 04/2022. Recall date initiated 6/18/2021.
KHN is seeking to trace where the lots originated.
Copies of any and all recall reports for RES # 88867 for a product called Cubicin (daptomycin for injection) 500 mg for
intravenous use, Lot 934778, the expiration date of June 2022. Recalling firm is Merck Sharp & Dohme Corp. Recall
number is D-0093-2022. NDC: 67919-011-01. KHN is seeking to trace where the lots originated.
I am writing to request the Detail Reports for antiarrhythmics (list of Active Pharmaceutical Ingredients provided below)
from January 1st, 2005 to January 1st, 2021. Adenosine Amiodarone Atenolol Bisoprolol carvedilol Digoxin Diltiazem
Disopyramide dofetilide dronedarone esmolol Flecainide ibutilide Lidocaine Magnesium Sulfate Metoprolol Mexiletine
nebivolol Phenytoin Procainamide Propafenone Propranolol Quinidine Sotalol Timolol Verapamil
most recent Establishment Inspection Report for Bloodworks Northwest's Eugene Oregon collection and distribution
site.
Package insert for Merck MMR II in use February 2000. To the best of my knowledge it was published March 1995. I am
requesting the MMR II package insert published PRIOR to updated version published August 2001.
Package inserts for the following vaccines in publication from 1-1-2000 to 8-17-2001. DTaP Infanrix (SmithKline
Beecham) DTaP (Lederle) Varicella (Merck) ( I believe the publication date is November 2000.) Hep B (SmithKline
Beecham) ( Publication dates are 8-9-2000 and 12-16-1998) HiB ( Haemophilus conjugate) Lederle MMR II (Merck)
publication date is probably March 1995 Prevnar / Pneumococcal conjugate (PCV-13) Lederle Polio (Connaught)
We are looking for and FAERS reports that have been submitted for Pegcetacoplan
all records, complaints, recalls, and documents related to the Medtronic MiniMed Paradigm pump, Model MMT-723
and Medtronic MiniMed Mio Infusion sets, and documents related to the Medtronic request for Pre-Market Approval of
its Medtronic MiniMed Paradigm pump, Model MMT-723, and Medtronic MiniMed Mio Infusion sets
Requesting for one electronic copy of US-FDA approval letter for “ALBUTEROL SULFATE”, ANDA# 074880.
SCILABS - Official correspondence from Office of the Commissioner, Office of Legislation, and Office of Regulatory Affairs
(2012-present) • Inspection/Investigation Records for the firms (2012-present); records of the company getting back its
license for nutraceutical manufacturing (2012 to present)
VIVERA PHARMACEUTICALS OFFICIAL CORR OES, ORA, OL; INSPECTION AND INVESTIGATION RECS, 2020-present
2020-8880, 2020-2549, 2020-1496, 2020-1883, 2019-6101, 2019-5864, 2017-6001
PERSONNEL RECS
Copy of the 483 for the Nov 4, 2019 - Nov 7, 2019 inspection of Okamoto Rubber Products Co., Ltd., 5 Tambon Khlong
Nung, Amphoe Khlong Luang, Chang Wat Pathum Thani 12120, Thailand. This inspection pertains to medical devices.
Copy of the 483 for the Jan 14, 2020 - Jan 22, 2020 inspection of American Fertility Medical Center, Genetic Infertility &
Andrology Lab, 2 Hughes STE 175,Irvine, CA 92618, USA. This inspection pertains to biologics.
Copy of the 483 for the Jan 20, 2020 - Jan 23, 2020 inspection of Sooil Development Co., Ltd, Korea, Huksokdong 111 1
Seoul Korea, Republic Of (South). This inspection pertains to medical devices.
Copy of the 483 for the Jan 27, 2020 - Jan 30, 2020(4 days) inspection of Angiplast Private Limited [Ahmedabad /
India]4803 Phase Iv Daskroi India. This inspection pertains to medical devices.
Copy of the 483 for the Nov 12, 2019 - Nov 21, 2019 inspection of EUCYT Laboratories LLC, 5670 S Wynn Rd Ste D, Las
Vegas, NV 89103, USA. This inspection pertains to biologics.
Copy of the 483 for the Oct 15, 2019 - Oct 22, 2019 inspection of Shriram Institute for Industrial Research, University
Road ,University Enclave, Delhi, 110007, India. This inspection pertains to human drugs.
Copy of the 483 for the Oct 21, 2019 - Nov 1, 2019 inspection of Centurion Medical Products Corporation, 100
Centurion Way, Williamston, MI 48895, USA. This inspection pertains to medical devices.
Copy of the 483 for the Oct 28, 2019 - Oct 31, 2019 inspection of Bedfont Scientific, Ltd., Station Rd, Harrietsham,
Maidstone ME17, UK. This inspection pertains to medical devices.
File Number 2017-8405
Hi, I am an investment professional for an asset management firm and would like to request all 483s issued to Fresenius
Kabi USA LLC, FEI number 1450022, in Melrose Park, IL from 6/1/20-12/23/21. Thank you.
syndrome, subacute inflammatory etc
We are seeking all available data related to a death in a clinical trial (NCT03362502) of of a DRUG (gene therapy) which
is Pfizer's PF-06939926 for Duchenne muscular dystrophy. Patient death was on or around 15 December. We hope to
understand more information into the cause of death, details about the patient that could help us determine how the
treatment interacted with patient specific factors. Thanks!
Long range safety and efficacy of "High Frucrose Corn Syrups"
K162191
All information about the following device. Device Name : Neurolutions Upper Extremity Rehabilitation System, De
Novo Number : DEN200046, Manufacturer : Neurolutions, Inc.
We request Form 483 that resulted from the inspection of the Medtronic Northridge, CA facility (FEI 3003166194) that
occurred on July 7, 2021. We also request the FDA Warning Letter associated with this inspection that was announced
December 15, 2021.
Would like records of all entries where Amy's Kitchen, Inc and Amy's Kitchen Inc located in CA, ID, and OR were listed as
the FSVP Importer.
Please provide Citizen Petition , Docket No. 1984-P-0086 along with its approval letter for the product THEO-DUR
(THEOPHYLLINE) TABLET, EXTENDED RELEASE ORAL 100MG,300MG for the Applicant SCHERING CORP-085328
Good afternoon, I am communicating on behalf of ingenio pichichi s.a in order to request the audit evaluation report
carried out in September by the FDA. Auditor Edith Gonzalez
All customs data for any entries that list Wegmans Food Markets, Inc. as the FSVP importer during the requested time
period. Please include derivations such as Wegmans, Wegman's, Wegman, Wegmans Warehouse, and Wegmans
Grocery
I am requesting sequences 0202, 0224, 0244, and 0245 for IND 051235. Our client, Metuchen Pharmaceuticals, did not
have a complete record of these submission when it was transferred from Mist Pharmaceuticals.
Copy of the 483 for the Mar 13, 2013 - Apr 2, 2013 (21 days) inspection of Dennis J. Hurwitz, M.D. located at Pittsburgh /
United States of America] 3109 Forbes Ave, Pittsburgh, PA 15213, USA. This inspection pertains to Medical Devices
Copy of the 483 for the May 11, 2015 - May 20, 2015 (10 days) inspection of Neuralight HD, LLC located at Phoenix /
United States of America] 4221 E Chandler Blvd #119, Phoenix, AZ 85048, USA. This inspection pertains to Human Drugs.
Copy of the Company Response for the Mar 13, 2013 - Apr 2, 2013 (21 days) inspection of Dennis J. Hurwitz, M.D.
located at Pittsburgh / United States of America] 3109 Forbes Ave, Pittsburgh, PA 15213, USA. This inspection pertains
to Medical Devices
Copy of the EIR for the Mar 13, 2013 - Apr 2, 2013 (21 days) inspection of Dennis J. Hurwitz, M.D. located at Pittsburgh /
United States of America] 3109 Forbes Ave, Pittsburgh, PA 15213, USA. This inspection pertains to Medical Devices
Report and/or the MDSAP Noncomformity Grading and Exchange Form (NC) for the inspection of GluStitch Inc., Delta,
Report and/or the MDSAP Noncomformity Grading and Exchange Form (NC) for the inspection of Meditech
International Inc., Etobicoke, Canada, end date 12-07-2017. FEI# 3003082988. This inspection pertains to medical
devices.
Report and/or the MDSAP Noncomformity Grading and Exchange Form (NC) for the inspection of Scican Ltd., North
York, Canada, end date 11-17-2017. FEI# 1000273801. This inspection pertains to medical devices.
Report and/or the MDSAP Noncomformity Grading and Exchange Form (NC) for the inspection of Southmedic, Inc.,
Barrie, Canada, end date 11-23-2017. FEI# 3001717360. This inspection pertains to medical devices.
Regulatory Assessment of BioLife Plasma Services L.P. Located at Saint George UT United States FEI Number:
3011200710 held on 11/12/2020.
Regulatory Assessment of BioLife Plasma Services LP Located at Dubuque IA United States FEI Number: 1938048 held on
11/23/2020.
Regulatory Assessment of BioLife Plasma Services, L.P. Located at Fort Wayne IN United States FEI Number: 3010569471
held on 11/18/2020.
for Animal Drugs & Feeds inspection of Pharmaceutics International Inc ending 09/29/2021 at the location in Hunt
Valley MD, United States. The Response (in electronic format) for Animal Drugs & Feeds inspection of Pharmaceutics
International Inc ending 09/29/2021 at the location in Hunt Valley MD, United States. Please send documents as email
attachments.
for Human Drugs inspection of Bristol-Myers Squibb Holdings Pharma Ltd. Liability Company ending 07/12/2021 at the
location in Manati PR, United States. The EIR (in electronic format) for Human Drugs inspection of Caribe Holdings
(Cayman) Co. Ltd dba PuraCap Caribe ending 07/02/2021 at the location in Dorado PR, United States. Please send
for Foods & Cosmetics inspection of Fernandez Development Co. ending 09/16/2021 at the location in Chatsworth CA,
United States. The EIR (in electronic format) for Foods & Cosmetics inspection of Fernandez Development Co. ending
09/16/2021 at the location in Chatsworth CA, United States. The Response (in electronic format) for Foods & Cosmetics
inspection of Fernandez Development Co. ending 09/16/2021 at the location in Chatsworth CA, United States. Please
Regulatory Assessment of Biolife Plasma Services L.P. Located at Waite Park MN United States FEI Number: 3010511597
held on 11/04/2020.
for Human Drugs inspection of RUCKLE, JON ending 08/03/1995 at the location in HONOLULU HI, United States. The
483 (in electronic format) for Human Drugs inspection of WASNICH, RICHARD ending 01/16/1991 at the location in
HONOLULU HI, United States. etc
complete 510(k) K190764
Copy of the disclosable portions of the drug approval package for ANDA 212514, Amphotericin B, Injectable, Liposomal,
Please provide Summary Basis of Approval of ATARAX (HYDROXYZINE HYDROCHLORIDE) TABLET ORAL 10mg,
25mg,50mg and 100mg for the Applicant PFIZER INC- N010392
for Biologics inspection of Jubilant HollisterStier, LLC ending 08/31/2021 at the location in Spokane WA, United States.
The Response (in electronic format) for Biologics inspection of Jubilant HollisterStier, LLC ending 08/31/2021 at the
location in Spokane WA, United States. Please send documents as email attachments.
for Human Drugs inspection of AbbVie Bioresearch Center, Inc. ending 11/18/2019 at the location in Worcester MA,
United States. The EIR (in electronic format) for Human Drugs inspection of Bristol-Myers Squibb Company ending
10/20/2021 at the location in Devens MA, United States. Please send documents as email attachments.
for Human Drugs inspection of Brock A. McConnehey, DO ending 04/02/2021 at the location in Boise ID, United States.
The Response (in electronic format) for Human Drugs inspection of Brock A. McConnehey, DO ending 04/02/2021 at the
location in Boise ID, United States. Please send documents as email attachments.
for Human Drugs inspection of Pyramid Laboratories, Inc. ending 02/03/2021 at the location in Costa Mesa CA, United
States. The EIR (in electronic format) for Human Drugs inspection of Amgen, Inc. ending 12/13/2019 at the location in
Thousand Oaks CA, United States. The EIR (in electronic format) for Human Drugs inspection of Irisys, LLC ending
04/07/2021 at the location in San Diego CA, United States. The Response (in electronic format) for Human Drugs
inspection of Irisys, LLC ending 04/07/2021 at the location in San Diego CA, United States. Please send documents as
email attachments.
2021-7097, 2021-7118, 2021-7124, 2021-7141, 2021-7153.
2021-7164, 2021-7165, 2021-7232, 2021-7269, 2021-7288.
2021-7290, 2021-7292, 2021-7296, 2021-7297, 2021-7298.
Supplemental approval package for Zynrelef Kit, NDA 211988/Supplement 5, approved 12/08/2021
2021-7299, 2021-7300, 2021-7302, 2021-7425, 2021-7452.
Please provide Summary Basis of Approval of BUPROPION HYDROCHLORIDE TABLET ORAL 75mg and 100mg for an
Applicant APOTEX INC ETOBICOKE SITE-A076143
Active Ingredient: SODIUMPHOSPHATE,DIBASIC,HEPTAHYDRATE; SODIUMPHOSPHATE,MONOBASIC,ANHYDROUS

Proprietary Name: SODIUMPHOSPHATESIN PLASTICCONTAINER Dosage Form; Route of administration: INJECTABLE;
INJECTION Strength: 142MG/ML;276MG/ML Reference Listed Drug: Yes Reference Standard: Yes TE Code: -
Application Number: N018892 Product Number: 001 Approval Date: May 10, 1983 Applicant Holder Full Name:
HOSPIRA INC Marketing Status: Prescription
Alkem Laboratories Limited Baddi, Solan, India End Dates of inspection: 21 February 2020 Project Area: Drug Quality
4/2/21 tentative approval letter for ANDA No. 212953 for Fingolimod (generic drug) etc
Aurobindo Pharma Ltd. Bachupally, India End Dates of inspection: 21 February 2020 Project Area: Drug Quality
Citagenix Inc. Bachupally, India End Dates of inspection: 21 February 2020 Project Area: Drug Quality Assurance District
for Medical Devices & Rad Health inspection of Novatech S.A. ending 09/05/2019 at the location in La Ciotat Cedex,
France. Please send documents as email attachments.
for Human Drugs inspection of Regeneron Pharmaceuticals Inc ending 10/25/2021 at the location in Rensselaer NY,
United States. The Response (in electronic format) for Human Drugs inspection of Regeneron Pharmaceuticals Inc
ending 10/25/2021 at the location in Rensselaer NY, United States. Please send documents as email attachments.
for Human Drugs inspection of Sanofi-Aventis U.S. LLC ending 10/01/2021 at the location in Bridgewater NJ, United
States. etc
The following two (2) CSV files: 1) Listing of all INSPECTIONS since Friday, January 1, 2021 (in CSV format) with
the following fields: FEI Number, Inspection Start Date, Inspection End Date, Legal Name, Address, City Name, State
inspection CITATIONS (from FDA's FACTS database) for each company since Friday, January 1, 2021 in CSV format with
the following columns: INSPECTION_ID, YEAR, INSPECTION_START_DATE, INSPECTION_END_DATE, FEI_NUMBER,
FIRM_Name, REF_NO, SHORT_DESC, Inspection Classification, Inspection Project Area. Please send CSV file to
support@fdazilla.com
for Animal Drugs & Feeds inspection of Hisun Pharmaceutical Hangzhou Co., Ltd ending 07/20/2021 at the location in
Hangzhou, China. The EIR (in electronic format) for Animal Drugs & Feeds inspection of Hisun Pharmaceutical Hangzhou
Co., Ltd ending 07/20/2021 at the location in Hangzhou, China. etc
for Human Drugs inspection of Helsinn Birex Pharmaceuticals Ltd. ending 10/25/2019 at the location in Mulhuddart,
Ireland. The EIR (in electronic format) for Human Drugs inspection of Maprimed S.A. ending 06/07/2019 at the location
in Ciudad Autonoma Buenos Aires, Argentina. etc
All records provided for control #2020-6396
I write to request copies of previously produced documents, communications, and information from the FDA’s Center
for Drug Evaluation and Research (“CDER”), Center for Biologics Evaluation and Research (“CBER”), and the Office for
Regulatory Affairs (“ORA”) concerning the inspection of facilities owned and/or operated by Catalent Pharma Solutions
(“Catalent”) that are located at 10381 Decatur Road, Philadelphia, Pennsylvania 19154.
Regulatory Affairs (“ORA”) that concern the inspection of facilities owned and/or operated by AGC Biologics, Inc. (“AGC
Biologics”) in Denmark, including its facilities located at Vandtårnsvej 83, 2860 Søborg, Denmark.
Regulatory Affairs (“ORA”) that concern the inspection of facilities owned and/or operated by Patheon Manufacturing
Services, LLC, part of Thermo Fisher Scientific (“Patheon”), including its facilities located at 5900 M.L.K. Jr Hwy,
Greenville, North Carolina 27834 and at Via Stucchi G. Battista 110, 20052 Monza, Italy (MI).
Regulatory Affairs (“ORA”) that concern the inspection of facilities owned and/or operated by the Lonza Group AG
(“Lonza”) located at 228 Bath Rd, Slough SL1 4DX, United Kingdom.
All documents sufficient to support that COVID-19 vaccines do not create or cause variants of the virus that causes
COVID-19.
I'm requesting FDA records for or relating to HPP being a kill step for pet food and/or raw pet food
All records and response letters provided for FOIA request 2019-184
The appeals log or spreadsheet record showing appeals logged by FDA FOIA department in the months of November
2021
responsive records from: 2018-8950.
Emmergency Use Authorization application FDA PEUA210205

I request a copy of all emails sent or received by FAERSESUB@fda.hhs.gov over the past 5 years.
RECORDS RE COVID-19 VACCINE LOT RELEASE
WARNING LETTER
Records pertaining to Zeller Power Products, Battery Beast, or Douglas R. Austin regarding 510(K) or FDA actions
regarding violations related to the manufacture and sale of AED batteries.
See attached request letter - all data (both positive and negative detections) associated with the Food and Drug
Administration’s program for sampling seafood for drug residues under the Chemotherapeutics in Aquaculture Seafood
Compliance Program, designated 7304.018.
We are requesting publicly available, non-confidential documents related to the recycling of pill vials and/or medicine
packaging for any type of food packaging applications.
K192764 - 510(k) - Trade/Device Name: NeuroOne Cortical Electrode
The approval letters for the following abbreviated new drug applications (ANDA) for the drug entacapone (Comtan):
ANDA 078941 ANDA 203437 ANDA 205792 ANDA 206669 ANDA 090690 The approval letters for the following ANDAs
for the drug carbidopa; entacapone; levodopa (Stalevo): ANDA 079085
All response letters and records provided for FOIA requests, 2020-5, 2020-865, 2020-6501, 2020-8007
Entity(ies): Zoll Medical Corporation; Zoll Manufacturing, and/or Zoll Services, LLC Facility: 121 Gamma Drive,
Pittsburgh, PA 15238 Inspections: Years: 2016, 2017, 2018, 2019, 2020 and/or 2021. Requests: a) Forms 483 for
inspections during 2019, 2020 and/or 2021; b) Establishment Inspection Reports (EIR) relating to inspections during
2019, 2020 and/or 2021; etc
Placebo controlled trial with Quetiapine (Seroquel) in elderly demested patients with behavioral disorders. I am
specifically looking for the trials that lead to Seroquel receiving a black box warning in 2005.
letter sent by Pfizer to the FDA notifying of the Marketing Status for COMIRNATY (NDC:0069-1000-01) or BLA 125742.
Any and all correspondence, including responses and subsequent correspondence, relating to warning letter to Global
Sanitizers, LLC (MARCS-CMS 614124), dated November 8, 2021.
483s issued to two facilities in located China from 11/1/21-present Suzhou Union Biopharm Biosciences Co., Ltd. No.
999 Longqiao Road, Wujiang District, Jiangsu Province, China And: Suzhou Junmeng Biosciences Co., Ltd. No.8
Pangyang Road,Wujiang District,Jiangsu Province, China
I am looking for Establishment Inspection Reports (EIRs), Form 483s, and Form 482s from Catalent's sites in Woodstock,
IL, Bloomington, IN, Morrisville, NC, and Brussels, Belgium.
PREVIOUSLY RELEASED RECORDS

All reports of adverse events and/or side effects for Vimpat (aka lacosamide)
I am requesting a employee email contact list in Excel Spreadsheet format for all FDA employees to be sent by email
Food Contact Notifications (FCN) 1478, 1753 and 1927.
483 issued to Macleods Pharmaceuticals Limited, Baddi, District Solan, India
for Human Drugs inspection of John Heymach, M.D ending 11/05/2021 at the location in Houston TX, United States.
for Human Drugs inspection of Catalent Massachusetts, LLC ending 11/30/2021 at the location in Chelsea MA, United
States. The EIR (in electronic format) for Human Drugs inspection of Catalent Massachusetts, LLC ending 11/30/2021 at
the location in Chelsea MA, United States. ETC
for Foods & Cosmetics inspection of Natures Health Options, LLC ending 09/28/2021 at the location in Boca Raton FL,
United States. The EIR (in electronic format) for Foods & Cosmetics inspection of Natures Health Options, LLC ending
09/28/2021 at the location in Boca Raton FL, United States. ETC
for Human Drugs inspection of KBI Biopharma, Inc. ending 03/06/2020 at the location in Boulder CO, United States. The
Response (in electronic format) for Human Drugs inspection of KBI Biopharma, Inc. ending 03/06/2020 at the location in
Boulder CO, United States.
We would like to request the Remote Regulatory Assessment (RRA) report of the assessment conducted at our facility
by Mr. Stephen Eich, Investigator, between Nov 18th and Dec 3rd 2021. We are a manufacturer of medical devices.
Operator number: 10046168. Thank you very much.
for Human Drugs inspection of Incyte Corporation ending 11/15/2021 at the location in Wilmington DE, United States.
Information on the NDA submission date by sponsor Applied Therapeutics for a drug listed as (potentially) AT-007 for
galactosemia or Classic Galactosemia (CG). Other important information would be helpful but the date of completed
NDA submission is the key request.
(1) Any adverse event report (AER) or serious adverse event report (SAER) for any product with the ingredient
higenamine a/k/a norcoclaurine, demethylcoclaurine, Aconite, Annona squamosal, Nandina domestica, Tinospora crispa
or1-[(4-Hydroxyphenyl)methyl]-1,2,3,4-tetrahydroisoquinoline-6,7-diol. and (2) Any AER or SAER for any LIPOCIDE
product.
Investigational New Drug (IND) submission granted to Cassava Sciences Inc. for Simufilam in 2017.
since Tuesday, November 30, 2021.
DOCUMENTS AVAILABLE TO ASSIST RELEASED PRISONERS

DEUTSCHE KASE HAUS, MIDDLEBURY, IN - INSPECTIONS, TESTING, AUDITS, ETC
We request Dr. Robert Redfields correspondence involving emails (to and from) containing the
words Great Barrington Declaration, Great Barrington, GBD, Gbdeclaration.org, AIER, American
Institute for Economic Research, Kulldorff, Bhattacharya, Gupta, John Snow Memorandum, or
Gonsalves
CVs for Ana Paula P Sandee, Marilyn S Babu, Keegan B Mixon, Jon P Antoniou, Laurie Nelson, etc
2016-8474, 2016-8527, 2016-8579, 2016-8676, 2016-8696.
2021-5515, 2016-8329, 2016-8424, 2016-8425, 2016-8473.
2021-6042, 2021-6416, 2021-6406, 2021-6785, 2021-6841.
2021-6944, 2021-6957, 2021-7029, 2021-7052, 2021-7094.
2021 Listeria monocytogenes outbreak stemming from Dole Packaged Salad
2021 Listeria monocytogenes outbreak stemming from Fresh Express
Packaged Salad
Importer of Record (IOR), or Consignee; for entry-lines with submission or arrival dates between December 1 and
December 31, 2021: 1) DUNS Number / Unique Facility Identifier (UFI) of: 080801169 2) Federal Tax ID Number (EIN)
of: 822349285 etc
Product registration documentation and all subsequent supplements for ANDA 062394 as per the attached request
letter
ALL FORM 483 BY/FOR MONARCH PCM, LLC LOCATED AT 7333 JACK NEWELL BLVD. NORTH SUITE 100 FORTH WORTH,
TX 76118
Any readily information available about the NDA application number 050537
Any readily information available for the ANDA # 065513
Any readily information available for the ANDA 064136

Original request and responsive material to log # 2018-1476
Please send me a copy of all Warning Letter responses (from both the company and the issuing office) and close out
letters related to the Warning Letters listed in the attached letter
Dear Sir or Madam, Please, can I be provided with an electronic, unredacted copy of the following report?
090177e196ea1800\Approved\Approved On: 30-Apr-2021 09:26 (GMT) 5.3.6 CUMULATIVE ANALYSIS OF POST-
AUTHORIZATION ADVERSE EVENT REPORTS OF PF-07302048 (BNT162B2) RECEIVED THROUGH 28-FEB-2021 Best
regards, Bruce Curb
All written communications, including memos, emails, and notes, pertaining to the maintenance and update of the "FAQ
for Comirnaty (COVID-19 Vaccine mRNA)" webpage (https://www.fda.gov/vaccines-blood-biologics/qa-comirnaty-covid-
19-vaccine-mrna) as well as any communications detailing the Department of Defense's citation of this webpage to
justify it's mandate of the EUA Pfizer-BioNTech vaccine etc
Produce documents sufficient to identify the total number of doses of Comirnaty (COVID-19 Vaccine mRNA)
administered within the United States of America following full FDA approval of Comirnaty (COVID-19 Vaccine mRNA).
Please note that this request does not seek and protected health information of any recipients of the product but is
merely seeking the total number of doses administered following approval on August 23, 2021.
Any and all internal and external communications to Peter Marks from staff at the White House regarding the Covid
vaccines for age group 5 to 16, including but not limited to booster and 2 dose regimen.
I would like the Conflict of Interest forms filed for clinical trial #NCT04079803 of Dr. Burns (of Cassava Sciences) and Dr.
Wang (of the City University of New York).
Please provide the disclosable portions of the TPL, scientific reviewers’ summaries, and any associated supporting
memoranda related to the modified risk granted orders issued December 23, 2021 for the following 22nd Century
Group, Inc. STNs (MR0000159-MR0000160).
This is the same request we submit for quarterly. C.H. Robinson Worldwide, Inc. requests a spreadsheet which includes
the 23 publicly available data points for all FSVP importer declarations.
Product registration documentation and all subsequent supplements for ANDA 065216 as per the attached request
letter.
Product registration documentation and all subsequent supplements for ANDA060730 as per the attached request
letter.
K140667
Hello, I would like to request all of the Adverse Medical Reports made (online or via mail or any other method) by or
about Ideal Breast Implants, Mentor Breast Implants, Sientra Breast Implants, Inamed Breast Implants, and Allergen
Breast Implants from 2000 to the present that are not available on MAUDE, containing the following: -responsible
manufacturer name -adverse event date -patient problem -device problem etc
HR RECS RE GRUBER, KRAUSE
RECS RE EMBARGO
U.S. Food and Drug Administration: Briefing Document for Psychopharmacologic Drugs Advisory Committee, December
13, 2006, http://www.fda.gov/ohrms/dockets/ac/06/briefing/2006–4272b1–01-FDA.pdf [fda.gov]
INDIVDIUAL RECS
INDIVIDUAL RECS
demyelinating polyradiculoneuropathy, demyelinating polyneuropathy, Guillain-Barre syndrome, etc
We would like to request a copy of the package insert for the discontinued Brand product, CELESTONE (Betamethasone
Sodium Phosphate injection).
K211069 K203712
This is a request under the Freedom of Information Act. I request that a copy of documents concerning the following
subject matter be provided to me: an electronic spreadsheet (not PDF, please) of Voluntary Cosmetic Registration
Program (VCRP) data, including VCRP category frequency of use totals, ingredient and category totals of frequency of
use data, as well as just ingredient frequency of use totals, as has been provided in recent years.
All documents, records, correspondence, or any other material provided in response to FOIA Request 2020-3721
Hi, We would like to FOIA the review documents for Fyarro
a copy of all tests that prove that receiving any of the Covid-19 vaccines will help prevent severe illness in individuals
For each Vaccine Manufactured by Pfizer Inc. during the referenced period of time, please release the following
information: 1. All active pharmaceutical ingredients 2.All non-active pharmaceutical ingredients
For each study supported by BioNTech and Pfizer, please provide the following: 1. The most current publicly
accessible link 2. The most current number of deaths broken down by category
When can a non-medically licensed individual without a prescription and without any documented medical need: 1.
Contain proof of using a substance which has the phrase “Rx only” on the packaging label?
Documents reflecting any documented case of an individual who: (1) never received a COVID-19 vaccine; (2) was
infected with COVID-19 once, recovered, and then later became infected again; and (3) died due to SARS-CoV-2.
510k number BK190401, 510k number BK100063
In accordance with Freedom of Information Act procedures, GRAS Associates, LLC requests information related to GRAS
Notices 162, 174, 189, 191, and 235. Specifically, we request any additional information to that provided on the GRAS
Notice Inventory, such as meeting minutes or email correspondence within CFSAN.
K211401, Soltive Laser System
for Biologics inspection of Jubilant HollisterStier, LLC ending 08/31/2021 at the location in Spokane WA, United States.
for Foods & Cosmetics inspection of United Pharma LLC ending 04/02/2021 at the location in Fullerton CA, United
for Medical Devices & Rad Health inspection of Euclid Systems Corporation ending 02/21/2019 at the location in Sterling
VA, United States. Please send documents as email attachments.
for Medical Devices & Rad Health inspection of Karl Storz Endovision, Inc. ending 09/17/2021 at the location in Charlton
MA, United States. Please send documents as email attachments.
format) for Biologics inspection of Packaging Coordinators, LLC ending 12/18/2020 at the location in Philadelphia PA,
for Human Drugs inspection of SK Life Science Inc. ending 08/11/2021 at the location in Paramus NJ, United States. The
EIR (in electronic format) for Human Drugs inspection of SK Life Science Inc. ending 08/11/2021 at the location in
Paramus NJ, United States. Please send documents as email attachments.
for Foods & Cosmetics inspection of Taylor Farms California Inc ending 02/14/2018 at the location in Yuma AZ, United
States. The EIR (in electronic format) for Foods & Cosmetics inspection of Taylor Farms California Inc ending
02/14/2018 at the location in Yuma AZ, United States. The Response (in electronic format) for Foods & Cosmetics
inspection of Taylor Farms California Inc ending 02/14/2018 at the location in Yuma AZ, United States. Please send
I need the 483 and EIR for BPI Sports, located in Fort Lauderdale, Florida 33312-6802 performed on 5/17/2017. The
FEI is 3011842031. Previous request showed no records. Current EIR noted this inspection. Inspection was VAI.
Thank you, Courtland
I would hereby like to request the following document through FOIA. o Drug product approval package for
Kayexalate (Sodium Polystyrene Sulfonate) Powder Oral/Rectal, NDA # N011287 o Any documents available regarding
the review and approval of this product by the FDA such as Review Package, Approval Letter, Clinical Pharmacology
review, Summary basis of Approval
I'm requesting access to and copies of the following under the Freedom of Information Act: - Any and all Health Hazard
Evaluations completed by FDER CDER for products that were issued under the recalls cited in the attached PDF file
Investigation of Hinkle Fine Foods; 4800 Wadsworth Rd; Dayton, OH 45414.
This email constitutes my Public Records Request to obtain electronic copies of the following documents regarding the
procurement and contract award for RFQ-1249560AMD02 - Real-Time Remote Captioning Service: 1. Proposal of the
awardee 2. All documents relating to the evaluation of the bidders 3. Scoring matrix for all bidders 4. All resulting
contract documents awarded
SE0012928
SE0012923
Hi I am completing a research project looking at osteonecrosis of the jaw associated with anti-TNF medications. The case
ID numbers I am requesting are as follows: 10567324 9980820 9245746 9239649 9193642 9049003 8572469 8257208
7971195 7687578 7372426
Any and all communications between the FDA and Valisure, since March 1, 2021 until the present, pertaining to the
company's test results that found benzene in multiple consumer products.
I'm requesting access to and copies of the following: - Any and all communications between the law firm Stinson LLP
and the FDA regarding the company Valisure and the FDA's inspection of Valisure that ended with a Form 483 being
issued on July 6, 2021. Please limit this request to March 1, 2021 and August 1, 2021
I'm requesting access to and copies of the following: - Any and all communications, including emails, between Johnson
& Johnson and the FDA regarding J&J's July 14, 2021 recall of products for benzene contamination. Please limit the date
range of this request from March 1, 2021 until July 21, 2021.
I'm requesting access to and copies of the following: - Meeting minutes for a meeting held between FDA and Johnson &
Johnson on July 6, 2021, pertaining to benzene being detected in J&J sunscreen products
I'm requesting access to and copies of the following: - The EIR issued in response to the inspection conducted of
Valisure LLC that ended on July 6, 2021. Valisure is located at 5 Science Park, New Haven, CT, 06511. A Form 483 was
issued that cited six observations.
Any and all audits or inspections conducted at Kite Pharma, Inc. located at either of the following address: 2355 Utah
Ave., El Segundo, CA 90245 OR 2383 Utah Ave., El Segundo, CA 90245
NICHOLS INSTITUTE 483 ETC
I would like to receive a copy of Medtronic's response to the warning letter the company received on December 9, 2021.
The EIR (in electronic format) for Medical Device inspection of EResearch Technology Gmbh, Inspection dates:
26/06/2017 to 29/06/2017 at the location in Sieboldstr.3, Estenfeld, Bavaria, 97230, Germany. (Medical Device
Manufacturer) The EIR (in electronic format) for Contact Research Organization Inspection of Biomedical Systems Corp
Inspection dates: 08/11/2016 to 17/11/2016 at the location in 77 Progress Pkwy, Maryland Heights, MO 63043-3701.
CALA Advanced Hand Sanitizer with Aloe Vera Extract Lot No. 20040718 Exp. Date 04/2023 NDC# : 74985-676-51 /
UPC# : 616513676511 The experimental method and the experimental result sheet.
I am trying to track down updated data supporting the findings in the presentation from the FDA Public Meeting:
Breakthrough Therapy Designation: Exploring the Qualifying Criteria held on April 24, 2015 in Washington, DC
Release of the complete and unredacted versions of the following documents associated with the "human drug"
companies EI, LLC (FEI: 3005832998) and Product Quest Manufacturing, Inc., Product Quest Manufacturing, LLC (FEI
3001554391) (“Entities”) between January 1, 2010 and December 31, 2018. This request includes the following: 1. All
correspondence from 2010 to 2018 between employee or contractor (“FDA Personnel”) to the Entities or any of their
employees. etc
I am seeking all communications between the Biden White House and FDA director of the Center for Biologics
Evaluation and Research Peter Marks regarding pending and future authorizations of COVID-19 vaccines and booster
doses for children in different age groups.
Documents and communications relating to the approval of Abbreviated New Drug Application (ANDA) No. 212514
including communications from FDA to applicant approving the ANDA and providing the basis for such approval and
information regarding the manufacture of the product disclosed in the ANDA
Any and all communications (this can include email, text messages, twitter direct messages, any agency intranet, agency
forum communications or bulletins, Microsoft TEAMs, etc.) between the following people from January 1, 2020 until
January 5, 2022. Anthony Fauci Francis Collins Ron Klain Deborah Birx Gregg Gonsalves Cliff Lane Lawrence Tabak
Janet Woodcock Rick Bright Dr. Rochelle P. Walensky etc
FDA fatality #20-068 which was reported to the CBER Fatality Transfusion Account on September 3, 2020. The report I
am requesting is the Table of Final Conclusion Summary.
Establishment Inspection Report for Noven clinical trial from July 2021 for University of California, Irvine (Orange, CA);
Firm Name: Tim Wigal. Kindly requesting EIR to be sent by email.
This request being made is for a copy of 510(k) K202101 submission: Trade/Device Name: GEM Hemochron 100 System,
GEM Hemochron 100 Activated Clotting Time Plus Test (ACT+), GEM Hemochron 100 Low Range Activated Clotting Time
Test (ACT-LR), directCHECK ACT+ Whole Blood Control, Level 1 and Level 2, directCHECK ACT-LR Whole Blood Control,
Level 1 and Level 2
and copies of, preliminary comments that the FDA sent to ChemoCentryx on October 26, 2016 pertaining to
On behalf of Lupin Pharmaceuticals, Inc. I request you to provide me with the labeling for BUMEX (NDA 018226) owned
by Validus Pharms approved on 10/29/2002 (Suppl-25).
FDA Complaint #163877
Form 483 and any other related inspection records for Catalent Belgium SA, FEI number: 3007647000. Firm address:
Font Saint-Landry 10, Brussels, Brussels-Capital Region 1120, Belgium.
Office of Orphan Product Development designation memorandum for the following designations: Adeno associated viral
vector expressing the human vascular endothelial growth factor gene designated for Treatment of critical limb ischemia
in no-option patients where other procedures, grafts, or angioplasty are not indicated. ETC
syndrome, etc
NADA 12-350 Amprolium Request for the FDA CVM approved methods for Amprolium in chicken feeds which may
include Type A medicated Articles, Type B and C Medicated Feeds.
Orphan designation memoranda for the following designations for treatment of Buerger's disease (thrombongiitis
obliterans): G-CSF mobilized autologous CD34+ cells 03/04/2021 (Caladrius Biosciences, Inc.) E-selectin/Adeno-
Associated Virus (E-sel/AAV2) Gene Therapy 10/12/2021 (Ambulero Inc)
FSVP SPREADSHEET
violation and the frequency in which they were observed between December 20, 2017 and December 31, 2021 (or the
most recently available date for 2021).
Chemistry & Toxicology Review Memos for FCN 1393
Copy of the 483 for the Apr 12, 2021 - Apr 20, 2021 (9 days) inspection of Emergent Manufacturing Operations
Baltimore LLC [Baltimore / United States of America] 5901 E Lombard St, Baltimore, MD 21202, USA. This inspection
pertains to biologics.
Copy of the 483 for the Apr 5, 2021 - Apr 16, 2021 (12 days) inspection of SURGENEX LLC [- / -] 15444 N 76th St #110,
Scottsdale, AZ 85260, USA. This inspection pertains to biologics.
Copy of the 483 for the Feb 23, 2021 - Apr 30, 2021 (67 days) inspection of Smiths Medical ASD Inc. [Plymouth / United
States of America] 6000 Nathan Ln N, Plymouth, MN 55442, USA. This inspection pertains to medical devices.
Copy of the 483 for the May 25, 2021 - Jun 24, 2021 (31 days) inspection of Invacare Corporation [Elyria / United States
of America] 1 Invacare Way, Elyria, OH 44035, USA. This inspection pertains to medical devices.
Copy of the Company Response for the May 11, 2015 - May 20, 2015 (10 days) inspection of Neuralight HD, LLC located
at Phoenix / United States of America] 4221 E Chandler Blvd #119, Phoenix, AZ 85048, USA. This inspection pertains to
Human Drugs.
Copy of the EIR for the May 11, 2015 - May 20, 2015 (10 days) inspection of Neuralight HD, LLC located at Phoenix /
United States of America] 4221 E Chandler Blvd #119, Phoenix, AZ 85048, USA. This inspection pertains to Human Drugs.
Report and/or the MDSAP Noncomformity Grading and Exchange Form (NC) for the inspection of BEST THERATRONICS
LTD., Kanata, Canada, end date 04-06-2018. FEI# 3006946288. This inspection pertains to medical devices.
Report and/or the MDSAP Noncomformity Grading and Exchange Form (NC) for the inspection of Coroneo Inc,
Montreal, Canada, end date 03-09-2018. FEI# 3003320928. This inspection pertains to medical devices.
Report and/or the MDSAP Noncomformity Grading and Exchange Form (NC) for the inspection of Emovi Inc, Laval,
Report and/or the MDSAP Noncomformity Grading and Exchange Form (NC) for the inspection of Luminex Molecular
Diagnostics, Toronto, Canada, end date 05-04-2018. FEI# 3002777243. This inspection pertains to medical devices.
Regulatory Assessment of Biomat USA, Inc Located at Pittsburgh PA United States FEI Number: 2572454 held on
12/01/2020.
Regulatory Assessment of Biomat USA, Inc. Located at Danville VA United States FEI Number: 3003103935 held on
12/07/2020.
Regulatory Assessment of Biomat USA, Inc. Located at Pittsburgh PA United States FEI Number: 3011918551 held on
12/10/2020.
Regulatory Assessment of Grifols Therapeutics LLC Located at Clayton NC United States FEI Number: 1050373 held on
12/11/2020.
Electronic listing (preferably csv format) of all RRAs conducted since October 1, 2021
Enforcement Reports
I request copies of all documents in the possession of FDA, from October 1, 2021 to December 31, 2021, regarding
products sold under the brand name: “Jamieson” including any: a) Form FDA 3500 Voluntary Reporting, b) Form FDA
3500B Voluntary Reporting for Consumer and, c) Form FDA 3500A Mandatory Reporting.
all TJX Brands - HomeGoods, HomeSense, Marshalls, Sierra, TJ Maxx, on FDA's list.
number 09-014-5707), ETC
Address (Line 1), and Address (Line 2) for each inspection that occurred between October 1, 2011 and December 31,
2021 (or the most recent available date).
January 1, 2022 or the most recently available date
Under FOIA, I request all text messages sent and received by Sean Duke (FDA-ORA) between November 1, 2021-
December 31, 2021.
Under FOIA, I request all text messages sent and received by Sean Duke (FDA-ORA) between November 1, 2021-
December 31, 2021.
We would like to make a request for the electronic FOIs for Hylartin (NADA 112-048) and Hyvisc (NADA 122-578), for the
active ingredient hyaluronate sodium.
I seekany and all Fda approval records relating to Theranos Inc., tests Compliance with Clia certification.
fda close out letter on Theranos Inc after its non compliance inspection report from Aug.2015-Sep 2015 against its CEO
and Founder Elizabeth A Holmes
I am requesting the Health Hazard Evaluation, including attached product list and test results, for benzene in Procter &
Gamble antiperspirants. I am also requesting the Health Hazard Evaluations, including attached product list and test
results, for benzene in Procter & Gamble dry shampoos and dry conditioners. The evaluations can be sent separately as
they are ready. I request the response to this FOIA be sent electronically via email. Thank you
We are requesting the 510k application for the device with approval number K041244, titled Polygram Net Biofeedback
Application
Please could I have a copy of the source documents and the MedWatch form for FAERS case number 19620185, which is
a case report of Angioedema and Anaphylactic Reaction associated with BTG product CroFab.
Meitheal Pharmaceuticals request the most recently submitted carton label for the 4mcg/2mL (2mcg/mL) strength of
NDA 021027 Hectorol (doxercalciferol injection). The label will be used for comparison against our ANDA therapeutic
equivalent to ensure it is updated to date and aligned with the RLD. Please send the label via electronic email as we are
working remotely due to COVID. Thank you,
Pursuant to the Freedom of Information Act (FOIA), I would like to obtain a copy of the De Novo request content for
the Dexcom G6® CGM System (DEN170088). I request that a copy of the following documents: Non-clinical data
including bench performance testing; Information on the reprocessing and sterilization, shelf life, biocompatibility,
software, electrical safety and electromagnetic compatibility, animal study, literature (if applicable); and stability data
that are relevant to support reasonable shelflife of the safety and effectiveness of the device. I understand that if I seek
a copy of this record, there may be a copying fee. Please inform me of that cost prior to making the copy. I can be
reached at CGM.RA@sinocare.com
test request
All food additive petitions for animal food records submitted to FDA CVM and FDA Division of Animal Feeds, March
2021-December 31, 2021
I am seeking all correspondence, all test results and all clinical trial results submitted to the FDA used to provide the
Phase 2 IND to Vaxart Inc.
1) All Form 483 issued to Laboratorios Farmacéuticos ROVI, S.A or ROVI Pharma Industrial Services for their facility in
San Sebastián de los Reyes, Spain, in 2016 and 2018. 2)All Form 483 issued to Laboratorios Farmacéuticos ROVI, S.A or
ROVI Pharma Industrial Services for their facility in Madrid, Spain, 2016 and 2018. etc
A copy of FDA’s review records related to FDA’s review of 22nd Century Group Inc.’s Modified Risk Tobacco Product
Applications for VLN King (MR0000159) and VLN Menthol King (MR0000160), including, but not limited to, additional
information requests and responses, FDA’s review records and technical reports, and any and all filings submitted by
22nd Century Group Inc. associated with and related to the modified risk granted order numbers MR0000159 and
MR0000160.
Form 483 Observations and Inspection Report from the FDA inspection of Amjad Plastics Research on July 28, 2021.
The following information details the documents: • Firm Name: Amjad Plastics Research • Location: Miami, FL, USA
• FEI: 3018839583 • Inspection Date: 07/28/2021 • Commodity Area: Drugs and Biologics • Investigator:
Ibrahim Amjad, MD, MBA, FACS, FAAP
I am requesting the full 510k records for the following K numbers: K181363, K163050, K163026, K130041, K802146,
K130581
I am writing to request copies of all documents produced by the Food and Drug Administration in response to a
previous request pursuant to Freedom of Information Act number 2021-8203 concerning pharmaceutical manufacturers
Laboratorios Farmacéuticos ROVI, S.A. and ROVI Pharma Industrial Services sites in San Sebastián de los Reyes and
Madrid, Spain
Core Requested Investigation of Limbrel memo and related documents
Please could I have a copy of the MedWatch form and any available source documentation for AERS report 17920987,
which is a case report associated with BTG product Voraxaze. Thank-you
for Human Drugs inspection of Altasciences Preclinical Seattle, LLC ending 09/13/2019 at the location in Everett WA,
for Biologics inspection of iuvo Bioscience Operations, LLC ending 05/27/2021 at the location in Rush NY, United States.
The Response (in electronic format) for Biologics inspection of iuvo Bioscience Operations, LLC ending 05/27/2021 at
the location in Rush NY, United States. Please send documents as email attachments.
for Human Drugs inspection of Experimur, Llc ending 10/26/2018 at the location in Chicago IL, United States. The
Response (in electronic format) for Human Drugs inspection of Experimur, Llc ending 10/26/2018 at the location in
Chicago IL, United States. Please send documents as email attachments.
for Human Drugs inspection of Teligent Pharma, Inc. ending 08/31/2021 at the location in Buena NJ, United States. The
EIR (in electronic format) for Human Drugs inspection of Accupac, Llc ending 11/18/2021 at the location in Lakewood NJ,
for Human Drugs inspection of Lonza Biologics, Inc. ending 05/06/2011 at the location in Hopkinton MA, United States.
The 483 (in electronic format) for Human Drugs inspection of Lonza Biologics, Inc. ending 03/01/2012 at the location in
Hopkinton MA, United States. The EIR (in electronic format) for Human Drugs inspection of Lonza Biologics, Inc. ending
03/01/2012 at the location in Hopkinton MA, United States. Please send documents as email attachments.
Pursuant to the Freedom of Information Act, 5 U.S.C. §552; and 21 C.F.R. §§20, et seq., we request access to, and copies
of, minutes of the October 5, 2016 meeting between the FDA and Reata Pharmaceuticals, Inc. pertaining to Reata’s drug
bardoxolone methyl.
1) All Form 483 issued to Pharmaceutics International, Inc. for its facility in Cockeysville, Maryland. Between 2015 and
2018. 2) All letters, emails and other communications between the FDA and Pharmaceutics International, Inc. for its
facility in Cockeysville, Maryland 2015 and 2018.
I am trying to track down a copy of the "Emerging oncology drug targets in the 21st century: An FDA analysis."
presentation (see the link below) that was presented by FDA employees (Emma C. Scott, Yutao Gong, Ashim Subedee,
Dickran Kazandjian, Richard Pazdur, V. Ashutosh Rao, Julia A. Beaver, Julie A. Schneider) at the 2020 ASCO Annual
Meeting. https://ascopubs.org/doi/abs/10.1200/JCO.2020.38.15_suppl.e14067
Inspection reports from all on-site inspections conducted as part of the E.Coli outbreak investigations with reference
numbers 5, 7, E-441626, 1010 and 1043.
All communication with Acella, the manufacturer of drug NP thyroid relating to all discussions about the recall that
occurred in April 2021.
Copy of FOIA request submitted by William Dickinson on October 8, 2021, for "all documents, including but not limited
to correspondence and/or inter-departmental investigations related to the billing practices of Natera, Inc., Invitae Corp.
and Myriad Genetics, Corp. between September 30, 2018 to September 30, 2021," and a copy of all documents
provided in response to this FOIA request.
Redacted copy of K203641 (E-Denture Pro- EnvisionTEC GmbH)
The following documents relating to Zimmer Surgical, Inc. and/or Zimmer Biomet, Inc. medical devices: warning letters;
responses to such warning letters; inspection results; compliance actions; audit reports; citations; corrective and/or
preventative action requests; corrective and/or preventative action plans.
510(k) - K070296
510(k) - K173119
We request a copy of Food Additive Petition 2308.
[Reference FGI# 22-76397] Relevant to FDA’s new Orphan Drug Designation application we are looking to secure the
complete application for Tepezza (teprotumumab-trbw), submitted to the FDA by Horizon Therapeutics. The drug was
designated on 6 May 2013 for the treatment of active thyroid disease.
I am looking for any documentation pertaining to copper in sheep feed from Valley View Milling at 2875 State Highway
63 in Seneca, Kansas.
EIRs for NASCO, Mocksville, NC: 04/26/2019, 06/05/2018, 07/07/2016, and 10/21/2015. Please note these inspections
are related to tobacco products.
syndrome, etc
2021-5397, 2016-8093, 2016-8136, 2016-8141, 2016-8147
Any and all documentation surrounding investigations performed at the Medical University of South Carolina (MUSC)
relating to atypical nontuberculous mycobacterium infections during the time period of 1/1/2017 to the present.
Copy of the disclosable portions of the original request letter and complete FDA response for File Number 2019-10157
EIR report for inspection conducted on 6/11/2021 at Sterling Technology, Inc. Location address is 133 32nd Ave S.
Brookings, South Dakota.
EIR, Hospira Pfizer, Mcpherson Kansas from April 16, 2010
EIR, Hospira Pfizer, Mcpherson Kansas plant, from February 18, 2018
EIR, Hospira Pfizer, Mcpherson Kansas from January 4, 2012
Hi, I would like to request the Form 483 issued, and the Company Response to, the June 23, 2021 manufacturing facility
inspection of Professional Disposables International, Inc. located in Orangeburg, NY. Thank you!
Human adverse event drug MedWatch reports for the following Case IDS: 16175245 16580464 15588199 15608982
15609317 15686978 14029588 14074197 14800116 14914381 14914500 14927962
I'm looking to receive a copy of the meeting minutes from the FDA's recent Type A meeting with Revance Therapeutics,
Inc. related to the company's DaxibotulinumtoxinA for injection product. The meeting was held in December 2021 or
January 2022.
FCN 2104
Please provide Summary Basis of Approval of DEPO-MEDROL (METHYLPREDNISOLONE ACETATE) INJECTION 80MG/ML
for the Applicant PFIZER INC-N011757
for Biologics inspection of Bio-Rad Laboratories, Inc. ending 12/13/2021 at the location in Woodinville WA, United
for Biologics inspection of Kokopelli Technologies, dba Embryodirector.com ending 12/01/2021 at the location in San
Antonio TX, United States. Please send documents as email attachments.
for Biologics inspection of Predictable Surgical Technologies ending 11/18/2021 at the location in Hebron KY, United
for Biologics inspection of Reproductive Health Specialists, Inc. ending 12/08/2021 at the location in Pittsburgh PA,
for Biologics inspection of Zhang Medical P.C. d/b/a New Hope Fertility Center ending 11/30/2021 at the location in
New York NY, United States. Please send documents as email attachments.
for Human Drugs inspection of Ausberto B. Hidalgo, M.D. ending 12/03/2021 at the location in Pembroke Pines FL,
for Human Drugs inspection of Eastman Chemical Company ending 12/01/2021 at the location in Kingsport TN, United
for Human Drugs inspection of Edge Pharmacy Services, LLC ending 11/30/2021 at the location in Colchester VT, United
for Medical Devices & Rad Health inspection of Microbiologics Inc ending 12/01/2021 at the location in Saint Cloud MN,
for Human Drugs inspection of Revance Therapeutics Inc ending 07/01/2021 at the location in Moffett Field CA, United
Penalties & Forfeitures penalty case number 2021270420312101

2016-8152, 2016-8233, 2016-8318, 2016-8324, 2016-8421.
2016-8476, 2016-8603, 2016-8608, 2016-8707, 2016-8738.
2016-8751, 2016-8771, 2021-6401, 2021-6784, 2021-7362.
Request for records that have led to Schnuck Markets, Inc (also listed as below names) to be listed on the FDA Importer
September, 4 2021 thru December, 16 2021. SCHNUCK MARKETS INC SCHNUCK MARKETS, INC. SCHNUCKS MARKETS
INC-ST LOUIS -NORTH PARK DRY SCHNUCKS MARKETS INC TOPCO
Requesting the following document in electronic PDF format: I am requesting access to all 483 letters given to the
Catalent facility in Brussels, Belgium (which may be for Catalent Belgium SA, FEI 3007647000) in 2021.
EIR, Hospira Pfizer Mcpherson Kansas plant, from April 3, 2015
EIR, Hospira Pfizer, Mcpherson Kansas from August 16, 2013
EIR, Hospira Pfizer, Mcpherson Kansas from August 27, 2009
EIR, Hospira Pfizer, Mcpherson Kansas from May 25, 2011
EIR, Hospira Pfizer, Mcpherson Kansas from October 24, 2012
EIR, Hospira Pfizer, Mcpherson Kansas plant, from August 15, 2018
EIR, Hospira Pfizer, Mcpherson Kansas plant, from January 17, 2020
EIR, Hospira Pfizer, Mcpherson Kansas plant, from June 8, 2016
EIR, Hospira Pfizer, Mcpherson Kansas plant, from October 27, 2017
I am requesting the accreditation records as well as all records of inspections performed over the last 4 years at the
following labs: The GeneIQ laboratory located at 3716 Standridge Dr, The Colony, TX 75056. The Nomi Health
laboratory at 1126 Caribbean Way, Miami, FL 33132.
Dear Sirs. I am an investment professional research analyst for an equity research firm and would like to request all 483s
issued to Catalent Belgium SA, FEI number 3007647000, from 1/1/21-12/17/21.
We would like to know if there are any warnings or recalls reports on Topcon Exam Solution OC-2200 Manual Recline
Ophthalmic Chair. Please respond to me at my email address in the enclosed letter, cajigr1@nationwide.com.
Technically, we'd like to know if there are any complaints about the chair since it's approval for use.
Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110 lead fractures, inappropriate shocks and
replaced ICD and/or leads
We would like to request case reports / case narratives for drug Galafold.
All documents, directives, and correspondences pertaining to goods La Squisita Food Corp. imported under Entry/CDP-
FDA 814-0247864-8/11-1, especially with respect to FDA hold notices, orders of fumigation or other such directives
requiring La Squisita to take any action with respect to these goods. Also seeking any documents or explanations
elaborating on the FDA line status was, "May Proceed Without FDA Examination," on 2/1/2017 for these goods, as
indicated on the the FDA ITACS page for Entry/CDP-FDA 814-0247864-8/11-1. I am enclosing a copy of this report under
the "request letter" optional attachment for ease of reference.
I am seeking information on a baby consumer product made by Munchkin, Inc. (based in California).
Records related to specific policy changes that occurred around 2018 or 2019 regarding the availability of the 510(k)
regulatory approval pathway to discourage the use of older predicate devices and to encourage the use of the FDA’s
“De Novo” pathway for devices lacking acceptable predicates. Please see attached for more detail.
Copy of the disclosable portions of the Observation Memo for the remote evaluation ending on 10/26/2021 for SciVac,
in Rehovat, Israel. This inspection pertains to biologics.
Hi, I would like to request the Form 483 and EIR for the Sterling Pharmaceutical Services manufacturing facility
inspection in Duplo, IL on 5/14/2021. Thank you
Any FDA-483 forms pertaining to Medical Devices for the following FDA registered establishment: "Viewray
Incorporated" Registration Number 3011233554 located in Mountain View, CA
for Foods & Cosmetics inspection of Bactolac Pharmaceutical, Inc. ending 11/19/2021 at the location in Hauppauge NY,
for Foods & Cosmetics inspection of Nutracap Labs LLC ending 12/06/2021 at the location in Norcross GA, United States.
for Medical Devices & Rad Health inspection of B&W Tek, Inc. ending 12/08/2021 at the location in Newark DE, United
for Medical Devices & Rad Health inspection of Katecho Inc ending 12/02/2021 at the location in Des Moines IA, United
for Medical Devices & Rad Health inspection of Ultrasonic Services, Inc. ending 12/10/2021 at the location in Houston
TX, United States. Please send documents as email attachments.
for Medical Devices & Rad Health inspection of Schoelly USA Inc ending 12/01/2021 at the location in Northborough
MA, United States. The 483 (in electronic format) for Medical Devices & Rad Health inspection of Integrated Ophthalmic
Systems, Inc ending 12/15/2021 at the location in Woburn MA, United States. Please send documents as email
attachments.
for Medical Devices & Rad Health inspection of RF Surgical System Inc Technical Center ending 08/18/2016 at the
location in Carlsbad CA, United States. The Response (in electronic format) for Medical Devices & Rad Health inspection
of RF Surgical System Inc Technical Center ending 08/18/2016 at the location in Carlsbad CA, United States. The 483 (in
electronic format) for Medical Devices & Rad Health inspection of Companion Medical, Inc. ending 08/14/2019 at the
location in San Diego CA, United States. Please send documents as email attachments.
Summary Basis of Approval information for NDA 212854: ZIMHI NALOXONE HYDROCHLORIDE 5MG/0.5ML
(5MG/0.5ML), approved October 15, 2021
Copies of all documents and information regarding Bluebird Bio, Inc., previously released by the FDA pursuant to a FOIA
request, from 2015 to the present.
Under terms of the Freedom of Information Act, I'm kindly requesting Inspection Records, Observations, Reports and
responses relating to the inspection of FUJIFILM DIOSYNTH BIOTECHNOLOGIES, 100 DISCOVERY DRIVE, SUITE 200
COLLEGE STATION, TX 77845, FDA ESTABLISHMENT NUMBER 301198449. Inspection period August 23-31, 2021.
All documents concerning the identification and location of entities in the United States that will be used, or have been
used, to manufacture Bluebird Bio Inc.’s ("Bluebird") betibeglogene autotemcel (“beti-cel”) gene therapy, LentiGlobin,
or the BB305 lentiviral vector. All FDA Form 483’s (“483s”) issued with respect to manufacturing facilities used to
produce or manufacture Bluebird’s beti-cel, LentiGlobin, and/or the BB305 lentiviral vector, including all responses to
the 483s (“483 Responses”), and any memoranda issued in reply to the 483 Responses.
all documents and correspondence relating to any U.S. Food and Drug Administration’s investigation and monitoring of
Mountain Country Pet Care, LLC d/b/a Mountain Country Foods, LLC at the following facilities from January 1, 2019 to
the present: 201 Industrial Drive, Okeene, OK 73763 185 East 1600 North, Spanish Fork, UT 84660 etc
Various records
DMFs for the following: #. Application Status Submit Date Holder Subject 14398 A II
9/10/1999 NUVIEW LIFE SCIENCES INC THALLIUM TL-201 RADIOCHEMICAL
18368 A II 5/18/2005 NUVIEW LIFE SCIENCES INC SODIUM IODIDE (I-123) RADIOCHEMICAL
etc
2021-8210 2021-8307 2021-4898 2021-3636 2020-7739 2020-8485 2019-8016
The approval letter and approved label (including prescribing information,

patient leaflet and instructions for use) for ANDA 213948.
• Any documents or communications related to Dinitrogen Tetroxide (N2O4) being utilized to turn cellulose into
Oxidized Regenerated Cellulose (ORC) products, such as Surgicel, Interceed, or Proceed. •Any documents or
communications related to nitrosamine formation during the creation of Oxidized Regenerated Cellulose (ORC)
products, such as Surgicel, Interceed, or Proceed. etc
EMAIL TO/FROM AVEXIS
All FDA guidances, manuals, memoranda, and other such documents which outline internal FDA procedures related to
the FAERS Database, from 01/01/2012 to the Present
At the url https://www.access.fda.gov/itacs/app/welcomeToITACS.jsf , FDA provides information about the status of

customs entries. We would like to receive a daily excel spreadsheet of all ITACS shipment entries containing two
columns: entry number and FEI number.
Copy of the 483 for the Mar 1, 2021 - Mar 5, 2021 (5 days) inspection of Durisan [Sarasota / United States of America]
7810 25th Ct E #106, Sarasota, FL 34243, USA. This inspection pertains to human drugs.
Copy of the 483 for the Mar 15, 2021 - Apr 9, 2021 (26 days) inspection of INNOVA MEDICAL GROUP, INC. [Pasadena /
United States of America] 800 E Colorado Blvd #200, Pasadena, CA 91101, USA. This inspection pertains to medical
devices.
Copy of the 483 for the Mar 2, 2021 - Mar 12, 2021 (11 days) inspection of Jubilant Generics Limited [Sikandarpur /
India] Roorkee - Dehradun Highway , Sikanderpur Bhainswal , , India ,. This inspection pertains to human drugs.
Copy of the 483 for the Oct 14, 2019 - Oct 17, 2019 (4 days) inspection of MANDELAY KFT [Tököl / Hungary] Huba Utca
25-2 Tokol Hungary. This inspection pertains to medical devices.
Report and/or the MDSAP Noncomformity Grading and Exchange Form (NC) for the inspection of Diros Technology, Inc.,
Markham, Canada, end date 05-04-2017. FEI# 3003630373. This inspection pertains to medical devices.
Report and/or the MDSAP Noncomformity Grading and Exchange Form (NC) for the inspection of Diva International Inc.,
Kitchener, Canada, end date 06-08-2017. FEI# 3005113602. This inspection pertains to medical devices.
Report and/or the MDSAP Noncomformity Grading and Exchange Form (NC) for the inspection of Laboratoires
Dermadry Inc., Saint-Leonard, Canada, end date 07-14-2017. FEI# 3013184917. This inspection pertains to medical
devices.
Report and/or the MDSAP Noncomformity Grading and Exchange Form (NC) for the inspection of Les Laboratoires
Blanchard, Sherbrooke, Canada, end date 05-26-2017. FEI# 3002807465. This inspection pertains to medical devices.
Regulatory Assessment of Biomat USA, Inc. Located at Mcallen TX United States FEI Number: 3006521911 held on
12/22/2020.
Any memoranda or other correspondence documenting FDA’s decision regarding whether 180-day exclusivity for
Vasopressin Injection USP, 20 units/mL, has been forfeited. Such memoranda or other correspondence may be
contained in ANDA 211538, approved on December 15, 2021, and identified as a first applicant eligible for such 180-day
exclusivity
Regulatory Assessment of Biomat USA, Inc. Located at Opelika AL United States FEI Number: 3013694758 held on
12/16/2020.
Regulatory Assessment of CSL Plasma Located at Corpus Christi TX United States FEI Number: 1677426 held on
12/21/2020.
Regulatory Assessment of PF Consumer Healthcare B.V. (Puerto Rico Operations) LLC Located at Guayama PR United
States FEI Number: 3007343300 held on 12/18/2020.
Copy of the disclosable portions of the supplemental approval packages for Caplyta, NDA 209500, for supplements 5
and 6, which were approved 12/17/2021.
FAERS Case Number 19230671, for Zepatier
Cosmetic Solutions LLC, 6101 Park of Commerce Blvd, Boca Raton, FL, 33487; Requesting any FDA visit reports, or any
records of 482, 483
Initial Freedom of Information from 1986 for Clavamox Drops (NADA 55-101)
Please Provide Citizen Petition for MIRTAZAPINE 7.5mg Tablets 02P-0249
We request all documents pertaining to FCN 1398. These documents may include but are necessarily limited to the
notification itself and correspondence (deficiency and response letters and emails) with the notifier, any amendments
to the notification, and any information developed by FDA regarding the notification such as summary memos.
Please provide a copy of the container and carton labeling for the discontinued injectable product cupric sulfate (EQ
0.4MG copper/mL) having NDA #019350 previously marketed by ABRAXIS PHARMACEUTICAL PRODUCTS.
I request a copy of the server logs for https://esg.fda.gov/* over the past 10 years.
Under FOIA law, I am requesting receipts for airline airline fare, airline tickets, taxi, and hotel along with any other travel
related expenses for dan mcchesney (FDA-CVM), for the dates of 09.10.17 through 09.16.17
1. We request all internal reports or memoranda prepared by FDA regarding N-Nitroso-Varenicline in Chantix
(varenicline) between April 1, 2021 and January 12, 2022. etc
Documents or documents containing the following information regarding the substance (Deferoxamine mesylate, CAS:
138-14-7, trade name e.g.: Desferal®): • Pre-natal developmental toxicity study cited in Label for NDA 016267
Desferal®, Novartis, 12/16/2011: o “Delayed ossification in mice and skeletal anomalies in rabbits were observed after
Desferal was administered in daily doses up to 4.5 times the maximum daily human dose. etc
Seeking the FDA Waring Letter issued to Sara Lange at Right Value Drug Stores, LLC, dba Carie Boyd's Prescription Shop,
Irving, TX on approximately 9/20/2021
participating in the FDA Foreign Supplier Verification Programs from approximately September 4, 2017 - December 3
2017.
All information or materials in your possession which identifies the specific pathogen(s), microbial species, or other
contaminant(s) the product identified in Recall Number Z-0810-2021 may contain. See attached request letter for
more information.
Climate assessment conducted on the Human Capital Management Staff/ CVM. The Office of Human Capital
Management/ FDA conducted this assessment around. - August 2021: Assessment is titled: "Complaint number - CVM -
001 -21
I'm seeking for the detail record of De Novo classification request (number: DEN170024) for the device of AQUABEAM
System of PROCEPT BioRobotics Corporation, and the detail record of 510(k) premarket notification (number :
K202961,K212835) for the device of AQUABEAM Robotic System of PROCEPT BioRobotics Corporation. Both the records
were submitted to FDA.
Request you to kindly share a copy of the observations in the warning letter issued against Aurobindo Pharma Ltd.'s,
India API facility at Hyderabad. The inspection that took place between Aug 2 to Aug 12 2021 and an OAI was issued in
November.
Recent warning letter issued to Aurobindo Pharma Limited following August 2021 inspection of the company's Unit 1
API manufacturing facility in Hyderabad, India.
To whom it may concern, We would like to see the inspection outcome regarding the 482 we received on Dec.02,
2021. The inspection was conducted by Patricia Alberto. at 4480 Gundry Ave. Long Beach, CA, 90807. Thank you,
Melody
Novocol Pharmaceutical of Canada, Inc. is requesting a duplicate copy of the 510(k) K131487, Fluor Protector S, by
Ivoclar Vivadent, Incorporated for R&D purposes.
Novocol Pharmaceutical of Canada, Inc., is requesting a duplicate copy of the 510(k) K945794, Duraphat, by Inpharma.
following two documents from NDA 215256 approved on 4, June 2021 for the product Wegovy. The second document
is referenced in the NDA. 1. Clinical Review Summary 2. dConrad, A. Proprietary Name Review for (b)(4) (IND 126360).
Silver Spring (MD): FDA, CDER, OSE, DMEPA (US); 2020 Oct 19. Panorama No. 2020-39466751.
COVID VACCINE QUESTIONS
Would like to request for all submission dossier information and clinical study protocol design for ScreenPoint Medical
B.V. which had submitted four separate 510ks K181704, K192287, K193229 and K210404.
for Medical Devices & Rad Health inspection of Guy & O'Neill, Inc. ending 10/29/2021 at the location in Fredonia WI,
United States. The 483 (in electronic format) for Medical Devices & Rad Health inspection of Titan Spine, LLC ending
12/11/2017 at the location in Milwaukee WI, United States. ETC
for Human Drugs inspection of Ultra Seal Corporation ending 11/19/2021 at the location in New Paltz NY, United States.
The Response (in electronic format) for Human Drugs inspection of Athenex Pharma Solutions, LLC ending 03/12/2020
at the location in Clarence NY, United States. The Response (in electronic format) for Human Drugs inspection of
Athenex, Inc. ending 09/17/2020 at the location in Buffalo NY, United States. Please send documents as email
attachments.
K111411
motor axonal neuropathy, acute motor-sensory axonal neuropathy, ETC
K203695, NObreath
for Human Drugs inspection of Smitha Reddy, M.D. ending 08/20/2021 at the location in Poway CA, United States. The
Response (in electronic format) for Human Drugs inspection of Smitha Reddy, M.D. ending 08/20/2021 at the location in
Poway CA, United States. Please send documents as email attachments.
for Medical Devices & Rad Health inspection of ARP Wave L.L.C. ending 12/06/2021 at the location in Apple Valley MN,
I hereby request copies of all information and communications pertaining to the marketing of Nanit baby products
without marketing clearance or approval of these products as medical devices under the Federal Food, Drug, and
Cosmetic Act.
I am requesting a digital copy of inspection results for an FDA inspection conducted on 24 February 2020 at Sterigenics,
Los Angeles, 4900 Gifford Ave, Vernon, CA. Inspection was conducted by Sarah Hassas. Inspection results were emailed
to the General Manager at the time, Alan Suppiphatvong, on 23 April 2020.
February 2021 FDA Report, following a Fire incident for the property at 2900-2950 NW 75th St, Miami, FL "Rivas Family
Enterprises a.k.a. Dependable Warehouse"
Detailed organizational chart including review and project management staff and immediate office staff for
CDRH/OPEQ/OHT7 (Center for Devices and Radiological Health/Office of Product Evaluation and Quality/Office of Health
Technology 7).
1. All FDA’s discipline reviewer guides and concerning scientific review (SE, EX REQ, and PMTA) of smokeless tobacco,
oral tobacco-derived nicotine pouches (e.g. ZYN, ON!, Velo), and cigars. 2. All scientific policy memoranda concerning
the scientific review (SE, EX REQ, and PMTA) of smokeless tobacco, oral tobacco-derived nicotine pouches (e.g. ZYN,
ON!, Velo), and cigars. 3. All scientific reports (i.e. literature reviews, evidence reviews, meta-analyses, FDA/CTP
funded research reports) concerning: a. Nicotine b. Smokeless tobacco c. Oral tobacco-derived nicotine pouches
d. Cigars 4. All data, findings, and documentation of the 2021 National Youth Tobacco Survey including a.
Questionnaire b. Codebook c. Methodology report d. Raw data files e. Summary data files f. Analyses g.
Summary reports I would appreciate communication by email or telephone, rather than postal mail. If necessary, or if
it will increase expediency, we are willing to receive the abovementioned materials on a rolling basis, with receipt of the
final responsive document constituting a complete response. Please feel free to contact me directly. Thank you for
your assistance.
A copy of the embedded PDF titled "HHE for Investigation INV115484_Aerosal S" located at the bottom left of page 6 of
the July 7, 2021 CDER Health Hazard Evaluation attached to this letter which contains product list and test results within
firms for Multiple Aerosol Sunscreen Products (see Section A of page 1 of CDER Health Hazard Evaluation relating to
"Product Description").
[R]ecords reflecting correspondence between employees of the Alzheimer’s Association and FDA personnel; Schedule
for Dr. Billy Dunn from May 1, 2019 to June 30, 2021. Any emails, memos, or other correspondence dated from May 1,
2019 to June 30, 2021 (1) sent TO or FROM Dr. Janet Woodcock, Dr. Patrizia Cavazzoni, Dr. Billy Dunn, Dr. Kevin Krudys
or Dr. Tristan Massie ETC
2021-5971 2021-6291 2021-7126 2021-7723 2021-7919 2021-7989 2021-7990 2021-8083 2021-8094 2021-8364
2021-8523
I'd like to request an adverse report for Opzelura in PDF and Excel from Jan 2021-2022.
RECS RE CHINA INITIATIVE
I am requesting a copy of the most current Investigator Drug Brochure for the Pfizer BNT162B2 (PF-07302048) vaccine.
Thank you,
Sharla Winters
Emails from Dr. Janet Woodcock mentioning "vaccines" or "vaccination" and "neurologic", "neurological," or "side
effects".
EUA for comirnaty 12-15 covid vaccine. When will the vaccine expected to be fully approved by the FDA for 12-15.
Study submitted from Phizer or others regarding vaccine for 12-15 to the FDA and CDC for approval.
All emails, memos and other correspondence related COVID-19 adverse event that were received or sent by FDA
employees, including, but not limited to, Acting FDA Commissioner Janet Woodcock.
1) A definition of COVID-19 etc
Please provide me with any emails, memos, or other correspondence to/from Dr. Stephen Hahn that include the terms:
vitamin C (a.k.a. vit C, VC, and ascorbic acid), hydroxychloroquine, corticosteroids (a.k.a. glucocorticoids) for the period
February 1, 2020 to April 1, 2020.
BIO-CONCEPT LABORATORIES INC INSPECTION RECS
VAERS Reporting System E-Report Numbers 356180, 355712 and 438697
Summary Based Approval Package pertaining to the Bioequivalence (BE) discipline review for ANDA 205742, Glycerol
Phenylbutyrate Oral Liquid, 1.1 g/mL held by Par Pharmaceutical Inc.
Summary Based Approval Package pertaining to the Bioequivalence (BE) discipline review for ANDA 207207, Sapropterin
Dihydrochloride Oral Powder, 100 mg/packet held by Par Pharmaceutical Inc.
Dihydrochloride Oral Powder, 100 mg/packet held by Dr. Reddys Laboratories Ltd.
Dihydrochloride Oral Powder, 500 mg/packet held by Par Pharmaceutical Inc.
K170867
I'd like to request an adverse report for Ayvakit in PDF and Excel from Jan 2021-2022.
Food warehousing and distribution of CHEESE and CREAM All records (inspection reports and correspondence) for:
GSUS EMPIRE (or GSUS)(owned by David & Elfy Gomez) 9901 San Fernando Road, Pacoima, CA 91331 (unit #31)
RLD- Active Ingredient: HYDROXYUREA Proprietary Name: HYDREA Dosage Form; Route of Administration: CAPSULE;
ORAL Strength: 500MG Reference Listed Drug: Yes Reference Standard: Yes TE Code: AB Application Number: N016295
Product Number: 001 Approval Date: Approved Prior to Jan 1, 1982 Applicant Holder Full Name: BRISTOL MYERS
SQUIBB CO
I am a reporter and fellow in MIT's Knight Science Journalism Program, which includes reporting for MIT Technology
Review. Paul Richards, an FDA communications representative, advised me to file this FOIA request, which I'm seeking
to be expedited as a member of the news media reporting in real time. For my reporting, I'm seeking data on how
many requests have been fielded by the FDA to allow treatments for individuals or very small groups in each of the
years 2018, 2019, 2020 and 2021. Emphasis on each year, given my desire to gauge whether the number of requests
has increased over time. Please note I am seeking data, not individual patient information. There is precedence for the
request. According to the below article from MIT Technology Review, "regulators in 2019 fielded more than 80 requests
to allow genetic treatments for individuals or very small groups." Aforementioned article:
https://www.technologyreview.com/2020/02/26/905713/dna-is-like-software-fix-the-code-personalized-medicine/
Thank you, Jared
K173620, Tonica Elektronik 510(k): Mag Vita TMS Therapy System with Theta Burst Stimulation
FAERS Public Dashboard case id:10684766 Please provide the case details for this Dysport (Botulinum Toxin Type A)
safety report.
K182700, Nexstim Navigated Brain Therapy (Nbt) System 2.
K182853, Horizon TMs Therapy System, by Magstim.
K183376, Horizon TMS Therapy System with Navigation, by Magstim.
K200247, Fusion Quattro Extraction Balloon
K201158, Neuronetics Neurostar Advanced Therapy
483s for Medtronic, located in Northridge, CA, for 04/02/2020 and 07/22/2016. This is a medical device firm.
K203735, Brainsway Deep TMS System.
K211389, Magstim Horizon 3.0 TMS Therapy System
participating in the FDA Foreign Supplier Verification Programs from approximately September 4, 2021 - December 16,
2021.
The most current FDA CDER Designated Medical Event (DME) list used in adverse event monitoring and signalling. The
DME list for Human drugs (used by Center for Drug Evaluation and Research (CDER) office of surveillance and
epidemiology)
As permitted by the Freedom of Information Act (FOIA), we vici health science hereby requesting the 3 most recent (last
3 years)documents : Form FDA 483(s), Establishment Inspection Report(s)EIR, observations, and 483(s)firm responses,
any root cause investigation, corrective action for : Solara Active Pharma Sciences Limited Kudikkadu, India, FEI
3003585876 .
and copies of, the November 1, 2016 meeting minutes that the FDA sent to ChemoCentryx on November 14, 2016
pertaining to ChemoCentryx’s drug avacopan (formerly CCX168 and now TAVNEOS).
483 Response from Teva Parenteral Manufacturing in Irvine California on August 20, 2021
483 Response from Teva Parenteral Manufacturing in Irvine California on July 29, 2016
483 from Teva Parenteral Manufacturing in Irvine California on April 24, 2012
483 from Teva Parenteral Manufacturing in Irvine California on August 20, 2021
483 from Teva Parenteral Manufacturing in Irvine California on August 30, 2019
483 from Teva Parenteral Manufacturing in Irvine California on January 18, 2019
483 from Teva Parenteral Manufacturing in Irvine California on July 29, 2016
483 from Teva Parenteral Manufacturing in Irvine California on June 4, 2013
483 from Teva Parenteral Manufacturing in Irvine California on May 14, 2010
483 issued to Catalent Pharmaceuticals, Brussels, Belgium, from Nov. 1, 2021, to Dec. 31, 2021.
Any agenda, list of attendees, minutes, transcripts, recordings, or other materials from the April 6, 2021 "Margolis
Alzheimer's Meeting" attended by Patrizia Cavazzoni or any other FDA officials.
Any agenda, list of attendees, minutes, transcripts, recordings, or other materials from the January 20, 2021 FDA
listening session between Patrizia Cavazzoni or any other FDA officials and patient representatives with Alzheimer's
disease (Alzheimer's Association).
Any documents related to Medolac FDA applications.
EIRs from Fresenius Kabi in Grand Island, New York on August 8, 2004
EIRs from Fresenius Kabi in Grand Island, New York on February 25, 2000
EIRs from Teva Parenteral Manufacturing in Irvine California for all inspections from July 1, 2021 to September 1, 2021
EIRs from Teva Parenteral Manufacturing in Irvine California on April 24, 2012
EIRs from Teva Parenteral Manufacturing in Irvine California on August 10, 2012
EIRs from Teva Parenteral Manufacturing in Irvine California on August 30, 2019
EIRs from Teva Parenteral Manufacturing in Irvine California on February 01, 2010
EIRs from Teva Parenteral Manufacturing in Irvine California on July 29, 2016
EIRs from Teva Parenteral Manufacturing in Irvine California on June 4, 2013
EIRs from Teva Parenteral Manufacturing in Irvine California on May 14, 2010
Please provide narrative case reports for the attached 11 FAERS case
The US Food & Drug Administration's Director of Division of Microbiology Devices, Uwe Scherf, on Jan. 7 wrote to
Abbott Diagnostic in reference to EUA202537/S003, to extend and update the shelf-life expiration of BinaxNOW COVID-
19 ag card to 15 months. I am requesting copies of the request, or requests, sent by Abbott Diagnostics, or any official
from the state government of Florida, to extend the expiration date of these tests.
K202527 full 510(k)
Requesting the report from the RRA conducted in April 2021 by Katelyn Staub-Zamperini of the Omnicell Warrendale
facility
I am requesting copies of the Congressional Correspondence with U.S. Rep. Bruce Poliquin with the Office of Legislation.
• Congressional Correspondence: o Synopsis: “4/11/17: to Scott Gottlieb: Oversight-(S) Rep. Bruce Poliquin writes
FDA to request updated information about RU486 and/or Mifepristone. (closed 6/26/18)” o Synopsis: “3/27/15: to
Thomas Kraus: [redacted] is writing in regard to his application for an exemption from nutritional labeling requirement
and with concern about the public posting of a Warning Letter his firm received. (closed 9/2/15)”
RECS RE FDA RECOMMENDATION OF 2000 CALORIES PER DAY
Please produce the documents related to 510k Number K082890, and please produce the changes to the Instructions
for Use made pursuant to Recall Numbers Z-0542-2008 and Z-0543-2008.
90's and 500's pack bottle labels of RLD is not available on DailyMed or FDA label repository. Kindly arrange to provide
the same for RLD, DETROL LA Extended Release Capsule,2mg and 4 mg,NDA # N021228, held by UPJOHN US 2 LLC
demyelinating polyradiculoneuropathy, demyelinating polyneuropathy, Guillain-Barre syndrome,ETC
Missing EIR for the following 1) OneBlood-Rockledge 1073283 inspected 11/14/2017 2) Tallahassee Memorial Hospital
3007786894 inspected 06/17/2017 3)Beaufort 3007994832 inspected on 06/26/2018 4)Boca Raton 1000140360
inspected 04/04/2018 5)Douglas 1000512128 inspected 07/12/2018 6) Homestead 3002945413 inspected 02/16/2018
7)Tampa General Hospital 3013850134 inspected 05/10/2018
I'd like to request the adverse event reports for Fintepla (fenfluramine) by Zogenix in PDF and Excel.
We kindly request all information on the D-psicose (allulose) GRAS submission from Blue California, filed as GRN 1024,
including the notice, any communications with the notifier before or since the notice was submitted, and any other
internal FDA communications such as memorandum regarding the notice or any pre-submission consultations.
Subject is FDA Inspection Report. Sibas Gida Sanayi Ve Ticaret A.S. is inspected in August,2021 by U.S. Food and Drug
Administration Investigator Nympha V. Florendo. We want to see FDA Inspection Report.
2020-8149, 2021-6434, 2021-6851, 2021-7080, 2021-7125.
CVs Jacob Hamilton, Erica Mahone, Riley Graham, etc
I'd like to request the full case reports of Fintepla (fenfluramine) by Zogenix in PDF and Excel for 19581582, 19601131,
19601125, 18255254, 18647457, 19606337, 18770182 and 19845826. If possible, please email the findings directly to
quinn.lin@point72.com. Thank you!
2021-5623, 2016-10506, 2020-6975, 2020-6976, 2020-7861.
2021-7205, 2021-7327, 2021-7356, 2021-7368, 2021-7370.
2021-7413, 2021-7702, 2021-7725, 2021-7838, 2021-7900.
Any investigational records, reports, or emails within FDA's Center for Biologics Evaluation and Research (CBER)
pertaining to the company Cryo-Cell International (also referred to as "Cryo-Cell") between April 2018 and this time this
request is processed.
copies of any and all FDA response(s), record(s), document(s) and correspondence to and regarding any and all industry
or other stakeholder inquires between January 1, 2017 and the date of this request letter related to whether certain
coloring materials from various plant materials subject to the inquiry meet the specifications in either the color additive
regulations for fruit juice under 21 CFR §73.250 or vegetable juice under 21 CFR §73.260.
Copy of slide set presented to FDA during listening meeting between Alliance for Pharmacy Compounding (APC) and the
FDA regarding the compounding of HCG. The notes from the meeting published by FDA to Docket FDA 2015 D 4750
indicated that the slide set would be posted to the docket and it has not yet appeared.
Hi, We wish to receive a copy of the voluntary Audit which summarizes the Foreign Remote Regulatory Assessment
conducted during 10th Jan 2022 till 14th Jan 2022 for National Foods Limited (FEI# 3009346227)
We are a group of researchers from the finance department at University of Oregon. We are working on a project
measuring the financial consequences of product recalls. We request to have Enforcement Weekly Report(Recall
Report) starting from 2000. We would like the content to be as complete as possible.
NDA 008845
EMAILS BETWEEN BIRX, HAHN, REDFIELD, ETC
for Medical Devices & Rad Health inspection of Medicrea International ending 12/05/2019 at the location in Rillieux La
Pape, France. Please send documents as email attachments.
for Human Drugs inspection of BROWN, DAVID ending 06/16/2014 at the location in AUSTIN TX, United States. Please
for Human Drugs inspection of Catalent Micron Technologies, Inc. ending 03/21/2019 at the location in Malvern PA,
for Human Drugs inspection of ENDO Pharmaceuticals Solutions, Inc. ending 10/23/2018 at the location in Cranbury NJ,
United States. The Response (in electronic format) for Human Drugs inspection of ENDO Pharmaceuticals Solutions, Inc.
ending 10/23/2018 at the location in Cranbury NJ, United States. Please send documents as email attachments.
for Human Drugs inspection of HBT Labs, Inc. ending 01/25/2019 at the location in Brea CA, United States. The EIR (in
electronic format) for Human Drugs inspection of HBT Labs, Inc. ending 01/25/2019 at the location in Brea CA, United
Narrative case reports for the following FAERS Case IDs (attached)
for Foods & Cosmetics inspection of Taylor Farms Northwest, LLC ending 08/08/2016 at the location in Kent WA, United
States. The EIR (in electronic format) for Foods & Cosmetics inspection of Taylor Farms Northwest, LLC ending
08/08/2016 at the location in Kent WA, United States. The Response (in electronic format) for Foods & Cosmetics
inspection of Taylor Farms Northwest, LLC ending 08/08/2016 at the location in Kent WA, United States. Please send
K143513 Full 510(k)
K163512 Full 510(k)
K181502 Full 510(k)
K190593 Full 510(k)
I would like all publicly available information relating to the IND filing for investigational product RBX2660., including the
IND submission and supplemental information.
ANDA # 076593 Sequences 0003, 0004, or 0005.
I would like to request the Establishment Inspection Report from the most recent inspection at the Memphis, Swinnea
Rd. facility, registration number 3009380063. This inspection started on 16-Nov-2021 and concluded on 18-Nov-
2021. .
All DEATH adverse event related to all polyethylene glycol 3350 products for pediatric and adult use 1970 to present.
Requesting detailed report, not summary. Thank you.
All adverse events for all polyethylene glycol 3350 products for adult and pediatric use, including all voluntary and
mandatory reports from 1970 to present. Requesting detailed report, not summary. Received wrong dates for this
recently. Please see dates 1970 to present. Thank you very much.
’The record we are looking to retrieve is the report that Philips Respironics has sent to the FDA in the month of
December 2021, in response to the aforementioned FDA 483 Form (FEI number 2518422), about the ongoing class 1
medical device recalls of various models of Philips Respironics ventilators, CPAP and BPAP devices, due to foam
degradation issues
Documents and information relating to certain implantable tissue markers, designed, and marketed by Focal and
Hologic since 2012. The markers include, the Biozorb Marker, Biozorb LP Marker, Bizororb Marker GOLD/LP Marker
GOLD and the BioZorb SP Marker (K143484), (K152070), (K171467), (K192371).
Clozapine prescription labeling which are not currently available at FDA Drugs under "Approval Dates(s), History, letters,
labels, reviews. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=019758
Labels dated: 02/05/1990 - SUPPL 1 06/12/1991 - SUPPL 8 10/27/1992 - SUPPL 10 08/30/1994 - SUPPL 22 08/31/1995 -
SUPPL 16
Records of entries in which Harris Teeter LLC or similar variations of such name is listed as the FSVP importer.
Please provide Original approval letter for ANDA 210362 approved on 06-19-2018.
21CFR 178.3260 says that I can get a copy of the "Journal of the Association of Official Agricultural Chemists" Volume 45
February 1962 , article "A More Sensitive and Selective Ultraviolet Absorption Criterion for Mineral Oil" from CFSAN
(HFS-200). I would like a copy please.
All information from the RRA of Patient Shield Concepts, LLC
Copy of the 483 for the Oct 2, 2019 - Oct 16, 2019 (15 days) inspection of Carroll-Baccari, Inc. dba Mavidon Medical
Products [Lake Worth / United States of America] 1820 2nd Ave N, Lake Worth, FL 33461, USA. This inspection pertains
to medical devices.
Copy of the 483 for the Oct 4, 2019 - Oct 11, 2019 (8 days) inspection of California IVF: Davis Fertility Center [Davis /
United States of America] 1550 Drew Ave #100, Davis, CA 95618, USA. This inspection pertains to biologics.
Copy of the 483 for the Sep 16, 2019 - Sep 20, 2019 (5 days) inspection of Conformis Inc. [Wilmington / United States of
America] 600 Research Dr, Wilmington, MA 01887, USA. This inspection pertains to medical devices.
Copy of the 483 for the Sep 16, 2019 - Sep 25, 2019 (10 days) inspection of Universal Diagnostic Laboratories [Los
Angeles / United States of America] 6700 Valjean Ave, Van Nuys, CA 91406, USA. This inspection pertains to biologics
Report and/or the MDSAP Noncomformity Grading and Exchange Form (NC) for the inspection of Bio Nuclear
Diagnostics Inc, Etobicoke, Canada, end date 04-20-2017. FEI# 3005892511. This inspection pertains to medical devices.
Report and/or the MDSAP Noncomformity Grading and Exchange Form (NC) for the inspection of CRH Medical
Corporation, Vancouver, Canada, end date 02-14-2017. FEI# 3004172371. This inspection pertains to medical devices.
Report and/or the MDSAP Noncomformity Grading and Exchange Form (NC) for the inspection of GMDASZ
Manufacturing Co., Ltd., Shenzhen, China, end date 08-15-2019. FEI# 3008197884. This inspection pertains to medical
devices.
Report and/or the MDSAP Noncomformity Grading and Exchange Form (NC) for the inspection of WUXI JIAJIAN
MEDICAL INSTRUMENT CO., LTD, Wuxi, China, end date 01-25-2019. FEI# 3007710601. This inspection pertains to
medical devices.
Copy of the disclosable portions of the open microphone discussions that took place during the November 3, 2021
meeting of the Circulatory System Devices Panel.
Regulatory Assessment of Biomat USA, Inc. Located at Midwest City OK United States FEI Number: 1640962 held on
12/31/2020.
Regulatory Assessment of Biomat USA, Inc. Located at Pueblo CO United States FEI Number: 1777475 held on
12/28/2020.
Regulatory Assessment of CSL Plasma Located at Omaha NE United States FEI Number: 1978037 held on 12/31/2020.
Regulatory Assessment of CSL Plasma, Inc Located at San Luis AZ United States FEI Number: 3012593588 held on
12/29/2020.
Electronic listing (preferably csv format) of all inspections conducted by FDA since August 1, 2021. The list should cover
all FDA centers and include each FDA inspection ID number, DUNS number and reason for inspection.
All records created by FDA relating to SAMSCA (tolvaptan) tablets, 15 mg and 30 mg NDA No. 22275
for Medical Devices & Rad Health inspection of JABIL INC. ending 10/22/2021 at the location in Monument CO, United
for Biologics inspection of Baxter Pharmaceutical Solutions, LLC ending 11/10/2021 at the location in Bloomington IN,
United States. The EIR (in electronic format) for Biologics inspection of Baxter Pharmaceutical Solutions, LLC ending
11/10/2021 at the location in Bloomington IN, United States. etc
for Foods & Cosmetics inspection of Taylor Farms Northwest, LLC ending 06/23/2015 at the location in Kent WA, United
States. The Response (in electronic format) for Foods & Cosmetics inspection of Taylor Farms Northwest, LLC ending
06/23/2015 at the location in Kent WA, United States. etc
for Medical Devices & Rad Health inspection of Remel Inc ending 10/23/2015 at the location in Lenexa KS, United States.
The EIR (in electronic format) for Medical Devices & Rad Health inspection of Remel Inc ending 10/23/2015 at the
location in Lenexa KS, United States. etc
Responsive documents to log # 2008-7042
responsive material to log #'s 2018-6525, 2015-9040, and 2013-7175
PETER MARKS EMAILS WITH CDC
February 25, 1994, letter from Dennis M. Bier, M.D., Professor of Pediatrics and Director, Children’s Nutrition Research
Center, College of Medicine, Baylor University, to David A. Kessler, M.D., Commissioner, Food and Drug Administration.
FDA inspection report for the Russian shipment of coronavirus supplies which landed at Kennedy Airport on April 1,
2020.
Eric
ICSR report (case 20198414)
We are requesting the FDA submission Data for 510(k) K992799. We have the 510 (k) Summary and Decision Letter and
would like a copy of the submission Data. We are the current manufacturer of the product. Our FDA Establishment
Registration is 2025099 and Device Listing is D021318.
Thank you,
Patrick Garcia, Director of Marketing, Biomerica, Inc.
Document numbers: CPT2101677, CPT2101678, CPT2101679, CPT2101682, CPT2101683, CPT2101685
Requesting an electronic copy in PDF format of the most recent approved prescribing information, including images of
the product carton and container labeling, for NDA 019350, Cupric Sulfate EQ 0.4mg copper/mL, Injectable; Injection. As
per Drugs@FDA, the most recent approved labeling was from June 9, 1992, however the label is not available on the
website.
The original FOI summary for the initial approval of the product "Synovex C", an animal health product with NADA #009-
576.
Records involving the safety for Samsung battery model 18650-25R Records involving complaints in connection to
Samsung battery model 18650-25R Hazards involving Samsung battery model 18650-25R
OneBlood, Inc is missing the Establishment Inspection Report (EIR) for Tallahassee Memorial Hospital- 3007786894
inspected on 08/01/2019
ClinicalTrials.govIdentifier Study: NCT04798716
Can I please request for all Establishment Inspection Reports since January of 2020 at Catalent Brussels, Belgium. Can I
also please request the 483 letter from January of 2020 for Catalent. Thank you,
Any/all documents in the possession of FDA and/or any of their agents regarding Charles B. Chrystal and any testing of
its products with regard to talc (including but not limited to correspondence, reports, test results).
FAERS NARRATIVE REPORTS
I'm requesting access to and copies of the following: - Records released in response to the previously released FOIA
request #s (including the original request): 2020-1451, 2021-5433, 2021-7312, 2021-7510, 2021-7511, 2021-7876, 2021-
7983, 2021-8017, 2021-8018, 2021-8019, 2021-8106, 2021-8221, 2021-8269, 2021-8639, 2021-8732
I'm looking for FDA documents regarding the investigation into the 2006 Spinach outbreak outlined in this CDC
overview: https://www.cdc.gov/ecoli/2006/spinach-10-2006.html I'm looking for investigation findings as well as email
exchanges within the FDA, and with industry.
I am looking for investigation findings and email exchanges in regard to this outbreak outlined here:
https://www.fda.gov/food/outbreaks-foodborne-illness/outbreak-investigation-e-coli-romaine-salinas-california-
november-2019 I am specifically looking for emails exchanges within the FDA and between the FDA and industry. In
total, there should be about 413 pages of emails.
Hello, I am cordially requesting all documents related to FAERS case IDs: 19274808 18731898 18738641 19158684
19318485
I am looking for investigation findings and email exchanges in regard to this outbreak outlined here:
https://www.fda.gov/food/outbreaks-foodborne-illness/outbreak-investigation-e-coli-romaine-november-2018 I am
specifically looking for emails exchanges within the FDA and between the FDA and industry. In total, there should be
about 413 pages of emails.
PMTA Approvals
In regard to the 510(k) numbered K200667: Material which may be disclosed, from the following: full FDA submission,
electronic (e-mail) communication, and any releasable documents related to the FDA decision-making process.
In accordance with Freedom of Information Act, Stryker Endoscopy is requesting safety and effectiveness information
for 510(k), K210265.
I request all records related to Julia Tierney's schedule from Jan. 20, 2021 through Dec. 31, 2021. Please include all
records that document her schedule, including but not limited to agenda sheets, appointments, day calendars,
itineraries, Google calendars, Outlook calendars, programs and timetables. The records should include the names of
invitees, notes, and any other attachments for a given entry.
I request all records related to Janet Woodcock's schedule from Jan. 20, 2021 through Dec. 31, 2021. Please include all
records that document her schedule, including but not limited to agenda sheets, appointments, day calendars,
itineraries, Google calendars, Outlook calendars, programs and timetables. The records should include the names of
invitees, notes, and any other attachments for a given entry.
FDA-related memoranda, review documents, and correspondence for the following SE reports: SE0016550 SE0016572
SE0017543
-the initial de novo application (DEN200080) submitted to the FDA, and associated subsequent FDA questions and
manufacturer's response -Pre-submission applications, meeting minutes, written FDA feedbacks which precedes the de
novo clearance of DEN200080.
Any and all notes, reports and documents from the investigation of Crystal Pines Rehabilitation and Healthcare Center
located at 335 Illinois Street, Crystal Lake, IL 60012, including, but not limited to, the investigation of the tampering of
patient's prescription medications.
method “RT-qPCR Detection of Mengovirus Using ABI 7500 Platform” developed by FDA’s GCSL as well as all associated
work instructions
Responsive documents to log numbers 2019-973, 2019-6673, and 2019-1965
syndrome, ETC
K211526
End of Phase 2 clinical trial (NCT02858895) meeting notes between Medicenna Therapeutics Corp and the FDA
regarding the regulatory and commercial pathway for MDNA55 and proceeding with the open-label hybrid control
design for a Phase 3 registration trial of MDNA55 in rGBM patients.
for Animal Drugs & Feeds inspection of Steril-Gene Life Sciences Pvt Ltd ending 12/10/2019 at the location in
Puducherry, India. Please send documents as email attachments.
for Human Drugs inspection of Bristol-Myers Squibb Holdings Pharma Ltd. Liability Company ending 07/12/2021 at the
location in Manati PR, United States. Please send documents as email attachments.
format) for Biologics inspection of Bio-Rad Laboratories, Inc. ending 12/13/2021 at the location in Woodinville WA,
for Human Drugs inspection of Pisgah Labs, Incorporated ending 10/21/2021 at the location in Pisgah Forest NC, United
States. The EIR (in electronic format) for Human Drugs inspection of Pisgah Labs, Incorporated ending 10/21/2021 at
the location in Pisgah Forest NC, United States. Please send documents as email attachments.
for Human Drugs inspection of Charles River Laboratories, Inc. ending 06/15/2018 at the location in Reno NV, United
States. The Response (in electronic format) for Human Drugs inspection of Charles River Laboratories, Inc. ending
06/15/2018 at the location in Reno NV, United States. Please send documents as email attachments.
for Human Drugs inspection of Charles River Laboratories, Inc. ending 06/15/2018 at the location in Reno NV, United
States. The Response (in electronic format) for Human Drugs inspection of Charles River Laboratories, Inc. ending
06/15/2018 at the location in Reno NV, United States. Please send documents as email attachments.
for Human Drugs inspection of Univar USA Inc. ending 11/01/2021 at the location in Kent WA, United States. The EIR (in
electronic format) for Human Drugs inspection of Univar USA Inc. ending 11/01/2021 at the location in Kent WA, United
States. The Response (in electronic format) for Human Drugs inspection of Univar USA Inc. ending 11/01/2021 at the
location in Kent WA, United States. Please send documents as email attachments.
Please provide all FDA Office of Criminal Investigations cases related to 2,4-Dinitrophenol that resulted in conviction
from 2017 to current date. Example: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-
investigations/press-releases/texas-woman-sentenced-6-months-federal-prison-selling-deadly-weight-loss-drug-
consumers
K153473 Full 510(k)
We are looking for a Summary Basis of Approval (SBOA) for the drug product OPZELURA (ruxolitinib) cream, 1.5% (NDA
215309) which was approved on 09/21/2021. We request you to provide us the SBOA of all disciplines (CMC, CLINICAL,
NON CLINICAL etc.)
The number case reports of diagnosed dilated cardiomyopathy in dogs recieved by the FDA in reference to it's ongoing
investigation of non-hereditary DCM; additionally, how many of those are reported to have died. I would like this
number spanning from 01/04/2014 to the most recent available. Thank you.
Emails, memoranda, Powerpoint presentations, and other documents related to the revocation of a standard of
identity for French dressing in the possession of Rumana Yasmeen or Carrol Bascus of the Center for Food Safety and
Applied Nutrition.
Uncashed/Unclaimed checks and funds

Unclaimed tax refunds and performance bonds
Tax Overpayments etc
Conflict of interest materials including real or potential conflicts pertaining to Sara Rothman
(Sara.Rothman@fda.hhs.gov).
ALL FORM 483, EIR, RESPONSE LETTERS, AND ANY OTHER COMMUNICATIONS WITH THE FDA BY/FOR RLC LABS INC
LOCATED AT 1850 E RIVERVIEW DR, PHOENIX, AZ AND 29455 N Cave Creek Rd Ste 118-629, Cave Creek, AZ
ALL FORM 483, EIR, RESPONSE LETTERS, AND ANY OTHER COMMUNICATIONS WITH THE FDA BY/FOR SPECIALTY
PROCESS LABS LOCATED AT 1030 E LONE CACTUS DR PHOENIX, AZ 85024
Freedom of Information Act (FOIA) request for records regarding: Package Insert and primary container labeling for the
below referenced product: Active Ingredient: ERIBULIN MESYLATE Proprietary Name:HALAVEN etc
Information on entries for which an FSVP importer is identified with "Whole Foods," "Whole Food," "Wholefoods," or
"Wholefood" as part of it's name, whether or not capitalized, to include manufacturer's name and address, filer's name
and address, arrival date, entry number, port of entry, country of origin, product description, and final admissibility.
Food Contact Notification (FCN) 1135
Request PMTA MDO ENDs related to Shenzhen Yibo Technology Co. Ltd.
The following internal Center for Tobacco Products memoranda, as well as any and all related internal documents and
memoranda: Office of Science (OS) Premarket Application Review Prioritization Plan (2020.08.31) Addendum to the
Office of Science (OS) Premarket Application Review Prioritization Plan Memorandum (2020.09.24) etc
interested in documents related to control numbers: 2021-7416 2021-7689 2021-7784 2021-7990 2021-8221 2021-
8459 2021-8523 2021-8640 2021-8672 2021-8776
Any and all US Food and Drug Administration inspection records for OneBlood, Inc located at 2229 SE Ocean Blvd,
Stuart, FL 34996.
Any and all US Food and Drug Administration inspection records for OneBlood, Inc located at 229 SE Ocean Blvd, Stuart,
FL 34996.
In September through December 2020, the CDC, FDA, and state partners investigated a cluster of STEC cases linked to a
restaurant (Outbreak code: 2010OHEXH-1). Pritzker Hageman represents several clients associated with this outbreak.
We are writing to request copies of any traceback records on file at the FDA regarding this outbreak.
Meitheal Pharmaceuticals would like to request the most recently submitted carton, container, and package insert
labels for both the reference listed drug and reference standard ANDA for Hydralazine HCl injection for our own ANDA
submission, please provide for both: RLD NDA 008303 RS ANDA 040730
Pursuant to the Freedom of Information Act, 5 U.S.C. § 552, et. seq., we are requesting that the FDA make available all
public data in its possession regarding its investigation of the multistate outbreak of listeriosis linked to packaged leafy
greens and iceberg lettuce produced at Dole facilities in Springfield, OH; Bessemer City, NC; Yuma, AZ; and Soledad, CA.
WCW requests copies of any active protocols involving Non-Human Primates.
Documents pertaining to covid vaccines containing graphene oxide
To Whom It May Concern: Pursuant to the Freedom of Information Act, I hereby request the following records: Access
to and copies of any complaints, investigation reports, warning letters or other documents pertaining to the product
"Snake Oil" marketed by Caroline Calloway, business address 250 N. 10th Street, Brooklyn NY 11211. etc
We request a copy of all Summary Basis of Approval documents for NDA 213436 for Trudhesa nasal spray by Impel
Neuropharma.
Pursuant to the Freedom of Information Act (FOIA), requesting records related to the type and extent of any follow-up
regarding investigation into Allegations Sent to the FDA - BY - CPT2001509 for the Medtronic ProdiGI™ Traction Wire.
I am seeking a copy of the FDA Congressional communications log from 3-2-2020 to the fulfillment of this request.
Any and all records maintained by the U.S. Food and Drug Administration including memoranda, draft memoranda,
email communications, email chains, research papers, data compilation, and other communications between Pfizer,
Merck and Company, and Ridgeback Biotherapeutics regarding, discussing, or otherwise concerning “resistance” or
“viral resistance” of Paxlovid and Molnupiravir from October 1, 2021 to January 24, 2022.
FCN 1558
Subject: Records related to: (1of2) projected "Ivermectin" approval for use to treat COVID based on an appropriate
medical practitioner and (2of2) pro and con results of studies of the drug and/or actual use of the drug to treat actual
COVID patients.
510(K) Submission for ClotTriever Thrombectomy System cleared 10OCT2018.
510(K) Submission for ClotTriever Thrombectomy System cleared 1116FEB2018.
510(K) Submission for CAPERE Thrombectomy System cleared 11JUN2018.
510(K) Submission for CAPERE Thrombectomy System cleared 11JUN2018.
510(K) Submission for ClotTriever Thrombectomy System cleared 09APR018.
• K162524 (AZUR CX Detachable 18 Peripheral Coil System) • K151358 (AZUR CX Detachable 35 Coils) • K123384
(AZUR CX DETACHABLE 18) • K120630 (AZUR Peripheral HydroCoil)
NDA 202107 Please provide a copy of the following: January 27, 2017, DMPP review by Sharon Williams (concurrence
from team leader Shawna Hutchins and from Meena Ramachandra of OPDP).
Please kindly send, via email ideally (e.g. PDF), or alternatively through US mail to the mailing address included: - All
emails relating to "Esperion" or "ETC-1002" or "IND 106654", that involve any of the following individuals or email
addresses: - Thanh Hai, Mary; or Smith, James P. (FDA/CDER); or Parks, Mary H; Rosebraugh, Curtis; Guettier, Jean-
Marc; Jenkins, John K; Johnson, Kati; Ashley Hall;ETC
IWGACP Scientific Opinions on Testing Methods for Asbestos in Cosmetic Products Containing Talc (including Talc
Intended for Use in Cosmetics) - I request any and all documents, written proposals, verbal proposals that were
recorded/transcribed, notes of hearings, transcripts of hearings, notes from meetings, transcripts of meetings, ETC
FDA/AMA Testing of Claire’s and Justice Cosmetic Talcum Powder Products
FDA/AMA 2009-2010 Testing of Cosmetic Talcum Powder Products
FDA Recalls/Advisory Notices - Any and all documents at any time related to any voluntary recall, FDA request to recall,
or FDA consumer advisory notice related to any Colgate-Palmolive Company and/or The Mennen Company talcum
powder products, including but not limited to Cashmere Bouquet, Mennen Shave talc, and/or Baby Magic. This request
does not have a specific date range.

Any FDA Testing of CPC/Mennen Cosmetic Talcum Powder Products

483s for the Becton Dickinson locations in Franklin Lakes, NJ; in Columbus, Nebraska ; Cuautitlán, Mexico ; Fukushima,
Japan ; Le Pont-de-Claix, France; Swindon, United Kingdom; and Tatabánya, Hungary
An FDA inspection/investigation was conducted at Eosera from September 13 - 15, 2021. We are requesting any
memos related to this investigation/inspection.
I would like to request the Establishment Inspection Report from the most recent Inspection of the Medtronic, Inc -
Philadelphia Distribution Center 1130 Commerce Blvd Ste 110, Swedesboro, NJ 08085, Registration Number
3007026906. Inspection started on 17 August 2021 and concluded on 18 August 2021.
Review Memorandum and Correspondence related to Elite Brothers, LLC
Reviewers' summaries regarding SE0016588-SE0016590 and SE0016754-SE0016755
AMA Analytical Services, Inc. - Over the past 10-15 years, the FDA has used AMA Analytical Services, Inc. to test cosmetic
talcum powder samples. I request any and all documents evidencing why and how AMA was selected as the testing
laboratory, including but not limited to the selection criteria used, and if any other laboratory was considered.
Adverse Event Reports - Any and all adverse event reports reported/filed for all time related to any and all Colgate-
Palmolive Company and/or The Mennen Company talcum powder products, including but not limited to Cashmere
Bouquet, Mennen Shave talc, and/or Baby Magic.
Any FDA Testing of Johnson & Johnson Cosmetic Talcum Powder Products
Human adverse event drug MedWatch reports for the following Case IDs: 12581349 12620152 12971086 12971110
12980840 13052535 13143464 13387928 13441020 13578893 13603479 13787042
Any and all inspection Form 483 and EIR records, issued to WuXi Biologics. (FEI # 3010606982) at the facility in 108
Meiliang Road, Binhu, Wuxi, Jiangsu 214092, China. The product types are 1) human drug, 2) BIologics. Please send the
documents in pdf as attachment to email. Thanks.
Full set of FOIA requests submitted to FDA since January 1995, including (1) a control number that uniquely identifies
each FOIA request, (2) the day on which the request was received by the FDA, (3) the date on which the FDA response is
due, etc
We are seeking for the full information of the FCN 1398. And the full information here refers to the full submission from
the company along with FDA’s review memoranda of that submission and the subsequent letter of no objection. The
language can be in English.
We would like to request whether there is a recall on Zimmer Biomet Implant Catalog Number 42557000114, 42-5320-
079-0, lot number 64072967, and Catalog Number 5126-009-18, lot number 62736936 and lot number 64288130. This
is a prosthetic joint for a left knee. Any information would be helpful.
All cancer treatments and cures that have been denied an FDA safety approval
Request for a list of inspections conducted by FDA pursuant to the Prescription Drug Marketing Act (PDMA) from 2018
to present.
Regarding Drysol prescription antiperspirant, by Person & Covey, containing aluminum chloride, I would like any
documentation indicating that Drysol can be legally manufactured and/or distributed in the U.S., including any ANDA or
communications between the company and FDA.
Could you send us a copy of the cover letter accompanying the EIR FEI: 3010449760. The inspection was conducted by
Investigator Mr Charles L. Zhou-S through 0729/2019 to 07/30/2019 at GIMOPHARM, 1 Chemin de Saulxier, 91160
Longjumeau, FRANCE. Best regards
- All communication between the FDA and TenderNeeds; - All documents relating to the facility inspection in
Greenville, Indiana, including the Form FDA 483; - Any FDA warning letters to or enforcement action against
TenderNeeds; and - TenderNeeds product recall notification.
Name of any companies that have identified Northgate Gonzalez, LLC (dba Northgate Markets) as Consignee, Importer
of Record, or FSVP Importer
Full copy of 510(k) submission: K161605 Made by: Aqueduct Critical Care, Inc. For Trade/Device Name: Smart External
Drain (SED) System Dated: September 23, 2016 Received: September 26, 2016
Date Range: 09/01/2018 – 01/01/2022; Complete EIR reports from FDA audits of Dishman Carbogen Amcis Limited. We
are requesting the reports for the following locations: 1) 1216/11 - 12 1216/24 25&26 Phase Iv, Gidc Estate,
Ahmedabad, Gujarat 382330, India 2) Survey No. 47 & 48 Paiki Sub Plot No. 1, Village- Lodariyal, Taluka - Sanand
(Bavla), Ahmedabad, Gujarat 382220, India
syndrome, etc
for Human Drugs inspection of Genzyme Corporation ending 10/20/2008 at the location in Cambridge MA, United
for Foods & Cosmetics inspection of Taylor Farms Tennessee, Inc. ending 11/23/2021 at the location in Smyrna TN,
for Human Drugs inspection of Charles River Laboratories ending 07/16/2021 at the location in Mattawan MI, United
for Medical Devices & Rad Health inspection of GE Healthcare Biosciences ending 08/06/2012 at the location in
Westborough MA, United States. Please send documents as email attachments.
format) for Biologics inspection of CSL Behring LLC ending 09/24/2021 at the location in Bradley IL, United States.
format) for Medical Devices & Rad Health inspection of Nalge Nunc International Corporation ending 09/26/2018 at the
location in Rochester NY, United States. Please send documents as email attachments.
format) for Medical Devices & Rad Health inspection of Phillips Respironics, Inc. ending 11/09/2021 at the location in
Murrysville PA, United States. Please send documents as email attachments.
for Animal Drugs & Feeds inspection of North China Pharmaceutical Co., Ltd. ending 05/31/2013 at the location in
Shijiazhuang, China. etc
2021-8223, 2021-8227, 2021-8228, 2021-8235, 2021-8247.
2021-7936, 2021-7993, 2021-8047, 2021-8070, 2021-8075.
2021-8081, 2021-8106, 2021-8116, 2021-8127, 2021-8138.
2021-8142, 2021-8160, 2021-8162, 2021-8166, 2021-8201.
Investigation records arising from Luminar Technologies ARO Report dated 12/1/2018, Reference COR19000286.
All records released under FOIA 2021-7730
I request that a copy of the following documents be provided to me: All records submitted by Importer of Record for
Entry Number: 9UG-0095081-2
All communications (including cease & desist letters, complaints, indictments, warnings, citations, charges, accusations)
to, from and concerning VIVERA PHARMACEUTICALS, INC. ETC
- All communication and documentation referencing Neuma Clamp. - All communication and documentation
referencing Neuma CSL Catheter Safety Lock. - All communication and documentation referencing Neuma LLC and
Neuma Innovations. - All correspondence naming Hal Rucker and Neuma Innovations LLC, located at 345 Poe Street,
Palo Alto California 94301.
- All communication with and documentation between the FDA and Mr. Suk Yoon regarding Gentueri, Inc. - All
documentation provided to the FDA by Mr. Suk Yoon regarding Gentueri, Inc. - All documentation referencing and
naming Mr. Suk Yoon regarding Gentueri, Inc.
- All documentation about the GID Group, Inc. - All documentation about the GID Group, Inc.'s ACTIVci treatment. - All
documentation about the GID Group, Inc.'s VIVEci treatment. - All documentation about the GID Group, Inc.'s SVF-2
device. - All documentation about the GID Group, Inc.'s cellular implant. - All documentation about the GID Group Inc.'s
study protocol. - All documentation about the GID Group Inc.'s clinical trials.
All communications to, from and/or between the FDA and any other individual, organization, committee
relating to the decision to give emergency use authorization for hydroxychloroquine for the treatment of
COVID-19.
All communications to, from and/or between the FDA and any other individual, organization, committee
relating to the decision to vacate/terminate/suspend/revoke the emergency use authorization for
hydroxychloroquine for the treatment of COVID-19
All communications between the FDA and the Countermeasures Injury Compensation Program (“CICP”)
and/or Health Resource & Service Administration (“HRSA”) relating to emergency use authorization for
hydroxychloroquine for the treatment of COVID-19.
All communications between the FDA and the Countermeasures Injury Compensation Program (“CICP”)
and/or Health Resource & Service Administration (“HRSA”) relating to the use of hydroxychloroquine,
remdesivir, azithromycin and/or ventilators for the treatment of COVID-19.
All documents, other than communications and not including any protected health information (“PHI”) as
defined under Health Insurance Portability and Accountability Act of 1996 , that refer to the use of
hydroxychloroquine, remdesivir, azithromycin and/or ventilators for the treatment of COVID-19.
VAERS REPORT
VAERS report
VAERS report
VAERS report
CMC review for ANDA 206604, ferumoxytol, byt Sandoz
483s and related correspondence concerning FDA inspection(s) of Medtronic's Northrigdge, CA facility. The inspections
occurred on or about June 7 though July 7, 2021.
reports of patients who were harmed by using ivermectin to treat COVID-19
Please provide the GenBank Sequence No. or other information describing the SARSCoV-2 full genome sequence
approved for (1) calibrating SARS-CoV-2 diagnostic tests and (2) manufacturing COVID-19 vaccines.
Any and all contracts, task orders, or other binding agreements relating to a Covid-19 vaccine in the possession of the
Food and Drug Administration in which Pfizer is a party and which were effective as of or after January 1, 2020.
A document that suggests Yale's Chemical and Biophysical Instrument Center is cGMP compliant and/or FDA registered.
All emails from Dr. Janet Woodcock containing the words "vaccine", "vaccines", or "vaccination" and "side effects."
Exclude spam and attachments. Thank you
Records indicating the date on which the Clinical Pharmacology Biopharmaceutics Review for Biologics License
Application 125276 for Actemra (tocilizumab) Injection (approved on January 8, 2010) was made publicly available on
the Drugs@FDA portion of FDA's website
Copy of the disclosable portions of the company response for the 483 issued following the 10/18/2021 - 10/26/2021
inspection of Catalent, located in Brussels, Belgium. This inspection pertained to human drugs.
Four Separate EIR reports related to 21 CFR 211.87 described below: Inspection number 959244 of Buderer Drug Co.
Inc. FEI 3005664940, Address 26611 Dixie Hwy Ste 119 Perrysburg, OH 43551-1749, Inspection ended Jan. 4, 2016
Inspection number 1050973, of UIP University of Iowa Pharmaceutics, FEI 1918751, Address 115 S Grand Ave Ste G18,
etc
1. All communications between the FDA and HHS regarding the company “Vaxart” and it’s involvement in Operation
Warp Speed and/or the development of a COVID-19 vaccine; and 2. All communications between the FDA and Vaxart
regarding Vaxart’s involvement in Operation Warp Speed and/or the development of a COVID-19 vaccine.
Recs re inspection of facilities owned and/or operated by Lonza Group AG (“Lonza”) and located at either 14905 Kirby
Drive, Houston, Texas 77047 or 101 International Drive, Portsmouth, New Hampshire 03801. .
All communications from Dr. Peter Marks with the words vaccines or vaccine; COVID-19, COVID19, or Covid; and
neurological, neurologic, or neuropathy
1. All emails at the FDA regarding Dr. Gruber and/or Dr. Krause, their concerns about COVID-19 boosters, and
discussions about them leaving the FDA. The time span of this request covers August 1, 2021 to the present. In
responding to this request, please search all email mailboxes assigned or formerly assigned to Marion Gruber, Philip
Krause, Peter Marks, FDA Chief of Staff Julia Tierney, and FDA Acting Director Janet Woodcock. ETC
Innovative Sterilization Technologies LLC trade complaints, Manufacturer and User Device Experience (“MAUDE”)
complaints, customer complaints and the like, received by the U.S Food and Drug Administration (“FDA”) from
customers, surveyors, inspectors, competitors, collaborators, users, organizations and other parties regarding IST’s One
Tray Sealed Sterilization Containers.
Emails, communications, correspondence, and/or Outlook calendar entries exchanged between Janet
Woodcock and CDC staff, during the above stated time period, including, but not limited to
communications with the following CDC staff: Rochelle Walensky
Any documents, contracts, or messaging

regarding the Razer Zephyr or Razer Zephyr Pro facemasks (or their previous
codename, Project Hazel) and N95 or other NIOSH standard labeling for its filters
complaints related to the RAZER ZEPHYR

brand mask from Jan. 5 to the date records for this request are produced. I am also
requesting any applications for NIOSH approval as an N-95 respirator for the same
mask, and any responses or correspondences from the CDC about that certification
RECS RE GRUBER, KRAUSE RETIREMENT
All emails referencing monoclonal antibody treatment restrictions.
[Reference FGI# 22-76449] Relevant to GS35F0617Y Order HHSF223201700019B (Task Order 6 - "CBER Systems and
Modernization BPA Task Order 6," a BPA Call, Number 75F40121F19005), we seek copies of the following: (1) Task
Order 6 with SOW/PWS, modifications and winning proposal (2) original and complete Solicitation/RFP with all
amendments, exhibits and attachments.
Duplications of Cover Letter, Letter of Authorization, Agent Appointment Letter of DMF #27998
Any and all research/findings on the medical application of marijuana/canibanoids in relation to depression/mental
illness
All data relied upon by the FDA in its decision to revise the authorizations of monoclonal antibodies to treat COVID-19
infection.
MECTA Sigma Instruction Manual Book One: Use of the Device MECTA Sigma Instruction Manual Book Two: Clinical
Issues in the Administration of ECT MECTA Sigma Service Manual: Book Three MECTA Sigma Titration and Pre-Selected
Dosing Tables Please contact me with any questions. Sincerely, Amber Rauscher Deputy Legal Coordinator Citizens
Commission on Human Rights International E-mail: amber@cchr.org Tel: 323-467-4242
The below parts of the Common Technical Document (“CDT”) Modules filed in connection with Biologics License
Application for ropeginterferon alfa-2b-njft (Application No. 761166 by PharmaEssentia Corporation).
EuCyt Laboratories, LLC’s (“EuCyt”) Clinical Trials Application for COVIXO: (1.) The investigational new drug
application (IND) as specified by FDA regulations [21 U.S.C. 355(i); 42 U.S.C. 262(a)(3); 21 CFR Part 312]; and ETC
As permitted by the Freedom of Information Act (FOIA), I am hereby requesting Form FDA 483 and corresponding
Establishment Inspection Report: Genesis Alkali LLC Green River, WY End Dates of inspection: 15 July 2021.
Pursuant to the Freedom of Information Act (FOIA), I hereby request the following: Any/all communications,
documents, reports to, from, or by David Sullivan, medical device investigator for Medical Device and Radiological
Health Operations Division 1-East within FDA's Office of Regulatory Affairs, which contain any of the following terms:
Lyme, Lyme disease, ELISA, EIA, ETC
Our project group needs the monthly Orange Book data for year 2017, please.
The Inspectional Request Memorandum, dated 4/28/2021, issued by FDA CDER's Office of Manufacturing Quality, which
is listed as Attachment 1 of the Establishment Inspection Report included as an attachment in my request, titled
"Valisure - FEI - 3012063246 For Cause memo" and is listed as being 11 pages long. (See page 1 and page 55 of the PDF
for reference).
The FDA Letter of No Objection dated December 21, 2021 issued to Revolution Company for their polymer Linear low
density polyethylene (LLDPE).
I would like to request a list of all Accelerated Approvals - including New Drug Application (NDA), Biologics Licensing
Application (BLA), and supplements - granted between June 30, 2021, and January 26, 2022.
The FDA Letter of No Objection dated May 5, 2020 issued to Arpema Plásticos SA de CV for their Linear low density
polyethylene (LLDPE), Low density polyethylene (LDPE), High density polyethylene (HDPE), or Polypropylene (PP)
polymers.
Summary basis of approval for cisplatin NDA 018057
Pursuant to the Freedom of Information Act (FOIA, 5 U.S.C. § 552), and the FOIA regulations administered by the U.S.
Food and Drug Administration (FDA) at 21 C.F.R. Part 20, we hereby request a copy of: • All chemistry and toxicology
memoranda related to Food Contact Notification (FCN) 2142; and • A copy of Food Contact Notification (FCN) 2142
and all other FDA internal review memoranda associated with the FCN
Please provide the document(s) supporting the voluntary withdrawal of Antizol-Vet (NADA 141-075) by Paladin Labs
(USA), Inc.
All meeting minutes taken by FDA-CVM at the AAFCO 2022 Midyear Meeting
All presentation documents associated notes for FDA-CVM employee William Burkholder's speech/presentation given at
the AAFCO 2022 Midyear Meeting 01.18.22-01.24.22
Recs re 1)The performance of contractors or subcontractors awarded COVID countermeasure contracts by the
Department of Health and Human Services, including the Assistant Secretary of Preparedness and Response and the
Biomedical Advanced Research and Development Authority, for the development and manufacturing of COVID
medicines, vaccines, therapies, syringes, respirators and other medical supplies for the response to the COVID-19
pandemic. 2)Any communications with the same COVID countermeasure contractors related to the FDA and/or
performance on the pandemic contracts in question. 3) Any communications or records related to the FDA history of the
COVID countermeasure contractors as it relates to the award of these contracts, both before and after award. Records
related to items 1, 2 and 3 should involve, but not be limited to, the attached contracts.
for Medical Devices & Rad Health inspection of Boston Scientific Corporation ending 11/18/2021 at the location in Saint
Paul MN, United States.
Please provide the document(s) supporting the voluntary withdrawal of Mylan Institutional, LLC's veterinary fomepizole
product (ANADA 200-472). Please also provide documents supporting the safety, efficacy, and bioequivalence of this
product.
for Animal Drugs & Feeds inspection of Siegfried Ltd ending 06/14/2019 at the location in Zofingen, Switzerland. Please
for Human Drugs inspection of Unither Manufacturing LLC. ending 10/15/2021 at the location in Rochester NY, United
for Human Drugs inspection of Zogenix, Inc. ending 07/15/2021 at the location in Emeryville CA, United States. Please
I am seeking all forms and supporting documents provided with Bayer Healthcare Consumer Care's request to list
patents in Orange Book in connection with NDA no. 213872 for Astepro Allergy and Children's Astepro Allergy, including
but not limited to forms 3542 and 3542(a).
All e-mail communications regarding the FDA decision to revise the authorizations of monoclonal antibodies to treat
COVID-19 infection.
https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-limits-use-certain-
monoclonal-antibodies-treat-covid-19-due-omicron
Please provide documents reflecting any studies indicating that monoclonal antibody treatments for COVID-19 are
ineffective for treating the omicron variant of COVID-19.
ANDA 207382, topiramate, by Zydus, approved 11/24/2017
All contents of K201081, Device Name: AltaTrack equipment, AltaTrack Guidewire, AltaTrack Catheter, Manufacturer:
Philips Medical System Nederland B.V.
Copies of Form 483s issued by the CDER Office in November 2021:
IRBs both in the United States and outside the United States that received such notices dated from December 1 to 31,
This request relates to records of the U.S. Food and Drug Administration (“FDA”), specifically, copies of all files, reports,
records, sampling and testing data, testing results, internal communications, letters, emails, memos, citations and
warning letters, related to any inspections and investigations made related to Real Water brand drinking water and its
owner, Brent Jones, at its facilities in Henderson, Nevada and Mesa, Arizona.
ANDA 213948 12/13/2021 Approval Letter FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE please email to:
michele.crawley@cipla.com
Approval (NDA) and adverse event documents for nystatin and triamcinolone (equivelent to NDC 00472-0155-60)
Copies of FDA's chemistry, toxicology, and environmental review memoranda for Food Contact Notifications (FCN) 2147
and 2162.
Kindly please provide copies of the following FAERS ID cases: 19626819, 19510441, 19301250, 19086481, 19086480,
19086469
Copy of the 483 for the Aug 12, 2019 - Aug 16, 2019 (5 days) inspection of Strong Fertility Center [Rochester / United
States of America] 500 Red Creek Dr #220, Rochester, NY 14623, USA. This inspection pertains to biologics.
Copy of the 483 for the Aug 12, 2019 - Aug 21, 2019 (10 days) inspection of The Dragontree Apothecary LLC [Portland /
United States of America] 12011 NE Marx St, Portland, OR 97220, USA. This inspection pertains to human drugs.
Copy of the 483 for the Aug 5, 2019 - Aug 16, 2019 (12 days) inspection of Reproductive Technologies, Inc. [Berkeley /
United States of America] 2115 Milvia St Fl 2nd, Berkeley, CA 94704, USA. This inspection pertains to biologics.
Copy of the 483 for the Jul 15, 2019 - Jul 17, 2019 (3 days) inspection of Cosmelab Co Ltd [- / Korea (Republic of)]
Gangnam Cl B/D, 42 Teheranro32-Gil Gangnam Korea (the Republic of). This inspection pertains to human drugs.
Report and/or the MDSAP Noncomformity Grading and Exchange Form (NC) for the inspection of Conmo Electronic Co.
Ltd., Shenzhen, China, end date 11-10-2018. FEI# 3010968402. This inspection pertains to medical devices.
Report and/or the MDSAP Noncomformity Grading and Exchange Form (NC) for the inspection of Remax Medi-Tech
(Shenzhen) Corporation, Shenzhen, China, end date 12-05-2018. FEI# 3012234230. This inspection pertains to medical
devices.
Report and/or the MDSAP Noncomformity Grading and Exchange Form (NC) for the inspection of SHENZHEN JIAN FENG
ELECTRONIC TECHNOLOGY CO., LTD., Shenzhen, China, end date 11-15-2018. FEI# 3009488655. This inspection pertains
to medical devices.
Report and/or the MDSAP Noncomformity Grading and Exchange Form (NC) for the inspection of Shandong Intco
Medical Products Co., Ltd, Qingzhou, China, end date 12-01-2018. FEI# 3011391433. This inspection pertains to medical
devices.
Regulatory Assessment of Biomat USA, Inc Located at Laredo TX United States FEI Number: 2072896 held on
01/06/2021.
Regulatory Assessment of CSL Plasma Inc. Located at East Point GA United States FEI Number: 3013773498 held on
01/07/2021.
Regulatory Assessment of CSL Plasma, Inc Located at Lawton OK United States FEI Number: 1676742 held on
01/11/2021.
Regulatory Assessment of Vertex Pharmaceuticals, Inc. Located at Boston MA United States FEI Number: 1000513211
substantive summary for K210009, 510(k) for CenterPoint LLC's Guiding Catheter.
Please provide a copy of each Health Hazard Evaluations (HHEs) and Health Risk Assessments (HRAs) completed during
the specified time frame for any/all drugs, biologics, consumer products and/or devices assessed/evaluated during the
foregoing time frame
12.31.2020
I would like all records for the 14th production of 2019-1704.
All feed additive petitions received by FDA-CVM for the animal feed/pet food term "Dried Black Soldier Fly Larvae"
INSPECTION DATA
format) for Human Drugs inspection of Bristol-Myers Squibb Holdings Pharma Ltd. Liability Company ending 07/12/2021
at the location in Manati PR, United States. Please send documents as email attachments.
for Human Drugs inspection of Bioscience Laboratories Inc ending 07/29/2016 at the location in Bozeman MT, United
States. The Response (in electronic format) for Human Drugs inspection of Bioscience Laboratories Inc ending
07/29/2016 at the location in Bozeman MT, United States. Please send documents as email attachments.
510(k) 970639 summary
All memorandums, documents, notes, technical project lead files (including all documents from each discipline review),
acceptance review files, filing review files, and reviews relating to the marketing denial order and any other material
relating to PMTA0001018 – PD1 -PD91 (inclusive) and PMTA0001292 – PD1 -PD5 (inclusive). The organization
requesting these documents is the owner of these PMTA files.
Copies of FDA's chemistry, toxicology, and environmental review memoranda for Food Contact Notifications (FCN) 54,
257, 418, 456, 491, 508 and 1492.
Establishment Inspection Report (EIR) for Inspection ID 1142913 of Cactus Botanics CA Inc (located in City of Industry,
CA, USA).
demyelinating polyradiculoneuropathy, demyelinating polyneuropathy, Guillain-Barre syndrome, ETC
Premarket Approval submission number P160053 for Magtrace TM And Sentimag(R) Magnetic Locatization System.
Under the Freedom of Information Act as amended, please provide all records previously disclosed regarding the 1982
Tylenol poisoning cases in Chicago.
Premarket Notification 510(k) submission number K103429 for Siemens Biograph mMR system.
Full set of FOIA requests submitted to FDA since January 1995, including (1) a control number that uniquely identifies
each FOIA request; (2) requester’s identity (both person and company); (3) record date; (4) close date; (5) target firm or
individual; (6) outcome of the request; (7) a short description of which agency records were requested; (8) the FDA
offices and the divisions to which the request is pertinent
K212797 ETC
We need a copy of the Establishment Inspection report for and Inspection performed on 11/2/2017 our North Seattle
Blood Collection Center - 10357 Stone Ave N North Seattle Ctr Seattle, WA 98133 . Thank you Catherine Trapp
Compliance Specialist
VAERS report for vaccination administered in December of 2015
We are requesting the full form 483, Establishment Inspection Report, and complete responses from Pyramid
Laboratories (FEI 1000160734) located in Costa Mesa, CA for the most recent 3 FDA inspections. According to the FDA
inspection database, these are dated: 06/05/2015, 04/02/2018, and lastly 09/29/2021.
All records related to NeuroLogix Technologies, Inc.'s product C3 Logix concussion app for iPad - including investigation
materials, FDA approval applications, communications between the FDA and NeuroLogix about this product.
Copy of the 483 for the inspection of Leila Chaychi, M.D. [San Carlos / United States of America] 1660 San Carlos Ave,
San Carlos, CA 94070, USA beginning 10/12/21 and ending 10/22/21. This inspection pertains to HUMAN DRUGS.
Copy of the 483 for the inspection of Norbrook Laboratories Limited [- / United Kingdom of Great Britain and Northern
Ireland] 7 Shepherds Dr, Carnbane Industrial Estate, Newry BT35 6JQ, UK beginning 10/04/21 and ending 10/15/21. This
inspection pertains to ANIMAL HEALTH.
Copy of the EIR for the inspection of Leila Chaychi, M.D. [San Carlos / United States of America] 1660 San Carlos Ave,
San Carlos, CA 94070, USA beginning 10/12/21 and ending 10/22/21. This inspection pertains to HUMAN DRUGS.
In accordance with Freedom of Information Act procedures, GRAS Associates, LLC requests any information within
CFSAN related to communications with the company BioNascent regarding their replicant proteins and manufacturing
process using insertion of human genes into microorganisms.
Copy of the EIR for the inspection of Norbrook Laboratories Limited [- / United Kingdom of Great Britain and Northern
Ireland] 7 Shepherds Dr, Carnbane Industrial Estate, Newry BT35 6JQ, UK beginning 10/04/21 and ending 10/15/21. This
inspection pertains to ANIMAL HEALTH.
FDA’s internal correspondence, review and memorandums including the application submitted for Turning Point Brands
Inc’s Premarket Tobacco Application (PMTA) for ENDS products which received a marketing denial order (MDO) in 2021.
for Human Drugs inspection of BMC 1092, Inc dba SOLO Laboratories, Inc. ending 11/10/2021 at the location in
Broadview IL, United States. Please send documents as email attachments.
FDA’s internal correspondence, review and memorandums related to American Vapor Inc’s Premarket Tobacco
Application (PMTA) for ENDS products which received a marketing denial order (MDO) in 2021 and products which
received a refusal to file (RTF) in 2021/22
K182964
for Human Drugs inspection of Daniel Tarquinio, DO ending 11/05/2021 at the location in Norcross GA, United States.
for Human Drugs inspection of Fresh Farms LLC ending 11/11/2021 at the location in Montebello CA, United States.
K210142, Fiber Dust, by Quanta System Spa.
Final report of American Vapor Inc and Artisan Vapor Franchise LLC’s inspection conducted by Danielle Lyke at 10710 N
Stemmons Fwy, Dallas TX 75220 in November 2021.
for Human Drugs inspection of Micron Inc ending 11/05/2021 at the location in Wilmington DE, United States. Please
Unredacted copies of FDA's chemistry, toxicology, and environmental review memoranda for Food Contact Notification
186.
Unredacted copies of FDA's chemistry, toxicology, and environmental review memoranda for Food Contact Notification
2095.
1. Copy of the disclosable portion of the most recent full 510k for Philips IntelliSpace Perinatal (K173941), formerly
Philips OB TraceVue (K970456), formerly Hewlett Packard (Agilent) Series 5008 TraceVue. 2. Copy of the disclosable
portion of the initial full 510k for Philips IntelliSpace Perinatal (K173941), formerly Philips OB TraceVue (K970456),
formerly Hewlett Packard (Agilent) Series 5008 TraceVue.
for Medical Devices & Rad Health inspection of Becton Dickinson Caribe LTD ending 11/23/2021 at the location in
Juncos PR, United States. Please send documents as email attachments.
for Medical Devices & Rad Health inspection of MedTorque Inc. ending 11/19/2021 at the location in Elmhurst IL, United
for Medical Devices & Rad Health inspection of Vivorte, Inc. ending 11/23/2021 at the location in Louisville KY, United
for Human Drugs inspection of Berkshire Sterile Manufacturing, Inc. ending 10/15/2021 at the location in Lee MA,
format) for Human Drugs inspection of Anup D. Patel, M.D. ending 01/30/2018 at the location in Columbus OH, United
All administrative processing records (including notes, emails, and memos) related to FDA FOIA request Control #2021-
5683 that are not protected by attorney-client privilege. Please be sure to include all attachments to any emails
Any and all records and information related to Stuart Stark, M.D. seeking approval for outside activity, including any
HHS-520 forms, and any approval or rejection by the FDA approving or rejecting Dr. Stark's ability to serve as a retained
medical expert in civil litigation
VAERS report
VAERS report
VAERS report
VAERS report
VAERS report
VAERS report
VAERS report
VAERS report
VAERS report
VAERS report
VAERS report
(Rq. #1) Copies of Form 483s issued to the following DEVICE companies from November 1-30, 2021.
(Rq. #1) Copies of Form 483s issued to the following DRUG companies from November 1-30, 2021.
Copies of Form 483s issued to the following CLINICAL INVESTIGATOR from November 1-30:
Seek pursuant to 5 USC 552 official Fda close out letter for Scientific Protein Laboratories relating to its January 20,
2011 Warning Letter WL 11-09 signed by Gerald J Berg Please include relevant dates per such letter
VAERS report
VAERS report
VAERS report
VAERS report
VAERS report
VAERS report
VAERS report
VAERS report
VAERS report
VAERS report
VAERS report
VAERS report
VAERS report
VAERS report
VAERS reprot
We request all documents and information produced in response to the following previous FOIA requests - 2021-2478,
2021-7334, 2021-5913, 2021-7188, 2021-5891, 2021-5161, 2021-8319, 2021-8275, 2021-6381, 2021-6056, 2021-6057,
2021-4817, 2021-6213, 2017-1493, 2021-5892, 2021-5971, 2021-7764, 2021-7339 and 2021-7979.
I am seeking all forms and supporting documents provided in connection with Bayer Healthcare Consumer Care's
request to list patents in the Orange Book in connection with NDA no. 213872 for Astepro Allergy and Children's Astepro
Allergy, including but not limited to forms 3542 and 3542(a).
ANDA 203433 FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE Approval Letter dated 12/17/2020 send via
email to michele.crawley@cipla.com
All documents relating to Innova Medical Group’s (IMG) application to the NIH Independent Test Assessment Program
(ITAP) for its COVID-19 assay, including all emails, texts, memoranda, correspondence, and notes of calls or meetings
within FDA and/or between FDA and NIH, relating to the NIH decision to reject IMG from ITAP.
Foreign Remote Regulatory Assessment - El Pez Volador - Honduras January 18 - 21, 2022 All finding to take corrective
actions
Summary Basis of Approval Package for NDA 021624 (Orginal-1) of RLD drug product held by Mylan Institutional LLC.
Please provide the summary basis of approval documents for Lanreotide Injection from Invagen Pharmaceuticals, Inc.
under NDA # 215395. If there are more detailed documents related to chemistry, medical and clinical pharmacology
reviews, then please provide those documents as well.
concerning the studies performed by or for the Application Holder concerning the effectiveness of the product: Xiaciato
(Clindamycin Phosphate) Vaginal Gel 2% - N215650
IND 66,943
FDA approval letters for the following abbreviated new drug applications (ANDAs) for the reference product entacapone
(Comtan): ANDA No. 202394 ANDA No. 212601 FDA approval letters for the following ANDAs for the reference product
carbidopa; entacapone; levodopa (Stalevo): ANDA No. 203424 ANDA No. 090833 ANDA No. 090786 ANDA No. 213212
I would like to request a list of all Accelerated Approvals - including New Drug Application (NDA), Biologics Licensing
Application (BLA), and supplements - that have been withdrawn or revoked between January 1, 1992 and January 27,
2022
Communications, responses and alerts between USFDA and Amazon.com Inc. referred to in FDA letter to Andy Jassy,
CEO, Amazon.com, Inc, dated July 26, 2021, CMS # 608717 as more fully described in attached letter request.
I am seeking adverse event records from a clinical trial NCT02672917 involving MVT-5873, also known as HuMab-5B1.
Regarding the prescription antiperspirant Hypercare that was manufactured by Sonar Products Inc. and sold by Stratus
Pharmaceuticals, I am requesting (1) any documentation reflecting the FDA requesting said companies to stop
distributing the unapproved drug Hypercare, (2) any documentation from the FDA or said companies to the FDA
regarding Hypercare's status/legal ability to be distributed, etc
The appeals log or spreadsheet record showing appeals logged by FDA FOIA department in the month of December
2021
We seek the following documents concerning Spectrum Pharmaceuticals, specifically related to the site inspection
conducted in May and/or June 2021 in Irvine, California: - All Form 483s - Any summaries of Establishment Inspection
Reports (Summary EIRs)
Zimmer Versys recall
All FDA documents discussing and referencing the facility inspection of AniCell BioTech, LLC (145 S. 79th St, Suite 9,
Chandler, AZ 85226) between 10/19/21 and 10/29/21 including but not limited to (a) the Form 483, (b) any notes taken
by the FDA inspectors during the inspection, (c) copies of any documents collected, etc
• Any internal communications related to FDA’s Closer to Zero initiative, from January 1, 2019, to the present; • All
records of communication with or relating to baby food manufacturers Plum, PBC; Campbell Soup Company; Sun-Maid
Growers, Beech-Nut Nutrition Company, Gerber Products Company; Nurture, Inc.; Hain Celestial Group, Inc.; Sprout
Foods, Inc.; and Walmart Inc. (“baby food manufacturers”), regarding the presence of heavy metals in baby and toddler
foods etc
Copies of the 510K Filings for the following: all documents Heartflow filed for a 510K premarket application to the FDA
to add advanced anatomic assessment and plaque evaluation to the HeartFlow FFRct Analysis product. Applicant:
Heartflow, Inc.
Copy of the disclosable portions of all EIRs, 483s, Remote Regulatory Assessment reports, Form 4003's, and Form
4003a's, for Rentschler Biopharma, located in Laupheim, Germany, from 02/01/2021 - Present.
Copy of the disclosable portions of the case detail forms for the following 13 FAERS Cases: 19795918, 19829743,
19767324, 19518536, 19582995, 19593190, 19614503, 19860570, 19905510, 19608827, 19826356, 19878223,
19901024.
Copy of the disclosable portions of the case detail forms for the following VAERS cases for Ervebo: 1440473, 1494383,
1536862, 1704763, 1713215, and 1740818.
Human adverse event drug MedWatch reports for the following Case IDs:12436789 12442374 12451449 12478287
12497430 11479812 11481025 11694803 11816144 12057615 12320377 12351728
Inventory of clinical investigators recorded in the Bioresearch Monitoring Information System (BMIS) as having been
inspected since January, 2000 to present, including the INVN and FEI numbers, investigator name, and investigator
location, address (street address, city, state, zip code, and country) and inspection date(s). Please provide the response
in CSV or other electronic format; Relevant Centers are CDER, CBER and CDRH.
format) for Human Drugs inspection of VistaPharm, Inc. ending 01/16/2018 at the location in Largo FL, United States.
Please provide the package insert, container label, and chemistry review for NDA #020166 (Sodium Thiosulfate 250
mg/mL) approved on 02/14/1992. The sponsor of the NDA #020166 is US ARMY Office Surgeon General and marketing
status is indicated as discontinued in Drugs@FDA: FDA-Approved Drugs.
The comment that FDA received in response to 85 FR 46126 stating that “FDA should restrict the use of any bulk drug
substance on the 503B Bulks List in combination with one or more other active ingredients, unless there is specific
clinical need for the combination product, as determined through FDA evaluation.’’
The following items are requested: (1) the Letter of No Objection dated 12/21/2021 granted to Arpema Plásticos SA de
CV for its Linear low density polyethylene (LLDPE), Low density polyethylene (LDPE), High density polyethylene (HDPE),
or Polypropylene (PP) (Recycle # 229); and (2) the preceding post-consumer recycled plastics submission filed by
Arpema Plásticos SA de CV for its Linear low density polyethylene (LLDPE), Low density polyethylene (LDPE), High
density polyethylene (HDPE), or Polypropylene (PP) process on which the LNO is based.
The following items are requested: (1) the Letter of No Objection dated 12/21/2021 granted to the Revolution
Company for its Linear low density polyethylene (LLDPE) (Recycle # 259); and (2) the preceding post-consumer recycled
plastics submission filed by the Revolution Company for its Linear low density polyethylene (LLDPE) process on which
the LNO is based.
Carcinogenicity study reports or summaries (including number of animals used) submitted by sponsors in support of
approved New Drug Applications (NDAs): 1. 210795 a.Study # G00576: 2 Year Oral Gavage Carcinogenicity Study with
TQ in mice etc
I request adverse events associated with Aduhelm, aducanumab and aducanumab-avwa in Excel/CSV format.
I request any and all information related to the following adverse events: 19787426, 20023535, 19882791, 20055337.
I'm requesting access to and copies of the following: - A copy of the FAERS report, and all associated documents, for
FAERS case ID #: 19073513 Please provide the records in a digital format, if possible.
clinical study reports in your agency’s database comparing: • Any type of prothrombin complex concentrate versus
placebo, no interventions, or other interventions utilised in patients on any kind of oral anticoagulation treatment.
- All documentation between and communication with the GID Group Inc. at 578 West Sagebrush Court, Louisville, CO
80027. - All documentation between and communication with the GID Group Inc. at 4655 Kirkwood Court, Boulder, CO
80301. - All documentation regarding 510(K) Number: K120902.
Any and all communications, documents, notes, and memoranda that were created as a result of any and all serious
adverse events reported to the FDA and/or any such reports made through the Safety Reporting Portal to the FDA for
the following supplements: • Standard Process General Health Daily Fundamentals (Dietary Supplement – 60 packs) •
Standard Process SP Detox Balance, Chai Flavored, Dietary Supplement 10000
Recs re FDA visit to Waymon Farms, Inc., in Somerton, Arizona
Requesting the FOI summary for

1. NADA# 012-204 (Depo-Medrol) and,
2. NADA# 012-198 (Vetalog Parenteral)
EMAIL RECORDS (REFERRAL FROM CDC)
Documents, emails, and data, relating to the use of “Rx only” labeling on Pfizer-BioNTech COVID-19 Vaccine. Please see
the attached photo for reference.
FDA email conversations regarding COVID treatments i.e. COVID 19 vaccines, ivermectin (being banned),
hydroxychloroquine (being banned) and now the monoclonal antibodies (being banned) between members in the Biden
Administration, Dr. Fauci and any member of the FDA. Data/information in the decision making to ban other treatments
vs the COVID 19 vaccines since none of the treatments have been against the Omnicron variant.
The agency's approval package for Pfizer's COVID-19 vaccine Comirnaty® (COVID-19 Vaccine, mRNA)
I am requesting records already released under control # 2021-7990. The request is for a copy of the case report for a
75 female who died after experiencing Amyloid-related imaging abnormalities (ARIA) while taking
Aduhelm/aducanumab. The case is listed in FAERS under the number 197874426.
I am requesting the following: Adverse events reported to FAERS from June 7, 2021 through today for Aduhelm,
aducanumab and/or aducanumab-AVWA.
I am requesting previously released files under the control number 2021-8083. The request is for the FAERS case
reports for aducanumab with the following Case IDs 19882791 19771050 19787426 19726309 19615330 19810715.
Kindly request a copy of the Drug Quality Assurance inspection report (#1125132) for the Millmount Healthcare Ltd.
facility (FEI 3004764499) conducted on 12/13/2019.
Firm Address: Unit 4, Donore Road Industrial Estate, Drogheda, Ireland.
Thank you
a complete case safety report of an adverse event "acute leukemia " of evolocumab, whose case ID is
12727644,including at least how long the event happened after first use of evolocumab, when the patient died, the
relationship of the event with evolocumab and why.
Waterstone Pharmaceuticals Co., Ltd. Tianmen, China FEI Number:
3010777606 End Dates of inspection: 29-09-2021 Project Area: Drug Quality Assurance District Decision: VAI I confirm
that Clarivate Analytics will be charged accordingly by FOI for this request, however please contact me if the charges
exceed $ 200.
brolucizumab (Beovu), Biologics License Application (BLA) 761125.
Pfizer Asia Manufacturing Pte Ltd. Singapore, FEI Number: 3013343601 End Dates of inspection: 10/27/2021 Project
Area: Drug Quality Assurance District Decision: VAI I confirm that Clarivate Analytics will be charged accordingly by FOI
for this request, however please contact me if the charges exceed $ 200. Thanks for your prompt attention to this
request.
Xinxiang Tuoxin Pharmaceutical Co. Ltd. Xinxiang, China FEI Number: 3008259785 End Dates of inspection: 10/22/2021
Project Area: Drug Quality Assurance District Decision: OAI I confirm that Clarivate Analytics will be charged accordingly
Copy of the disclosable portions of the 483 for the 10/22/2021 inspection of Luminex, located in Northbrook, IL. This
inspection relates to medical devices.
EIR and 483 for September 2020 inspection of: KBI Biopharma, Inc. 1101 Hamlin Road Durham, North Carolina, 27704
USA
Establishment Inspection Report for Freudenberg Medical, Baldwin Park, CA , FEI 3008581151
Establishment Inspection Reports for FDA inspections of Mipharm S.p.A., Milan Italty, FEI 3002807647. Human Drug
manufacturer.
GRANULES FORM 483 FOR VIRGINIA PLANT 3 OBSERVATIONS
syndrome, subacute inflammatory demyelinating polyneuropathy, Zika virus associated Guillain Barre syndrome after
receipt of Janssen COVID-19 vaccine
1) Listing of all INSPECTIONS since Monday, February 1, 2021 (in CSV format) with the following fields: FEI Number,
FDA483, Full Name, District, Center, INSPECTION REASON 2) Listing of releasable inspection CITATIONS (from FDA's
FACTS database) for each company since Monday, February 1, 2021 in CSV format with the following columns:
for Animal Drugs & Feeds inspection of Belcher Pharmaceuticals, LLC ending 11/15/2021 at the location in Largo FL,
for Human Drugs inspection of King Bio Inc. ending 08/12/2021 at the location in Asheville NC, United States. Please
for Human Drugs inspection of TAILSTORM HEALTH INC ending 07/21/2021 at the location in Chandler AZ, United
format) for Medical Devices & Rad Health inspection of Medtronic Xomed, Inc. ending 10/29/2021 at the location in
for Animal Drugs & Feeds inspection of Zhejiang Ruibang Laboratories ending 07/21/2016 at the location in Wenzhou,
China. The EIR (in electronic format) for Animal Drugs & Feeds inspection of Zhejiang Ruibang Laboratories ending
07/21/2016 at the location in Wenzhou, China. The Response (in electronic format) for Animal Drugs & Feeds
inspection of Zhejiang Ruibang Laboratories ending 07/21/2016 at the location in Wenzhou, China. Please send
format) for Human Drugs inspection of Macco Organiques Inc. ending 02/28/2020 at the location in Salaberry-De-
Valleyfield, Canada. The EIR (in electronic format) for Human Drugs inspection of Macco Organiques, s.r.o. ending
09/17/2014 at the location in Bruntal 1, Czech Republic. The EIR (in electronic format) for Human Drugs inspection of
Macco Organiques, s.r.o. ending 02/07/2019 at the location in Bruntal 1, Czech Republic. Please send documents as
email attachments.
Kimberly Clark’s Cottonelle Flushable Wipes product recall numbers F-0075-2021 and F-0076-2021
Please identify the three growers/Farms in the Romaine/Ecoli outbreaks A, B, C Based on the information indicating that
ill people in Maryland were exposed to romaine lettuce harvested in Salinas, California, FDA, with the assistance of staff
from the California Department of Public Health and the California Department of Food and Agriculture, immediately
deployed investigators to three farms in the Salinas area that were identified based on the traceback investigation.
Importer of Record (IOR), or Consignee; for entry-lines with submission or arrival dates between January 1 and January
31, 2022: 1) DUNS Number / Unique Facility Identifier (UFI) of: 080801169 2) Federal Tax ID Number (EIN) of:
822349285 3) FDA Establishment Identifier (FEI) of: 3014302990 ETC
since Friday, December 31, 2021. If the zipped files do not exceed 25 Megabytes, please send to
support@fdazilla.com, otherwise please send these on CD or DVD media to: Govzilla Inc., 9800 Dunmore Circle
Johnston, IA, 50131
I’m writing to request a (1) copy of the information that was submitted as part of 3M Company’s previous request for a
letter of no objection.
We are seeking documents regarding brolucizumab (Beovu), Biologics License Application (BLA) 761125.
Hi there! I'm looking for email communications between FDA and appropriate agencies/companies regarding the
October 2018 E. coli Romaine outbreak. This is the FDA's outbreak summary: https://www.fda.gov/food/outbreaks-
foodborne-illness/outbreak-investigation-e-coli-romaine-november-2018 Thank you!
We received an email that we were listed as the FSVP Importer on an entry/line of food and your D-U-N-S number was
not provided. We are looking for details as to which entry so we can follow up with our customs broker.
I am trying to track down a copy of underlying analysis, supporting data, and results that support the "Emerging
oncology drug targets in the 21st century: An FDA analysis."
Documents related to research with LSD, psilocybin or other psychedelics prior to 1968 and documents related to the
classification of LSD as an experimental drug in 1965
Please consider this a request for a copy of the 1/24/22 effective approval letter for ANDA No. 203053 for Efavirenz;
Emtricitabine; Tenofovir Disoproxil Fumarate (generic drug).
Any and all open or closed investigations concerning Mosaic Meadows, LLC or LaClare Family Creamery farming
operations.
Request to issue Establishment Inspection Report of Daicel Chiral Technologies Pvt Ltd of the inspection done in the
month of march 2019.
Requesting of RRA report conducted at Aspen Surgical Las Piedras, PR during above mentioned dates.
information about how the FDA decided to no longer recommend the use of monoclonal antibodies for the treatment
of mild to moderate COVID-19.
2021-8279
All documents regarding FAERS case ID # 19353149 (empaveli / pegcetacoplan)
All documents, including those contained in the file for ANDA No. 211538, approved on 12/15/2021, relating to FDA’s
decision to grant Eagle Pharmaceuticals, Inc. 180 days of exclusivity as the first to file for its vasopressin ANDA. This
request includes all documents related to FDA’s decision that Eagle has not forfeited the 180-day exclusivity.
List of inspections manufacturers of APIs (Active Pharmaceutical Ingredients) and FDFs (Finished Dosage Forms).
Preferred delivery format would be Excel. List would include, for each inspection, Company name, address, FEI,
Inspection start date, inspection end date, and was 483 issued (Y/N?).
weekly Enforcement Reports
list of companies participating in the FDA Foreign Supplier Verification Programs
Previously released records under the FOIA as per the listing provided for this request.
2003P-0278
2003P-0280
Requesting copy of Form 483 issued to Luminex Corporation after inspection of their Northbook (IL) facility during
October 2021 inspection. Requesting copies of any other Form 483s issued to Luminex Corporation during any
inspections of their facilities which took place from January 2021 to January 2022.
The STERIS Franklin Park facility located at 11457 Melrose Ave Franklin Park, IL 60131-1303, Establishment Identification
# 3007412809, was inspected by the U.S. FDA on September 21-23, 2021. We are requesting a copy of the
Establishment Inspection Report (EIR) for the inspection under the Agency’s proactive release procedure under 21 CFR
Part 20.64(d)(3).
February 1, 2022
FAERS REPORTS
All versions of preliminary reports, interim reports, and other unfinalized assessments of studies m-RNA-1273-P903 and
mRNA-1273-P911. Thank you.
I am requesting the supplemental new drug application (sNDA) review(s) for the human drug product CAPLYTA
(lumateperone tosylate). The sNDA review action date is December 17, 2021 for submission "SUPPL-5" and "SUPPL-6".
This is the sNDA that led to FDA-approval of the new indication, "Depressive episodes associated with bipolar I or II
disorder (bipolar depression) in adults, as monotherapy and as adjunctive therapy with lithium or valproate".
Individual Case Reports including a redacted narrative relating to Rituximab HYCELA for the following case numbers:
14036018 14036113 14267907 ETC
#K190292 #K201404
I would like a copy of the FDA filing for the Omnipod 5 Automated Insulin Delivery system including SmarAdjust
Technology clearance (K203774), Omnipod 5 Pod and Omnipod 5 App (K203768) and the Omnipod 5 SmartBolus
Calculator (K203772). Thank you
for Human Drugs inspection of Accupac, Llc ending 11/18/2021 at the location in Lakewood NJ, United States. Please
for Medical Devices & Rad Health inspection of Compass Health Brands Corp. ending 11/17/2021 at the location in
Brookpark OH, United States. Please send documents as email attachments.
for Medical Devices & Rad Health inspection of Fox Converting,Inc ending 11/19/2021 at the location in Green Bay WI,
for Medical Devices & Rad Health inspection of Halo Innovations, Inc. ending 11/19/2021 at the location in New York
for Medical Devices & Rad Health inspection of Kapstone Manufacturing LLC ending 11/16/2021 at the location in
Charlotte NC, United States. Please send documents as email attachments.
for Medical Devices & Rad Health inspection of Lifescience Plus, Inc. ending 11/16/2021 at the location in Mountain
View CA, United States. Please send documents as email attachments.
for Medical Devices & Rad Health inspection of Bose Corporation ending 11/12/2021 at the location in Framingham MA,
United States. The 483 (in electronic format) for Medical Devices & Rad Health inspection of 3-D Matrix, Inc. ending
11/17/2021 at the location in Newton MA, United States. Please send documents as email attachments.
for Medical Devices & Rad Health inspection of MAST Biosurgery USA Inc ending 11/19/2021 at the location in San
Diego CA, United States. The 483 (in electronic format) for Medical Devices & Rad Health inspection of Valencia
Technologies ending 11/17/2021 at the location in Valencia CA, United States. Please send documents as email
attachments.
Documents reflecting that the Vaccine Adverse Events Reporting System (VAERS) captures all deaths which occur
following COVID-19 vaccination.
Documents reflecting the percent of deaths reported to VAERS after COVID-19 vaccination that the Food and Drug
Administration (“FDA”) has concluded are likely causally related to receipt of a COVID-19 vaccine
Documents reflecting the percent of deaths reported to VAERS after COVID-19 vaccination that the Food and Drug
Administration (“FDA”) has concluded are likely not causally related to receipt of a COVID-19 vaccine.
Fallopian Tube Formula is claiming that their supplements can assist women get pregnant is they have medical
conditions that make it impossible to become pregnant without medical procedures (surgery or IVF procedures). Please
check to see if they are registered or if they need to be registered. Link to company's website:
https://fallopiantubeformula.com/
I'm looking for previously requested EIRs and 483s from Catalent's sites in Baltimore, Maryland and Harmans, Maryland.
The Synergy Health AST, LLC Saxonburg site located at 7225 N. Noah Drive, Saxonburg, PA 16056, FEI #3009882464, was
inspected by the FDA on July 8-16, 2021. The inspection resulted in zero form 483 observations. Our firm did not receive
a copy of the Establishment Inspection Report (EIR) prepared following the conclusion of the inspection. We are
requesting a copy of the EIR at this time.
We are the manufacturer who received the inspection. We would like to request an un-redacted version of our
establishment inspection report: FEI: 3015399803 Jabil Inc.; Monument , CO 80132 EI Start: 10/12/2021 EI End:
10/22/2021
510K SUMMARY
(1) Any and all policy manuals, memoranda or other documents which detail the process, standards or requirements for
commissioning or decommissioning inspectors which have been adopted or used by FDA since the initial publication of
the Regulatory Procedures Manual dated December, 2017 and which are used on FDA tobacco inspection contracts
since December, 2017 ETC
All contents of K# K121698, Device Name:NUPRO SENSODYNE PROPHYLAXIS PASTE WITH NOVAMIN, Manufacturer:
DENTSPLY INTERNATIONAL INC.
All contents of K#: K070854, Device Name: GC MI Paste PLUS, Manufacturer: GC America, INC.
Filed submissions, including all supporting documentation submitted therewith by applicants for 510-K Registration Nos.
K133724 and K861730.
Form FDA-483 issued to Dr. Nancy A. Krywonis, MD on 07/23/2021 at the conclusion of the Compliance Inspection. Also
to include response from Dr. Krywonis to FDA-483 and any response by FDA. The eNSpect Operation ID is 185746. The
firm's physical address is 4545 E 9th Ave Ste 420, Denver, CO, 80220-3904, US.
GIAPREZA (ANGIOTENSIN II ACETATE), EQ 0.5MG BASE/ML (Applicant Number # N209360) is approved on Dec 23, 2021.
Currently, Package insert for this strength i.e. 0.5 mg base/mL is not available in drugs@FDA or daily med. Requesting
Agency to provide the Package insert of GIAPREZA (ANGIOTENSIN II ACETATE), EQ 0.5MG BASE/ML.
Please provide the Summary Basis of Approval and Labels (Container, Carton, and Package Insert for all presentations),
for the RLD for Sterile Water for Injection, USP (Hospira NDA 018801).
CORR RE MCGUFF COMPOUNDING

Requesting records showing where Zinpro Corporation has been identified as FSVP Importer.
Unredacted review memoranda associated with FCN 2191, specifically, the chemistry and toxicology memoranda.
Zolmitriptan nonclinical juvenile toxicology/toxicokinetic, and toxicology-associated pharmacokinetic data. Including but
not limited to: NDA 21-450/S-008 post-market requirement (PMR) 2921-1 juvenile rat toxicology study; NDA 020768
and nonclinical Supplements; NDA 021450 and nonclinical Supplements; IND 053848 and nonclinical Supplements;
- All communications between FDA’s Center for Veterinary Medicine and the Association of Animal Feed Control
Officials (AAFCO) that include the term “frass,” from January 1, 2020 to present ETC
All communications between FDA’s Center for Veterinary Medicine and the Association of Animal Feed Control Officials
(AAFCO) that include the terms “black soldier fly larvae” or “BSFL,” from January 1, 2018 to present. All other
documents in possession of CVM that include the terms “black soldier fly larvae” or “BSFL,” from January 1, 2018 to
present.
The Animal Food GRAS Notice — designated AGRN No. 52 — submitted by Jiminy’s LLC on or about 11/15/2021,
including any appendices or supplemental information included with this Notice, and any other supplemental
information or documents FDA has received from third parties (including the sponsor) regarding the subject of this
Notice.
1. All minutes and/or transcripts of meetings conducted by the FDA regarding the drug DSUVIA. 2. All FDA
Adverse Event Reporting System (FAERS) reports regarding DSUVIA. 3. All communications with AcelRx regarding
human factors studies. etc
NDA 008975 - Efficacy supplement (sNDA) submitted in June 2021 to bring Cortrophin Gel back to market.
FD&C Red. No. 4 (21 CFR § 74.2304), D&C Red No. 7 (21 CFR § 74.2307),D&C Red No. 33 (21 CFR § 74.1333), D&C
Green No. 6 (21 CFR § 74.2206), EXT. D&C Violet No. 2 (21 CFR § 74.2602a), D&C Orange No. 4 (21 CFR § 74.2254),
D&C Red No. 34 (21 CFR § 74.2334), D&C Red No. 36 (21 CFR § 74.2336)
I am requesting under the Freedom of Information Act all information pertaining to the safety data of Pfizer BioNtTech
and Cormirnaty Covid-19 vaccine, including but not limited to the statistics on any adverse events and long term side-
effects, broken down by age groups, and broken down by the number of series of shots to by the number of boosters
received. etc
Please provide all data and information submitted by Moderna relating to the FDA review and approval of Spikevax. This
includes, but is not limited to, all safety and effectiveness data and information; all data and information in the
biological product file; and all ingredients.
I request the recent FDA Form 483 issued to the Luminex facility site in Northbrook, IL, United States. Our understanding
is that this form 483 was issued to Luminex in Oct 2021 and that’s what we are requesting. The site address is: 4088
Commercial Ave, Northbrook, IL, 60062-1829
All meeting minutes taken by FDA-CVM at the AAFCO 2022 Midyear Meeting
All response letters and records provided for FOIA requests, 2021-330, 2021-333, 2021-3026, 2021-3481
FDA-CVM employee William Burkholder's speech/presentation given at the AAFCO 2022 Midyear Meeting 01.18.22-
01.24.22
PA 19522 12.01.21-01.31.22
and copies of, the FDA’s November 1, 2016 meeting minutes that the FDA sent to ChemoCentryx concerning a Type C
meeting pertaining to ChemoCentryx’s drug avacopan (formerly CCX168 and now TAVNEOS), etc
All 483 letter thats have been conducted by Yvins Dezan
All communications (no matter the form), reports, memos, records, voicemails, text messages, correspondence, warning
letters, sent or received to CDRH Allegations, including but not limited to the following FDA employees: Dr. Jeff Shuren
Jeff.Shuren@fda.hhs.gov; Erin Keith Erin.Keith@fda.hhs.gov; Ken Skodacek Ken.Skodacek@fda.hhs.gov; or Paola Barnett
Paola.Barnett@fda.hhs.gov regarding Oxygen Health Systems, LLC; Hyperbaric Pro LLC; Zen Earth; Autism Defeated; or
The Truth Behind Cancer Store
All communications (no matter the form), reports, memos, records, voicemails, text messages, correspondence, warning
letters, sent or received to FDA or CDRH Allegations, including but not limited to the following FDA employees: Dr. Jeff
Shuren Jeff.Shuren@fda.hhs.gov; Erin Keith Erin.Keith@fda.hhs.gov; Ken Skodacek Ken.Skodacek@fda.hhs.gov; or Paola
Barnett Paola.Barnett@fda.hhs.gov regarding Restore Hyper Wellness + Cryotherapy; Restore Hyper Wellness; Restore
HyperWellness; or any similar abbreviated name of the full business name; including any of the following search terms:
hyperbaric; oxygen concentrator; Vitaeris 320; Oxy-Flow, OxyFlow; Oxy Flow; Oxy-Air, OxyAir, Oxy Air, misbranded,
adulterated, Nicole Welch, Oxygen Health Systems, NFPA 99, Chapter 14.
EMAILS RE ADUHELM DUNN, WOODCOCK, HAHN, ETC
1. FAP 9M4673 – Seeds for Sprouting 2. FAP 9M4682 – Molluscan Shellfish
All final assessments, analyses, or research productions used by the FDA in
determining whether to approve Aduhelm
All email communications (including emails, email attachments, complete email

chains, and calendar invitations) sent by the current and former members of the
Peripheral and Central Nervous System Drugs Advisory Committee listed below
regarding Biogen or Aduhelm (aducanumab).
510(k) K193006 Device Name MagVenture TMS Therapy – For Treatment Of OCD, MagVenture TMS Therapy System
Tonica Elektronik A/S
Dear Sir or Madam, I am requesting a copy of the Remote Regulatory Assessment report for Passy-Muir, Inc. (Irvine, CA)
with Officer Sarah Hassas, that took place from February 2, 2022 - February 3, 2022. Thank you in advance. Best
Regards, Ms. Trina Diep
FCN No. 1617 Dear Sirs, We would like to make a FOIA request regarding Food Contact Notification No. 1617 (Klueber
Lubrication). We kindly ask for non-confidential information (incl. food master files) related to the above mentioned
FCN.
File numbers - 2021-4970, 2021-5246, 2021-5256
orphan designation status for treatment of chronic myeloid leukemia on approximately 12/23/2020.
motor axonal neuropathy, acute motor-sensory axonal neuropathy, etc
Hi, I would like to request the Form 483's issued during the 10/27/20 and 10/15/21 inspections of Berkshire Sterile
Manufacturing facility located in Lee, MA. Also, I'd like to request the EIR issue following the 10/15/21 inspection. Thank
you
Nanocopoeia, LLC’s nilotinib oral tablets orphan designation status for treatment of chronic myelogenous leukemia on
approximately 5/28/2020.
K212237
file numbers 2021-4039, 2021-4287, 2021-4363
file numbers 2021-4447, 2021-4529, and 2021-4849
Any and all records maintained by the U.S. Food and Drug Administration Center for Devices and Radiological Health,
including memoranda, draft memoranda, reports, email communications, email chains, research, studies, testing, and
other communications exchanged with (1) National Health Information Sharing & Analysis Center and (2) MedISAO that
contains the following KEY WORDS: (1) Sensitive Compartmented Information Facility (2) SCIF (3) Emerging Threats
etc
I am requesting FDA's decision memo and FDA's classification memo for an inspection of Valisure in New Haven,
Connecticut, that ended July 6, 2021. Please send the response electronically if possible and please send the memos as
they are ready if they aren't ready at the same time. Thank you
FOIA 2021-5897
Minutes from Biogen Inc's Type C meetings with the FDA in June 2019, and on 10-21-19 regarding aducanumab. Or
other documents, memoranda, emails, correspondence, meeting notes and minutes, presentations, i.e., powerpoint
documents relating to aducanumab
email or other communications between Brad Kimberly, the FDA's director of social media, to executives, managers, or
other employees at Twitter and/or Facebook and/or its subsidiary Instagram and/or Google and/or subsidiary YouTube
regarding COVID and and/or Sars-Cov-2 etc
All reports of adverse effects on any Drug and Medical Device from Judge Rotenberg Center, 250 Turnpike Street,
02021, Canton Massachusetts.
(d Conrad, A. Proprietary Name Review for (IND 126360). Silver Spring (MD): FDA, CDER, OSE, DMEPA (US); 2020 OCT
19. Panorama No. 2020-39466751.)
Please provide the entire 510(k) submission for following: (1) K200404 & (2) K193601
Requester seeks the following: 1. A copy of the investigation new drug application submitted by BioMarin
Pharmaceutical regarding an investigational AAV5-phenylalanine hydroxylase (PAH) gene therapy known as BMN 307
(“BMN 307”). etc
We seek records regarding the application process for approval of Aduhelm by the FDA, including communications
between the FDA and Biogen regarding the Biologics License Application (“BLA”) for Aduhelm, from July 8, 2020 through
June 7, 2021, ETC
We seek the following documents concerning Spectrum Pharmaceuticals, specifically related to the Irvine, CA plant
inspection in or around May 2016:(i) All Form 483s (ii) Spectrum's responses to any 483s (iii) Any Establishment
Inspection Reports (EIRs) (iv) The Complete Response Letter (CRL)
Copy of the 483 for the May 27, 2019 - May 31, 2019 (5 days) inspection of CGA Limited [Port of Spain / Trinidad and
Tobago] Eastern Main Road, Port of Spain, Trinidad and Tobago. This inspection pertains to human drugs.
Copy of the 483 for the Jun 24, 2019 - Jun 28, 2019 (5 days) inspection of Sunstar Guangzhou Ltd. [Guangzhou / China]
Modern Industry Centre, Blk D F/5; 203 Conbo Avenue Guangzhou China. This inspection pertains to human drugs.
Copy of the 483 for the May 20, 2019 - May 31, 2019 (12 days) inspection of Westlake IVF LLC [Austin / United States of
America] 300 Beardsley Ln Bldg B Ste 200, Austin, TX 78746, USA. This inspection pertains to biologics
Copy of the 483 for the May 27, 2019 - May 31, 2019 (5 days) inspection of Wild Child WA Pty Ltd. [Malaga / Australia] 2
Action Rd, Malaga WA 6090, Australia. This inspection pertains to human drugs.
Copy of the 483 for the inspection of Maria A. Carballosa MD [Hialeah / United States of America] 4395 Palm Ave,
Hialeah, FL 33012, USA beginning 08/05/21 and ending 08/26/21. This inspection pertains to HUMAN DRUGS.
Copy of the EIR for the inspection of Augusto E. Focil, M.D. [Oxnard / United States of America] 300 S A St #105, Oxnard,
CA 93030, USA beginning 08/23/21 and ending 08/27/21. This inspection pertains to HUMAN DRUGS.
Copy of the EIR for the inspection of Gittelman, Marc C, MD [Miami / United States of America] 21150 Biscayne Blvd
#300, Miami, FL 33180, USA beginning 08/17/21 and ending 08/26/21. This inspection pertains to HUMAN DRUGS.
Copy of the EIR for the inspection of Maria A. Carballosa MD [Hialeah / United States of America] 4395 Palm Ave,
Hialeah, FL 33012, USA beginning 08/05/21 and ending 08/26/21. This inspection pertains to HUMAN DRUGS.
Report and/or the MDSAP Noncomformity Grading and Exchange Form (NC) for the inspection of CHANGZHOU
JIUHONG MEDICAL INSTRUMENT CO., LTD., Changzhou, China, end date 06-27-2018. FEI# 3006750742. This inspection
pertains to medical devices.
Report and/or the MDSAP Noncomformity Grading and Exchange Form (NC) for the inspection of Famidoc Technology
Co., Ltd., Changan Town, China, end date 03-30-2018. FEI# 3005621440. This inspection pertains to medical devices.
Report and/or the MDSAP Noncomformity Grading and Exchange Form (NC) for the inspection of Guangzhou Wondfo
Biotech Co., Ltd., Guangzhou, China, end date 11-02-2018. FEI# 3004635103. This inspection pertains to medical
devices.
Report and/or the MDSAP Noncomformity Grading and Exchange Form (NC) for the inspection of Wujiang City Cloud &
Dragon Medical Device Co.,Ltd., Suzhou, China, end date 08-03-2018. FEI# 3007993446. This inspection pertains to
medical devices.
Regulatory Assessment of ADMA BioCenters Georgia Inc. Located at Marietta GA United States FEI Number:
Regulatory Assessment of Alkermes Inc Located at Wilmington OH United States FEI Number: 1000142940 held on
Regulatory Assessment of Novo Nordisk US Bio Production Inc. Located at West Lebanon NH United States FEI Number:
Regulatory Assessment of Pharmacia Hepar, LLC Located at Franklin OH United States FEI Number: 1524067 held on
Please provide the orphan drug designation request documents submitted by Genentech for the Actemra (tocilizumab)
orphan drug designation for the treatment of chimeric antigen receptor (CAR) T-cell-induced cytokine release syndrome
(date designated 08/01/2017).
ADVERSE EVENTS COVID VACCINE
DEATHS FROM COVID-19 VACCINES
ANDA 205894, cyclosporine ophthalmic emulsion, by Mylan, approved 02/02/2022.
HAROLD J MILLER, MD - EIR
Documents reflecting the percent of Food and Drug Administration (“FDA”) employees that are completely
unvaccinated for COVID-19.
Documents reflecting the percent of Food and Drug Administration (“FDA”) employees that are fully vaccinated for
COVID-19.
Documents reflecting the percent of Food and Drug Administration (“FDA”) employees that are partially vaccinated for
COVID-19.
All communications to and from Dr. Peter Marks mentioning the name "Wallskog." Thanks.
All communications to and from Konstantin Chumakov mentioning COVID, COVID-19, or SARS-CoV-2, and side effect or
adverse event.
All emails to and from Lorrie McNeill mentioning "meeting" and "vaccine," "vaccination", or "injured"
All emails to and from Paul Richards mentioning "symptoms", "Covid or Covid-19", and "vaccine" or "vaccines.
All emails to and from Veronika Pfaeffle, Alison Hunt, and Abigail Capobianco mentioning "Moderna", "SBRA",
"https://www.fda.gov/media/155841/download", "Zack" , "Zachary", "Stieber", or "Epoch."
All preliminary, interim, and final versions of the FDA's SBRA on Moderna's COVID-19 vaccine approval.
The FDA meta-analysis of four healthcare claims databases in CBER’s Biologics Effectiveness and Safety System, as
mentioned in the FDA's SBRA on Moderna's COVID-19 vaccine approval. The quantitative, age-stratified benefit-risk
analysis in males =18 years of age, using healthcare claims and CDC surveillance databases, mentioned in same
document.
all records of The Comirnaty or Pfizer Biotech COVID 19 being FULLY approved by the FDA for use in pregnant and
lactating women.
ANDA 075972 Metformin Hydrochloride Tablets, 500 mg, 625 mg, 750 mg, 850 mg, 1000 mg, approved January 24,
2002, original ANDA Approval Letter.
Complete Case Report for Case ID 16287729 retrieved from the FDA Adverse Event Reporting System. Product:
Technetium Tc-99m Exametazime
FDA Submission of “Insignis Subcutaneous Needle Sets”, 501(K) Number K202279. Further details attached.
I request the Establishment Inspection Reports (EIR), FDA-483, FDA-482, and Warning Letters filed since January 1, 2016
for each of the below facilities: Pharmavite LLC 4701 Northpark Dr Opelika, AL 36801 Pharmavite LLC 1150 Aviation Pl
San Fernando, CA 91340 ETC
Full Summary Basis of Approval for ABELCET NDA 050724 - approved on 11/20/1995
K211269 Visualase MRI Guided Laser Ablation System (SW 3.4); Freedom of Information (FOI) request for the
corresponding submission content and correspondence, and the associated FDA reviewer's Notes, Memos, Letters,
emails and/ or correspondence for the 510k submission, between the dates of 01/01/2021 and 02/04/2022
Please provide all records where Costco is listed as the FSVP importer of record. This information is needed to identify
and address the incorrect use of "UNK" by a customs entry filer as advised by FDA on January 18, 2022.
Request for NDA approval Documents
We would like the SBOI (Bioequivalence review) for Mylan's ANDA 205894 Cyclosporine Ophthalmic Emulsion, 0.05%.
I am seeking access to copies of Form 483's issued following pre-license inspections conducted at 1) Lonza Biologics in
October 2021, as referenced on page 13 of FDA's "summary basis for regulatory action" in recent approval of Moderna's
biologics license application for Spikevax. I believe the Lonza facility is at 101 International Drive, Portsmouth, N.H.; 2)
Catalent's facility at 1300 S Patterson Drive, Bloomington, IN, in August and September 2020; etc
Any records of complaints, inspections, violations or responses to warning letters concerning Utah Cord Bank , or
pertaining to the product STEMVIVE.
Materials responsive to the FOIA requests with the following control numbers: 2021-4593; 2021-4594; 2021-4595;
2021-4596; 2021-4597; 2021-4671; 2021-4817; 2021-4835; 2021-4929; 2021-5005; 2021-5028; 2022-132; 2022-133;
2022-134; 2022-135; 2022-136; 2022-191; 2022-353.
Requesting copy of the FDA inspection report for the Millmount Healthcare Ltd. facility (FEI 3004764499) conducted on
Mar 2020. Firm Address: Block 7 City North Business Campus, STAMULLEN, Ireland (IRL) Thank you
FOIA Request for agency records pertaining to Midwestern Pet Foods, Inc. including emails, inspection reports, warning
letters, reports from the public, complaints, correspondences with the firm, notes, necropsies, etc. Date Range
01/01/2021 - present
FOIA Request for agency records related to canine dilated cardiomyopathy Date Range 06/01/2019 – present date 2022
I am requesting any and all data in regards to Pfizer's COVID-19 vaccine.

CVs Matthew Duff, Natalie Reese, Gabrielle Swain, Christina Cross, etc
2016-10333, 2016-10388, 2016-7964, 2016-8088, 2021-7386.
2020-7313, 2021-5433, 2021-7609, 2021-7650, 2021-7726.
2021-7752, 2021-7756, 2021-7779, 2021-7780, 2021-7884.
2021-7917, 2021-8248, 2021-8253, 2021-8293, 2021-8296.
I would like the FDA's Type C Written Response to Zosano Pharma.
All the reported AE/SAEs for Indigo Carmine and Indigotindisulfonate Sodium Injection from 1992 till the current date.
Establishment Inspection Report FDA-483 Requesting Bristol Myers Squibb (FEI #2650089) FDA-483 and EIR regarding
the FDA inspection conducted from 5/11-7/12/21 at the Manati, PR facility.
internal Center for Tobacco Products (CTP) memorandum "Premarket Application Review Prioritization Plan," signed
August 31, 2020 — as well as addendums to the memorandum dated September 24, 2020 and May 11, 2021.
510(k) K111520
File Numbers 2019-6574, 2017-9740, and 2017-2261
Bioequivalence review for ANDA 212514, Amphotericin B, approved 12/14/2021.
I'm requesting access to and copies of the following: - Any and all records released in response to the following FOIA
control #s (including the original request): 2021-8366, 2020-505, 2020-506, 2020-552, 2022-706
11094202 11114138 11129913 11142509 11200685 11313594 11473187 11473416
I'm requesting access to and copies of the following: - the Health Hazard Evaluation produced by FDA CDER associated
with the recall of Coppertone sunscreen products that was announced here: https://www.fda.gov/safety/recalls-
market-withdrawals-safety-alerts/coppertoner-issues-voluntary-nationwide-recall-specific-lots-pure-simple-spf-50-
spray-2021-launch
The EIR (in electronic format) for Animal Drugs & Feeds inspection of Union Quimico Farmaceutica SA ending
06/01/2017 at the location in Sant Celoni, Spain. The Response (in electronic format) for Animal Drugs & Feeds
inspection of Union Quimico Farmaceutica SA ending 06/01/2017 at the location in Sant Celoni, Spain. Please send
The 483 (in electronic format) for Human Drugs inspection of Johnson Memorial Cancer Center ending 10/21/2021 at
the location in Enfield CT, United States. The EIR (in electronic format) for Human Drugs inspection of Johnson
Memorial Cancer Center ending 10/21/2021 at the location in Enfield CT, United States. The Response (in electronic
format) for Human Drugs inspection of Johnson Memorial Cancer Center ending 10/21/2021 at the location in Enfield
CT, United States. Please send documents as email attachments.
The EIR (in electronic format) for Human Drugs inspection of Thermo Fisher Scientific dba Patheon Biologics LLC
ending 08/02/2019 at the location in Saint Louis MO, United States. The Response (in electronic format) for Human
Drugs inspection of Thermo Fisher Scientific dba Patheon Biologics LLC ending 08/02/2019 at the location in Saint Louis
MO, United States. Please send documents as email attachments.
The EIR (in electronic format) for Human Drugs inspection of Professional Disposables International, Inc. ending
06/23/2021 at the location in Orangeburg NY, United States. The Response (in electronic format) for Human Drugs
inspection of Professional Disposables International, Inc. ending 06/23/2021 at the location in Orangeburg NY, United
States.
I want my Consumer Investigation or Reports regarding my Complaint: 167445
for Medical Devices & Rad Health inspection of NeedleTech Products, Inc ending 10/08/2021 at the location in North
Attleboro MA, United States. Please send documents as email attachments.
Records relating to Philips Respironics CPAP recall and related remediation program, includes updates on the progress
of such remediation program and the FDA’s analysis of the adequacy/ sufficiency of such remediation / replacement
program, together with any and all correspondence , written or otherwise, between the FDA and Philips Respironics or
its representatives on Complaint # 172187
2019-11654
Looking for any information behind FAERS case 19840209 as a 5 week old should have never been administered product
and we as sponsor have not received this Serious case from the CTU nor the reporter.
Testimony on behalf of the Association of State and Territorial Health Officials, Council of State and Territorial
Epidemiologists, National Alliance of State and Territorial AIDS Directors, Association of State and Territorial Public
Health Laboratory Directors, FDA Blood Products Advisory Committee; June 22, 1994; Washington, DC.
available transcripts or documents from four FDA meetings: Meeting n°1: March 15,1991, meeting of the Peripheral
and Central Nervous System Drugs Advisory Commitee 8:30 a.m., Regency Rm„ Crowne Plaza Holiday Inn, 1750 Rockville
Pike, Rockville, MD. [FR Doc. 91-3054 Filed 2-7-91; 8:45 am] BILLING CODE 4160-01-M Announced, FR of Wed, July 3,
1991, p. 30592 Meeting n°2: July 15,1991, meeting of a public advisory committee of the FDA 8 a.m. to 5 p.m.,
Bethesda Marriott, 5151 Pooks Hill Rd., Bethesda, MD. [FR Doc. 91-16034 Filed 7-3-91; 2:43 pm] BILLING CODE 4160-01-
M Announced: FR of Fri. February 8th, 1991, p. 5219 Meeting n°3: March 18, 1993 meeting of the Peripheral and
Central Nervous System Drugs Advisory Committee. [No docket found, announced in the FR of the Tuesday, February,
16, 1993, p. 8599] etc
We submitted this FOIA request to obtain all the detailed records associated with the shipment of the company (FEI
number 3013281800) of which the product have been refused entry into the United States. We can only get general
information on products from the FDA's Import Refusal Report (IRR), we also request to acquire more records, for
instance, the International logistics waybill Number; etc
Please provide the documents below for the following company: 4G Clinical 370 Washington St. Wellesley, MA 02481
Documents related to inspection history and compliance actions as follows:: • Warning Letters • 483s •
Establishment Inspection Reports • Responses to Warning Letters, 483s, EIRs by company • Consent decrees or
other compliance/inspection information
Dear FOI team, We would like to request AE/SAEs reported for Indigo Carmine and Indigotindisulfate Sodium injection
from the period of 01/01/1992 till cuurent date. If we can receive individual subject level data or report CIOMS that will
be very helpful on an urgent basis to respond to an agency response to our filed NDA 216264 which is currently under
review.
75F40121P00533.
All communications sent or received by Janet Woodcock, Marion Gruber, and/or Philip Krause dated between August 1,
2021 and October 31, 2021 that include any of the following terms: “Salus”, “Humetrix”, “JAIC”, and/or “Joint Artificial
Intelligence Center”.
Documents reflecting the number of COVID-19 infections and, of those, the total number of breakthrough infections
among Food and Drug Administration employees in the month of August 2021.
among Food and Drug Administration employees in the month of July 2021.
among Food and Drug Administration employees in the month of June 2021.
I am requesting a copy of documentation (solicitation, RFP, contract file, proposal, etc.)
associated with the following awarded contract:
-Award ID#: HHSF22301004T
- IDV ID#: HHSF223201310062I
-Recipient: The Elocen Group LLC
All FDA-CVM testing records for the FDA announcement on December 23, 2021, for the Woody’s Pet Food Deli of
Minneapolis, MN, recall.
All email records for FDA CVM employee David Edwards containing the key search term: AAFCO
testing records associated with FDA warning
2018-4074
I am requesting the records that show Mika Alewynse's, and FDA-CVM's vote on the AAFCO feed labeling committee
minutes, and the vote was casted in September 2021 or October 2021.
all communication or records of communication with non-agency persons regarding Premium nature, premium assure
or shuzy rock inc
I would like to know the top 5 prohibited personnel practices and offenses reported by the FDA.
"Biological Testing Procedures for Fluoride Dentifrices" these testing procedures are on file under Docket No. 80N-0042
in the Division of Dockets Management (HFA-305), FDA,5630 Fishers Lane, Room 1061, Rockville, MD 20852, and are
available on request to that office
Copy of the disclosable portions of all correspondence between FDA and Mead Johnson regarding Enfamil Neuropro
Infant Formula, from 01/01/2020 - Present.
Documents related to Atrium Medical Corporation's C-QUR mesh products produced in response to any other FOIA
request.
Establishment Inspection Reports for Atrium Medical Corporation's facilities located at 5 Wentworth Drive, Hudson,
New Hampshire and 40 Continental Boulevard, Merrimack, New Hampshire.
Evaluations and approvals of Atrium Medical Corporation's ProLite and C-QUR mesh products. Recalls of C-QUR mesh
and recalls of ProLite mesh (if any).
FDA evaluations, studies or reviews of the safety and efficacy of surgical mesh in general, and such evaluations, studies
or reviews regarding Atrium Medical Corporation's C-QUR and ProLite mesh products in particular.
FMD-145 Letter and EIR for MTF Tissue Services Syracuse New York FEI: 3000718045 Inspection started on 4/15/2019
and close-out 4/19/2019. Please see the attached 482 notice of inspection.
FOR THIOLA DRUG PRODUCT NDA 019569: MEDICAL REVIEW CLINICAL REVIEW SUMMARY REVIEW CLINICAL
PHARMACOLOGY AND BIOPHARMACEUTICS REVIEW OTHER REVIEWS
emails sent to and from the following individuals within the Food and Drug Administration's Center for Tobacco
Products related to the Puff Bar and related e-cigarettes, including from those outside the agency. Please search for
communications that occurred between Feb. 1, 2020 through the present day. Director Mitch Zeller Deputy Director:
Michele Mital Chief Science Officer: etc
I would appreciate it if you would email to me the FDA approval letter for Lisinopril-HCTZ tablets. The strengths are
10mg/12.5mg; 20mg/12.5mg and 20mg/25mg. The ANDA number is 076230. The date of the FDA approval is July 1,
2002.
Internal memoranda, internal notes, internal white papers, consultation requests and responses, meeting minutes,
internal studies, briefing documents, or other documents generated by the FDA in connection with Atrium Medical
Corporation's ("Atrium") hernia mesh products, including FDA Form 483 Observations issued to Atrium.
On behalf of Lupin Pharmaceuticals, Inc. I request you to provide me with the latest Package Insert for PROMACTA
(Eltrombopag olamine) (NDA 022291/Suppl-31) held by Novartis.
Pursuant to the Freedom of Information Act (FOIA, 5 U.S.C. § 552), and the FOIA regulations administered by the U.S.
Food and Drug Administration (FDA) at 21 C.F.R. Part 20, we hereby request a copy of the submission associated with
EcoBlue Letter of No Objection #256 and all FDA internal review memoranda documenting the Agency’s review of the
information in support of LNO #256.
The Consent Decree entered in US v. Atrium Medical Corp., 1:15-cv-00041 (D.N.H.).
and copies of, the FDA’s July 14, 2016 meeting minutes that the FDA sent to ChemoCentryx on August 9, 2016
concerning an End of Phase 2 meeting pertaining to ChemoCentryx’s drug avacopan (formerly CCX168 and now
TAVNEOS)
Consolidated Response to Pending Citizen Petitions on the Regulation of Ultrasound Contrast Agents, Docket No. 96P-
0511, 53 (July 25, 1997)
a line listing containing the following fields (Product, Manufacturer Report Number, CAERS report number, age, sex,
date received by the FDA, therapy dates, MedDRA Terms, case narrative and outcome) pertaining to the production of
all Adverse Event Reports and related documents relating or referring to Iovate products which have been received by
FDA from November 5, 2021 to date.
Under the Freedom of Information Act, as amended, 5 U.S.C. §§ 552, et seq., COGENCY GLOBAL INC. hereby requests
any FOIA requests that have been made for the terms “enfortumab vedotin” or Padcev.
We request a list of all companies that currently (as of today's date) have a valid qualified facility attestation for their
registered human food facility as submitted in accordance with the Food Safety Modernization Act of 2011, and Subpart
D of the implementing regulation entitled "Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based
Preventive Controls for Human Food (21 CFR Part 117)."
- All correspondence between the FDA and the individual, Joseph M. Mercola, DO and his associated business entities
including but not limited to: Optimal Wellness Center, Dr. Mercola’s Natural Health Center, Thermography Diagnostics
Centers, Mercola.com LLC, Mercola.com Health Resources, LLC. etc
Dear Sir/Madam, I am a researcher at Auburn University. I am looking for food, drug, and medical device recalls from
the weekly enforcement reports published by the FDA to use in my research project. The time period is from 1/1/2001
to 12/31/2010. Thank you!
NDA records pertaining to: 1. Ketalar (by Parke-Davis; NDA 016812; approved 02/19/1970) 2. Sernyl (aka
phencyclidine; also by Parke-Davis; NDA number unknown, approved by FDA sometime in the late 1950s before being
withdrawn by Parke-Davis in 1965) etc
Please provide, in electronic form, safety data on devices which contain Polyhydroxystearic Acid, Poly(3-
Hydroxyoctanoic Acid, or Polylactic Acid, including dental and spinal uses, use in collagen dressing, recall data, and
adverse events reports (see below please). Toxicity, irritation, sensitization, genotoxicity, carcinogenicity, and dermal
absorption data are of particular interest. etc
FDA 483s and EIRs for Clinical Investigator John Panuto, MD in Middleburg Heights, OH, Franklin, TN and Smyrna, TN
I am needing access to the records released for 2021-7851
Requesting any documentation associated with an issued Form 483, as well as the manufacturer's response, for a site
inspection of Hugel Inc.'s Korean manufacturing facility in August 2021 and any follow-up inspections or
correspondence. The inspection was related to the BLA filing for letibotulinumtoxinA for treatment of glabellar lines,
which has a PDUFA date of 3/31/22.
The expedited request denial letter FDA provided for 2021-5683
I would like to request all communication between the FDA and Eli Lilly as it relates to using the iADRS endpoint for their
Phase 3 Alzheimer's study (TRAILBLAZER-ALZ 2).
I'd like to request a full case report of Ayvakit by Blueprint Medicines in PDF and Excel for 20038309, 20222527,
20100204, 19974517, 19741800 and 18362397? Would be great if the materials could be emailed directly to
quinn.lin@point72.com. If not, is it possible to mail the materials using a USB stick instead of CD-ROM?
Food additive petition for Polysorbate 60. FAP 4A3774
All documents pertaining to exchanges between the FDA and Impossible Foods (or any party acting on behalf of
Impossible Foods).
I am requesting any and all available data recorded for pharmacokinetic, biodistribution, or Genotoxicity studies done in
relation to the Pfizer & Moderna mRNA vaccines.
I am requesting all documents and records pertaining to Pfizer's and Moderna's vaccine safety and efficacy data
submitted to the FDA and/or in the FDA's possession; including a full list of ingredients in each vaccine, the control
studies conducted, and the results of each study. Federal law clearly requires the release of this information now that
the vaccines are authorized by the FDA.
All data and information for the Pfizer Vaccine enumerated in 21 C.F.R. § 601.51(e)1 with the exception of publicly
available reports on the Vaccine Adverse Events Reporting System.
Request for the most recent labels for NDA 208385, Daptomycin 350MG/VIAL, Action Date 02/07/2022, SUPPL-8. The
RLD labeling will be used to keep our label aligned and updated per their most recent updates.
K201193
We are seeking full drug-level information on ANDA Paragraph IV filings filed in 2003 and before, with the same
variables as you currently provide for filings after 2003
K210497
AUROBINDO AUROLIFE LLC FORM 483
I would like a copy of the following 510(k) submissions -K111738,K120677and K213631-regarding the TriReme Medical,
Inc. products for Chocolate PTA Balloon Catheter.
Documentation or memo from Remote Regulatory Assessment conducted by Charles Larson, Investigator/OMDRHO, at
eScreen Phoenix location ending Feb. 4th, 2022.
Redacted copy of K200761 Tenax Laser Resistant Endotracheal Tube
Redacted copy of K213028 Tenax Laser Resistant Endotracheal Tube, Bryan Medical, Inc.
RECS RE IMVT-1401 AND RVT-1401

Redacted copy of K935842 Rusch Laserbus/Rusch Laser Resistant Cuffed with Murphy Eye, Rusch Inc.
Redacted Copy of K993582 Modification to Laser Shield XOMed, Inc.
Hello - I am looking for the below 510(k)s: K111210 K122361 K141758 K143189 K160482 K160056 K162080 K193483
K201214
1. All documents and correspondence related to SOCLEAN, Inc.’s application for FDA Regulatory Approval from
August 2021 to present, including but not limited to laboratory test results, drawings, scans, diagrams, patent
information, scientific reports, charts, industry reports, safety claims, and all other representations about how the
SOCLEAN CPAP cleaner works. 2. All documents and correspondence related to the FDA’s Safety Communication,
titled “Potential Risks Associated with The Use of Ozone and Ultraviolet (UV) Light Products for Cleaning CPAP Machines
and Accessories: FDA Safety Communication,” dated February 27, 2020, including but not limited to patient reports,
communications with manufacturers on recommended testing to support use of these devices, and preliminary
laboratory research such as the tests performed in minimally ventilated spaces. ETC
We would like to know if FDA could share the open data for Cephapirin Benzathine (NADA 108-114, ToMORROW®)?
Please provide documents, data, and communications related to the 501(k) submissions for the MC3 dual lumen
catheter. Provide reports or complaints submitted to any division of the FDA relating to the MC3 dual lumen catheter.
Provide all communication between FDA, MC3 or Medtronic regarding complications and adverse events with MC3’s
dual lumen cannula
NDC Labeler codes FDA expansion from a five to six-digit labeler code when the five-digits codes are exhausted. What is
the estimated number of available 5-digit labeler codes available to assign? Will 99999 be assigned as a labeler code?
What is the current rate of utilization annually? What was the utilization rate from 01/01/2019 to 02/01/2022?
We would like to request 2 memos (chemistry, toxicology) associated with Food Contact Notification (FCN) 1234.
CRIMINAL INVESTIGATION RECS
The Drug Master File number and holder for the Nelarabine active pharmaceutical ingredient referenced in ANDA
215037 for Nelarabine Injection, 250 mg/50 mL (5 mg/mL), approved on November 17, 2021.
The manufacturing site address and/or country of origin for the Nelarabine active ingredient referenced in ANDA
215037 for Nelarabine Injection, 250 mg/50 mL (5 mg/mL), approved on November 17, 2021.
K052643 FIRST PARTY

510(k)s for K180474, K122660, and K173619.
for Human Drugs inspection of QPS, LLC ending 08/25/2017 at the location in Newark DE, United States. Please send
for Foods & Cosmetics inspection of Taylor Farms Pacific, Inc. (MacArthur Facility) ending 05/20/2021 at the location in
Tracy CA, United States. The EIR (in electronic format) for Foods & Cosmetics inspection of Taylor Farms Retail Inc.
ending 09/22/2016 at the location in San Juan Bautista CA, United States. Please send documents as email attachments.
On behalf of Lupin Pharmaceuticals, Inc. I request you to please provide me with the latest label for the product
Percocet (NDA 040330) approved on 03/04/2021 as per Suppl-57.
Please provide the disclosable portions of the TPL, scientific reviewers’ summaries, and any associated supporting
memoranda for STN SE0000014. The substantial equivalence determination was made on December 5, 2019.
Current Labeling for Lotensin HCT® (Benazepril Hydrochloride/Hydrochlorothiazide) Tablet, NDA 020033 held by
Validus Pharma.
13764898 15070245 13763756 12522544 12611420 6684675 3813740 16608951 15799858 13792951
17271575 13764898 13792951 15408658 14162120 13940023 16874612 16479526 16923513
18658454 12504057 14426389 15552573 14768391 14510269 13763752 13269848 11536592 11472779 11302119
10039349 10244739 10039402 9856260 9359934 9772506
19122763 14801124 17094253 19130188 15251662 13280039 10244650 15594167 16996336 13792951 16615292
6256372 16924532
I am interested in obtaining a list of random company names with registered dietary supplement manufacturing
facilities. The list should have 25 companies from each of the 48 contiguous states for a total of 1,200 companies. The
company's legal name and the state will suffice.
I request copies of documents that would contain data on statistics of marijuana arrests and their demographics.
For Tentatively approved NDA #211875 for Paclitaxel Protein-Bound Particles for Injectable Suspension (Albumin-
Bound), lyophilized powder for reconstitution, 100 mg/vial - Medical Reviews, Chemistry Reviews, Pharmacology
Reviews, Clinical and Biopharmaceutics Review, Administrative documents and, correspondences and statistical
Reviews.
for Human Drugs inspection of Spectrum Laboratory Products, Inc. ending 03/12/2021 at the location in Gardena CA,
United States. The Response (in electronic format) for Human Drugs inspection of Spectrum Laboratory Products, Inc.
ending 03/12/2021 at the location in Gardena CA, United States. Please send documents as email attachments.
for Human Drugs inspection of United Guardian Inc ending 08/02/2018 at the location in Hauppauge NY, United States.
The EIR (in electronic format) for Human Drugs inspection of United Guardian Inc ending 08/02/2018 at the location in
Hauppauge NY, United States. The Response (in electronic format) for Human Drugs inspection of United Guardian Inc
ending 08/02/2018 at the location in Hauppauge NY, United States. Please send documents as email attachments.
records regarding Wi-Fi passwords used at the Food and Drug Administration since January, 1991
2022-660
All records pertaining to and arising out of Warning Letter #605595 issued to Norbert Gleicher and Fertility
Nutraceuticals LLC dated May 20, 2021 etc
Greetings, I would like to receive the records for all international shipments in which Relish labs DBA Home Chef has
been identified as the FSVP Importer" (by adding my DUNS numbers at the point of entry) from 11/1/21 - 12/31/21.
FAERS RECORDS
CBER ID 000333 on the SRID method
I would like to request all communications between Novavax and the FDA as it relates to manufacturing of their covid
vaccine, NVX-CoV2373. Also, I would like to include any mentions of the Serum Institute of India in the Novovax
communications.
A copy of the 77-page report, titled “2020 GDUFA III Data Call Responses for Industry,” providing responses of the FDA
to the request for data submitted by industry negotiators in preparation for the negotiations related to reauthorization
of the Generic Drug User Fee Amendments of 2017 (GDUFA II).
All addenda, amendments, supplements, or other related final memoranda, to the Center for Tobacco Products' Office
of Science August 31, 2020, Premarket Application Review Prioritization Plan.
Copy of the 483 for the inspection of Milton Hom, OD [Azusa / United States of America] 822 E Alosta Ave a, Azusa, CA
91702, USA beginning 08/31/21 and ending 09/03/21. This inspection pertains to HUMAN DRUGS.
Copy of the 483 for the inspection of Val Hansen, M.D. [- / -] 520 Medical Dr Suite 300, Bountiful, UT 84010, USA
beginning 08/30/21 and ending 09/03/21. This inspection pertains to HUMAN DRUGS.
Copy of the EIR for the inspection of Milton Hom, OD [Azusa / United States of America] 822 E Alosta Ave a, Azusa, CA
Report and/or the MDSAP Noncomformity Grading and Exchange Form (NC) for the inspection of Beijing Choice
Electronic Tech C, Shuangyuan Rd, China, end date 11-09-2017. FEI# 3009897311. This inspection pertains to medical
devices.
Copy of the EIR for the inspection of Val Hansen, M.D. [- / -] 520 Medical Dr Suite 300, Bountiful, UT 84010, USA
beginning 08/30/21 and ending 09/03/21. This inspection pertains to HUMAN DRUGS.
Electronic Technology Co., Ltd., Beijing, China, end date 11-09-2017. FEI# 3005569927. This inspection pertains to
medical devices.
Report and/or the MDSAP Noncomformity Grading and Exchange Form (NC) for the inspection of Edan Instruments,
Inc., Shenzhen, China, end date 03-09-2018. FEI# 3003971136. This inspection pertains to medical devices.
Report and/or the MDSAP Noncomformity Grading and Exchange Form (NC) for the inspection of Foshan United
Medical Tech Ltd, Foshan, China, end date 11-15-2017. FEI# 3009109670. This inspection pertains to medical devices.
Copy of the disclosable portions of the EIR for the 06/07/2021 - 07/07/2021 inspection of Medtronic, located in
Northridge, CA. Please note this inspection pertains to medical devices.
Copy of the disclosable portions of the EIR for the 07/15/2021 - 07/23/2021 inspection of Mead Johnson, Wanamingo,
MN. This inspection related to foods.
Copy of the disclosable portions of the EIRs for the following food-related inspections: (1) PBM Nutritionals, Covington,
OH, 09/15/2021; (2) Nestle Healthcare Nutrition, Eau Claire, WI, 06/11/2021; (3) Gerber Products dba Nestle Infant
Formula, Eau Claire, 08/13/2021; and (4) Mead Johnson Nutrition, Evansville, IN, 08/26/2021.
Federal Food, Drug, and Cosmetic Act, food contact substance notification (FCN) - FCN No. 751, completed FDA Form
3480 and all related attachments filed by the notifier (Akzo Nobel Surface Chemistry LLC).
I need the 510(k) application for K182075.

I respectfully request copies of any and all information related to Philips Respironics’ response to the Form-483 (FEI #
2518422) for the period between November 9, 2021 and January 8, 2022.
I would a list of all FSVP inspections and related citations between December 20, 2017 - December 31, 2021. Please
include the following columns in the spreadsheet: Company FEI (if available); Company Name; Company Address Line 1;
Company Address Line 2; Company City; Company State/Region/Province; Company Postal Code; Company Country;
Company Email; Date of Inspection.
Please provide disclosable portions of the original FOIA request letter and complete FDA response for file number 2021-
7548.
Please provide disclosable portions of the original FOIA request letter and the page count for the entire fulfillment
regarding file number 2021-8359.
Please provide documents for the following company: Catalent Pharma Solutions, 7330 Carroll Drive, San Diego, CA
92121. Documents related to Inspection history and compliance actions as follows: Warning Letters 483's
Establishment Inspection Reports Responses to Warning Letters, 483's, EIRs by company Consent decrees or other
compliance/inspection information
Please provide the documentation listed below for the following company: DocuSign, 221 Main Street, San Francisco,
CA, 94105 Documents related to inspection history and compliance actions as follows: Warning Letters 483's
Please provide the documents below for the following company Access, 249 North Street, Danvers, MA 01923
Documents related to inspection history and compliance actions as follows: Warning Letters 483's Establishment
Inspection Reports Responses to Warning Letters, 483's, EIRs by company Consent decrees or other
compliance/inspection issues
Please provide the documents below for the following company: LabCorp, 3402 Kingsman Blvd, Madison, WI, 53704
Inspection Reports Responses to Warning Letters, 483's, EIRs by company Consent decrees or other
Please provide the documents listed below for the following company: EPL Archives, 435 Tolbert Ln SE, Leesburg, VA,
20175 Documents related to inspection history and compliance actions as follows: Warning Letters 483's
Please provide the documents listed below for the following company: Moravek Biochemicals, 577 Mercury Lane, Brea,
CA, 92821 Documents related to Inspection history and compliance as follows: Warning Letters 483's Establishment
Inspection Reports Responses to Warning Letters, 483's, EIR's by company Consent decrees or other
Records of lines of entries in which Topco Associates, LLC or similar variations of such name is listed as the FSVP
importer
for Medical Devices & Rad Health inspection of Luminex Corporation ending 10/22/2021 at the location in Northbrook
IL, United States. Please send documents as email attachments.
for Medical Devices & Rad Health inspection of Wickimed (Huizhou) Medical Equipment Manufacturing Co., Ltd. ending
09/14/2021 at the location in Huizhou, China. Please send documents as email attachments.
for Foods & Cosmetics inspection of Crunch Pak, LLC ending 04/15/2021 at the location in Cashmere WA, United States.
for Human Drugs inspection of BioClinica, Inc. ending 02/05/2021 at the location in Princeton NJ, United States. Please
The 483 (in electronic format) for Animal Drugs & Feeds inspection of First Priority, Inc. ending 11/18/2021 at the
location in Elgin IL, United States. The EIR (in electronic format) for Animal Drugs & Feeds inspection of First Priority,
Inc. ending 11/18/2021 at the location in Elgin IL, United States. The Response (in electronic format) for Animal Drugs &
Feeds inspection of First Priority, Inc. ending 11/18/2021 at the location in Elgin IL, United States. Please send
The 483 (in electronic format) for Foods & Cosmetics inspection of Taylor Farms Texas, Inc. ending 12/19/2019 at the
location in Dallas TX, United States. The EIR (in electronic format) for Foods & Cosmetics inspection of Taylor Farms
Texas, Inc. ending 12/19/2019 at the location in Dallas TX, United States. The Response (in electronic format) for Foods
& Cosmetics inspection of Taylor Farms Texas, Inc. ending 12/19/2019 at the location in Dallas TX, United States. Please
Postmarket Surveillance and Studies for VLN King and VLN Menthol King and their ability to reduce nicotine
consumption.
NDA 019032
All clinical trial results for Cryselle manufactured by Teva Generics. Thank you
Please provide documents listed below for the following company: Navin Fluorine International Ltd., New Industrial
Area No. 2, A.B. Road, Dewas-455001, Madhya Pradesh, India Documents related to inspection history and compliance
actions as follows: Warning Letters 483's Establishment Inspection Reports Responses to Warning letters, 483's,
EIR's by company Consent decrees or other compliance/inspection information
Please provide the documents listed below for the following company: ComplianceWire, 202 Carnegie Center, Suite 301,
Princeton, NJ, 08540 Documents related to inspection history and compliance actions as follows: Warning Letters
483's Establishment Inspection Reports Responses to Warning letters, 483's, EIR's by company Consent decrees or
Please provide the documents listed below for the following company: H & A Scientific, 105 Regency Blvd, Suite A,
Greenville, NC, 27835 Documents related to inspection history and compliance actions as follows: Warning Letters
483's Establishment Inspection Reports Responses to Warning Letters, 483's, EIR's by company Consent decrees or
Please provide the documents listed below for the following company: Veeva Systems Inc., 4280 Hacienda Drive,
Pleasanton, CA, 94588 Documents related to Inspection history and compliance actions as follows: Warning Letters
Hello Please provide all communications from Stephen Hahn or Peter Marks to any of the following persons: Hayley
Gans Arnold Moto Paula Annunziato Archana Chaterjee Holly Janes Amanda Cohn Michael Kurilla Steven Pergam Myron
Levine Steven Pergam Andrea Shane Cody Meissner Paul Spearman Geeta Swamy Sheldon Toubman
Hello Please provide all communications from Stephen Hahn or Peter Marks to any of the following persons: Oveta
Fuller James Hildreth Juan Gea-Banacloche David Kim Patrick Moore Stanley Perlman Eric Rubin Jeannette Lee Ofer Levy
Pamela McInnes Mark Sawyer Ralph Tripp Melinda Wharton
recalled meat, poultry, fish, shellfish, and dairy products in

the United States from 2011-2021.
(1) All documents relating to Centro Sperimentale del Latte, S.R.L. (an Italian company with a principal place of
business in Zelo Buon Persico, LO, Italy) (“CSL”)’s registration as a foreign facility pursuant to the Federal Food Drug and
Cosmetic Act, as amended by the Bioterrorism Act of 2002 and the FDA Food Safety Modernization Act, including
without limitation all communications between CSL and the Food and Drug Administration; etc
to obtain the 510k submission documents by email.
Please provide the documents listed below for the following company: EPL Archives Inc, 45610 Terminal Drive, Sterling,
VA, 20166 Documents related to Inspection history and compliance actions as follows: Warning Letters 483's
Establishment Inspection Reports Responses to Warning letters, 483's, EIR's by company Consent decrees or other
Please provide the documents listed below for the following company: Frontage Clinical Services, 200 Meadowlands
Parkway, Secaucus, NJ, 07094 Documents related to Inspection history and compliance actions as follows: Warning
Letters 483's Establishment Inspection Reports Responses to Warning letters, 483's, EIR's by company Consent
decrees or other compliance/inspection information
Please provide the documents listed below for the following company: Genewiz Inc, 733 Concord Ave, Cambridge, MA,
02138 Documents related to Inspection history and compliance actions as follows: Warning Letters 483's
Please provide the documents listed below for the following company; PRA Health Sciences, 995 Research Park Blvd,
Suite 300, Charlottesville, VA, 22911 Documents related to Inspection history and compliance actions as follows:
Warning Letters 483's Establishment Inspection Reports Responses to Warning letters, 483's, EIR's by company
Consent decrees or other compliance/inspection information
Please provide the documents listed below for the following company: Greenphire, 1018 West 9th Ave, Suite 200, King
of Prussia, PA, 19406 Documents related to Inspection history and compliance actions as follows: Warning Letters
Please provide the documents listed below for the following company: ICON-Lenexa, 9755 Ridge Drive, Lenexa, KS,
Please provide the documents listed below for the following company: The Forsyth Institute, 245 First St, Cambridge,
MA, 02142 Documents related to Inspection history and compliance actions as follows: Warning Letters 483's
Copies of Cover letter and Annual report that we submitted in 2017 of DMF #27998.
[Reference FGI# 22-76750] Relevant to GS35F0074S Order 75F40121F80434 we specifically request copies of the
following agency records: (1) Contract, with applicable SOW/
Would like to request for the records for Lunit Insight MMG, Regulation Number 21CFR 892.2090 and reference number
K211678
List of all COVID-19 Tests and Collection Kits FULLY AUTHORIZED by the FDA, do not include Emergency Use Authorized
by FDA.
Certificates of Free Sale issued to Redcon1, LLC.
• Any and all communications from the compounding industry to FDA related to sodium thiosulfate and all
documents provided to FDA by the compounding industry related to sodium thiosulfate. ETC
We would like a list of Entries filed where the FSVP was listed as the FSVP Importer on an entry/line of food and their D-
U-N-S number was not provided.
We request all records of the FDA mandated "Dear Doctor" letter sent following the FDA's 2009 approval of the drug,
Metoclopramide, known by its brand name, Reglan.
Adverse Event Reports for any product that contains Wharton's Jelly. Adverse Event Reports for any product
manufactured or distributed by New Life Medical Services, LLC or New Life Regenerative Medicine. Adverse Event
Reports for biologic product with proprietary name ReStor. Investigational New Drug Applications submitted by New
Life Medical Services, LLC or New Life Regenerative Medicine. ETC
Copy of the 483 for the Jan 31, 2019 - Mar 1, 2019 (30 days) inspection of AllerQuest LLC [Plainville / United States of
America] 10 Farmington Valley Dr #106, Plainville, CT 06062, USA. This inspection pertains to human drugs.
Any submissions, reviews, notes of meeting or other correspondence on the use of , 1,25 dihydroxycholecalciferol-
glycosides in animal feed. As would be found in the Division of Animal Feed files.
Copy of the 483 for the Feb 13, 2019 - Feb 25, 2019 (13 days) inspection of Virginia Center for Reproductive Medicine
[Reston / United States of America] 11150 Sunset Hills Rd #100, Reston, VA 20190, USA. This inspection pertains to
biologics.
Copy of the 483 for the Mar 12, 2019 - Mar 22, 2019 (11 days) inspection of Lohxa LLC [Worcester / United States of
America] Sky Mark Tower, 600 Main St #110, Worcester, MA 01608, USA. This inspection pertains to human drugs.
Copy of the 483 for the May 20, 2019 - May 24, 2019 (5 days) inspection of Tismor Health and Wellness Pty Limited
[Kingsgrove / Australia] 19A Garema Cct, Kingsgrove NSW 2208, Australia. This inspection pertains to human drugs.
Copy of the 483 for the May 20, 2019 - May 24, 2019 (5 days) inspection of Tismor Health and Wellness Pty Limited
[Kingsgrove / Australia] 19A Garema Cct, Kingsgrove NSW 2208, Australia. This inspection pertains to human drugs.
Regulatory Assessment of Actavis Laboratories FL, Inc. Located at Sunrise FL United States FEI Number: 3003937591
Regulatory Assessment of Azzur Labs, LLC Located at Schnecksville PA United States FEI Number: 3009596279 held on
Regulatory Assessment of Bayer Healthcare LLC Located at Emeryville CA United States FEI Number: 3010261923 held
Regulatory Assessment of Corden Pharma Boulder, Inc. Located at Boulder CO United States FEI Number: 3005231248
Electronic listing (preferably csv format) of all RRAs conducted since November 1, 2021.
FDA records relating to the GlaxoSmithKline Cidra pharmaceutical facility as described in the attached letter.
EPIROS USA LLC FSVP inspection conducted on 01/21/2022
Food Contact Notification FCN No. 2154 (SNF SA, SNF Inc.)
Which shipment our firm was listed as the FSVP Importer or for which shipment our brokerage firm transmitted “UNK”
in place of the FSVP Importer’s D-U-N-S number. We receive emails titled [FDA Notice to FSVP Importers: URGENT]
FSVP DUNS Number Requirement for Food Entries
Any and all records created or received by the Office of Criminal Investigations, Office of Regulatory Affairs, U.S. Food
and Drug Administration, Department of Health and Human Services, including memoranda, draft memoranda, email
communications, email chains, investigative reports, actionable intelligence and other communications or data
exchanged with employees or representatives of the Chinese Ministry of Public Security from January 2018 to January
2021.
Drug Establishment annual registration from THE EARLIEST POSSIBLE DATE to 1/1/2022 by calendar year
I am seeking all data, work product, and communications, inclusive of emails, records of meetings, meeting notes,
memorandums, interviews, and all other information exchanged, between Hi-Tech Pharmaceuticals and/or their
representatives and any FDA employee, related to the following alert and recall: https://www.fda.gov/safety/recalls-
market-withdrawals-safety-alerts/hi-tech-pharmaceuticals-issues-allergy-alert-various-aps-isomorph-28-products-and-
iforce-nutrition etc
I am seeking all data, work product, and communications, inclusive of emails, records of meetings, meeting notes,
memorandums, interviews, and all other information exchanged, between Redcon1, LLC and the FDA related to
Redcon1's (approximately) 4/5/2021 recall of products containing an undeclared allergen.
483 issued to AGC Biologics A/S, Denmark at CDER inspection
483 issued to AGC Biologics, Inc. (FEI No.3000209996) on SEA-DO inspection (Inspection ID 1149254)
483 issued to AGC Biologics, Inc. by SEA-DO inspection
510(k) # K800023 CADEMA MEDICAL PRODUCTS, INC Date Received01/07/1980 Decision Date01/01/1985
Records and communications relating to perfluorinated compounds, including but not limited to per- and
polyfluoroalkyl substances ("PFAS") tested, found, or detected in pizza delivery boxes used and/or manufactured by
Domino's Pizza, Smurfit-Stone Container Corporation, Burrows, Novolex, Weyerhaeuser, International Paper,etc
This is a request for the VAERS ID number for all events from any COVID19 vaccine reported as having occurred in
Contra Costa County, California, on the CDC's Vaccine Adverse Event Reporting System (VAERS).
I am requesting a copy of the report from our Remote Regulatory Assessment. The report was reviewed with inspector
Suyang Qin over the phone on 2-4-22.
Please provide the documentation listed below for the following company: Almac Clinical Services Ltd, Finnabar
Business Park, Haggardstown, Dundalk Co, Louth, Ireland A91 P9KD Documents related to inspection history and
compliance actions as follows: Warning Letters 483's Establishment Inspection Reports Responses to Warning
letters, 483's, EIR's by Company Consent decrees or other compliance/inspection information
Please provide the documents listed below for the following company: ALMAC Clinical Services LLC, 25 Fretz Road,
Souderton, PA, 18964 Documents related to inspection history and compliance actions as follows: Warning Letters
483's Establishment Inspection Reports Responses to Warning letters, 483's, EIR's by Company Consent decrees or
Please provide the documents listed below for the following company: Absorption Systems, 436 Creamery Way, Suite
600, Exton, PA, 19341 Documents related to Inspection history and compliance actions as follows: Warning Letters
Please provide the documents listed below for the following company: Acumen Medical Communications, 82 Fuller St,
APT 1, Brookline, MA, 02446 Documents related to Inspection history and compliance actions as follows: Warning
Please provide the documents listed below for the following company: Almac Clinical Services LLC, 4204 Technology
Drive, Durham, NC, 27704 Documents related to inspection history and compliance actions as follows: Warning
Letters 483's Establishment Inspection Reports Responses to Warning letters, 483's, EIR's by Company Consent
Please provide the documents listed below for the following company: Almac Clinical Services, 9 Charlestown Road,
Craigavon, United Kingdom, BT63 5PW Documents related to inspection history and compliance actions as follows:
Warning Letters 483's Establishment Inspection Reports Responses to Warning letters, 483's, EIR's by Company
Please provide the documents listed below for the following company: Asymchem, No. 99 Hongda Rd, Economic
Development Zone, Dunhua, Jilin, 133700, China Documents related to inspection history and compliance actions as
follows: Warning Letters 483's Establishment Inspection Reports Responses to Warning letters, 483's, EIR's by
Company Consent decrees or other compliance/inspection information
Please provide the documents listed below for the following company: Canopy Biosciences, 4340 Duncan Ave, St Louis,
MO, 63110 Documents related to Inspection history and compliance actions as follows: Warning Letters 483's
Please provide the documents listed below for the following company: Catalent Pharma Solutions, 10245 Hickman Mills
Drive, Kansas City, MO, 64137 Documents related to inspection history and compliance actions as follows: Warning
Letters 483's Establishment Inspection Reports Responses to Warning letters, 483's, EIR's by Company Consent
Please provide the documents listed below for the following company: Catalent Pharma Solutions, 37 Hollands Road,
Haverhill, United Kingdom, CB9 8PR Documents related to inspection history and compliance actions as follows:
Please provide the documents listed below for the following company: Catalent Pharma Solutions, 8 Orchard Place,
Nottingham, United Kingdom, NG8 6PX Documents related to inspection history and compliance actions as follows:
Please provide the documents listed below for the following company: Cell Carta, 48383 Fremont Blvd, Suite 118,
Fremont, CA, 94538 Documents related to Inspection history and compliance actions as follows: Warning Letters
Please provide the documents listed below for the following company: Cellcarta, 1331 W 75 St, Suite 401, Naperville,
IL, 60540 Documents related to Inspection history and compliance actions as follows: Warning Letters 483's
Please provide the documents listed below for the following company: Covigilant LLC, 1500 District Ave, Burlington,
Please provide the documents listed below for the following company: Data Intensity, 22 Crosby Drive, Suite 100,
Bedford, MA, 02048 Documents related to Inspection history and compliance actions as follows: Warning Letters
Please provide the documents listed below for the following company: F.I.S. Via Dovaro snc, Lonigo (VI), Italy 36045
Inspection Reports Responses to Warning letters, 483's, EIR's by company Consent decrees or other
Please provide the documents listed below for the following company: F.I.S. Viale Milano 26, 36075, Montecchino,
Maggiore-Alte VI, Italy Documents related to inspection history and compliance actions as follows: Warning Letters
Please provide the documents listed below for the following company: PPD Inc. 8551 Research Way, Suite 90,
Middleton, WI, 53562 Documents related to inspection history and compliance actions as follows: Warning Letters
Please provide the documents listed below for the following company: TransPerfect Translations, 420 Boylston St,
Boston, MA, 02116 Documents related to inspection history and compliance actions as follows: Warning Letters 483's
Please provide the documents listed below for the following company: Yuhan, 74 Noryangjin-Ro, Dongjak-Gu, Seoul,
South Korea, 06927 Documents related to inspection history and compliance actions as follows: Warning Letters
Please provide the documents listed below for the following company: eClinical Solutions LLC, 603 West St, Mansfield,
test test test
As permitted by the Freedom of Information Act (FOIA), we vici health science hereby requesting the 3 most recent
documents : FDA 483(s), if 483 (s)not issued provide EIR (Establishment Inspection Report(s) )summary for : Solara
Active Pharma Sciences Limited Kudikkadu, India, FEI 3003585876.
Hi, I would like to request the Form 483 issued to Ajinomoto Althea, Inc. during the May 25, 2021 facility inspection in
San Diego, CA. Thank you.
10968778 10931598 10786890 10767578 10736028 10734008 10692344 10645638
Original PMA and 2020 to current date supplements for: Device VNS Therapy System Generic Name Stimulator,
Autonomic Nerve, Implanted For Epilepsy PMA Number P970003 Applicant LivaNova USA, Inc. 100 Cyberonics Blvd.
Houston, TX 77058
for Biologics inspection of Lonza Biologics, Inc. ending 10/22/2021 at the location in Portsmouth NH, United States. The
EIR (in electronic format) for Biologics inspection of Rentschler Biopharma Inc. ending 12/13/2019 at the location in
Milford MA, United States. Please send documents as email attachments.
for Human Drugs inspection of West Pharmaceutical Services, Inc. ending 12/17/2021 at the location in Exton PA,
United States. The EIR (in electronic format) for Human Drugs inspection of ICON Clinical Research ending 12/16/2021
at the location in North Wales PA, United States. Please send documents as email attachments.
for Medical Devices & Rad Health inspection of Compass Health Brands Corp. ending 11/17/2021 at the location in
Brookpark OH, United States. The Response (in electronic format) for Medical Devices & Rad Health inspection of
Compass Health Brands Corp. ending 11/17/2021 at the location in Brookpark OH, United States. Please send
for Medical Devices & Rad Health inspection of Nalge Nunc International Corporation ending 09/26/2018 at the location
in Rochester NY, United States. etc
Nutritional facts about school lunch items being served at schools in the Monroe County Community School Corporation
and the Richland-Bean Blossom Community School Corporation in Monroe County, Indiana, for the past three years.
Copy of the the publicly available medical, clinical pharmacology, nonclinical, and biostatistical
reviews from FDA for the supplemental approval of Fabrazyme (agalsidase beta), BLA
103979/S-5309, approved on 11 March 2021
2016-10328, 2021-6901, 2021-7510, 2021-7511, 2021-8600.
2021-5621, 2021-5627, 2016-10011, 2016-10016, 2016-10129.
2021-8831, 2021-7782, 2021-8126, 2021-8674, 2022-138.
2022-234, 2022-254, 2022-268, 2022-278, 2022-314
offices, from December 1, 2021 through December 31, 2021.
Please send all adverse events reporting for the drug, Savaysa.
We would like to FOIA the review documents for the device Vitalojak
It has been observed that SBOA for Reference Listed Drug (RLD) product Cleocin Phosphate® (Clindamycin Injection, USP
150mg/mL) (NDA # 050441; Approved Prior to Jan 1, 1982) is not available at Drugs@FDA and Orange book. As it is a
public document, we request you to arrange for SBOA of mentioned RLD for our reference.
We are seeking information regarding complaints filed against PEMF Systems, a company with locations in Sherman
Oaks, CA and Las Vegas, NV. We would like to attain records of these complaints include the status of the investigations
to date. Specifically we are aware that a complaint was filed against PEMF Systems in August 2021 and seek any
information regarding this complaint that is available.
Surety Performance Bond information of Dr. Janet Woodcock, Acting Commissioner of the FDA which would include the
Bond Number.
All complaints or allegations of regulatory misconduct submitted to the FDA regarding Transcranial Magnetic
Stimulation.
Copy of the disclosable portions of the FDA reviews for the following substantial equivalence orders for Commonwealth
brands: SE0002732, Montclair Blue 100s Box; SE0002733, Montclair Blue King Box; SE0002734, Montclair Gray 100s Box;
SE0002735, Montclair Gray King Box; SE0002736, Montclair Menthol Green 100s Box; SE0002739, Montclair White 100s
Box; and SE0002740, Rave Gold 100s Box.
130 ADE reports for the events of accidental Altrenogest exposure
Letter to Food Manufacturers about Accurate Serving Size Declaration on Food Products March 12, 2004
Solicito informe de inspeccion realizada de manera virtual.
Import Alert 89-08

We request all available documents, analyses, memos, emails, etc. relating to INV115484. This is an FDA investigation
of benzene in sunscreens.
for Human Drugs inspection of Amarex Clinical Research, LLC ending 12/29/2021 at the location in Germantown MD,
for Human Drugs inspection of Kenia Castro, M.D. ending 01/07/2022 at the location in Hialeah FL, United States.
for Human Drugs inspection of Amgen Manufacturing Ltd ending 09/08/2021 at the location in Juncos PR, United States.
for Human Drugs inspection of Eli Lilly & Company ending 01/13/2022 at the location in Indianapolis IN, United States.
for Human Drugs inspection of EuTech Scientific Services Inc ending 12/28/2021 at the location in Highland Park NJ,
United States. The 483 (in electronic format) for Human Drugs inspection of Bi-Coastal Pharma International ending
01/14/2022 at the location in Shrewsbury NJ, United States. Please send documents as email attachments.
for Human Drugs inspection of Immunex Rhode Island Corporation ending 12/07/2021 at the location in West
Greenwich RI, United States. The EIR (in electronic format) for Human Drugs inspection of Immunex Rhode Island
Corporation ending 12/07/2021 at the location in West Greenwich RI, United States. ETC
Meitheal Pharmaceuticals would like to request the most recent container, carton, and package insert labels of NDA
022341 Victoza (Liraglutide Recombinant) for our own label development for an ANDA submission. Please send the
labels via electronic email as we are currently working remote. Best Regards,
the FDA FAERS database for (lonapegsomatropin-tcgd) (brand name SKYTROFA).
FDA FAERS database for enfortumab vedotin (brand name PADCEV).
FDA FAERS database for tisotumab vedotin-tftv (brand name TIVDAK).
FDA FAERS database for tucatinib (brand name TUKYSA).
FDA FAERS database for zanubrutinib (brand name BRUKINSA).
Nature Works LLC, Jan 3, 2002 FCN 178 Polylactide polymers

N=16 FAERS Individual Case Reports Suspected Drug: Orladeyo (berotralstat) Case report numbers from FAERS Public
Dashboard ID list in attachment in ascending order
all calendar records from fda-ora employee Steven Porter (steven.porter@fda.hhs.gov) 01.01.18-06.30.18
All communications to and from Dr. Janet Woodcock mentioning "Rogan" Thanks
All communications to and from Dr. Janet Woodcock mentioning "ivermectin" Thanks
All communications to and from Dr. Peter Marks mentioning "Rogan" Thanks
All emails to or from Brad Kimberly, Erica Jefferson, and Sandy Walsh mentioning "ivermectin"
Please provide the "preliminary assessment" by the FDA of Pfizer and BioNTech's COVID-19 vaccine based on data the
companies provided to the agency, as outlined in this press release https://www.fda.gov/news-events/press-
announcements/coronavirus-covid-19-update-fda-postpones-advisory-committee-meeting-discuss-request-
authorization
EIR for inspection of Altasciences (formerly known as Algorithme Pharma) in April 2016, located at 575 Armand-Frappier
Blvd, Laval, QC, Canada H7V4B3. Inspection report never received and former request #FDA2064028 never addressed.
Emails from Marion Gruber and Phil Krause mentioning "booster" or "boosters" or "additional dose" or "additional
shot" or "third dose" or "third shot" Thanks
Orencia (abatacept) Summary Basis for Approval (SBA) for BLA 125118/S-240, approved December 15, 2021, for the use
of abatacept for the prophylaxis of acute graft versus host disease (aGVHD), in combination with a calcineurin inhibitor
and methotrexate, in adults and pediatric patients 2 years of age and older undergoing hematopoietic stem cell
transplantation (HSCT) from a matched or 1 allele-mismatched unrelated donor.
Please provide documents listed below for the following company: ICON, 840 Memorial Drive, 1st Floor, Cambridge,
Please provide the documents listed below for the following company: ICON Lab Services, 8282 Halsey Road,
Whitesboro, NY, 13492 Documents related to Inspection history and compliance actions as follows: Warning Letters
Please provide the documents listed below for the following company: ICON, South County Business Park,
Leopardstown, Dublin 18, Ireland Documents related to Inspection history and compliance actions as follows:
Please provide the documents listed below for the following company: LabCorp Clinical Research Unit, 3402 Kingsman
Blvd, Madison, WI, 53704 Documents related to Inspection history and compliance actions as follows: Warning
Please provide the documents listed below for the following company: LabCorp Drug Development, 671 South
Meridian, Greenfield, IN, 46140 Documents related to Inspection history and compliance actions as follows: Warning
Please provide the documents listed below for the following company: LabCorp Drug Development, 8211 Scicor Drive,
Indianapolis, IN, 46214 Documents related to Inspection history and compliance actions as follows: Warning Letters
Please provide the documents listed below for the following company: LabCorp, 1904 TW Alexander Drive, Research
Triangle Park, NC, 27709 Documents related to Inspection history and compliance actions as follows: Warning Letters
Please provide the documents listed below for the following company: LabCorp, 7 Rue Moise-Marcinhes 7, 1217
Geneva, Switzerland Documents related to Inspection history and compliance actions as follows: Warning Letters
Records of lines of entries in which the following names and banners owned by The Albertsons Companies, or similar
variations of such names are listed as the FSVP importer
Stage 2 Submittal package documents for recently awarded projects for Funding Opportunity Announcement (FOA)
Number - RFA-FD-20-030
concerning the studies performed by or for the Application Holder concerning the effectiveness of the product: Dartisla
ODT (Glycopyrrolate) Tablet 1.7mg - Edenbridge N215019.
concerning the studies performed by or for the Application Holder concerning the effectiveness of the product:
Silvadene (Silver Sulfadiazine) Topical Cream 1% N017381 King Pharmaceuticals LLC
concerning the studies performed by or for the Application Holder concerning the effectiveness of the product: Twyneo
(Benzoyl Peroxide; Tretinoin) Topical Cream 3%; 0.1% N214902 - SOL-GEL TECHNOLOGIES LTD
This is to request Summary Basis of Approval (SBoA) for Reference Listed Drug: DECADRON (Dexamethasone Sodium
Phosphate) Ophthalmic Solution 0.1% with Application Number: N011984. The Applicant Holder is Merck and Co Inc.
We are hoping to obtain information related to historical and discontinued National Drug Codes.
We would like a copy of EIR audit report for the inspection which was occurred on 03/06/2019-03/08/2019. Firm name:
Sutumed Corporation Location of the inspected facility: 9280 College Pkwy Set 5 Fort Myers, FL 33919-4848. Type of
inspection record: FDA EIR report
All communications (including, but not limited to, emails, phone call transcripts, video call transcripts, and meeting
transcripts) between FDA officials and Pfizer representatives pertaining to the company’s vaccine for children under 5,
beginning in November 2021.
FDA Forms 483 request for listed organizations

483 1. UCB Pharma S.A., site of Braine-L’Alleud. Chemin du Foriest. B- 1420 Braine-L’alleud 2. UCB Pharma
GmbH,. Alfred-Nobel-Strasse 10. 40789 Monheim am Rhein]
ROMAINE LETTUCE OUTBREAK RECS
Testing results for FDA sample 1157659 from Century Foods International Plant 3
We would like to request information on which shipments our brokerage firm has transmitted "UKN" in place of the
FSVP Importer's D-U-N-S number.
Please provide the documents listed below for the following company: Global Submit, 123 S Broad St, Philadelphia, PA,
Please provide the documents listed below for the following company: Medidata Solutions Inc, 350 Hudson St, New
York City, NY, 10014 Documents related to Inspection history and compliance actions as follows: Warning Letters
To obtain individual case reports containing edited narratives
All records pertaining to the Remote Regulatory Assessment that was conducted in 2022 at Alere San Diego, Inc. dba
Immunalysis Corporation, Establishment Registration Number 2020952. The site is located in Pomona, CA, USA.
Please provide the documents listed below for the following company: Medpace Inc, 5375 Medpace Way, Cincinnati,
OH, 45277 Documents related to Inspection history and compliance actions as follows: Warning Letters 483's
Please provide the documents listed below for the following company: NeoGenomics Laboratories Inc, 31 Columbia,
Aliso Viejo, CA, 92656 Documents related to Inspection history and compliance actions as follows: Warning Letters
Please provide the documents listed below for the following company: NeoGenomics Laboratories Inc, 7256 South Sam
Houston Parkway West, Suite 300, Houston, TX, 77085 Documents related to Inspection history and compliance
actions as follows: Warning Letters 483's Establishment Inspection Reports Responses to Warning letters, 483's,
EIR's by company Consent decrees or other compliance/inspection information
Please provide the documents listed below for the following company: Oregon Health & Sciences University, 3181 SW
Sam Jackson Park Rd, Portland, Oregon, 97239 Documents related to Inspection history and compliance actions as
company Consent decrees or other compliance/inspection information
Please provide the documents listed below for the following company: PPD, 3900 Paramount Parkway, Morrisville, NC,
Please provide the documents listed below for the following company: Parexel International, 1 Federal St, Billerica,
Please provide the documents listed below for the following company: Parexel International, Suite 7, 3001 Hanover St,
Baltimore, MD, 21225 Documents related to Inspection history and compliance actions as follows: Warning Letters
Please provide the documents listed below for the following company: Parexel International, Parexel House, Castle
Wharf, 4 Canal St, Nottingham, UK, NG1 7EH Documents related to Inspection history and compliance actions as
company Consent decrees or other compliance/inspection information
Please provide the documents listed below for the following company: Pharm Olam, 450 N Sam Houston Parkway E,
Suite 250, Houston, TX, 77060 Documents related to Inspection history and compliance actions as follows: Warning
Please provide the documents listed below for the following company: Pharm Olam, 79 TW Alexander Drive, Research
Triangle Park, NC, 27709 Documents related to Inspection history and compliance actions as follows: Warning Letters
Please provide the documents listed below for the following company: Phlexglobal Inc, 400 Chesterfield Parkway, Suite
120, Malvern, PA, 19355 Documents related to Inspection history and compliance actions as follows: Warning Letters
Please provide the documents listed below for the following company: Polaris Compliance Consultants, 1151 Executive
Circle, Suite 202, Cary, NC, 27511 Documents related to Inspection history and compliance actions as follows:
Please provide the documents listed below for the following company: Pyxant Labs, 1121 E 3900 S, Building C, Suite
210, Salt Lake City, Utah, 84124 Documents related to Inspection history and compliance actions as follows: Warning
Please provide the documents listed below for the following company: Smithers, 11 Firstfield Road Gaithersburg, MD,
Please provide the documents listed below for the following company: Syneos Health, 100 Brandywine Blvd, George
School, PA, 18940 Documents related to Inspection history and compliance actions as follows: Warning Letters 483's
Please provide the documents listed below for the following company: Syneos Health, 1030 Sync St, Morrisville, NC,
Please provide the documents listed below for the following company: Tigermed-MacroStat LLC, 27 Selvage St,
Irvington, NJ, 07111 Documents related to Inspection history and compliance actions as follows: Warning Letters
Please provide the documents listed below for the following company: Treximo, 800 Hillgrove Ave, Suite 201, Western
Springs, IL, 60558 Documents related to Inspection history and compliance actions as follows: Warning Letters 483's
Please provide the documents listed below for the following company: WCG Clintrax Global, 5000 Centregreen Way,
Cary, NC, 27513 Documents related to Inspection history and compliance actions as follows: Warning Letters 483's
Please provide the documents listed below for the following company: WIRB-Copernicus Group, 212 Carnegie Center,
Suite 301, Princeton, NJ, 08540 Documents related to Inspection history and compliance actions as follows: Warning
Please provide the documents listed below forr the following company: Veristat, 134 Turnpike Road, Suite 200,
Southborough, MA, 01772 Documents related to Inspection history and compliance actions as follows: Warning
FDA WARNING LETTERS
FDA WARNING LETTERS
Copy of the 483 for the Dec 7, 2018 - Feb 4, 2019 (60 days) inspection of University Fertility Laboratory, Inc. [Torrance /
United States of America] 23550 Hawthorne Blvd #210, Torrance, CA 90505, USA. This inspection pertains to biologics
Copy of the 483 for the Feb 4, 2019 - Feb 8, 2019 (5 days) inspection of Polimeros y Servicios S.A. [- / Costa Rica] Parque
Industrial Condal Tibas Costa Rica. This inspection pertains to human drugs.
Copy of the 483 for the Nov 26, 2018 - Nov 30, 2018 (5 days) inspection of SnugZ USA, Inc. [West Jordan / United States
of America] 9258 S Prosperity Rd, West Jordan, UT 84081, USA. This inspection pertains to human drugs.
Copy of the 483 for the Sep 13, 2021 - Sep 24, 2021 (12 days) inspection of Lusys Laboratories, Inc. [San Diego / United
States of America] 10054 Mesa Ridge Ct Ste 118-120, San Diego, CA 92121, USA. This inspection pertains to medical
devices.
Copy of the 483 for the inspection of Alexandra Rogers, MD [Santa Barbara / United States of America] 540 W Pueblo St
Fl 3, Santa Barbara, CA 93105, USA beginning 09/27/21 and ending 10/01/21. This inspection pertains to MEDICAL
DEVICES.
Copy of the 483 for the inspection of Jose Luis Bautista, M.D. [Fresno / United States of America] 1350 O St, Fresno, CA
Copy of the EIR for the inspection of Alexandra Rogers, MD [Santa Barbara / United States of America] 540 W Pueblo St
Fl 3, Santa Barbara, CA 93105, USA beginning 09/27/21 and ending 10/01/21. This inspection pertains to MEDICAL
DEVICES.
Copy of the EIR for the inspection of Jose Luis Bautista, M.D. [Fresno / United States of America] 1350 O St, Fresno, CA
Electronic Technology Co Ltd., Beijing, China, end date 11-07-2017. FEI# 3012075817. This inspection pertains to
medical devices.
Report and/or the MDSAP Noncomformity Grading and Exchange Form (NC) for the inspection of Famidoc Technology
Co., Ltd., Changan Town, China, end date 03-30-2017. FEI# 3005621440. This inspection pertains to medical devices.
Report and/or the MDSAP Noncomformity Grading and Exchange Form (NC) for the inspection of GUANGDONG
BIOLIGHT MEDITECH CO., LTD, Zhuhai, China, end date 10-12-2017. FEI# 3007305624. This inspection pertains to
medical devices.
Report and/or the MDSAP Noncomformity Grading and Exchange Form (NC) for the inspection of Onbo Electronic
(Shenzhen) Co., Ltd, Shen Zhen, China, end date 10-26-2017. FEI# 3003010579. This inspection pertains to medical
devices.
Copy of the disclosable portions of all infant formula submissions from 01/01/2019 to the present for: (1) Enfamil
Gentlease; and (2) Enfamil Premium A2.
Regulatory Assessment of AstraZeneca Pharmaceuticals LP Located at Frederick MD United States FEI Number:
Regulatory Assessment of Genzyme A Sanofi Company Located at Waltham MA United States FEI Number: 3002525139
Regulatory Assessment of Glaxosmithkline Consumer Healthcare LP Located at Fresno CA United States FEI Number:
Regulatory Assessment of Janssen Ortho LLC Located at Gurabo PR United States FEI Number: 3002942061 held on
Please provide disclosable portions of all progress reports and any relevant correspondence or documentation related
to the task order HHSF22301003T (Performed under Contract: HHSF223201310030I) as it relates to work or research
performed by Battelle Memorial Institute, Battelle Public Health Research Center, and/or Jess Wilhelm regarding the
Effect of pH of Smokeless Tobacco Products on the Pharmacokinetics of Nicotine in Current Users.
Documents reflecting all confirmed cases of a child 11 years of age or younger dying of COVID-19.
Documents reflecting all confirmed cases of a child 11 years of age or younger, without a pre-existing health condition,
dying of COVID-19.
Documents reflecting all confirmed cases of a child 12 years of age through 15 years of age dying of COVID-19.
Documents reflecting all confirmed cases of a child 12 years of age through 15 years of age, without a pre-existing
health condition, dying of COVID-19.
> FDA Form 483 listing inspectional observations at Pfizer Healthcare India Private Limited (FEI: 3008316085) issued at
the end of inspections dated September 2018, September 2019, and any subsequent inspections at the facility
IRBs both in the United States and outside the United States that received such notices dated from January 1 to 31,
Any memoranda or other correspondence documenting FDA's decision regarding whether First Interchangeable
Exclusivity awarded to Semglee (insulin glargine-yfgn) under 42 U.S.C. 262(k)(6) etc
FCN 958 filed by Kureha Corporation, for polyglycolic acid (CAS: Reg. No. 26124-68-5), effective Jun 2, 2010
Pursuant to the Freedom of Information Act, 5 U.S.C. Section 552 et seq.("FOIA"), I request any and all information
related to the following adverse events: 20132931, 20200825, 20023535, 20055337, 1978426.
Hello, can you please provide a copy of the warning letter sent to Dr. Leslie Baumann on 01/11/2010 coded MACMIS
#18181 (BLA #125274) as well as her response to the letter.
Request FDA Submission Reviewer Memo Notes and FDA Consulting Memo Notes regarding the following CDRH
submissions. • G210116, Original IDE Application, FDA Submission Received April 13, 2021 • G210116-R001, etc
FOLLOW UP RECALL DATA

I am requesting all information pertaining to certain Aduhelm/aducanumab serious adverse event reports.
narrative case reports of the following FAERS cases Case ID Suspect Product Names Suspect Product Active Ingredients
20132931Aduhelm Aducanumab-Avwa 20200825 Aduhelm Aducanumab-Avwa 20023535 ETC
I'm requesting the current number of food facilities inspected by the FDA, as well as the number of food safety
inspectors employed by the FDA (and inspecting these facilities). These stats should be from 2022. Thank you!
All documentation relating to the January 10, 2020 anhydrous ammonia leak that occurred at a cold storage warehouse
located at 3776 Taylorsville Highway, in Statesville, North Carolina, including but not limited to complete copies of:
reports, memoranda, correspondence, violations, citations whether generated by your office or received by your office.
Copies of response to FOIA Requests 2019-11953 and 2019-10223.
Correspondence, reports, notes, transcripts and/or audio records regarding Minerva Surgical Inc
Individual adverse event reports submitted to FAERS relating to the use of Aducanumab aka Aduhelm (brand name)
unredacted to extent permitted by law.
List of all recipients who have received "It has come to our attention" (or similar) letters FDA sent to stem cell
clinics/entities from 2019 to present and an exemplar copy of the letter.
Status and progress of multiple investigations regarding complaints against Neil Sadick MD, Sadick Dermatology
practice, nurses Jennifer Schroeder Kennedy and Maria Russo, and Eclipse PRP (operating as REVIVE, a marketing
company for Eclipse).
The Isomedix Operations Inc Spartanburg site located at 2072 Southport Rd, Spartanburg, SC 29306-6256, FEI #1047843,
was inspected by the FDA on November 15-19, 2021. The inspection resulted in zero form 483 observations. Our firm
did not receive a copy of the Establishment Inspection Report (EIR) prepared following the conclusion of the inspection.
We are requesting a copy of the EIR at this time.
We respectfully request all documents and communications previously released under FOIA concerning NVX-CoV2373
(Novavax's Coronavirus vaccine candidate), including but not limited to the FOIA requests referenced in the attached
letter.
CITIZEN PETITION FDA-2013-P-0228-0001
1. The number of people in the USA who

have died at any time between January 1st 2020 through December 31 2021, after
having been injected with at least 1 dose of any of the Covid19 emergency use
authorization vaccines(Pfizer or Moderna or other).
All documents sufficient to support that COVID-19 vaccines do not change or interact with a vaccine recipient’s DNA in
any way.
Documents sufficient to show that COVID-19 vaccines are not driving the emergence of any variants that are resistant to
the immunity provided by COVID-19 vaccines.
(Rq. #1) Copies of Form 483s issued to the following DEVICE companies from December 1-31, 2021.
(Rq. #1) Copies of Form 483s issued to the following DRUG companies from December 1-31, 2021.
(Rq. #2) Copies of Form 483s issued to the following DRUG companies from December 1-31, 2021.
483 observation report applicable to LipidChem located in Johor, Malaysia from an FDA inspection that occurred
December 5, 2017.
Copies of Form 483s issued by the CDER Office from December 1-31, 2021:
ADM Protexin, Lopen Head, South Petherton, Somerset TA13 5JH; Requesting any FDA visit reports, or any records of
482, 483
Aspire Pharmaceuticals, 39 Veronica Ave, Somerset, NJ 08873 and 37 Veronica Ave, Somerset, NJ 08873 and 41
Veronica Ave, Somerset, NJ 08873; Requesting any FDA visit reports, or any records of 482, 483
Avanti Nutritional Laboratories; 14101 Commerce Way, Miami Lakes, FL 33016 and 14740 NW 60th Avenue, Miami, FL
33014 and 14050 Palmetto Frontage Road, Miami Lakes, FL 33016; Requesting any FDA visit reports, or any records of
482, 483
Bio-Botanica; 75 Commerce Dr, Hauppauge, NY 11788 and 85 Commerce Dr, Hauppauge, NY 11788; Requesting any
FDA visit reports, or any records of 482, 483
Captek Softgel; 16218 Arthur St, Cerritos, CA 90703 and 2710 Progress St, Vista, CA 92081; Requesting any FDA visit
reports, or any records of 482, 483
Copies of Form 483s issued to the following CLINICAL INVESTIGATOR from December 1-31, 2021:
Copy of the disclosable portions of all 483s and Warning Letters issued to Innovent, for all facilities in China, from
05/18/2021 - Present. Please note that this is a biologics firm.
EIR report issued to Jubilant Generics Limited Location No. 18, 56, 57 &58 Kiadb Industrial Area, Nanjungud, Mysore,
Karnataka 571302. EIR dated Feb 26, 2020 for Inspection conducted at the site 12-10-2018 to 12-18-2018.
K171708, Aloka Arietta 850.
K173739, Aloka Arietta 850.
Please provide a copy of the disclosable portions of any meeting minutes, meeting agendas, or decision logs created
between November 2, 2021 and February 15, 2022, by the “FDA Nicotine Steering Committee.”
summaries and any associated supporting CTP memoranda for the STN SE0015804.
for Foods & Cosmetics inspection of Agrosale, Inc. ending 01/25/2022 at the location in Miami FL, United States. Please
for Foods & Cosmetics inspection of BAJA FRESKO PRODUCE ending 01/24/2022 at the location in Los Angeles CA,
for Foods & Cosmetics inspection of Fres Co Llc ending 01/24/2022 at the location in Bronx NY, United States. Please
for Medical Devices & Rad Health inspection of Nelson Environmental Technologies, Inc. ending 01/24/2022 at the
location in Stafford TX, United States. Please send documents as email attachments.
for Human Drugs inspection of AMPAC Fine Chemicals, LLC dba AMPAC Analytical ending 10/17/2018 at the location in
El Dorado Hills CA, United States. Please send documents as email attachments.
for Human Drugs inspection of AbbVie Inc. ending 12/15/2021 at the location in North Chicago IL, United States. Please
for Biologics inspection of Nicola P. Klein, M.D. ending 01/03/2022 at the location in Oakland CA, United States. The EIR
(in electronic format) for Biologics inspection of Nicola P. Klein, M.D. ending 01/03/2022 at the location in Oakland CA,
United States. etc
Hello, Please provide all communications to or from Dr. Stephen Han received from or sent to Albert Bourla or
Stephane Bancel. Thanks
(1) all records, including communications, pertaining to a New Drug Application submitted by
Akebia on or about March 30, 2021, and accepted by the FDA on or about June 1, 2021, for a drug
called vadadustat etc
Please see attached letter.
Pursuant to the Freedom of Information Act (“FOIA”) 5 U.S.C. § 552 et seq., as amended, and the applicable agency
regulations, 21 C.F.R. Part 20, we request copies of all records that the FDA Center for Drug Evaluation and Research
produces regarding meetings attended by Patrizia Cavazzoni in response etc
We request the following data: The number of Submissions and Approvals within Drugs and Biologics per year 1990-
present
All documents relating to Dr. Susan Kalota and her involvement with the Center for Devices and Radiological Health
Medical Devices Committee. Please prioritize sending Dr. Susan Kalota's application to be on the Center for Devices and
Radiological Health Medical Devices Committee, which she was required by law to complete, and disclose all documents
related to her income and conflicts of interest.
all documents relating to the Food and Drug Administration’s investigation the voluntary recall of red, yellow, white,
and sweet onions because of possible Salmonella Newport contamination from May 1, 2020 to the present and any
correspondence with Onions 52, Inc. in relation to that investigation.
Would like to see a list of the exporters that have named Raley's, Raley's Distribution Center, and Raley's Family of Fine
Stores, as an FSVP Importer.
Please provide the Final Approval letter for ANDA: 204852; ANDA holder: Aurolife
I am requesting the testing records for K9 Naturals voluntary recall that FDA suggested to K9 Naturals.
I'm requesting all testing records for Redbarn, Chewy Louie, Bentley's, and Good Lovin' that resulted in the 03.06.18
recall announcement https://www.fda.gov/safety/recalls/ucm600124.htm
I'm requesting the testing records for Blue Ridge Beef of Eatonton, GA, is voluntarily recalling lot#GA0131 of BRB
Complete raw pet food because of the potential of contamination with Salmonella and Listeria monocytogenes.
for Human Drugs inspection of Vi-Jon LLC ending 10/13/2021 at the location in Saint Louis MO, United States. Please
for Animal Drugs & Feeds inspection of UPM Pharmaceuticals ending 10/28/2016 at the location in Bristol TN, United
for Human Drugs inspection of Rhodes Pharmaceuticals, L.p. ending 07/27/2016 at the location in Coventry RI, United
for Human Drugs inspection of UPM Pharmaceuticals ending 08/14/2015 at the location in Bristol TN, United States.
The Response (in electronic format) for Human Drugs inspection of UPM Pharmaceuticals ending 08/14/2015 at the
location in Bristol TN, United States. Please send documents as email attachments.
for Biologics inspection of Organon Teknika Corporation LLC ending 04/01/2016 at the location in Durham NC, United
States. The EIR (in electronic format) for Biologics inspection of Organon Teknika Corporation LLC ending 04/01/2016 at
the location in Durham NC, United States. Please send documents as email attachments.
for Human Drugs inspection of Aldrich Chemical Co LLC ending 12/13/2021 at the location in Miamisburg OH, United
States. The EIR (in electronic format) for Human Drugs inspection of Aldrich Chemical Co LLC ending 12/13/2021 at the
location in Miamisburg OH, United States. The Response (in electronic format) for Human Drugs inspection of Aldrich
Chemical Co LLC ending 12/13/2021 at the location in Miamisburg OH, United States. Please send documents as email
attachments.
CVs Steven Bowen, Yen-tso Kuo, Jose Torres, Lirissia Mccoy, Ninfa Innocent, Paul Klug, etc
2021-6826, 2021-7082, 2021-7573, 2021-8130, 2021-8132.
2021-8136, 2021-8156, 2021-8191, 2021-8217, 2021-8254.
2021-8291, 2021-8308, 2021-8366, 2021-8378, 2021-8551.
2021-8670, 2021-8673, 2021-8736, 2022-56, 2022-630.
Disclosable portions, including FDA Memo and correspondences, of DEN200069 Cognoa ASD Diagnosis Aid
Disclosable portions, including FDA Memo and correspondences, of DEN210005 Luminopia One.
2022-23
Disclosable portions, including FDA Memo and correspondences, of DEN210014 EaseVR.
Drug product ANDA approval letter

K100055 K100763 K101123 K101600 K101681 K101692
We would like to request all documents related to FCN No. 2001
See Request letter attached. Palladio is the owner of NDA 203009 and is requesting all e Files for this NDA to be sent to
ProPharma (authorized on our behalf).
Please provide Supplement-9 of NDA # 204200 dated 01/29/2019.
We request the following 510(k) Submissions: K172566 K152723 K181974
51K APPLICATION FOR ONCOBLOT SUBMITTED BY MORNUCO INC
LEPTOSPIROSIS VACCINE FOR DOGS COMPLAINTS, ETC
Under FOIA, I request all records from FDA-CVM for agency policy, agency regulations, and agency compliance policies
for pet foods containing only feed grade ingredients being labeled and marketed to consumers with human grade
pictures.
Who authorized the addition of an N3 Primer to be added to the COVID19 test kits in the initial phases of the COVID19
pandemic in 2019 until March 2020
All emails sent by Dr. Janet Woodcock.

All emails to and from Dr. Robert Califf.
All emails to and from Abby Capobianco, Alison Hunt, and Veronika Pfaeffle mentioning "Project Veritas" or
"Christopher Cole." Thanks
All emails to or from Dr. Janet Woodcock or Dr. Peter Marks mentioning "Project Veritas" or "Christopher Cole."
PFIZER BRIEFING DOCUMENT
Vaccine and Related Biological Products Advisory Committee (VRBPAC)

Briefing Document (BD) relating to the planned February 15, 2022 Meeting to
Discuss Request for Authorization of Pfizer-BioNTech COVID-19 Vaccine for
Children 6 Months Through 4 Years of Age, that was created, modified,
maintained, sent, or received by the FDA
Copies of all “meeting presentation(s)” relating to the Vaccine and Related
Biological Products Advisory Committee (VRBPAC) February 15, 2022
Planned Meeting to Discuss Request for Authorization of Pfizer-BioNTech
COVID-19 Vaccine for Children 6 Months Through 4 Years of Age, that were
created, modified, maintained, sent, or received by the FDA, or sponsored,
submitted or sent by Pfizer, BioNTech or its agents to the FDA.
All emails and their attachments received by the FDA, sent from Pfizer or
BioNTech, in connection with the planned February 15, 2022 Vaccine and
Related Biological Products Advisory Committee (VRBPAC) Meeting to
Discuss Request for Authorization of Pfizer-BioNTech COVID-19 Vaccine for
Children 6 Months Through 4 Years of Age.
Who authorized the use of a N3 primer until February 26, 2020 under the Emergency Use Authorization Act to be
added to COVID19 PCR test kits that botched COVID19 test results for USA citizens until February 26, 2020?
Provide the FIRST AND LAST NAME of the person(s) that recommended and/or authorized the use of a N3 primer (until
February 26, 2020 under the Emergency Use Authorization Act) to be added to COVID19 PCR test kits that botched
COVID19 test results for USA citizens until February 26, 2020.
Please provide the 483 and EIR for the inspection ending 4/24/2019 for Sharp Packaging Services, LLC at 7541 Keebler
Way / Allentown PA (FEI Number 3004161147).
The subject of the following FOAI request is to obtain the following 510(k) Premarket Notification records: Mazor X
(Mazor Robotics Ltd.) - K163221, Excelsius GPS (Globus Medical Inc.) - K171651, and ExcelsiusGPS Spine 1.1 Interbody
Module (Globus Medical Inc.) - K191100.
We are interested in obtaining any Form 483s related to Braeburn Pharmaceuticals Inc. manufacturing at Pharmaceutics
International in Hunt Valley, MD. Please also include any additional documentation available from the BRIXADI pre-
approval inspections at this facility.
We are interested in obtaining any materials, documentation, or files related to the Office of the United States Attorney
for the Southern District of New York’s informal request to Indivior PLC regarding allegations around the manufacturing
process for the drug Suboxone. We would also like to receive a copy of any complaints submitted to the FDA against
Indivior.
Hi FDA, I am a reporter in North Carolina with the USA Today Network, writing with the following information request:
1. A list of the people and/or facilities in North Carolina that currently hold a permit to feed garbage to swine as defined
in this state information page: http://reports.oah.state.nc.us/ncac/title%2002%20-%20agriculture%20and%20consumer
%20services/chapter%2052%20-%20veterinary/subchapter%20h/subchapter%20h%20rules.pdf
Hi, please provide all emails from Janet Woodcock and Peter Marks mentioning "Pfizer" or "vaccine."
Family Dollar inspection report
Please release the Establishment Inspection Report for the Family Dollar warehouse for the inspection that ended on
Feb. 11, 2022.
Under the U.S. Freedom of Information Act, I am asking for a copy of the Establishment Inspection Report for the Family
Dollar Distribution Facility in West Memphis, AR, which was the basis for this recent FDA alert:
https://www.fda.gov/news-events/press-announcements/fda-alerts-public-potentially-contaminated-products-family-
dollar-stores-six-states Thank you!
all records containing the following information: Any communication between Molly Fogarty (Nestle Lobbyist) and the
three following FDA representatives Tracey Sanders (Food Safety Issues); Kari Barrett (Public Engagement); Larry Morris
(Office of Foods and Veterinary Medicine) between the dates of 01/01/2018 through 01/01/2022.
A copy of the documents provided to Consumer Reports last year relating to Johnson & Johnson's Sunscreen/Benzene
CDER Health Hazard Evaluation form in response to Consumer Reports' FOIA request.
Norditropin, a growth hormone manufactured by Novo Nordisk, issues Prescription Information that contains Table 1
entitled "Adverse Reactions with 5% or more Overall Incidence in Adult Onset Hormone." I would like the study or
studies submitted to the FDA by Norditropin or Novo Nordisk that explain or support or refer to Table 1.
I'd like all studies conducted for the following drugs: Dexedrine Spansule, Zenzedi, ProCentra, Adderall, Ritalin, and
Vyvanse.
Records of adverse effects of the Johnson & Johnson COVID-19 Vaccine.
Copies of FDA Communications (i.e., No further comments, DMF Adequate) for DMF 024418. Nobilus Ent. was the
holider of the DMF at this time; the current holder of the DMF is C-squared PHARMA S.à r.l. B&H Consulting Services,
Inc. is the US Agent for Noblius Ent (Designation Letter attached).
I am seeking for detailed information of the following 4 FCN dossiers:FCN 2076, FCN 1463,FCN 1935,FCN 830.I’d also like
to request technical review memoranda or other pertinent documents associated with these FCNs.The language can be
in English. We are willing to pay fees for the processing of the FOIA request. The detailed information in the FOIA
request letter is attached for your reference.
Family Dollar warehouse in West Memphis violations
Laboratory Packet for FDA Sample 1117538
-Please provide a full copy of the Establishment Inspection Report, the Form 483 along with the Notice of Inspection and
any other responses from the company or related documents for the inspection conducted from January to Feb 11th of
2022 at the Family Dollar Distribution Center in West Memphis, AR. etc
The inspection report of the Family Dollar distribution facility in West Memphis, Arkansas, related to the inspection
that concluded on Feb. 11.
My name is Annabelle Timsit and I am a reporter for The Washington Post. I am writing with a request under the
Freedom of Information Act. I am requesting a copy of the final report from FDA inspectors who investigated Family
Dollar Distribution Center 202 in West Memphis, Arkansas, in January and February 2022, including any photos or
videos taken in the course of the investigation of the facility.
I would like a copy of the cease and desist letters send to Goldreallas LLC for any and all products with the Goldreallas
trademarked logo. This includes but are not limited to Goldreallas Original and Goldreallas XXX. The FDA has a Public
Notice on 6/02/2014 and 2/03/2017. There maybe more.
I would like additional information on Import Alert 45-02 for Very Amazing Products Limited where we saw our name
and a product manufactured by us on the Red list and would like additional information regarding why our product is
listed there.
Please provide the following 1 inspection-related documents in electronic PDF format: The Establishment Inspection
Report (in electronic format) for inspection of K.C. Pharmaceuticals, Inc. (Sterile OTC Drug (Eye Drop) Manufacturer)
ending 01/30/2020 at the location in 3201 Producer Way Pomona, CA 91768.
Human adverse event drug MedWatch Reports for the following case IDs: 19972654 19983612 20021625 20025189
20025243 20025363 20025460 10619468 10602048 10507876 10507497 10506833
for Biologics inspection of BioLife Plasma Services LP ending 12/16/2021 at the location in Jacksonville FL, United States.
for Biologics inspection of CSL Plasma Inc. ending 12/15/2021 at the location in South Portland ME, United States.
for Biologics inspection of CSL Plasma Inc. ending 12/16/2021 at the location in Dothan AL, United States. Please send
I am writing to request copies of the chemistry and toxicology review memoranda from Food Contact Notifications
(FCNs) 1583 and 1584. We believe these files reside in the records of the Food and Drug Administration’s (FDA) Office of
Food Additive Safety (OFAS). If possible, we would prefer to receive the files for each FCN as they may become available,
rather than waiting to receive all of them at once.
for Biologics inspection of SAFC Carlsbad Inc ending 12/16/2021 at the location in Carlsbad CA, United States. Please
for Biologics inspection of Signature Biologics, LLC ending 12/16/2021 at the location in Irving TX, United States. Please
description of serious adverse events for the drug ORLAAM: deaths, hospitalizations, all other 'serious' types.
format) for Human Drugs inspection of Q Laboratories Inc ending 11/21/2019 at the location in Cincinnati OH, United
for Foods & Cosmetics inspection of Gourmet Boutique LLC ending 02/14/2020 at the location in Jamaica NY, United
States. The Response (in electronic format) for Foods & Cosmetics inspection of Gourmet Boutique LLC ending
02/14/2020 at the location in Jamaica NY, United States. Please send documents as email attachments.
for Medical Devices & Rad Health inspection of Zyno Electric & Machinery Ltd, Shanghai ending 08/16/2018 at the
location in Shanghai, China. The Response (in electronic format) for Medical Devices & Rad Health inspection of Zyno
Electric & Machinery Ltd, Shanghai ending 08/16/2018 at the location in Shanghai, China. Please send documents as
email attachments.
request for most recent GMP inspection ( issued 483 ) to both Transfer Technology, INC located at 5702 Bolsa Ave. Suite
200, Huntington Beach, California (CA) 92649 USA , this facility is linked to DUNS 037968132, as well as the most recent
GMP inspection of Akron Coatings and Adhesives, located at 365 Stanton Ave, Akron, Ohio (OH) 44301, United States
(USA), this facility is registered under DUNS # 186569323 and FEI# 3001992168
PREVIOUSLY RELEASED INSPECTION RECS
Hello, I am hoping to get a list of manufacturers/suppliers and associated product code descriptions for imports that we
have been listed as the Import of Record during the time period from January 1st of 2019 through February 22nd, 2022.
Our FEI number is 3005022724. Thanks!
Hello, We would like the list of all Outsourcing Facility Products for 2021. In other words, we need the list of all the
products each Outsourcing Facility makes. Sincerely, Genevieve
Please provide the most recently approved labeling (i.e., Container, Carton, and Package Insert) for all presentations for
the RLD for Sterile Water for Injection, USP (Hospira NDA 018801).
I am requesting the FDA forms 483 for inspections of Abbott Nutrition's Sturgis, Michigan facility ending Sept. 24, 2021
and Sept. 24, 2019.
A copy of the complete Summary Basis of Approval for TYRVAYA (Varenicline Tartrate) Nasal Spray’s New Drug
Application (NDA 213978), owned by Oyster Point Pharma and approved on October 15, 2021, including all available
reviews (e.g., Medical, Chemistry, Pharmacology, Statistical, etc.) and correspondence pertaining to the application.
All supporting information, studies or documents related to over-the-counter hearing aids.
emails (with or without text) showing email communications to or from OPDP (and/or Andrew S. T. Haffer, Pharm D,
OPDP) regarding a company, Cytodyn, Inc. and any other departments or individuals within HHS/CDC/and/or OPDP itself
Electronic listing (preferably csv format) of all inspections conducted by FDA since September 1, 2021. The list should
cover all FDA centers and include each FDA inspection ID number, DUNS number and reason for inspection.
Requesting the Agency to provide list of last five years Form 483 (Notice of Inspectional Observations) for Biological E.
Limited with FDA establishment identifier # 3008377265.
An electronic spreadsheet (not PDF, please) of Voluntary Cosmetic Registration Program (VCRP) data, including VCRP
category frequency of use totals, ingredient and category totals of frequency of use data, as well as just ingredient
frequency of use totals, as has been provided in recent years.
FDA Staff Manual Guide 4850.7
RECS RE OUTBREAK IN ENOKI MUSHROOMS
Copy of the intake information of a complaint against CK Products, LLC. made this year stating to the effect that Scott
Osburn was not putting “polysorbate” and “vegetable gum” or substituting them in a product for “American Crafts”.
We are specifically seeking the name of person making the complaint and the date of the complaint along with any
other statements recorded of the individual against CK Products, LLC.
K191412 to include safety and effectiveness information supporting the FDA finding of substantial equivalence
Per FOIA: Provide records on Robert M. Califf, M.D including 1. A Copy of Oath of Office 2. The surety Bond/ Fidelity
Bond/Insurance policies covering errors & omissions, crimes, negligence, liability, violation of Constitution, violation of
Public Trust, umbrella insurance policy and any and all other coverage or reinsurance to cover his liability as a public
official, 3. a copy of the Power of Attorney that he gave to the Bond Holder, as applicable. etc
Requesting the Agency to provide list of last three Form 483 (Notice of Inspectional Observations) for Recipharm Monts
with FDA establishment identifier # 1000171152.
A copy FDA’s memorandum documenting the disposition of 180-day exclusivity for Dasatinib Tablets, 80 mg and 140
mg, approved under ANDA 203180 on November 23, 2021.
A list of farms that grew samples of "Josie's Organic Baby Spinach" that tested positive for E. Coli in Minnesota.
Copy of the disclosable portions of the 483 for the January-February, 2022 inspection of Family Dollar, located in West
Memphis, Arkansas.
Case records from the FDA Adverse Event Reporting System (FAERS) referencing magrolimab (a monoclonal antibody
designed to block the macrophage inhibitor immune checkpoint cluster of differentiation 47, or CD47), which is being
developed by Gilead Sciences and its subsidiary Forty Seven Inc.
K211526, K191166, K173032, K170871, K163484. - Clinical Testing Data and/or Reports related to the following 510(k)
Premarket Notification submissions: K211526, K191166, K173032, K170871, K163484. Sincerely, Aaron Hannon
+353864419492
For GRAS Notice Number 1001, we kindly request: 1. GRAS notice amendments 2. Email correspondence between FDA
and the notifiers 3. Internal FDA correspondence regarding the notice
Hi, We would like to request an electronic copy of the FDA direct report to FAERs for the following 3 cases: 20045958
(granisetron) 20099108 (aprepitant) 20187412 (aprepitant) In order to assess impact to Heron marketed products.
Many thanks! Tricia
Please provide FOIA request for MedWatch 20048590
Pursuant to the Freedom of Information Act (FOIA), 5 U.S.C. § 552, I hereby request the production of FDA’s
correspondence with ECI Pharmaceuticals, LLC, dated October 26, 2021 and December 10, 2021, which are referenced
in CDER’s February 3, 2022 Warning Letter to ECI Pharmaceuticals, LLC (WL #2267). Please include all attachments and
exhibits to the aforementioned FDA correspondence
Quality Assurance Profiles for: Quotient Sciences, 3080 McCann Farm Drive, Garnet Valley, PA 19060 Quotient Sciences,
3 Chelsea Pkwy, Bothwyn, PA 19061 Eurofins, 4780 Discovery Drive, Columbia, MO Alcami Corproation, 2320 Scientific
Park Drive, Wilmington, NC 28405
We request an electronic list of all FDA Prior Notice information submitted to FDA where the manufacturer is La
Casearia Carpenedo, SRL (FFR 18193190696) from October 1, 2021 to October 31, 2021
We are requesting FOI versions of the 3 following 510(k)s: (1) Baxter MiniCap Extended Life PD Transfer Sets - K192705
(2) Baxter FlexiCap Disconnect Cap With Povidone-Iodine Solution, MiniCap With Povidone-Iodine Solution - K152129
(3) Fresenius Stay safe® catheter extension set with Safe-Lock - K173593
483 issued to Lifepoint Research, Wakad, Pune, India
Request a copy of the Quality Assurance Profile (QAP) for GBA Pharma GmbH as a release and stability testing facility for
human drugs. GBA Pharma GmbH, Anna-Sigmund-Strasse 7, Neuried, Bavaria 82061, Germany. FEI: 3004477049, DUNS:
342374604
I need individual case safety reports (ICSRs) of Covid vaccines (Pfizer-BioNTech COVID-19 Vaccine (Comirnaty), Moderna
COVID-19 Vaccine (Spikevax), Janssen COVID-19 Vaccine) received at FDA. The ICSRs can be in XML, CSV, or excel
format. It would be good to include all reports types such as spontaneous, studies, emergency use etc. in the ICSR
datasets.
I'm requesting access to and copies of the following: - Records released in response to FOIA request #2022-1498 when
those records are processed.
I'm requesting access to and copies of the following: - The Form 483 issued in response to an inspection conducted of a
facility owned by Abbott Nutrition, located at 901 N Centerville Rd, Sturgis, MI 49091-9302. The inspection ended on
9/24/2019.
I'm requesting access to and copies of the following: - the Form 483 issued in response to FDA inspection (ID #:
1153684) of a facility operated by Abbott Nutrition, located at 901 N Centerville Rd, Sturgis, MI 49091-9302. The
inspection end date was 9/24/2021.
I'm requesting access to and copies of the following: - the Form 483 issued in response to FDA inspection (ID #:
1153684) of a facility operated by Abbott Nutrition, located at 901 N Centerville Rd, Sturgis, MI 49091-9302. The
inspection end date was 9/24/2021.
Pursuant to The Freedom of Information Act, I am writing to respectfully request information about FDA breakthrough
therapy decisions contained in FDA presentations from the FDA/CMS Summit held every year in December. I am
specifically trying to track down the CDER New Drugs Program Update presentations that was presented at the 2020 as
well as the 2021 summits.
Any internal review of cosmetic talcum powder in relation to ovarian cancer.
Record for Nutraceutical Product called Legal Lean sexual enhancement liquid. I'd like to know the manufacturer's
name of this product to check if I can export this product overseas.
The Compliance Policy Guideline -CPG 540.525 has undergone multiple changes, to wit; Issued: 10/1/80 Reissued:
7/1/81 Revised: 10/30/89, Revised:3/95, Revised:7/26/95, Revised: 5/2005 Updated: 11/29/2005 I am requesting a
copy of the original issuance and each revision. Thanks JDB
VAERS report for vaccination administered 8/21/2020
NDA 20414/S-001 and NDA 20414/S-005
Documents submitted by an EUA sponsor leading to issuance of the EUA210417 for Device "BD Veritor At-Home COVID-
19 Test". I am requesting access to technical documentation submitted by the sponsor in support of their original EUA
application for which the authorization letter was issued on August 24th, 2021.
I would like to request the FDA Inspection reports for Trinity Biotech (Primus Corporation dba Trinity Biotech) located at
4231 East 75th Terrace, Kansas City, MO 64132 for the following inspection dates:
08/28/2018 - 09/06/2018 (Auditor Eric Fox)
01/27/2020 - 02/06/2020 (Auditor Christina Bigham) 09/13/2021 - 09/17/2021 (Auditor Eric Fox)
FDA FAERS database for sotorasib (brand name LUMAKRAS).

I am requesting all the FDA Adverse Event Reporting System (FAERS) reports and events for Biomarin's Voxzogo
(vosoritide) which was approved on November 19, 2021
Copy of the 483 for the Aug 17, 2021 - Aug 24, 2021 (8 days) inspection of Blaine Labs Inc [Santa Fe Springs / United
States of America] 11037 Lockport Pl, Santa Fe Springs, CA 90670, USA. This inspection pertains to human drugs.
Report and/or the MDSAP Noncomformity Grading and Exchange Form (NC) for the inspection of Dako Denmark A/S,
Glostrup, Denmark, end date 05-18-2018. FEI# 3002806778. This inspection pertains to medical devices.
Copy of the 483 for the Aug 2, 2021 - Aug 5, 2021 (4 days) inspection of Curewave Lasers LLC [Dallas / United States of
America] 4101 McEwen Rd #670, Dallas, TX 75244, USA. This inspection pertains to medical devices
Copy of the 483 for the Jul 28, 2021 - Aug 25, 2021 (29 days) inspection of DeVilbiss Healthcare LLC [Somerset / United
States of America] 100 Devilbiss Dr, Somerset, PA 15501, USA. This inspection pertains to medical devices.
Copy of the 483 for the Jul 7, 2021 - Jul 30, 2021 (24 days) inspection of Criticare Systems, Inc [North Kingstown / United
States of America] 125 Commerce Park Rd, North Kingstown, RI 02852, USA. This inspection pertains to medical devices.
Copy of the 483 for the inspection of Mark R. Newton, M.D. [Waterloo / United States of America] 146 W Dale St,
Waterloo, IA 50703, USA beginning 09/20/21 and ending 09/23/21. This inspection pertains to MEDICAL DEVICES.
Copy of the EIR for the inspection of Juan M. Ruiz-Unger, M.D. [- / -] 9000 SW 152nd St STE 202, Palmetto Bay, FL 33157,
USA beginning 09/13/21 and ending 09/22/21. This inspection pertains to HUMAN DRUGS.
Copy of the EIR for the inspection of Mark R. Newton, M.D. [Waterloo / United States of America] 146 W Dale St,
Waterloo, IA 50703, USA beginning 09/20/21 and ending 09/23/21. This inspection pertains to MEDICAL DEVICES.
Copy of the EIR for the inspection of Sabine S. Hazan, M.D. [Ventura / United States of America] 1835 Knoll Dr, Ventura,
CA 93003, USA beginning 09/13/21 and ending 09/21/21. This inspection pertains to BIOLOGICS.
Report and/or the MDSAP Noncomformity Grading and Exchange Form (NC) for the inspection of Arrow International
CR, a.s., Hradec Kralove 4, Czech Republic, end date 11-15-2018. FEI# 1000563940. This inspection pertains to medical
devices.
Report and/or the MDSAP Noncomformity Grading and Exchange Form (NC) for the inspection of DGS DIAGNOSTICS A/S
(POLAND), Middelfart, Denmark, end date 06-14-2018. FEI# 3012249824. This inspection pertains to medical devices.
Report and/or the MDSAP Noncomformity Grading and Exchange Form (NC) for the inspection of Immunotech A.S.,
Prague 10, Czech Republic, end date 11-02-2017. FEI# 3003385757. This inspection pertains to medical devices.
Please provide the disclosable portions of the Comparative Brand Analysis (“FDA 50”) data set, which was a 2011
analysis of 50 popular cigarettes funded by an interagency agreement (224-10-9022) between CTP and CDC. Please also
include any associated unpublished analyses, test protocols, or supporting memoranda.
and dog and cat treats from 11.01.2021-01.31.2022. etc
All records provided for 2018-7843 "I'm requesting FDA records for or relating to HPP being a kill step for pet food
and/or raw pet food"
I am requesting all testing records related to pet food company Vibrant K9 for the year of 2020. On March 10, 2020
Frank Lee of FDA Division5W (Los Angeles District) wrote the company Vibrant K9 and stated their raw turkey blend was
"recently tested and the presence of bacteria was found." Please provide all testing records related to company Vibrant
K9
I'm requesting all video from Sean Duke filmed on this day 01.23.19 (employee info: works at
/DHHS/FDA/ORA/ORA/OHAFO/OHAFOE/DHAFOEII/HAFIB, Job Title Is CONSUMER SAFETY OFFICER, email is
Sean.Duke@fda.hhs.gov)
I'm requesting calendar records for dan mcchesney, for the dates of 09.10.17 through 09.16.17
I'm requesting this testing record from a recall initiated by FDA in July of 2015 Bravo Blend Chicken diet for dogs & cats -
Chub Item # 21 - 102 UPC 829546211028 http://wayback.archive-it.org/7993/20170112072656/http://www.fda.gov/
Safety/Recalls/ArchiveRecalls/2015/ucm455867.htm
I'm requesting this testing record from a recall initiated by FDA in July of 2015 Bravo Blend Chicken diet for dogs & cats -
Chub Item # 21 - 102 UPC 829546211028 http://wayback.archive-it.org/7993/20170112072656/http://www.fda.gov/
Safety/Recalls/ArchiveRecalls/2015/ucm455867.htm
The appeals log or spreadsheet record showing appeals logged by FDA FOIA department in the month of September
2021-December 2021
The Federal Register of 1/12/2018 listed under "Food and Drug Administration—Completed Actions": "Sequence No.
249, Title Updated Standards for Labeling of Pet Food, Regulation Identifier No. 0910-AG09". Please provide all
'completed actions' performed by FDA for updated standards for labeling of pet food. Please provide detailed
information on what pet food label changes were completed by FDA per this Federal Register disclosure.
Data and records for the term "hydrogenated fat" submitted to CVM in October 2018.
All response letters and records provided for FOIA requests 2021-5112, 2021-5114, 2021-5389, 2021-5696
Copy of the disclosable portions of all EIRs, 483s, Warning Letters, and Company Responses for BrightFarms, located in
Rochelle, Illinois, from 01/01/2021 - 12/31/2021. Please note this inspection pertains to Foods.
EXCEL LIST OF INSPECTIONS OF APIs
for Human Drugs inspection of New Vision Pharmaceuticals LLC ending 10/29/2021 at the location in Tamarac FL,
for Animal Drugs & Feeds inspection of Sparhawk Laboratories Inc ending 03/23/2021 at the location in Lenexa KS,
United States. The 483 (in electronic format) for Human Drugs inspection of Aire-Master of America Inc ending
10/19/2021 at the location in Nixa MO, United States.
for Medical Devices & Rad Health inspection of Aesculap AG ending 07/16/2015 at the location in Tuttlingen, Germany.
The 483 (in electronic format) for Medical Devices & Rad Health inspection of ORPYX MEDICAL TECHNOLOGIES INC.
ending 02/15/2019 at the location in Calgary, Canada.
I am asking for the resulting report from the Foreign Remote Regulatory Assesment (FRRA) held from August 9th to
16th ,2021 at the seafood processing plant PRODUCTOS MAR y SOL S.A. de C.V., located at Canton El Jaguey, La Union El
Salvador, Central America Thank you
for Foods & Cosmetics inspection of Nate's Fine Foods LLC ending 12/17/2019 at the location in Roseville CA, United
States. The Response (in electronic format) for Foods & Cosmetics inspection of Nate's Fine Foods LLC ending
12/17/2019 at the location in Roseville CA, United States. ETC
Reviewers' summaries regarding EX0001634.PD1-EX0001637.PD1
We would like to request copies of the 510k submissions for the following devices: K171626 - truFreeze® System, and
K072883 - Arbel Medical ICE-SENSE® Device Best regards, Nathan Slota
I request a copy of the most recent results of Total Diet Study (TDS) data with copies of updated sampling reports from
October 2017 until January 2022 containing the TDS modernizing methods to understand American’s dietary exposure
to industrial chemicals to be provided to me in the form of a pdf or excel spreadsheet in a digital format.
K131401, K153501
One copy of the "Report of the Center for Devices and Radiological Health (CDRH) Task Force for Retrospective Review
of the Recordkeeping and Reporting Requirements of 21 CFR 1002". The report was published in or after 1985.
The completed FDA-2579 form notifying FDA of the assembly of the Philips Brilliance 10-Slice CT Scanner at St. John's
Riverside Hospital, Dobbs Ferry Pavilion, 128 Ashford Ave, Dobbs Ferry, NY 10522. The precise date of assembly is not
known, but it is expected to be in or after 2005, the year the CT scanner was manufactured.
Dear Sir / Madam,

I am requesting a copy of the Remote Regulatory Assessment Report for Clearlab US INC. The report will be used to
ensure any difficiencies identified during the RRA will be corrected.
The RRA was carried out by US FDA Employee: Ms. Dawn M. Braswell over the following dates:
04 February 2022
07 February 2022
09 February 2022
11 Februrary 2022
Clearlab Participants
Dr. John Christopher Phelan
Ms. Sohee Kim
Clearlab US INC
4200 Jenkins Court
Suwanee GA 30024
483: 3-D Matrix, Inc. Newton, Massachusetts End Dates of inspection: 17 November 2021 Project Area: Compliance:
Devices FEI: 3015528146 District Decision: VAI I confirm that Clarivate Analytics will be charged accordingly by FOI for
All communications between FDA’s Center for Veterinary Medicine and the Association of Animal Feed Control Officials
(AAFCO) that include the terms “Tenebrio” or “mealworms,” from January 1, 2017 to present. ETC
All documents of FDA’s Center for Food Safety and Applied Nutrition (CFSAN) include the words “cricket flour,”
“mealworm flour,” or “mealworm powder,” from January 1, 2017 to present.
SE0018246 ETC
Hi, please provide all emails to or from Dr. Peter Marks mentioning "vaccine" or "Pfizer" sent to or received from Hana
El Sahly, Hayley Altman-Gans, Adam Berger, Archana Chatterjee, Henry Bernstein, Amanda Cohn, Holly Janes, Arnold
Monto, David Kim, Paul Offit, Steven Pergam, Eric Rubin, Andrea Shane, and Geeta Swamy.
All communications from to or from Jane Baumblatt and Narayan Nair mentioning "Moderna." Exclude duplicates.
Hello, please provide all emails from Dr. Marks to Marion Gruber or Phil Krause.
Hi, please provide all communications from Drs. Rachel Zhang, Anuja Rastogi, and Jaya Goswami mentioning "Moderna"
or "vaccine." Thanks
Hi, please provide all communications from Hong Yang, Patrick Funk, and Osman Yogurtcu TO one of the others in this
group. For example, please provide all communications from Hong Yang to Patrick Funk or Osman Yogurtcu. Thanks
We would like to request the TPL and any scientific disciplinary reviews for the 4 Verve tobacco products (STNs
PM0000470-PM0000473) that received marketing granted orders on October 19, 2021.
Copy of the disclosable portions of the salmonella serotypes identified for all samples collected from Sunland, Portales,
NM between 09/17/2012 - 10/16/2012. Please see attached. This request is related to foods.
For GRAS Notice Number 42, we kindly request: 1. GRAS notice amendments 2. Email correspondence between FDA and
the notifiers 3. Internal FDA correspondence regarding the notice
Information regarding inspections of Royal Ice Cream Company, Manchester, CT 12/01/2020 & recall info 02/2022.
Please see attached for further information.
Form 483 and EIR for Inspection of Bristol-Myers Squibb Holdings Pharma Ltd. Liability Company , Manati PR 00674.
Inspection ID 1147009, end 07/12/2021.
1. All Substantial Equivalence orders issued for tobacco products between January 1, 2021 and February 25, 2022. 2.
All Substantial Equivalence Exemption Request orders issued for tobacco products between January 1, 2021 and
February 25, 2022.
Regulatory Assessment of 3M Company Located at Columbia MO United States FEI Number: 3003399824 held on
01/13/2021.
Regulatory Assessment of CSL Plasma, Inc, Located at Port Arthur TX United States FEI Number: 3013158871 held on
01/20/2021.
Regulatory Assessment of CSL Plasma, Inc. Located at Norman OK United States FEI Number: 1000118555 held on
01/11/2021.
Regulatory Assessment of Pfizer Pharmaceuticals LLC Located at Vega Baja PR United States FEI Number: 2623619 held
The full 510k submission number K111943 for "Agilis PF Introducer System", Applicant Name: St. Jude Medical, CRMD,
Cleared on: September 29, 2011
The full 510k submission number K191546 for "Epicardial Access System", Applicant Name: Baylis Medical Company
Inc., cleared on August 2 2019
DEN160056 De Novo Submission to FDA (Philips IntelliSite Pathology Solution Original and Deficiency Responses
(Supplements))
all of the deaths heart attacks or any comucations from the pfizer covid vacceine from 2020 to the prescient
1.) Payments and documents relating to payments from Pfizer-BioNTech under THE PRESCRIPTION DRUG USER FEE ACT
for COVID Vaccine approval process. 2.) Payments and documents relating to payments from Moderna under THE
PRESCRIPTION DRUG USER FEE ACT for COVID Vaccine approval process. 3.) Payments and documents relating to
payments from Jansen or Johnson and Johnson under THE PRESCRIPTION DRUG USER FEE ACT for COVID Vaccine
approval process.
All data and information for the Moderna Vaccine enumerated in 21 C.F.R. § 601.51(e) with the exception of publicly
available reports on the Vaccine Adverse Events Reporting System. See letter for further details.
End of Phase 2 clinical trial (NCT02858895) meeting notes between Medicenna Therapeutics Corp and the FDA
regarding the regulatory and commercial pathway for MDNA55 and proceeding with the open-label hybrid control
design for a Phase 3 registration trial of MDNA55 in rGBM patients.
First party copy of any/all information collected for Limbrel (Flavocoxid)

Foreign Remote Regulatory Assessment. Lacteossa, FEI #: 3005827010
Studies from NDA 20-657 & NDA 22-561. Please see the second page of the attachment for a list of the studies.
Please provide the Summary basis of approval for Sterile Water for Injection for ANDA 211188 (Applicant Medefil Inc.).
Specifically, we request to see Sections 32S, 32P4, and 32P5 of the approved application.
1. All emails and written correspondence, both internal and with the manufacturers of Mifeprex and Mifepristone
regarding review and acceptance of those drugs’ drug stability and dissolution test results. 2. Reports from all FDA
inspections and assessments of DANCO and GenBio manufacturing facilities, and assessment of compliance with
applicable laws and regulations.
1. Investigational New Drug Applications and related materials for the drug Mifeprex and its generic equivalent,
Mifepristone. 2. New Drug Applications and related materials for the drug Mifeprex and its generic equivalent,
Mifepristone.
1. Stability test results for the drug Mifeprex and its generic equivalent, Mifepristone, pursuant to ICH requirements,
including but not limited to, records reflecting long-term stability, and accelerated and forced degradation results. 2.
Drug Product Transportation Stability studies for the drug Mifeprex and its generic equivalent, Mifepristone, including
but not limited to, the expiry and temperature statements. 3. Dissolution test results for the drug Mifeprex and its
generic equivalent, Mifepristone.
Hello, please provide all communications from Dr. Janet Woodcock mentioning "Ron Johnson" or "Ted Cruz". Thank you
Hi, please provide all emails mentioning "Stieber" or "Epoch" from Abigail.Capobianco@fda.hhs.gov and
Alison.Hunt@fda.hhs.gov
Hi, please provide all emails mentioning "Stieber" or "Epoch" from Drs. Woodcock and Marks.
effective/tentative approval letter for ANDA No. 208303
483: AbbVie Inc. North Chicago, Illinois End Dates of inspection: 15 December 2021 Project Area: Bioresearch
Monitoring FEI: 3009751352 Classification: VAI I confirm that Clarivate Analytics will be charged accordingly by FOI for
483: ADMA Biologics Inc. Boca Raton, Florida End Dates of inspection: 12 August 2021 Project Area: Vaccines
and Allergenic Products FEI: 1000525461 Classification: VAI I confirm that Clarivate Analytics will be charged accordingly
483: Accelerated Analytical Laboratories Inc. Milwaukee, Wisconsin End Dates of inspection: 27 September
2021 Project Area: Drug Quality Assurance FEI: 3006442227 Classification: VAI I confirm that Clarivate Analytics will be
WCW requests copies of all noncompliance reports submitted to the NIH Office of Laboratory Animal Welfare by FDA
laboratories between 1/1/2020 – present.
483: Accra Pac, Inc Elkhart, Indiana End Dates of inspection: 05 November 2021 Project Area: Compliance:
Devices FEI: 1818911 Classification: VAI I confirm that Clarivate Analytics will be charged accordingly by FOI for this
request, however please contact me if the charges exceed $ 200
483: Amplion Clinical Communications, Inc. Nashville, Tennessee End Dates of inspection: 08 September
2021 Project Area: Compliance: Devices FEI: 3009164985 Classification: VAI I confirm that Clarivate Analytics will be
483: Ava Inc Willowbrook, Illinois End Dates of inspection: 29 September 2021 Project Area: Compliance:
483: BLA Enterprises, LLC dba Green Mountain Pharmaceuticals Lakewood, Colorado End Dates of
inspection: 13 December 2021 Project Area: Compliance: Devices FEI: 3008763196 Classification: VAI I confirm that
Clarivate Analytics will be charged accordingly by FOI for this request, however please contact me if the charges exceed
$ 200.
SBOA/NDA approval package for below product. Active Ingredient: BACLOFEN Proprietary Name: FLEQSUVY Dosage
Form; Route of Administration: SUSPENSION
483: Beeken Biomedical, LLC Stoughton, Massachusetts End Dates of inspection: 08 July 2021 Project Area:
Compliance: Devices FEI: 3009348684 Classification: VAI I confirm that Clarivate Analytics will be charged accordingly by
483: Berkshire Sterile Manufacturing, Inc. Lee, Massachusetts End Dates of inspection: 15 October 2021
Project Area: Drug Quality Assurance FEI: 3012144557 Classification: VAI I confirm that Clarivate Analytics will be
483: Beverly Hills Uniforms Bronx, New York End Dates of inspection: 26 October 2021 Project Area:
483: BioVision Technologies, LLC Boulder, Colorado End Dates of inspection: 16 December 2021 Project Area:
483: Bioelements Inc. Colorado Springs, Colorado End Dates of inspection: 27 October 2021 Project Area:
Drug Quality Assurance FEI: 3008137936 Classification: VAI I confirm that Clarivate Analytics will be charged accordingly
This is a request under the Freedom of Information Act (FOIA) for information on Drugs (Finished Dosage Forms and
Active Pharmaceutical Ingredients) registered with Food and Drug Administration (FDA) as per the guideline.
483: Blickman Industries LLC Clifton, New Jersey End Dates of inspection: 20 August 2021 Project Area:
Compliance: Devices FEI: 2244019 Classification: VAI I confirm that Clarivate Analytics will be charged accordingly by FOI
for this request, however please contact me if the charges exceed $ 200.
483: Breas Medical, Inc. North Billerica, Massachusetts End Dates of inspection: 18 January 2022 Project
Area: Compliance: Devices FEI: 3010817335 Classification: VAI I confirm that Clarivate Analytics will be charged
accordingly by FOI for this request, however please contact me if the charges exceed $ 200.
483: CSL Plasma Inc. Cincinnati, Ohio End Dates of inspection: 11 August 2021 Project Area: Blood and Blood
Products FEI: 3013704884 Classification: VAI I confirm that Clarivate Analytics will be charged accordingly by FOI for this
483: Catalent Massachusetts, LLC Chelsea, Massachusetts End Dates of inspection: 30 November 2021
Project Area: Compliance: Devices FEI: 3011696115 Classification: VAI I confirm that Clarivate Analytics will be charged
483: Ceela Naturals Louisville, Kentucky End Dates of inspection: 31 August 2021 Project Area: Drug Quality
Assurance FEI: 3009528637 Classification: VAI I confirm that Clarivate Analytics will be charged accordingly by FOI for
483: Center for Fertility and Reproductive Endocrinology UPP Pittsburgh, Pennsylvania End Dates of
inspection: 08 December 2021 Project Area: Blood and Blood Products FEI: 3004081056 Classification: VAI I confirm
exceed $ 200.
483: Cetylite Industries, Inc. Pennsauken, New Jersey End Dates of inspection: 24 September 2021 Project
Area: Drug Quality Assurance FEI: 2242327 Classification: VAI I confirm that Clarivate Analytics will be charged
accordingly by FOI for this request, however please contact me if the charges exceed $ 200
483: Clinical Resolution Laboratory Inc. Brea, California End Dates of inspection: 27 April 2021 Project Area:
483: Dakhil, Dr Shaker Wichita, Kansas End Dates of inspection: 21 May 2021 Project Area: Bioresearch
483: EZGO GROUP INC Sterling Heights, California End Dates of inspection: 22 December 2021 Project Area:
Postmarket Assurance: Devices FEI: 3013419467 Classification: VAI I confirm that Clarivate Analytics will be charged
483: Elegant Direct Corp Brooklyn, New York End Dates of inspection: 10 November 2021 Project Area:
483: Eli Lilly & Company Indianapolis, Indiana End Dates of inspection: 16 March 2021 Project Area: Drug
Quality Assurance FEI: 1819470 Classification: VAI I confirm that Clarivate Analytics will be charged accordingly by FOI
for this request, however please contact me if the charges exceed $ 200.
483: Energium Health Sterling Heights, Michigan End Dates of inspection: 30 November 2021 Project Area:
483: Fangyinmeng MD Inc. Irvine, California End Dates of inspection: 22 October 2021 Project Area: Human
Cellular, Tissue, and Gene Therapies FEI: 3016712601 Classification: VAI I confirm that Clarivate Analytics will be
483: Gauthier Biomedical, Inc. Grafton, Wisconsin End Dates of inspection: 21 December 2021 Project Area:
Postmarket Assurance: Devices FEI: 3010938185 Classification: VAI I confirm that Clarivate Analytics will be charged
483: Harmac Medical Products, Inc. Buffalo, New York End Dates of inspection: 11 February 2022 Project
Area: Compliance: Devices FEI: 1317547 Classification: VAI I confirm that Clarivate Analytics will be charged accordingly
483: Hightech American Industrial Laboratories, Inc. Lexington, Massachusetts End Dates of inspection: 25
January 2022 Project Area: Compliance: Devices FEI: 3003046678 Classification: VAI I confirm that Clarivate Analytics
will be charged accordingly by FOI for this request, however please contact me if the charges exceed $ 200.
483: NextPhase Medical Devices LLC Rochester, New Hampshire End Dates of inspection: 10 January 2022
483: RJ General Corporation Cincinnati, Ohio End Dates of inspection: 12 January 2022 Project Area: Drug
Quality Assurance FEI: 3010952666 Classification: VAI I confirm that Clarivate Analytics will be charged accordingly by
483: A.M. Surgical, Inc. Smithtown, New York End Dates of inspection: 27 July 2021 Project Area: Compliance Devices
FEI: 3001617730 District Decision: VAI I confirm that Clarivate Analytics will be charged accordingly by FOI for this
483: Abaco Partners, LLC Grand Rapids, Michigan End Dates of inspection: 10 November 2021 Project Area:
Compliance Devices FEI: 3001617730 District Decision: VAI I confirm that Clarivate Analytics will be charged accordingly
for Animal Drugs & Feeds inspection of Gaylord Chemical Company, LLC ending 02/26/2018 at the location in
Tuscaloosa AL, United States. Please send documents as email attachments.
for Animal Drugs & Feeds inspection of Xinfa Pharmaceutical Co., Ltd ending 04/07/2016 at the location in Dongying,
China. Please send documents as email attachments.
for Foods & Cosmetics inspection of C & H Sugar - ASR Group ending 03/28/2019 at the location in Crockett CA, United
for Foods & Cosmetics inspection of Eastman Chemical Company ending 02/13/2020 at the location in Kingsport TN,
for Foods & Cosmetics inspection of ILSHINCHEMICAL CO.,LTD. ending 04/27/2012 at the location in Yangsan, Korea,
Republic Of (South). Please send documents as email attachments.
for Foods & Cosmetics inspection of ISP Chemicals LLC ending 10/04/2019 at the location in Calvert City KY, United
for Human Drugs inspection of Eastman Chemical Company ending 12/01/2021 at the location in Kingsport TN, United
for Human Drugs inspection of ISP Chemicals LLC ending 01/10/2019 at the location in Calvert City KY, United States.
for Foods & Cosmetics inspection of APAC Chemical ending 08/13/2021 at the location in Monrovia CA, United States.
The EIR (in electronic format) for Animal Drugs & Feeds inspection of Nitto Avecia Pharma Services, Inc ending
09/06/2019 at the location in Irvine CA, United States. Please send documents as email attachments.
for Foods & Cosmetics inspection of Vantage Specialties Inc ending 11/13/2019 at the location in Gurnee IL, United
States. The EIR (in electronic format) for Foods & Cosmetics inspection of Roquette America Corp. ending 11/05/2019
at the location in Gurnee IL, United States. Please send documents as email attachments.
The EIR (in electronic format) for Foods & Cosmetics inspection of Gadot Biochemical Industries Ltd ending 12/08/2019
at the location in Haifa, Israel. The EIR (in electronic format) for Foods & Cosmetics inspection of Hebei Yuxing Bio-
Engineering Co., Ltd. ending 05/17/2018 at the location in Xingtai, China. The EIR (in electronic format) for Foods &
Cosmetics inspection of HAYASHIBARA CO., LTD. OKAYAMA FUNCTIONAL SACCHARIDE PLANT ending 06/11/2018 at the
location in Okayama, Japan. Please send documents as email attachments.
Abaco Partners 483 November 2021 4560 Danvers Dr SE Kentwood MI 49512
Inspection records as indicated in the attached letter relating to the distribution facility located at 1800 Family Dollar
Pkwy, West Memphis, Arkansas 72301 or relating to any Family Dollar affiliate.
Requesting a copy of our facility's Establishment Inspection Report. FEI number 1073612
a. Unredacted Technical Project Lead (TPL) Review documents relating to EX0001504-PD1 (Kool 100s Box), EX0001504-
PD3 (Kool Blue Box), EX0001504-PD5 (Kool Box). etc
I am requesting the full Submission for K170155
We request, as the owner of and first party to the records related to NDA #022306 and all documents related thereto, a
copy of said orphan drug designation request, dated on or about August 14, 2007 and submitted by Academic
Pharmaceuticals Inc. as part of NDA #022306 Designation request - 07-2477
Please provide all public comments (~130,47K) on

https://www.regulations.gov/document/FDA-2021-N-1088-0001/comment?pageNumber=7 for "Vaccines and Related
Biological Products Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments. V
Importer of Record (IOR), or Consignee; for entry-lines with submission or arrival dates between February 1 and
February 28, 2022
To whom it may concern, I am studying the interaction between Bevacizumab and ONJ. I am hoping to review the
following cases: 18375839, 10461309, 15419892, 10935625, 16109909, 7696302, 7837435, 14025640, 12366065,
18201358
I'm looking for all records regarding the FDA partial clinical hold on drug YTX-7739.
510(K) request and FDA responsive decision for BIOBEAM GM 2000, BIOBEAM GM 3000, BIOBEAM GM 8000 and X
BEAM machines made by Gamma-Service Medical GmbH .
(1) A copy of the clinical hold letters issued to Kiromic BioPharma, Inc. ("Kiromic") on July 16, 2021 for the following
product candidates: ALEXIS-PRO-1 and ALEXIS-ISO-1. (2) A copy of any communication, including email, regarding any
clinical hold to be issued by the FDA to Kiromic for ALEXIS-PRO-1 and ALEXIS-ISO-1.
510(K) submission and any FDA response related to BMS RADGIL2 X-RAY blood irradiator.
Ablynx NV Gent, Belgium FEI Number: 3008915297 Inspection End Date: 09 February 2021 Project Area: Drug Quality
Assurance Classification: Voluntary Action Indicated (VAI) I confirm that Clarivate Anal ytics will be charged accordingly
Copersam Red SL Zuera, Spain FEI Number: 3010432247 Inspection End Date: 23 February 2021 Project Area: Drug
Quality Assurance Classification: Voluntary Action Indicated (VAI) I confirm that Clarivate Anal ytics will be charged
Nadia Bahi-Buisson Paris, France End Dates of inspection: 19 November 2021 Project Area: Bioresearch Monitoring FEI:
3020199769 Classification: VAI I confirm that Clarivate Analytics will be charged accordingly by FOI for this request,
EIR for inspections of Altasciences (formerly known as Vince and Associates) in December 2016, October 2017 and May
2019, located at Metcalf Ave, Overland Park, KS, USA 66212.
Dear Sir/Madam, Please Provide the SBOA or ANDA approval package for below product. Active Ingredient:
EPINEPHRINE Proprietary Name: EPINEPHRINE
Human adverse event drug MedWatch reports for the following case IDs: 10365667 10305349 10229851 10220923
10020666 9914237 9914111 9858445 9768950 9669430 9580957 9580690
Intertek, the Agent for Nouryon, request the release of FCN No. 1808
The following two (2) CSV files: 1) Listing of all INSPECTIONS since Monday, March 1, 2021 (in CSV format) with the
following fields: FEI Number, Inspection Start Date, Inspection End Date, Legal Name, Address, City Name, State
inspection CITATIONS (from FDA's FACTS database) for each company since Monday, March 1, 2021 in CSV format with
Please provide the patient information submitted for Crinone NDA 020701 by Allergan during the last Annual Report.
2022-28, 2022-29, 2022-30, 2022-51, 2022-124.
2021-438, 2021-8745, 2021-8746, 2021-8797, 2022-27.
2022-136, 2022-137, 2022-203, 2022-212, 2022-216.
I'm requesting access to and copies of the following CAERS report #s, and any associated records with those files: 2019-
CFS-001032 2020-CFS-000064 2020-CFS-003484 2020-CFS-004062 etc
Unredacted 510k filing numbers k040317 and k955529 issued to Dr. Mark H. Friedman DDS.
for Medical Devices & Rad Health inspection of Abbott Vascular ending 11/15/2007 at the location in Temecula CA,
for Animal Drugs & Feeds inspection of Polypeptide Laboratories, Inc. ending 11/19/2021 at the location in Torrance CA,
for Foods & Cosmetics inspection of Barretts Minerals Inc ending 01/10/2020 at the location in Dillon MT, United States.
for Foods & Cosmetics inspection of Church & Dwight Company, Incorporated ending 06/25/2020 at the location in
Green River WY, United States. Please send documents as email attachments.
for Foods & Cosmetics inspection of Lakeshore Technologies Llc ending 11/19/2019 at the location in Norton Shores MI,
for Human Drugs inspection of SPI Pharma, Inc. ending 04/29/2019 at the location in Grand Haven MI, United States.
for Medical Devices & Rad Health inspection of Sarstedt Inc ending 07/02/2018 at the location in Newton NC, United
for Foods & Cosmetics inspection of Archer Daniels Midland Co ending 07/16/2019 at the location in Southport NC,
United States. The EIR (in electronic format) for Foods & Cosmetics inspection of Archer Daniels Midland Co ending
02/11/2021 at the location in Southport NC, United States. Please send documents as email attachments.
for Human Drugs inspection of Alchemix Corporation ending 02/14/2019 at the location in College Park GA, United
States. The EIR (in electronic format) for Human Drugs inspection of Patheon API Manufacturing, Inc. ending
03/30/2018 at the location in Greenville SC, United States. Please send documents as email attachments.
for Foods & Cosmetics inspection of Univar USA Inc. ending 11/29/2018 at the location in Jacksonville FL, United States.
for Foods & Cosmetics inspection of Univar USA Inc. ending 11/29/2018 at the location in Jacksonville FL, United States.
for Human Drugs inspection of Amgen Manufacturing Ltd ending 09/27/2019 at the location in Juncos PR, United States.
format) for Human Drugs inspection of Avista Pharma Solutions, Inc. dba Cambrex ending 12/18/2019 at the location in
Agawam MA, United States. Please send documents as email attachments.
for Human Drugs inspection of AET Laboratories Private Limited ending 09/20/2019 at the location in Sangareddy
District, India. The EIR (in electronic format) for Human Drugs inspection of AET Laboratories Private Limited ending
09/20/2019 at the location in Sangareddy District, India. The Response (in electronic format) for Human Drugs
inspection of AET Laboratories Private Limited ending 09/20/2019 at the location in Sangareddy District, India. Please
since Friday, January 28, 2022.
Regenerative Medicine and Advanced Therapy (RMAT) designation and the approval of such a designation
Requesting copy of the NDA for Chenix (Chenodiol) NDA# 018513 Tablet/Oral Leadiant Biosciences Inc.
The EIR (in electronic format) for inspection of Beijing ADSS Development Co., Ltd. at the location in Beijing ,China. The
inspection was conducted in the first half of 2018. Our registration Number of FDA is 3007084556.Please send
documents as email attachments.I confirm that we will be charged accordingly by FOI for this request.
Woudl like to see who listed Natural Partners as part of the FSVP program.
FDA's laboratory analysis report and the test method used for the products sampled in entry number DM4-05948637 of
Mayaland LLC. In Notice of FDA Action Number 5, dated December 6, 2021
Copies of all materials submitted by Abbott Laboratories for the approval of its SIMILAC® HUMAN MILK FORTIFIER
HYDROLYZED PROTEIN CONCENTRATED LIQUID single serving packet, including all requirements of and approval for
packaging materials for such product.
FDA 483 INSPECTION REPORT FOR MEDTRONIC MINIMED, INC. District: LOS FEI Number: 3003166194
Inspection Date: 07/07/2021 FDA 483: Yes Commodity: Med Dev & Rad Health Firm Name: Medtronic MiniMed Firm
Address: 18000 Devonshire St City: Northridge State: CA Zip: 91325-1219 Country: US
For Abbreviated New Drug Application No. 203976: (1) Approval Routing Sheet; (2) Tentative Approval Letter; (3) Final
Approval Letter
Please provide the Form 483 associated with the FDA’s inspection of Acella Pharmaceuticals, LLC's (FEI #: 3006691461)
Alpharetta, GA facility that concluded on 9/17/2021 (Inspection ID: 1152922). Facility address: 1880 Mcfarland Pkwy,
Ste 110, Alpharetta, GA 30005-1795.
Please provide the Form 483 associated with the FDA’s inspection of Allay Pharmaceuticals, LLC's (FEI #: 3007007565)
Hialeah, FL facility that concluded on 11/15/2021. Facility address: 16600 NW 54th Ave Unit 23, Hialeah, FL, 33014-
6109.
Please provide the Form 483 associated with the FDA’s inspection of Bioiberica, SAU's (FEI #: 1000418405) Palafolls,
Spain facility that concluded on 2/4/2022. Facility address: C/ Antic Cami De Tordera 109-119, 08389 Palafolls
(Barcelona, Spain).
Please provide the Form 483 associated with the FDA’s inspection of Specialty Process Labs LLC's (FEI #: 3017888878)
Phoenix, AZ facility that concluded on 11/19/2021. Facility address: 1030 E Lone Cactus Dr., Phoenix, AZ, 85024-5651.
Please provide the Summary Basis of Approval for Bicillin L-A (penicillin G benzathine injectable suspension) for the
original NDA 050141 by Kings Pharmaceutical. Please also provide the approval summary for the PAS for Manufacturing
(CMC)-Packaging change approved on 08/31/1993.
Requesting the following records: - Final No Objection Letter issued for Fresh Pak Corporation. - Entire original
application submission packet filed by, or on behalf of, Fresh Pak Corporation for consideration of suitability of a specific
process for producing post-consumer recycled (PCR) plastic to be used in manufacturing of food-contact articles.
Requesting the following records: - Final No Objection Letter issued for KW Plastics. - Entire original application
submission packet filed by, or on behalf of, KW plastics for consideration of suitability of a specific process for producing
post-consumer recycled (PCR) plastic to be used in manufacturing of food-contact articles.
Requesting the following records: - Final No Objection Letter issued for Papier-Mettler KG. - Entire original application
submission packet filed by, or on behalf of, Papier-Mettler KG for consideration of suitability of a specific process for
producing post-consumer recycled (PCR) plastic to be used in manufacturing of food-contact articles.
September 20, 1999 CFSAN Summary Memorandum associated with GRAS Notice 19 and any other summary
memoranda associated with this notice.
I would like to know how many cases of fat hypertrophy were reported secondary to liposuction with CoolSculpting by
Zeltiq from 2014 onwards.
All documents that were generated as part of the investigation of and enforcement against Erb Avore (of Grand Rapids,
Michigan) and/or his companies Impulsaria LLC, a Nevada company & Impulsaria LLC, a Michigan company, with regards
to a sexual enhancement dietary supplement sometimes marketed as Stiff Nights. etc
Unredacted Establishment Inspection Reports (EIR)s for the FDA inspections of Triad Group/H&P Industries. Inspection
dates 11.29.2010-01.07.2011, 7.15.2009 -7.17.2009, 04/19/2010 - 05/18/2010. Medline Industries purchased the
company assets in 2013 therefore we are requesting unredacted copies. Documentation regarding purchase can be
provided (but was well documented in the media).
We are writing to request copies of any records, compiled between July 1, 2021 and the present on file at the FDA
regarding the investigation of this outbreak (CDC ID: 2109MLJJX-1). We specifically request: • all summary reports of
investigations and analyses done for this outbreak; • any emails or communications between the CDC and the FDA
regarding the sources of this outbreak; etc
have a complete record of these submission when it was transferred from Mist Pharmaceuticals.
FAERS database for ciltacabtagene autoleucel (brand name CARVYKTI).
All comments to proposed rule-making for the Food and Drug Administration's "Guidance for Industry on 180-Day
Exclusivity When Multiple Abbreviated New Drug Applications Are Submitted on the Same Day; Availability" as
described in 68 FR 45252 (Federal Register Vol. 68, No. 148, Page No. 45252). Comments would be filed under Docket
No. 2003D–0325.
All publicly available documents to proposed rule-making for the Food and Drug Administration's "Guidance for Industry
on 180-Day Exclusivity When Multiple Abbreviated New Drug Applications Are Submitted on the Same Day; Availability"
as described in 68 FR 45252 (Federal Register Vol. 68, No. 148, Page No. 45252). For Docket No. 2003D–0325.
Any documents that have been previously released under FOIA relating to the FDA's investigation into or evaluation of
the presence of benzene in Neutrogena sunscreen products manufactured by Johnson & Johnson Consumer, Inc.
Please provide the copy of the latest version of the bottle label, blister label and blister-carton labels (NDC’s 27437-209-
08 and 27437-209-11) for Suprax (cefixime) Capsules, 400 mg, NDA # 203195.
RRA report for ICONN Orthopedics, LLC
To whom it may concern, I am studying the interaction between Bevacizumab and ONJ, and association with Colon
cancer. I am hoping to review the following cases: 8467047, 7950076, 7691645, 7614184, 9854059, 7864234
I am requesting the records provided for the previous FOIAs outlined in my attached letter
Trade Allegation results for allegations raised against R-Zero and UVDI
483 and/or establishment inspection report for the Abbott Nutrition manufacturing plant in Sturgis, Michigan, which
has been the epicenter of a recent infant formula recall for bacterial contamination.
Any and all FDA inspection reports/483’s for Abbott Nutrition’s Sturgis, Michigan facility located at 901 N Centerville St,
Sturgis, MI 49091 for the last four years – from January 1, 2018 through March 1, 2022.
CERTIFIED RECORDS
1. The names and locations of all clinics, pharmacies, medical facilities, pediatrician offices, urgent care centers,
hospitals, military installations, and any other location in the United States and its territories that currently offers and
has offered since August 2021 the COMIRNATY® labeled Covid-19 vaccine. etc
I am requesting all public comments received for the animal feed and pet food ingredient, dried black soldier fly larvae,
prior to the ingredient being approved as an AAFCO ingredient, and adopted as a federal regulation by acceptance by
FDA-CVM.
PA 19522 02.01.22-02.28.22
NDC EXPIRED DATA
RECS RE BRUSHING/FLOSSING
Copy of the disclosable portions of the 483 for the 09/20-24/2021 inspection of Abbott Nutrition, Sturgis, MI. Please
note this inspection pertains to foods.
DOCUMENT REQUEST - 483 from CDER: FDA 483 for the FDA Drug Quality Assurance inspection, conducted by CDER, on
firm Olon S.p.A., FEI 3002716636 and DUNS 433371143.
Deerland Enzymes; 3800 Cobb International Blvd., Kennesaw, GA 30152; Records of 482 483 report observations
Eagle Labs, Inc.; 10540 72nd Street, Seminole, FL 33777; 630 Brooker Creek Blvd, Suites 335, 340, 350, Oldsmar, FL
34677; Records of any 482 483 report observations
FDA Form 483 for inspection of QPharma, Malmo, Sweden for the dates of inspection 12/11/2017-12/15/2017 and the
Establishment Inspection report
Herbaland Naturals, Inc.; 13330 Maycrest Way, Richmond, BC Canada V6V 2J7; Records of any 482 483 report
observations
Enforcement Reports
I am requesting a copy of Amigo Mobility's Remote Regulatory Assessment report.

Ion Labs; 8031 114th Ave, Suite 4000, Largo, FL 33773; Records of 482 483 report observations
Manhattan Drug Company; 225 Long Avenue, Hillside, NJ 07205; Records of 482 483 report observations
inspection, Investigator name(s), product(s) being inspected, and whether or not a 483 was issued
YouBar; 597 Monterey Pass Rd, Monterey Park, CA 91754; Records of 482 483 report observations
March 2, 2022
Primary Physician/Consumer submitted report of adverse events affecting patients utilizing Buprenorphine/Naloxone.
Case numbers have been extracted from the FDA's Adverse Events Reporting System Dashboard. Numbers are provided
in the request letter.
To whom it may concern, I am studying the interaction between Bevacizumab and ONJ, and association with Colon
cancer. I am hoping to review the following cases: 7774562 9840291 17720427 7600112 7507729 9755838 7839492
18385642 8049632 7619358
We are conducting a study on bevacizumab-associated ONJ in the setting of colon cancer. We are hoping to review the
following cases: 14926703 11136101 17996213 15299514 18263240 12736069 12727492 13849236 7911308 7899077
Thank you!
We are seeking full drug-level information on ANDA Paragraph IV filings filed in 2003 and before
VAERS Report
All applications, licenses, permits and inspections for the following facilities: 1) Captek Pharma, 14535 Industry Circle,
La Mirada, CA 90638 2) Captek Softgel International (CSI) 16218 Arthur Street, Cerritos, CA 90703
Summary Basis of Approval for Cardene ® (Nicardipine Hydrochloride Injection, 25 mg/10 mL (2.5 mg/mL) for Original
and all its supplements approval till date, (NDA # 019734) held by Chiesi USA Inc.
The following records relating to the company Real Water, Inc., a manufacturer of alkaline water called "Real Water": 1.
All analyses/reports relating to the samples of "Real Water" that were analyzed during the investigation of the outbreak
of acute non-viral hepatitis (starting in late 2020) potentially associated with the water product. 2. Any necropsy
analysis reports for any cats or dogs whose deaths were investigated as being potentially linked to consumption of "Real
Water." ETC
510(k): submission: K200422 VisionQuest BioMedical, Inc. 510(k) submission: K200667 EyeNuk De Novo submission:
DEN180001 IDx LLC
ARRANON Labels - 50mL in 1 VIAL

CSV listing of Memoranda of Understanding, Mutual Recognition Agreements (MRAs) and other agreements in place
with foreign nations. Please include titles, date and country/countries included in each contract.
Copy of the 483 for the Jul 19, 2021 - Jul 29, 2021 (11 days) inspection of Bryan Corporation [Woburn / United States of
America] 4 Plympton St, Woburn, MA 01801, USA. This inspection pertains to medical devices.
Copy of the 483 for the Jul 8, 2021 - Jul 19, 2021 (12 days) inspection of C. James Chuong MD., M.P.H., DBA Cooper
Institute [Houston / United States of America] 7500 Beechnut St #308, Houston, TX 77074, USA. This inspection pertains
to biologics.
Copy of the 483 for the Jun 16, 2021 - Jul 8, 2021 (23 days) inspection of CellEra LLC [LIBERTY TNSP / United States of
America] 1045 Reed Dr Ste C Monroe OH 45050-1717 United States. This inspection pertains to medical devices.
Copy of the 483 for the Jun 3, 2021 - Jul 15, 2021 (43 days) inspection of Magnolia Medical Technologies [Seattle /
United States of America] 2001 6th Ave #1630, Seattle, WA 98121, USA. This inspection pertains to medical devices.
Copy of the 483 for the inspection of James E. Cain, M.D. [Lampasas / United States of America] 207 W Ave E, Lampasas,
TX 76550, USA beginning 08/23/21 and ending 08/27/21. This inspection pertains to HUMAN DRUGS.
Copy of the EIR for the inspection of James E. Cain, M.D. [Lampasas / United States of America] 207 W Ave E, Lampasas,
TX 76550, USA beginning 08/23/21 and ending 08/27/21. This inspection pertains to HUMAN DRUGS.
Copy of the EIR for the inspection of Sarah E. Zauber, M.D. [Indianapolis / United States of America] 362 W 15th St,
Indianapolis, IN 46202, USA beginning 09/13/21 and ending 09/16/21. This inspection pertains to HUMAN DRUGS.
Report and/or the MDSAP Noncomformity Grading and Exchange Form (NC) for the inspection of Arthrex Medizinische
Instrumente GmbH, Odelzhausen, Germany, end date 10-12-2017. FEI# 3007193505. This inspection pertains to
medical devices.
Report and/or the MDSAP Noncomformity Grading and Exchange Form (NC) for the inspection of BERLIN HEART GMBH,
Berlin, Germany, end date 07-21-2017. FEI# 3004582654. This inspection pertains to medical devices.
Report and/or the MDSAP Noncomformity Grading and Exchange Form (NC) for the inspection of Syntacoll Gmbh, Saal
a.d.Donau, Germany, end date 12-06-2017. FEI# 3005433617. This inspection pertains to medical devices.
Report and/or the MDSAP Noncomformity Grading and Exchange Form (NC) for the inspection of Zimmer
Medizinsysteme Gmbh, Neu-Ulm, Germany, end date 09-28-2017. FEI# 7759. This inspection pertains to medical
devices.
Regulatory Assessment of Biomat USA, Inc. Located at Bakersfield CA United States FEI Number: 1641184 held on
01/22/2021.
Regulatory Assessment of CSL Plasma Inc Located at El Paso TX United States FEI Number: 1047112 held on 01/26/2021.
Regulatory Assessment of CSL Plasma, Inc. Located at Canton OH United States FEI Number: 2171832 held on
02/11/2021.
Regulatory Assessment of Eurofins Advantar Laboratories, Inc Located at San Diego CA United States FEI Number:
3007801780 held on 02/05/2021.
FOIA request for MedWatch form for Case ID 20246385.
I would like the source document for FAERS ICSR 197897561. The report was submitted for the drug Danyelza.
for Biologics inspection of CSL Behring LLC ending 09/24/2021 at the location in Bradley IL, United States. Please send
The EIR (in electronic format) for Animal Drugs & Feeds inspection of Avantor Performance Materials LLC ending
04/14/2021 at the location in Paris KY, United States. The Response (in electronic format) for Animal Drugs & Feeds
inspection of Avantor Performance Materials LLC ending 04/14/2021 at the location in Paris KY, United States. Please
The EIR (in electronic format) for Human Drugs inspection of Pharmasol Corporation ending 08/04/2016 at the
location in South Easton MA, United States. The EIR (in electronic format) for Animal Drugs & Feeds inspection of
Pharmasol Corporation ending 06/14/2021 at the location in South Easton MA, United States. Please send documents
as email attachments.
The 483 (in electronic format) for Human Drugs inspection of Acella Pharmaceuticals, LLC ending 09/17/2021 at the
location in Alpharetta GA, United States. The EIR (in electronic format) for Human Drugs inspection of Acella
Pharmaceuticals, LLC ending 09/17/2021 at the location in Alpharetta GA, United States. The Response (in electronic
format) for Human Drugs inspection of Acella Pharmaceuticals, LLC ending 09/17/2021 at the location in Alpharetta GA,
FCN No. 1931
Request for summary basis of information (SBOI)/FOI for RLD- XARELTO; Rivaroxaban for oral suspension, 1 mg/mL
Request for following information for NDA# 215859, XARELTO; Rivaroxaban for oral suspension, etc
I'm requesting access to and copies of the following: - Any and all records released in response to the following FOIA
request #s, including the original requests: 2021-5135, 2021-6806
The 483 Inspection report and any written communications between FDA staff and the owners of the Abbott
Laboratories infant formula facility located in Sturgis, Michigan, between the date range specified above.
NBC News is requesting any and all consumer complaints, documentation, records, transcription of consumer complaint
phone calls, recordings of consumer complaint phone calls, MedWatch Online Voluntary Reporting completed Forms,
paper voluntary Medwatch forms related to products from Abbott Nutrition’s Sturgis, MI facility. NBC News is also
requesting any and all consumer complaints or complaints from medical providers related to Cronobacter sakazakii in
the same timeframe.
documents relating to the Food and Drug Administration’s investigation of potential food contamination at a bakery
manufacturing facility owned by Café Valley Bakery, LLC aka CV Intermediate, LLC, located at 3701 S. Adamas St.,
Marion, Indiana 46953 from January 1, 2016 to the present.
(1) Documents and contracts that describe the relationship between the FDA and the Clozapine Product
Manufacturers’ Group (CPMG) from the beginning of the Clozapine REMS program (2008) through the present. etc
PREFERRED MEALS INSPECTION REPORT

Copies of any internal review memoranda analyzing the agency’s view of allegations of misconduct submitted in trade
complaints against R-Zero and UVDI on August 30th 2021. ETC
483: Wuxi Biologics Co Ltd Wuxi, China End Dates of inspection: 02 April 2021 FDA District Office: Center for Drug
Evaluation and Research
EIR issued to AGC Biologics (FEI No.3000209996) , on FDA inspection (210319)
I am looking for a redacted inspection report of Kimball Electronic's Indianapolis site of a recent PAI and general
inspection.
Please provide tentative approval letters and labels for following ANDAs: ANDA #206788, ANDA #208815 and ANDA
#209938. Thanks.
Inspection documents pertaining to the West Memphis Arkansas Family Dollar Distribution Center
We respectfully request the date that Amerisal Foods, LLC (FEI No. 3010709997) first registered as a Food Handling
Facility with the FDA under the Bioterrorism Act.
Any and all records related to any inspections, audits and/or assessments performed at
the Pita Pal Foods, LP facility located at 3100 Canal St., Houston TX 77003 from 1/1/16
-12/31/19.
Copies of any and each record (including all internal FDA

communications, including but not limited to all e-mails, text messages,
memoranda, reports, letters, etc.) from February 2002 to November 2019
which is in any way related or specifically refers to the safety or efficacy of
hydroxychloroquine or chloroquine for the prevention of or active
treatment against infection with SARS-CoV, the causative virus of the
respiratory disease known as “SARS.”
All e-mail correspondences sent or received by

“FDAInternetPharmacyTaskForce-CDER@fda.hhs.gov” or “COVID-19-
Task-Force-CDER@fda.hhs.gov,” ETC
Corr between the FDA and any
state board of pharmacy and/or other applicable state pharmacy regulatory
body in the United States—including any member, staff, counsel, or other
individual agent or representative of each such state pharmacy board/regulatory
body—which is in any way related or specifically refers to the use, prescribing,
or dispensing of hydroxychloroquine, chloroquine, or ivermectin for the
prevention of or active treatment against infection with SARS-CoV-2, the
causative virus of the respiratory disease known as “COVID-19.”
All adverse event reports for hydroxychloroquine, chloroquine and
ivermectin from January 1, 2016 to present
Corr by the FDA to any licensed pharmacy in the United States—

including, but not limited to, any retail, hospital, home care, assisted living, longterm
care, mail order, compounding or regulatory pharmacy—which is in any
way related or specifically refers to the use, prescribing, or dispensing of
hydroxychloroquine, chloroquine, or ivermectin for the prevention of or active
treatment against infection with SARS-CoV-2, the causative virus of the
respiratory disease known as “COVID-19.”
All internal FDA communications (including, but not limited to, all e-mails, text messages, memoranda, reports, letters,
etc.) which are in any way related or specifically refer to the use, prescribing, or dispensing of hydroxychloroquine,
chloroquine, or ivermectin for the prevention of or active treatment against infection with SARS-CoV-2
inspection of facilities owned and/or operated by Pharmaceutics International Inc. (“Pii”) located at either 10819 Gilroy
Rd, Hunt Valley, Maryland 21031 or 103 Beaver Court; Cockeysville, Maryland 21030.
all data and information for the Pfizer Vaccine enumerated in 21 C.F.R. § 601.51(e)5 with the exception of publicly
available reports on the Vaccine Adverse Events Reporting System.
(1) any meeting requests submitted by Avadel Pharmaceuticals PLC (Avadel) in January or February 2022; (2) any
requests for supervisory review or dispute resolution submitted by Avadel in January or February 2022; (3) minutes of
any meeting held between FDA and Avadel in January or February 2022; and (4) any slides, presentations, or handouts
used by Avadel in any meeting with FDA in January or February 2022.
ANDA 087916 – Dexamethasone Tablets USP 2mg – ANI Pharmaceuticals, Inc. is requesting the basis of submission; FDA
review summary of original ANDA; and all FDA review correspondences for subsequent amendments to original ANDA
up till ANDA approval (08/26/1982). ANDA 088306 – Dexamethasone Tablets USP 1mg – ANI Pharmaceuticals, Inc. is
requesting the basis of submission; FDA review summary of original ANDA; and all FDA review correspondences for
subsequent amendments to original ANDA up till ANDA approval (09/15/1983).
DOCUMENT REQUEST - 483 from CDER: FDA 483 for the FDA Drug Quality Assurance inspection, conducted by CDER, of
firm UQUIFA S.A., FEI 1000260514 and DUNS 810105874 on date July 23-27 2018.
DOCUMENT REQUEST - 483 from CDER: FDA 483 for the FDA Drug Quality Assurance inspection, conducted by CDER, on
firm Olon S.p.A., FEI 3003227153 and DUNS 862278942. Date of inspection 01/20-01/24 of 2020.
ANDA 212514
I am requesting raw data and/or survey results for the agency's 2020-2021 Federal Employee Viewpoint Survey (FEVS);
the Merit Principles Survey; the Annual Employee Survey (AES); and the most current Federal Human Capital Survey
(FHCS).
A Line Listing of all reports of Steven Johnsons Syndrome in Valproic Acid ALONE (not in combination with Lamotrigine
or any other Anti- Eplicipeitc Not the 3500A reports themselves just a summary line listing
Would like to have entire submission package of following

-Original New Animal Drug Application NADA #141-295
(PALLADIA toceranib phosphate Tablets dogs)
-Any communication between FDA CVM and the submitter regarding this submission
Please provide the Establishment Inspection Report (EIR) associated with the FDA’s inspection of Specialty Process Labs
LLC's (FEI #: 3017888878) Phoenix, AZ facility that concluded on 11/19/2021. Facility address: 1030 E Lone Cactus Dr.,
Phoenix, AZ, 85024-5651.
All records including, but not limited to, registration information, inspections, correspondence, press releases, warnings,
FDA actions taken, and state enforcement actions, related to: STAQ Pharma, Inc., Denver, CO, under Facilities
Registered As Human Drug Compounding Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and
Cosmetic Act
FDA records that describe the Agency’s assessments of Chelsea Therapeutics’ orphan drug designation (ODD) request
for the drug droxidopa in the treatment of symptomatic neurogenic orthostatic hypotension (NOH) in patients with
primary autonomic failure.
Pursuant to the Freedom of Information Act, 5 U.S.C. Section 552, and the implementing regulations under 21 C.F.R.
Part 20, I hereby request all accepted Letters of Intent submitted in application to the Innovative Science and
Technology Approaches for New Drugs (ISTAND) pilot program.
The disclosable portions of the letter sent to Ocugen denying an EUA for Covaxin. If such a letter is not disclosable,
please provide us with the date the letter was sent to Ocugen
CUMULATIVE ANALYSIS OF POST-AUTHORIZATION ADVERSE EVENT REPORTS OF PF-07302048 with the date of Feb
28,2021
All notifications i.e. letters and any other notice or communication to Nrx Pharmaceuticals from the FDA in reference to
the status and determination of their various applications for their drug Zyesami “Aviptadil” RLF-100.
Recs re SNS of hydroxychloroquine or chloroquine
VAERS RECS ETC
RECORDS PRODUCED BY FDA IN IN RE NATIONAL PRESCRIPTION OPIOID LITIGATION ETC

Emails between: rappp@mail.nih.gov AND (marina.picciotto@yale.edu OR tmayhewnoel@ccny.cuny.edu OR
imoore@ccny.cuny.edu OR rwesson@ccny.cuny.edu OR alexander.runko@hhs.gov OR ryanl@mail.nih.gov)
Emails between: rappp@mail.nih.gov AND (marina.picciotto@yale.edu OR tmayhewnoel@ccny.cuny.edu OR
imoore@ccny.cuny.edu OR rwesson@ccny.cuny.edu OR alexander.runko@hhs.gov OR ryanl@mail.nih.gov)
Emails of: rappp@mail.nih.gov containing the words; ( simufilam OR cassava OR retraction OR erratum OR PTI-125 OR
corrigendum )
CVs Rhonda Anderson, Kaitlyn Kornberg, Stephanie Jameson, Karissa Mccaw, Tanya Keigley, Latrice Jones, Stacey
Witherwax, Nia Walker, Jonathan Green, Nibin Varghese, Jerrod Whitney, Lisa Marko, etc
2021-1048, 2021-2193, 2021-2210, 2021-2648, 2021-3648.
2021-3737, 2021-3953, 2021-4154, 2021-4898, 2021-3790.
Copy of the 483 for the Nov 26, 2018 - Nov 30, 2018 (5 days) inspection of Lifeforce Cryobanks [Altamonte Springs /
United States of America] 270 Northlake Blvd #1012, Altamonte Springs, FL 32701, USA. This inspection pertains to
biologics
Copy of the 483 for the Nov 5, 2018 - Nov 9, 2018 (5 days) inspection of Carolina Liquid Chemistries Corp [Brea / United
States of America] 510 W Central Ave Ste C, Brea, CA 92821, USA. This inspection pertains to medical devices.
Copy of the 483 for the Oct 2, 2018 - Nov 27, 2018 (57 days) inspection of Nationwide Laboratories, LLC [Woodbridge
Township / United States of America] 33 S Wood Ave #600, Iselin, NJ 08830, USA. This inspection pertains to human
drugs.
Copy of the 483 for the Oct 9, 2018 - Nov 2, 2018 (25 days) inspection of TEI BIOSCIENCES INC. [Boston / United States
of America] 7 Elkins St, Boston, MA 02127, USA. This inspection pertains to medical devices.
Copy of the 483 for the inspection of Augusto E. Focil, M.D. [Oxnard / United States of America] 300 S A St #105,
Oxnard, CA 93030, USA beginning 08/23/21 and ending 08/27/21. This inspection pertains to HUMAN DRUGS.
Copy of the 483 for the inspection of Gittelman, Marc C, MD [Miami / United States of America] 21150 Biscayne Blvd
#300, Miami, FL 33180, USA beginning 08/17/21 and ending 08/26/21. This inspection pertains to HUMAN DRUGS.
Copy of the 483 for the inspection of Mehrnaz Hojjati MD [- / -] Concord Building, 11346 Mountain View Ave Ste E Loma
Linda CA 92354-3833 United States beginning 08/23/21 and ending 08/26/21. This inspection pertains to HUMAN
DRUGS.
Copy of the EIR for the inspection of Mehrnaz Hojjati MD [- / -] Concord Building, 11346 Mountain View Ave Ste E Loma
Linda CA 92354-3833 United States beginning 08/23/21 and ending 08/26/21. This inspection pertains to HUMAN
DRUGS.
Report and/or the MDSAP Noncomformity Grading and Exchange Form (NC) for the inspection of DENTSPLY DeTrey
GmbH, Konstanz, Germany, end date 04-28-2017. FEI# 3004724816. This inspection pertains to medical devices.
Report and/or the MDSAP Noncomformity Grading and Exchange Form (NC) for the inspection of Henke-Sass & Wolf
Gmbh, Tuttlingen, Germany, end date 05-18-2017. FEI# 3007130719. This inspection pertains to medical devices.
Report and/or the MDSAP Noncomformity Grading and Exchange Form (NC) for the inspection of IBL International
GmBH, Hamburg, Germany, end date 05-05-2017. FEI# 3002676602. This inspection pertains to medical devices.
Report and/or the MDSAP Noncomformity Grading and Exchange Form (NC) for the inspection of Karl Storz Gmbh & Co.
Kg, Neuhausen ob Eck, Germany, end date 03-23-2017. FEI# 3010707607. This inspection pertains to medical devices.
Copy of the disclosable portions of all FDA internal review memoranda associated with FCN 2141, which relates to
Poly(2-ethyl-2-oxazoline).
Regulatory Assessment of CSL Plasma Inc Located at Memphis TN United States FEI Number: 1047138 held on
02/19/2021.
Regulatory Assessment of CSL Plasma Located at Springfield OH United States FEI Number: 1527870 held on
02/19/2021.
Regulatory Assessment of Cardinal Health 414 LLC Located at Las Vegas NV United States FEI Number: 3004771217 held
on 02/17/2021.
Regulatory Assessment of City Of Hope National Medical Center Located at Duarte CA United States FEI Number:
2070105 held on 02/17/2021.
firm Buchler GmbH, FEI 3002806608 and DUNS 331565379 on date August 12-15 2019.
firm UQUIFA S.A., FEI 1000260514 and DUNS 810105874 on date July 23-27 2018.
We would like to request the following Viokace case: 19754553
we would like to request the following 2 EXPAREL cases: 19861945, 20151819
we would like to request the following 5 Zenpep cases: 18021930, 20001269, 200000607, 19754730, 17766598
Partial response to FOIA request F10-10223 that was emailed on November 5, 2019 to Kalah Auchincloss of Greenleaf
Health, Inc. The response included IHCTOA letters dated 12/20/2018, 4/3/2019, and 8/28/2019.
Please provide disclosable portions of the FDA Establishment Inspection Reports for inspections occurring January 2021-
June 2021 for the following RJ Reynolds facilities and that were issued in connection with Vuse Solo PMTA
authorizations PM0000551, PM0000553, & PM0000560: RJ Reynolds Manufacturing Facility in Tobaccoville, North
Carolina; and RJ Reynolds Bowman Gray Technical Center in Winston-Salem, North Carolina.
(1) Communications, whether in electronic or hard copy format, between any representative of the Center for Devices
and Radiological Health and any individual listed below that relates to the data, methodology, analysis, or conclusions
set forth in the following article: “Association of Use of an Intravascular Microaxial Left Ventricular Assist Device vs Intra-
aortic Balloon Pump With In-Hospital Mortality and Major Bleeding Among Patients With Acute Myocardial Infarction
Complicated by Cardiogenic Shock”, JAMA. 2020;323(8):734-745 etc
Establishment Inspection Report for FEI 3010334444 (3/11/19 - 3/12/19) exhibits
Manufacturer requesting the Establishment Inspection Report (EIR) for site inspection performed in Sept 2021 of
Custom Ultrasonics, Inc., located at 144 Railroad Drive, lvyland, PA 18974. Wassenburg Medical, Inc. acquired Custom
Ultrasonics, Inc, in January 2022.
for Medical Devices & Rad Health inspection of Northern Biomedical Research, Inc. ending 11/13/2021 at the location in
Norton Shores MI, United States. Please send documents as email attachments.
format) for Human Drugs inspection of Johnson and Johnson Consumer Inc, Div Of Mcneil,Inc. ending 12/09/2010 at the
location in Fort Washington PA, United States. Please send documents as email attachments.
format) for Human Drugs inspection of Mayne Pharma Inc ending 05/11/2012 at the location in Greenville NC, United
for Human Drugs inspection of Accu Bio-Chem Laboratories ending 08/31/2021 at the location in Glendale CA, United
States. The Response (in electronic format) for Human Drugs inspection of Accu Bio-Chem Laboratories ending
08/31/2021 at the location in Glendale CA, United States. Please send documents as email attachments.
for Human Drugs inspection of SAFECOR Health LLC ending 02/02/2018 at the location in Columbus OH, United States.
A linktable between the Medical Device Recall Database primary recall key and the AccessGUDID Global Unique Device
Identification Database primary device keys o Primary key within the Medical Device Recall Database is the “Recall
Number” or “Recall Event ID” o Primary Keys within the AccessGUDID database are the “Public Device Record Key”
and the “DEVICE_ID”
We are specifically interested in address, number of mammogram machines, certification dates and the total annual
mammography procedures reported for each facility identified. The region we are interested includes all
mammography facilities located in specified zip codes (we can provide a list of zip codes) located in PA, KY, WV, VA, and
OH and its bordering areas.
re: the tobacco division PMTA process, I'd like a copy of the FDA's epidemiology review , the FDA's toxicology review and
the FDA's document summarizing health effects for applications PM0000553 and PM0000560, which have been
authorized.
I am requesting a listing of ALL INSPECTIONS available and releasable from the FACTS database to date (2022-03-07)
I need the package insert for the Glaxo Smith Kline Fluarix Quadrivalent Vaccine issued for 2013-2014 and the package
insert for the Glaxo Smith Kline Fluarix Quadrivalent Vaccine issued for 2014-2015. What I am specifically looking for are
the ingredients in both vaccines. A full package insert should include that. Both in the .5 ml dose.
I seek quarterly data (or monthly if easier for you) showing the mean, median and 25-75% of response times to pre-IND
submissions and IND submissions, grouped by therapeutic office (within CDER).
1) All FDA communications (including, but not limited to, emails, texts, chats, online messages, letters, memorandum,
warnings, or notes) to or from Cassava Sciences, Inc. (“Cassava”) or Pain Therapeutics or Dr. Hoau-Yan Wang pertaining
to the Citizen Petition, dated August 22, 2021, requesting that FDA halt two ongoing trials of the drug Simufilam
(formerly PTI-125) sponsored by Cassava (NCT04388254 and NCT04994483), etc
To disprove the following: “COMIRNATY (COVID-19 Vaccine, mRNA) is the only fully licensed and approved COVID-19
Vaccine”, I kindly request the following: 1. Each Covid-19 Vaccine license number approved only under the Emergency
Use Authorization. 2. Each Covid-19 Vaccine license number approved only under full FDA approval.
All AE reports for Ayvakit.
All FAERS for Skytrofa (lonapegsomatropin).
Requesting the Agency to provide list of last three inspected Form 483 (Notice of Inspectional Observations) for Gland
Pharma Limited, with FDA establishment identifier # 3002647489.
Requesting the Agency to provide list of last three inspected Form 483 (Notice of Inspectional Observations) for Gland
Pharma Limited, with FDA establishment identifier # 3009056604.
Requesting the Agency to provide list of last three inspected Form 483s (Notice of Inspectional Observations) for MSN
Laboratories Private Limited, with FDA establishment identifier # 3011033544.
All documents concerning the identification and location of US entities used (or will be) for manufacturing of Bluebird
Bio's beti-cel, lentiGlobin, or BB305 vector; in addition I would like all materials regarding 483s for such sites, including
reponses and any memoranda issued in reply to 483 responses.
Requesting the complete application for FDA 510(k) number K213622.
Copy of the disclosable portions of the protocol and study stimuli for Docket FDA-2021-N-0132.
Waymon Farms, Inc. in Somerton, Arizona “Environmental Assessment for Investigation Conducted at Waymon Farms,
AZ during Summer 2018.”
RE: Arrow Reliance. Tukwila, WA: Please furnish complete Establishment Inspection Reports (NOT endorsements),
conumer complaints (if any), results of any sample analyses (if any), and all related correspondence pursuant to
Inspection ID #1145794 and Inspection ID #1090637
RE: Bravo Packing, Inc., Carneys Point, NJ: Please supply complete Establishment Inspection Reports, Forms 483 (if
issued), results of sample analyses (if any), and all correspondence pursuant to Inspections carried out at this location
during the indicated time period, including but not limited to, Inspection ID #1142761 and Inspection ID #1139741.
Copies of all 483 forms for the years 2017, 2018, 2019 and 2021 tied to FEI #1815692.
1_ Orphan drug designation applications for niraparib 2) Orphan drug designation applications for rucaparaib 3) Orphan
drug designation applications for olaparib. 2) FDA correspondence regarding items 1, 2, and 3.
I would like to request: - A database sufficient all incident reports filed about pet products with the FDA, including the
severity of the incident. This includes problems both with pet health and human health incidents. - A key to that
database. Please provide this in a .csv or .xls file.
firm Newchem S.p.A., FEI 3005786129 and DUNS 339975127 ending 29 November 2018.
All communications between FDA, HHS and Vaxart (VXRT) and its involvement in Operation Warp Speed (OWS).
Documents reflecting why the VAERS report attached hereto is not currently available in VAERS.
All testing records associated with this FDA warning:

https://www.fda.gov/AnimalVeterinary/NewsEvents/CVMUpdates/ucm629447.htm?utm_campaign=1-14-2019-
petfood&utm_medium=email&utm_source=Eloqua&elqTrackId=36D622A1932BECE560614F0F106491CC&elq=64f9c1ac
fc4149a1988c6b3d48353235&elqaid=6476&elqat=1&elqCampaignId=5284
I'm requesting all testing records for Redbarn, Chewy Louie, Bentley's, and Good Lovin' that resulted in the 03.06.18
recall announcement https://www.fda.gov/safety/recalls/ucm600124.htm
all inspection documents for FDA inspection of Tuffy's Pet Foods Inc, located at 145 1st Ave N, Perham, MN
1. Policies of your agency on the retention and management of instant messages etc
I am requesting all documents provided for 2018-8268
In an e-mail dated Friday. August 03, 2018 (9:45AM), Dean Duke makes a statement "Josh, I'll send you my most recent
EIR from Lystn LLC". I'm requesting that EIR document that Sean Duke is talking about. etc
Complete copies of Food Contact Notifications (FCN) 1811 and 2161.
Copies of FDA's chemistry, toxicology, and environmental review memoranda for Food Contact Notifications (FCN) 1176,
2133, and 2161.
Copy of the disclosable portions of the case detail forms for the attached 29 FAERS cases for molnupiravir. Please see
second page of attachment for the case numbers
Dana Farber Cancer Institute located in Boston, MA, 02115 ( 450 Brookline Avenue) Need to get the records for clinical
site inspections findings (483 findings) and site response related to the findings between 01 Jan 2019 to 09 March 2022
FDA Remote Regulatory Assessment of Eagle Medical Packaging, Sterilization, Inc., completed 25 Jan 2022.
FDA application review files for NDA 215859
Module 4 nonclinical study reports and Module 2.4 nonclinical overview for bavituximab
Need to get a copy of our EIR from 02/26/2020
Notifications, communications, and/or documents from the FDA to either Radiant Customs and/or Radiant Global
regarding the FDA's detainment of Entry No. 671-0230615-5. Please see attached letter for specific descriptions.
Please provide FOIA request for MedWatch 20108342 and 20196018
Please provide Updated legible copy for carton and container label of SUCCINYLCHOLINE CHLORIDE INJECTION
20MG/ML (QUELICIN) for the Applicant HOSPIRA-N008845 with Labeling-Container/Carton Labels Supplement No-
SUPPL-79 dated as of 02/17/2022
Request for last EIR or last 483 for Denison Pharmaceuticals listed under FEI 1210580 and DUNS 001207208 located at
One Powder Hill Road, Lincoln, Rhode Island (RI) 02865, United States (USA)
I am requesting the FDA's responses to the FOIA requests outlined in the attached letter
I would like to see the biocompatibility and performance testing data that Applied Medical Technology, Inc. included
with their submission of the 510K premarket notification of their Low Profile Balloon Feeding Device. etc
FDA Form 483 for WuXi Biologics. (FEI # 3010606982) at the facility in 108 Meiliang Road, Binhu, Wuxi, Jiangsu 214092,
China.Biologics Co., Ltd. 2 issued in this time period - April 2019 and April 2021
Food Contact Substance (FCS) Notifications FCN No. 2057 and FCN No. 2058 for Poly(ethylene furandicarboxylate) (CAS
Reg. No. 52733-28-5) by DuPont Industrial Biosciences LLC
Inspection records, Golden West Specialty Foods, 300 Industrial Way, Brisbane, CA 94005
This is an official FOI request to your office. Please provide all unredacted documentation including all clinical studies,
published or unpublished, articles, opinion pieces, meta analyses, industry/manufacturer documentation etc along with
unredacted author(s) and associations/employer information of said authors/writers related to support FDA’s
withdrawal of the use of the available monoclonal antibodies to treat patients with for Sars COV-2, Covid 19.
All documents related to submissions made by EndoShape, Inc., or Boulder iQ, Inc., regarding the Peripheral Vascular
embolic coil device named or known as the Nitinol Enhanced Device (NED). Documents requested include, but are not
limited to, all emails, letters, testing, meeting minutes, handwritten notes, faxes, voicemails, videos, 510(k) submissions,
Premarket Approval Submissions, transcripts, etc
We are requesting information pertaining to the color additive petition for butterfly pea extract under Sec. 73.69 -
Butterfly pea flower extract. Specifically, we need the following: 1. Copy of the color additive petition - CAP 8C0313
etc
We request copies of any and all written and electronic documents related to the Food and Drug Administration's
(FDA's) Summary Basis of Approval and Clinical Review for Biological License Application (BLA) 103705/S-5450 Rituxan®
(rituximab) for the treatment of adult patients with moderate to severe pemphigus vulgaris (PV), etc
All Freedom of Information Act (FOIA) requests submitted to FDA by or on behalf of Zachary Silbersher; Joseph Saveri
Law Firm, Inc.; Markman Advisors; Kroub, Silbersher & Kolmykov PLLC; Goldstein & Russell P.C.; or Herrera Kennedy
LLP1 since January 1, 2015 that relate to one or more of the following topics: (a) the pharmaceutical drug Zytiga; (b)
Patent No. 8,822,438; (c) United States ex rel. Silbersher v. Janssen Biotech, Inc. et al., Civil Action No. 19-12107 (D.N.J.);
or (d) United States ex rel. v. Janssen Biotech, Inc. et al., Civil Action No. 17-cv-07250 (N.D. Cal.). etc
Any and all documents, concerning FDA’s May 7, 2022 decision to
approve gene-edited cattle through a “low-risk determination for
enforcement discretion” from March 2019 until now.
483: Accu Bio-Chem Laboratories Glendale, California End Dates of inspection: 31 August 2021 Project Area:
Drug Quality Assurance FEI: 3004876794 Classification: OAI I confirm that Clarivate Analytics will be charged accordingly
A list of all FDA inspections since 2000, including (1) inspected facility's Legal Name (2) Location (3) Inspection start date
and inspection end date (4) Classification (no action indicated, voluntary action indicated, official action indicated) (5)
Project area (6) Product type. A list contains information similar to that in FDA data dashboard.
Form 483 from inspection conducted from 24th February to 10th March, 2022 on Zydus Lifesciences Ltd's injectable
facility situated in Jarod, Gujarat.
To disprove the following: “VAERS data is accurate”, please provide the following documented information for any
submittal related to a Covid-19 vaccine: 1. Documents relating to false information being entered
I would like to request the most current or last approved labeling components for ZOETIS (NADA 055060). Can you
please provide. Thank you!
Summary Review and available review notes and records for original Abbreviated New Drug Application (ANDA) 211880
for Epinephrine Injection USP, 30 mg/30 mL (1 mg/mL), Multiple-Dose Vials, as held by International Medication
Systems, Limited and approved 04/24/2020. .
Summary review and available review notes and records for CMC Manufacturing Supplement SUPPL-2 approved
12/23/2015 for New Drug Application (NDA) 204640 Adrenalin (current NDA holder Par Sterile Products).
We would like a complete copy of K212659 including all correspondence.
I request correspondence between FDA and the office of U.S. Senator Michael Crapo regarding BioMimetix, BMX-001,
BMX-010, or manganese butoxyethyl pyridyl porphyrin, between January 1, 2012 and March 10, 2022.
Copy of the disclosable portions of all correspondence between FDA and Smiths Medical/ICU Medical regarding quality
issues and updates to the Medfusion Pumps, from 01/01/2022 - Present. Please note this relates to the 02/23-
4/28/2021 inspection of, and subsequent Warning Letter for, the Minneapolis, MN facility of this device manufacturer.
Copy of the disclosable portions of the EIR for the 02/02/2021 - 02/08/2021 inspection of Abbott/St. Jude Medical,
located in St Paul, MN. Please note this inspection relates to devices.
FDA FAERS database for (lonapegsomatropin-tcgd) (brand name SKYTROFA).

I am requesting the FAERS case reports for aducanumab / Aduhelm with the following Case IDs: 20023535, 20132931,
20200825, 20055337, 19629797 and 20359581.
I am requesting the following: Adverse events reported to FAERS from February 4, 2022 through today for Aduhelm,
aducanumab and/or aducanumab-AVWA.
RE: Abbott Nutrition, Sturgis, MI (FEI #1815692): Please supply FDA Form 483, Establishment Inspection Report, and any
lab reports and correspondence (including Warning Letter and/or Untitled Letter, if issued) pursuant to Inspection ID
#1103455, completed on September 24, 2019.
RE: Abbott Nutrition, Sturgis, MI. (FEI #1815692): Please supply FDA Form 483, Establishment Inspection Report (if
available), consumer complaint records, lab reports, and any correspondence pursuant to Inspection ID #1153684,
completed on September 24, 2021. In addition, please supply any consumer complaint reports received subsequent to
the above-cited inspection.
All correspondence between Dr. Ted Love and the FDA between 6/1/2018-12/6/2018. The specific search terms are:
Voxelotor, accelerated approval, hemoglobin, vaso-occlusive crises, and VOC. Also please provide answers to this
request via the email provided.
Please provide the documentation supporting the nomination and evaluation (for clinical need or other criteria) of
Betamethasone Acetate and Betamethasone Sodium Phosphate as substances for placement on the 503B Bulks List,
including from compounders, outsourcing facilities or their representatives or from FDA.
We noticed that "OREGONS WILD HARVEST INC" is listed on the Foreign Supplier Verification Programs - List of
Participants (Name and State Only) September 4, 2021 - December 16, 2021. For which foreign supplier(s) is this
participant listed, and what are the relevant article(s) that were imported during this time for which OREGONS WILD
HARVEST INC is an FSVP Importer?
Would like to receive a list of the importers who are designating East West Tea Company in Oregon as the FSVP
importer as derived from the Foreign Suppliers Verification Programs Importer List.
https://www.fda.gov/food/importing-food-products-united-states/foreign-suppliers-verification-programs-fsvp-list-
participants
All documents since January 1, 2015 relating to whether FDA has the authority to review BGB-3111 or zanubrutinib
under the accelerated approval pathway, including communications from Abbvie, Pharmacyclics, Janssen, Acerta, and
Astra Zeneca. Please provide answers to this request via email
20373072, 20377474, 20423419
I am requesting the following two FDA facility inspection reports: 1. Firm Name: Smithfield Grain City/State: Wilson,
NC Firm FEI Number: 3008816474 Inspection end date for the EIR in question: 8/31/2021 Commodity area: 70
animal feed (non-medicated). 2. Firm Name: Smithfield Grain etc
Any and all reports to and from Stryker Corporation regarding the defect, malfunction and fracture of the Scandinavian
Total Ankle Replacement (STAR) implant components: Talar Implant (left) medium REF 400-257, serial number
100218/2657, Tibial Implant REF 400-264, Serial Number 130409/0149 and Mobile Bearing/Sliding Core REF 400-142,
Lot 1311203
Freedom of Information Act Request: Request for Documents and Information Relating to the pharmaceutical drug
Implanon/Nexplanon (etonogestrel implant)
Product: transparent face masks containing antimicrobial and UV technology. Entities involved: Redcliffe Medical
Devices, Inc. (Operator: 10075592, MI) and HongritaPrecision Component (Mfg, China). Records: any directives
concerning import detention without physical examination, import bans and alerts, letters of cease and desist, entity
registration forms, inventory inspection (10760 Plaza Dr., Whitmore Lake, MI 48189), etc
483: Blaine Labs Inc Santa Fe Springs, California End Dates of inspection: 24 August 2021 Project Area: Drug
Quality Assurance FEI: 3001744192 Classification: OAI I confirm that Clarivate Analytics will be charged accordingly by
483: Aurobindo Pharma Limited (Unit I) Doultabad India End Dates of inspection: 12 August 2021 Project Area:
All scientific data FDA-CVM reviewed for FDA Making Low-Risk Determination for Marketing of Products from Genome-
Edited Beef Cattle After Safety Review: https://www.fda.gov/news-events/press-announcements/fda-makes-low-risk-
determination-marketing-products-genome-edited-beef-cattle-after-safety-review?
utm_medium=email&utm_source=govdelivery
A copy FDA’s memorandum documenting the disposition of 180-day exclusivity for Lenalidomide Capsules, 2.5 mg and
20 mg, approved under ANDA 209348 on October 14, 2021.
A copy FDA’s memorandum documenting the disposition of 180-day exclusivity for Lenalidomide Capsules, 5 mg, 10 mg,
15 mg, and 25 mg, approved under ANDA 201452 on May 21, 2021.
All documents in PMA #P200036 (Valencia Technologies Corporation - ECoin Peripheral Neurostimulator)
Chunghwa Chemical Synthesis & Biotech Co., Ltd New Taipei City Taiwan End Dates of inspection: 21 June 2021 Project
Area: Drug Quality Assurance FEI: 3002806677 Classification: VAI
Copies of Form 483s issued by the CDER Office (complex) in January 1-31, 2022.
Copies of Form 483s issued by the CDER Office in January 1-31, 2022.
Copies of Form 483s issued to the CLINICAL INVESTIGATOR from January 1-31, 2022:
Copies of Form 483s issued to the DEVICE COMPANIES from January 1-31, 2022:
Copies of Form 483s issued to the DRUG COMPANIES from January 1-31, 2022:
Entire unredacted SBA for Vabysmo (faricimab-svoa), BLA 761235, for the indication of treatment of patients with
neovascular (wet) age-related macular degeneration (nAMD) and diabetic macular edema (DME), approved January 28,
2022.
Human adverse event drug MedWatch reports for the following case IDs: 7805261 6412318 7461954 7548393 7684823
We are writing to request, via FOIA, the FDA FAERS full case reports with following FDA case numbers: 19657580
19737496 20196874 20199053 20220190 20316077 20450567
Please may we request an individual case report for the following case IDs, which have been identified from the FAERS
Public Dashboard and have the suspect drug of Epidiolex: 19560041 19912066 19974058 19978624 20060530
20104193 20187597
for Animal Drugs & Feeds inspection of Pharmasol Corporation ending 02/10/2022 at the location in South Easton MA,
for Foods & Cosmetics inspection of Mother Nature Mountain Spring Water Inc ending 10/21/2013 at the location in
Ashcamp KY, United States. Please send documents as email attachments.
for Medical Devices & Rad Health inspection of Eagle Medical Inc ending 07/13/2017 at the location in Paso Robles CA,
for Human Drugs inspection of Dario D. Altamirano, DO ending 02/09/2022 at the location in Hialeah FL, United States.
The 483 (in electronic format) for Human Drugs inspection of Ionetix Corporation ending 02/09/2022 at the location in
Miami FL, United States. Please send documents as email attachments.
for Human Drugs inspection of Family Dollar Distribution Inc. ending 02/11/2022 at the location in West Memphis AR,
United States. The 483 (in electronic format) for Human Drugs inspection of Luis Zepeda, M.D. ending 02/15/2022 at
the location in Houston TX, United States. Please send documents as email attachments.
for Human Drugs inspection of Sharp Packaging Services, LLC ending 01/28/2022 at the location in Allentown PA, United
States. The EIR (in electronic format) for Human Drugs inspection of Sharp Packaging Services, LLC ending 01/28/2022
at the location in Allentown PA, United States. etc
Please provide the latest , approved package Insert Labeling for HYDROCORTISONE SODIUM PHOSPHATE EQ 50 mg Base
mL - 12/01/1997 NDA 012052 - Merck & Co. (Discontinued). Thank you!
Review Memorandum and Correspondence related to MRTP Marketing Orders for 22nd Century Group’s VLN® King and
VLN® Menthol King Combusted, Filtered Cigarette Products
Requesting a copy of the observations raised on the Zydus Lifesciences (earlier Cadila Healthcare) Gujarat plant in the
interest of the general public. The inspection on the injectable facility at Jarod, Gujarat took place from 24th February to
10th March, 2022 and three observations were raised. Kindly oblige
Under the U.S. Freedom of Information Act, I am requesting copies of the 483 report and establishment inspection
report dated September 2021 for the Abbott Nutrition Manufacturing Facility in Sturgis, MI.
1. Establishment Inspection Report (EIR) records provided by FDA to Orthodent Laboratory, Inc, Buffalo, NY, USA
(registration number 3015421090) within the timeframe of January 1, 2010 to date. 2. Establishment Inspection
Report (EIR) records provided by FDA to Specialty Appliances Lab, Inc, Cumming, GA, USA, (registration number
3004158247) within the timeframe of January 1, 2010 to date. etc
Can I have Zydus Lifesciences (Cadila) form 483 for the inspection of Jarod (Vadodra) facility held between 24th Feb
2022 to 10th March 2022?
Consumer complaints: (1) Complaint # 163143 (07-08-20); (2) Complaint #165009 (10/07/2020); (3) Complaint # 165312
(10-23-20); (4) Complaint # 166013 (12-08-20) and (5) Complaint # 168163 (05-07-21); regarding multiple
rhabdomyolysis cases being caused by the NEUBIE medical device.
I am requesting an Excel file of Food recalls for the period requested.
results of complaint for CC 171458
"product list and test results within firms HHE" are attached and also on page 6, it shows an attachment titled "HHE for
Investigation." I would like to obtain these referenced attachments if they are publicly available.
I am requesting to receive copies of training documents containing the following: 1. The name grade and title of the
trainer(s) who provided me with the field trainings. 2. Name and FEI numbers of each Firm where I received the field
trainings. etc
K004028
Any and all monitoring and clinical trial results from the 522 study conducted by American Medical Systems Holdings
Inc. regarding use of vaginal mesh for pelvic organ prolapse repair.
CDRH COMMUNICATIONS
ADVERSE EVENTS HYDROXYCHLOROQUINE, IVERMECTIN, ETC

2016-10007, 2021-6655, 2021-6864, 2021-6865, 2021-7816
2021-8372, 2022-46, 2022-148, 2022-199, 2022-201.
2022-267, 2022-277, 2022-290, 2022-364, 2022-824.
2022-826 2022-827, 2022-832, 2022-1203, 2022-1204.
Zydus Life or Cadila Health Injectable facility At Jarod Gujarat
Summary review and basis for approval, including available review and approval notes and records for Efficacy-New
Indication supplement SUPP-9 approved 01/29/2019 for New Drug Application (NDA) 204640 Adrenalin (current NDA
holder Par Sterile Products).
Copy of the disclosable portions of the Medical Review documents for the supplemental approval of Jardiance, NDA
204629/S33, approved 02/24/2022.
NEW VISION PHARMACEUTICAL INSPECTION REPORT

Please provide disclosable portions of the original FOIA request letters and the fulfillment page counts for file numbers
2021-7045 and 2022-502.
Request Unredacted Review Memorandum and Correspondence related to Fumari’s NSE
Review Memorandum and Correspondence related to American Vapor Group
K820723
Hi there! I'm requesting written complaints regarding the Peanut Corporation of America plants in Texas, Georgia and
Virginia from Jan 1, 2006 to March 1, 2009. These should include those written anonymously or sent via email. Thank
you!
ICON 483 Dr. Noah Merin at Samuel Oschin Comprehensive Cancer Institute; Parent account: Cedars-Sinai Medical
Center
I am requesting removal of redactions from specific records made publicly available for NDA 214985. I
Records of Sampling and Testing by FDA for Best Brand Consumer Products, Inc. Hand Sanitizer, Lots 20D21 and 20E21
I would like all emails to and from Janet Woodcock between September 1, 2021 through February 3, 2022 that include
the keyword "Rogan"
2016-1037 • 2016-9753 • 2017-200

• 2020-5391 • 2020-3180 • 2020-1764
• 2021-439 • 2021-2741
K160084
K081467
K183290
21 CFR 178.3297 lists an analytical chemistry method. I want a copy of this method. Method Title: ‘‘Determination of
PAH Content of Carbon Black,’’ dated July 8, 1994, as developed by the Cabot Corp., which is incorporated by reference
in accordance with 5 U.S.C. 552(a) and 1 CFR part 51.
all FDA review documents of NDA 212304 including medical officer and clinical pharmacology reviews
Device Name: XenMatrix AB Surgical Graft Applicant: C.R. Bard 100 Crossings Boulevard Warwick, RI 02886 Following
documents associated with the 510K K162193 - Section 16: Sterilization, Biological Safety, Shelf Life and Packaging -
Section 20: Performance Testing- Bench, especially Invitro Elution, Assay Identity & Impurities. - Section 21:
Performance Testing- Animal - Product Specifications
The partial response to FOIA Request F19-10233, including IHCTOA letters dated 12/20/2018, 4/3/2019 and 8/28/2019,
as referenced in the attached letter dated June 17, 2020.
All FOIA requests lodged by Pfizer, Moderna, or Johnson & Johnson concerning their COVID-19 vaccine(s).
Hello, please provide all emails and attachments received by the FDA, sent from Pfizer or BioNTech, in connection with
the planned February 15, 2022 VRBPAC meeting. Additionally, please provide all communications from an FDA CBER
employee to another FDA CBER employee concerning said meeting
Hello, please provide all records regarding the FDA's rejection of Ocugen Inc.'s COVID-19 vaccine for children. This
request includes but is not limited to emails, notes, and transcripts.
Hello, please provide any documentation received from or sent to Pfizer Inc. regarding the release date of the data from
the COVID-19 vaccine trial for 6-month to 4-year old children.
Hi, please provide all communications from Dr. Peter Marks or Dr. Janet Woodock to any and all email addresses ending
with "@pfizer.com." that include the words "child", "children", "kids", or "pediatric" Thanks
Device Name: PIVIT CRM (TYRX ANTIMICROBIAL PACEMAKER POUCH), MODEL CMRM-0601 510K: K063091 Documents
Requested: All Documents related to Performance Testing Bench and Animal, Shelf life, Assay identity and impurities,
Product Specifications, In Vitro Elution.
all records from previously requested FOIA request 2019-1974: all calendar records from fda employee Steven Porter
(steven.porter@fda.hhs.gov) 01.01.18-06.30.18
FDA FOIA Log/Spreadsheet showing all FOIA requests filed by FOIA Services, Inc. in the year 2021
Document(s): Personal Protective Equipment EUAs: 1) Were surgical masks or cloth masks ever under an EUA for
minors aged 5-17 years old. 2) Can fines/fee or punishments be assessed to minors for refusing to wear an EUA mask
or EUA Covid Rapid Test who is asymptomatic. (Any docs to support are VERY appreciated!)
I would like to receive all documents submitted for Emergency Use Authorization of Moderna COVID-19 Vaccine and
SPIKEVAX and all documents submitted for FDA approval of SPIKEVAX.
Hi, please provide all communications from Drs. Marks, Woodcock, Witten, or Califf mentioning "Florida" or "Ladapo"
or "pediatric" or "DeSantis" (note, this is a clarified request as requested by the FDA re: # FDA2281900 in a March 14
email)
Hi, please provide the following: The VRBPAC briefing document related to the FeB. 15, 2022 VRBPAC meeting on
Pfizer's vaccine - include all draft and finalized versions All meeting presentations relating to the same meeting,
including presentations created by Pfizer and sent to the FDA, presentations created by the FDA, and presentations the
FDA received from other parties such as but limited to the CDC
Hi, please provide the following: The number of employees who work for the FDA as of March 14, 2022. The number of
employees in each of the following categories: unvaccinated, have received one COVID-19 vaccine dose, are deemed
fully vaccinated (2 doses of Moderna or Pfizer, or one dose of J&J), have received a booster dose.
Hi, please send any documents, files, or records from the Food and Drug Administration related to any inspections or
investigations conducted by the FDA's Office of Regulatory Affairs—including the division's Office of Biological Products
Operations—into any complaints submitted by Ventavia Research Group employees or contractors pertaining to Pfizer's
Phase III trial for the COVID-19 vaccine.
All communications from January 1, 2022 to the present relating to the part 15 hearing (including but not limited to
preparation for the meeting, presentations, background materials, questions to be asked of presenters, and any other
information relevant to participation in the meeting) held on March 10, 2022 to discuss Scientific Data and Information
Related to the Residue of Carcinogenic Concern for the New Animal Drug Carbadox
All releasable information concerning studies undertaken by CDER in 2021 assessing a draft Consumer Update article
about children’s OTC and homeopathic cough and cold products, including but not limited to copies of the protocols and
the results of the studies..
File Number 2021-3088 (CV for Robert Neligan)
for Foods & Cosmetics inspection of Balajee Trade Link LLC ending 01/21/2022 at the location in Taylor PA, United
for Medical Devices & Rad Health inspection of Alan W. Partin, MD ending 02/09/2022 at the location in Baltimore MD,
for Medical Devices & Rad Health inspection of Circuit Works Corporation ending 02/15/2022 at the location in
Waukegan IL, United States. Please send documents as email attachments.
for Medical Devices & Rad Health inspection of Harmac Medical Products, Inc. ending 02/11/2022 at the location in
Buffalo NY, United States. Please send documents as email attachments.
for Medical Devices & Rad Health inspection of Micron Products, Inc ending 02/16/2022 at the location in Fitchburg MA,
for Medical Devices & Rad Health inspection of Sunnex, LLC ending 02/18/2022 at the location in Charlotte NC, United
for Human Drugs inspection of Novo Nordisk Pharmaceutical Industries LP ending 02/10/2022 at the location in Clayton
NC, United States. Please send documents as email attachments.
for Foods & Cosmetics inspection of Woodstock Sterile Solutions Inc ending 05/23/2019 at the location in Woodstock IL,
United States. The Response (in electronic format) for Foods & Cosmetics inspection of Woodstock Sterile Solutions Inc
ending 05/23/2019 at the location in Woodstock IL, United States. Please send documents as email attachments.
We would like to request importer records for Fresh Quality Produce (DUNS number 963967562) to view all of the
imports made.
• Request for MedWatch Report for Case ID 20141068 • Suspect Product: Amondys 45;Vyondys 53;Exondys 51 •
Reaction: Product Packaging Confusion;Product Appearance Confusion;Product Prescribing Error;Intercepted Product
Prescribing Error;Product Name Confusion • Patient of unspecified gender and age • Country of occurrence: Not
specified • Manufacturer Control Number: N/A
483s and EIRS from Indiana Chem Port
Data set of pediatric extensions given to drugs, including the exclusivity code and the date upon which the awarded
exclusivity would expire. I would like to request a data set of all pediatric extensions granted to drugs. This should
include the drug's ingredient, applicant name, date of expiry, as well as method of use of the drug product.
1. All recommendations issued by the Tissue Reference Group (“TRG”) in response to a third-party request for guidance
determining that a human cell, tissue, or cellular or tissue-based product (“HCT/P”) meets the criteria for sole regulation
under Section 361 of the Public Health Service Act (“PHS”); 2. All formal agency decisions issued by the Office of
Combination Products (“OCP”) in response to a third-party request for designation determining that an HCT/P meets the
criteria for sole regulation under Section 361 of the PHS; etc
Approval Letter for Fetroja (cefiderocol), including the package insert and any post-marketing commitments
Approval Letter for Recarbrio (imipenem, cilastatin, and relebactam), including the package insert and any post-
marketing commitments
I would like a copy of the full 510K submission for the Mimosa (510K K190334) and the Moleculight (510K #s K211901,
K210882, K191371). I have been asked to provide consulting regarding compliance, and I do not feel comfortable
making any recommendations without the full submission data from the devices listed above.
EMPLOYEE EMAILS
Form 483/inspection record with three observations from FDA inspection of Zydus Lifesciences Limited's injectable
facility in Jarod, Gujarat, India from Feb. 24, 2022 to March 10, 2022.
12 Med Watch Reports for Case Nos.: 6960628; 10713074; 10912634; 12394755; 13524140; 13805439; 14065789;
14572763; 16145866; 17136307; 17772336; 17936384
FDA Foreign Remote Regulatory Assessment Memo-McCormick de Centro América S.A. de C.V.
CVM Division of Animal Feeds DAF 06281
A list of all sites inspected by FDA for GMP and GLP for the referenced date periods. Please see attached document of
full details of request.
I would like all emails to and from Janet Woodcock (Acting Commissioner) between January 1, 2020 and February 28,
2022 that include the keywords, "ivermectin" or "ivm".
Thank you,
Sharida McKenzie
Copy of the disclosable portions of the infant formula submissions from 01/01/2019 to the present for (1) Similac Pro-
Sensitive; and (2) Gerber Good Start Gentlepro.
Please provide a copy of Food Contact Notification No. 554 and all related attachments filed by the notifier (Ciba
Specialty Chemicals Corporation).
Please provide all documents submitted in support of Food Additive Petition FAP-3A1019. We do not know the identity
of the submitter or the specific time period the petition was filed but believe it was in the 1986 - 1988 time-frame.
483 reports on fill/finish production of vaccine at Catalant's fill/finish factory in Bloomington, Indiana
Documents realted to FDA Conducted Cheese Sampling Assignments

The Matheson Tri-Gas facility in Vernon CA inspection recs
ORLAAM DETAILED REPORT
I am requesting all information pertaining to the safety data of the Pfizer Covid-19 vaccine, including but not limited to
the statistics on any adverse events and long term side-effects, broken down by age groups and by the number in the
series of shots
Hi, Please provide the following: Documents reflecting that the Vaccine Adverse Events Reporting System (VAERS)
captures all deaths which occur following COVID-19 vaccination. Documents reflecting the percent and number of
deaths reported to VAERS after COVID-19 vaccination that the Food and Drug Administration (FDA) has concluded are
likely causally related to receipt of a COVID-19 vaccine Documents reflecting the percent and number of deaths
reported to VAERS after COVID-19 vaccination that the FDA has concluded are likely not causally related to receipt of a
COVID-19 vaccine.
Hi, please provide any and all communications between the FDA and representatives of Pfizer, Moderna, or Johnson &
Johnson mentioning "fetal cells" and "vaccine" and "COVID-19."
Hi, please provide communications regarding the lack of availability of COMIRNATY-branded Pfizer vaccine vials and
when these vials will be available in the United States
All communications between any of the following individuals: Dr. Elizabeth Miller, Assistant Commissioner for Medical
and Tobacco Operations, Office of Regulatory Affairs, FDA Dr. Donald Prater - Associate Commissioner for Imported
Food Safety, Office of Food Policy and Response, FDA Dr. Louis Bluhm - Director, Laboratory Quality Assurance,
Response, and Coordination Staff, Food Safety and Inspection Service (FSIS), ETC
Inspection Recs U&I Corporation, headquarter 20, Sandan-ro, 76beon-gil(Rd), Uijeongbu-si, Gyeonggi-do, Korea 11781;
(b) U&I Seoul R&BD Center, 1, Sangwon 12-gil, Seongdong-gu, Seoul, Republic of Korea; (c) D.K.M. Co. Ltd.; etc
Disaggregated seroconversion data by trial center and site visit reports (if any) from the multicenter clinical trial iPREX
(Published as DOI: 10.1056/NEJMoa1011205) submitted by Gilead Sciences as part of the 2012 Expanded Use
Authorization application for FTC/TDF ("Truvada") for HIV Pre-Exposure prophylaxis ("PrEP").
FDA study of 1,4 dioxane in consumer products that was conducted in 1980 & 1981
We would like all adverse event reports submitted to the FDA for VABYSMO since its approval (BLA 761235)
TE codes of all the products (either with ANDA number or with NDA number) discontinued till date
All records for previously requested: I am requesting the testing records for K9 Naturals voluntary recall that FDA
suggested to K9 Naturals.
All records and response letters provided for 2019-4713
All records provided for 2019-10195
We request an electronic list of all FDA Prior Notice information submitted to FDA where the manufacturer is Depalim
LLC (FFR 16801714900) from February 1, 2022 to March 17, 2022
Grocery
In order to further investigate a Newly Identified Safety Signal (NISS), ANI Pharmaceuticals, Inc. is requesting the
complete case report files, including all follow-up communications for the 9 identified cases as listed in the attached pdf
document. All case information noted in the table has been sourced from the FDA Adverse Event Reporting System
(FAERS) Dashboard.
Most recent approved labeling for NDA 020027, Cardizem, held by BIOVAIL LABORATORIES INTERNATIONAL SRL. This
labeling is required to develop an ANDA for diltiazem injection, but is not publicly available on Drugs@FDA.
for Human Drugs inspection of Granules Pharmaceuticals Inc ending 01/28/2022 at the location in Chantilly VA, United
for Human Drugs inspection of Johnnie M. Woodson, MD ending 02/02/2022 at the location in Henderson NV, United
for Human Drugs inspection of Lifecycle Biotechnologies, LP ending 01/28/2022 at the location in Loveland CO, United
for Human Drugs inspection of Vijay M. Patel, M.D. ending 02/04/2022 at the location in Saint Petersburg FL, United
for Biologics inspection of KITE PHARMA INC ending 01/28/2022 at the location in Santa Monica CA, United States.
for Human Drugs inspection of Bristol-Myers Squibb ending 02/02/2022 at the location in Princeton NJ, United States.
The EIR (in electronic format) for Foods & Cosmetics inspection of Abbott Nutrition ending 09/24/2021 at the location
in Sturgis MI, United States. The Response (in electronic format) for Foods & Cosmetics inspection of Abbott Nutrition
ending 09/24/2021 at the location in Sturgis MI, United States. Please send documents as email attachments.
Please provide the product label (PI, carton and bottle label) for the discontinued Sodium Thiosulate product under NDA
020166 held by the UNITED STATES ARMY OFFICE SURGEON GENERAL.
FDA (bioterrorism act) registrations by Amerisal Foods LLC. This is a first party request by the owner via counsel (a letter
of authorization is attached).
RRA Inspection Records for IsoRay Medical, Inc., Richland, Washington - January 19 - February 2, 2022
Any internal review of cosmetic talcum powder in relation to ovarian cancer
Please produce a complete copy of the following: 1. Any and all WARNING LETTERS to ReBuilder Medical Technologies,
Inc., related to ReBuilder EMS/TENS cleared under K882980; 2. Any and all responses to any WARNING LETTERS in #1
above; 3. Any and all 510K clearance for ReBuilder EMS devices related to 1-2 above.
Please provide the copy of the latest version of the bottle labels and package insert of MEDROL, NDA# 011153. Thank
you.
Please provide a complete copy of the following: 1. Any and all Warning Letters to Restorative Products, Inc., including
but not limited to FLA-06-08, relating to any product manufactured or sold by the company; 2. Any and all responses to
any Warning Letters identified or related to #1 above; 3. Any and all 510K Clearance Letters provided to Restorative
Products, Inc.; 4. Any and all 510K Clearance Letters provided to Restorative Products, Inc., related to any ANONDYNE
THERAPY SYSTEM; 5. Any and all WARNING LETTERS related to any ANODYNE THERAPY SYSTEMS related to 1-4 above.
Thank you.
Redacted K193054 - Traditional 510(k) and redacted K201005 - Traditional 510(k)
unredacted reviews for our NDA 208010 Rayaldee (calcifediol) extended release capsules .
FOIA LOG
An electronic spreadsheet (not PDF, please) of Voluntary Cosmetic Registration Program (VCRP) data, including VCRP
category Conc of use totals, ingredient and category totals of Conc of use data, as well as just ingredient Conc of use
totals, as has been provided in recent years.
I am requesting previously released records for: All testing records related to pet food company Vibrant K9 for the year
of 2020. On March 10, 2020 Frank Lee of FDA Division5W (Los Angeles District) wrote the company Vibrant K9 and
stated their raw turkey blend was "recently tested and the presence of bacteria was found." Please provide all testing
records related to company Vibrant K9
GORE MESH RECS
Hi, please provide documents reflecting any documented case of an individual who: (1) never received a COVID-19
vaccine; (2) was infected with COVID-19 once, recovered, and then later became infected again; and (3) died due to or
with SARS-CoV-2.
The Medicago COVID19 vaccine known as COVIFENZ or MT-2766 is reported to be produced in Medicago's Research
Triangle North Carolina facility. Vaccine production starts with a plant-specific bacterial vector containing a SARS-CoV-2
viral sequence. (See https://www.fiercepharma.com/manufacturing/medicago-s-plant-based-production-platform-
bearing-fruit-gsk-partnered-covid-shot#:~:text=Manufacturing-,With%20plant%2Dbased%20manufacturing%2C%20GSK
%20partner%20Medicago%20takes%20COVID%2D,vaccine%20production%20into%20the
%20greenhouse&text=Medicago's%20vaccine%20starts%20production%20not,are%20made%20using%20plant
%20leaves.) That plant-specific bacterial vector is used to infect plants so that the plants express a SARS-CoV-2 Virus Like
Particle. THE FOIA REQUEST: Can you please, at your earliest convenience, provide all available information on the
plant-specific bacterial vector that contains a SARS-CoV-2 sequence that is being used in North Carolina by Medicago to
infect plants. Thank you. Kind regards, /Thomas J Kowalski/
510(k) submissions for: • K182766 for the Cufitect Surgical Mask • K190268 for the Hydrofera Blue READY –
Border (Absorbent Wound dressing)
All information from the RRA of Patient Shield Concepts, LLC
Copy of the 483 for the Feb 14, 2017 - Feb 28, 2017 (15 days) inspection of Moon Valley Bee's and Botanicals LLC
[Deming / United States of America] 3288 Valley Hwy, Deming, WA 98244, USA. This inspection pertains to human
drugs.
Copy of the 483 for the Mar 6, 2017 - Mar 29, 2017 (24 days) inspection of Criticare Systems, Inc [North Kingstown /
United States of America] 125 Commerce Park Rd, North Kingstown, RI 02852, USA. This inspection pertains to medical
devices.
Copy of the 483 for the Mar 6, 2017 - Mar 9, 2017 (4 days) inspection of PROSANA DISTRIBUCIONES SA DE CV [Ciudad
de México / Mexico] Calle Ote 225 97, Agrícola Oriental, Iztacalco, 08500 Ciudad de México, CDMX, Mexico. This
inspection pertains to human drugs.
Copy of the 483 for the inspection of Kord Strebel, MD [Las Vegas / United States of America] 1950 Pinto Ln, Las Vegas,
NV 89106, USA beginning 08/10/21 and ending 08/25/21. This inspection pertains to HUMAN DRUGS.
Copy of the 483 for the inspection of Robert Clark Brown, MD, PhD [Atlanta / United States of America] 5461 Meridian
Mark Rd UNIT 400, Atlanta, GA 30342, USA beginning 08/09/21 and ending 08/20/21. This inspection pertains to
HUMAN DRUGS.
Copy of the 483 for the inspection of Smitha Reddy, M.D. [Poway / United States of America] 15725 Pomerado Rd # 108,
Poway, CA 92064, USA beginning 08/04/21 and ending 08/20/21. This inspection pertains to HUMAN DRUGS.
Report and/or the MDSAP Noncomformity Grading and Exchange Form (NC) for the inspection of Karl Storz GMBH & Co
KG (KSVEM), Garching-Hochbruck, Germany, end date 03-14-2017. FEI# 3006453991. This inspection pertains to
medical devices.
Report and/or the MDSAP Noncomformity Grading and Exchange Form (NC) for the inspection of Karl Storz Gmbh & Co.
KG, Stutensee, Germany, end date 03-16-2017. FEI# 3012086585. This inspection pertains to medical devices.
Report and/or the MDSAP Noncomformity Grading and Exchange Form (NC) for the inspection of Karl Storz SE & Co. KG,
Tuttlingen, Germany, end date 03-16-2017. FEI# 3002808268. This inspection pertains to medical devices.
Copy of the disclosable portions of the 510(k) for K010739, Watch-Pat 100 by Itamar Medical
Copy of the disclosable portions of the 510(k) for K042916, Watch-Pat 100s by Itamar Medical
Copy of the disclosable portions of the 510(k) for K080427, Watch-Pat Model 100s-2, by Itamar Medical
Copy of the disclosable portions of the 510(k) for K161579, Watch-Pat200u, by Itamar Medical.
Copy of the disclosable portions of the SS&E for K010156, Sleep Pat 200 Device, by Itamar Medical.
Copy of the disclosable portions of the SS&E for K010739, Watch-Pat 100, by Itamar Medical.
Regulatory Assessment of Biomat USA Inc Located at Lake Charles LA United States FEI Number: 3006197651 held on
03/04/2021.
Regulatory Assessment of CSL Behring LLC Located at Bradley IL United States FEI Number: 1410248 held on
03/09/2021.
Regulatory Assessment of CSL Plasma, Inc. Located at Tampa FL United States FEI Number: 3010719422 held on
03/04/2021.
Regulatory Assessment of Cardinal Health 414 LLC Located at Denver CO United States FEI Number: 3008212446 held on
03/02/2021.
EIR for Catalent Belgium, located in Brussels, Belgium for the 10/26/2021 inspection. Please note this request pertains
to Human Drugs.
FDA Written Responses for Spark Therapeutics’ product, Luxturna (AAV2-hRPE65v2 or voretigene neparvovec-rzyl)
(STN#:125610), from both the End of Phase 2 and Pre-BLA meetings. Please also include any further follow-up/request
for clarification/summary/additional written responses/etc. directly stemming from these two interactions.
Please provide copies of the disclosable portions of all revisions, additions, or updates occurring from July 13, 2020 to
present regarding the CTP Chemistry Reviewer Guide for SE reports.
483 issued to two facilities from 1/1/22-present. The first facility in Germany makes APIs; the second facility does
fill/finish on biologics (among other functions). Their names/addresses are: Rentschler Biopharma SE Erwin-Rentschler-
Str. 21 Laupheim, Baden-Wurttemberg 88471 Germany FEI: 1000291122 And: UCB Pharma S.A. Chemin Du Foriest,
Avenue de I'Industrie Braine-l'alleud, Brabant Wallon 1420 Belgium FEI: 3003909356
copy of the 483 for the Mar 13, 2017 - Mar 17, 2017 (5 days) inspection of Dae Young Foods Co., Ltd. [Boeun-gun /
Korea (Republic of)] 32 Gumgul-4-gil, Boeun-eup Boeun-gun Korea (the Republic of). This inspection pertains to human
drugs
MR0000192
• K153193, Nimbus II Ambulatory Infusion System •K170982, CADD-Solis Ambulatory Infusion Pump with Wireless
Communication • K141389, Sapphire Infusion Pump o While K141389 is already a FOIA Releasable 510(k), the
document link does not work. https://www.accessdata.fda.gov/CDRH510K/K141389.pdf
I am seeking all communications, inclusive of reports, emails, records of meetings, meeting notes, memorandums,
interviews, and all other information exchanged, concerning any adverse events and reports thereof ("Adverse Event
Reports"), which concern the dietary supplement company "Redcon1."
510K K173730 released date, 01/13/2018: Titled Kinas QuickCare a battery powered Thermometer.is also known as
VDT985US thermometer
Form FDA 483: Paul R. Sieber, M.D. Lancaster, Pennsylvania

United States End Dates of inspection: 23 October 2019 Project Area: Bioresearch Monitoring FEI: 3009315840.
Full copy of ANDA records for 070274 Betamethasone Dipropionate Lotion USP, 0.05%. (all original ANDA submission
records, all amendments) until April 2021.
Full copy of ANDA records for 074839 Etodolac Tablets USP, 400mg (all original ANDA sumbission records, all
amendments) until August 24, 2016.
Full copy of ANDA records for 088045 Fluocinilone Acetonide Cream, 0.025% (all original ANDA submission records, all
amendments, all supplements).
Documents related to inspections for the vendor Primera (Primera Corporation) at their Princeton, NJ site.
Seeking Complete 510k Filing of Vascutherm (K061866), B&J Manufacturing (K201532, K200568, K200154). Particularly
interested in the substantial equivalence test methods and results provided in the 510k filing, including mechanical and
simulated use, biological, and transportation, if applicable.
Human Drug Safety Reports submitted to the FDA related to compounded ketamine products or simply all Human Drug
Safety Reports related to ketamine over the previous year.
I am requesting a copy of the report from our Remote Regulatory Assessment. The report was reviewed with inspector
Suyang Qin over the phone on 2-4-22.
Please consider this a request for a list of pediatric priority review voucher sales reported by pharmaceutical
manufacturers between January 2020 to December 2021.
CUMULATIVE ANALYSIS OF POST-AUTHORIZATION ADVERSE EVENT REPORTS OF mRNA-1273 (COVID-19 mRNA Vaccine
Moderna) Essentially the equivalent documentation released from Pfizer via their court order, which has not been
released from Moderna as of yet.
CVs Kathryn King, Roberto Dookhan, Lee Pai Scherf, Sorana Black, Iris Tan, Sara Valenzuela, Olalere Fasipe, Stephanie
Kelly, David Bailey, Erica Woody, Nirjal Bhattarai, Daniel Munoz, Robin Mathew, etc
2022-1218, 2022-1357, 2022-1465, 2022-1510, 2022-1528.
2022-886, 2022-991, 2022-1046, 2022-1172, 2022-1211.
We request all claim information submitted to the Center for Food Safety and Applied Nutrition (CFSAN) by U.S. Food
and Drug Administration Special Agent, Cheryl Zuñiga, at the Lost Angeles Office of Criminal Investigations relating to
the sale of potato starch by Good Fortune Supermarket located at located at 137 S San Gabriel Blvd., San Gabriel,
California 91776.
Hi, please provide all communications to or from Drs. Marks, Witten, and Chumakov mentioning "Pfizer", "Moderna", or
"booster" Thanks
Import Alert 89-08 CDRH RECS
(i) all FOIA requests filed with the Food and Drug Administration ("FDA") since November 2020 by Center for Food
Safety ("CFS"), seeking FDA documents regarding or related to AquaBounty Technologies, Inc.'s AquAdvantage® Salmon,
FDA's review of the New Animal Drug Application for AquAdvantage® Salmon, and/or assessments relevant to
AquAdvantage Salmon pursuant to the Federal Food, Drug & Cosmetic Act ("FDCA"), ETC
483 Inspectional Observation report for Bactolac Pharmaceutical, Inc. 7 Oser Avenue FEI#3000207006 Inspection
ID#1157283 Inspection Date 11/19/2021
510(k) file of K961800 Head Mounted Display, Vista Medical, 1996-11-09 I am looking for the available information
from the application file and other content that may exist on FOIA related to this 510(k).
A listing of all domestic and foreign FDA Form 483 Notices of Inspectional Observations made available for FOIA request
in the month of February 1 to 28, 2022, including for any inspections dated before Feb. 1, for: • Pharmaceutical,
biologics and medical device manufacturing facilities, including premarket approval inspections; AND Clinical research
facilities, investigators and IRBs.
Complaint report #143588 Investigation done for the firm Bella Silueta Esthetic in Caguas, PR with FEI #3012248375
FCN 2032. Please see attached request letter.
for Medical Devices & Rad Health inspection of NextPhase Medical Devices LLC ending 01/10/2022 at the location in
Rochester NH, United States. Please send documents as email attachments.
for Medical Devices & Rad Health inspection of Precision Biometrics, Inc. ending 12/21/2021 at the location in Seattle
WA, United States. Please send documents as email attachments.
for Human Drugs inspection of Shire ending 01/05/2017 at the location in North Reading MA, United States. Please
for Foods & Cosmetics inspection of Packer's Canning Company, Inc. dba HoneeBear Canning ending 06/10/2021 at the
location in Lawton MI, United States. The Response (in electronic format) for Foods & Cosmetics inspection of Packer's
Canning Company, Inc. dba HoneeBear Canning ending 06/10/2021 at the location in Lawton MI, United States. Please
for Human Drugs inspection of Dario D. Altamirano, DO ending 02/09/2022 at the location in Hialeah FL, United States.
The Response (in electronic format) for Human Drugs inspection of Dario D. Altamirano, DO ending 02/09/2022 at the
location in Hialeah FL, United States. Please send documents as email attachments.
CA, United States. The EIR (in electronic format) for Medical Devices & Rad Health inspection of Respironics California
LLC ending 05/21/2018 at the location in Carlsbad CA, United States. The 483 (in electronic format) for Medical Devices
& Rad Health inspection of EZGO GROUP INC ending 12/22/2021 at the location in Rancho Cucamonga CA, United
documentation and written communication related to the refusal of entries 799-5465376-1/11/1/ and AEK-4020631-
7/11/1/
1. All records relating to any review, analysis or investigation by the FDA of any Bio360-branded product – including
investigation memorandum, reports, correspondence, e-mails or notes (“FDA Review”); 2. All records relating to
any FDA Review of any Stada Corp. product branded under the name Bio360; ETC
We are requesting record of Foreign Remote Regulatory Assessment (FRRA) executed between February 7 - 10, 2022, to
Panificadora Superman, S.A. de C.V., company with Foreign Food Facility Registration number 12497009200 and located
in the city of San Pedro Sula, Honduras
Requesting any documentation associated with an issued Form 483, as well as the manufacturer's response, for a site
inspection of Hugel Inc.'s Korean manufacturing facility in August 2021 and any follow-up inspections or
correspondence. The inspection was related to the BLA filing for letibotulinumtoxinA for treatment of glabellar lines,
which has a PDUFA date of 3/31/22.
All records related to FDA’s sample collection and testing and data reports of all 68% Ethyl Alcohol Hand Sanitizer
products manufactured and/or distributed by Best Brand Consumer Products, Inc. under any and all lot numbers during
the relevant time period (07/01/2020-12/31/2021).
Requesting the Agency to provide list of last three inspected Form 483 (Notice of Inspectional Observations) for Zhejiang
Hisun Pharmaceutical Co., Ltd., with FDA establishment identifier # 3007719313.
Eli Lilly and Company is requesting the clinical, stats, and summary reviews for Rinvoq NDA211675 for Supplement 004
(AtD) and Supplement 007 (UC). Thank you.
Copy of the disclosable portions of the Bioequivalence Review for ANDA 91482, Fluvoxamine maleate, by Actavis
Elizabeth, approved 11/18/2013.
Copy of the disclosable portions of the MedWatch reports for the following 3 molnupiravir cases: 20559729; 20559635;
and 20548595.
Please provide disclosable portions of final determinations and the associated TPLs for all determinations received by
Swedish Match USA, Inc. or any of its subsidiaries from 10/1/2020 – 9/30/2021.
All records related to drug approval package and review of application for ANDA 206497 methylphenidate transdermal
from Mylan Tech Viatris.
I would like a copy of the 483 letter Abbott received for its Sturgis MI infant formula plant.
Please provide disclosable portions of final determinations and the associated TPLs for all determinations received by
Swedish Match USA, Inc. or any of its subsidiaries from 10/1/2021 – 3/11/22.
for Biologics inspection of Reproductive Care Center ending 02/11/2022 at the location in Sandy UT, United States.
for Biologics inspection of Department of the Navy, Fort Belvoir Community Hospital ending 02/10/2022 at the location
in Fort Belvoir VA, United States. The 483 (in electronic format) for Biologics inspection of CCRM Fertility Northern
Virginia ending 02/11/2022 at the location in Vienna VA, United States. Please send documents as email attachments.
for Biologics inspection of OsteoLife Biomedical, LLC ending 01/27/2022 at the location in Jupiter FL, United States. The
483 (in electronic format) for Biologics inspection of Osteolife Biomedical I LLC ending 02/04/2022 at the location in
Miami FL, United States. Please send documents as email attachments.
for Medical Devices & Rad Health inspection of Lifecore Biomedical, LLC. ending 01/21/2021 at the location in Chaska
MN, United States. The EIR (in electronic format) for Medical Devices & Rad Health inspection of Surgical Technologies
Inc ending 01/31/2020 at the location in Saint Paul MN, United States. Please send documents as email attachments.
for Human Drugs inspection of Halo Pharmaceutical, Inc. ending 03/20/2017 at the location in Whippany NJ, United
States. The EIR (in electronic format) for Human Drugs inspection of Halo Pharmaceutical, Inc. ending 03/20/2017 at
the location in Whippany NJ, United States. The Response (in electronic format) for Human Drugs inspection of Halo
Pharmaceutical, Inc. ending 03/20/2017 at the location in Whippany NJ, United States. Please send documents as email
attachments.
We would like to request copy of the latest version of the package insert, container labels and container-cartons of
FIRVANQ oral solution, 25 mg/mL and 50 mg/mL; NDA # 208910/S-005.
Request for (a) the 483 (electronic format) for inspection of Primera Analytical Solutions Corp. ending 05/18/2018 at
Cranbury NJ, USA; and (b) the response (electronic format) for inspection of Primera Analytical Solutions Corp. ending
05/18/2018 at Cranbury NJ, USA. Kindly send documents as email attachment if possible. FEI 3013030741
I am requesting the following documentation for this announcement FDA-ORA-22-IMP-11269928-GP and Control
number 618900400
Request for Meeting Minutes conducted under IND 18080 related to approved BLA 125746 CARVYKTI (ciltacabtagene
autoleucel). The meetings minutes for the following meetings: 21Aug2019 Type B, 08 Dec 2020 Type B, 14 Feb 2020
Type B, 18 Aug 2020 Type B, 28 Aug 2020 Type C, 02 Oct 2020 Type B
I request complaints received by the U.S. Food and Drug Administration's Adverse Events Reporting System between
December 2016 to March 2022 related to the birth control implant Nexplanon.
RE: Sunshine Mills, Inc., Tupelo, MS: Please supply FDA Form 483, EIR (if available), product recall notices, subsequent
correspondence, consumer complaints, and results of sample analyses pursuant to any inspection initiated at this
location during Calendar Year 2021.
all detailed narrative data columns of adverse events (a total of 51 patients with disseminated tuberculosis during
treatment with adalimumab for psoriasis)
All public records for the FCN 2175 submission. Thank you.
MED-FIBERS INC RRA
I am looking to find updated information on any studies conducted by the FDA on the side effects and possible dangers
of MDMA (ecstasy).
I'm looking for any records/documents/emails pertaining to the regulation or banning of NAC (N-Acetylcysteine) as a
dietary supplement.
Laboratory/Pathology Results re: FDA Complaint No. 172632
documents relating to labeling of pizza with cheese analog (imitation cheese).
PREVIOUSLY RELEASED RECORDS PFIZER
PREVIOUSLY RELEASED RECS MERCK
Request of Memo of the foreign regulatory assessment.
Email copies of all correspondence between the U.S. Food and Drug Administration and Novavax, Inc., pertaining to
their Covid-19 vaccine candidate (NVX-CoV2373). Search should be conducted from 12/01/2021 to the date of search.
Avanos Cortrak EAS device data
Dear Sir or Madam, I am requesting a copy of the Remote Regulatory Assessment report for Passy-Muir, Inc. (Irvine, CA)
with Officer Sarah Hassas, that took place from February 2, 2022 - February 3, 2022. Thank you in advance. Best
Regards, Ms. Trina Diep
customs brokers using 'UNK' as ACE identifier code in FSVP importers INSTEAD of using our DUNS number
I am requesting all documents involving: 1) reporting of adverse effects (illness, injury), events and labeling concerns on
Gluten including adverse effects of Gluten ingestion (i.e., reports to FDA’s Safety Information and Adverse Event
Reporting Program and MedWatch voluntary reports), as detailed here, https://www.fda.gov/food/nutrition-education-
resources-materials/gluten-and-food-labeling etc
I would like to obtain the response letter from Antonio Migliarese, interim CEO of CytoDyn, to the FDA, responding to
the FDA's warning letter of Feb. 11: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-
investigations/warning-letters/cytodyn-inc-626957-02112022
Requesting the Copan Diagnostics, Inc. located at 26055 Jefferson, Remote Regulatory Assessment, (RRA) Final Report.
All communications between FDA and MarDX Diagnostics, Inc. (an in vitro diagnostics manufacturer), of Carlsbad, CA,
and/or its representatives, including but not limited to Arthur Markovits and Barry Menefee, in the calendar years 1994-
1999.
Hi - I would like to request all Adverse Events reported for Faricimab (Vabysmo) - including those pre-approval as well as
post approval. Thank you.
for Human Drugs inspection of Lifecore Biomedical, LLC. ending 11/20/2015 at the location in Chaska MN, United States.
for Medical Devices & Rad Health inspection of Lifecore Biomedical, LLC. ending 03/02/2017 at the location in Chaska
MN, United States. The Response (in electronic format) for Medical Devices & Rad Health inspection of Lifecore
Biomedical, LLC. ending 03/02/2017 at the location in Chaska MN, United States. Please send documents as email
attachments.
for Foods & Cosmetics inspection of National Bakery, Inc. ending 09/02/2021 at the location in Scranton PA, United
States. The EIR (in electronic format) for Foods & Cosmetics inspection of National Bakery, Inc. ending 09/02/2021 at
the location in Scranton PA, United States. The Response (in electronic format) for Foods & Cosmetics inspection of
National Bakery, Inc. ending 09/02/2021 at the location in Scranton PA, United States. Please send documents as email
attachments.
Product Area: Biologics ¿Request record: FDA review record for approval of SUPPL-115, SUPPL-114, SUPPL-113
*Biologic License Application (BLA): 125274 ¿Company: IPSEN BIOPHARM LTD (FEI: 1000346340) ¿ Address: Ipsen
Biopharm Ltd., Wrexham, LL13 9UF, UK
¿Product Area: Biologics ¿Request record: FDA review record for approval of SUPPL-5236 *Biologic License
Application (BLA): 103000 ¿Company: Allergan Inc. (FEI: 3002806285) ¿Address: ALLERGAN PHARMACEUTICALS
IRELAND CASTLEBAR RD. WESTPORT Mayo, IE
FDA review documents for ATROPEN, NDA 017106 action date 5/15/1973
for Human Drugs inspection of CIL Isotope Separations, LLC ending 01/25/2022 at the location in Xenia OH, United
for Human Drugs inspection of Donna S. Hrozencik, M.D. ending 01/26/2022 at the location in Canton MI, United States.
for Human Drugs inspection of Zennova LLC ending 01/27/2022 at the location in Orangeburg NY, United States. Please
test test
All records provided for FOIA request, 2018-7850
09.30.2021
All response letters and records provided for FOIA requests 2021-6453, 2021-6588, 2021-6590, 2021-6591
All records and response letters provided for FOIA requests 2019-221, and 2019-552
I'm requesting all calendar records for Steven Solomon (CVM)
All records for pet foods tested for aflatoxin in 2021
Hello, Please provide all emails to or from Dr. Janet Woodcock sent to or received from the following addresses:
DeanofPublicHealth@brown.edu ajha@hsph.harvard.edu ashish_jha@brown.edu
Hello, Please provide all emails to or from Dr. Robert Califf sent to or received from the following addresses:
Hello, Please provide all emails to or from Dr. Stephen Hahn sent to or received from the following addresses:
Hello, Please provide the following: All requests for information from the FDA to Janssen, Pfizer, and Moderna
concerning reports of deaths following COVID-19 vaccination.
Hello, please provide all emails between Marion Gruber and Philip Krause
Hello, please provide the following from FDA's BEST system: Raw data, all draft analyses, and all final reports on COVID-
19 vaccine effectiveness and safety Thank you
Hi there, Please provide all emails to or from Dr. Peter Marks sent to or received from any the following individuals:
Arnold Monto Paula Annunziato Amanda Cohn Hayley Gans Michael Kurilla Cody Meissner Paul Offit Steven Pergam
Oveta Fuller James Hildreth Jeannette Lee Ofer Levy Patrick Moore Michael Nelson Stanley Perlman Jay Portnoy Eric
Rubin Mark Sawyer Melinda Wharton
Hi there, Please provide all emails to or from Hong Yang mentioning "benefits" or "risks" and "vaccine"
I'm requesting all calendar records for Tracey Forfa, cvm 01.01.19-03.31.19
All meeting minutes from FDA-CVM's March 22, 2022 Ingredient Definition Meeting with AAFCO. All science FDA-CVM
reviewed for the AAFCO term "corn protein meal" All emails from FDA-CVM employees David Edwards, Charlotte
Conway, for the month of January 2022, the month of February 2022, and March 1-March 22, 2022, containing key
search terms, Corn Gluten Meal, Corn Protein Meal, AAFCO.
I'm requesting all e-mails from cvmrecalls@fda.hhs.gov containing key words small batch, david vogel, michael vogel
I'm requesting all text message records for 913-953.7710 Miguel Hernandez, works at ORA Lenexa KS 66214
ALL PHASE 1, PHAE 2, AND PHASE 2/3 CLINICAL TRIAL DATA FR MODERNA'S mRNA-1273 and mRNA-1273.214.
All emails between Dr. Marks and Dr. Fauci
Hello, please provide all emails between Dr. Califf and Dr. Marks or Dr. Woodcock mentioning "vaccine" or "vaccines"
and "covid-19", "Covid", or "coronavirus"
Hi there, please provide all emails mentioning "covid", "covid-19", or "coronavirus" between Dr. Califf and addresses
ending with "@who.eop.gov”, excluding spam and attachments and mass daily emails
Hi, please provide all emails between Dr. Hahn or Woodcock and any addresses ending with @chinacdc.cn
WE WULD LIKE ALL PHASE 1 AND PHASE 2/3 CLINIAL TRIAL DATA FOR MODERN'S mRNA ADOLESCENT VACCINE
KidCOVE. ALSO ANYTHING FROM THE DATA SAFETY MONITORING BOARD REEGARDING THESE STUDIES AND PHASES OF
THE CLINICAL TRIAL
-In reference to all 510(K) documents pertaining to the following 510(K) numbers: K182735, K180194, K201048,
K133694, K192869, K123326, K133432 -All 510(K) documents pertaining to Paragonix Technologies, Inc. -All
communication records between Paragonix Technologies, Inc. and the FDA -Any and all other documents pertaining to
Paragonix Technologies, Inc. during interactions with the FDA
Copy of the disclosable portions of all FDA reviews for Logic brand STNs PM0000529.PD1-PM0000531.PD1,
PM0000535.PD1-PM0000537.PD1, PM0000540.PD1-PM0000541.PD1.
Electronic submissions that were made between October 2017 and June 2018 for IND's of Pidilizumab (otherwise
referred to as CT-011 or MDV9300): - IND100,551 from sequence 0188 and onwards - IND 114,135 from sequence 0092
and onwards Please refer to the attached request letter for more details.
FCN 1135: food contact notification and review memos
Full 510(k) Application/Records related to K110424 510(K) Number K110424 Device Name DIGNITY MINI PORT-
ATTACHABLE; DIGNITY MINI PORT- PRE ATTACHED; DIGNITY LOW PROFILE PORT- ATTACHABLE; DIGNITY LOW PROFIL
Applicant MEDCOMP
Hi, I would like to request any Form 483 observations issued to Sterling Pharmaceutical Services during any 2022
inspection of the manufacturing facility located in Dupo, IL. Thank you
I would like an import report for MarketShield, Inc. with DUNS number 12-189-0620, for the period between August 1st
2021 to March 1st 2022.
Sintilimab CRL decision for BLA application in 1L NSCLC
concerning the studies performed by or for the Application Holder concerning the effectiveness of the product:
OPZELURA (RUXOLITINIB PHOSPHATE) CREAM; TOPICAL EQ 1.5% BASE, N215309, INCYTE CORP, Approved Sep 21, 2021.
database entries on genome edited plants
Please provide all drug applications and submissions, interim and final reports, protocols, guidance, warning letters, and
case studies for isotretinoin.
A copy FDA’s memorandum documenting the disposition of 180-day exclusivity for Mycophenolic Acid Delayed-release
Tablets, 360 mg, approved under ANDA 091248 on January 8, 2014.
A copy FDA’s memorandum documenting the disposition of 180-day exclusivity for Pioglitazone Hydrochloride and
Metformin Hydrochloride Tablets, 15 mg/500 mg and 15 mg/850 mg, approved under ANDA 090406 on February 25,
2011.
Electronic listing (preferably csv format) of all inspections conducted by FDA since October 1, 2021. The list should cover
Report and/or the MDSAP Noncomformity Grading and Exchange Form (NC) for the inspection of Cerner Healthcare
Solutions Private Ltd., Bangalore, India, end date 12-07-2018. FEI# 3008058132. This inspection pertains to medical
devices.
Report and/or the MDSAP Noncomformity Grading and Exchange Form (NC) for the inspection of Philips India Limited,
Chakan, India, end date 09-25-2019. FEI# 3010685285. This inspection pertains to medical devices.
Report and/or the MDSAP Noncomformity Grading and Exchange Form (NC) for the inspection of O&M Halyard
Honduras S.A de C.V., Villanueva, Honduras, end date 12-14-2018. FEI# 1000582923. This inspection pertains to
medical devices.
Report and/or the MDSAP Noncomformity Grading and Exchange Form (NC) for the inspection of Metronic Sofamor
Danek Deggendorf GmbH, Deggendorf, Germany, end date 03-01-2017. FEI# 3011795235. This inspection pertains to
medical devices.
Copy of the 483 for the Sep 20, 2018 - Sep 25, 2018 (6 days) inspection of Surgisil [Plano / United States of America]
6020 W Plano Pkwy, Plano, TX 75093, USA. This inspection pertains to medical devices.
Copy of the 483 for the Sep 25, 2018 - Sep 27, 2018 (3 days) inspection of Asclemed USA Inc. dba Enovachem
Manufacturing [Torrance / United States of America] 379 Van Ness Ave #1403, Torrance, CA 90501, USA. This inspection
pertains to human drugs.
Copy of the 483 for the Oct 17, 2018 - Oct 30, 2018 (14 days) inspection of B & B Pharmaceuticals, Inc. [Englewood /
United States of America] 8591 Prairie Trail Dr C600, Englewood, CO 80112, USA. This inspection pertains to human
drugs.
Copy of the 483 for the Oct 25, 2018 - Oct 30, 2018 (6 days) inspection of U.S. Continental Marketing, Inc. [Corona /
United States of America] 310 Reed Cir, Corona, CA 92879, USA. This inspection pertains to human drugs.
Regulatory Assessment of CSL Plasma Inc Located at Chattanooga TN United States FEI Number: 1076457 held on
04/07/2021.
Regulatory Assessment of CSL Plasma Inc Located at Louisville KY United States FEI Number: 1047137 held on
04/07/2021.
Regulatory Assessment of Cardinal Health 414, LLC Located at Dallas TX United States FEI Number: 3004010371 held on
04/05/2021.
Regulatory Assessment of Biomat USA, Inc. Located at Panama City FL United States FEI Number: 3013155361 held on
04/02/2021.
Form FDA 483: Accupac, Llc Lakewood, New Jersey United States End Dates of inspection: 18 November 2021
for Human Drugs inspection of Cardinal Health 414 LLC ending 04/07/2021 at the location in Wichita KS, United States.
for Foods & Cosmetics inspection of Dole Fresh Vegetables Inc. ending 01/07/2022 at the location in Bessemer City NC,
United States. The EIR (in electronic format) for Foods & Cosmetics inspection of Dole Fresh Vegetables Inc. ending
01/07/2022 at the location in Bessemer City NC, United States. The Response (in electronic format) for Foods &
Cosmetics inspection of Dole Fresh Vegetables Inc. ending 01/07/2022 at the location in Bessemer City NC, United
for Foods & Cosmetics inspection of Koster Keunen Inc ending 10/19/2017 at the location in Watertown CT, United
States. The Response (in electronic format) for Foods & Cosmetics inspection of Koster Keunen Inc ending 10/19/2017
at the location in Watertown CT, United States. Please send documents as email attachments.
for Medical Devices & Rad Health inspection of Breas Medical, Inc. ending 01/18/2022 at the location in North Billerica
MA, United States. The 483 (in electronic format) for Medical Devices & Rad Health inspection of Suture Concepts
ending 12/20/2021 at the location in Beverly MA, United States. Please send documents as email attachments.
for Medical Devices & Rad Health inspection of Elaine E. Tseng, M.D. ending 01/07/2022 at the location in San Francisco
CA, United States. Please send documents as email attachments.
for Medical Devices & Rad Health inspection of Gauthier Biomedical, Inc. ending 12/21/2021 at the location in Grafton
WI, United States. Please send documents as email attachments.
We request the bottle label of 100's counts for 2 mg, 5 mg and 10 mg strength and 500's count for 5mg and 10 mg
strength of RLD. Valium® (diazepam) Tablets 2 mg, 5 mg and 10 mg, Application No. N013263 held by Hoffmann La
Roche Inc. This is required for ANDA submission planned on 20th April 2022.
Please provide FDA's summary basis of approval review including the clinical/medical, statistical, chemistry,
pharmacology/toxicology, biopharmaceutics, correspondence, and administration sections related to NDA 020723
(Supplement-020) for ALDARA (imiquimod) Cream, 5%.
Food and Drug Administration (“FDA”) review of: (1) the Investigational New Drug (“IND”) Application, submitted to the
FDA by Reata Pharmaceuticals, Inc. (“Reata”) in approximately October 2016, for bardoxolone methyl (“bardoxolone”)
for the treatment of patients with chronic kidney disease (“CKD”) etc
1. A description of the recycling process, including a description of the following: a. The sources of PCR. b. Any
controls put in place to prevent contamination of PCR from other materials in the plastics recycling stream. 2. Any test
results for the following: a. Removal of incidental contaminants by the recycling process. etc
Please provide VAERS report for vaccination administered on 07/08/2020.
Any and all records, documents, reports, complaints (whether submitted by consumers, medical/health professionals,
manufacturers, distributors, facilities personnel, or others), recalls, recall effectuation materials, market withdrawals,
etc re Flow Organic Lemon/Ginger Alkaline Spring Water (Lot# BB2023 August 29, 11:24:06 V5; 049864-00), any other
product manufactured, produced, or distributed by Flow Beverage Corp., and/or any other alkaline spring water
product.
MODERNA COVID 19 vaccine injections available for adult use in the United states between 12/1/2020 and 12/1/2021:
• Per 21 C.F.R. § 601.51(e)(4), a list of all active ingredients and any inactive ingredients • 21 C.F.R. § 601.51(e)(7),
all records showing the manufacturer's testing of a particular lot, after deletion of data or information that would show
the volume of the drug produced, manufacturing procedures and controls, yield from raw materials, costs, or other
material falling within § 20.61 of this chapter. •etc
COMM BETWEEN ROBERT TEMPLE AND VANDA PHARMACEUTICALS ETC

K181893
WHITE OAK VIDEO FEED
POSIMIR (NDA 204803) review and approval documentation from 12 April 2013 (NDA Filing Date) to 01 February 2021
(NDA Approval Date),
RECALL RECS OAKES FARMS, INC, ETC
Suspect Drug - Danyelza (naxitamab) Source - FAERS quarterly data file Q2 2021 Case ID - 19112384
Copy of the disclosable portions of the 510(k) for K201634, RG 3mL Medication Cartridge.
certain information from the U.S. Food and Drug Administration (“FDA”) as referenced in FDA’s letter to manufacturers
and distributors of fluorinated polyethlene food contact articles https://www.fda.gov/media/151326/download.
Any and all food safety inspection reports and related documents pertaining to facilities operated by Newrest at the
below listed locations dated January 1, 2018 up to and including today’s date: - 1000 Parliament Ct #400, Durham, NC,
27703 - 3555 W Ninigret Dr, BLDG VI, Salt Lake City, UT, 84104 - 1500 M H Jackson Service Rd, Atlanta, GA, 30337 - 4507
Wright Rd, Houston, TX, 77032
WELLBUTRIN XL(NDA No.021025)
A copy of the Informed Consent form for clinical trials: NCT04994483 and NCT05026177.
Listing of all FDA approved "Complex Generics" from fiscal year 2014 up to and including 3/31/22.
Study Protocol and Statistical Analysis Plan for NCT04491006
All adverse event reports for off-label use of the drug Adequan on felines including but not limited to acute and chronic
side effects such as inappetence, paralysis, lameness, allergic reactions, vomiting, diarrhea, facial swelling, hives,
scratching, pale gums, shock, seizures, cold limbs, abnormal bleeding (blood in stool, dark stool, nose bleeds), rapid
breathing, coma, death.
I retrieved the adverse events of disseminated tuberculosis associated with adalimumab from FAERS Public Dashboard.
I am requesting all detailed narrative columns of these cases (a total of 12 cases), and the case numbers were: 6179122
6202607 6720575 7020682 7531126 7712358 7775921 8793225 8838507 8855139 8906058 9065206 Thank you very
much!
Request for (a) the EIR (electronic format) for inspection of Primera Analytical Solutions Corp. ending 01/23/2017 at
Princeton NJ, USA; and (b) the 483 response (electronic format) for inspection of Primera Analytical Solutions Corp.
ending 01/23/2017 at Princeton NJ, USA. Kindly send documents as email attachments if possible. FEI 3006195211
(1) The wording, text, and language of all FOIA requests to FDA and corresponding responses by FDA; and (2) the
wording, text, and language of all Subject (description of records) of FOIA requests to FDA and corresponding responses
by FDA. (3) I am NOT asking for any personal identifiable information of requesters nor any of the underlying records
produced to the requesters.
2022-577, 2022-588, 2022-620, 2022-703, 2022-710.
ANDA Approval Package for: ANDA 205548 - Ciprofloxacin 0.3% and Dexamethasome 0.1% Otic Suspension, held by
Dr. Reddy's Labs Ltd. [Approved generic for Novartis NDA 021538 for Ciprodex (Ciprofloxacin 0.3% and Dexamethasone
0.1%) Otic Suspension]
Variables: FEI, District, Legal Name, City, State, Zip, Country/Area, Inspection Start Date, Inspection End Date, Center,
Project Area, Classification, Inspector names, Number of inspectors. Thank you!
Hello, I'm looking for a list of registered food facilities with the FDA.
510(k) Premarket notification submission with 510k number K192176 and device name IntelePACS and product
classification LLZ
Any and all records pertaining to inspections and assessments of the following regulated facility: Abbott Laboratories
dba Abbott Nutrition in Sturgis, Michigan. This request includes, but is not limited to Inspection Reports and
Establishment Inspection Results from 09/01/2015 to 03/28/2022.
all correspondence in releasable format, including all related photos and videos, for
the period 10/31/2021 to 1/31/2022 between the Office of Laboratory Animal Welfare, Division of Compliance
Oversight and the following Maryland (61) institutions
483: Acella Pharmaceuticals, LLC
Alpharetta, Georgia United States End Dates of inspection: 17 September 2021 Project Area:
Copies of all records, including documents and internal and external emails, that contain the term “White Coat Waste,”
“White Coat Waste Project,” “Justin Goodman,” “Anthony Bellotti,” “#BeagleGate,” “#FauciLiedBeaglesDied,”
“#MonkeyIsland,” “Broken Bureaucracy,” or refer to the White Coat Waste Project between Jan 1, 2017 and the present
Copy of the disclosable portions of the infant formula notification and memoranda of FDA evaluation of the notification
for ByHeart Whole Nutrition Infant Formula.
Please provide the Establishment Inspection Report (EIR) associated with the FDA's inspection of Allay Pharmaceuticals,
LLC's (FEI #: 3007007565) Hialeah, FL facility that concluded on 11/15/2021. Facility address: 16600 NW 54th Ave Unit
23, Hialeah, FL, 33014-6109.
Documentation or memo from Remote Regulatory Assessment conducted by Charles Larson, Investigator/OMDRHO, at
eScreen Phoenix location ending Feb. 4th, 2022.
All contents of K061711, Device Name: OASIS WOUND MATRIX, Manufacturer: COOK BIOTECH
Premarket notification submission for 510(k) K212149, including internal FDA correspondence in regards to all phases of
the review (refuse to accept, administrative review, substantive review) and external FDA correspondence in regards to
all phases of the review (refuse to accept, requests for additional information, interactive reviews, and sponsor's
replies).
We request the full submissions for: FCN No. 566
We request all documents related to Phileo, Division of S.I.Lesaffre's purified yeast cell wall GRAS notification (AGRN 56).
483: Acorn Stairlifts, Inc
Belle Isle, Florida United States End Dates of inspection: 16 July
for Human Drugs inspection of Family Dollar Distribution Inc. ending 02/11/2022 at the location in West Memphis AR,
United States. The Response (in electronic format) for Human Drugs inspection of Family Dollar Distribution Inc. ending
02/11/2022 at the location in West Memphis AR, United States. Please send documents as email attachments.
for Foods & Cosmetics inspection of UAS Laboratories LLC ending 11/18/2021 at the location in Wausau WI, United
for Human Drugs inspection of Gilead Sciences Inc. ending 12/17/2021 at the location in La Verne CA, United States.
The EIR (in electronic format) for Human Drugs inspection of Gilead Sciences Inc. ending 12/17/2021 at the location in
La Verne CA, United States. The Response (in electronic format) for Human Drugs inspection of Gilead Sciences Inc.
ending 12/17/2021 at the location in La Verne CA, United States. Please send documents as email attachments.
for Medical Devices & Rad Health inspection of Becton Dickinson Caribe LTD ending 11/23/2021 at the location in
Juncos PR, United States. The Response (in electronic format) for Medical Devices & Rad Health inspection of Becton
Dickinson Caribe LTD ending 11/23/2021 at the location in Juncos PR, United States. Please send documents as email
attachments.
We request the full submission for: FCN No. 776 BASF Aktiengesellschaft Food Contact Substance: Formamide, N-
ethenyl-, homopolymer, and formamide, N-ethenyl-, copolymer with ethenamine, hydrochloride or sulfate. Notifier:
BASF Aktiengesellschaft Manufacturer/Supplier: BASF Aktiengesellschaft Intended Use: The FCS is a wet-strength
agent, dry-strength agent, fixing agent, or retention aid, which is applied prior to the sheet-forming operation in the
manufacture of paper and paperboard. Limitations/Specifications: For use at a level not to exceed 1.5 percent
polymer (pure polymer without water) by weight of the finished dry paper or paperboard. The FCS is intended to
contact all food types under Conditions of Use B through G as defined in Table 2. Effective Date: Apr 4, 2008
We request the full submission for: FCN No. 1157 Mitsubishi Chemical Corporation Food Contact Substance: Poly(N-
vinylformamide), 10-90 percent hydrolyzed hydrochloride salts. The FCS is specifically known as one of the following: a)
formamide, N-ethenyl-, polymer with ethanamine, hydrochloride (CAS Reg. No. 111616-55-8) or b) formamide, ethenyl-,
homopolymer, hydrolyzed, hydrochlorides (CAS Reg. No. 183815-54-5). Notifier: Mitsubishi Rayon America, Inc.
Manufacturer/Supplier: Mitsubishi Chemical Corporation Intended Use: For use only as strengthening agents, fixing
agents, or retention aids prior to the sheetforming operation in the manufacture of paper and paperboard.
Limitations/Specifications: The FCS will be used at a level not to exceed 1.5 percent resin by weight of the finished
dry paper or paperboard. Effective Date: May 16, 2012
Importer of Record (IOR), or Consignee; for entry-lines with submission or arrival dates between December 17, 2021,
and March 16, 2022
Any documents related to the Omnipod Smart Bolus Calculator (K203772) including, but not limited to, the summary of
safety and effectiveness, testing methods, instructions for use, indications for use, and any other applicable materials.
for Biologics inspection of Catalent Maryland Inc ending 11/17/2021 at the location in Harmans MD, United States. The
EIR (in electronic format) for Biologics inspection of Catalent Maryland Inc ending 11/17/2021 at the location in
Harmans MD, United States. The Response (in electronic format) for Biologics inspection of Catalent Maryland Inc
ending 11/17/2021 at the location in Harmans MD, United States. Please send documents as email attachments.
The EIR (in electronic format) for Human Drugs inspection of Spectrum Laboratory Products, Inc. ending 07/14/2021 at
the location in New Brunswick NJ, United States. The Response (in electronic format) for Human Drugs inspection of
Spectrum Laboratory Products, Inc. ending 07/14/2021 at the location in New Brunswick NJ, United States. Please send
Requesting information on the background and conduct of this Investigator audit: 677234 Rivero, Orlando MD
Global Research Solutions 8300 W.Flager St Suite 210/ 252A Miami FL USA 33144 06/18/18 FC NAI 00
Please provide the portion of the New Infant Formula Submission for the time period January 1, 2010 through
December 31, 2015for Enfamil Enspire (https://www.enfamil.com/products/enfamil-enspire-infant-formula/) filed with
FDA that states the basis on which each ingredient is authorized for the intended use.
Thompson Hine is requesting the Center for Tobacco Products, Office of Science disciplinary reviews and decision
memos in connection with the marketing granted orders for Vuse Replacement Cartridge Original 4.8% G1 and Vuse
Replacement Cartridge Original 4.8% G2.
K183048
Report and/or the MDSAP Noncomformity Grading and Exchange Form (NC) for the inspection of Haemonetics
Corporation, Braintree, MA , end date 08-31-2017. FEI# 1219343. This inspection pertains to medical devices.
Report and/or the MDSAP Noncomformity Grading and Exchange Form (NC) for the inspection of FOCUS SURGERY, INC.,
Indianapolis, IN , end date 01-11-2018. FEI# 3002132857. This inspection pertains to medical devices.
Regulatory Assessment of Cardinal Health 414 LLC Located at West Chester OH United States FEI Number: 3003572888
held on 05/05/2021.
Regulatory Assessment of Biomat USA, Inc. Located at Jacksonville FL United States FEI Number: 1052094 held on
05/06/2021.
Regulatory Assessment of Biomat USA, Inc Located at Houma LA United States FEI Number: 3013370583 held on
05/06/2021.
Regulatory Assessment of Biomat USA, Inc. Located at Jacksonville FL United States FEI Number: 3007895922 held on
05/10/2021.
Copy of the 483 for the Jul 11, 2018 - Jul 20, 2018 (10 days) inspection of Inopak Ltd [Ringwood / United States of
America] 24 Executive, Ringwood, NJ 07456, USA. This inspection pertains to human drugs.
Copy of the 483 for the Jul 10, 2018 - Jul 12, 2018 (3 days) inspection of University of Miami Reproductive and Fertility
Center [Miami / United States of America] 1400 NW 12th Ave #5, Miami, FL 33136, USA. This inspection pertains to
biologics
Report and/or the MDSAP Noncomformity Grading and Exchange Form (NC) for the inspection of Natus Manufacturing
Limited, Galway, Ireland, end date 08-30-2019. FEI# 3005581270. This inspection pertains to medical devices.
Report and/or the MDSAP Noncomformity Grading and Exchange Form (NC) for the inspection of Integra Lifesciences
(Ireland) Limited, Tullamore, Ireland, end date 12-14-2018. FEI# 3006697299. This inspection pertains to medical
devices.
Hello, Please provide all memorandums from Dr. Janet Woodcock to all FDA staffers and all memorandums from Dr.
Woodcock to all department heads
Hello, please provide all memorandums from Dr. Peter Marks to all CBER staffers and all memorandums from Dr. Marks
to all heads of CBER office and division heads
Hi there, Please provide all memorandums from Dr. Califf to all FDA staffers and all memorandums from Dr. Califf to all
FDA office and center heads
LISTS OF INSPECTIONS
Hello, Please provide all communications, including emails and text messages, between Dr. Peter Marks, Dr. Janet
Woodcock, Marion Gruber, Dr. Celia Witten, or Dr. Phil Krause and employees and representatives of ICON Plc
Hello, please provide all communications, including emails and text messages, between Dr. Peter Marks, Dr. Janet
Woodcock, Marion Gruber, Dr. Celia Witten, or Dr. Phil Krause and employees and representatives of Ventavia Research
Group
483 FEI Number:3014310427 Firm Name:Shanghai STA Pharmaceutical Product Co., Ltd. Firm Address:No. 4 Plant, 31
Yiwei Road, Waigaoqiao Free Trade Zone
all inspection documents for FDA inspection of OC Raw Dog LLC, located at 1500 Commerce St., Ste. A #101 Corona, CA
92880-1715
I am writing to request all the review documents for TARPEYO NDA 215935, such as integrated review and
administrative and correspondence documents.
I request all EIRs and 483s in electronic format that are associated with Drug Inspections conducted since March 1, 2015
to the present (March 28, 2022) for Jiangsu Hansoh Pharmaceutical Co. located in Lianyungang China and identified with
the following 3 FEI numbers: 3008316144 3007086869 3003663251
We require SBOA of RLD - MIACALCIN INJECTION (NDA # N017808). Basically, CMC related information of the NDA /
RLD.
NDA of the following three products: 1. <Drug name> Baqsimi, <Active ingredients> glucagon, <NDA #>210134,
<Dosage form/route> powder;nasal, <Company> Eli Lilly and Company, <Approval date> 7/24/2019, 2. <Drug name>
Onzetra Xsail, <Active ingredients> sumatriptan succinate, <NDA #>206099, <Dosage form/route> powder;nasal,
<Company> Currax, <Approval date> 1/27/2016, etc
Please provide label information for ANDA #212560
Please consider this a request for a copy of the 3/15/22 Effective approval letter for ANDA No. 211699 for Budesonide;
Formoterol fumarate dihydrate (generic drug). Please consider this a request for a copy of the 12/15/14 Tentative
approval letter for ANDA No. 202073 for Darunavir etc
Hi, please provide all records of communications, whether by email (on .gov or non.gov email accounts), text message,
or instant chat, from Dr. Stephen Hahn, Dr. Peter Marks, or Dr. Janet Woodcock regarding Brook Jackson
Hello, Please provide all emails to or from Dr. Peter Marks and Dr. Janet Woodcock mentioning "Brianne Dressen"
Hi, please provide all emails from Dr. Stephen Han to Robert Redfield or Anthony Fauci
Hello, please provide all emails, text messages, and instant chat messages between Dr. Califf and Anthony Fauci
Hi, please provide all communications, including instant chat, emails, and text messages, between Dr. Califf and Albert
Bourla or Stephane Bancel.
Hi, please provide all communications between Marion Gruber or Phil Krause and Dr. Anthony Fauci
Hello, Please provide all emails between Marion Gruber or Phil Krause to addresses ending with "@who.eop.gov”
Hi there, please provide the following: Preliminary, draft, interim, or final reports, and notes, on inspections or
investigations conducted by the FDA's Office of Regulatory Affairs—including the division's Office of Biological Products
Operations—into Pfizer's COVID-19 vaccine clinical trial
All emails to or from Brad Kimberly, Erica Jefferson, and Sandy Walsh mentioning "ivermectin."
All emails from Dr. Janet Woodcock mentioning "ivermectin."
I'm requesting all records for consumer complaint #152594
I'm requesting all records for FOIA request 2018-6114
Subvisible particle content, formulation and dose of erythropoietin peptide memetic product associated with severe
adverse post marketing events. Used by FDA CBER and CDER in development and release of the Journal of Pharma Sci
article "Subvisible Particle Content, Formulation, and Dose of an Erythropoietin Peptide Mimetic Product are Associated
with Severe Adverse Post Marketing Events"
We are requesting the summary basis of approval of efficacy supplement for the use of Daytrana (NDA 21514) in the
treatment of Attention Deficit and Hyperactivity Disorder (ADHD) in adolescent ages 13 to 17 years.
Copy of the disclosable portions of the MedWatch reports for the following 3 molnupiravir cases: 20613050, 20391703,
and 20599812.
Copy of the disclosable portions of the Chemistry Review for ANDA 210111, Pomalidomide, by Breckenridge, approved
10/30/2020.
Any documents, correspondence, memoranda, or other communications received by the U.S. Food and Drug
Administration (“FDA”) from Jazz Pharmaceuticals plc (“Jazz”) related to Avadel CNS Pharmaceuticals, LLC’s (“Avadel’s”)
product FT218 (sodium oxybate) for extended release oral suspension, including, without limitation
Emails sent or received by Peter Marks that contain any of the following terms: Barrington or gbdeclaration or kulldorff
or kuldorff or bhattacharya or battacharya or Gupta or “john snow” during the time period of October 8, 2020 and
December 8, 2020.
UNREDACTED copy of the Multi-Discipline Review for NDA 209627Orig1s000 FDA Reference ID: 4304958
UNREDACTED copy of the Product Quality Review for NDA 209627Orig1s000
ANDA 087954
CDER’s Health Hazard Evaluation (HHE) for North American Custom Laboratories, LLC.
I am requesting a history of all changes recorded in the archived data for all drug shortages reported to the FDA from 1
January 2010 (or the earliest date on which the FDA began keeping records) until the date of submission. FDA publicly
releases current drug shortage information that can be viewed online or in a downloadable file.
Summary Basis for Approval for NDA 208289
Summary Basis of Approval for NDA 208289 supplement 6
Please provide the summary basis of approval documents and review documents (in particular, the chemistry review)
for ANDA 089454 (Protamine Sulfate Injection, USP from Fresenius Kabi USA LLC) and NDA 006460 (Protamine Sulfate
Injection, USP from Eli Lilly and Co.).
Copy of the 483 for the May 17, 2018 - May 18, 2018 (2 days) inspection of Barox Co., Ltd. [Seongnam-si / Korea
(Republic of)] Jungwon, Hallasigma 545 Dunchon-Daero Seongnam Korea (the Republic of). This inspection pertains to
human drugs.
Copy of the 483 for the Jul 16, 2018 - Jul 20, 2018 (5 days) inspection of CAO Medical Equipment Co., Ltd. [Langfang
Shi / China] Bai He Jie, Guan Xian, Langfang Shi, Hebei Sheng, China. This inspection pertains to human drugs.
Review documents listed below (as available) for the 12 May 2021 approval of NDA 211988 Zynrelef (bupivacaine and
meloxicam) extended-release solution: Product quality review Multi-disciplinary or summary review
Pharmacology/toxicology reivew Clinical pharmacology review Clinical review Risk assessment and risk mitigation review
All detailed narrative columns of the adverse event named "disseminated tuberculosis" associated with adalimumab
retrieved from FAERS Public Dashboard. The case numbers were: 9323786 9335397 9633049 9668130 9689378
9733391 9922454 10051875 10072611 10553628 10642011 10882760
I am writing to request the Orphan Drug Application for Tarpeyo designated as "To slow the progression of
immunoglobulin A nephropathy & delay kidney failure in patients affected by the disease"
I am writing to request the Orphan Drug Application for sparsentan as treatment of immunoglobulin A (IgA)
nephropathy.
483: Actavis Laboratories UT, Inc. Salt
Lake City, Utah United States End Dates of inspection: 20 August 2021 Project Area: Drug
To Whom it May Concern: As permitted by the Freedom of Information Act (FOIA), I am hereby requesting the
following document: Form FDA 483: Adamas Pharmaceuticals, Inc.
Emeryville, California United States End Dates of
inspection: 28 June 2021 Project Area: Bioresearch Monitoring FEI: 3007281742 Classification: VAI I confirm that
$ 200.
483: Advanced Cooling Therapy Inc.
Chicago, Illinois United States End Dates of inspection: 22 October 2021 Project Area:
FOI for this request, however please contact me if the charges exceed $ 200
483: Advanced Medical Innovations
Northridge, California United States End Dates of inspection: 20 August 2021 Project Area:
We are requesting the releasable records in support of FCN 1336. FCN 1336 is cited heavily in FCN 1376 for the use of
Fluorphlogopite-based pearlescent pigments.as filed by Eckart GmbH Altana AG. We have received the FCN 1376
under the FOI provisions earlier. We note that FCN 1336 is not listed on the agency listing of FCNs.
483: Advanced Pharmaceutical Technology Inc.
Elmsford, New York United States End Dates of
inspection: 23 August 2021 Project Area: Drug Quality Assurance
FEI: 3009963974 Classification: OAI I confirm that Clarivate Analytics will be charged
483: AGC Biologics, Inc. Bothell, Washington
United States End Dates of inspection: 23 July 2021 Project Area: Blood and Blood Products
FEI: 3000209996 Classification: VAI I confirm that Clarivate Analytics will be charged accordingly by FOI for this request,
483: Aire-Master of America Inc. Nixa,
Missouri United States End Dates of inspection: 19 October 2021 Project Area: Drug Quality
Assurance FEI: 3002764676 Classification: OAI I confirm that Clarivate Analytics will be charged accordingly by FOI for
483: Airgas USA, LLC. Phoenix,
Arizona United States End Dates of inspection: 17 June 2021 Project Area: Drug Quality
483: Ajinomoto Althea, Inc. San
Diego, California United States End Dates of inspection: 25 May 2021 Project Area: Drug
FOI for this request, however please contact me if the charges exceed $ 200
offices, from March 1, 2022 through March 31, 2022.
Under provisions of the Freedom of Information Act, I would like to request a list of all Foreign and Domestic Drug
Inspections which were conducted from January 1, 1990 to the present. This list should include CROs (Contract Research
Organizations), drug manufacturers, repackers/packers, labelers/relabelers, control laboratories and contract sterilizers
that underwent a Drug GMP or PAI/PLI inspection.
483: Cangene BioPharma, LLC dba Emergent BioSolutions.
Baltimore, Maryland United States End Dates of inspection: 16 April 2021 Project Area: Drug
We would like information on Document Number: CPT2200472 Allegation of Regulatory Misconduct. Please inform me
of the results of the investigation when it is closed.
483: Baxter Pharmaceutical Solutions, LLC.
Bloomington, Indiana United States End Dates of inspection: 10 November 2021
Project Area: Vaccines and Allergenic Products FEI: 1000115571 Classification: VAI I confirm that Clarivate Analytics will
be charged accordingly by FOI for this request, however please contact me if the charges exceed $ 200.
have a complete record of these submission when it was transferred from Mist Pharmaceuticals. Attached is a letter of
authorization from Metuchen.
I am looking for records on KUA Candy FEI 2128347. Specifically inspection number 1144039. I would also like any
information on any complaints filed from 1/1/2021, thru 12/31/2021.
SharePoint Support Services Contract Number: GS35F0579Y-HHSF223201700007B Under the provisions of the Freedom
of Information Act, I am requesting access to the following: 1. Copy of the request for proposal (RFP) and Statement
of Work (SOW) 2. Copy of the contract and any contract modifications. 3. Copy of the annual report. Sincerely, Eric
Davis
K203434, WellDoc BlueStar RX
100% ARTISAN FOODS INSPECTION REPORT 1/24/22
RECS RE TAINTED SYRINGES
RECS FACILITY AT BIOMAT USA, CHICAGO, IL ETC
ACTION PACKAGE METOCLOPRAMIDE ETC

Somerset Facility lupin 13 observations
Ask the FDA and CLIA Transcripts from 2013.
483 reports forHinz Medical Foods and West Duluth Distribution Company, d/b/a CHK Nutrition of Duluth, Minnesota,
plus all correspondence sent to thisse companies or to Martin Hinz, M.D. (aka Marty Hinz). Also FDA letter to Dr. Hinz or
CHK Nutrition dated August 9, 2018. This is an update oif my request # FOI 2020-2495
I need the human tissue registration for the following companies and years. MTF ID#3006813973 2012-2021 Zimmer
Biomet ID#1000160576 2012-2021 Etex ID#3008787425 2012-2016 Lifenet Health ID#3005064037 2014-2018
Commmunity blood center ID#3008808182 2021 MiMedx ID#3005897621 2014-2021 Wright medical ID#3010994039
2012-2020 Innovasis ID#3004719693 2012-2021 Lifelink ID#300828687 2012-2021
I would like to request the most recent establishment inspection report for the Family Dollar distribution center located
at 1800 Family Dollar Pkwy, West Memphis, Arkansas. This would correspond with an investigation launched by the FDA
since January 2022 and this press release in February 2022:
https://www.fda.gov/news-events/press-announcements/fda-alerts-public-potentially-contaminated-products-family-
dollar-stores-six-states
The Judge Rotenberg Education Center, Inc./Electrical Stimulation Devices

I'm seeking an Establishment Inspection Report from May 1963 of the Promak Laboratories in Chicago, Illinois, in
connection with the FDA investigation of the cancer drug Krebiozen. I'm also seeking any related memoranda or draft
speeches from FDA Inspector Robert Palmer in connection with the Krebiozen investigation.
RECS RE THE FINE CHEESE CO OLIVE OIL & SEA SALT CRACKERS
RECS RE TATTOOED CHEF PLANT BASED EGG ROLL BOWL
RECS RE WALGREENS SUPPLEMENTS
RECS WELBY ELDERBERRY GUMMIES FROM ALDI
RECS RE SUPPLE BEARS QUERCETIN BROMELAIN GUMMIES
RECS RE KROGER SALT & VINEGAR POTATO CHIPS
RECS RE SESAME SOY VEGETABLE SEASON BLEND
RECS RE WALGREENS CHILDREN'S MULTIVITAMIN GUMMIES
483: David L. Wirta, M.D. Newport Beach,
California United States End Dates of inspection: 13 August 2021 Project Area: Bioresearch
483: Edward C. Hsiao, M.D., Ph.D. San
Francisco, California United States End Dates of inspection: 29 June 2021 Project Area:
Bioresearch Monitoring FEI: 3018841197 Classification: VAI I confirm that Clarivate Analytics will be charged accordingly
by FOI for this request, however please contact me if the charges exceed $ 200
RECS RE THREE CRABS FISH SAUCE
RECS RE THE SALSA TEXAN
Any and all reports, memoranda, emails, SMS and MMS

messages, and any other written communications regarding lasers targeting
and/or injuring in any way any officers under the command and supervision of
the United States Department of Homeland Security deployed to Portland,
Oregon between May 1, 2020 and August 6, 2020
Copy of the disclosable portions of the 510(k) for K181323, Bard Atlas Gold PTA Dilatation Catheter.
for Human Drugs inspection of Coral Pharmaceuticals LTD ending 05/24/2019 at the location in Freeport City, Bahamas.
The EIR (in electronic format) for Human Drugs inspection of Actelion Pharmaceuticals Ltd. ending 04/19/2013 at the
location in Allschwil, Switzerland. The EIR (in electronic format) for Human Drugs inspection of Actelion
Pharmaceuticals Ltd. ending 05/22/2015 at the location in Allschwil, Switzerland. Please send documents as email
attachments.
for Human Drugs inspection of Corcept Therapeutics Incorporated ending 05/09/2014 at the location in Menlo Park CA,
United States. The Response (in electronic format) for Human Drugs inspection of Corcept Therapeutics Incorporated
ending 05/09/2014 at the location in Menlo Park CA, United States. The EIR (in electronic format) for Human Drugs
inspection of Corcept Therapeutics Incorporated ending 10/19/2020 at the location in Menlo Park CA, United States.
syndrome, etc
format) for Human Drugs inspection of Hovione LLC ending 05/28/2021 at the location in East Windsor NJ, United
for Human Drugs inspection of StageBio ending 09/03/2021 at the location in Frederick MD, United States. Please send
We request a spreadsheet identifying the firms that received FDA Warning Letters between October 1, 2011, and April
1, 2022 or the most recently available date, to include the following: Company FEI; Company Name; Company Address
Line 1; Company Address Line 2; Company City; Company State/Region/Province; Company Postal Code; Company
Country; etc
violation and the frequency in which they were observed between December 20, 2017 and March 31, 2022 (or the most
recently available date for 2022).
1) Listing of all INSPECTIONS since Thursday, April 1, 2021 (in CSV format) with the following fields: FEI Number,
FDA483, Full Name, District, Center, INSPECTION REASON etc
Copy of the disclosable portions of the Orphan Drug Designation application, related amendments, and all
correspondence, meeting minutes, and memorandum regarding the Orphan Drug Designation and Exclusivity
determination for Carvykti (citacabtagene autoleucel), BLA 125746, approved 2/28/2022.
Enforcement Reports
Copy of the disclosable portions of the Summary Review (or equivalent) for NDA 214965, Verkazia ophthalmic emulsion,
by Santen, approved 06/23/2021.
Address (Line 1), and Address (Line 2) for each inspection that occurred between October 1, 2011 and March 31, 2022
(or the most recent available date). We request 3 additional columns to include classification, project area, and end
date.
We request a spreadsheet which includes the 23 publicly available data points for all entries that led to our company's
inclusion in this list as of 3/31/2022 or the most recently available date.
all TJX Brands - HomeGoods, HomeSense, Marshalls, Sierra, TJ Maxx, on FDA's list.
number 09-014-5707), Payco Foods Corp (DUNS number 36-295-4588), etc
FOOD LABELING YOUTUBE DATA FILE

A. Documents sufficient to identify: (1) drug product lot numbers for all Pfizer/BioNTech vaccines manufactured in the
United States; and (2) the total number of units and/or doses in each such lot. ETC
A. Documents sufficient to identify: (1) drug product lot numbers for all Moderna COVID-19 vaccines manufactured in
the United States; and (2) the total number of units and/or doses in each such lot. ETC
A. Documents sufficient to identify: (1) each state or U.S. territory to which all or part of any Pfizer/BioNTech COVID-
19 vaccine lot was shipped; and (2) the total number of units and/or doses from each individual Pfizer/BioNTech COVID-
19 vaccine lot shipped to each such state or U.S. territory. ETC
A. Documents sufficient to identify: (1) each state or U.S. territory to which all or part of any Moderna COVID-19
vaccine lot was shipped; and (2) the total number of units and/or doses of each individual Moderna COVID-19 vaccine
lot shipped to each such state or U.S. territory. ETC
Copies of the Certificates of Analysis for each Moderna COVID-19 vaccine lot distributed in the United States, including
United States territories.
Copies of the Certificates of Analysis for each Pfizer/BioNTech COVID-19 vaccine lot distributed in the United States,
including United States territories.
I respectfully request copies of any and all information related to SoClean’s (FEI # 3009534409) response to the
PhilipsRespironics recall for the period between June, 30, 2021 and September 28, 2021. This request includes but is not
limited to, copies of the following correspondence, documentation, or communications
I respectfully request copies of any and all information related to SoClean’s (FEI # 3009534409) response to the Philips
Respironics recall for the period between September 29, 2021 and March 10, 2022. This request includes but is not
limited to, copies of the following correspondence, documentation, or communications
Importer of Record (IOR), or Consignee; for entry-lines with submission or arrival dates between March 1 and March 31,
2022
Summary of Review and Biopharmaceutical review anda 209190 RHODES PHARMS Lidocaine 5% patch
All records related to ByHeart's infant formula.
Full 510(K): K151790 PMT Platinum Depthalon Depth Electrodes
Copies of the U.S. Food and Drug Administration’s (FDA) chemistry, toxicology and environmental review memoranda
for the following Food Contact Notifications (FCN): • FCN 716 is described by the Inventory of Effective Food Contact
Substances (FCS) as “REPLACED BY FCN 818.” ETC
• The Form 483 for the November 2021 inspection of Exactech’s facility in Gainesville, Florida ((note that this
document has been previously released via FOIA by the FDA) • The Form 483 for the March 2017 inspection of
Exactech’s facility in Gainesville (note that this document has been previously released via FOIA by the FDA) • ETC
All MedWatch ESUBMITTER generated form 3500A documents for Manufacturer Number 1417592 from April 1, 2012
through March 30, 2022. This requests includes FDA Form 3500A for Manufacturer Report Number 1417592-2014-
00107; Manufacturer Report No. 1417592-2016-00058; Manufacturer Report No. 1417592-2019-00203; and
Manufacturer Report No. 1417592-2019-00162, attached hereto.
FDA form 483 observations for the following site: Actavis Laboratories FL, Inc. 4955 Orange Dr Davie, FL 33314-3902
United States FEI number for the site: 3003194604
I would like to request all information regarding Beyond Meat, and its products. This includes any pending or historical
investigations, reports of adverse events, irregular sales tactics, facility/manufacturing irregularities, whistleblower suits,
or faulty product reports.
K030603 K033120 K130672 K141422 K141717 K151123 K151150 K151852 K153528 K160577 K162662 K200330
K201182 K202831 FIRST PARTY
Requesting email correspondence under IND 017016 for ACTUS-101.
483 (FEI# 3017502582) and any associated responses and warning letters for Alison R. Sehgal, MD at University of
Pittsburgh Medical Center (5150 Centre Ave, Pittsburgh, PA 15232-1309), Inspection ID 1134296, End Date 12/29/2020.
Seeking records for Droperidol associated cardiovascular related events.
All exclusivity information regarding Aadi Bio's approved drug, Fyarro. Particularly, information about orphan drug
exclusivity and potential Orange Book backlogs and/or clerical errors in public information on this drug. The drug
received orphan drug designation in December 2017 and was approved in November 2021. However, FDA Orange Book
does not show the orphan drug exclusivity (ODE) code in exclusivity data for the drug.
Copies of any untitled letters, or other official communication regarding a violation of the Federal Food, Drug, and
Cosmetic Act, related to Corcept Therapeutics.
K920977
I would like a copy of TG Labs' response to the 483, any remediation activities or CAPAs initiated, as well as any
subsequent FDA responses, investigations, or compliance activities resulting from the October 2021 inspection.
(1) All records, including communications, pertaining to the New Drug Application submitted by Akebia Therapeutics on
or about March 30, 2021, and accepted by the FDA on or about June 1, 2021, for the drug called vadadustat. ETC
De Novo request for classification of Cosmo Artificial Intelligence – AI, Ltd. GI Genius (DEN200055), including all
supporting documents included in the De Novo request submission.
2019-11770
I would like to kindly request data on Inspection citations from From FDA 483 for inspections conducted in all drug and
device manufacturing facilities between 1999 and 2021.
full set of FOIA requests submitted to FDA since January 2015, including (1) a control number that uniquely identifies
each FOIA request, (2) the day on which the request was received by the FDA, (3) the date on which the FDA response is
due, (4) the FDA offices and the divisions to which the request is pertinent, (5) the identity of the individual requesting
the information (requester name) ETC
We are looking for a copy of K102329

Full 510(k) submission package on K212153 cleared on 03/25/2022.
Requesting for assesment results from Foreign Remote Regulatory Assessment
I am seeking the MONTHLY adverse event TALLY reports for the 15 months in 2021 and 2022 Crysvita, Spinraza, Evrysdi,
ETC
Form 483 for Lupin Somerset facility inspection in March 2022

2022-1695, 2022-834
Food Contact Notification FCN No. 179 on Copolymers and polymers made from the reaction of dimethyl terephthalate
or terephthalic acid
Food Contact Notification FCN No. 689 on 1,4-benzenedicarhoxylic acid polymer with 1,4-cyclohexanedimethanol and
1,2-ethanediol (CAS Reg. No. 25038-91-9
Food Contact Notification FCN No. 1234 on Copolymers and polymers made from the reaction of dimethyl terephthalate
or terephthalic acid
Food Contact Notification FCN No. 87 on 1,4-cyclohexanedimethanol
Food Contact Notification FCN No. 280 on Copolyesters of dimethyl terephthalate or terephthalic acid with ethylene
glycol, 1,4-cyclohexanedimethanol and diethylene glycol (CAS Reg. No. 148105-13-9 and 156209-91-5)
Food Contact Notification No. 939 on (cis.trans)-(1,3)/(1,4)-cyclohexanedimethanol (1,3-cyclohexanedimethanol, CAS
Reg. No. 3971-28-6) and 1,4-cyclohexanedimethanol, CAS Reg. No. 105-08-8)
Food Contact Notification FCN No. 1898 on 1,4-Cyclohexanedimethanol (CAS Reg. No. 105-08-8)
MEETINGS, NOTES, EMAILS ETC RE DIRECTIVES OR DECISIONS MADE TO ALTER/MODIFY/CHANGE FDA Q&A WEBSITE RE
COMIRNATY VACCINE
I request the two most recent inspection reports between 2019 and 2021 for Bluebird Bio Inc.’s manufacturing facility
located at 1733 TW Alexander Drive, NC 27709.
2021-102, 2022-492, 2022-529, 2022-537, 2022-568.
2015-2281
I request to inspect last three inspections conducted at the following facility: Coca Cola Bottling Company Consolidated
located at 4774 Southpoint Drive, Memphis, TN. If by chance the facility was located at a different address, please
include those as well.
Remote Regulatory Assessment (RRA) Report for Circa Scientific, Englewood, Colorado, conducted from June 21, 2021 to
July 8, 2021
Establishment Inspection Record (EIR) for audit performed at Centurion's Howell, MI facility by Thomas Peter.
Hi, I would like to request all form 483 issued to the following two sites from January 2022 to present. This is in
reference to Control #2022-1303. 1. UCB Pharma S.A., site of Braine-L’Alleud. Chemin du Foriest. B- 1420 Braine-
L’alleud 2. UCB Pharma GmbH,. Alfred-Nobel-Strasse 10. 40789 Monheim am Rhein
Establishment Inspection report (EIR) for the audit performed at Centurion's Williamston, MI facility, by Thomas Peter.
All FDA reviews and/or evaluations on file for Food Contact Substance (FCN) No. 1453 (see attachment for details).
Including but not limited to all correspondence between FDA and the notifier as well as all publicly available documents
submitted by the notifier.
Test results from Murray State University Breathitt Veterinary Center for a sample of Commercial 28% Gamebird Starter
(AVT)(PC) Lot S62117462386. We understand that the Division V, Office of Human and Animal Foods Operations-East
has a copy of these results.
The complete Technical Project Lead Decision Summary(ies) for the Marketing Granted Orders for Logic Technology
products with the following STNs: PM0000529.PD1, PM0000530.PD1, PM0000531.PD1, PM0000535.PD1,
PM0000536.PD1, PM0000537.PD1, PM0000540.PD1, and PM0000541.PD1
483 for the 02/2022 inspection of Mankind Pharma, Rampur Ghat Rd, Paonta Sahib, Himachal Pradesh 173025, India.
This inspection pertains to human drugs
The premarket tobacco product applications (PMTAs) for The Logic Regular Cartridge/Capsule Package, the Logic
Vapeleaf Cartridge/Capsule Package, the Logic Vapeleaf Tobacco Vapor System, the Logic Pro Capsule Tank System,
Logic Pro Tobacco E-Liquid Package, the Logic Power Tobacco e-Liquid Package, and the Logic Power Rechargeable Kit.
The TPL review documents (in their entirety) for The Logic Regular Cartridge/Capsule Package, the Logic Vapeleaf
Cartridge/Capsule Package, the Logic Vapeleaf Tobacco Vapor System, the Logic Pro Capsule Tank System, Logic Pro
Tobacco E-Liquid Package, the Logic Power Tobacco e-Liquid Package, and the Logic Power Rechargeable Kit.
The TPL review documents (in their entirety) for VERVE Discs Blue Mint, VERVE Chews Blue Mint, VERVE Discs Green
Mint, VERVE Chews Green Mint, Vuse Solo Power Unit, Vuse Replacement Cartridge Original 4.8% G1, Vuse
The premarket tobacco product applications (PMTAs) for VERVE Discs Blue Mint, VERVE Chews Blue Mint, VERVE Discs
Green Mint, VERVE Chews Green Mint, Vuse Solo Power Unit, Vuse Replacement Cartridge Original 4.8% G1, Vuse
Complete unredacted copy of K911110 for the Ophta Sil eye sphere implant. Ownership of K911110 was transferred
from FCI's previous regulatory consultant (GWB International) to FCI upon issuance of the 510K clearance; thus FCI is
authorized to receive an unredacted copy of the 510K to archive in FCI's regulatory files.
This request is for .CSV files of all dated records for the below drugs, from January 2020 through today / the latest
available date, from the FDA Adverse Event Reporting System (FAERS) database. Please send in the .CSV file format.
Drug list: opzelura
I am an investment professional for an asset management firm and would like to request all 483s issued under
inspection IDs #1105907 and #1117145 for Interquim S.A. The facility’s FEIN is 3002807304 and it is located at Calle De
Joan Buscalla 10, Sant Cugat del Valles, 08173, Spain. Thank you!
510K submission for K051814 JMS SYSLOC MINI A.V. FISTULA NEEDLE SET AND APHERESIS NEEDLE SET
Ki142564 510K submission for the JMS SysLoc MINI A.V. Fistula Needle Set (V4), JMS SysLoc MINI Apheresis Needle Set
(V4)
EIR Summary issured for Takeda Pharmaceutical Company, Hikari, Japan (FEI: 3004664162) on FDA inspection.
EIR Summary issued to Ajinomoto Company, Kawasaki-City, Japan (FEI: 3002806336) on FDA inspection.
Any documents submitted as part of the DE NOVO CLASSIFICATION REQUEST FOR IDX-DR (DEN180001) and any
feedback provided to IDX by FDA in the clearance process.
Humanitarian Use Device application and approval or denial information for PECA Labs “MASA valve” Humanitarian
Device Exemption application for PECA Labs “MASA valve” Information in regard to approval or denial of PECA Labs
HDE application for the “MASA valve. PECA Labs 4424 Penn Ave Suite 201 Pittsburgh, PA 15224
Request you to kindly share the 13 observations raised on Lupin Ltd's Somerset, New Jersey plant. The inspection was
conducted from 7 to 30 March. A warning letter was issued in June 2021. Please share a copy of the observations in
public interest
Form 483 issued to Lupin's plant at Somerset, NJ. The inspection was done between March 7, 2022 and and March 30,
2022
Form 483 issues to Macleods Pharmaceuticals facility at Baddi India following the inspection in Oct 2021
I am requesting all letters written by Peter Marks, M.D., Ph.D., the director of the Center for Biologics Evaluation and
Research (CBER) of the Food and Drug Administration (“FDA”) to pharmaceutical companies developing and/or
manufacturing a Covid-19 vaccine (including, but not limited to Pfizer, Moderna, AstraZeneca and Johnson & Johnson,
Merck, CureVac, Inovio, Sanofi, GlaxoSmithKline) or representatives thereof, regarding any conditions, criteria,
standards, requirements or processes governing emergency use authorizations of a coronavirus vaccine. This
information will be to assess how the coronavirus vaccine was considered to be safely made.
LUPIN TARAPUR PLANT FOUR OBSERVATIONS
all communications related to the agency's decision to include "other medical and factors (including race and ethnicity)"
in its December 2021 Emergency Use Authorization guidance ETC
since Monday, February 28, 2022.
CVS Samir Gala, Sara Onyango, Addie Scott Boston, Nathaniel Phillips Sylvain, ETC
Form FDA 483: Dana E. Rathkopf, M.D. New

York United States End Dates of inspection: 30 May 2014 Project Area: Bioresearch
Monitoring FEI: 3009650696 Classification: VAI
The following documents related to STNs PM0000529.PD1, PM0000530.PD1, PM0000531.PD1, PM0000535.PD1,
PM0000536.PD1, PM0000537.PD1, PM0000540.PD1, and PM0000541.PD1
I request that a copy of all approval records for Pre-Market Approval (PMA) P100034, including any supplements, be
provided to me.
Please provide a redacted traditional 510(k) submission for the Biopsy Sciences, LLC Lung Biopsy Site Marker (K041331) -
clearance dated June 15, 2004.
Duraprep, Prevail-FX one step, Hibistat, and Hibiclens these product labels
CDER pharmaceutical recalls and medical device recalls from the years 2002 to 2020
1. All correspondence relating to Food & Drug Administration inspections of the Abbott Laboratories, Inc. D/B/A
Abbott Nutrition facility located in Sturgis, Michigan from January 1, 2012 to present. ETC
AWARD ID: HHSF22301028T VENDOR: LANGUAGE ON DEMAND CONTRACTING AGENCY: FOOD AND DRUG
ADMINISTRATION CONTRACTING OFFICE: FDA OFFICE OF ACQ GRANTS SVCS
AWARD ID : 75F40118F01026 VENDOR NAME: LANGUAGE ON DEMAND CONTRACTING AGENCY: FOOD AND DRUG
ADMINISTRATION CONTRACTING OFFICE: FDA OFFICE OF ACQ GRANT SVCS
K193420
HHSF223201710232C
HHSF223201710215C
I am the new regulatory counsel for the sponsor of the Pre-Market Tobacco Application assigned the STN PM0001249.
This request is for all submission files submitted as part of the PMTA.
This request is for all submission files submitted as part of the Pre-Market Tobacco Application assigned the STN
PM0000470 – PM0000473.
Any and all communications, correspondence, documents and information consisting of or relating to the New Infant
Formula Notification for the ByHeart, Inc. infant formula, including the date of submission and acknowledgement letter.
Copy of the disclosable portions of the Food Contact Notifications, FDA review memoranda, and correspondence for
FCNs 750 and 812, both filed by Danisco. We would also like the chemistry and toxicology review memoranda only for
FCN 2047, filed by DuPont.
Copies of the briefs submitted by FDA in the following cases: Nutrilab, Inc. v. Schweiker, 547 F.Supp. 880 (ND Ill. 1982)
Nutrilab, Inc. v. Schweiker, 713 F.2d 335 (7th Cir. 1983) American Health Products Co. v. Hayes, 574 F. Supp. 1498
(S.D.N.Y. 1982) American Health Products Co. v. Hayes, 744 F.2d 912 (2d Cir. 1984)
Por medio de la presente solicito Copia de reporte de inspección (evaluación) a Productos Marinos C.A, empresa
procesadora de carne de cangrejo azul; ubicada en San Francisco, Edo- Zulia; Venezuela. Inspección (evaluación)
realizada por la Licenciada Lisa Bowden, desde el 28 de Marzo de 2022 hasta el 01 de Abril de 2022.
510k information K212725ViperCross Support CathetersCardiovascular Systems Inc.9/24/2021
for Human Drugs inspection of Frontage Laboratories, Inc. ending 08/13/2021 at the location in Concord Township OH,
The 483 (in electronic format) for Foods & Cosmetics inspection of Bell Flavors & Fragrances, GmbH ending 02/08/2017
at the location in Leipzig, Germany. The EIR (in electronic format) for Foods & Cosmetics inspection of Bell Flavors &
Fragrances, GmbH ending 02/08/2017 at the location in Leipzig, Germany. The Response (in electronic format) for
Foods & Cosmetics inspection of Bell Flavors & Fragrances, GmbH ending 02/08/2017 at the location in Leipzig,
Germany. Please send documents as email attachments.
I am looking for the Summary and/or Medical Reviews for Tofacitinib (XELJANZ, NDA #203214) for the supplemental
applications S-017 (psoriatic arthritis indication), S-018 (ulcerative colitis indication), S-024 (updated boxed warnings), S-
026 (juvenile idiopathic arthritis indication, S-028 (active ankylosing spondylitis indication) and S-031 (JAK inhibitor class
labeling update).
I am looking for copies of all Establishment Inspection Reports conducted on Applied Technical Services in Everett, WA
(Registration Number: 3004065885, Owner/Operator Number: 10052600).
Form 483 following the USFDA inspection of Lupin's Tarapur site. The inspection was conducted between March 22,
2022 and April 4, 2022.
Form 483 of Lupin''s API facility situated in Tarapur which was inspected from 22th March to 4th April 2022 and noted 4
observations by USFDA.
Novel lab's (Lupin's subsidary) inspection Form 483 for Somerset, NJ. The inspection commenced on March 7, 2022 and
concluded on March 30, 2022. The inspection closed with thirteen observations.
To K072539 K110653 K080881 K132500
COMM BETWEEN FDA AND TEVA RE TASIMELTEON ETC
FILES, MEMOS, COMM RE TASIMELTEON, ETC
Identification of outbreak strain, research and analysis of illnesses associated to the outbreak
strain by WGS utilizing CDC assigned WGS nomenclature identifying the outbreak. Research
and analysis of potential sources of outbreak strain broken down by all U.S. states and Canada
where outbreak patients resided. Whole Genomic Sequencing for 2020 Onion Salmonella
newport outbreak identified by all WGS for the outbreak
strain as well as any other WGS nomenclature broken down by states where outbreak patients
resided.
(Rq.#1) Copies of Form 483s issued to the following CLINICAL INVESTIGATOR from February 1-28, 2022:
(Rq.#2) Copies of Form 483s issued to the following CLINICAL INVESTIGATOR from February 1-28, 2022:
(Rq.#1) Copies of Form 483s issued to the following DEVICE COMPANIES from February 1-28, 2022:
(Rq.#1) Copies of Form 483s issued to the following DRUG companies from February 1-28, 2022.
Copies of Form 483s issued by the CDER Complex Office in February 1-28, 2022.
Copies of Form 483s issued by the CDER Office in February 1-28, 2022.
K010485
K182964
K063217
Copy of the disclosable portions of the 483s for the inspections ending on 03/22/2018 and 11/07/2018 for Midwest
Sterilization, located in Jackson, MO. Please note these inspection pertain to medical devices.
Form 483 record with four observations from US FDA March 22, 2022 to April 4, 2022 inspection at Lupin Limited's
manufacturing facilities in Tarapur, India.
Requesting a copy of the PowerPoint presentation that trains FDA CORs and participants (AKA PAG Training) in how to
conduct source selection.
documents relating to 21 C.F.R. 101.95 which deals with terms "Fresh," "freshly frozen," "fresh frozen," "frozen fresh."
for Biologics inspection of The University of Kansas Health System ending 05/08/2015 at the location in Kansas City KS,
I would like to have access to all publicly available documentation relating to the submissions, evaluation, and
subsequent approval of Product NDA 018664 (IOSAT 65mg Potassium Iodide).
Consumer Complaints related to Real Water; Correspondence between Real Water and the FDA; Form 483 from the
Henderson, NV, Mesa, AZ, and any other facility location related to Real Water, including any responses; EIRs for the
Real Water inspections at the Henderson and Mesa location; etc
The 483 (in electronic format) for Human Drugs inspection of DuPont Nutrition USA, Inc ending 12/15/2021 at the
location in Newark DE, United States. The EIR (in electronic format) for Human Drugs inspection of DuPont Nutrition
USA, Inc ending 12/15/2021 at the location in Newark DE, United States. The Response (in electronic format) for
Human Drugs inspection of DuPont Nutrition USA, Inc ending 12/15/2021 at the location in Newark DE, United States.
for Human Drugs inspection of ICON Laboratory Services, Inc. ending 11/22/2019 at the location in Whitesboro NY,
for Biologics inspection of Grifols Therapeutics LLC ending 12/13/2018 at the location in Clayton NC, United States.
The technical Project Lead (TPL), and all documents referenced therein, for SE0017370 (which received an order of
Substantial Equivalence on March 31, 2022). This is a primary request from the SE applicant's outside counsel. An
authorization letter from the SE applicant, Davidoff of Geneva USA Inc., is attached.
Records of any communications with Dante Labs Ltd and CEO Andrea Riposati. I n particular any concerning FDA
concerns over pharmacogenomics claims made by the company.
Seeking all safety and efficacy preclinical information related to any Investigational New Drug (IND) filing for
molecule/drug FL1003 (aka methoxatone, 2-(5-methyl-2-furyl)-3-keto-L-gulonolactone 3,6 hemiketal) by Forest Labs.
Establishment Information Report (EIR) for: Haupt Pharma Wolfratshausen GmbH (FEI# 3000310230), for inspection
(GMP inspection re: human drugs) conducted by U.S. FDA during February 2020
Please provide Summary Basis of Approval of ASPRUZYO SPRINKLE GRANULES, EXTENDED RELEASE (RANOLAZINE) ORAL
500MG and 1GM for the Applicant SUN PHARMA INDUSTRIES LTD-N216018
We are requesting a full FOI version of the 510(k) approval letter for "FlexiCap Disconnect Cap With Povidone-Iodine
Solution, MiniCap With Povidone-Iodine Solution."
Information found under log Oct 2018 (1), D914 related to Medtronics INFUSE
Any and all INDIVIDUAL adverse event reports, pediatric and adult, voluntary and mandatory, for events related to
polyethylene glycol 3350 products and ANY of the following adverse events:1. kidney, 2. urinary, 3. failure to grow, etc
Please provide any and all documentation, including emails or correspondence from members of Congress such as Sen.
Mitt Romney and/or the White House, that led up to the FDA's decision on April 3, 2020 to issue an Emergency Use
Authorization for the Logix Smart Coronavirus Disease 2019 (COVID-19) kit for Co-Diagnostics, Inc.
I am writing in reference to my Freedom of Information Act (FOIA) request for all documents relating to the Center for
Disease Control’s investigation of Onions 52, Inc. in relation to a voluntary recall of red, yellow, white, and sweet onions
because of possible Salmonella Newport contamination from May 1, 2020 to the present
COMPANY: Stillmeadow Inc. ADDRESS: 12852 Park One Drive, Sugar Land TX 77478 REQUEST: FDA Establishment
Inspection Reports (EIRs), FDA 483s. Any inspection with emphasis on Global Laboratory Practices (GLP), and any other
inspections should also be included.
I request all communications between the FDA (or any of its components) and Apotex Inc. (or any agent or other
representative entity thereof) addressing, concerning, discussing, mentioning, or relating to the drug tasimelteon etc
Copy of the disclosable portions of the Food Contact Notifications for FCN 907 and FCN 916, including all related
correspondence and review memoranda.
Copy of the disclosable portions of the EIR and 483 for Tailor Cut Produce, Located in North Brunswick, NJ for the
12/10/2019-2/7/2020 inspection.
I'm requesting all records for all pet food plants (and manufacturers) FDA inspected in 2021 for issues relating to
tularemia
I'm requesting all records for all pet foods FDA tested in 2021 for tularemia
I'm requesting all e-mails sent and received by Eric Nelson 07.01.18-07.02.18
Hi, please provide All communications to and from Dr. Janet Woodcock mentioning "ivermectin"
Hello, please provide all emails to and from Marion Gruber and Phil Krause mentioning "vaccine" and "COVID-19",
"Covid", or "coronavirus"
Hi there, Please provide the following: Total number of FOIA requests received by FDA Total number of requests where
expedited processing was requested Total number of requests where expedited processing was denied Total number of
requests expedited processing was approved
I am requesting the record from FDA-CVM for the official definition of "perfect weight" for use on dog food packages. I
am also requesting the record from FDA-CVM for the official definition of "perfect weight" for use on cat food packages.
I am requesting the record from FDA-CVM for the official definition of "dried poultry waste" for use in animal feed
Records for all inquiries made to AskCVM mailbox for the year 2021, including log information, tracking information,
forwarding information, and CVM responses to the inquiry. If this information exists as a spreadsheet, the spreadsheet
containing all inquiries made to AskCVM mailbox in 2021 would satisfy this request.
The appeals log or spreadsheet record showing appeals logged by FDA FOIA department in the month of August 2021
in the month of March 1 to31, 2022, including for any inspections dated before March 1, for: • Pharmaceutical,
biologics and medical device manufacturing facilities, including premarket approval inspections;etc
All email records containing the keyword “AAFCO” for FDA employee Lourdes Andujar for the date range of February 1,
2021-March 31, 2022. (Employee location /DHHS/FDA/ORA/ORA/OHAFO/OHAFOW/DDHAFO/DHAFOB)
All email records containing the keyword “AAFCO” for FDA employee Lei Tang for the date range of April 01, 2021-
March 31, 2022. (Employee location /DHHS/FDA/CVM/CVM/OSC/DAF)
Request for all documents released for FOI 2016-10102
ZEUS Scientific, Inc., Branchburg, NJ EIIR
NDA 016466
Center for Tobacco Product’s denial of premarket tobacco product applications for PM0000527.PD1, PM0000532.PD1,
PM0000533.PD1 and PM0000538.PD1. (Marketing Denial Order was issued on March 24, 2022.) Logic Technology
Development LLC (Logic) requests the following documents: The administrative record, including but not limited to the
Technical Project Lead and memoranda, for the PMTAs and denials above Additional documents containing information
related to the above referenced denials
Panaceutics Nutrition, Inc., 6 Davis Drive, Research Triangle Park, NC 27709; Records of any 482, 483 reports with
reported observations included
Any and all inspection reports, violation notices and enforcement orders from the U.S. Food & Drug Administration to
CVS Warehouse Distribution Center, located at 322 Revco Rd, Somerset, PA 15501, from Jan 1, 2022 to the present
date.
A copy of the action package for approval for HYFTOR (sirolimus topical gel) approved by FDA on or about March 22,
2022, under New Drug Application #213478.
DEN150057 Medical Device approval records
Citizens Petition – Docket Number 84P-0308 for ESTRACE (Estradiol) Tablets, 0.5 mg; approved March 24, 1986.
FDA's chemistry, toxicology, and environmental review memoranda for Food Contact Notifications (FCN) 1800, 1927,
and 1935.
All available records pertaining to IDE application, approval or denial of PECA Labs “MASA Valve”, which may be termed
as PTFE or ePTFE valve. PECA Labs is located at 4424 Penn Ave. Suite 201 Pittsburgh, PA 15224
Dear sir/madam Please give me the following details of all the food and beverages manufacturing plants in India that
were inspected by the USFDA in 2020 and 2021: 1. Name of the company that owns the plant 2. Date of inspection of
the plant 3. Address of the plant 4. What action was taken after the inspection of the plant In case you have a log that
has the details of the food and beverages manufacturing plants inspected in India in the aforementioned two years,
please share that. That in itself will work. Regards
Can I please have the results of my sons formulas that were tested.
Please send the full reports for the following cases, including narrative descriptions. These are cases associated with the
drug Finasteride. 10928330 12177811 14795205 14873124 17352812 17630287 17706849 17893240 18088307
18089264 18191361 18557774
Summary basis of approval review for NDA 21-346 / S-028 for the use of Risperdal CONSTA as a monotherapy for the
maintenance treatment of bipolar I disorder.
Please provide Summary basis of Approval of EMFLAZA SUSPENSION ORAL (DEFLAZACORT) 22.75MG/ML for an
Applicant PTC THERAPEUTICS INC-N208685
The TPLs (review documents) for the April 8, 2022, marketing denial orders (MDOs) issued by the Center for Tobacco
Products to Fontem US, LLC, including those covering the following products: myblu Device Kit, myblu Intense Tobacco
Chill 2.5%, myblu Intense Tobacco Chill 4.0%, myblu Intense Tobacco 2.4%, myblu Intense Tobacco 3.6%, myblu Gold
Leaf 1.2%, and myblu Gold Leaf 2.4%.
The April 8, 2022, marketing denial orders (MDOs) issued by the Center for Tobacco Products to Fontem US, LLC,
including those covering the following products: myblu Device Kit, myblu Intense Tobacco Chill 2.5%, myblu Intense
Tobacco Chill 4.0%, myblu Intense Tobacco 2.4%, myblu Intense Tobacco 3.6%, myblu Gold Leaf 1.2%, and myblu Gold
Leaf 2.4%.
Copy of the disclosable portions of the following 5 case reports for Ervebo: 2122934, 2039657, 1761333, 1782963,
1948421.
All inspection records for samples taken from The Metro Group, Inc's lab located at 50-23 23rd Street, Long Island City,
NY 11101, as further referenced in the attached correspondence.
Regulatory information request under the Freedom of Information Act (FOIA) as per the guideline.
2022, pursuant to New Drug Application No. 213478
Electronic listing (preferably csv format) of all RRAs conducted since January 1, 2022.
Regulatory Assessment of Biolife Plasma Services L.P. Located at Findlay OH United States FEI Number: 3003887920 held
on 05/18/2021.
Please provide VAERS Report
Regulatory Assessment of CSL Plasma, Inc Located at Tulsa OK United States FEI Number: 1672443 held on 05/17/2021.
Regulatory Assessment of Biomat USA Inc. Located at Toledo OH United States FEI Number: 3006986921 held on
05/13/2021.
Regulatory Assessment of Biomat USA, Inc. Located at Mobile AL United States FEI Number: 1038058 held on
05/11/2021.
Copy of the 483 for the Mar 5, 2018 - Apr 13, 2018 (40 days) inspection of New Era Naturals [Durango / United States of
America] 278 Sawyer Dr STE 4, Durango, CO 81303, USA. This inspection pertains to human drugs.
Copy of the 483 for the Apr 16, 2018 - Apr 20, 2018 (5 days) inspection of Longbow First Aid Products Manufactory
[Foshan Shi / China] Building F, 2 Guiping W Rd, Nanhai Qu, Foshan Shi, Guangdong Sheng, China, 510370. This
Copy of the 483 for the Apr 17, 2018 - Apr 20, 2018 (4 days) inspection of Hangzhou Guoguang Touring Commodity
Co.,Ltd. [Hangzhou / China] Yuhang District, No. 8 Yushun Road; Jingshan Town Hangzhou China. This inspection
pertains to human drugs.
Copy of the 483 for the May 7, 2018 - May 11, 2018 (5 days) inspection of Prescription Dispensing Laboratories Inc.
[Cedar Park / United States of America] 211 S Bell Blvd, Cedar Park, TX 78613, USA. This inspection pertains to human
drugs.
Report and/or the MDSAP Noncomformity Grading and Exchange Form (NC) for the inspection of Pursuit Vascular Inc,
Maple Grove, MN , end date 02-14-2019. FEI# 3011277191. This inspection pertains to medical devices.
Report and/or the MDSAP Noncomformity Grading and Exchange Form (NC) for the inspection of Interrad Medical Inc,
Minneapolis, MN , end date 10-30-2019. FEI# 3007795799. This inspection pertains to medical devices.
Report and/or the MDSAP Noncomformity Grading and Exchange Form (NC) for the inspection of Metrex Research, LLC.,
Romulus, MI , end date 07-15-2015. FEI# 1000117344. This inspection pertains to medical devices.
Report and/or the MDSAP Noncomformity Grading and Exchange Form (NC) for the inspection of Kerr Corporation,
Romulus, MI , end date 07-17-2015. FEI# 1815757. This inspection pertains to medical devices.
Please send Module 3, Section 3.2.P Drug Product, Subsection 3.2.P.2 Pharmaceutical Development for the following
Products/NDAs 1. Viekirax NDA 208624 Approved 7/16/2016, subsequently discontinued 2. Vyndaquel NDA 211996
Approved 5/3/2019 Redaction is understood. Thank you.
The Letter of No Objection or LNO granted to EREMA for its 5-6 low-density polyethylene (LDPE) process. All of the pre-
submission documents and filings made by EREMA to FDA to obtain the LNO designation.
Any and all records maintained by the Forensic Chemistry Center, Office of Medical Products, Tobacco and Specialty
Laboratory Operations (OMPTSLO), Office of Regulatory Science (ORS), Office of Regulatory Affairs (ORA), U.S. Food and
Drug Administration including reports, memoranda, data or other form of records related to confirmed instances of
product tampering, counterfeiting of pharmaceuticals, etc
1) ANDA 088045 -Fluocinilone Acetonide Cream, 0.025%: Full copy of ANDA paper records (all original ANDA
submission records, all amendments, all supplements) unitl January 2019. 2) ANDA 070274-Betamethasone
Dipropionate Lotion USP, 0.05%: Full copy of ANDA paper records (all original ANDA submission records, all
amendments, all suppplements) until April 2021. 3) ANDA 074839-Etodolac Tablets USP, 400mg: Full copy of ANDA
paper records (all original ANDA sumbission records, all amendments, all suppplements) until August 24, 2016.
FDA EIR: 1.FEI: 3003885745 Firm Name:Zhejiang Huahai Pharmaceutical 2.FEI:3013842722 Firm Name:Jiangsu
Sihuan Bioengineering Pharmaceutical 3.FEI: 3017990295 Firm Name:Wuxi Jinnong Biotechnology 4.FEI :3014310427
Firm name: Shanghai STA Pharmaceutical Product Co. Ltd
FDA Human Drugs 483: 1.FEI:3013842722 Firm Name:Jiangsu Sihuan Bioengineering Pharmaceutical 2.FEI:
3008481334 Firm Name:Hisun Pharmaceutical Hangzhou Co., Ltd
COVID-19 Vaccination Statistics for Illinois
FDA EIR: 1.FEI: 2211100 Firm Name:Janssen Pharmaceuticals, Inc. Firm add:1000 US Highway 202
Commodity:Biologics
2022-421, 2022-672, 2022-773, 2022-1300, 2022-628.
2022-788, 2022-1024, 2022-1142, 2022-1167, 2022-1205.
2022-1212, 2022-1214, 2022-1232, 2022-1303, 2022-1311.
2022-1314, 2022-1326, 2022-1386, 2022-1389, 2022-1493.
All documents related to the FDA's inspection of Sharp Packaging Solutions, LLC, Allentown, PA 18106 (FDA
Establishment Identification (FEI) No.: 3004161147) that occurred between December 20, 2021, and January 28, 2022.
This request includes, but is not limited to, any FDA Form 483s or Enterprise Inspection Reports (EIRs) associated with
this inspection.
Please send Module 3, Section 3.2.P Drug Product, Subsection 3.2.P.2 Pharmaceutical Development for the following
products: 1. Fenofibrate ANDA 076529 12/29/2005 2. Technivie NDA 207931 July 24, 2015 (Discontinued) 3. Zepatier
NDA 208261 January 28, 2016 4. Mavyret NDA 209394 August 8, 2017 Redaction is understood. Thank you.
Copy of the disclosable portions of the FDA reviews for the following products that were issued MDOs on 04/08/2022:
myBlu Device Kit; myBlu Intense Tobacco Chill 2.5%; myBlu Intense Tobacco Chill 4.0%; myBlu Intense Tobacco 2.4%;
myBlu Intense Tobacco 3.6%; myBlu Gold Leaf 1.2%; myBlu Gold Leaf 2.4%.
Searching for any FDA records of any EIR and 483 inspection findings or reports for Biolab Sciences Inc. of Scottsdale
Arizona.
Mirror request for all LAP-BAND records and materials produced to the Dysart Law Firm, PC pursuant to its FOIA
requests, including requests on 1/25/2016 (control no. 2016-647); 7/23/2018 (control no. 2018-5894); and 8/28/2018
(control no. 2018-6980).
K191031
Copy of the disclosable portions of the FAERS case reports for the following ertugliflozin cases: 20200107_1626487;
20200107_1610967; 20200107_1611544.
K112822
K001852
2020-5937
2008-2894
2015-8250
K051187
2021-5223 2021-5186 2021-5157 2021-5091
Copy of the 483 for the Mar 26, 2018 - Mar 30, 2018 (5 days) inspection of Newton Laboratories Inc [Conyers / United
States of America] 455 Gees Mill Business Ct NE, Conyers, GA 30013, USA. This inspection pertains to human drugs.
Copy of the 483 for the Mar 26, 2018 - Mar 29, 2018 (4 days) inspection of Hangzhou Karic Commodities Co., Ltd. [New
York / United States of America] 5th Ave, New York, NY, USA. This inspection pertains to human drugs.
Complete 510(k) for Diros OWL Sterile Single Use Trident RF Insulated Cannulae. K150371
Complete 510(k) for LCCS VC-S RF Cannula. K191293
Copy of the 483 for the Mar 19, 2018 - Mar 22, 2018 (4 days) inspection of Leventon S. A. U. [Sant Esteve Sesrovires /
Spain] Pol. Industrial Sesrovires, Carrer Newton, 18-24, 08635 Sant Esteve Sesrovires, Barcelona, Spain. This inspection
Copy of the 483 for the Feb 21, 2018 - Mar 5, 2018 (13 days) inspection of The Fertility Partnership LLC [St. Peters /
United States of America] 5401 Veterans Memorial Pkwy #201, St Peters, MO 63376, USA. This inspection pertains to
biologics
Regulatory Assessment of Biomat USA, Inc. Located at Kannapolis NC United States FEI Number: 3012979736 held on
05/19/2021.
Regulatory Assessment of CSL Plasma, Inc. Located at Pinellas Park FL United States FEI Number: 3011398647 held on
05/20/2021.
Regulatory Assessment of CSL Plasma, Inc. Located at Pinellas Park FL United States FEI Number: 3011398647 held on
05/20/2021.
Regulatory Assessment of Biomat USA, Inc. Located at Rock Hill SC United States FEI Number: 3011358294 held on
05/21/2021.
Regulatory Assessment of Biomat USA Inc Located at Kissimmee FL United States FEI Number: 3011871534 held on
05/21/2021.
Report and/or the MDSAP Noncomformity Grading and Exchange Form (NC) for the inspection of Micromedics, Inc.,
Saint Paul, MN , end date 11-14-2018. FEI# 2183425. This inspection pertains to medical devices.
Report and/or the MDSAP Noncomformity Grading and Exchange Form (NC) for the inspection of Respiratory
Technologies, Inc., Saint Paul, MN , end date 04-05-2018. FEI# 3004961434. This inspection pertains to medical devices.
Report and/or the MDSAP Noncomformity Grading and Exchange Form (NC) for the inspection of CoAg, Saint Paul, MN ,
end date 03-24-2017. FEI# 3011400126. This inspection pertains to medical devices.
for Biologics inspection of SAFC Carlsbad Inc ending 12/16/2021 at the location in Carlsbad CA, United States. The
Response (in electronic format) for Biologics inspection of SAFC Carlsbad Inc ending 12/16/2021 at the location in
Carlsbad CA, United States. Please send documents as email attachments.
format) for Human Drugs inspection of Yusef Manufacturing Laboratories, LLC ending 09/24/2021 at the location in
Clearfield UT, United States. Please send documents as email attachments.
Report and/or the MDSAP Noncomformity Grading and Exchange Form (NC) for the inspection of R & D Systems, Inc.,
Minneapolis, MN , end date 08-17-2017. FEI# 2182501. This inspection pertains to medical devices.
for Animal Drugs & Feeds inspection of UNIVAR SOLUTIONS USA INC. ending 08/25/2021 at the location in Cincinnati
OH, United States. Please send documents as email attachments.
Electronic listing (preferably csv format) of all inspections conducted by FDA since December 1, 2021. The list should
for Human Drugs inspection of Aurora Medbiochem Company ending 09/04/2014 at the location in Escondido CA,
I am requesting the FAERS case reports for aducanumab / Aduhelm with the following Case IDs: 12235391 and
12203934. Please send electronically to sroberts@dal.ca or by mail to the provided address.
I am requesting the following information: Adverse events reported to FAERS from February 1, 2016 through today for
Aduhelm, aducanumab and/or aducanumab-AVWA. Please send electronically to sroberts@dal.ca or by mail to the
provided address.
20463171, 19726309, 19771050, 20638335, 20633877. Please send electronically to sroberts@dal.ca.
I am requesting the following information: Adverse events reported to FAERS from February 1, 2016 through today for
Aduhelm, aducanumab and/or aducanumab-AVWA. Please provide the information in an Excel/CSV file. Please send
electronically to sroberts@dal.ca.
(Please delete my previous request for these records, and instead file this request with my corrected email address.
Thank you!)
Previously released records under the FOIA as per the listing provided for this request.
-All documents relating to the testing of Artnaturals products as referenced by the Food and Drug Administration
(“FDA”) in an update posted to its website dated October 4, 2021. etc
I am requesting for a list of issues related to the Rabipur rabies vaccine and HyperRAB S/D rabies human
immunoglobulin which were reported to the FDA during the specified time period.
The redacted version of the FDA Inspection Report (EIR) for the PQ LLC (formerly PQ Corporation) - Utica, Illinois facility
(FEI #1421453), located at 340 East Grove Street, Utica. IL 61373; the subject inspection was conducted by the FDA from
February 15 - 22, 2022.
application forms and any accompanying data and supporting attachments/information for applications submitted to
the FDA by the following companies and their associated products: Company Name: Takeda Pharmaceutical Company
(licensed to Oak Hill Bio): Drug Candidate: OHB-607 (formerly TAK-607), is a proprietary, recombinant version of insulin-
like growth factor 1 (IGF-1) Applications & Supporting Information Requested: Fast-Track Designation ETC
All information concerning FDA inspections conducted at any Norco, Inc. facility in the state of Idaho for the period
January 1, 1998 through present, including, without limitation, any Form 483 Inspectional Observations, Establishment
Inspection Reports and/or Warning Letters.
materials, documentation or files related to the questions below with regards to the Moderna COVID 19 vaccine
A list of those companies that reported either of the following two chemicals to the VCRP for the years indicated: (1)
Perfluorohexylethyl Triethoxysilane; or (2) Polytetrafluoroethylene (PTFE).
FDA Guidance "Methods for Conducting Recall Effectiveness Checks"

participating in the FDA Foreign Supplier Verification Programs from approximately December 17, 2021 - March 16,
2022. We request a modified version of this same list to include the Firm's FDA FEI Number. This is the same request as
our previous FOI request with control number 2021-1456 (fulfilled by CFSAN), but, with a different date range.
PM0000530 and PM0000531
PM0000529, PM0000535, PM0000536,
PM0000537, and PM0000540
PM0000720, PM0000724-
PM0000726, PM0000728-PM0000744
FDA documentation and records RE Premarket Tobacco Product

Applications (PMTAs) submitted by Logic Technology Development LLC, but FDA issued a
marketing denial order (these were referenced in FDA’s March 24, 2022, press release)
1. Documents produced in response to FOIA Request Number 2021-3181 for “[a]ll correspondence, communications,
and documents exchanged between the FDA and ChemoCentryx, Inc. concerning clinical trials and the new drug
application for avacopan.” 2. Documents produced in response to FOIA Request Number 2021-4663 for
“Communications between the FDA and ChemoCentryx (including its executive officers and/or directors) pertaining to
ChemoCentryx’s C5a receptor inhibitor, avacopan (CCX168).”
I request the two most recent inspection reports for Bluebird Bio Inc.’s facility at 60 Binney Street, Cambridge,
Massachusetts 02142.
1) What is the FDA.gov URL I can access to search for breakthrough device approval/decline designations based on a
device manufacturer name? I note that https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm?
lid=756018&lpcd=OAE identifies the Farapulse product assigned to the OAE product code, but DOES NOT indicate any
BREAKTHROUGH designation. 2) Please identify the Breakthrough device approval designation process, and the
names/organization/roles of the participants who voted or approved the Farapulse device breakthrough designation.
BNF000164, High Oleic Soybean FAD2KO I would like to request the administrative records for BNF164, including the
original submission, any questions from the agency and any additional information Calyxt provided.
Please provide a copy of the ANDA approval letters for the following applications: A076772 Actavis Laboratories FL
Inc A210818 Alvogen Inc A211918 Andor Pharmaceuticals LLC A211009 Ascent Pharmaceuticals Inc A206726
ETC
I hereby request all correspondences among
CDC Immunization Safety Office employees
that include the words VAERS or Vaccine Adverse Event Reporting System and COVID-19
or coronavirus or COVID or Pfizer or BioNTech or Moderna or Johnson and Johnson or
Janssen
I am requesting the establishment inspection reports for two inspections at Abbott's Sturgis, Michigan facility. The
inspections ended Sept. 24, 2021 and March 18, 2022. Please send them electronically if possible to
aedney@bloomberg.net. Thank you
We are seeking records of Stage 2 submission package for a proposal in response to FDA Broad Agency Announcement
FDABAA-21-00123. The proposal is titled "VALIDATION OF A NOVEL METHODOLOGY FOR ENDPOINTS ASSESSING
RESPONSE TO LYMPHOMA TREATMENT IN REAL-WORLD STUDIES" and was awarded to Cardinal Health in September
2021.
Request Establishment Inspection Reports and/or 483 Reports on Changzhou MaoKang Medical Products Co., Ltd. This
will guide us whether or not to continue purchasing antiseptic wipes and alcohol wipes.
Please provide committee meeting material for FDA's Cardiovascular & Renal Drugs Advisory Committee for Cordarone
I.V. that occurred on October 14, 1994.
Request for records that have led to SCHNUCK MARKETS INC, SCHNUCK MARKETS, INC., SCHNUCKS MARKETS, INC., and
SCHNUCKS MARKETS INC-ST LOUIS -NORTH PARK DRY to be listed on page 396 of the FDA Importer List on 4 line items
between December 17, 2021 - March 16, 2022.
Please see the attached letter requesting copies of FAERS report nos. 11812970 and 13441390. Thank you.
format) for Human Drugs inspection of Patheon Manufacturing Services LLC ending 08/14/2020 at the location in
Greenville NC, United States. Please send documents as email attachments.
for Human Drugs inspection of Strides Pharma, Inc. ending 02/08/2022 at the location in Chestnut Ridge NY, United
for Medical Devices & Rad Health inspection of Nomax Inc ending 02/01/2018 at the location in Saint Louis MO, United
States. The EIR (in electronic format) for Medical Devices & Rad Health inspection of Nomax Inc ending 02/01/2018 at
the location in Saint Louis MO, United States. Please send documents as email attachments.
for Animal Drugs & Feeds inspection of Zurex PharmAgra, LLC ending 01/08/2016 at the location in Middleton WI,
for Animal Drugs & Feeds inspection of Procos S.p.A. ending 02/26/2016 at the location in Cameri, Italy. Please send
483's - FDA inspection observations of the facility details mentioned below for inspection completed on Apr 01, 2022.
Facility Details: TriRx Huntsville Pharmaceutical Services, LLC 120 Vintage Drive, Huntsville, Alabama (AL) 35811, United
States (USA) Registration (FEI) Number: 3003197096 DUNS Number: 117090286
format) for Human Drugs inspection of Amgen, Inc. ending 03/16/2018 at the location in Thousand Oaks CA, United
Hello, I would like to request the Form 483 and EIR issued during the 2022 inspection of the Protalix BioTherapeutics
manufacturing facility located in Carmiei, Israel. Thank you.
Dear officer, we're seeking for full FCN information of FCN No. 829, that is, the full dossier of this FCN. Thank you! Best
regards, Yini Jin
I am requesting a copy of all applications and all approvals for a temporary marketing permit to use drained weight on
the label to comply with the fill of container law under the canned tuna standard of identify 21CFR161.190. The
temporary was given evergreen status in 2016.
All documents associated with the September 29, 2016 Administrative Stay of Action issued for Amneal Pharmaceuticals
LLC’s ANDA No. 204711, including, but not limited to, the decision to lift that stay.
(1) The Tentative Approval Routing Summary for Par Pharmaceutical Inc.’s Abbreviated New Drug Application (“ANDA”)
No. 203976. (2) In relation to Amneal Pharmaceuticals LLC’s ANDA No. 204711: (a) the Tentative Approval Letter (if
any); (b) the Tentative Approval Routing Summary (if any); (c) the Final Approval Letter; and (d) the Final Approval
Routing Summary.
A copy of the cleared K190277
Copy of the disclosable portions of the following documents for the 01/21/2022 supplemental approval of Skyrizi, BLA
761105, Supplement 14: Multi-Discipline Review, Other Reviews, Administrative Documents and Correspondence.
Please provide releasable records relating to Miles Laboratories product with Product ID P800032, "Biostator Glucose
Controller." We specifically request 1. SSED documents/summary; 2. Labeling and user manuals; and 3. Approval letters.
Greetings, I would like to receive the records for all international shipments in which Relish labs DBA Home Chef has
been identified as the "FSVP Importer" (by adding my DUNS numbers at the point of entry) from 1/1/2022 - 3/31/22.
RLD Solaraze (diclofenac sodium) topical gel, 3% received a labeling supplement approval NDA 021005/S-023. The FDA
website includes only PI and Medguide labeling. Please provide carton and container labels as these components were
updated in the supplement as well. RLD approval letter is attached (approved 04/052022).
Request for a copy of FDA 483 for cause inspection (VAI) and EIR for Dr. Samantha Jaglowski located at The Ohio State
University, The James Cancer Hospital, Solove Research Institute, A354 Starling Love Hall 321 West Tenth Ave,
Columbus, Ohio, 43210
Please provide releasable records relating to Bayer Corp. product with Product ID K964630. We specifically request: 1.
SSED documents/summary; 2. Labeling and user manuals as submitted with applications and any updates; and 3.
Approval letters.
Please provide releasable records relating to Fresenius product with Product ID K901040, "Ionometer EH-F and
Accessories." We specifically request: 1. SSED documents/summary; 2. Labeling and user manuals as submitted with
applications and any updates; and 3. Approval letters.
Pursuant to the Freedom of Information Act, 5 U.S.C. Section 552 et seq.("FOIA"), I request records released in response
to previous request 2022-287. I am further requesting that the Records be provided to me on computer files or, if not
maintained on computer files, in the same format as they are currently maintained at the Food and Drug
Administration.
additional information regarding certain Foreign Supplier Verification Program (FSVP) entries filed between January 1,
2019 and April 12, 2022.
Emails communications from shield Illinois , shield T3, governor JB Pritzker to FDA in regards to approval or request for
approval of saliva test . Language may include please approve EUA , saliva test , university of Illinois shield program .
NeuroRX Pharma EUA denial letter etc
Request you to kindly share the 13 observations raised on Lupin Ltd's Somerset, New Jersey plant. The inspection was
conducted from 7 to 30 March. A warning letter was issued in June 2021. Please share a copy of the observations in
public interest
a copy of U.S. Food and Drug Administration (FDA) Complete Response Letter (CRL) for the Biologics License Application
(BLA) for somatrogon (Pfizer/Opko) issued about January 21, 2022.
Copy of the disclosable portions of the chemistry review memoranda for the following No Objection Letters: NOL 193
(Ecotech Consumer Products); NOL 202 (Envision Plastics); NOL 217 (Plastic Recycling); NOL 228 (KW Plastics).
All 510(k) submission records for K211079 - for BioFire COVID-19 Test 2; AND All DeNovo submission records for
DEN200031 - for BioFire Respiratory Panel 2.1 (RP2.1).
K213424
All documents provided to FDA by R.J. Reynolds Vapor Company, or any affiliated entity, in response to Appendix C
(entitled “Postmarket Reporting”) to the October 12, 2021 Marketing Granted Orders issued to R.J. Reynolds Vapor
Company for Vuse Solo Power Unit and replacement cartridges, STNs PM0000551, PM0000553, PM0000560.
All records relating to the following Import Refusal: Manufacturer FEI: 2150117 / Manufacturer Name: Pharmaceutical
Specialties, Inc. / Manufacturer Address: 1620 Industrial Dr NW / Manufacturer City: Rochester /
Manufacturer Province/State: MN / Manufacturer Country/Area: United States / Product Code: 62WBY99 / FDA Product
Description: ASTRINGENT/ANTI-PERSPIRANT N.E.C. / Refusal Date: 10-Dec-2021 / FDA District: DNEI /
ENTRY/DOC/LINE/SFX: AV3-0053889-7/51/1
Final report for investigation conducted at the northeast lab regarding an incident in the IH office.
All documents associated with FDA’s decision to issue: 1) an “AB” rating for Perrigo’s products approved under NDA No.
203098 in or near July 2014; 2) a “BX” rating for Upsher Smith’s 12.5 mg/1.25 gm actuation product approved under
NDA No. 204399 in or near November 2014; and 3) an “AB2” rating for Upsher Smith’s 50 mg/5 gm packet product
approved under NDA No. 204399 in or near January 2015.
The CDER OCC Tracking Information Form (or equivalent) for: 1) AbbVie’s citizen petition, docket no. FDA-2011-P-0610,
and 2) Auxilium’s citizen petition, docket no. FDA-2013-P-0371.
All correspondence between FDA, Ocugen or Bharat concerning Covaxin. All correspondence between the FDA, Ocugen
or Bharat concerning the FDA's COVID-19 vaccine EUA guidance. All documents concerning the FDA's proposal that
Ocugen pursue a Biologics License Application for Covaxin. All documents concerning Covaxin application for FDA
approval. etc
Any dietary supplement adverse events tied to or that mention eating disorders (i.e. anorexia, bulimia, binge eating,
etc.)
VAERS report for vaccinations administered on 6/17/2019. VAERS ID: 820772
Requesting a copy of the most recent approved labeling for NDA 019350 for Cupric Sulfate EQ 0.4 mg Copper/mL
Injection. The NDA is held by ABRAXIS PHARM and the most recent labeling as per Drugs@FDA website was approved
on June 9, 2022.
2022, under New Drug Application #213478.
Please provide Summary Basis of Approval for both CALCIPOTRIENE OINTMENT TOPICAL 0.005% (DOVONEX) for the
Applicant LEO PHARMA AS-N020273 and CALCIPOTRIENE OINTMENT TOPICAL 0.005% for the Applicant GLENMARK
PHARMACEUTICALS INC USA - A090633
Communications between the FDA and Apyx Medical concerning Renuvion.
All communications between FDA and Eli Lilly & Co (LLY) relating to iADRS endpoint for the Ph3 TRAILBLAZER-ALZ 2.
Any external communications, studies, presentations, complaints, reports or other similar records that informed FDA's
belief that "information from real-world sources" indicated computer-aided triage and notification for large vessel
occlusion were used for diagnosis rather than its intended use.
Pursuant to the United States Freedom of Information Act (“FOIA”), 5 U.S.C. § 552, we are seeking the names and
affiliations of all five peer reviewers of FDA's white paper "External Peer Review of the Interagency Working Group on
Asbestos in Consumer Products' (IWGACP) White Paper: Scientific Opinions on Testing Methods for Asbestos in
Cosmetic Products Containing Talc."
documents related to an inspection of Woodstock Sterile Solutions located at 2210 Lake Shore Drive Woodstock, IL
60098.
Adverse events for the following FDA approved drugs: - Nivolumab - Pembrolizumab - Cemiplimab - Ipilimumab -
Atezolizumab - Durvalumab - Avelumab
We request copies of all records that the FDA Center for Drug Evaluation and Research produces regarding Aduhelm in
response to prior Freedom of Information Act requests submitted to the Food & Drug Administration (“FDA”), including:
Request No. 2022-918: EMAILS RE ADUHELM DUNN, WOODCOCK, HAHN, ETC Request No. 2022-920 etc
2022-804, 2002-805, 2022-806 etc
FAERS DEXTROMETHORPHAN
All documents pertaining to the administration’s review of Pfizer/BioNTech’s COVID-19 vaccine, both for Emergency Use
in December 2020 and granting full approval in August 2021. Specifically, I am seeking data from clinical trials and
manufacturing information submitted by Pfizer-BioNTech concerning the safety and potential side effects of the
vaccination.
Color Additive Petition CAP 0C0270 (65 FR 13770, March 14, 2000) and any related correspondence including pre-
submission meeting notes.
I am requesting the PDF record David Edwards (FDA CVM) sent to Erin Bubb (PA Department Of Agriculture) on March
26, 2019
FDA Commissioner etc Your Oath of Office etc
I request all records of communication originating from or directed to the Office of the Commissioner with respect to a
field mice found inside FDA headquarters, to include any communications with the General Services Administration.
I request all records of communication originating from or directed to the Office of the Commissioner with respect to
field mice found inside FDA headquarters, to include any communications with the General Services Administration.
I request all communications within FDA about field mice found inside headquarters buildings and a POLITICO article
about the issue. Please include all emails referencing "POLITICO," "mice" and "field mice." Please include any
correspondence containing this link: https://www.politico.com/news/2022/04/11/field-mice-fdas-maryland-
headquarters-00024447
MEDICAL DEVIC ADVERSE EVENT REPORTS
505(b)(2) applications for prodrugs
All communications between Biogen and the FDA regarding Biogen's Aduhelm (aducanumab-avwa) between January 1,
2019 through April 15, 2022. These may include all records relating to FDA's accelerated approval program, discussions
between Biogen staff and agency staff during the review process and FDA's decision.
All records including, but not limited to, registration information, inspections, correspondence, press releases, warnings,
FDA actions taken, and state enforcement actions, related to: QualMed Pharmacy, 14 Inverness Dr E, Englewood, CO,
80112-5625, under Facilities Registered As Human Drug Compounding Outsourcing Facilities Under Section 503B of the
Federal Food, Drug, and Cosmetic Act
FDA’s inspection of Abbott Laboratory dba Abbott Nutrition (“Abbott”), located at 907 N. Centerville Rd., Sturgis, MI
49091
Subject: All contents of K193407, Device Name: Contour® next GEN Blood Glucose Monitoring System, Manufacturer:
Ascensia Diabetes Care
Establishment Inspection Report for Marianna Industries, Inc.
All contents of K181131, Device Name: Accu-Chek Guide Me Blood Glucose Monitoring System, Manufacturer: Roche
Diabetes Care
All contents of K160944, Device Name: ACCU-CHEK Guide Blood Glucose Monitoring System, Manufacturer: Roche
Diabetes Care, Inc
N018531(RLD of injectable NITROGLYCERIN), held by HOSPIRA INC, was not discontinued for safety or effectiveness
reasons. We'd like to have its label for reference to support our product developement.
RECS RE VACCINE LOT NUMBERS
2022-1898, 2022-1899, 2022-1929, 2022-1997, 2022-2013.
2022-2034, 2022-2068, 2022-2118, 2022-2146, 2022-2193
CV/Resume Saikat Bhuiyan, Emily Camire, Paul Chefor, ETC.
Individual medwatch (case reports) retrieved from FAERS dashboard search: 99009336 ,8297823, 8295659, 6835515,
9909022, 9908714, 6836543, 5407601, 3996084, 2711834, 1019220, 9891266
Establishment Inspection Report for inspection conducted 8/12/21-8/20/21 Hugel Inc Site 2 23 Geodudanjil-1- gil
Chuncheon, Gangwon Dongnae-myeon Republic of Korea 24398 FEI Number 3012163998
Please provide the following documents from Summary Basis of Approval (SBOA) for ACYCLOVIR CREAM; TOPICAL, 5%,
ANDA# 208766: 1) CHEMISTRY REVIEW(S) 2) CLINICAL PHARMACOLOGY AND BIOPHARMACEUTICS REVIEW(S) 3)
MEDICAL REVIEW(S) 4) ADMINISTRATIVE and CORRESPONDENCE DOCUMENTS
Review history for NDA approval - Xipere
RE: Abbott Nutrition, Sturgis, MI (FEI #1815692. Please supply Consumer Complaint/Adverse Event reports submitted to
FDA during the period September 1, 2021 through current date, inclusive.
Copy of the EIR for the 2020 Osypka Medtec Inc. (FEI# 3010376846) Inspection end date: 1/31/2020 Inspection ID#
1117794
Please provide us the summary basis of approval (SBOA) for the NDA 019185: OXYTOCIN IN DEXTROSE 5% (NDA Holder :
ABBOTT LABORATORIES PHARMACEUTICAL PRODUCTS DIV). Thank you. Sincerely, Nirav Patel, Ph.D.
This a request under the Freedom of Information Act. I request a list of all Temporary Marketing permits requested and
all TMPs granted under the me-to suggestion to participate in the Canned Tuna Drained Weight temporary marketing
permit published in the Federal Register Mar 7, 2016, Docket No. FDA-2012-P-1189. Thanks
Request for Letters, Reviews, Labels, Patient Package Insert for brand name CHYMODIACTIN/ generic name
chymopapain. NDA 18-663 was approved November 1982. It was later reclassified as BLA018663 in March 2020.
Request for a copy of citizen petition filed by ChymoCorp on February 12, 2002. (Docket No. 02P-0068/CP1)
I am requesting the Integrated Summary Of Safety for the initial Epidiolex (cannabidiol), NDA 210365 for the treatment
of DS and LGS approved June 28, 2018
I would like the integrated summary of safety for the following 2 indications of Fintepla (fenfluramine): 1. indication -
treatment of DS, NDA 212102 approved 06/25/2020 2. indication - treatment of LGS, NDA 212102/S-003 approved
03/25/2022
Seeking all safety and efficacy preclinical information related to any Investigational New Drug (IND) filing for
molecule/drug FL1003 (aka methoxatone, 2-(5-methyl-2-furyl)-3-keto-L-gulonolactone 3,6 hemiketal) by Forest Labs.
Please see attached Request Letter for additional detail.
Any and all information or any documents or records concerning an investigation regarding the malfunction of an
Avance Anesthesia Machine used during the 4/1/2021 open heart surgery on my client
All documents, data, email, internal FDA communications, consumer complaints, analysis and/or other data related to
and/or discussing Seresto flea and tick collars involving harm to pets and/or humans. etc
I would like to request all serious adverse event reports submitted regarding drug products by Outpatient Surgery
Center of Hilton Head of 190 Pembroke Drive, Hilton Head Island, SC 29926.
I would like to request all serious adverse event reports regarding drug products submitted by Coastal Pediatric
Dentistry in South Carolina between these dates. Please include reports filed by practice's individual dentists, which
include TERRI HAWKINS HUBBARD, Ashley Schuller and AMY ZELKO.
All emails, letters, memos, documents, and other records since January 1, 2018, between officers
at the U.S. Food and Drug Administration’s Center for Veterinary Medicine discussing or
mentioning the investigation into canine dilated cardiomyopathy (DCM) and boutique, exotic
ingredient, or grain-free diets
Adverse events reported to the FDA adverse event reporting system (FAERS) associated with the drug TEZEPELUMAB
(also known as TEZEPELUMAB-EKKO; brand name: TEZSPIRE) over the dates detailed (Jan 1, 2022 to April 19, 2022)
Adverse events reported to the FDA adverse event reporting system (FAERS) associated with the drug faricimab (also
known as faricimab-svoa; brand name: Vabysmo) over the dates detailed (Jan 1, 2022 to April 19, 2022)
Copies of all FDA 2579 form submissions, that have section 3, subsection b marked as "C-Arm Fluoroscopic"
I would like to request all documentation related to Nuvasive 510(k) application K203714.
Hello, I would like to request the EIR and any 483 notices or warning letters for the 2017 agency inspection of: NCM
USA LLC FEI 3012484129 390 Concord Ave Bronx, NY 10454 (
PLEASE CONFIRM THE DATE OF CHANGE REGARDING US REGISTERD AGENT FOR REVIAN.
Drug Establishment annual registration from THE EARLIEST POSSIBLE DATE to present, that include the following fields:
Field Name FDA ESTABLISHMENT IDENTIFICATION (FEI) NUMBER DUNS_NUMBER (if available) FIRM_NAME
ADDRESS Date of First Registration with FDA(exact date if possible; fiscal/calendar year acceptable) Date of
DeRegistration, etc
With regard to a Medical Device Inspection, please provide the FDA-483 document for: Innovative Sterilization
Technologies, LLC. 7625 Paragon Rd, Ste A, Dayton, OH 45459
With Regard to a Human Drug Inspection, please provide the FDA-483 document for: Family dollar Distribution, Inc.,
1800 Family Dollar Pkwy, West Memphis, AR 72301
With regard to a Human Drug Inspection, please provide a FDA-483 document for: Sharp Packaging Services, LLC., 7451
Keebler Way, Allentown, PA 18106
With regard to a Medical Device Inspection, please provide a FDA-483 document for: Nelson Environmental
Technologies, Inc., 10518 Cash Rd., Stafford, TX 77477
With regard to a Human Drug Inspection, please provide the fda-483 document for: Greenfield Global USA, Inc., 58 Vale
Rd., Brookfield, CT 06804
With regard to a Medical Device Inspection, please provide the FDA-483 document for: Hightech American Industrial
Laboratories, Inc., 320 Massachusetts Ave. Lexington, MA 02420
With regards to a Human Drug Inspection, please provide the FDA-483 for: Aspire Pharmaceuticals, Inc., 37 & 41
Veronica Ave. Somerset, NJ 08873
Request for Module 2.7 and Module 5 for ANDA 205960, approved on March 9, 2021 held by Breckenridge.
For a Human Drug Inspection, please provide the FDA-483 document for: American Chinese Medicine Association, Inc.,
2432 Mckenzie Ct., Aurora, IL 60503
For a Medical Device Inspection, please provide the FDA-483 for: Datascope Corp., 45 Barbour Pond Dr., Wayne, NJ
07470
All Substantial Equivalence Marketing Orders and decision summaries issued for any and all tobacco products from June
2021 through April 2022.
• A copy of any and all available letters, correspondence, and/or electronic communications regarding a 90-day
notification submitted under Section 904(c) of the Tobacco Control Act by tobacco product manufacturers and between
the manufacturers and the U.S. Food and Drug Administration (“FDA”) or the Center for Tobacco Products (“CTP”) from
January 2022 to current. etc
All tobacco product establishment registrations and all tobacco product listings submitted to FDA in June 2021 and
December 2021.
All Marketing Granted Orders for any and all premarket tobacco product applications (“PMTAs”) and decision
summaries/executive summaries issued for all tobacco products in March 2022 and April 2022.
The Human Drug Inspection FDA-483 document for: Altaire Pharmaceuticals, Inc. 311 W Lane, Aquebogue, NY 11931
FIRST PARTY
1. K200004 (submission in June 2020)
2. K200004 (submission in December 2019)
1. All documents and communications, including research/scientific evidence, public comments, medical reports,
meeting minutes and correspondence from Todd Bourcier regarding Belviq and/or Belviq XR from January 2018 to
present; etc
All documents that support the CDC’s following claims: 1. “They [COVID-19 viral vector vaccines] do not affect or
interact with our DNA in any way” ; 2. “The genetic material delivered by the viral vector does not integrate into a
person’s DNA.” ; 3. “They [COVID-19 mRNA vaccines] do not affect or interact with our DNA in any way” ; etc
Each and every email communication between December 30, 2020 and the date of search sent or received by Paul
Richards that includes the words (“Maddie” or “Madeline”) and (“deGaray” or “de Garay”) in the body, subject line, or
any other part of the email.
Copies of all FOIA requests submitted to the Food and Drug Administration by Janssen on or after December 1, 2020,
and the final response made in response to each such FOIA request.
Copies of all FOIA requests submitted to the Food and Drug Administration by Moderna on or after December 1, 2020,
Any data referenced at endnote/reference number 5 of the Varivax product insert attached hereto as Exhibit A.
Copies of all FOIA requests submitted to the Food and Drug Administration by Johnson & Johnson on or after December
1, 2020, and the final response made in response to each such FOIA request.
All emails sent to or from Peter Marks, Paul Richards, Janet Woodcock and/or Tom Shimabukuro involving Gregory
Poland (including, but not limited to, emails sent to/from Gregory Poland, emails including the term “Gregory Poland”
or “Greg Poland,” etc.) dated February 1, 2021, through date of search.
All synthetic nicotine tobacco product establishment registrations and all synthetic nicotine tobacco product listings
submitted to FDA pursuant to the recently enacted federal legislation to provide FDA the specific authority to regulate
synthetic nicotine products—Consolidated Appropriations Act, 2022, Pub. L. No: 117-103, Div. P, Subtitle B, § 111(e)
(Mar. 15, 2022) etc
Requesting the FACTS Collection Reports, Sample Laboratory Worksheets, and FACTS Laboratory Classification for FDA
samples collected during the Inspection of Jule's Food (FEI 3018682555) from 4/21-5/24/2021.
During review of the 2021 3rd and 4th quarter FAERS files, three case reports were identified that were not sent to
Digestive Care, Inc. As the manufacturer of Pertzye (pancrelipase) drug product, we would like to request the following
case reports that list Pertzye as the primary suspect. Case ID 19865464, 19865532, and 20126676.
Please produce the following documents relating to the company Real Water, Inc., a manufacturer of alkaline water
called "Real Water": 1. Any Establishment Inspection Report (and any attachments/exhibits) for the Henderson, NV
facility. 2. Any Form 483s for the Mesa, AZ facility. 3. Any photographs or videos taken during FDA's inspections of the
Henderson, NV or Mesa, AZ facilities. etc
Please provide any and all records associated with the FAERS Case ID #s: 17224415 16714815 16590736 15802716
15252393 12527864 12341355 11880115 11234598 10973634 9580651
A copy of National Institute for Occupational Safety and Health (NIOSH) comments filed with FDA concerning the Notice
of Proposed Rulemaking regarding Over-the-Counter Hearing Aids, Docket No. FDA-2021-N-0555 filed between October
20, 2021 and January 18, 2022.
All records related to 510(k) application K193659, ITero Element 5D
RE: Pet Center, Inc., Inglewood, CA. FEI #3003054732 Please supply FDA Form 483s, complete Establishment Inspection
Reports, consumer complaint records for the specified request date range, results of lab sample analyses (if any), any
Warning Letters and/or Untitled Letters, and any other correspondence pursuant to inspection ID #1153979 (completed
10808/2021) and Inspection ID #1146608 (completed 07/13/2021)
RE: Sunshine Mills, Tupelo, MS. FEI #1018573 Please supply complete Establishment Inspection Reports and all
correspondence (including Warning Letters, Untitled Letters, and responses to those letters) pursuant to Inspection ID
#1151246 (completed 09/01/2021) and Inspection ID #1132062 (completed 10/27/2020)
All archived electronic Structured Product Labeling (SPL) files for FDA approved drugs and biologics dating back to 2005
We are seeking FDA final review documents associated with the NDA # 017106 (AtroPen). Specifically, we are
requesting: 1. Approval Package 2. Clinical Pharmacology and Biopharmaceutics Review(s) 3. Chemistry Review(s) 4.
Correspondence 5. Microbiology Review 6. Medical Review(s) 7. Pharmacology Review 8. Other Review(s) as well as any
other final NDA Reviews that are available.
Documents Request for ANDA 075894; Fluvoxamine Maleate Tablets 25 mg, 50 mg, and 100 mg 1. Copies of the most
current labels and package insert. 2. Copies of the most current batch manufacturing records. etc
FCN 2165, including chem/tox memos & correspondence.
RE: Hill's Pet Nutrition, Inc., Topeka, KS. FEI #1912875. Please supply complete Establishment Inspection Reports for
Inspection ID #1149618 (completed 07/16/2021) and Inspection ID #1085591 (completed 03/27/2019)
Copy of the disclosable portions of the MedWatch reports for the following 2 Molnupiravir cases: 20674076, and
20669710.
Request for copies of all records, documents (including entry documents), and Notices of FDA action associated with
import entry 799-4482439-8 that was refused by the Division of Southeast Imports (DSEI) of the Agency in January 2020.
Copy of the disclosable portions of the 510(k) for K182540, DiLumen Endolumenal Interventional Platform, by Lumendi.
ANDA 78-310
ANDA 78-310
Request to provide SBoA ( Medical Review, Chemistry Review, Pharmacology Review, Microbiology Review, Clinical
Pharmacology Biopharmaceutics Review, Administrative Documents & Correspondences) for ANDA# 212942 Timolol
Maleate Ophthalmic Gel Forming Solution, 0.25% and 0.5% of Alembic Pharmaceuticals Ltd.
ANDA 78-310 - Lamotrigine Tablets sequence 0004 with a date of submission of May 10, 2007.
Copy of the disclosable portions of the Food Additive Petition, the FDA chemistry and toxicology reviews, and
correspondence, for FAP 9B4647.
I'm seeking the full contents of any and all reports submitted to the CFSAN Adverse Event Reporting System (CAERS)
database regarding the cereal Lucky Charms (from General Mills) from January of 2021 up to the present.
All records related to 510(k) application K172007, Duerr Dental, CamX Triton HD Proxi Head.
Request for copies of all records, documents (including entry documents), and Notices of FDA action associated with
import entry 799-9121433-7 that was refused by the Division of Southeast Imports (DSEI) of the Agency in December
2020.
for Biologics inspection of Therapure Biopharma Inc ending 02/07/2020 at the location in Mississauga, Canada. The
Response (in electronic format) for Biologics inspection of Therapure Biopharma Inc ending 02/07/2020 at the location
in Mississauga, Canada. Please send documents as email attachments.
for Biologics inspection of Octapharma Plasma Inc ending 02/14/2022 at the location in Saint Clair Shores MI, United
for Biologics inspection of The Laboratory at the Center for Advanced Reproductive Svcs ending 02/15/2022 at the
location in Farmington CT, United States. Please send documents as email attachments.
for Biologics inspection of Tissue Transplant Technology, Ltd. d/b/a Bone Bank Allograft ending 02/18/2022 at the
location in San Antonio TX, United States. The 483 (in electronic format) for Biologics inspection of CSL Plasma Inc.
ending 02/15/2022 at the location in Dallas TX, United States. Please send documents as email attachments.
for Biologics inspection of Blood Assurance, Inc. Columbia Donor Center ending 02/14/2022 at the location in Columbia
All records related to 510(k) application K123402, DIAGNOcam 2170
I request all consumer complaints relating to the recent Class 1 recall of Philips/Respironics CPAP devices and ventilators
announced 6/14/2021. The Event ID's for this recall are 88071 and 88058.
Please provide the Establishment Inspection Report (EIR) associated with the FDA's inspection of Bioiberica SAU's (FEI #:
1000418405) Palafolls, Spain facility that concluded on 2/4/2022. Facility address: Carrer Antic Cami de Tordera 109-
119, Palafolls, Barcelona, 08389, Spain.
Copy of the disclosable portions of all releasable records related to interactions from January 2020 to the present
between Mead Johnson (and its parent company Reckitt Benckiser) and FDA, related to the Enfamil NeuroPro infant
formula.
between Perrigo (and its affiliate PBM Nutritionals) and FDA, related to infant formula products.
between ByHeart and FDA, related to the ByHeart infant formula
between Bobbie Baby and FDA, related to infant formula products.
Copy of the discloseable portions of all releasable records related to interactions from January 2020 to the present
between Nestle Infant Nutrition and FDA, related to Gerber Good Start infant formula products.
between Abbott Laboratories and FDA, related to Similac 360 Total Care infant formula products.
Complete file including FDA actions for premarket notification K103783
Ivermectin Case ID: 20232232

STRATEC SE FDA EIR, for audit in April 2019, conducted by FDA inspector Christopher B. May
I’m looking for any information about Flow Hydration and their product that they label as Flow Alkaline Spring Water.
Including, if possible, any information on inspections, testing and investigations. I’d also like to have any available
records on the recall of their organic lemon & ginger flavored water.
EMPLOYEE VACCINATION INFORMATION
I would like all peer-reviewed publications available to the public, that were presented as part of the application for 343
FDA approved AI applications (see attached file with submission numbers).
Memorandum of Observations, result of Foreign Remote Regulatory Assessment

Warning letter from James Wood, Deputy Director, Center for Devices and Radiological Health to James Plante CEO
Pathway Genomics Corp.
Complete investigative file including but not limited to all warning letters,corrective actions, fines, and findings
associated with inspections, compliance, enforcement and criminal investigations pertaining to JW Nutritional LLC
and/or Jesse D. Windrix or any other subsidiaries or companies owned or controlled by Jesse D. Windrix.
1. Beyond Meat, Inc. (f/k/a Savage River, Inc.) - All adverse event reports (including aggregate FAERS data) and
consumer complaints involving Beyond Meat products.
2. Beyond Meat, Inc. (f/k/a Savage River, Inc.) - All inspectional type records for Beyond Meat facilities located in
Columbia, MO and Devault, PA from January 2019 to present.
Rentschler Biopharma SE Erwin-Rentschler-Str. 21 Laupheim, Baden-Wurttemberg 88471 Germany FEI: 1000291122
EIR
FAERS REPORTS
Form 483, Issued to Macleods Pharmaceuticals Limited, Baddi, District Salon, India
2020-4266 CERTIFIED
Copy of the disclosable portions of a CSV listing of all 482s issued from 01/01/2020 - Present. The list should include the
date, site name, and FEI for each 482 issued. We would like the information from CDRH, CDER, and CBER.
Copy of the disclosable portions of the REMS review associated with the 03/08/2022 supplemental approval of Qsymia
(NDA 22580/S20).
source documents for information that was quoted on the CDC’s webpage titled: COVID-19 Vaccine Related Codes.
Summary Basis of Approval (SBOA) for: Active Ingredient: COLESTIPOL HYDROCHLORIDE Proprietary Name: COLESTIPOL
HYDROCHLORIDE Dosage Form; Route of Administration: TABLET/ORAL Strength: 1GM Application Number: 077510
Application Holder: IMPAX LABS (Date Range for Record Search: From 10/01/2005 To 10/01/2007)
I am requesting an FOI version of K212522, Fresenius APD Cycler, 510(k) cleared by FDA/CDRH on 15 April 2022.
On behalf of Lupin Pharmaceuticals. Inc. I request you to please provide me the Summary Basis of Approval (SBOA) for
the RLD [HALOG® solution (Halcinonide Topical solution USP, 0.1%)] (N017823) approved prior to 01/01/1982
QAP Request for Xttrium Laboratories, Inc.
Request for BE Review for ANDA 205960 approved on March 9, 2021 held by BRECKENRIDGE.
K172452, Bruxor mouthguard
Bioequivalence review for ANDA 212514, Amphotericin B, approved 12/14/2021. (2022-1009) Chemical review for
ANDA 212514, Amphotericin B, approved 12/14/2021.
Review documents listed below (as available) for the 1 Feb 2021 approval of NDA 204803 Posimir (bupivacaine)
extended-release solution: Product quality review Multi-disciplinary or summary review Pharmacology/toxicology
reivew Clinical pharmacology review Clinical review Risk assessment and risk mitigation review
Freedom of Information Act (FOIA): Requesting the Agency to provide list of last five years Form 483 (Notice of
Inspectional Observations) for Abryl Laboratories Private Limited with FDA establishment identifier # 3015793804.
1) Email correspondence from 1/1/2020 to 1/1/2022 among authors and FDA personnel relating to the concept and
design of the FDA-sponsored study, “Effect of Oral Ranitidine on Urinary Excretion of N-Nitrosodimethylamine (NDMA),”
published in the Journal of the American Medical Association in 2021. etc
Review Memorandum and Correspondence related to Vertigo Vapor
All email records for FDA CVM employee David Edwards containing the key search term: AAFCO 10.01.2021-03.31.2021.
03.31.2022. All email records for FDA CVM employee Steven Solomon containing the key search term: AAFCO
08.01.2021-03.31.2022.
RECS RE AWARD ID 75F40121F80083
records concerning issued marketing denial orders (MDOs) to Fontem
US, LLC for several myblu electronic nicotine delivery system (ENDS) products ETC
- All currently licensed food processing facilities located in the state of New Mexico with address location and
classifications as applicable. -All currently licensed warehouse facilities that handle food in the state of New Mexico
with address location and classifications as applicable.
Approval letter for : Proprietary Name: GADOTERATE MEGLUMINE Application Number: A215304 Approval Date: Apr
11, 2022 Applicant Holder Full Name: JIANGSU HENGRUI MEDICINE CO LTD
Summary basis of approval for Proprietary Name: GADOTERATE MEGLUMINE Application Number: A215304 Approval
Date: Apr 11, 2022 Applicant Holder Full Name: JIANGSU HENGRUI MEDICINE CO LTD
Regulatory Assessment of CSL Plasma Inc Located at Willoughby Hills OH United States FEI Number: 3016250026 held on
05/25/2021.
Regulatory Assessment of CSL Plasma, Inc. Located at Orlando FL United States FEI Number: 3011713385 held on
06/01/2021.
Regulatory Assessment of Becton Dickinson Caribe LTD Located at Juncos PR United States FEI Number: 2649711 held
on 06/02/2021.
Regulatory Assessment of CSL Plasma Located at Tulsa OK United States FEI Number: 1641185 held on 06/03/2021.
Copy of the FDA response only to the following file numbers: 2021-4908; 2021-4895; 2021-4743; 2021-473; 2021-4670.
Copy of the FDA response only to the following file numbers: 2021-3758; 2021-3757; 2021-3686; 2021-3592; 2021-
3518.
Copy of the 483 for the Feb 26, 2018 - Feb 28, 2018 (3 days) inspection of JT Cosmetics & Chemicals Pvt Ltd. [Kalol /
India] 53 Kalol Gidc Estate Panchmahal India. This inspection pertains to human drugs.
Copy of the 483 for the Dec 4, 2017 - Dec 7, 2017 (4 days) inspection of GAELTEC DEVICES LTD [Hamilton / United States
of America] 8251 Princeton Glendale Rd, Hamilton, OH 45011, USA. This inspection pertains to medical devices.
Copy of the 483 for the Sep 25, 2017 - Sep 27, 2017 (3 days) inspection of Les Produits Chimiques B.G.R., Inc. [Pointe-
Claire / Canada] 600 Avenue Delmar, Pointe-Claire, QC H9R 4A8, Canada. This inspection pertains to human drugs.
Copy of the 483 for the Sep 1, 2017 - Sep 11, 2017 (11 days) inspection of TAIWAN BIOTECH CO., LTD. [- / Taiwan] 22,
Chieh-Shou Rd., Taoyuan District Taoyuan City Taiwan. This inspection pertains to human drugs.
Report and/or the MDSAP Noncomformity Grading and Exchange Form (NC) for the inspection of Heart Imaging
Technologies, LLC., Durham, NC , end date 11-15-2018. FEI# 3005107869. This inspection pertains to medical devices.
Report and/or the MDSAP Noncomformity Grading and Exchange Form (NC) for the inspection of Avioq, Inc., Durham,
NC , end date 08-17-2017. FEI# 3008376326. This inspection pertains to medical devices.
Report and/or the MDSAP Noncomformity Grading and Exchange Form (NC) for the inspection of Bio Compression
Systems, Inc., Moonachie, NJ , end date 10-22-2015. FEI# 2424387. This inspection pertains to medical devices.
Report and/or the MDSAP Noncomformity Grading and Exchange Form (NC) for the inspection of Suntech Medical, Inc.,
Morrisville, NJ , end date 09-29-2017. FEI# 1036863. This inspection pertains to medical devices.
summaries and any associated supporting CTP memoranda for STN SE0015386.
FOIA Request for Documents Related to GRNs 162, 189, and 235
Copy of the disclosable portions of the OOPD Review dated 06/13/2013 for Procysbi (NDA 203389/S20; for 06-2310 in
the OOPD database).
(See attached letter) Any discipline reviews (including clinical and statistical reviews) created during FDA’s evaluation of
the original applications for Reglan: NDAs 017854, 017862, and 018821.
Specific to Lupin's ANDA #209713 for Levothyroxine Sodium, please provide: All Chemistry, Manufacturing and Controls
(CMC) Reviews/Supplements, including: 1. 3.2.P.8.1. Stability Summary and Conclusions 2. 3.2.P.8.3. Stability Data 3.
3.2.P.5.1. Specifications 4. 3.2.P.5.2. Analytical Procedures
Specific to Genus Lifesciences' NDA #021137 for Levolet (Levothyroxine Sodium), please provide: All Chemistry,
Manufacturing and Controls (CMC) Reviews/Supplements, including: 1. 3.2.P.8.1. Stability Summary and Conclusions 2.
3.2.P.8.3. Stability Data 3. 3.2.P.5.1. Specifications 4. 3.2.P.5.2. Analytical Procedures
Specific to Abbvie's NDA #021402 for Synthroid (Levothyroxine Sodium), please provide: All Chemistry, Manufacturing
and Controls (CMC) Reviews/Supplements, including: 1. 3.2.P.8.1. Stability Summary and Conclusions 2. 3.2.P.8.3.
Stability Data 3. 3.2.P.5.1. Specifications 4. 3.2.P.5.2. Analytical Procedures
Specific to Mylan's ANDA #076187 for Levothyroxine Sodium, please provide: All Chemistry, Manufacturing and
Controls (CMC) Reviews/Supplements, including: 1. 3.2.P.8.1. Stability Summary and Conclusions 2. 3.2.P.8.3. Stability
Data 3. 3.2.P.5.1. Specifications 4. 3.2.P.5.2. Analytical Procedures
Specific to Provell's NDA #021292 for Euthyrox (Levothyroxine Sodium), please provide: All Chemistry, Manufacturing
Specific to Lannett's NDA #021342 for Levo-T (Levothyroxine Sodium), please provide: All Chemistry, Manufacturing and
Specific to Pfizer's NDA #021301 for Levoxyl (Levothyroxine Sodium), please provide: All Chemistry, Manufacturing and
Specific to Amneal's NDA #021210 for Unithroid (Levothyroxine Sodium), please provide: All Chemistry, Manufacturing
Specific to Alvogen's NDA #021116 for Thyro-Tabs (Levothyroxine Sodium), please provide: All Chemistry,
Manufacturing and Controls (CMC) Reviews/Supplements, including: 1. 3.2.P.8.1. Stability Summary and Conclusions 2.
3.2.P.8.3. Stability Data 3. 3.2.P.5.1. Specifications 4. 3.2.P.5.2. Analytical Procedures
Specific to Accord's ANDA #212399 for Levothyroxine Sodium, please provide: All Chemistry, Manufacturing and
I’m looking for any information about Flow Hydration and their product that they label as Flow Alkaline Spring Water.
Including, if possible, any information on inspections, testing and investigations. I’d also like to have any available
records on the recall of their organic lemon & ginger flavored water.
I am requesting the 04/09/2020 whole supplemental application for Ingrezza.
According to Burger et al. 2004 - Mercury in canned tuna: white versus light and temporal variation. Environmental
research, 96(3), 239-249. and I quote " In 1969 the FDA developed an administrative guidance of 0.5 ppm for
commercial fish, and in the earlier 1970, millions of cans of fish exceeding this level were seized. In 1974 this was
converted to an Action level, but in 1979 the FDA raised the action level to 1.0 ppm" My request. 1) Please send me a
copy of the 1969 guidance and 2) a copy of the 1974 action level mentioned above.
K212265
Request for Approved Documents of Table-1
documents regarding Massachusetts Public Schools school lunch policies
CLOSED INVESTIGATIONS
LOGIC TECHNOLOGY DEVELOPMENT LLC PREMARKET TOBACCO PRODUCT MARKETING GRANTED ORDERS
RECS RE SHANDONG LUXI PHARMACEUTICAL CO LTD AND POLYMYXIN B. SULFATE

I'm looking to get all the public information available for the PMA submitted to the FDA for Cologuard. The company is
Exact Sciences Corporation, PMA # P130017.
for Human Drugs inspection of Jost Chemical Co Inc ending 01/21/2022 at the location in Saint Louis MO, United States.
The 483 (in electronic format) for Human Drugs inspection of Andre Kalil, M.D. ending 01/14/2022 at the location in
Omaha NE, United States. Please send documents as email attachments.
for Human Drugs inspection of CFP Acquisitions Inc. ending 01/18/2022 at the location in Tulsa OK, United States.
for Human Drugs inspection of RJ General Corporation ending 01/12/2022 at the location in Cincinnati OH, United
Copy of the disclosable portions of the following MedWatch case reports for molnupiravir: 20689036, and 20683663.
Regarding Human Drug Inspection, please provide the FDA-483 document for: Pharmasol Corporation, 1 Norfolk Ave.,
South Easton, MA 02375
Regarding Human Drug Inspection, please provide the FDA-483 document for: Bi-Coastal Pharma International, 1161
Broad St., Ste 2116, Shrewsbury, NJ 07702
for Human Drugs inspection of Kashiv BioSciences, LLC ending 01/14/2022 at the location in Chicago IL, United States.
The 483 (in electronic format) for Human Drugs inspection of American Chinese Medicine Association, Inc ending
01/20/2022 at the location in Aurora IL, United States. Please send documents as email attachments.
Regarding Medical Device Inspections, please provide the FDA-483 document(s) for: InfuTronix LLC and/or Zynno
Medical LLC at the same address: 177 Pine Street, Natick, MA 01760
Regarding a Human Drug Inspection, please provide the FDA-483 document for: Colorlab Cosmetics, Inc., 110 Pioneer
Dr., Williston, VT 05495
Regarding a Medical Device Inspection, please provide the FDA-483 document for: Empowered Diagnostics LLC, 3341
W Mcnab Rd., Pompano Beach, FL 33069
Regarding a Human Drug Inspection, please provide the FDA-483 document for: Guardian Drug Co., Inc., 2 Charles Ct.
Dayton, NJ 08810
Regarding a Medical Device Inspection, please provide the FDA-483 document for: WHPM. Inc., 5358 Irwindale Ave/
Ste B. Irwindale, CA 91706
Regarding a Human Drug Inspection, please provide the FDA-483 document for: Amneal Pharmaceuticals, LLC 1 New
England Ave., Ppiscataway, NJ 08854
Regarding a Human Drug Inspection, please provide the FA-483 document for: Xellia Pharmaceuticals USA LLC, 200
Northfield Rd. Bedford, OH 44146
Regarding a Medical Device Inspection, please provide the FDA-483 document for: Paraffin USA LLC, 11049 N 23rd Dr.,
Ste 104, Phoenix, AZ 85029
Copy of P010003 for BioGlue, manufactured by CryoLife Inc.
1. All risk-benefit analyses stratified by age that were done for Covid vaccines by the CDC and/or FDA using VAERS
death data after the vaccines were rolled out. 2. All autopsy results that showed that the proper tests were done that
ruled out the Covid vaccine being a proximate cause of death for the 21 people in the treatment arm of the Pfizer Phase
3 clinical trial who died in the pre-unblinding phase.
All communications regarding the VAERS report attached hereto for the period of November 1, 2021 through the date
of search.
All documents concerning VAERS ID 1887456.
• Full reports of all accrediting body investigations at mammography facilities as submitted to the FDA from Jan. 1,
2021-today • All documents informing facilities of Level 1 or Level 2 deficiencies as identified by those investigations •
Any/all documents summarizing the inspections performed at mammography facilities each month from Jan. 1, 2018-
today
Correspondence relating to the decision to postpone Moderna EUA for vaccines for children under 5 until June and the
reasons why; Correspondence relating to Pfizer asking for delay on Moderna EUA under 5 approval; Correspondence on
Moderna EUA for children under 5 being delayed due to Pfizer delay etc
RECS RE EPA POLICY
We would like to make an FOI request with regard to the CDRH Device Allegation report for Fenom Pro (spelt Phenom
Pro) of Caire Diagnostics.
Vero Biotech CRL for submission of Genosyl DS GEN III As CMO the Gerresheimer company name is listed in the CRL we
are requesting a copy.
FDA Form 3542 submitted with respect to Pirfenidone (Esbriet) Tablets 267 MG on or about 02/10/2017 with respect to
the below listed patents
RECS RE Exactech Optetrak, Optetrak Logic, and Truliant

Knee Replacement Systems
Certified copies of: (a) Final Summary Minutes of the Joint Gastrointestinal Drugs Advisory Committee and Pediatric
Advisory Committee Meeting, May 3, 2018 for the NDA 209904 for stannosporfin injection submitted by InfaCare
Pharmaceutical Corporation; ETC
Labeling (Prescribing Information and Medication Guide) for the reference listed drug (RLD), Roxicet (Oxycodone
Hydrochloride and Acetaminophen) Oral Solution, 5 mg/325 mg per 5 mL, ANDA 089351/S-033 approved on March 4,
2021.
We would like to request the un-redacted Summary Basis of Approval for Secuado NDA 212268. Please let us know if
any additional information is needed.
K171272 - requesting all information regarding K171272 for the Cook-Swartz Doppler Flow Probe. Including in this
request, all Additional Information requests, response documents, and substantive summaries available.
RECS RE ENDS
LEGAL DUTIES AND RESPONSIBILITIES FOR FDA COMMISSIONER
COVID VACCINE EXPIRATION DATES
from March 16, 2018-March 31, 2022. a. Please include the type of animal, the reaction, the brand name and the
product name of the food item to which the dog or cat reacted, the symptoms displayed and the outcome, if available.
etc
I'm requesting all calendar records for FDA-CVM employee steven solomon 01.01.22-03.31.22
Cadila Healthcare Limited Jarod India End Dates of inspection: 10 March 2022 Project Area: Drug Quality Assurance FEI:
483: BPI Labs. Evanston, Wyoming
United States End Dates of inspection: 10 March 2022 Project Area:
483: AeroBiotix LLC Miamisburg, Ohio
483: Allstar Marketing Group Llc Hawthorne,
New York United States End Dates of inspection: 21 March 2022
Project Area: Postmarket Assurance: Devices FEI: 3003799587 Classification: VAI I confirm that Clarivate Analytics will
be charged accordingly by FOI for this request, however please contact me if the charges exceed $ 200.
483: Alon Medical Technology Metairie,
Louisiana United States End Dates of inspection: 08 March 2022
Project Area: Human Cellular, Tissue, and Gene Therapies FEI: 3014679622 Classification: VAI I confirm that Clarivate
Analytics will be charged accordingly by FOI for this request, however please contact me if the charges exceed $ 200.
483: Amplify Surgical, Inc. Irvine, California
483: APDM Wearable Technologies, Inc. Portland,
Oregon United States End Dates of inspection: 10 March 2022
I request all 483 Forms for the Airgas National Carbonation facility in Phoenix, Arizona in the time range provided. I
believe that this facility is inspected annually. The facility stores and delivers food-grade carbon dioxide (CO2). As the
purpose of this information is for a work of journalism I request that all fees be waived.
I would like to request the complete 510(k) and any related decision records for K190887, Leksell Vantage Stereotactic
System, manufactured by Elekta Instrument AB. Thank you.
I would like to request the complete 510(k) and any related decision records for K080355, Leksell Stereotactic System,
manufactured by Elekta Instrument AB. Thank you.
I would like to request the complete 510(k) and any related decision records for K972324, Leksell Stereotactic System,
manufactured by Elekta Instrument AB. Thank you.
All submitted applications and communications to and from FDA regarding the breakthrough device designation
awarded to Bridge to Life Ltd. for their LifeCradle Heart Preservation Transport System.
P060040 and including all supplements which have been filed. P100047 and including all supplements which have been
filed.
All documents relating to any assertion, made by individuals or entities outside the FDA, that DRYFT-branded tobacco
products or Velo-branded tobacco products were not on the United States market on August 8, 2016, or that DRYFT-
branded tobacco products or Velo-branded tobacco products were modified in any way since August 8, 2016. etc
Copy of the disclosable portions of the case reports for the following 3 VAERS cases: 2154986 (Eevebo); 2196502
(Ervebo); and 2198139 (Vaxneuvance).
Zoll Medical Corporation and Bio-Detek, Inc. inspection recs

NDA# N050740
BA Study/Comparative BA study reports
483: Center For Ocular Prosthetics, LLC
Portland, Oregon United States End
Dates of inspection: 7 March 2022 Project Area: Compliance: Devices FEI: 1000524564 Classification: VAI I confirm that
$ 200.
K212522, Lilliput APD Cycler by Fresenius
Requesting inspection report for a FDA Inspection conducted on April 8, 2022 at PMC Biogenix, Inc., 1231 Pope St.,
Memphis, TN 08108 by Investigator Anetra Wyatt.
ANDA# A212514
Please provide any and all of the following documents relating to any CAERS adverse event and product complaint
reports related to Sincerely Nuts, including: any case reports, complaint forms, notes, interview documentation,
investigation documents, correspondence between the FDA and Sincerely Nuts, documentation submitted to the FDA by
Sincerely Nuts, and any warnings as a result of reporting.
Please provide any and all of the following documents relating to any CAERS adverse event and product complaint
reports related to JJ Nuts, including: any case reports, complaint forms, notes, interview documentation, investigation
documents, correspondence between the FDA and Sincerely Nuts, documentation submitted to the FDA by JJ Nuts, and
any warnings as a result of reporting.
I request that a copy of the De Novo application records for Parathyroid Detection (Model PTeye) System with the
SUBMISSION NUMBER: DEN170056 by AiBiomed, Corp.
483: Dane Technologies
Maple Grove, Minnesota United States End Dates of
inspection: 18 March 2022 Project Area: Compliance: Devices FEI: 3003857817 Classification: VAI I confirm that
$ 200.
483: Dhaliwal Pharmaceuticals Laboratories, LLC
Mesquite, Texas United States
End Dates of inspection: 01 March 2022 Project Area: Compliance: Devices FEI: 3015306170 Classification: VAI I
confirm that Clarivate Analytics will be charged accordingly by FOI for this request, however please contact me if the
charges exceed $ 200.
483: Exogenesis Corporation
Billerica, Massachusetts United States End Dates of
inspection: 12 April 2022 Project Area: Compliance: Devices FEI: 3009492128 Classification: VAI I confirm that Clarivate
Analytics will be charged accordingly by FOI for this request, however please contact me if the charges exceed $ 200
483: Greenwich Fertility & Ivf Center, P.c.
Greenwich, Connecticut United States
End Dates of inspection: 11 March 2022 Project Area: Blood and Blood Products FEI: 3007656673 Classification: VAI I
RECS RE SOY, POISONING PLANT DATABASE, STUDIES ETC
483: Innovative Medical Equipment
Beachwood, Ohio United States
End Dates of inspection: 10 March 2022 Project Area: Compliance: Devices FEI: 3007353136 Classification: VAI I
483: Ivenix, Inc. North Andover,
Massachusetts United States End Dates of inspection: 18 March
charged accordingly by FOI for this request, however please contact me if the charges exceed $ 200
483: KORR Medical Technologies, Inc. Salt Lake
City, Utah United States End Dates of inspection: 17 March
483: Logic PD, LLC. Eden Prairie, Minnesota
which shipments by Entry Number our brokerage firm (Filer 94D) transmitted “UNK” in place of the FSVP Importer’s D-
U-N-S number
EDF is requesting the following information for: 1. Any correspondence between FDA and the companies for the 11
GRAS notifications (GRNs) listed in Table 1; 2. The GRAS notice and any correspondence between FDA and the
companies for the 60 GRNs listed in Table 2; and 3. The GRAS notice and any correspondence between FDA and the
companies for any other GRNs received by FDA by April 27, 2022 but not yet posted on the website.
Please accept this letter as our FOIA request for the following: • Any and all information concerning all Cronobacter
investigations for the last 3 years, including all plant inspection results for all Abbott facilities for the last 3 years. etc
I request copies of all documents in the possession of FDA, from January 1, 2022 to March 31, 2022 regarding products
sold under the brand name "Jamieson" including any a)From FDA 3500 Voluntary Reporting, b) Form FDA 3500B
Voluntary Reporting for Consumer and c) Form FDA 3500A Mandatory Reporting.
All submitted applications and resultant communications to and from FDA for the date range regarding the
breakthrough device designation awarded to Diatiro Health for their Kidney Preservation Device.
Copy of the disclosable portions of the EIR for the 12/07/2021 - 12/15/2021 of Aphena Pharma Solutions - Maryland,
located in Easton, MD. Please note this inspection pertains to human drugs.
Copy of the disclosable portions of all disciplinary and scientific review documents as well as full Technical Project Lead
memos for the recent MGOs issued by CTP for NJOY (PM0000613, PM0000614, PM0000615, and PM0000622. We
would also like to request all reviews for the MDOs issued to NJOY for their blueberry and watermelon flavored
cartridges.
Please provide copies of the disclosable portions of the Center for Tobacco Products (CTP), Office of Science (OS), Office
of Compliance & Enforcement (OCE), and Office of Health Communication and Education (OHCE), reviewers’ summaries,
technical project lead memo (TPL), and any associated supporting CTP memoranda for the following STNs which
received a market order on April 26, 2022: PM0000613.PD1, PM0000614.PD1, PM0000615.PD1, and PM0000622.PD1
Any records from the OCI agent regarding the investigation into the sale of potato starch by Good Fortune Supermarket
located at 137 S San Gabriel Blvd., San Gabriel, CA 91776
483: Heany Industries Incorporated Scottsville,
New York United States End Dates of inspection: 23 March 2022
483: Lucid Diagnostics, Inc. Foxboro,
Massachusetts United States End Dates of inspection: 21 March
483: BioLife Plasma Services LP Aurora,
Colorado United States End Dates of inspection: 25 March 2022
Project Area: Blood and Blood Products FEI: 3017670443 Classification: VAI I confirm that Clarivate Analytics will be
483: Diamond Wipes International Inc.
Bucyrus, Ohio United States End Dates of inspection: 03 March
483: Galbraith Laboratories Inc. Knoxville,
Tennessee United States End Dates of inspection: 02 March
483: Product Design and Development Corp.
Ellisville, Missouri United States End Dates of inspection: 17
March 2022 Project Area: Postmarket Assurance: Devices FEI: 3008146975 Classification: VAI I confirm that Clarivate
483: R. N. Eaton & Company, Inc. Riverside,
Missouri United States End Dates of inspection: 02 March 2022
Project Area: Drug Quality Assurance FEI: 3017124544 Classification: VAI I confirm that Clarivate Analytics will be
483: Samjan Group, Inc. East Brunswick,
New Jersey United States End Dates of inspection: 03 March
483: National Genetics Institute. Los
Angeles, California United States End Dates of inspection: 02
March 2022 Project Area: Blood and Blood Products FEI: 3003082450 Classification: VAI I confirm that Clarivate
483: PAVmed Inc. Foxboro, Massachusetts
United States End Dates of inspection: 15 April 2022 Project
483: MD Logistics, LLC Plainfield, Indiana
United States End Dates of inspection: 04 March 2022 Project
Area: Drug Quality Assurance FEI: 3004026589 Classification: VAI I confirm that Clarivate Analytics will be charged
483: General Air Service & Supply Co., Inc.
Commerce City, Colorado United States End Dates of
inspection: 25 March 2022 Project Area: Drug Quality Assurance FEI: 1717152 Classification: VAI I confirm that
$ 200.
GRAS Notice files, GRN 546, 547, 571, and 650. These PDF files are now unavailable on the website while others are
available. I believe these files are freely accessed by all users. Due to certain technical issue, they are now missing.
K935189
for Human Drugs inspection of QPS, LLC ending 06/25/2010 at the location in Newark DE, United States. etc
for Medical Devices & Rad Health inspection of Bradshaw Medical, Inc. ending 08/15/2017 at the location in Kenosha
510(K) FOR K951721 APPLIED MEDICAL
RE: Mars PetCare US, Everson, PA. Please provide FDA Forms 483, Establishment Inspection Reports, results of
environmental and finished product lab analyses, consumer complaints, adverse event reports, and all correspondence
pursuant to investigations of Salmonella Schwarzengrund outbreak investigation.
Copy of the disclosable portions for all EIRs from 01/01/2018 - Present for the following 2 locations for Nestle:
Anderson, IN and Waverly, IA. Please note the realm of these inspections is Foods.
All communication to, from/by or between FDA (including the Interagency Working Group on Asbestos in Consumer
Products - "IWGACP") and ASTM International ("ASTM") regarding the development of analytical methods and
standards for detecting asbestos in talc.
2022-1498, 2022-1503, 2022-1527, 2022-1541, 2022-1628.
Copies of all FOIA requests relating to COVID-19 vaccines (including any requests related to VAERS reports or data),
submitted to the Food and Drug Administration (FDA) by Moderna, on or after December 1, 2020, including each
request’s corresponding production and final response letter produced by the FDA.
Copies of all FOIA requests relating to COVID-19 vaccines (including any requests related to VAERS reports or data),
submitted to the Food and Drug Administration (FDA) by Pfizer, on or after February 11, 2021, including each request’s
corresponding production and final response letter produced by the FDA.
All government contracts or binding agreements with McKinsey & Company Inc., in the possession of the Office of
Acquisition & Grants Services, that relate to COVID-19, and were created, modified, or obtained between January 1,
2020 and the date of the search.
I'm looking for any inspection related documents (483s, EIRs, etc.) for Axsome Therapeutics' drugs AXS-05 (bupropion +
dextromethorphan) and AXS-07 (meloxicam + rizatriptan). These may also go by AXS05 or AXS07. There is one
inspection listed under Axsome Therapeutics that occurred around 7/1/2021 (FEI: 301881531, Inspection ID: 1146168),
and I would like the EIR and any 483s for this inspection, as well as those same documents for the inspections for their
contract manufacturer for the same drugs. I don't have the FEI or facility name/address for this facility, but it is the same
facility for AXS-05 and AXS-07.
Summary Basis of Approval for Nexplanon NDA 021529 Supplement 7. Approval 5/13/2011. Efficacy - Manufacturing
Change with Clinical Data.
We are seeking the following FDA Application Review Files that are part of the Drug Approval Package for the Oxbryta
(voxeletor) Supplement-6 submission (supplement category: Efficacy - New Indication) that was approved on 17
December 2021: 1. Integrated Review Document (this may also be called the Multi-Disciplinary review document). 2.
Administrative and Correspondence Document 3. Other Reviews Document
All records provided for FOIA request 2019-5503 "I'm requesting all records showing financial transactions between FDA
to Florida pertaining to AFRPS, Animal Feed Regulatory Program Standards Cooperative Agreement Program"
All records provided for FOIA request 2019-5503 "I'm requesting all records showing financial transactions between FDA
to Florida pertaining to AFRPS, Animal Feed Regulatory Program Standards Cooperative Agreement Program"
I herein request the FDA Form 483 issued at the conclusion of the site inspection of the Serum Institute of India facility
in India performed by US FDA in April 2022 for product type = vaccines (human drugs).
PLEASE SEE ATTACHMENT FOR DETAILS CONCERNING SYEDA, SYEDA (DROSPIRENONE and ETHINYL ESTRADIOL) FAERS
REPORTS REQUEST.
I'm requesting all text messages sent and received by Sean Duke
/DHHS/FDA/ORA/OGROP/ORA/OHAFO/OHAFOE/DHAFOEII/HAFIB
Hi there, Please provide all copies of autopsy reports obtained by FDA concerning any VAERS-reported deaths following
COVID-19 vaccination.
FUJIFILM Diosynth Biotechnologies UK Limited Billingham United Kingdom End Dates of inspection: 25 March 2021
Project Area: Drug Quality Assurance
Gfm Gesellschaft fur Micronisierung mbh Bremen Germany End Dates of inspection: 22 June 2021 Project Area: Drug
Quality Assurance
FDA Form 483 for an inspection of Macleods Pharmaceuticals Limited in Baddi, District Salon, India
requesting all
documents related to the No Objection Letter (NOL) provided to EcoBlue Limited (EcoBlue), NOL
#256, on October 26, 2021
Copies of the results of testing related to the recalled lots of Sandoz orphenadrine citrate for the presence of
nitrosamines to include the levels and/or concentrations of NMOA, N-nitrosodimethylamine (“NDMA”), N-
Nitrosodiethylamine (“NDEA”) and any other nitrosamine impurities.
K202830
POLIOVAX vaccine that was once used in the USA: dates used, reasons discontinued
I am seeking to obtain a complete listing of the name, city, state, type (inpatient, outpatient) of pharmacies currently
registered with the clozapine REMS program.
Full EIR and FDA 483 for: LyoContract GmbH Ilsenburg (Harz) Germany FEI # 3014034890
Please consider this a request for a copy of the 4/14/2022 effective approval letter for ANDA No. 215323 for Dofetilide
(generic drug). etc
All Orphan Drug Designation requests, and related correspondence to and from FDA, regarding use of AbbVie's Humira
(adalimimab) in treatment of hydradenitis superativa Hurley stages 2 and 3, in adult and pediatric patients.
Package insert of NORMODYNE (LABETALOL HYDROCHLORIDE), 5 MG/ML (N018686) held by SCHERING CORP SUB
SCHERING PLOUGH CORP.
Public records pertaining to the 2019 Cyclospora Outbreak caused by basil. 2. Public records pertaining to any food-
borne pathogen testing related to the 2019 Cyclospora Outbreak caused by basil. 3. Any documents related to FDA
inspection and/or testing of any facilities, growing fields, or transportation vehicles related to the investigation of the
2019 Cyclospora Outbreak caused by basil.
A copy of all disclosable records provided in response to FOIA request 2020-1795 seeking memorandum and
correspondence related to FDA orphan drug designation and orphan drug exclusivity decisions for Nayzilam
(midazolam) and Valtoco (diazepam nasal spray). The FOIA request 2020-1795 was submitted by Arent Fox LLP.
We are seeking documents regarding brolucizumab (Beovu), Biologics License Application (BLA) 761125.
All disclosable records provided in response to FOIA request #2020-62 seeking orphan drug information for Signifor LAR.
The FOIA request 2020-62 was submitted by FOI Services, Inc., and FDA responded to that request in or about
September 2020.
Please provide Summary Basis of Approval of CALCITONIN-SALMON INJECTION 200 IU/ML for the Applicants: 1.
CUSTOPHARM INC-A212416 2. PAR STERILE PRODUCTS LLC-A209358
Requesting Warrant of Authority for Contracting Officer Steven D. Gagnon. Thank you
Please provide sun pharma halol form 483 by usfda
Form 483 Inspectional Observations Report of Sharp Packaging Services, LLC (7451 Keebler Way, Allentown,
Pennsylvania 18106). Last day of inspection was January 28, 2022. FEI# 3004161147
Copy of the disclosable portions of the MedWatch forms for the following 3 case numbers for ertugliflozin: 16067751,
16404544, and 16799751.
Please provide us the summary basis of approval (SBOA) for the NDA 215252: DILTIAZEM HYDROCHLORIDE IN
DEXTROSE 5% (NDA Holder : EXELA PHARMA) Thank you. Sincerely, Nirav Patel, Ph.D.
Regulatory Assessment of BioLife Plasma Services LP Located at Coralville IA United States FEI Number: 1937444 held on
06/09/2021.
K160578
K113560
K072474
K173196
K172179
K122434
1. All Documents produced, or that will be produced, by the FDA in In re Nat’l Prescription Opiate Litig., Case No. 17-
md-2804-DAP (N.D. Ohio). 2. Any transcripts of testimony and any video-taped or audio-taped testimony, by any of
Your current or former employees, officers or directors, or agents, including any exhibits referred to in that testimony,
taken in In re: Nat’l Prescription Opiate Lit., Case No. 17-md-2804-DAP (N.D. Ohio).
STUDY, REPORT, FILES RE USE OF POLYETHYLENE GLYCOL 1500 IN FOODS, DRUGS, COSTMETICS, APPROVED PRODUCTS,
HARMFUL PROPERTIES, ETC.
Please send form 483 of Aurobindo Pharma Unit 7
Iron Dextran, INFeD, safety reports, advisory letters, warning letters, safety letters, safety committee communications,
voluntary recall, black box warning, physician letters, pharmacy letters, marketing changes, FDA recall
Approval Date(s) and History, Letters, Labels, Reviews for BLA 101995 for SANTYL (COLLAGENASE, 250U/GRAM,
OINTMENT;TOPICAL), by Smith & Nephew.
RLD Epiduo Forte (adapalene and benzoyl peroxide) topical gel received labeling supplement approval NDA 207917/S-
004 and S-008. Please provide copies of the Carton and Container labels that were updated as part of the supplement.
The FDA website includes only the Prescribing Information and Patient Information. RLD Approval Letter is attached
(approved 04/27/2022).
1. ANDA 211434 (filed January 10, 2020) for beclomethasone 2. ANDA 209917 (filed December 23, 2016) for
fluticasone 3. ANDA 211287 (filed May 11, 2018) for tiotropium 4. ANDA 204032 (filed February 27, 2012) for
levalbuterol
Documents related to marketing granted orders issued to NJOY, LLC for its NJOY ACE closed ENDS device and
accompanying tobacco-flavored e-liquid pods, including its NJOY ACE POD Classic Tobacco 2.4%, NJOY ACE POD Classic
Tobacco 5%, and NJOY ACE POD Rich Tobacco 5%, including Center for Tobacco Products, Office of Science disciplinary
reviews and decision memos in connection with the marketing granted orders for these NJOY ACE products
(PM0000613-615 and PM0000622).
Regulatory Assessment of CSL Plasma Located at Wilmington NC United States FEI Number: 3014545156 held on
06/07/2021.
Report and/or the MDSAP Noncomformity Grading and Exchange Form (NC) for the inspection of Lake Region Medical,
Ltd., New Ross, Ireland, end date 04-20-2018. FEI# 3002807439. This inspection pertains to medical devices.
Report and/or the MDSAP Noncomformity Grading and Exchange Form (NC) for the inspection of Alma Lasers Ltd.,
Caesarea, Israel, end date 05-29-2019. FEI# 3004167969. This inspection pertains to medical devices.
Regulatory Assessment of CSL Plasma Located at Macon GA United States FEI Number: 3014545041 held on
06/07/2021.
Regulatory Assessment of CSL Plasma, Inc. Located at Greece NY United States FEI Number: 3014345742 held on
06/07/2021.
Copy of the 483 for the Jul 17, 2017 - Jul 31, 2017 (15 days) inspection of Custom Assemblies Inc [Princeton / United
States of America] 330 E Main St, Princeton, NC 27569, USA. This inspection pertains to medical devices.
Copy of the 483 for the Aug 7, 2017 - Aug 11, 2017 (5 days) inspection of Ming Fai Industrial (Shenzhen) Co LTD
[Shenzhen / China] Ming Fai Industrial Estate, Bainikeng, Pinghu, Longgang Shenzhen City China. This inspection pertains
to human drugs.
Copy of the 483 for the Aug 15, 2017 - Aug 18, 2017 (4 days) inspection of Foshan Jinxiong Technology Co., Ltd.
[Foshan / China] Shang'an, Sanshui District, Foshan, Guangdong Province, China. This inspection pertains to human
drugs.
Copy of the 483 for the Aug 28, 2017 - Aug 31, 2017 (4 days) inspection of Dexcowin Co. Ltd. [- / Korea (Republic of)] #
606 Woolim Lions Valley II Gansan-dong, Geumcheon-gu Korea (the Republic of). This inspection pertains to medical
devices
Report and/or the MDSAP Noncomformity Grading and Exchange Form (NC) for the inspection of Align Technology, Ltd.,
Or Yehuda, Israel, end date 07-09-2018. FEI# 3009646999. This inspection pertains to medical devices.
Report and/or the MDSAP Noncomformity Grading and Exchange Form (NC) for the inspection of ADIN DENTAL
IMPLANTS SYSTEM LTD, Alon Tavor, Israel, end date 08-09-2018. FEI# 3007518363. This inspection pertains to medical
devices.
Importer of Record (IOR), or Consignee; for entry-lines with submission or arrival dates between April 1 and April 30,
2022: I. DUNS Number / Unique Facility Identifier (UFI) of: 080801169 II. Federal Tax ID Number (EIN) of: 822349285
III. FDA Establishment Identifier (FEI) of: etc
2022-1642, 2022-1762, 2022-1767, 2022-1776, 2022-1872.
for Human Drugs inspection of Sastry, Bhagavatula K. S., MD, Clinical Investigator ending 03/21/2013 at the location in
Hyderabad, India. The EIR (in electronic format) for Human Drugs inspection of Jinming Liu ending 05/08/2015 at the
location in Shanghai City, China. The Response (in electronic format) for Human Drugs inspection of Jinming Liu ending
05/08/2015 at the location in Shanghai City, China. Please send documents as email attachments.
for Biologics inspection of Merck Teknika LLC ending 02/23/2022 at the location in Durham NC, United States. Please
for Human Drugs inspection of RLC Labs ending 11/04/2021 at the location in Phoenix AZ, United States. Please send
for Human Drugs inspection of Almac Pharma Services LLC ending 02/03/2022 at the location in Audubon PA, United
States. The EIR (in electronic format) for Human Drugs inspection of Almac Pharma Services LLC ending 02/03/2022 at
the location in Audubon PA, United States. Please send documents as email attachments.
The 483 (in electronic format) for Human Drugs inspection of Woodstock Sterile Solutions Inc ending 03/03/2022 at
the location in Woodstock IL, United States. The EIR (in electronic format) for Human Drugs inspection of Woodstock
Sterile Solutions Inc ending 03/03/2022 at the location in Woodstock IL, United States. etc
The 483 (in electronic format) for Human Drugs inspection of Darmerica, LLC ending 03/11/2022 at the location in
Casselberry FL, United States. The Response (in electronic format) for Human Drugs inspection of Darmerica, LLC ending
03/11/2022 at the location in Casselberry FL, United States. Please send documents as email attachments.
2022-1629, 2022-1633, 2022-1634, 2022-1639, 2022-1640.
the most recent FDA 483 of Naturich Labs. audit dates 03/03/2020 -03/06/2020
FDA Inspection reports for Advanced Accelerator Applications USA inspections for 2020-2022 (FEI 3012484129)
ABBOTT WHISTLEBLOWER REPORT
Electronic listing (preferably csv format) of all RRAs conducted since 2/1/22.
Copy of the disclosable portions of the MedWatch case report for case ID 20724533, Molnupiravir.
We request a spreadsheet identifying the firms that received FDA Warning Letters between October 1, 2011, and May
1, 2022
FDA publishes weekly Enforcement Reports on its website

(http://www.fda.gov/Safety/Recalls/EnforcementReports/default.htm) identifying all recalls monitored by FDA once
they are classified according to the level of hazard involved.
Pursuant to the Freedom of Information Act (FOIA), 5 U.S.C. § 552, as amended, and the regulations promulgated by the
U.S. Food and Drug Administration (“FDA”) in 21 C.F.R. Part 20, I hereby request a report of all FOIA requests filed with
FDA’s Center for Food Safety and Applied Nutrition (“CFSAN”), including related offices, from April 1, 2022 through April
30, 2022.
(1) Any and all records prepared for, during or distributed at the meeting held on or about March 31, 2022 by or for
the FDA, regarding Section 804 proposals and re-importation of prescription drugs.
I would like to request emails or phone calls from Jennifer Rinehimer and Dana Maxwell regarding my store location
Southern Magnolia Farmhouse Boutique.
Amgen’s Lumakras (sotorasib) approval package. - Preliminary Meeting Comments - Type B Pre-NDA Meeting
(conducted around 9/1/2020-12/31/2020) - Appendix 2_Sotorasib RTOR Pre-submission Plan for submission timelines
(submitted around 9/1/2020-12/31/2020) - NDA Filing Communication Sent at Day 60 (sent around 1/1/2021-
3/1/2021) - ETC
Adagrasib (MRTX849) breakthrough designation. - The completed CDER Breakthrough Therapy Designation
Determination Review Template (BTDDRT) and BTD determination review presentation (likely published 3/1/21-
6/24/21) - Grant – Breakthrough Therapy Designation (likely published 6/1/21-7/1/21) - Filing Communication
(likely published 1/1/22-3/1/22)
`FAERS# 17756425
Hi, I am an investment professional for an asset management firm and would like to request the documents produced
for Control# 2022-2847 regarding the FAERS events for Vabysmo (faricimab) from Jan 1, 2022 to April 19, 2022). If you
can send to me via email or cloud storage, that would be preferred, though CD works as well if the first two options are
unavailable. Thank you!
2022-2388, 2022-2891, 2022-2994

I am seeking any and all post-approval study results from application number P140003 / PAS001
LIST OF FOOD ENTITIES, LAKE COUNTY, FLORIDA
Request for all documents released for FOI 2019-285. The agency released approximately 6,254 pages as part of this
request and subsequently unredacted some portions after discussions with the initial requestor. I am requesting the
least redacted, final version of the documents.
1. Suspect drug: Taxotere 2. Source of case numbers: FAERS Public Dashboard 3. Case numbers (n = 5 total): 6674533
6671692 6966105 7294863 7590703
See attached letter. • Any internal communications to or from Dr. Janet Woodcock and/or any other FDA employees
involved with drafting the aforementioned letter, relating to Study VP-VLY-686-4403 or IND 131545 and concerning the
difficulties of predicting long-term toxicities concerning the difficulties of predicting long-term toxicities and/or their
potential effects on human subjects. ETC
I am requesting any and all correspondence involving any and all FDA staff and any and all employees or representative
of the company Abiomed on the topic of a research study published in the Journal of the American Medical Association
titled "Association of Use of an Intravascular Microaxial Left Ventricular Assist Device vs Intra-aortic Balloon Pump With
In-Hospital Mortality and Major Bleeding Among Patients With Acute Myocardial Infarction Complicated by Cardiogenic
Shock."
The following two (2) CSV files: 1) Listing of all INSPECTIONS since Saturday, May 1, 2021 (in CSV format) with the
inspection CITATIONS (from FDA's FACTS database) for each company since Saturday, May 1, 2021 in CSV format with
since Wednesday, March 30, 2022.
for Human Drugs inspection of Mirum Pharmaceuticals, Inc. ending 05/12/2021 at the location in Foster City CA, United
CVs Lauren Barber, Joo Jin, Kathleen Jordan, Elise Mcdevitt, etc
PMTA Submissions: PM0000010, PM0000011, PM0000012, PM0000013, PM0000014, PM0000015, PM0000016, and
PM0000017.
• Modified Risk Submissions: MR0000020, MR0000021, MR0000022, MR0000024, MR0000025, MR0000027,
MR0000028, and MR0000029
PM0000613, PM0000614, PM0000615, and PM0000622
Premarket Tobacco Product Applications (PMTAs) submitted by NJOY LLC
Medtronic Neuromodulation, Minneapolis MN 10-26-15, ETC - EXHIBITS TO PREVIOUSLY RELEASED RECORDS
Per a request from FDAs Office of Food Additive Safety, I am requesting a copy of releasable information from Color
Additive Petition 4C0299 "from" CFSAN/Office of Food Additive Safety.
Shilpa Medicare Shilpa Medicare US FDA Issues 4 Observations For Nacharam Unit In Hyderabad US FDA Issues 4
Observations After An Inspection From April 26-29
FDA registration file for Extreme Products Group Registration Number: 3014944826 Medical Device Registration
Establishment: Extreme Products Group 6635 W. Happy Valley Road, Suite A104, #213 Glendale, AZ 85310 Registration
Number: 3014944826 FEI Number: 3014944826 Status: Active Initial Distributor/Importer: Yes Date of Registration
Status: 2022
case ID 20631610, 18434120, 18331720, and 17911877
Breakthrough Designation Application for MagSense® HER2 imaging agent device from Imagion Biosystems
We are looking for Summary Basis of Approval (SBOA) documents for Pred Forte (NDA 017011) and Omnipred (NDA
017469)
Specifically seeking test results from product samples collected from FDA Inspection of my facility. FEI: 3007351626, see
page 14 of Inspection report for samples collected. Sample #1134237 (Curcumin Turmeric Root Extract 665 mg) Sample
#1134238 (PoweRelief)
The 483 (in electronic format) for Human Drugs inspection of Frontage Laboratories, Inc. ending 02/18/2022 at the
location in Exton PA, United States. The EIR (in electronic format) for Human Drugs inspection of Frontage Laboratories,
Inc. ending 02/18/2022 at the location in Exton PA, United States. The Response (in electronic format) for Human Drugs
inspection of Frontage Laboratories, Inc. ending 02/18/2022 at the location in Exton PA, United States. Please send
The 483 (in electronic format) for Human Drugs inspection of CooperSurgical, Inc ending 03/04/2022 at the location in
North Tonawanda NY, United States. The EIR (in electronic format) for Human Drugs inspection of CooperSurgical, Inc
ending 03/04/2022 at the location in North Tonawanda NY, United States. The Response (in electronic format) for
Human Drugs inspection of CooperSurgical, Inc ending 03/04/2022 at the location in North Tonawanda NY, United
The 483 (in electronic format) for Human Drugs inspection of Pfizer Pharmaceuticals LLC ending 02/17/2022 at the
location in Vega Baja PR, United States. The EIR (in electronic format) for Human Drugs inspection of Pfizer
Pharmaceuticals LLC ending 02/17/2022 at the location in Vega Baja PR, United States. The Response (in electronic
format) for Human Drugs inspection of Pfizer Pharmaceuticals LLC ending 02/17/2022 at the location in Vega Baja PR,
for Medical Devices & Rad Health inspection of American Preclinical Services ending 04/13/2018 at the location in
Please provide any public statements concerning the addition of a black box warning on Sodium Nitroprusside, Nipride,
or Nitropress from January 1, 2012 - January 1, 2014. Please also provide the existing black box warning for Sodium
Nitroprusside, Nipride, and/or Nitropress in August 2013.
IDE for MagSense® HER2 imaging agent device from Imagion Biosystems
We request a spreadsheet identifying the name and contact information related to each Drug Master File (DMF) Original
Submission from January 1, 2019, to December 31, 2019 and from January 1, 2021 to December 31, 2021
"information from real-world use" that is being referred to in the following sentence of the April 11, 2022 Letter to
Health Care Providers titled "Intended Use of Imaging Software for Intracranial Large Vessel Occlusion - Letter to Health
Care Providers"
RECS RE CHURCH & DWIGHT VITAFUSION
for Human Drugs inspection of Global Blood Therapeutics, Inc. ending 03/11/2022 at the location in South San Francisco
CA, United States. The EIR (in electronic format) for Human Drugs inspection of Beigene USA, Inc. ending 04/08/2022 at
the location in San Mateo CA, United States. Please send documents as email attachments.
for Animal Drugs & Feeds inspection of HMS Veterinary Development Inc ending 03/04/2022 at the location in Tulare
CA, United States. The EIR (in electronic format) for Animal Drugs & Feeds inspection of HMS Veterinary Development
Inc ending 03/04/2022 at the location in Tulare CA, United States. Please send documents as email attachments.
for Biologics inspection of Kite Pharma, Inc. ending 03/04/2022 at the location in Frederick MD, United States. Please
for Biologics inspection of National Genetics Institute ending 03/02/2022 at the location in Los Angeles CA, United
States. The 483 (in electronic format) for Biologics inspection of Incinta Fertility Center, L.L.C. ending 03/03/2022 at the
location in Torrance CA, United States. Please send documents as email attachments.
for Biologics inspection of North Hudson IVF Center for Fertility & Gynecology P.C. ending 03/03/2022 at the location in
Englewood Cliffs NJ, United States. Please send documents as email attachments.
for Biologics inspection of U.S. Department of Veteran Affairs VA Medical Center ending 02/23/2022 at the location in
Chillicothe OH, United States. Please send documents as email attachments.
for Biologics inspection of RMA Long Island IVF ending 03/01/2022 at the location in Melville NY, United States. Please
I'm requesting all records for consumer complaint #152594
Date Range: 01/01/2018 - 12/31/2021; I'm requesting all records showing financial transactions between FDA and the
[attached states identified in letter] pertaining to AFRPS, Animal Feed Regulatory Program Standards Cooperative
Agreement Program;
all inspection documents for FDA inspection of OC Raw Dog LLC, located at 1500 Commerce St., Ste. A #101 Corona, CA
92880-1715 01.01.21-12.31.21
on 11.27.2017, Linda Benjamin of FDA-CVM sent an email to Jacqueline Hernandez. The email I am referencing is
publicly available on FDA's FOIA reading room. https://www.fda.gov/media/158078/download. I am requesting all
attachments to/for that email. HPP
I would like to receive all possible information related to COVID vaccines for children under 6 years of age. This includes
minutes from all internal meetings, memos and other documents that have not been made public, and any other
information on internal deliberations and discussions around COVID vaccines for young children (under 6 years of age).
I'm requesting receipts for airline airline fare, airline tickets, taxi, and hotel along with any other travel related expenses
for dan mcchesney, for the dates of 09.10.17 through 09.16.17
I'm requesting all calendar records for Erin Dugan 01.01.18-12.31.18. These records appear to have been provided via
2019-5041
I am seeking communications or planning records (emails, meeting agendas/notes/other materials) pertaining to

determining when the following meetings to review covid vaccines for children under 5 would be scheduled: 1) The
2/15/22 meeting (which was subsequently cancelled) to review Pfizer's Under 5 covid vaccine EUA application etc
Hi there, Please provide the full responses to FOIA requests 2019-9900 and 2019-10108
Please provide the documents listed below for the following company: Ventavia Research Group All documents related
to inspection history and compliance actions, including but not limited to: warning letters, 483's, establishment
inspection reports, responses to warning letters, and consent decrees
Hello, Please provide copies of all FOIA requests submitted to the FDA by Johnson & Johnson, Moderna, and Pfizer and
the final response made in response to each request.
Hi, please provide the FDA forms 483 for inspections of Abbott Nutrition's Sturgis, Michigan facility as well as the
whistleblower complaint that triggered the inspections and any other notes and documents relating to the inspections.
A copy of any report prepared by the Food and Drug Administration in 2020 or 2021 documenting the United States
prevalence of Immunoglobulin Nephropathy (IgAN). Such report may have been prepared by the Office of Surveillance
and Epidemiology, the Office of Orphan Products Development, or another FDA office.
We want all the food permit holders in Lake County Florida

Food Entity Number,
Food Entity Name,
Food Entity Address,
etc
Copy of the disclosable portions of the food sample collection reports and analytical results from the FDA Office of
Regulatory Affairs (ORA), for all samples of the meal replacement drink identified as "Reference #1060" on the
Coordinated Outbreak Response and Evaluation (CORE) Investigation Table.
(1) FDA Adverse Event Reporting System No. 20626836 and (2) FDA Adverse Event Reporting System No. 20653749.
ANDA 062475 most recent Package Insert found under SUPPL-50, 04/22/2020
Copy of the disclosable portions of the original request letters and complete FDA responses for the following four File
Numbers: 2017-7100; 2017-10721; 2017-9705; and 2021-7548.
Copy of the disclosable portions of the Swedish Match MRTP Annual Reports from 10/22/2019 to the present for the
following products: MR0000020: General Loose; MR0000021: ETC
Copy of the disclosable portions of the IQOS MRTP Annual and Quarterly Reports from 07/07/2020 to the present for
MRTPA MR0000192, IQOS 3 System Holder and Charger.
Copy of the disclosable portions of the IQOS Annual and Quarterly Reports from 03/01/2020 - 04/30/2022 for the
following 5 IQOS PMTAs: PM0000634, IQOS 3 System Holder and Charger; PM0000424, Marlboro Heatsticks;
PM0000425, Marlboro Smooth Menthol Heatsticks; PM0000426, Marlboro Fresh Menthol Heatsticks; and PM0000479,
IQOS System Holder and Charger.
McGuff Compounding Pharmacy Services Inc. EIR Exhibits LFM 1 through Exhibit LFM 60.
Regulatory Assessment of Grifols Biomat USA Inc Located at Toledo OH United States FEI Number: 3000717632 held on
06/14/2021.
We are seeking the 510k submission documents for K180141. I am willing to pay a fee of no more than $1000. We
prefer to obtain the 510k submission documents by email. If you have any questions, please contact me via email at
ra.micro-tech@outlook.com Thanks for your help.
Regulatory Assessment of Fresenius Kabi Compounding, LLC Located at Canton MA United States FEI Number:
3013438665 held on 06/11/2021.
Regulatory Assessment of Biomat USA, Inc. Located at Sparks NV United States FEI Number: 3013164241 held on
06/11/2021.
NDA 018531
Regulatory Assessment of Biomat USA, Inc. Located at Fort Walton Beach FL United States FEI Number: 3013848392
held on 06/09/2021.
Please provide the complete files of all adverse reports received during the period of May 14, 2020, through June 12,
2020 regarding St Jude Medical Neuromodulation Penta 3MM Leed, 60 CM SCS Paddle Lead, Model Numbaer 3228. We
would like to know the name of the person or institution/group who filed each report and the name of the operator it
that is available. We will be happy to pay all reasonable fees for processing this request.
All records from the Gilead Sciences Clinical Trial on Remdesivir for children and infants. This would include all
submitted reports, data tables and figures as well as all correspondences between FDA officials and Gilead Sciences
officials related to this specific remdesivir clinical trial. This would also include all documents associated with the
approval process for this particular therapeutic.
Please provide disclosable portions of the final response letters for file numbers 2022-2646 and 2022-2647
for Human Drugs inspection of Experimental Pathology Labs ending 09/20/2007 at the location in Durham NC, United
States. The EIR (in electronic format) for Human Drugs inspection of Experimental Pathology Labs ending 08/14/2012 at
the location in Durham NC, United States
etc
The 483 (in electronic format) for Human Drugs inspection of Adam M. Sun, M.D ending 02/25/2022 at the location in
Rosemead CA, United States. The 483 (in electronic format) for Human Drugs inspection of Ark Pharmacy, PC (dba
Regency Medical Pharmacy) ending 02/24/2022 at the location in Newbury Park CA, United States.
Please email a complete list of all current FDA approved medications current to 2022. Please email a complete list of all
psychiatric/psychotropics medications current to 2022. This is strictly for a Clinical Pocket Guide for phycians and
psychiatrists.
Hi all, I want to request the 483 report associated with Novartis manufacturing facility in New Jersey with regard to its
Lutathera and Pluvicto products. Novartis recently have announced that it will voluntarily pause its production of these
two cancer products (https://www.novartis.com/news/media-releases/novartis-provides-update-production-
radioligand-therapy-medicines).
I would like all FAERS, or FDA’s Adverse Event Reporting System, submissions regarding the “Copper IUD,” “Paragard,”
“The Coopers Company,” or any other related submission the the copper iud device.
We hereby request the following documentation and appreciate your support on this: Documentation (including
establishment inspection report and 483s) for the FDA inspection in 2021 on Pharmaceutics International Pii3 (FEI
3006503202) in Cockeysville, MD and Pharmaceutics International Pii (FEI 1000513101) in Hunt Valley, MD.
Copy of the disclosable portions of a CSV listing of all 482s issued from 01/01/2010 - 12/31/2019. The list should include
the date, site name, and FEI for each 482 issued. We would like the information from CDRH, CDER, and CBER.
EIRs and 483s for Brigham and Womens: I would like the FDA Establishment inspection Reports and FDA 483s for
Brigham and Women's Hospital (FEI 3012030543) for the 2019 and 2021 inspections. Inspection ID: 1152063 and
1100702.
K181739 - Invisalign System with Mandibular Advancement Feature Decision date: October 26, 2018
NDA 211950
LABORATORIES LOCATED AT 11111 M STREET, SUITE 110 OMAHA, NE 68137
ALL FORM 483, EIR, RESPONSE LETTERS, AND ANY OTHER COMMUNICATIONS WITH THE FDA BY/FOR RLC LABS LOCATED
AT 1850 E. RIVERWALK DR. PHOENIX, AZ 85034.
ALL FORM 483, EIR, RESPONSE LETTERS, AND ANY OTHER COMMUNICATIONS WITH THE FDA BY/FOR Specialty Process
Labs LOCATED AT 1030 E. LONE CACTUS DR. PHOENIX, AZ 85024
for Biologics inspection of Health Park Medical Center ending 02/28/2022 at the location in Fort Myers FL, United
for Human Drugs inspection of Dennis Marcus, M.D. ending 02/22/2022 at the location in Augusta GA, United States.
The 483 (in electronic format) for Human Drugs inspection of Mikell Jaratt, M.D. ending 02/24/2022 at the location in
Gastonia NC, United States. Please send documents as email attachments.
Copy of the disclosable portions of all guidelines, guidances, memos, process maps, or other documents used by CTP to
evaluate PMTAs for deemed new tobacco products which were required to be submitted by 9/9/2020 and subject to a
one-year review period by 9/9/2021.
The record requested is: a copy of Applicant's (e.g., Juno Therapeutics') submission to FDA requesting RMAT
(Regenerative Medicine Advanced Therapy) designation for the product now approved as BREYANZI (lisocabtagene
maraleucel), BLA 125714, also known as JCAR017.
CAERS REPORTS IOVATE PRODUCTS 2/5/22 TO PRESRENT
meeting minutes relating the original approval of Lumakras

I am requesting all records related to the voluntary recall of the Cook Medical Zenith Alpha Thoracic products that was
issued in 2017.
Please produce a complete copy of the following: 1. Any and all WARNING LETTERS to Restorative Products, Imc.,
including but not limited to FLA-06-08, relating to any product manufactured or sold by the company; etc
Please produce a complete copy of the following: 1. Any and all WARNING LETTERS to ReBuilder Medical Technologies,
Inc., related to ReBuilder EMS/TENS cleared under K882980; 2. Any and all responses to any Warning Letters identified
or related to #1 above; 3. Any and all 510K Clearance Letters for ReBuilder EMS devices related to 1-2 above. Thank you.
Please send Form 483 for Sun Pharmas Halol facility
Wis-Pak of Watertown, LLC - (FEIN: 2124502) - plant located at 860 West Street, Watertown, WI DOR is requesting a
copy of the inspection report for the FDA performed inspection of the plant located at 860 West Street, Watertown, WI
in 2017 or 2018.
All document, including surveys, findings or reports, related to MasterPharm, LLC's recall of medications containing
undeclared minoxidil as described here: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/
masterpharm-llc-issues-voluntary-nationwide-recall-finasteride-plus-125mg-due-presence-undeclared
The NDA file submitted and approved for New Drug Application (NDA): 050703 Company: GLAXOSMITHKLINE Drug
Name: Bactroban; Active ingredient: Mupirocin Calcium; Strength EQ 2% base; Dosage Form/Route: Ointment; Nasal
I would like information related to FDA's 2018 Withdrawal of Proposed Rule on Supplemental Applications Proposing
Labeling Changes for Approved Drugs and Biological Products. I would like information on the parties that commented
on the proposed rule, their specific concerns, and any legislative or other proposals they had to update outdated
generic drug labeling.
- A copy of any and all correspondence or documents related to any listing of any patent for Calquence® or NDA No.
210259 .
All documents, communications and things related to premarket submission number K190764 (SurgicalAR) and
premarket submission number K163232 (VitreaView)
I am looking for the inspection report of Advanced Accelerator Applications FEI#: 3012484129, inspection ID 1129463
performed on 8/18/2020.
I would like to make FOIA request for FDA's Form 483 sent to Novartis Pharmaceuticals in March 2022 about CMC
/manufacturing issues at the Novartis Millburn, NJ radiopharmaceutical plant. This is in relation to Lutathera and
Pluvicto marketed cancer products that are now experiencing US supply issues.
Form 483 for Millburn, NJ, manufacturing facility owned by Novarts/Advanced Accelerator Applications
We are hereby requesting the Summary Basis of Approval (Chemistry review), for Amphastar Pharmaceutical Inc.'s
ANDA 212613 for Ganirelix Acetate Injection.
All 483s and warning letters from LivaNova's (legacy business is Sorin) Munich, Germany facility.
Active Ingredient: SUCRALFATE Proprietary Name: SUCRALFATE Dosage Form; Route of administration: SUSPENSION;
ORAL Strength: 1GM/10ML Reference Listed Drug: No Reference Standard: No TE Code: AB Application Number:
A211884 Product Number: 001 Approval Date: Mar 15, 2022 Applicant Holder Full Name: VISTAPHARM INC Marketing
Status: Prescription
Documents (invoice/shipping docs/container labels) identifying product refusal dated 11/29/2021. Shipment ID 799-
5678359-0/11/1
Please send Form 483 for Aurobindo Pharmas. unit 7 facility
I am requesting information on whether FDA has requested any drug manufacturers to change their drug labeling since
the MODERN Labeling Act (adopted into the Consolidated Appropriations Act of 2021 and codified as Section 503D of
the Food, Drug, and Cosmetics Act) was enacted. I would like to know the drug manufacturer(s), the drug product(s),
and the requested changes.
K212470
2022-2722 2022-2723 2022-2725
FAERS case reports for aducanumab / Aduhelm with the following Case IDs: 20132931, 20200825, 20463171,
19726309, 19771050, 20638335, 20633877.
The EIR (in electronic format) for Human Drugs inspection of Celgene a Bristol Myers Squibb Company ending
03/14/2022 at the location in Summit NJ, United States. The 483 (in electronic format) for Human Drugs inspection of
Nikolaos T. Pyrsopoulos, M.D. ending 02/22/2022 at the location in Newark NJ, United States. Please send documents
for Biologics inspection of Spark Therapeutics, Inc. ending 03/04/2022 at the location in Philadelphia PA, United States.
The EIR (in electronic format) for Human Drugs inspection of Catalent CTS LLC ending 03/04/2022 at the location in
Kansas City MO, United States. The EIR (in electronic format) for Human Drugs inspection of Jost Chemical Co ending
01/21/2022 at the location in Saint Louis MO, United States. The Response (in electronic format) for Human Drugs
inspection of Jost Chemical Co ending 01/21/2022 at the location in Saint Louis MO, United States. Please send
for Human Drugs inspection of Pq Corporation ending 02/22/2022 at the location in Utica IL, United States. Please send
for Human Drugs inspection of Lilly del Caribe, Inc ending 02/25/2022 at the location in Carolina PR, United States.
for Human Drugs inspection of Central Admixture Pharmacy Services, Inc. ending 02/25/2022 at the location in Phoenix
AZ, United States. Please send documents as email attachments.
for Human Drugs inspection of Azurity Pharmaceuticals, Inc. ending 02/24/2022 at the location in Wilmington MA,
All documents and communications regarding each VAERS report deleted from VAERS between April 1, 2022 and April
29, 2022 including, but not limited to, the following VAERS report numbers (see attached request for list of report
numbers).
Hi, please provide all communications between the FDA and addresses ending with "@state.mn.us" that mention
"infant formula"
all documents regarding the FDA’s decision to wait over a month to discuss Moderna’s application, and any other
documents relating to the FDA’s messaging and decision making regarding the approval and use of COVID-19 vaccines
for children under 5 years old
Hello, Please provide all emails to or from Dr. Robert Califf mentioning "Florida" and "vaccine"
Hello, Please provide all emails to or from Dr. Peter Marks mentioning "Florida" and "vaccine"
Hello, please provide all emails to or from Dr. Peter Marks mentioning "TTS", "clots", or "thrombosis" and "Johnson &
Johnson" or "J&J"
All reports prepared by McKinsey & Co. for the FDA that related to the agency's food program reorganization.
(i) All communications between the FDA and Advaite, including any and all individuals acting on Advaite’s behalf,
regarding Advaite’s EUA request # 202686 (EUA # 202686) for its RapCov(TM) COVID-19 Rapid Test and any
amendments thereto; etc
Records mentioning “Approved Risk Evaluation and Mitigation Strategies (REMS)” with regards to “Mifeprex” or
“mifepristone” between the dates of 2000-today.
Any Pharmacovigilance Reviews regarding all fluoroquinolone drugs: -Fluoroquinolones (oral and parenteral
formulations): Noroxin® (norfloxacin)—Merck and Co. Cipro® Cipro XR® (ciprofloxacin)—Bayer HealthCare Levaquin®
(levofloxacin)—Janssen Pharmaceuticals Avelox® (moxifloxacin)—Bayer HealthCare Factive® etc
Need Form 483 of Sun Pharma Halol plant inspected during 26th April 2022 to 9th May 2022. FEI of Halol plant is
3002809586.
483 issued to Sun Pharma Halol Gujarat India
Request to share Sun pharmaceutical industries, Halol plant, Gujarat, India Form 483 issued on 09 May, 2022
All email records for FDA CVM employee Charlotte Conway containing the key search term: AAFCO.
I request you provide me with the following information: 1. All reports of adverse events and/or reactions dog and/or
cats have had to dog and cat food and dog and cat treats from July 1, 2020-April 30, 2022. a. Please include the type of
animal, the reaction, the brand name and the product name of the food item to which the dog or cat reacted, the
symptoms displayed and the outcome, if available. b. Please include whether any of the reports of adverse events
triggered any sort of follow up by the FDA.
for Human Drugs inspection of HistoScientific Research Laboratories (HSRL), Inc. ending 05/08/2006 at the location in
Mount Jackson VA, United States. The EIR (in electronic format) for Human Drugs inspection of HistoScientific Research
Laboratories (HSRL), Inc. ending 04/03/2012 at the location in Mount Jackson VA, United States. Please send
for Foods & Cosmetics inspection of WDC Greenhouse LLC dba Bright Farms ending 01/26/2017 at the location in
Elkwood VA, United States. The EIR (in electronic format) for Foods & Cosmetics inspection of WDC Greenhouse LLC
dba Bright Farms ending 01/26/2017 at the location in Elkwood VA, United States. The Response (in electronic format)
for Foods & Cosmetics inspection of WDC Greenhouse LLC dba Bright Farms ending 01/26/2017 at the location in
Elkwood VA, United States. Please send documents as email attachments.
for Human Drugs inspection of I3 PHARMACEUTICALS LLC ending 02/22/2022 at the location in Warminster PA, United
for Human Drugs inspection of Saima Jehangir, M.D. ending 02/25/2022 at the location in Austin TX, United States.
for Human Drugs inspection of Kimball Electronics - Indianapolis ending 02/24/2022 at the location in Indianapolis IN,
for Human Drugs inspection of Mohnark Pharmaceuticals Inc ending 02/25/2022 at the location in Davie FL, United
for Biologics inspection of Octapharma Plasma Inc ending 03/04/2022 at the location in Knoxville TN, United States.
2022-1178
Any and all reviews, associated drafts, and any other communication regarding the abstract/presentation by FDA for the
Society for Research on Nicotine & Tobacco (SRNT) on menthol during the 2017 Annual Meeting on March 8-11, 2017:
POS4-111, “Scientific Review of The Effects of Menthol in Cigarettes on Addiction,” Kia Jackson, Olga Rass, Megan
Schroeder (CTP).
Underlying data relating to initiation to progression from James N. Nonnemaker, PhD for report during Tobacco Product
Scientific Advisory Committee Meeting (Hersey, J.C., Nonnemaker, J. Homsi, G.,& Allen, J. (2010). Menthol cigarettes,
saliva cotinine, and nicotine dependence in adolescents. Report for the Food and Drug Administration Center for
Tobacco Products.)
2022-1726, 2022-1727, 2022-1750, 2022-1759, 2022-1760
FDA Chemistry Review for ANDA 211526 (Difluprednate Ophthalmic Emulsion 0.05% - Amneal)
Requesting the 510(k) and supporting documents for 510(k) K934073
Hello - requesting information for the rapports Aduhelm Aducanumab drug by Biogen. This is in regards to case #
19787426.
Requesting all currently approved labeling for Quelicin (succinylcholine chloride) injection Preservative-Free, 20 mg/mL
single-dose vial held by Hospira under NDA 008845. Single dose vial label, carton label and package insert labeling.
Complete Summary Basis of Approval, All Review Disciplines and Approved Labeling: DIAPID (lypressin), Nasal Solution;
0.185 mg/mL; NDA 016755, Date of Approval 1970, Marketing Status Discontinued; Review not available on
Drugs@FDA.
I am seeking any and all agreements, memoranda of understanding, contracts, and any and all other accords involving
the FDA (or any FDA agencies or centers) and the American College of Radiology (ACR) relating to the study of
computer-aided triage and notification (CADt) devices for intracranial large vessel occlusion (LVO), as well as any and all
records received by FDA pursuant to this/these accords involving FDA and ACR.
Please provide the document entitled “Interdisciplinary OS State of the Science on Electronic Nicotine Delivery Systems
(ENDS Sos) referenced on page 3 of Decision-Making Principles for Review of Premarket Tobacco Applications for
Electronic Nicotine Delivery Systems (Version: June 12, 2020 DRAFT). Please see attached.
Copy of the disclosable portions of the 483 for the 08/14/2017 - 08/17/2017 inspection of MFCI (Huanggang) Co,
Huanggang, China. Please note that this inspection relates to human drugs.
Scope: Records containing information on nonclinical safety studies submitted to support approved Premarket Tobacco
Product Applications (PMTAs) for NJOY LLC: ACE Device; ACE POD Classic Tobacco 2.4%, 5.0%;ACE POD Rich Tobacco 5%
and Logic Technology Development LLC: Regular Cartridge/Capsule Package; Vapeleaf Cartridge/Capsule Package; etc
LIST OF EMPLOYEES
Any and all records including email communications, email chains, email attachments, messages through social media
communications platforms, reports or memoranda sent, received or maintained in the accounts of Dr. Judy McMeekin,
Associate Commissioner for Regulatory Affairs (ACRA), Office of Regulatory Affairs (ORA), U.S. Food and Drug
Administration containing the following key words: (1) Alimentum (2) EleCare (3) Similac (4) Abbott Nutrition (5)
Cronobacter (6) Whistleblower (7) Sturgis
Requesting Establishment Inspection Report for inspection conducted between 6/1/2021 and 6/8/2021 at: BioLife
Plasma Services L.P. 1455 W. Arbrook Blvd Arlington, TX 76015 USA FEI #: 3017393622
Any and all records including email communications, email chains, email attachments, messages through social media
communications platforms, reports or memoranda sent, received or maintained in the accounts of Kaniz Shireenk, Email
Address Kaniz.Shireen@fda.hhs.gov Center for Food Safety and Applied Nutrition, U.S. Food and Drug Administration
containing the following key words: (1) Alimentum (2) EleCare (3) Similac (4) Abbott Nutrition (5) Cronobacter
Plasma Services L.P. 13710 E. 14 Mile Rd Warren, MI 48088 FEI #: 3017483223
Re:Vaccine Adverse Event Reporting System Report
Copy of the disclosable portions of the MedWatch reports for the following three case reports for Molnupiravir:
20769336; 20764377; and 20740588.
September 5, 2008 Warning Letter sent by CDRH to Dr. Rodney White, Harbor-UCLA Medical Center, 1000 West Carson
Street, Torrance, CA 90502. Also the warning letter was based on violations observed during an inspection from May
21, 2008 to June 13, 2008. I would like a copy of that inspection report.
I would like records on the snoo by happiest baby and the information from the last 2 years they have been in the FDA
breakthrough device program. And why there has been no outcome. Despite not following AAPs safe sleep guidelines.
A copy of any and all correspondence between FDA and NJOY, including, but not limited to, additional information
requests and responses, FDA’s marketing granted order (MGO) and summary, and any and all TPL documents relating to
the MGOs for the following products: • NJOY Ace Device • NJOY Ace Pod Classic Tobacco 2.4% • NJOY Ace Pod
Classic Tobacco 5% • NJOY Ace Pod Rich Tobacco 5%
483 issued to Meiji Seika Pharma, Odawara, Japan (FEI:3015407855) on the FDA inspection.
Request for form 483 with respect to recent USFDA inspection at Halol (3002809586) facility of Sun Pharmaceuticals and
industries limited
FORM 483 for USFDA Inspection of SUN PHARMA's HALOL PLANT , GUJARAT
EIR Summary for the FDA inpction to Taiho Pharmaceutical Co., Ltd.; Kitajima Plant (FEI#: 3010872322) conducted
during May 18 - May 22, 2015.
Form 483, Issued to Sun Pharma's manufacturing Facility based out of Halol, Gujarat, India. FEI NUMBER 3002809586
RE: Hill's Pet Nutrition, Inc., Topeka, KS. Pursuant to the company's voluntary recalls, dated January 31, 2019, March 20,
2019, and May 20, 2019, please supply the following information: 1. Number of households that submitted complaints
linked to the products included in the three Hill's recall notices ETC
Sun Pharma Halol Plant Form 483 for inspection conducted from 26 April to 9 May 2022
Requesting Form-483 issued to Sun Pharmaceuticals with 10 observations for Halol facility (Gujarat, India). The
inspection was conducted from April 26 to May 9, 2022.
Requesting the information/details on the 10 observations raised in Form 483 on Sun Pharmaceutical Industries Ltd's
Halol (Gujarat) plant. The inspection took place between April 26 to May 9, 2022.
for Foods & Cosmetics inspection of Taylor Farms Illinois Inc. ending 11/15/2017 at the location in Chicago IL, United
States. The EIR (in electronic format) for Foods & Cosmetics inspection of Taylor Farms Illinois Inc. ending 11/15/2017
at the location in Chicago IL, United States. The Response (in electronic format) for Foods & Cosmetics inspection of
Taylor Farms Illinois Inc. ending 11/15/2017 at the location in Chicago IL, United States. Please send documents as
email attachments.
for Biologics inspection of Juno Therapeutics Inc, a subsidiary of Bristol-Myers Squibb ending 03/18/2022 at the location
in Seattle WA, United States. Please send documents as email attachments.
for Human Drugs inspection of Scapa Tapes North America LLC ending 02/07/2020 at the location in Knoxville TN,
The initial substantial equivalence reports (“SE Reports”) for SE0018150.PD1,
SE0018151.PD1, and SE0018152.PD1
INVESTIGATION RECS
for Human Drugs inspection of Robert Joseph Jeanfreau, MD ending 02/25/2022 at the location in Metairie LA, United
for Biologics inspection of CSL Plasma Inc. ending 03/10/2022 at the location in Normal IL, United States. Please send
for Biologics inspection of Long Island Jewish Medical Center ending 03/10/2022 at the location in New Hyde Park NY,
for Biologics inspection of Hendrick Regional Blood Center ending 03/07/2022 at the location in Abilene TX, United
for Biologics inspection of Hendrick Regional Laboratory Transfusion Services ending 03/10/2022 at the location in
Abilene TX, United States. Please send documents as email attachments.
Form 483 with 10 observations from inspection of Sun Pharmaceutical Industries Limited's Halol facility in Gujarat, India
from April 26 to May 9, 2022.
Please provide the following information in regard to this RFI: 1. The NAICS Code assigned to this contract 2. The name
and contact information of the contractor who was awarded this contract. 3. The official contract number affiliated
with this contract. 4. The solicitation number affiliated with this contract. 5. The price list which was supplied by the
contractor who was awarded this contract
(1) Any banned substances monitoring program agreements for dietary supplement products considered, reviewed,
approved, or denied by the FDA between March 1, 2011 and September 30, 2017.; (2) Any communications about
banned substances monitoring program agreements for dietary supplement products between March 1, 2011 and
September 30, 2017.; etc
Please provide a MedWatch for 20546667.
I'd like a copy of the letter the FDA sent to Protagonist Therapeutics in April 2022 indicating "an intent to rescind" the
breakthrough designation of their product rusfertide.
Here is a link to the SEC filing referencing the letter: https://d18rn0p25nwr6d.cloudfront.net/CIK-

0001377121/61deefe7-452a-425c-aed3-1b95d36df2ec.pdf.
Request you to share a copy of the six observations issued to Aurobindo Limited's Jedcherla, Hyderabad facility. The
inspection was conducted from 2nd to 10th May 2022.
Please provide the EIR previously denied because it was still open for Request #2022-1475. This is for the Family Dollar
Distribution Center located at 1800 Family Dollar Pkwy, West Memphis, AR.
I'm seeking electronic copies of ANDAs and subsequent amendments on FDG and Ammonia. The ANDA number for the
FDG is 204512 and the ANDA number for the Ammonia is 204515. NCM-USA is the owner of the referenced ANDAs.
Copy of the disclosable portions of the 510(k) for K220158, G-EYE System, by Smart Medical Systems.
I am an investment professional for an asset management firm and would like to request a copy of the Real-Time
Oncology Review (RTOR) Request table. Thank you!
Olympus would like to request the entire 510(k) record for K142922 (SpyGlass DS Direct Visualization System, Boston
Scientific).
Full 510k submission package for K141877. If possible, please also provide the full 510k package for its predicate device
K130752 (if multiple 510k package requests can't be combined in one FOIA request, please provide K141877 full 510k
package as a priority)
Establishment Inspection Reports for Kauffman's Animal Health, FEI 2523915 21 Keystone Drive Lebanon, PA 17042-
9791 Inspection dates 03/20/2020 & 03/01/2021 Animal feed supplements.
Establishment Inspection Report for Sterling Technology, Inc., FEI 3003302546, Sterling Technology Inc., 133 32nd
Avenue South, Brookings, South Dakota, 57006-4719 Animal Feed Supplement
We request the FDA's discipline-specific standard NDA/BLA filing review templates via FOIA request as stated on page
18 of the CDER 21st Century Review Process Desk Reference Guide
(http://inside.fda.gov:9003/ProgramsInitiatives/Drugs/21stCenturyReview/ucm034190.htm).
I need a copy of a letter that was sent to me, Robert Camponovo, from the FDA, Division of Northeast Imports. This
would probably have been between February and April. The letter would be Notice Number 1 and it was regarding Entry
Number 0521117-0,
1. FDA’s documents, reviews, and files regarding the Shockwave Medical Lithoplasty System - 510(k) No. K161384 and
all supplements - from August 1, 2016 to the present. 2. FDA’s documents, reviews, and files regarding the Shockwave
Intravascular Lithotripsy (IVL) System with Shockwave C2 Coronary Intravascular Lithotripsy (IVL) Catheter - PMA No.
P200039 and all supplements - from August 1, 2020 to the present.
I would like to receive the 482 and 483 inspection reports associated with the ImClone Systems, LLC dba Eli Lilly and
Company, FEI# 3002889358, Inspection 1128945 and Inspection 1111276.
All documents relating to the investigation by the FDA into Spinal Solutions, LLC and Orthopedic Alliance, LLC, which
were both located at 26157 Jefferson Avenue, Murrieta, California 92562 at the time of the FDA's investigation.
Form 483 for Aurobindo Pharma Unit VII facility, Hyderabad inspection conducted between 2nd to 10th may 2022
Pentadecanoic Acid (C15:0) [FA15] has been approved by Generally Recognized as Safe (GRAS) as a fortifier in plant-
based milks, plant-based meats and nutritional bars in 2021. The GRAS document that was found online, gives only the
Expert Panel Conclusion. We would like to request for a full detailed copy of the Generally Recognized as Safe (GRAS)
document of Pentadecanoic Acid (C15:0) [FA15].
All adverse event reports or complaints submitted by Redcon1 directly, and/or any of their agents (e.g., “Supplement
Safety Solutions” and any agent, owner, or employee thereof, or any other agency submitting such a report), and/or by
any outside actors (i.e., consumers, doctors, customers, etc.), concerning any flavor or version of the Redcon1 product:
“MRE,” “MRE Lite,” MRE Light,” Meal Ready to Eat Light,” “Meal Ready to Eat Lite,” MRE Bar,” “Meal Ready to Eat Bar,”
and “Meal Ready to Eat.”
We are requesting the initial IND submission for IND 15255.
Request details of Form 483 issued to Sun Pharma's Halol plant (Gujarat India). Inspection conducted from April 26 to
May 9, 2022.
Request details of Form 483 issued to Aurobindo Pharma's Unit 7 located in Hyderabad India. Inspection conducted
from May 2-10, 2022
Kindly share form 483 issued to Novel Laboratories, Inc., based in Somerset, NJ. The inspection commenced on March
7, 2022 and concluded on March 30, 2022.
US FDA conducted a Good Manufacturing Practices (GMP) inspection of Sun Pharmaceutical Industries Limited's Halol
facility (Gujarat, India) from April 26 to May 9, 2022. At the conclusion of the inspection, the US FDA issued a Form-483,
with 10 observations. I request US FDA to kindly share the details of form-483.
Form 483 with six observations from inspection of Aurobindo Pharma Limited's Unit VII oral manufacturing facility at
Jedcherla, Hyderabad, India from 2nd to 10th May 2022.
FORM 483 FOR AUROBINDO'S UNIT 7 PLANT
I am seeking 483 observations for Sun Pharmaceutical Industry Limited, Halol facility.
for Human Drugs inspection of American Peptide Company ending 02/10/2017 at the location in Vista CA, United States.
The Response (in electronic format) for Human Drugs inspection of American Peptide Company ending 02/10/2017 at
the location in Vista CA, United States. Please send documents as email attachments.
for Human Drugs inspection of Sanofi-Aventis U.S. LLC ending 10/09/2018 at the location in Bridgewater NJ, United
To whom it may concern, I would like to request the records from the drug candidate Sotatercept (generic name) for
the treatment of Pulmonary Arterial Hypertention for the following designations: - Orphan Drug Designation (Date
designated: September/2019) application and approval records - Breakthrough Therapy Designation (Date designated:
April/2020) application and approval records Kind wishes.
for Human Drugs inspection of Miami University ending 11/05/2021 at the location in Oxford OH, United States. The
Response (in electronic format) for Human Drugs inspection of Miami University ending 11/05/2021 at the location in
Oxford OH, United States. Please send documents as email attachments.
format) for Medical Devices & Rad Health inspection of Euromed, Inc. ending 03/03/2020 at the location in Orangeburg
format) for Medical Devices & Rad Health inspection of Microbiologics Inc ending 12/01/2021 at the location in Saint
Cloud MN, United States. Please send documents as email attachments.
for Biologics inspection of Aventura Fertility & IVF ending 03/10/2022 at the location in Aventura FL, United States.
for Biologics inspection of Alon Medical Technology ending 03/08/2022 at the location in Metairie LA, United States.
for Biologics inspection of Row1 Inc. dba Regenative Labs ending 03/30/2022 at the location in Pensacola FL, United
Any “notification of release” from the Director, Center for Biologics Evaluation and Research (CBER) referenced on page
two of the FDA’s August 23, 2021 BLA Approval letter to BioNTech and Pfizer for Comirnaty, attached hereto as Exhibit
A.
All records (including e-mails, documents, letters, memos, text messages, voicemails, recordings, reports,
correspondence, notes, etc...) to/from Dick Clarke and any employee of the FDA's CDRH Division, pertaining to the
emergency use authorization request regarding hyperbaric oxygen therapy.
510K submission files for K990658
CONGRESSIONAL CORR RE INFANT FORMULA OUTBREAK 3/1/22 TO PRESENT
We would like to request the Summary basis of Approval information for GYNOREST (Dydrogesterone) Tablets 5 mg and
10 mg; NDA# 017388 of SOLVAY; Currently the orange book indicates following message: **Federal Register
determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
On behalf of Lupin Pharmaceuticals, Inc. I request you to please provide me with the latest final approval letter of
product Diclofenac sodium (ANDA 207714 ) which is approved on 05/06/2022 for Apotex Inc. according to USFDA
Bulletin.
Copy of the disclosable portions of the EIR, company response, and any related correspondence for the inspection
ending on 08/17/2017 for MCFI (Huanggang) Co., located in Huanggang, China. Please note this inspection pertains to
Human Drugs.
Meeting minutes, meeting materials, emails and other correspondence, memoranda, reviewer documents, reviewer's
summaries and scientific review memoranda from June 2021 to May 2022 between an FDA representative and an entity
developing "cell-cultured," "cell-based," "cultured," or "cultivated" meat, poultry, or seafood ETC
Product at Issue: Ivermectin Case ID: 19951346: Request you to please share the case reports ( Complete Case
Narrative, Details on concomitant medication, Medical History, ETC
All NDA Review and Approval documents for Kerlidex, or Betaxolol/Chlorthalidone or Lorex NDA 19807
I request the abbreviated new drug applications, or ANDAs, for four generic drugs. Two were filed by Abhai LLC. They
are A208593 and A211499. The other two were filed by Avanthi Inc. They are A091393 and A203495.
510(k) K212153
Copy of the disclosable portions of the supplemental REMS review associated with the approval of Suboxone, NDA
22410/S45, approved 05/03/2022.
Copy of the disclosable portions of the supplemental REMS review associated with the approval of Juxtapid, NDA
203858/S23, approved 02/01/2022.
Copy of the disclosable portions of the supplemental REMS review associated with the approval of Tracleer, NDA
21290/S43, approved 04/29/2022.
AstraZeneca is requesting unredacted 1. Product Quality Review and 2. Multi-Discipline Review documents for
AstraZeneca's own BLA 761224 (Approval Date: 12/17/2021) for TEZSPIRE (TEZEPELUMAB-EKKO- SUBCUTANEOUS
Solution).
FOIA Mirror Request 2022-2789
Please send me any entries with "Lucky Charms" listed as the product in CAERS (Center for Food Safety and Applied
Nutrition Adverse Event Reporting System) Reports between 01/01/2021 and the current date at time of processing.
Please send as a computer file: EXCEL or JSON or similar would be great. Thanks! -Pat
I request a copy of all documents submitted by Allegiance Healthcare Corp. or any other company in connection with
obtaining approval of a 510(k) Premarket Notification for the Airlife HEPA Filter. The 510(k) Number for this application
is K011132.
FCN 141 and FCN 320
I request a copy of all documents generated by the FDA pertaining to the 510(k) Premarket Notification for the Airlife
HEPA Filter. The 510(k) Number for this application is K011132.
Unredacted Establishment Inspection Report for Human Genome Sciences, Inc, 9910 and 9911 Belward Campus Drive,
Rockville Maryland 20850. Inspection Date: 22-24, 27-29 January 2020.
Request for Medical Review(s) (PDF), Chemistry Review(s) (PDF) and Clinical Pharmacology Biopharmaceutics Review(s)
(PDF) of Reference listed drug (RLD) LOPRESSOR HCT (metoprolol tartrate and hydrochlorothiazide) tablets 50 mg/25
mg,100 mg/25 mg and 100 mg/50 mg with application no. N018303, applicant holder-Validus Pharmaceuticals LLC
which is required for development of generic drug product of Metoprolol Tartrate and Hydrochlorothiazide Tablets
Form 483 issued with six observations to Aurobindo Pharma's Unit VII, an oral manufacturing facility situated at
Jedcherla, Hyderabad. Inspection was conducted from 2-10 May 2022.
We want to appply for the technique documents or technical parameter of Flexo Dental Resin which K number is
K061501, becasue it is our predicate device, we want to conduct predicate comparison with then when prepare 510k
submission documents.
1. Records between agency officials and representatives of Facebook and Twitter about how Facebook and Twitter
will deal with posts on their platforms about safety, effects, side effects, adverse reactions, and reactions reported to
VAERS and/or found in the VAERS data. 2. Records between agency officials and representatives of the news media
responding to inquiries from the media about citations of data or information obtained from the VAERS database. etc
Hello, Please provide the following: —All communications between FDA CDER and the House Select Subcommittee on
the Coronavirus Crisis —All video recordings, audio recordings, transcripts, notes, presentations, and summaries from
the FDA's briefing to the select subcommittee
Application Review Files for ZIMHI (naloxone hydrochloride injection, solution), NDA 212854, from Adamis Pharms Corp.
All documents sufficient to identify the percentages or specific dollar amounts of the Fiscal Year 2023 budget of $59.4M
for Capacity Building and $43.7M for Essential Services that are allocated for responding to Freedom of Information Act
(FOIA) requests and other FOIA-related activities.
Can you kindly provide list of all NDAs approved under 505(b)2 pathway since 1 Jan 2012? Please provide the list along
with the application number. Thank you in anticipation.
OTC Sunscreen Label Submissions: Please produce all labels and related informational submissions, including Product
Listings (exemplar labels, National Drug Codes (“NDC”), drug name, dosage form and route of administration, active and
inactive ingredient unique ingredient identifier code (“UNIC”) and amount/strength, No Change Notifications, and
Change Requests), etc
I would like the original filing for a 510K submittal by Beijing Lead Beauty S & T Co.Ltd.
application number K161777 for a EMSculpting device received by FDA October 17, 2018
510(K) Number: K200828 Device Name: Athelas Home Decision Date: 03/22/2022 510(k) Number: K181288 Device
Name: Athelas One Decision Date: 11/05/2018
A copy of each Form FDA 3542 submitted to FDA for the following patents listed in the Orange Book for Epidiolex
(cannabidiol) Oral Solution (NDA 210365): U.S. Patent Nos. 9,949,937; 9,956,183; etc
I am requesting the complete FAERS reports for the product pegcetacoplan specifically for the following cases:
20102463 19939906 19630663 19685262 19353149
We would like to request the following 4 case records for Zenpep on behalf of Nestle Health Science: Case ID:
20616776, 20606463, 20421308, 20351493.
Remote Regulatory Assessment for facility report
We would like the 510k applications for the devices with the following 510k numbers:
K190285
K090750
Medical Review(s) for NDA 215712 (NASONEX 24HR ALLERGY, MOMETASONE FUROATE NASAL SPRAY, 0.05MG/SPRAY)
Administrative Document(s) and Correspondence for NDA 215712 (NASONEX 24HR ALLERGY, MOMETASONE FUROATE
NASAL SPRAY, 0.05MG/SPRAY)
Clinical Pharmacology Biopharmaceutics Review(s) for NDA 215712 (NASONEX 24HR ALLERGY, MOMETASONE FUROATE
NASAL SPRAY, 0.05MG/SPRAY)
Pharmacology Review(s) for NDA 215712 (NASONEX 24HR ALLERGY, MOMETASONE FUROATE NASAL SPRAY,
0.05MG/SPRAY)
Complete EIR and FDA 483 for LyoContract GmbH Ilsenburg (Harz) Germany FIE # 3014034890
FSMA Inspection Records Ingenio la UnionS.A Guatemala, Santa Lucía Cotzumalguapa
VAERS REPORT
We are seeking any compliance or inspection records the FDA has for the Nephron Pharmaceuticals facilities at 4500
12th St. Extension, West Columbia, SC, during the prescribed time period.
Please provide the following documents from the Summary Basis of Approval for ADLARITY (NDA 212304) ORIG-1; FDA
Approval on 03/11/2022. • Summary Review • Clinical Pharmacology Review • Medical Review • Statistical
Review(s) • Product Quality Review(s) • Non-Clinical Review(s) • Administrative and Correspondence Documents
Copies of all information and correspondence provided in regards to the closed FOIA request from Robbins Geller
Rudman & Dowd LLP, control #2021-7496. Please provide it electronically, if possible.
I am seeking any records of the company Kabrita going through the FDA regulatory process for infant formula. Has the
company Kabrita filed papers to go through the FDA regulatory process for infant formula? If so, please share any
correspondence between Kabrita and the FDA regarding this process.
The Establishment Inspection Report (EIR) from the device inspection of the Fisher Wallace Laboratories Inc. facility in
Brooklyn, New York on June 25, 2019
for Human Drugs inspection of Pyramid Laboratories, Inc. ending 09/29/2021 at the location in Costa Mesa CA, United
States. The EIR (in electronic format) for Human Drugs inspection of Pyramid Laboratories, Inc. ending 09/29/2021 at
the location in Costa Mesa CA, United States. The Response (in electronic format) for Human Drugs inspection of
Pyramid Laboratories, Inc. ending 09/29/2021 at the location in Costa Mesa CA, United States. Please send documents
format) for Human Drugs inspection of Pfizer Inc. Groton Laboratories ending 09/22/2017 at the location in Groton CT,
for Biologics inspection of Invitrx Therapeutics Inc. ending 03/22/2022 at the location in Lake Forest CA, United States.
for Biologics inspection of Puerto Rico Fertility and Reproductive Center PSC ending 03/18/2022 at the location in
Bayamon PR, United States. Please send documents as email attachments.
for Biologics inspection of Department of Air Force 88th Medical Group SGQC WPAFB ending 03/30/2022 at the location
in Wright Patterson Afb OH, United States. Please send documents as email attachments.
for Biologics inspection of BioLife Plasma Services LP ending 03/25/2022 at the location in Aurora CO, United States.
for Biologics inspection of Greenwich Fertility & Ivf Center, P.c. ending 03/11/2022 at the location in Greenwich CT,
for Biologics inspection of CNY Fertility Center ending 03/17/2022 at the location in Latham NY, United States. Please
I am looking for the Schedule 483 with the inspection observations for the complete response letter to the filing of
bimekizumab in psoriasis by UCB. The manufacturing site in question is Braine l'Alleud, Wallonia, Belgium.
form 483s issued by USFDA, EIA reports issued by USFDA, as well as responses sent by the companies to the USFDA in
the following cases: 1. FEI no: 3008068944, company name: Patanjali Ayurved Limited 2. FEI no: 3007993199, company
name: Patanjali Ayurved Limited 3. FEI no: 1000500626, company name: MTR Foods Private Limited etc
Form 483 issued to Sun Pharmaceutical post the inspection of the Halol Formulation site. The inspection was concluded
in May 2022
Requesting a record of manufacturing-related site inspections of WuXi Biologicals (Mashan, WuXi City, China) as a
contract manufacturer of commercial-scale drug substance and drug product of GMP certification.
Hi. I would like you to look through the names of companies trying to get FDA approval to sell infant formula in the
United States. I would like copies of their filings to get approval and copies of any interactions/emails/phone calls the
FDA has had with these companies. Specifically, the companies whose names I am looking for incude the words "Feihe"
or "Shijiazhuang Junlebao" or "Yili" or "health & happiness" or "H&H". Thank you for your time.
Product at Issue: Ivermectin Case ID: 20246765:
PleaThe premarket tobacco product applications (“PMTAs”) for PM0000613.PD1-

PM0000615.PD1 and PM0000618.PD1-PM0000622.PD1 (collectively, the
“PMTAs”); etc
I would like to make FOIA requests for FDA 483 Forms sent to Novartis Pharmaceuticals about CMC/manufacturing
issues at the Novartis Millburn, NJ radiopharmaceutical plant. Potentially impacted/ related products could be Lutathera
and Pluvicto
Please provide a copy of the August 2021 inspection report at the Fujifilm Diosynth Biotechnologies facility located at
100 Discovery Drive, Suite 200, College Station, TX 77845. The inspection ID number is 1150333, end date is 8/31/2021,
division is Biologics. Classification is Voluntary Action Indicated, VAI.
I am requesting the record or records from FDA-CVM for the definition for the ingredient "chicken meal" (for use in
animal feed and pet foods). This ingredient definition is not available on the federal register. This ingredient definition is
also not available anywhere on FDA's website.
I'm requesting all email records AAFCO from Sean Duke (FDA-ORA) with the key term: AAFCO 04.01.22-04.30.22
2022-1202
A copy of OEIO-WIDE PROCEDURE, Food and Drug Administration, Office of Regulatory

Affairs, SOP-000302, “Processing of Sodium Thiopental Entries,” Version 2.0 (Effective April
16, 2012) etc
TEST RESULTS
ANDA 086262 for Bethanechol Hydrochloride Tablets, 10 mg FDA approved March 22, 1978 • ANDA 086263 for
Bethanechol Hydrochloride Tablets, 25 mg FDA approved March 22, 1978 • ANDA 085882 for Bethanechol
Hydrochloride Tablets, 50 mg FDA approved March 22, 1978
A copy of all documents and correspondence related to the new infant formula submission required under 21 CFR
106.120 for Similac 360 Total Care Infant Formula. The requested records are maintained at the Center for Food Safety
and Applied Nutrition, Office of Nutrition and Food Labeling.
A copy of all documents and correspondence related to the new infant formula submission required under 21 CFR
106.120 for ByHeart Whole Nutrition Infant Formula. The requested records are maintained at the Center for Food
Safety and Applied Nutrition, Office of Nutrition and Food Labeling.
We are requesting UCB’s bimekizumab inspection report, specifically the Forms 483 (Notice of Inspectional
Observations) that was issued following the Belgium manufacturing plant inspection.
PM0000635, PM0000636, PM0000646, PM0000712, PM0004287, PM0004293.
Looking to obtain the following 510k submissions: Product Code DZJ K150796, Synthes, Dental Bone Cutting
Instruments (2015) K943540, Stryker, Surgical Cutting Burs (1994) Product Code DZI K213208, Biomet Microfixation,
Twist Drills (2021) K200265, Implant Direct Sybron Manufacturing, Surgical Drills (2020) K090260, Straumann,
Modification to Guided Instruments (2009) K082532, Straumann, Guided Instruments (2008)
I am trying to locate an FDA document cited in GRAS Notice No. GRN 000127 as: FDA. 1981. Spirulina. Talk Paper #T81-
18. U.S. Food and Drug Administration.
The complete Decision Summary/Technical Project Lead (TPL) Review of PMTAs for STNs PM0000635, PM0000636,
PM0000646, PM0000712, PM0004287, and PM0004293, dated May 12, 2022. See attached letter.
The complete Decision Summary/Technical Project Lead (TPL) Review of PMTAs for STNs PM0000613, PM0000614,
PM0000615, and PM0000622.
The Complete Response Letter (CRL) the FDA sent to the biopharmaceutical company UCB in May 2022 regarding the
Biologics License Application (BLA) for bimekizumab (commercial product name "Bimzelx") for the treatment of adults
with moderate to severe plaque psoriasis.
Drug summary basis of approval (SBA): Somatuline Depot (lanreotide) Injection, NDA 22074 Supplement No. 11: Efficacy
New Indication, submitted on Jun 23, 2014 and approved Dec-16-2014.
Drug summary basis of approval (SBA): Somatuline Depot (lanreotide) Injection, NDA 22074 Supplement No. 17: Efficacy
New Indication, submitted on Aug 15, 2016 and approved on Sep 15, 2017
Hi, We are looking for any 483s on any UCB S.A. facilities, mainly in Brandt, Belgium. Specifically Biologic, pre-approval
inspection for bimekizumab.
The FDA's response to closed FOIA Requests with Control numbers 2021-4817 dated 07/23/21, 2021-4593 dated
07/14/21, 2021-4594 dated 07/14/21, 2021-4595 dated 07/14/21, 2021-4596 dated 07/14/21, etc
Report and/or the MDSAP Noncomformity Grading and Exchange Form (NC) for the inspection of Premier Dental
Products Co, Plymouth Meeting, PA , end date 01-17-2019. FEI# 2511556. This inspection pertains to medical devices.
Report and/or the MDSAP Noncomformity Grading and Exchange Form (NC) for the inspection of Curvebeam, Hatfield,
PA , end date 05-01-2019. FEI# 3009543051. This inspection pertains to medical devices.
Report and/or the MDSAP Noncomformity Grading and Exchange Form (NC) for the inspection of Henry Schein Inc. and
Glove Club HSI Gloves Inc., Melville, NY , end date 08-22-2019. FEI# 1000522050. This inspection pertains to medical
devices.
Report and/or the MDSAP Noncomformity Grading and Exchange Form (NC) for the inspection of Ortho Clinical
Diagnostics Inc, Raritan, NJ , end date 09-28-2017. FEI# 2250051. This inspection pertains to medical devices.
OTC Sunscreen Label Submissions: Please produce all labels and related informational submissions, including Product
Listings (exemplar labels, National Drug Codes (“NDC”), drug name, dosage form and route of administration, active and
inactive ingredient unique ingredient identifier code (“UNII”) and amount/strength, etc
Salmonella Newport Outbreak in Summer 2020 Recall Numbers: F-1272-2020; F-1273-2020; F-1274-2020; F-1275-2020
Confirmation # FDA2070729
I would like to request a copy of the FDA cleared 51O(k) Submission #K143120 for: Device Classification Name:
Orthodontic Led Accessory; Device Name: OrthoPulse; Applicant: BIOLUX RESEARCH LTD., 825 POWELL STREET, SUITE
220, Vancouver, CA V6a 1h7; Date Received: 10/30/2014; Decision Date: 07/24/2015.
Please provide a copy of the FDA form 483 for the inspection of firm BAL PHARMA LIMITED, FEI 3006807057, ending on
16 November 2018.
Please provide the all CAPA responses from Uquifa SA , FEI 1000260514, and FDA CAPA correspondence for the
inspection conducted 07/23/2018 to 07/27/2018 resulting in inspection classification VAI.
"Review" package for the following application: New Drug Application (NDA): 022388
ANDA 072927
Meeting minutes of EoP 2 meeting (15-Oct-2009), Type C (08-Jan-2010) and Pre-NDA meeting (0-Jul-2010) for
NDA#201635.
for Human Drugs inspection of Plastikon Healthcare LLC ending 11/04/2021 at the location in Lawrence KS, United
for Medical Devices & Rad Health inspection of Tegra Medical Costa Rica Sa ending 05/18/2017 at the location in La
Aurora, Costa Rica. The Response (in electronic format) for Medical Devices & Rad Health inspection of Tegra Medical
Costa Rica Sa ending 05/18/2017 at the location in La Aurora, Costa Rica. Please send documents as email attachments.
for Foods & Cosmetics inspection of Taylor Farms Maryland, Inc. ending 07/13/2020 at the location in Annapolis
Junction MD, United States. Please send documents as email attachments.
format) for Biologics inspection of Novartis Pharma Stein AG ending 08/24/2017 at the location in Stein AG, Switzerland.
for Biologics inspection of MD Anderson Cord Blood Bank ending 03/24/2022 at the location in Houston TX, United
for Biologics inspection of Ochsner Health System Blood Bank ending 03/31/2022 at the location in New Orleans LA,
United States. The 483 (in electronic format) for Biologics inspection of Blood Center (The) Mandeville Donor Center
ending 03/11/2022 at the location in Mandeville LA, United States. etc
for Biologics inspection of Aldevron LLC ending 11/05/2021 at the location in Fargo ND, United States. Please send
all written correspondence in releasable format between each of the facilities indicated below and the Office of
Laboratory Animal Welfare documenting noncompliance items
2022-1289, 2022-1323, 2022-2534, 2022-2535, 2022-2568
2022-2569, 2022-2603, 2022-2761, 2022-3033, 2022-3045
Copies of Form 483s issued by the CDER Office in March 1-31, 2022.
Copies of Form 483s issued by the CDER Complex Office in March 1-31, 2022.
Copies of Form 483s issued to the following CLINICAL INVESTIGATOR from March 1-31, 2022:
(Rq.#1) Copies of Form 483s issued to the following DEVICE companies from March 1-31, 2022.
(Rq.#1) Copies of Form 483s issued to the following DRUG companies from March 1-31, 2022.
CVs Ling Yang, Sandra Wilson, Douglas Scott, Kayleigh Macmaster, Cheryl English, Siobhan Taylor, Crystal Nevins, Amogh
Pathi, Jacob Lutz, Lisa Parsons, Lixia Cai, Mark Johnson, etc
Copy of the disclosable portions of all communications between CBER and Stability Biologics regarding particle size or
morselized human drug tissue products, from 01/01/2018 to the present. Please note we are not looking for any
information contained in a non-approved product submission.
in the month of April 1 to30, 2022, including for any inspections dated before April 1, for: • Pharmaceutical, biologics
and medical device manufacturing facilities, including premarket approval inspections; AND • Clinical research
facilities, investigators and IRBs. Please include the state in which each recipient of a 483 is located (as requested by
FDA FOI Technician Claire Stansbury).
All disciplinary and scientific review documents as well as full Technical Project Lead memos for the recent MGOs issued
by CTP for Vuse Ciro and Vibe ENDS products: PM0000635, PM0000636, PM0000646, PM0000712, PM0004287,
PM0004293
Copy of the disclosable portions of the MedWatch reports for the 2 following molnupiravir cases: 20784930; and
20775245.
Previous FOIA Request Control # 2021-4929 submitted 07/28/21 and FDA Response.
Requesting FDA consumer complaint number 172435 and any other additional documents.
I am seeking the data sets used by FDA using the 21 Forward System to track the infant formula supply nationwide.
recs re (1) Restore Hyper Wellness or Restore HyperWellness; (3) Vitaeris 320; (4) Nicole Welch; (5) Oxygen Health
Systems; (6) Oxy-Flow, OxyFlow, or Oxy Flow (hyperbaric chamber); (7) OxyHealth or Oxy Health; or (8) Bart Kemper.
Any medical device adverse event reports submitted regarding Atrium Medical Corporation's hernia mesh products,
including the ProLite- and C-QUR products. I am making the request as the MDR:s from the designated time period are
not available through MAUDE.
I would like to request a copy of 2021 SteriPack USA EIR.
• All requests for fast-track status for any drug intended to treat gastroparesis, and any records attached to,
contained in, relating to, or disposing of such requests. • etcstroparesis.
ABBOTT NUTRITION EIR
The Statistical Analysis Plan (SAP) for clinical trial NCT02547220 (EudraCT number 2015-000726-11; sponsor protocol
number SHP616-302) is available on the FDA website at
https://clinicaltrials.gov/ProvidedDocs/20/NCT02547220/SAP_001.pdf On page 37/78, that document refers to a DMC
SAP (presumably Data Monitoring Committee Statistical Analysis Plan).
Any internal review of cosmetic talcum powder in relation to ovarian or fallopian tube cancer. Also, any communications
referencing the Screening Assessment of Talc by Health Canada.
Would like to obtain the Establishment Inspection Report for the inspection conducted end date of 9/22/2017 the
Inspection ID #is 1030265 at Paragon Medical Inc. 8 Matchett Drive Pierceton, Indiana 46562.
Would like a copy of the Establishment Inspection Report for the inspection conducted end date 04/09/2019, at
Paragon Medical a Division of NN Inc, 7350 E. 86th Street, Indianapolis Indiana. Inspection ID 1092869
I request the recent FDA Form 483 issued to the UCB Pharma at their Braine-l'alleud facility in Belgium. Our
understanding is that this form 483 was issued to UCB Pharma in Feb 2022 and that’s what we are requesting
Please provide Summary Basis of Approval of BACLOFEN SUSPENSION ORAL (FLEQSUVY) 25MG/5ML for the Applicant
AZURITY PHARMACEUTICALS INC-N215602
Please provide Summary Basis of Approval of DILTIAZEM HYDROCHLORIDE TABLET ORAL (CARDIZEM) 30mg,
60mg,90mg,120mg for the following mentioned Applicant Holders : 1. BAUSCH HEALTH US LLC-N018602 2.
EDENBRIDGE PHARMACEUTICALS LLC-A211596
FDA 483 for inspection of R.L.Fine Chem Private Limited, FEI 3005560263 / DUNS 871410195, ending on 2/22/2019.
Including any CAPA correspondence related to corrective actions for the FDA observations.
K191080
510(k) Submission for Medtronic Extended Infusion Set K210544.
510(k) submission for SmartAdjust technology, part of Insulet Omnipod 5 Automated Insulin Delivery System, K203774.
Hi! I'd like to see record of any documents requested by Bloomberg or Bloomberg LP or Bloomberg News pertaining to
baby formula, infant formula and Abbott Laboratories.
The 483 (in electronic format) for Animal Drugs & Feeds inspection of Taylor Farms Maryland, Inc. ending 08/25/2017
at the location in Annapolis Junction MD, United States. The EIR (in electronic format) for Animal Drugs & Feeds
inspection of Taylor Farms Maryland, Inc. ending 08/25/2017 at the location in Annapolis Junction MD, United States.
The Response (in electronic format) for Animal Drugs & Feeds inspection of Taylor Farms Maryland, Inc. ending
08/25/2017 at the location in Annapolis Junction MD, United States. Please send documents as email attachments.
The 483 (in electronic format) for Human Drugs inspection of Pfizer Inc. Groton Laboratories ending 10/27/2010 at the
location in Groton CT, United States. The EIR (in electronic format) for Human Drugs inspection of Pfizer Inc. Groton
Laboratories ending 10/27/2010 at the location in Groton CT, United States. The Response (in electronic format) for
Human Drugs inspection of Pfizer Inc. Groton Laboratories ending 10/27/2010 at the location in Groton CT, United
The 483 (in electronic format) for Medical Devices & Rad Health inspection of Amtai Medical Equipment, INC ending
02/28/2022 at the location in Raleigh NC, United States. The 483 (in electronic format) for Medical Devices & Rad
Health inspection of 360 Imaging LLC ending 03/03/2022 at the location in Atlanta GA, United States. Please send
for Medical Devices & Rad Health inspection of Meddev Corp ending 02/28/2022 at the location in Sunnyvale CA, United
for Medical Devices & Rad Health inspection of WHPM Inc. ending 02/28/2022 at the location in Irwindale CA, United
RECS RE THE HAPPY GROUP
Copy of the 483 for the Jan 18, 2017 - Feb 3, 2017 (17 days) inspection of Center for Reproductive Health Joliet IVF LLC
[Crest Hill / United States of America] 2246 Weber Rd, Crest Hill, IL 60403, USA. This inspection pertains to biologics.
Summary Basis of Approval for NDA 215935
Copy of the 483 for the Apr 26, 2017 - May 2, 2017 (7 days) inspection of Phase 4 Pharmaceutical Llc [Aventura / United
States of America] 21055 NE 37th Ave APT 2202, Aventura, FL 33180, USA. This inspection pertains to human drugs.
Copy of the 483 for the May 29, 2017 - May 30, 2017 (2 days) inspection of AN Co. Ltd. [Yeongdong-gun / Korea
(Republic of)] 1452-248 Yeongdong hwanggan-ro, Hwanggan-myeon Yeongdong-gun Korea (the Republic of). This
Copy of the 483 for the Jul 10, 2017 - Jul 14, 2017 (5 days) inspection of Deserving Health International Corp
[Richmond / Canada] 13160 Vanier Pl #110, Richmond, BC V6V 2J2, Canada. This inspection pertains to human drugs.
Report and/or the MDSAP Noncomformity Grading and Exchange Form (NC) for the inspection of Bioventus, LLC,
Cordova, TN , end date 08-14-2015. FEI# 3010203571. This inspection pertains to medical devices.
Report and/or the MDSAP Noncomformity Grading and Exchange Form (NC) for the inspection of Curvebeam, Hatfield,
PA , end date 05-18-2017. FEI# 3009543051. This inspection pertains to medical devices.
Report and/or the MDSAP Noncomformity Grading and Exchange Form (NC) for the inspection of Dental Imaging
Technologies Corp., Hatfield, PA , end date 06-14-2017. FEI# 1000221167. This inspection pertains to medical devices.
Report and/or the MDSAP Noncomformity Grading and Exchange Form (NC) for the inspection of PECA Labs, Inc,
Pittsburgh, PA , end date 11-30-2018. FEI# 3013718163. This inspection pertains to medical devices.
Email communications to or from hoauyan@gmail.com regarding Clinical Trial: NCT04079803 AND any previously
released FOIAs involving Clinical Trial: NCT04079803
Electronic listing (preferably csv format) of all inspections conducted by FDA since January 1, 2022 The list should cover
Regulatory Assessment of Biomat USA Inc. dba Grifols Located at Johnson City TN United States FEI Number: 1071197
held on 06/22/2021.
Regulatory Assessment of CSL Plasma Located at State College PA United States FEI Number: 3015996550 held on
06/17/2021.
Regulatory Assessment of Biomat USA, Inc. Located at Cedar City UT United States FEI Number: 3011853315 held on
06/17/2021.
Regulatory Assessment of CSL Plasma Inc. Located at Orange City FL United States FEI Number: 3012194482 held on
06/15/2021.
ANDA 070182 for Methyldopa/Hydrochlorothiazide Tablets, 250/15 mg FDA approved Jan 15, 1986 • ANDA
070183 for Methyldopa/Hydrochlorothiazide Tablets, 250/25 mg FDA approved Jan 15, 1986 etc
Request is for the "Form 483" issued to Aurobindo Pharma Limited (FEI number 3007373532) address: Unit Vii,
Formulation Plant, Plot S-1, Survey 411, 425, 434-435, 458, Tsiic, Green Ind. Park Polepally, Mahaboob Nagar, Telangana
509302 India
K161229 K103792
Copy of the EIR for the following inspection: Etienne M. H. Sokal, MD, PhD. - Inspection, 2021-06-04
Copy of the EIR for the following inspection: Dorota Gliwicz- Miedzinska - Inspection, 2021-06-18
Copy of the EIR for the following inspection: Loreto Hierro, MD - Inspection, 2021-04-16
Hi! I'd like to see any records and emails and phone calls pertaining to counterfeit baby formula or counterfeit infant
formula. That could also show up as "fake" baby formula or infant formula. Thanks!
• Request for MedWatch Report for Product Case ID 20582952 • Suspect Product: Exondys 51 • Reaction: Wrong
Product Administered;Product Dispensing Error;Product Name Confusion;Product Packaging Confusion • Male 4 YR •
Country of occurrence: Not Specified • Manufacturer Control Number: Not provided
(1) Any and all reports received by FDA pursuant to post-approval study number P140003 S004/PAS001, titled Impella
AMI CS PAS (listed here: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma_pas.cfm?
t_id=577423&c_id=3925), and (2) Any and all reports received by FDA pursuant to post-approval study number
P140003 S005/ PAS001 etc
Pertaining to a Medical Device inspection, please provide the FDA-483 document for: Dynex Technologies, Inc., 14340
Sullyfield Circle, Chantilly, VA 20151
Pertaining to a Medical DEVICE inspection, please provide the FDA-483 document for: Sunnex, LLC, 8001 Tower Point
Dr., Charlotte, NC 28227
Pertaining to a Medical DEVICE inspection, please provide the FDA-483 document for: Custom Wire Technologies, Inc.,
1123 Mineral Springs Dr., Port Washington, WI 53074
Pertaining to a Medical DEVICE inspection, please provide the FDA-483 document for: Breas Medical, Inc., 16 Esquire
Rd., North Billerica, MA 01862
Pertaining to a Medical DEVICE inspection, please provide the FDA-483 document for: Nantsound, Inc., 960 N.
Northwest Hwy. Park Ridge, IL 60068
Looking for VAERS Report
Pertaining to a Medical DEVICE inspection, please provide the FDA-483 document for: Spineology, Inc. 7800 3rd St. N
Ste 600, Saint Paul, MN 55128
Pertaining to a Medical DEVICE inspection, please provide the FDA-483 document for: Nikao, Inc., 1880 N Commerce
Pkwy, Ste 1 Weston, FL 33326
Pertaining to a Medical DEVICE inspection, please provide the FDA-483 document for: Micron Solutions, Inc., 25
Sawyer Passway, Fitchburg, MA 01420
Request for the summary basis of approval for the product HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B
SULFATE - A062423 manufactured by Sandoz Inc.
toxicology, including all toxicity studies and toxicology review memoranda generated by FDA, and chemistry, including
all chemistry review memoranda, of the following substances: • Calcium phosphate, tribasic (CAS Reg. No. 7758-87-4) •
Calcium phosphate, dibasic (CAS Reg. 7757-93-9) • Calcium phosphate (CAS Reg. No. 10103-46-5)
Please provide the following photos described in the FDA inspection of the Sturgis, MI Abbott Laboratories plant
concluding 9/24/2021 with FEIN 1815692: (Exhibit 27-Photographs RIMG0003 & RIMG0004) (Exhibit 28-Photograph
RIMG0007).
(1) The Technical Project Lead (TPL) memorandum and any and all related documents associated with RJRV’s PMTA
submissions and the documents associated with each FDA scientific review discipline (e.g., epidemiology, behavior,
biology, chemistry, engineering, toxicology, addiction, social science, public health, etc.) for the products and
applications listed above (PM0000635 (Vuse Vibe Power Unit);etc
Please send me all FD-483 forms for Abbott Nutrition's baby formula plant in Sturgis, Michigan, located at 901 N.
Centerville Road.
Please send me all Form 483s for Abbott Nutrition's plant in Columbus, Ohio that is located at 585 Cleveland Avenue.
A list of all synthetic nicotine products for which a premarket tobacco product application (PMTA) has been submitted
to FDA by May 14, 2022 pursuant to the recent enactment of federal legislation to provide FDA the specific authority to
regulate synthetic nicotine tobacco products.
records and documents in paper and electronic form regarding Abbott Laboratories recall of baby food at the Sturgis, MI
plant including but not limited to inspection reports containing facts pertaining to conditions at the plant, patent
information, warning letters, consent decries, and correspondence between Abbott Laboratories and the United States
government
Requesting FOIA on K130255
Requesting FOIA on K171771.

Requesting a copy of the FDA EIR from an FDA Inspection that was conducted in our CSL Plasma, Inc.- Baltimore , MD
location (3012614076) September 27, 2021- September 28, 2021.
Requesting a copy of the FDA EIR from an FDA Inspection that was conducted in our CSL Plasma, Inc.-El Paso, TX location
(1047112) October 29, 2021 - November 3, 2021.
Requesting a copy of the FDA EIR from an FDA Inspection that was conducted in our CSL Plasma, Inc. -MIdvale , UT
(3017028952) November 8, 2021 - November 12, 2021.
Under FOIA, I request the FAERS "detail report" for oxycodone hydrochloride within the date range set above.
We wish to obtain a copy of the report from the voluntary Remote Regulatory Assessment held on the period of 11 Jan
2022 through 28 Jan 2022.
510(k) submission for Omnipod 5 SmartBolus Calculator, part of the Insulet Omnipod 5 Automated Insulin Delivery
System.
510(k) submission for Omnipod 5 ACE Pump (Pod), part of the Insulet Omnipod 5 Automated Insulin Delivery System.
Inquiry concerns information on Axsome Therapeutics' NDA for AXS-05
Any documentation pertaining to the GED-3A and GED-4 devices operated by the Judge Rotenberg Center as mentioned
on page 4 of the “FDA Executive Summary Prepared for the April 24, 2014 meeting of the Neurological Devices Panel
Electrical Stimulation Devices for Aversive Conditioning" ETC
I am seeking records regarding the drug Diacels, previously known as Anox.
• Request for MedWatch Report for Tebentafusp Case ID 20503971 • Suspect Product:
Pembrolizumab;Dacarbazine;Tebentafusp;Fotemustine • Reaction: Acute Myeloid Leukaemia • Female 72 YR • Country
of occurrence: France • Manufacturer Control Number: FR-009507513-2202FRA005657
• Request for MedWatch Report for Tebentafusp Case ID 20508964 • Suspect Product: Tebentafusp • Reaction:
Decreased Appetite;International Normalised Ratio Increased;Aspartate Aminotransferase Increased;Muscular
Weakness;Alanine Aminotransferase Increased;Fall;Blood Alkaline Phosphatase Increased;Prothrombin Level
Increased;Asymptomatic Covid-19;Fatigue • Male 86 YR • Country of occurrence: Not specified • Manufacturer Control
Number: Not provided
• Request for MedWatch Report for Tebentafusp Case ID 15642098 • Suspect Product:
Nivolumab;Ipilimumab;Tebentafusp • Reaction: Skin Hypopigmentation;Tumour Pain;Malignant Neoplasm
Progression;Skin Hyperpigmentation;Fatigue;Erythema Multiforme;Dysgeusia;Photosensitivity Reaction;Cytokine
Release Syndrome;Hyperhidrosis • Male 51 YR • Country of occurrence: Germany • Manufacturer Control Number: DE-
BRISTOL-MYERS SQUIBB COMPANY-BMS-2018-109252
• Request for MedWatch Report for Tebentafusp Case ID 15243475 • Suspect Product: Durvalumab;Tebentafusp •
Reaction: Cytokine Release Syndrome • Female 18366 DAY • Country of occurrence: GB • Manufacturer Control
Number: GB-ASTRAZENECA-2018SE98914
The information requested pertains to the Drug Safety Communication (DSC) issued by the United States Food and Drug
Administration (“FDA”) on October 15, 2020 concerning avoidance of nonsteroidal anti-inflammatory drugs (NSAIDs)
beginning at week 20 of pregnancy due to the risk of neonatal renal dysfunction and oligohydramnios.
All documents and correspondence, within or among FDA, HHS, DEA, NIDA, and/or ONDCP, related to DEA’s February 4,
2020 request that HHS conduct an eight-factor analysis of and make a scheduling recommendation for FRS as a class ETC
I would like any and all information pertaining to PCR testing machines, the brands
most commonly used, their distribution and implementation across the US ETC
Underlying case records from the FDA Adverse Event Reporting System (FAERS) referencing lumakras
(sotorasib), which is being developed by Amgen, in combination with certain checkpoint inhibitors (PD-
1/PD-L1 class of drugs) to treat lung cancer.
for Human Drugs inspection of AAA Pharmaceutical, Inc. ending 04/03/2019 at the location in Lumberton NJ, United
for Medical Devices & Rad Health inspection of X-Cel X-Ray Corp ending 03/04/2022 at the location in Crystal Lake IL,
for Medical Devices & Rad Health inspection of Wound Healing Technologies ending 03/02/2022 at the location in
Brooklyn NY, United States. Please send documents as email attachments.
for Medical Devices & Rad Health inspection of Texas Medical Technology Inc. ending 03/03/2022 at the location in
Houston TX, United States. Please send documents as email attachments.
for Medical Devices & Rad Health inspection of Vaupell Midwest Molding and Tooling ending 03/04/2022 at the location
in Constantine MI, United States. The 483 (in electronic format) for Medical Devices & Rad Health inspection of C&A
TOOL ending 03/02/2022 at the location in Auburn IN, United States. Please send documents as email attachments.
for Medical Devices & Rad Health inspection of Bradshaw Medical, Inc. ending 02/28/2022 at the location in Kenosha
for Medical Devices & Rad Health inspection of Stand Aid Of Iowa Inc ending 03/03/2022 at the location in Sheldon IA,
United States. The 483 (in electronic format) for Medical Devices & Rad Health inspection of American Contract
Systems, Inc. ending 03/02/2022 at the location in Kansas City MO, United States. The 483 (in electronic format) for
Medical Devices & Rad Health inspection of Troy Hounshell, D.O. ending 03/04/2022 at the location in West Des Moines
IA, United States. Please send documents as email attachments.
On behalf of Lupin Pharmaceuticals, Inc. I request you to provide me with the latest label for the product EXFORGE(NDA
021990) approved on 04/07/2021 as per SUPPL-41.
Any and all emails sent or received by FDA employees in the Office of Non-prescription Drugs that contains the text "ISO
24442", "ISO 24443", and/or "ISO 24444"
(1). Form 483 issued during February 2022 to Cangene BioPharma (Emergent BioSolutions) located at 1111 South Paca
Street, Baltimore, Maryland 21230. (2). Response to Form 483 from Cangene BioPharma (Emergent BioSolutions) dated
March 10, 2022. (3). Letter from FDA to Cangene BioPharma (Emergent BioSolutions) dated May 16, 2022 with status
designation of the February 2022 inspection.
This FOIA request is for a copy of the 510(k) K201346 DePuy Synthes Retrograde Femoral Nail Advanced System, DePuy
Synthes Locking Screws for Medullary Nails, 5.0 mm.
We request to have the Establishment Registration and Medical Device Listing Files from 2000 to 2022. Thanks.
https://www.fda.gov/medical-devices/device-registration-and-listing/establishment-registration-and-medical-device-
listing-files-download
Documents referring to "suspected but unconfirmed" COVID-19 cases -- or cases that were not PCR confirmed -- among
clinical trial participants in the Pfizer and BioNTech application for Emergency Use Authorization (EUA) for a COVID-19
vaccine (BNT162b2).
All CRO's (Contract Research Organizations) registered with the FDA in that time period. Please only include each CRO
once, if they register multiple times. Please include the CRO name, contact information provided, primary mailing
address, and any personnel associated with the registered company.
Cpies of all Food and Drug Administration ("FDA") contracts and blanket purchase agreements ("BPAs") awarded to
McKinsey & Company, Inc. or any affiliate thereof (“McKinsey”) during the period of January 1, 2012–May 11, 2022.
Please provide any correspondence between the FDA, the CDC, HHS and any outside entity including Pfizer and
Moderna discussing the possibility of pulling the Pfizer and/or Moderna mRNA Covid vaccines from the market. I would
also like to request any correspondence between the above listed entities showing discussions about non renewal of
the emergency use authorizations for the mRNA Covid vaccines produced by both Pfizer and Moderna? Thank you
Requesting report submitted on 1/4/22 for: Adverse Event (a symptom, reaction or disease associated with the product)
FDA ICSR ID 2123600
Hi, I am an investment professional for an asset management firm and would like to request the FAERS (adverse events)
data for Paxlovid (nirmatrelvir; ritonavir) for December 2021-present. Can you please email in PDF format if possible?
Thank you.
Microsoft Excel model described in the article "Benefit-risk assessment of COVID-19 vaccine, mRNA (Comirnaty) for
age16–29 years" by Funk et al. https://doi.org/10.1016/j.vaccine.2022.03.030
510(k) K190792
Guidance, opinion letters, or other commentary concerning whether bottled drinking water that has been processed
through industrial scale granular activated carbon filters, including those made by Apex Water Systems, or ion-exchange
resin devices, including the Diphonix system made by Eichron Technologies, Inc., should be labeled as “purified water”
under the standard of identity for "Bottled Water" codified at 21 CFR 165.110(a)(2)(iv).
All Estabishment Inspection Reports for the Abbott Nutrition facility in Sturgis, MIchigan.
Please send establishment inspection reports, citations, records pertaining to investigations and final classification
letters at Abbott Nutrition's plant in Columbus, Ohio that is located at 585 Cleveland Avenue. This relates to baby
formula.
Please send me all Form 483s and citations on final classification letters related to baby formula at Abbott Nutrition's
facility in Cootehill, Ireland.
INDIVIDUAL RECS
Would like more information regarding entries for which Markon ShamrockArizona and Gordons Springfield/O Markon
Cooperative was declared as FSVP
2022-126
2022-132
2022-133
2022-134
2022-135
2022-136
2022-191
2022-497
2022-649
NBC News is requesting any and all emails to or from Susan Mayne using this email address or any other official
government email address - Susan.Mayne@fda.hhs.gov - that includes the words "Abbott" and/or "formula".
NBC News is requesting any and all emails to or from Elizabeth P. Mayer's official FDA email account that include the
words "formula" and/or "Abbott" and/or "Sturgis". NBC News is requesting any and all emails to or from Adam M.
True's official FDA email account that include the words "formula" and/or "Abbott" and/or "Sturgis".
1. All emails sent to and from FDA Commissioner Robert M. Califf, Principal Deputy Commissioner Janet Woodcock,
Center for Food Safety and Applied Nutrition Director Susan T. Mayne, and Office of Food Safety Director Mark
Moorman referencing any of the following terms: “Abbott Nutrition”, “baby formula”, “infant formula”, “Cronobacter
sakazakii”, “Salmonella”, and/or “White House ETC
A) All calendar items that reference or include the terms “formula” and any of the
following: “shortages,” “safety”, or “import.”
B) All records of or referencing baby formula shortages or safety issues with the
manufacture or importation of baby formula.
C) All records containing the terms “price gouging” and “formula.”
D) All records containing or referencing proposals to import internationally manufactured
baby formula
for Human Drugs inspection of AAA Pharmaceutical, Inc. ending 04/03/2019 at the location in Lumberton NJ, United
States. The Response (in electronic format) for Human Drugs inspection of AAA Pharmaceutical, Inc. ending 04/03/2019
at the location in Lumberton NJ, United States. Please send documents as email attachments.
for Human Drugs inspection of Lohxa, LLC ending 07/19/2021 at the location in Worcester MA, United States. Please
for Human Drugs inspection of Jawahar L. Taunk, M.D. ending 12/09/2021 at the location in Palm Harbor FL, United
States. The Response (in electronic format) for Human Drugs inspection of Jawahar L. Taunk, M.D. ending 12/09/2021
at the location in Palm Harbor FL, United States. Please send documents as email attachments.
for Human Drugs inspection of West Coast Cosmetics Inc ending 03/09/2022 at the location in Chatsworth CA, United
States. The 483 (in electronic format) for Human Drugs inspection of Green Wave Analytical, LLC ending 03/07/2022 at
the location in San Diego CA, United States. Please send documents as email attachments.
for Human Drugs inspection of Clario Inc. ending 03/04/2022 at the location in Princeton NJ, United States. Please send
for Human Drugs inspection of Mid-Continent Packaging, Inc ending 03/07/2022 at the location in Enid OK, United
for Human Drugs inspection of MD Logistics, Llc ending 03/04/2022 at the location in Plainfield IN, United States. Please
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20654558 20645233 20610204 20567564 20552479 20520829 20503954 20480722 20484363 20480656 20375642
20436273 20423055 20432361 20362684 20355429
A topline listing of human adverse events associated with Excedrin sourced from the FAERS Public Dashboard.
Hello! I’m looking for information of whether “Danone” or “Nestle” or “Reckitt” are trying to get permission from the
FDA to import more products in from other countries, now that the FDA is allowing more types of baby/infant formula
in. Some (but not all) brands include Aptamil, Enfamil and Gerber.
All documents and records involving the FDA Inspection of Sturgis, Michigan production facility for Similac, Alimentum
and EleCare.
Requesting any records pertaining to explosion or fires involving lithium ion batteries. In particular, the MXJO 18650
Hello, Please provide all preliminary, interim, and finalized reports on the FDA's investigation of cronobacter infections
in infants and of the investigation into Abbott's Michigan facility Also provide all unpublished memorandums,
investigation notes, and other documents related to the probe
Hi, Please provide all emails, instant chat messages, and texts to or from Dr. Califf mentioning "baby formula."
Hi, Please provide all emails, instant chat messages, and texts to or from Dr. Woodcock mentioning "baby formula."
Hello, Please provide the names and titles of all FDA employees working on baby formula. According to Dr. Califf, the
number of such workers is nine.
The data we want is the 10109 cases of consumer-reported variables for the 2007 melamine. We find this data
appears in one Ph.D. thesis and a peer-review article with the same author (The attachment is the peer-review article
containing these data). We aim to visualize the 10109 cases data in a different way. Thus, it would be great if we can
have the original data.
Request for information on company owned properties (Establishment Inspection Report and 483's)
Request for information on company owned properties (Establishment Inspection Report and 483's).
Good morning, please can I request the 483 form as supplied to others in requests 2022-1303 and 2022-2519.
Request on studies referenced in the NON-CLINICAL REVIEW of application number 212895Orig1s000 for
Levamlodipine Maleate product Conjupri by CSPC Ouyi Pharmaceutical Co., LTD. Reports of studies mentioned in
Sections 3 to 9 are requested.
At FDA's website there is a reference to the VCRP and a monthly status report -
https://www.fda.gov/cosmetics/voluntary-cosmetic-registration-program/cosmetic-registration-reports. We request
the 23 available data points (to include FEI numbers if possible) for the 5,096 active cosmetic registrations in FDA's
database since the VCRP was established in 1972.
Can I please request the CRL - complete response letter that UCB received from the FDA on Bimekizumab on May 12/13,
2022? Thank you
we would like to request the following Exparel FAERS case: 20572223
We want to appply for the technique documents or technical parameter of KeyPrint® KeySplint Soft™ which K number is
K183598, becasue it is our predicate device, we want to conduct predicate comparison with them when prepare 510k
submission documents
Please produce correspondence, inspection reports, complaints, and/or regulatory action taken by the FDA as to
Novavax or FUJIFILM Disoynth Biotechnologies regarding manufacturing deficiencies at its College Station, Texas and/or
Morrisville, North Carolina facilities.
I request access to and copies of FDA Establishment Inspection Report for Sagent Pharmaceuticals, Inc. (Schaumburg,
Illinois) FEI #3006167046; for December 9 - 18, 2019 inspection
I request access to and copies of FDA Establishment Inspection Report for Sagent Pharmaceuticals / Xellia
Pharmaceuticals (Raleigh, North Carolina) FEI #3005208599; for October 9-11 and October 15-18, 2019 inspections
FOIA request for K113871 PRO-DENSE BONE GRAFT SUBSTITUTE, Product Code MQV, by WRIGHT MEDICAL
TECHNOLOGY, INC
Request FDA 483 associated with Hikal Limited, FEI: 3003560263 / DUNS: 918602129, FDA inspection, end: 02 Aug 2019,
Category: Human Drugs Inspection - Location: Bangalore, India. Please include any previously released documentation
associated with this inspection. If not available, then just the FDA 483.
We are seeking the memo from the remote data review done for the Aveo AV-951-15-303 clinical trial from 13 Oct 2020
to 26 Oct 2020 at BC Cancer Vancouver. The PI is Dr. Christian Kollmannsberger.
We are seeking the memo documenting the remote data review of the Tesaro GARNET clinical trial done 02 Mar 2021 to
18 Mar 2021 at BC Cancer Kelowna.
Plasma Services, L.P. 9312 Arlington Expy, Jacksonville, FL 32225-8213 USA. FEI # 3017219911
Requesting Establishment Inspection Report for inspection conducted between 10/21/2021 and 10/27/2021 at BioLife
Plasma Services L.P. 1968 Mount Zion Road, Morrow, GA 30260-3316 USA. FEI # 3016620519
EIR for the CDRH QSIT inspection of Millstone Medical Outsourcing, LLC, 580 Commerce Drive, Fall River, MA 02720 on
October 19-22, 2021.
Request to acquire the FDA 483 for FDA inspection of S8092 Sun Pharmaceuticals - FEI: 3003952717 Category: Human
Drugs Inspection, ending 08 Nov 2019, Location: Baruch, India. Including any previously FOIA released documents
related to this inspection. If not available, then just the FDA 483.
RE: Pet Center Inc., Inglewood, CA (FEI #3003054732). Please supply FDA Form 483, complete Establishment Inspection
Report, Results of sample analyses (if any), and all correspondence pursuant to Inspection ID #1153 (end date of
10/08/2021).
RE: Pet Center Inc., Inglewood, CA (FEI #3003054732). Please supply FDA Form 483, complete Establishment Inspection
Report, results of any sample analyses (if available) and all correspondence pursuant to inspection end date
07/06/2000.
FDA RULES AND REGULATIONS REGARDING THC AND CBD USES AS RELATED TO MEDICINES AND TREATMENTS
HYDROCHLOROTHIAZIDE ADVERSE EVENTS, RECALL, APPROVAL
RECS RE STANDARD SET FORTH BY AMERICAN NATIONAL STANDARDS INSTITUTE AND ASSOCIATION FOR THE
ADVANCEMENT OF MEDICAL INSTRUMENTATION APPLICABLE TO ECG TRUNK CABLES AND PATIENT LEADWIRES
K823737, K010675 FIRST PARTY
SUPPLEMENTS THAT CONTAIN LABELING CHANGE 1/3/02 SUPPL-30 NARDIL
NAME AND ADDESS OF MANUFACTURER OF LISINOPRIL, SIDE EFFECTS, WARNINGS
for Foods & Cosmetics inspection of Abbott Laboratories dba Abbott Nutrition ending 03/18/2022 at the location in
Sturgis MI, United States. The Response (in electronic format) for Foods & Cosmetics inspection of Abbott Laboratories
dba Abbott Nutrition ending 03/18/2022 at the location in Sturgis MI, United States. Please send documents as email
attachments.
for Biologics inspection of Seqirus Vaccines Limited ending 06/28/2019 at the location in Liverpool, United Kingdom.
The EIR (in electronic format) for Biologics inspection of Seqirus Vaccines Limited ending 06/28/2019 at the location in
Liverpool, United Kingdom. The Response (in electronic format) for Biologics inspection of Seqirus Vaccines Limited
ending 06/28/2019 at the location in Liverpool, United Kingdom. Please send documents as email attachments.
I am requesting any and all correspondence and records related to new companies who are inquiring about shipping
infant formula to the US from overseas under the new relaxed rules announced to alleviate the shortage. We want to
see what new formula brands and companies have inquired about shipping their formula here to meet the heightened
demand. Thank you,
for Biologics inspection of Central Coast Multispecialty Medical Group, Inc. ending 04/14/2022 at the location in
Monterey CA, United States. The 483 (in electronic format) for Biologics inspection of Fisch LTD d.b.a Green Valley
Fertility Partners ending 04/13/2022 at the location in Henderson NV, United States. Please send documents as email
attachments.
for Biologics inspection of Cleveland Clinic Fertility Center ending 04/01/2022 at the location in Beachwood OH, United
for Biologics inspection of Rhode Island Blood Center, a Division of New York Blood Cent ending 04/15/2022 at the
location in Westerly RI, United States. Please send documents as email attachments.
EIR and FDA 483 for the inspection ending on 4/4/2019 of: Cambrex Karlskoga AB Karlskoga, Sweden FEI #
30001686607 Inspection ID # 1099984 An EIR summary is acceptable if it will expedite this request.
for Biologics inspection of Sher Fertility Solutions New York ending 04/01/2022 at the location in New York NY, United
Please provide the addresses and FEI numbers for all of the FDA-registered facilities, in the U.S. and abroad, where
Abbott Laboratories or any associated entity such as Abbott Nutrition manufactures, processes or handles infant
formula.
Pursuant to the Freedom of Information Act (5 U.S.C. §§ 552 et seq.), I am writing to request copies of the U.S. Food and
Drug Administration’s (FDA) chemistry and toxicology review memoranda for Food Contact Notification (FCN) 1649.
LANXESS Corporation is the Notifier and Manufacturer/Supplier for FCN 1649, which covers the use of 2-methyl-4-
isothiazolin-3-one (CAS Reg. No. 2682-20-4) for use as preservative in: (1) coatings that comply with 21 CFR § 175.300
(Resinous and polymeric coatings) and § 175.320 (Resinous and polymeric coatings for polyolefin films) and (2) can-end
and side-seam cements that comply with 21 CFR § 175.300.
“Xulane” by manufacturer, Mylan Technologies. Supplemental Approvals needed 1. 4/29/2022, SUPPL-14 Labeling-
Package Insert, Labeling-Package Insert, Labeling-Patient Package Insert; 2. 12/31/2020, SUPPL-10 Labeling-Package
Insert, Labeling-Patient Package Insert; 3. 4/24/2020, SUPPL-8 Labeling-Package Insert.
RECS RE LISINOPRIL
RECS RE BARD BENTRAL LEX HERNIA PATCH
PERCENTAGE OF POPULATION WITH DISEASE OR CONTRAINDICATORS WHO CANNOT TAKE COVID VACCINES ETC
Any and all records pertaining to cronobacter and salmonella infections in infants who consumed powdered infant
formula - dates, sources, etc
all documents related to the recent approval of Orencia (Abatacept) for the prevention of acute graft versus host
disease (aGVHD), in combination with a calcineurin inhibitor (CNI) and methotrexate (MTX), in adults and pediatric
patients two years of age and older undergoing hematopoietic stem cell transplantation (HSCT) from a matched or one
allele-mismatched unrelated donor.
NDA 215039
I am requesting incoming-and-outgoing correspondence between the Office Of The Commissioner Of The Food And
Drug Administration, which should be narrowed to emails containing the keywords “formula”, and/or “baby formula”,
AND “shortage”, and email accounts ending in the domain @governor.virginia.gov from 04/01/2022 to the present.
I am seeking all communications, interactions and meetings, between the FDA and U.S manufacturers of infant formula,
including Abbott Laboratories, the makers of Similac formula, between February 1, 2022 and May 16, 2022 etc
NDA 021014 Product Number: 001 Approval Date: Jan 14, 2000 Applicant Holder Full Name: NOVARTIS
PHARMACEUTICALS CORP Marketing Status: Prescription
Active Ingredient: OXCARBAZEPINE Proprietary Name: OXCARBAZEPINE Dosage Form; Route of Administration: TABLET;
ORAL Strength: 150MG, 300 mg and 600 mg Reference Listed Drug: No Reference Standard: No TE Code: AB Application
Number: ANDA 215939 Product Number: 001 Approval Date: Jan 11, 2022 Applicant Holder Full Name: ANNORA
PHARMA PRIVATE LTD Marketing Status: Prescription
Subject: Reference Listed Drug (ASCOR) Ascorbic Acid Injection, USP 25,000 mg/50 mL (500 mg/mL) – Q & Q (Qualitative
& Quantitative) Composition.
BRECKENRIDGE PHARMACEUTICAL INC. Details of this generic product are given below- Active Ingredient:
OXCARBAZEPINE Proprietary Name: OXCARBAZEPINE Dosage Form; Route of Administration: TABLET; ORAL Strength:
150MG, 300 mg and 600 mg Reference Listed Drug: No Reference Standard: No TE Code: AB Application Number: ANDA
078069 Product Number: 001 Approval Date: Jan 11, 2008 Applicant Holder Full Name: BRECKENRIDGE
PHARMACEUTICAL INC Marketing Status: Prescription
GLENMARK PHARMACEUTICALS LTD. Details of this generic product are given below- Active Ingredient:
077802 Product Number: 001 Approval Date: Oct 9, 2007 Applicant Holder Full Name: GLENMARK PHARMACEUTICALS
LTD Marketing Status: Prescription
RUBICON RESEARCH PRIVATE LTD. Details of this generic product are given below- Active Ingredient: OXCARBAZEPINE
Proprietary Name: OXCARBAZEPINE Dosage Form; Route of Administration: TABLET; ORAL Strength: 150MG, 300 mg
and 600 mg Reference Listed Drug: No Reference Standard: No TE Code: AB Application Number: ANDA 077747 Product
Number: 001 Approval Date: Apr 9, 2008 Applicant Holder Full Name: RUBICON RESEARCH PRIVATE LTD Marketing
SUN PHARMACEUTICAL INDUSTRIES LTD Details of this generic product are given below- Active Ingredient:
077794 Product Number: 001 Approval Date: Oct 9, 2007 Applicant Holder Full Name: SUN PHARMACEUTICAL
INDUSTRIES LTD Marketing Status: Prescription
SUN PHARMACEUTICAL INDUSTRIES LTD Details of this generic product are given below- Active Ingredient:
CARBIDOPA; LEVODOPA Proprietary Name: CARBIDOPA AND LEVODOPA Dosage Form; Route of Administration:
TABLET, ORALLY DISINTEGRATING; ORAL Strength: 10 mg/ 100 mg, 25 mg/100 mg and 25 mg/250 mg Reference Listed
Drug: No Reference Standard: No TE Code: AB Application Number: A078690 Product Number: 002 Approval Date: Jul
31, 2009 Applicant Holder Full Name: SUN PHARMACEUTICAL INDUSTRIES LTD Marketing Status: Prescription
IMPAX LABORATORIES INC Details of this generic product are given below- Active Ingredient: CARBIDOPA; LEVODOPA
Proprietary Name: CARBIDOPA AND LEVODOPA Dosage Form; Route of Administration: TABLET, ORALLY
DISINTEGRATING; ORAL Strength: 10 mg/ 100 mg, 25 mg/100 mg and 25 mg/250 mg Reference Listed Drug: No
Reference Standard: No TE Code: Application Number: A090631 Product Number: 001 Approval Date: Jun 8, 2010
Applicant Holder Full Name: IMPAX LABORATORIES INC Marketing Status: Discontinued
IMPAX LABORATORIES INC Details of this generic product are given below- Active Ingredient: CARBIDOPA; LEVODOPA
Proprietary Name: CARBIDOPA AND LEVODOPA Dosage Form; Route of Administration: TABLET, ORALLY
DISINTEGRATING; ORAL Strength: 10 mg/ 100 mg, 25 mg/100 mg and 25 mg/250 mg Reference Listed Drug: No
Reference Standard: No TE Code: Application Number: A090631 Product Number: 001 Approval Date: Jun 8, 2010
Applicant Holder Full Name: IMPAX LABORATORIES INC Marketing Status: Discontinued
UCB INC Details of this generic product are given below- Active Ingredient: CARBIDOPA; LEVODOPA Proprietary Name:
PARCOPA Dosage Form; Route of Administration: TABLET, ORALLY DISINTEGRATING; ORAL Strength: 10 mg/ 100 mg, 25
mg/100 mg and 25 mg/250 mg Reference Listed Drug: No Reference Standard: No TE Code: Application Number:
A076699 Product Number: 001 Approval Date: Aug 27, 2004 Applicant Holder Full Name: UCB INC Marketing Status:
Discontinued
INDAPAMIDE Proprietary Name: LOZOL Dosage Form; Route of Administration: TABLET; ORAL Strength: 1.25MG and 2.5
MG Reference Listed Drug: Yes Reference Standard: No TE Code: Application Number: N018538 Product Number: 002
Approval Date: Apr 29, 1993 Applicant Holder Full Name: SANOFI AVENTIS US LLC Marketing Status: Discontinued
SBOA of the current approved generic product- ANI PHARMACEUTICALS INC Details of this approved generic product are
given below- Active Ingredient: INDAPAMIDE Proprietary Name: INDAPAMIDE Dosage Form; Route of Administration:
TABLET; ORAL Strength: 2.5MG Reference Listed Drug: No Reference Standard: Yes TE Code: AB Application Number:
A074299 Product Number: 001 Approval Date: Jul 27, 1995 Applicant Holder Full Name: ANI PHARMACEUTICALS INC
Marketing Status: Prescription
SBOA of the current approved generic product- ACTAVIS ELIZABETH LLC Details of this approved generic product are
given below- Active Ingredient: INDAPAMIDE Proprietary Name: INDAPAMIDE Dosage Form; Route of Administration:
TABLET; ORAL Strength: 1.25 mg and 2.5MG Reference Listed Drug: No Reference Standard: No TE Code: AB Application
Number: A074722 Product Number: 002 Approval Date: Jun 17, 1996 Applicant Holder Full Name: ACTAVIS ELIZABETH
LLC Marketing Status: Prescription
PERIOD: January 1, 2018 to present SCOPE: 1) All documents submitted from the company Else Nutrition to obtain
infant formula FDA compliance. 2) All photos and video footage associated with safety testing from the company Else
Nutrition. 3) All communication to and from employees of the company Else Nutrition related to obtaining FDA approval
for their infant formula. 4) All communication to and from FDA staff or faculty related to the company Else Nutrition
obtaining FDA approval for their infant formula.
SBOA of the current approved generic product- CHARTWELL RX SCIENCES LLC Details of this approved generic product
are given below- Active Ingredient: INDAPAMIDE Proprietary Name: INDAPAMIDE Dosage Form; Route of
Administration: TABLET; ORAL Strength: 1.25MG and 2.5 MG Reference Listed Drug: No Reference Standard: No TE
Code: Application Number: A074594 Product Number: 001 Approval Date: May 23, 1996 Applicant Holder Full Name:
CHARTWELL RX SCIENCES LLC Marketing Status: Discontinued
SBOA of the current approved generic product- MYLAN PHARMACEUTICALS INC Details of this approved generic
product are given below- Active Ingredient: INDAPAMIDE Proprietary Name: INDAPAMIDE Dosage Form; Route of
Code: Application Number: A075105 Product Number: 001 Approval Date: Jul 23, 1998 Applicant Holder Full Name:
MYLAN PHARMACEUTICALS INC Marketing Status: Discontinued
SBOA of the current approved generic product- RISING PHARMA HOLDINGS INC Details of this approved generic
Code: Application Number: A074461 Product Number: 002 Approval Date: Mar 26, 1997 Applicant Holder Full Name:
RISING PHARMA HOLDINGS INC Marketing Status: Discontinued
SBOA of the current approved generic product- TEVA PHARMACEUTICALS USA INC Details of this approved generic
Code: Application Number: A074665 Product Number: 001 Approval Date: Apr 4, 1997 Applicant Holder Full Name:
TEVA PHARMACEUTICALS USA INC Marketing Status: Discontinued
SBOA of the RLD- TEVA PHARMACEUTICALS USA INC Details of this RLD are given below- Active Ingredient: PIMOZIDE
Proprietary Name: ORAP Dosage Form; Route of Administration: TABLET; ORAL Strength: 1MG and 2 MG
Reference Listed Drug: Yes Reference Standard: No TE Code:
Application Number: N017473 Product Number: 003 Approval Date: Aug 27, 1997 Applicant Holder Full Name: TEVA
PHARMACEUTICALS USA INC Marketing Status: Discontinued
RE: Hill's Pet Nutrition, Inc., Topeka, KS (FEI # 1912875). Please supply complete Establishment Inspection Report
#1079756 (Inspection date February 19, 2019).
SBOA of the approved generic product - PAR PHARMACEUTICAL INC Details of this approved generic product are given
below- Active Ingredient: PIMOZIDE Proprietary Name: PIMOZIDE Dosage Form; Route of Administration: TABLET; ORAL
Strength: 1MG and 2 MG Reference Listed Drug: No Reference Standard: No TE Code: Application Number: A204521
Product Number: 001 Approval Date: Sep 28, 2015 Applicant Holder Full Name: PAR PHARMACEUTICAL INC Marketing
Please send me any studies that in any way compare the Prolia to Xgeva.
You can do so electronically to my email address: fcharat@yahoo.com
Thank you,
Francis Charat
Under FOIA, I request the facility inspection reports for the KVK Tech Inc. facility at 110 Terry Drive, Newtown, PA,
18940, during the time range listed above, Jan. 1, 2010 to May 20, 2022.
Food Contact Notification (FCN) 2201, including all submission documents, correspondence, reviews, etc.
We would like to request the Biopharmaceutics/Bioequivalence Section of the Summary Basis of Approval (SBOA) for:
Active Ingredient: COLESTIPOL HYDROCHLORIDE Proprietary Name: COLESTIPOL HYDROCHLORIDE Dosage Form; Route
of Administration: TABLET/ORAL Strength: 1GM Application Number: 077510 Application Holder: IMPAX LABS (Date
Range for Record Search: From 10/01/2005 To 10/01/2007)
We are requesting Texas Procurement LLC's, FEI #: 3019582795, initial registration date for Human Cell and Tissue
Establishment Registration.
Incidence of pneumothorax related to methotrexate use.
ANDA 086262 for Bethanechol Hydrochloride Tablets, 10 mg FDA approved March 22, 1978 • ANDA 086263 for
Bethanechol Hydrochloride Tablets, 25 mg FDA approved March 22, 1978 • ANDA 085882 for Bethanechol
Hydrochloride Tablets, ETC
FOIAs Mentioning Oz: I am requesting copies of all FOIA requests submitted to the FDA which mentions Mehmet Oz (aka
“Dr. Oz”) from January 1, 2021, to May 20, 2022.
Requesting a copy of the Establishment Inspection Report for Inspection conducted at Life Sciences Vandalia, LLC
Inspection ID is 956396 on January 11, 2016.
detailed narrative data of the cases with disseminated tuberculosis during treatment with adalimumab for psoriasis
retrieved from the FAERS public dashboard. The case IDs are: 10963752 10979536 12949989 13486004 13791550
13916609 14245592 14706494 14707047 16265244 16334375 16836136
RE: The J.M. Smucker Co., Lexington, KY (FEI #1021607): Please supply FDA Form 483(s) (if available), complete
Establishment Inspection Report(s), results of sample analysis, product recall notices and any correspondence pursuant
to, but not limited to, Inspection ID #669833 (dated 6/24/2010).
Historical versions of the Center for Veterinary Medicine's Guidance # 170 entitled "CVM GFI # 170 Animal Drug User
Fees and Fee Waivers and Reductions." In particular we are requesting copies of the draft guidance document dated
March 14, 2004; September 4, 2008 and October 1, 2008.
2022-2867, 2022-2998, 2022-3003, 2022-3054, 2022-3073.
2022-2435, 2022-2488, 2022-2516, 2022-2531, 2022-2542.
Form 483 for Rentschler Biopharma for the complete response letter for bimekizumab. The site in question I believe is:
Erwin-Rentschler-Strasse 21 88471 Laupheim Germany I would like to understand the nature of the observations raised.
This is a request for records under 510(k) #K200755. The following records under K200755 are being requested: 1)
Device Description 2) Executive Summary/Predicate Comparison 3) Substantial Equivalence Discussion 4) Proposed
Labeling (including attachments) 5) Software 6) Electromagnetic Compatibility and Electrical Safety 7) All Performance
testing - Bench, Animal and Clinical (including attachments)
RE: The JM Smucker Co. (FEI #1021607). Please supply FDA Form 483 (if available), complete Establishment Inspection
Report, results of sample analysis (if available) and any correspondence pursuant to Inspection ID #918187 (inspection
end date 03/13/2015)
FDA reviews for flurbiprofen/ANSAID NDA #018766
RE: JM Smucker Co., Lexington, KY (FEI #1021607) Please supply complete Establishment Inspection Report, results of
sample analysis (if available) and any correspondence pursuant to Inspection ID #1046897 (inspection end date
02/28/2018)
RE: The JM Smucker Co., Lexington, KY (FEI #1021607). Please supply complete Establishment Inspection Report, results
of any sample analysis and any correspondence pursuant to Inspection ID #613586 (inspection end date 08/31/2009)
RE: Abbott Nutrition, Sturgis, MI (FEI #1815692). Please supply complete Establishment Inspection Reports for all of the
following Inspection IDs (inspection end date in brackets after each ID number). 1067126 (09/18/2018) 1026919
(09/14/2017) 986371 (09/16/2016) 966718 (03/25/2016) 952733 (12/09/2015) 944642 (09/16/2015) 884374
(06/20/2014) ETC
RE: The JM Smucker Co., Lexington, KY (FEI #1021607) Please supply complete Establishment Inspection Report, results
of sample analysis (if any) and all correspondence pursuant to inspection ID #711512 (inspection end date 03/02/2011)
Previously released FOIA documents: FOIA 2012-8684 12/06/2012 FDA/OMPT/CDRH/OCER/DFOI KYOCERA Medical
Corporation K011533 FOIA 2012-8684 1/07/2013 KYOCERA Medical Corporation
Form 483 for Glenmark's US Facility in Monroe Glenmark's Goa Facility, India
Request for latest form 483 issued by USFDA to Glenmark Pharmaceuticals' formulations manufacturing facility in Goa
(India) (FEI NO: 3004672766), Inspection ending date of 20 May 2022
Request for form 483 issued by USFDA to Glenmark Pharmaceuticals' formulations manufacturing facility at Monroe,
North Carolina (FEI NO: 3011585599), Inspection ending date of 19 May 2022.
Meeting minutes of EoP 2 meeting (15-Oct-2009) for NDA#201635.
most recent (i.e., current) Public Health Service (PHS) Animal Welfare Assurance documents for the following
institutions:
1. FDA - Food and Drug Administration - Center for Food Safety and Applied Nutrition (CFSAN) (PHS Assurance D16-
00650; A4294-01);
2. FDA - Food and Drug Administration - Center for Veterinary Medicine Office of Research (CVM) (PHS Assurance
D16-00656; A4301-01); ETC
for Biologics inspection of New York Cryo ending 04/25/2022 at the location in Great Neck NY, United States. The EIR (in
electronic format) for Biologics inspection of New York Cryo ending 04/25/2022 at the location in Great Neck NY, United
for Medical Devices & Rad Health inspection of 180 Innovations LLC ending 01/29/2020 at the location in Lakewood CO,
United States. The Response (in electronic format) for Medical Devices & Rad Health inspection of 180 Innovations LLC
ending 01/29/2020 at the location in Lakewood CO, United States. Please send documents as email attachments.
for Medical Devices & Rad Health inspection of Life Technologies, Corp. ending 10/02/2015 at the location in Grand
Island NY, United States. Please send documents as email attachments.
for Biologics inspection of Novus Surgical Solutions LLC ending 04/01/2022 at the location in Allentown PA, United
for Biologics inspection of Covenant Medical Center ending 04/08/2022 at the location in Lubbock TX, United States.
The 483 (in electronic format) for Biologics inspection of Amarillo VA Health Care System - Blood Bank ending
04/19/2022 at the location in Amarillo TX, United States. Please send documents as email attachments.
for Biologics inspection of The Fertility Center of Oregon ending 04/13/2022 at the location in Eugene OR, United States.
for Biologics inspection of Specialists in Reproductive Medicine & Surgery, P.A. ending 04/15/2022 at the location in Fort
Myers FL, United States. The 483 (in electronic format) for Biologics inspection of Cryos International USA, LLC ending
03/08/2022 at the location in Orlando FL, United States. Please send documents as email attachments.
Request for records under DEN190040. The following records under DEN190040 are being requested: 1) Device
Description 2) Software (including attachments) 3) All Performance Testing - Bench/Non-Clinical, Animal, Clinical
(including attachments) 4) Benefit-Risk Analysis 5) Labeling including User Manual(s) (including attachments)
All records related to complaints of injury and injury/potential injury incident files (IPII) related to the product known as
PROLIFIC HAIR CREAM DEVELOPER VOLUME 20 that is manufactured by Marianna Industries, Inc.
All records related to complaints of injury and injury/potential injury incident files (IPII) related to the product known as
PRAVANA PURE LIGHT POWER LIGHTENER manufactured by Henkel US Operations Corporation.
Any information to include reports of the side effects from use, complications from use, off-label uses for the product,
cord compression resulting from the product’s use in the Cervical Spine, and cord swelling allegedly associated with the
use of Gelfoam and/or Surgifoam of size 50 or any size in the Cervical Spine.
Copy of the disclosable portions of the 483 for Grifols Diagnostic Solutions, located in San Diego, CA, for the inspection
on 02/17/2022. This inspection relates to Biologics.
All internal and external correspondence regarding FOIA Request No. 2022-2724, including any records released to the
requester.
Label, product insert, and review documents for NDA #020166 (Sodium Thiosulfate 250 mg/mL; US ARMY) approved on
02/14/1992.
Any inspection results and 483 Warning letters issued to Nephron Pharmaceuticals Corp in 4500 12th Street, West
Columbia, South Carolina.
Copies of FDA's Chemistry, Toxicology, and Environmental Review Memoranda for Food Contact Notification (FCN)
2198.
RE: JM Smucker, New Bethlehem, PA (FEI #2515870): Please supply complete Establishment Inspection Reports for each
of the following Inspection IDs (Inspection end dates in brackets) 1154619 (09/30/2021) 1012221 (05/10/2017) 865376
(02/06/2014) 755119 (11/23/2011) 564001 (02/23/2009)
Copy of the disclosable portions of the MedWatch reports for the following 6 case numbers for Molnupiravir: 20818409,
20818246, 20807652, 20802571, 20802545, and 20796352.
We hereby request the following documentation and appreciate your support on this: Sponsor response to the
establishment inspection report for the FDA inspection in 2021 on Pharmaceutics International Pii3 (FEI 3006503102) in
Cockeysville, MD and Pharmaceutics International Pii (FEI 1000513101) in Hunt Valley, MD.
All 510(K) submission and appoval records and any addendums related to 510(K) submission K990358
FDA 483 for FDA inspection of Pharmacia & Upjohn Company - FEI: 1810189 Category: Animal Drugs & Feeds / Human
Drugs, ending 21 Sep 2018, Location: Kalamazoo, United States. Including any previously FOIA released documents
Any FDA communications between the FDA’s Office of the Chief Counsel and the U.S Attorney’s Office in the Southern
District of New York or any other person or agency regarding the Walgreen’s settlement that is referred to in the
following Press Release entitled “Manhattan U.S. Attorney Announces $269.2 Million Recovery From Walgreens In Two
Civil Healthcare Fraud Settlements” at https://www.justice.gov/usao-sdny/pr/manhattan-us-attorney-announces-2692-
million-recovery-walgreens-two-civil-healthcare.
Any FDA communications between the FDA’s Office of the Chief Counsel and the U.S Attorney’s Office in the Southern
District of New York or any other person or agency regarding the settlement with PillPack, LLC (“PillPack”), a wholly-
owned subsidiary of Amazon.com, Inc., that is referred to in the following Press Release entitled “U.S. Attorney
Announces Settlement Of Fraud Lawsuit Against Online Pharmacy For Overdispensing Insulin” at
https://www.justice.gov/usao-sdny/pr/us-attorney-announces-settlement-fraud-lawsuit-against-online-pharmacy-
overdispensing.
RE: JM Smucker, Memphis, TN (FEI #1024224): Please supply complete Establishment Inspection Reports for the
following Inspection IDs (inspection end dates in brackets): 926824 (05/21/2015) 835502 (06/05/2013) 746109
(07/29/2011) 680910 (09/02/2010) 574511 (03/24/2009)
510(k)s for 13 products
The products are listed below:

DEVICE NAME MANUFACTURER
1 ACMI Dur-Digital Ureteroscope and Choledochoscope Systeem ACMI Corporation K060269
2 Ureterorenoscope System Shanghai AnQuing Medical Instrument Co. Inc. K180367
3 LithoVue System Boston Scientific Corp. K153049
4 Pusen Eview Medical Video Endoscope Image Processor Zhuhai Pusen Medical Technology Co. Ltd. K190648
5 WiScope Digital Endoscope SystemOTU Medical Inc. K181977
6 Applied Medical 1.5 mm Reusable Angioscope Applied Medical Resources, LeMaitre Vascular K951721
7 Vascular FiberscopeKarl Storz Endovision K001408
8 Baxter 4.5 F Imagecath Coronary Angioscope Baxter Edwards K952638
9 Intramed Angioscope Intramed Laboratories Inc. K934696
10 Baxter Coronary Angioscope Inflation Device Baxter Edwards K931464
11 Disposable Vascular Angioscope Endovascular Inc. K923996
12 Disposable Vascular Angioscope Nobles-LAI K914570
13 Angiolaz Angioscope CatheterAngiolaz, Inc. K913129
ANDA 214585
K173420
I am writing to request copies of any written correspondence between Abbott Laboratories (dba Abbott Nutrition) and
the FDA related to the baby formula manufacturing plant in Sturgis, Michigan and the formula shortage that occurred
after the plant was shut down.
I am writing to request copies of all internal memos and/or reports related to the Abbott Laboratories (dba Abbott
Nutrition) baby formula manufacturing plant in Sturgis, Michigan.
FDA 483 for FDA inspection of Johnson Matthey Inc. - FEI: 2245277 Category: Animal Drugs & Feeds / Human
Drugs, ending 08 Mar 2019, Location: West Deptford, United States. Including any previously FOIA released documents
I am writing to request copies of any written correspondence among FDA staff related to the baby formula
manufacturing plant in Sturgis, Michigan and the formula shortage that occurred after the plant was shut down.
Requesting FDA 483 issued to FEI: 3001599766 Jiangsu Jiaerke Pharmaceuticals Group issued from FDA Human Drugs
inspection ending 26 Jul 2018 Location: Changzhou, China. Including any previously FOIA released documents related to
this inspection. If not available, then just the FDA 483.
Hello, Please provide all emails, instant chat messages, and texts mentioning "baby formula" to or from Susan Mayne.
Request for Summary Basis of Approval (SBOA) of TYRVAYA™ (varenicline solution) nasal spray 0.03 mg
Establishment inspection report of Daicel Chiral Technologies (India) Pvt. Ltd for the audit conducted in the month of
March-2019
Dear FOIA Officer, Pursuant to the Freedom of Information Act, I am requesting an opportunity to review all records
related to the 1982 Tylenol contamination/poisoning which led to multiple deaths. I am hoping to review records
related to complaints, investigations and all other documents.
For the feed ingredient, Chicken Meal, approved for use in animal feeds "regulated" by FDA. I request the following
documents this approved feed ingredient: - All documents associated with AAFCO Ingredient Definition Request
Process of the above listed ingredient - Associated Feeding Trial submissions for the above listed ingredient
CHEF MYRON PRODUCTS - RECALLS, INSPECTIONS, CORR ETC
For the feed ingredient, Chicory Root Extract, approved for use in animal feeds "regulated" by FDA. I request the
following documents this approved feed ingredient: - All documents associated with AAFCO Ingredient Definition
Request Process of the above listed ingredient - Associated Feeding Trial submissions for the above listed ingredient
all “Pre-Notices of Noncompliance to encourage compliance with the ClinicalTrials.gov requirements” the Food and
Drug Administration has sent.
I am seeking details of 483 observations from inspection of a manufacturing facility in Braine (Belgium) in relation to the
company "UCB" and its NDA for the drug bimekizumab
Hello! I'd like to see any records or documents related to "Fonterra" or "Bellamy's Organic" or "Bellamy's" applying to
import or sell infant or baby formula in the United States. Thanks very much!
1. ANDA Application No. 076798, originally filed by Watson Pharmaceuticals, Inc. and later transferred to Celltrion, Inc.
2. ANDA Application No. 091298, filed by Torrent Pharmaceuticals Limited.
Copy of the disclosable portions of the VAERS forms for the following 2 Vaxneuvance case reports: 2228531, and
2245957.
Certain ANDA approval routing summaries
All email records for FDA CVM employee Charlotte Conway containing the key search term: AAFCO.
I am requesting all public comments received for the animal feed and pet food ingredient, chicken meal, prior to the
ingredient being approved as an AAFCO ingredient, and adopted as a federal regulation by acceptance by FDA-CVM
calendars, transcripts, and email and/or other communications delivered and received by the FDA's Center for Devices
and Radiological Health from 01/01/2013 to 05/19/2022 that mention the following: -- the VALID Act -- the Expanded
Genetic Screening Act -- noninvasive prenatal screening tests (also known as "NIPTs" or "NIPS" or "noninvasive prenatal
genetic screening") etc
communications, interactions and meetings, between the FDA and U.S manufacturers of infant formula, including
Abbott Laboratories, the makers of Similac formula, between February 1, 2022 and May 16, 2022.
All records that include the following terms: • Baby formula • Infant formula • Enfamil • Similac • Enfamil •
Abbott • Mead Johnson • Nestle • Perrigo • Sturgis NOTE: For this search, please exclude records that are news
articles or newsletters shared without comment. Please search for records held by the following agency officials: •
Robert Califf, Commissioner • Janet Woodcock, Principal Deputy Commissioner • Frank Yiannas, Deputy
Commissioner for Food Policy and Response • Julia (Julie) Tierney, Chief of Staff • Erica Jefferson, Associate
Commissioner for External Affairs • Dayle Lewis Cristinzio, Director of Stakeholder Engagement Staff • Director
of the Office of Media Affairs and any staff in that office whose duties include communicating with the news media •
etc
This request pertains to the data reported in the New England Journal of Medicine, 383:e97, 2020. 1. For the 43 EAU
requests without design or validation problems, what were the time intervals between receipt of the request and the
granting of the EUA? As an alternative, what were the mean and median times, the range, and the standard deviation?
As an alternative, a list of all intervals can be provided, from which we can compute these data. 2. For these 43 assays,
how many of these EUAs were based upon RT-PCR, how many on isothermal amplification assays, and how many on
methods that did not depend upon nucleic acid amplification? etc
FDA internal deliberations, meeting minutes, comments on marketing material submissions, guidelines and other
documents, that relate to the Agency’s oversight of drug/device industry websites and social media with respect to
multiple jurisdictions (e.g., different indications for use in the U.S. and the EU).
Form 483. UCB facility in Braine, Belgium
Communications about topoxx and/or tecovirimat in the past 90 days
I would like a copy Report of Sample Analysis for 15 pounds of basil that were taken by the FDA during an inspection on
7/22/19 from my facility at 8303 NW 27th St, Unit 11, Miami FL 33122 The sample number is DI 1077267.
Memorandum of Observations, result of Foreign remote Regulatory Assessment

for Human Drugs inspection of Sant P. Chawla, MD ending 04/15/2022 at the location in Santa Monica CA, United
for Human Drugs inspection of Havix Group Inc d/b/a Aavis Pharmaceuticals ending 04/19/2022 at the location in
Hoschton GA, United States. Please send documents as email attachments.
for Human Drugs inspection of LGM Pharma, LLC ending 04/14/2022 at the location in Boca Raton FL, United States.
The 483 (in electronic format) for Human Drugs inspection of David F. Jativa, M.D. ending 04/25/2022 at the location in
Doral FL, United States. Please send documents as email attachments.
format) for Biologics inspection of Pfizer Ireland Pharmaceuticals ending 11/12/2019 at the location in Dublin 22,
Ireland. The Response (in electronic format) for Biologics inspection of Adimmune Corporation ending 07/30/2018 at
the location in Taichung City, Taiwan. Please send documents as email attachments.
for Animal Drugs & Feeds inspection of Mccrone Associates, Inc. ending 01/15/2019 at the location in Westmont IL,
for Human Drugs inspection of Janssen Ortho LLC ending 08/28/2018 at the location in Gurabo PR, United States.
Recs re FDA-approved Fall 2019 revisions to the labeling for insulin pens1 and requests
that manufacturers change the labeling of sealed containers of multiple insulin
pens to specify that insulin pens should be dispensed to a single patient in their
original, sealed carton including any “further steps as warranted” etc
Seeking communications between FDA and Abbott Labs over issues related to baby formula, and inspection records and
company responses. Please see attached.
We are requesting a complete list for the time period where Target Corporation is listed as FSVP importer for any
commodity. Target DUNS number (006961700) is used for import entry, however, Target DUNS number should not be
listed for FSVP importer (FSVP FEI Number 3004613289).
Complete "Drug Approval Package" for - RADICAVA ORS (EDARAVONE) ORAL SUSPENSION Company: MITSUBISHI
TANABE Application No.: 215446 Approval Date: 05/12/2022
for Human Drugs inspection of Micron Inc ending 11/05/2021 at the location in Wilmington DE, United States. Please
Can we please review the Type B Pre-NDA meeting between Blueprint Medicines Corporation and the U.S. Food and
Drug Administration (FDA) regarding the supplemental new drug application for AYVAKIT™ (avapritinib) for the
treatment of adult patients with advanced systemic mastocytosis (SM)? The sNDA was submitted on December 17,
2020.
the 510k in full with all attachments: K973865
the full 510k with attachments: K203835, MIS Solution.
Can we please review the minutes from any Pre-NDA correspondence between Blueprint Medicines Corporation and
the U.S. Food and Drug Administration (FDA) regarding the supplemental new drug application for AYVAKIT™
(avapritinib) for the treatment of adult patients with advanced systemic mastocytosis (SM)?
On January 13, 2020, Blueprint announced that "Based on ongoing discussions with the FDA, the company plans to
focus its supplemental NDA on data from patients in the Phase 1 EXPLORER and Phase 2 PATHFINDER trials who started
at the proposed indicated dose of 200 mg once daily (QD), supported by pooled data from all doses. To allow for a
sufficient number of patients and follow-up, Blueprint Medicines now plans to submit the supplemental NDA to the FDA
in the second half of 2020."
VAERS RECS
Request inspection report and all documents from and/or related to FDA's 2022 inspection of AnazaoHealth, Las Vegas,
Nevada.
All documents, communications and/or records related in any way, to FDA's 2022 inspection of Central Admixture
Pharmacy Services, Phoenix, Arizona.
All documents, communications and/or records related, in any way, to FDA's 2022 inspection of Fagron Compounding
Services, DBA as Fagron Sterile Services, Wichita, KS.
All documents, communications and/or records related, in any way, to FDA's 2022 inspection of Nephron Sterile
Compounding Center, LLC (NSCC), West Columbia, South Carolina.
Can we please receive all FDA Application Review Files (i.e. Multi-Discipline Review) for the approval of AYVAKIT™
(avapritinib) for the Treatment of Adults with Advanced Systemic Mastocytosis on June 16, 2021?
• The summary basis for approval for NDA 016267 Deferoxamine mesylate, CAS: 138-14-7, Desferal®. This should
include the animal studies in the 1968 original and the 1978 efficacy supplement #11.
ANDA 212025 Clinical Review Summary and Review Package including any evaluation of the ANDA product for use in
the Apokyn pen device.
I would like to request a copy of the Establishment Inspection Report for LaVezzi Precision, 250 Madsen Drive,
Bloomingdale Illinois. The inspection ID #1077908 conducted on 11/27/2018.
Any and all inspection reports related to the J.M. Smucker Co. manufacturing facility located in Lexington, Kentucky
Establishment Inspection Report cover page + summary page for FDA inspection of Sequent Research Limited, located at
120 A & B Industrial area, Baikamapady, New Mangalore 575011, Karnataka, India completed on February 14, 2020
(inspection ID 1121166; FEI Number 3013078323).
Establishment Inspection Report cover page + summary page for FDA inspection of Shanghai Kyowa Amino Acid Co., Ltd,
No. 158 Xintuan Road, Qingpu Industrial Zone, 201707, Shanghai, China completed on August 09, 2019 (inspection ID
1101886; FEI Number 3005253125).
Establishment Inspection Report cover page + summary page for FDA inspection of Solara Active Pharma Sciences Ltd.,
Plot No. 120 A&B, 36, 120P & 121, Industrial Area, Baikampady, Mangaluru, 575011, Karnataka, India, completed on
2020-02-21 (Inspection ID 1123049; FEI 3008252997).
Establishment Inspection Report cover page + summary page for FDA inspection of Yuki Gosei Kogyo Co. Ltd, Joban
Factory: Ochiai 788, Jobannishigomachi, Iwaki-shi, 972-8316, Fukushima, Japan, completed on 2021-07-28 (Inspection
ID 1149608; FEI 3002808534).
The official name of the Interagency Vaccine Work Group referenced by Dr. David Kim at the Vaccines and Related
Biological Products Advisory Committee Meeting on April 6, 2022 ; and a list of the name, title, and agency of each
member of the Interagency Vaccine Work Group.
For Odactra (BLA# 125592), please provide the following BLA submission sections and the FDA’s corresponding review:
1. 3.2.S Drug Substance 2. 3.2.P Drug Product
Establishment Inspection Report and 483 classified VAI for Janssen Cilag Manufacturing LLC (FEI number 3006244497)
for inspection ending on November 23, 2021 - inspection ID 1158642.
All communications related to the Interagency Vaccine Work Group referenced by Dr. David Kim at the Vaccines and
Related Biological Products Advisory Committee Meeting on April 6, 2022 . Communications include, but are not limited
to, emails, memos, meeting minutes, meeting recordings, and meeting notes.
This request seeks the tentative (where applicable) and final approval routing summaries for the following Abbreviated
New Drug Applications (ANDAs): 1. ANDA Application No. 202467, filed by Macleods Pharmaceuticals Limited; 2. ANDA
Application No. 077210, filed by Teva Pharmaceuticals USA.
Salmonella Senftenberg J.M. Smucker Company facility in Lexington, Kentucky
(Submission Tracking Numbers: PM0000635, PM0000636, PM0000646, PM0000712, PM0004287, PM0004293). ETC
I'm looking for fatalities of Paroxysmal Nocturnal Hemoglobinuria from Soliris; Ultomiris; blood transfusions; blood
thinners; steroids; blood clots and bone marrow transplants.
RECORDS RE CHURCH OF SCIENTOLOGY, E-METER ETC
South Texas Comprehensive Cancer Center Investigation Recs

AppHarvest, Inc. and any potential audits, complaints, inspections, investigations conducted or received by the FDA in
relation to AppHarvest, Inc. The relevant date range is October 1, 2020 through August 10, 2021.
We respectfully request a copy of the protocol and associated study submissions as well as the Clinical study report with
all relevant appendices and associated datasets (SDTM/ADaM or other datasets submitted) for the Phase 1 clinical trial:
“Study to Assess the Metabolism and Elimination of [14C]-Labeled Varespladib Methyl in Healthy Male Subjects”
(NCT01359605) submitted to either IND 076432 or IND 078695.
for Medical Devices & Rad Health inspection of Oxoid Limited ending 03/15/2017 at the location in Basingstoke, United
Kingdom. Please send documents as email attachments.
for Medical Devices & Rad Health inspection of Menarini Silicon Biosystems ending 06/25/2020 at the location in
Huntingdon Valley PA, United States. The Response (in electronic format) for Medical Devices & Rad Health inspection
of Menarini Silicon Biosystems ending 06/25/2020 at the location in Huntingdon Valley PA, United States. Please send
for Human Drugs inspection of Aaron E. Miller, M.D. ending 04/21/2022 at the location in New York NY, United States.
The EIR (in electronic format) for Human Drugs inspection of Aaron E. Miller, M.D. ending 04/21/2022 at the location in
New York NY, United States. Please send documents as email attachments.
for Human Drugs inspection of Benjamin A. Gartrell, M.D. ending 04/01/2022 at the location in Bronx NY, United States.
for Human Drugs inspection of Brookfield Medical/Surgical Supply, Inc. ending 04/04/2022 at the location in Brookfield
CT, United States. Please send documents as email attachments.
for Animal Drugs & Feeds inspection of LGM Pharma LLC ending 04/08/2022 at the location in Erlanger KY, United
for Human Drugs inspection of NEOLPHARMA, INC. ending 04/01/2022 at the location in Caguas PR, United States.
for Human Drugs inspection of Circadia by Dr Pugliese, Inc. ending 04/01/2022 at the location in Leesport PA, United
INVESTIGATION RECS
Requesting a copy of the FDA EIR from an FDA Inspection that was conducted in our CSL Plasma, Inc.- Houston TX
location (3016665630) July 19, 2021 -July 23, 2021.
K210575
Any and all registration records retained on file for the following registered medical device establishment: ZHONG
SHAN LEBO MEDICAL COMPANY LIMITED No.60, Weimin Road, Dongsheng Town Zhongshan City Guangdong, CN
528414 Registration Number: 3013495708 FEI Number*: 3013495708
1) A copy of medical device Adverse Event Report #2438477-2019-00034 (identified in MAUDE) 2) Any and all
manufacturer registration records retained on file for the manufacturer identified in the above report, ZHONGSHAN
LEBORN MEDICAL COMPANY LIMITED. (they did not come up in the Medical Device Establishment Registration & Device
Listing online database).
Copy of the disclosable portions of the food sample collection reports and analytical results from the FDA Office of
Regulatory Affairs (ORA), for all samples of the meal replacement drink identified as "Reference #1060" on the
Coordinated Outbreak Response and Evaluation (CORE) Investigation Table.
Please provide the establishment inspection report related to FEI number 2518422. The inspection was of Philips
Respironics, Inc. and took place 8/26/2021-11/9/2021. If this report has been previously released, please provide in it
most expeditious manner possible. Thank you.
SUMMIT CLINICAL RESEARCH LLC, PINNACLE CLINCAL RESEARCH PLLC - AUDITS, INSPECTIONS ETC
Re-Import refusal dated April 04,2022 Entry No. 178-4527842-7/12/1 Need addtional information related to entry
no. 178-4527842-7/12/1 1. Importer and Exporter 2. Product name and quantity 3. Loading port and discharge port 4.
which company or person FDA has been contacting with for this issue¿ 5. refusal reason
OCI INVESTIGATION RECS
Need EIR for inspections 1136263 and 1114933 for FEI number 1910436 - Kellogg Omaha, Nebraska
FDA Inspection reports (EIRs, FDA Form 483s, PAI outcomes) for the Fujifilm Diosynth facilities located at the following
addresses: 101 J Morris Commons Ln. Morrisville, NC 27560 USA 3939 Biomedical Way, College Station, Texas 77845
USA Thanks so much!
Copy of the disclosable portions of all 483s or other inspectional observations for Pharmaceutics International (PII),
located in Hunt Valley, MD & Cockeysville, MD. Please note these inspections would pertain to human drugs.
We would like to request copies of the FCN submissions for FCN 96 dated Nov 22, 2000 and FCN 1892 dated Jul 13,
2018
K130283, EVRF System
Cardio-Renal Drugs Advisory Committee on Dec. 13, 1990
Public Records Request Salmonella Newport Outbreak in Summer 2020 Recall Numbers: F-1272-2020; F-1273-2020; F-
1274-2020; F-1275-2020 Confirmation # FDA2070729 PLEASE SEE ATTACHED LETTER
The Bambermycins Feed assay method for the Type B liquid animal feed.
Regulatory Assessment of CSL Plasma Inc. Located at Linden NJ United States FEI Number: 3014744187 held on
06/25/2021.
Clearance and approval forms related to: Zeltiq's cryolipolysis device, which is likely to be branded as CoolSculpting.
Please provide the following public record: Regarding the FDA files for: SOLIRIS (eculizumab) A copy of Sponsor's
application for Orphan Drug Designation, or the FDA's annotated copy thereof.
Regulatory Assessment of CSL Plasma Inc Located at Irondale AL United States FEI Number: 3015837280 held on
06/23/2021.
Report and/or the MDSAP Noncomformity Grading and Exchange Form (NC) for the inspection of LivaNova USA Inc,
Houston, TX , end date 06-29-2018. FEI# 1000117004. This inspection pertains to medical devices.
Regulatory Assessment of CSL Plasma Inc. Located at Charlotte NC United States FEI Number: 3014286251 held on
06/23/2021.
Regulatory Assessment of Cardinal Health, Inc Located at Houston TX United States FEI Number: 3003613908 held on
06/23/2021.
Report and/or the MDSAP Noncomformity Grading and Exchange Form (NC) for the inspection of TeDan Surgical
Innovations LLC, Sugar Land, TX , end date 01-18-2019. FEI# 3005726885. This inspection pertains to medical devices.
for Human Drugs inspection of Cangene BioPharma LLC ending 02/18/2022 at the location in Baltimore MD, United
Report and/or the MDSAP Noncomformity Grading and Exchange Form (NC) for the inspection of Wright Medical
Technology, Inc., Memphis, TN , end date 11-16-2017. FEI# 3010667733. This inspection pertains to medical devices.
Report and/or the MDSAP Noncomformity Grading and Exchange Form (NC) for the inspection of MicroPort
Orthopedics Inc., Arlington, TN , end date 02-09-2019. FEI# 3010536692. This inspection pertains to medical devices.
K182741
Any and all registration records retained on file for the following formerly registered medical device establishment:
Zhongshan Leborn Medical Company Limited, registration #3009655605
List of tobacco SE marketing orders. Please see attached for details.
My request is to receive a copy of the 510(K) submission for xvision Spine system (XVS), K190929
My request is to receive a copy of the 510(K) submission for ARAI Surgical Navigation System, K211254
Complete 510(K) filing for 510(k) BK050055 , GenesisCS Component Concentrating System, Classification: II Device
Code: JQC Applicant: Perfusion Partners & Associates, Inc 6227 Foxfire Lane Fort Myers FL 33912 510(k) number:
BK050055 Product: GenesisCS Component Concentrating System
Please provide a copy of the FDA's establishment inspection report for Abbott Nutrition's baby-formula plant at 901 N
Centerville Rd., Sturgis, Michigan, from September 2019.
for Animal Drugs & Feeds inspection of Zoetis Belgium SA ending 09/28/2021 at the location in Tullamore, Ireland.
I'm requesting an FOIA for the following ResMed 510(K): K140054
I'm requesting an FOIA for the following ResMed 510(K): K151901
format) for Animal Drugs & Feeds inspection of Sterling Pharmaceutical Services LLC ending 02/18/2022 at the location
in Dupo IL, United States. Please send documents as email attachments.
for Foods & Cosmetics inspection of JM Smucker LLC ending 06/24/2010 at the location in Lexington KY, United States.
for Human Drugs inspection of Tender Corporation ending 09/23/2021 at the location in Littleton NH, United States.
Please provide copies of all tobacco related (including cigarette; electronic cigarette; electronic nicotine or vaping
product; or tobacco heating system) product injury/adverse event/reaction reports voluntarily reported to the FDA
Center for Tobacco Products, the FDA Safety Reporting Portal, MedWatch program, and the FDA Adverse Event
Reporting System from December 2021 – May 2022.
I would like the report of the Remote Regulatory Assessment conducted in Feb/Mar of 2022 for Regenesis Biomedical.
for Human Drugs inspection of Conopco, Inc ending 04/06/2022 at the location in Jefferson City MO, United States. The
483 (in electronic format) for Human Drugs inspection of Illinois Tool Works Inc ending 04/01/2022 at the location in
Olathe KS, United States.
I am requesting the record from FDA-CVM for the official definition of "perfect digestion" for use on dog food packages.
I am also requesting the record from FDA-CVM for the official definition of "perfect digetsion" for use on cat food
packages.
I hereby request digital copies of all reports, notes, correspondence and related documents created or generated as
part of the FDA inspection process, and for which the Freedom of Information Act applies, for the following clinical
investigator inspection: Inspection of Clinical Investigator Ravindran, Arun V PHD (ID Number 610920), inspected on the
listed date of 01/07/19 at the Centre For Addiction And Mental Health at 250 College St., Toronto, Ontario, Canada,
postal code M5T 1R8.
For the feed ingredient, Chicken Meal, approved for use in animal feeds "regulated" by FDA. I request the following
documents this approved feed ingredient: - All documents associated with AAFCO Ingredient Definition Request
Process of the above listed ingredient - Associated Feeding Trial submissions for the above listed ingredient 01.01.1990-
12.31.1999
Date range of request: January 2019 through the present. Any inspection records for any facility managed, owned or
otherwise associated with Bob Baffert Racing Stable Inc. • Any records, correspondence, memorandum or any other
documents related to “Bob Baffert Racing Stable Inc.”
Date range of request: January 2019 through the present. I request that a copy of documents containing the following
information be provided to me: Any records, correspondence, memorandum or any other documents related to
“performance enhancing drugs” and/or “PEDs” related to “horse racing” and/or “Thoroughbred horse racing.”
FDAs summary basis of approval for palbociclib

I hereby request a copy of the Action Package (Approval Package) for Tyvaso DPI (treprostinil) inhalation powder
approved via NDA 214324.
On behalf of Lupin Pharmaceuticals, Inc I request you to please provide me the FORM 3542 for Lokelma (Sodium
zirconium cyclosilicate) oral suspension (NDA 207078).
Hi, I am an investment professional for an asset management firm and would like to request the 483’s issued to two
facilities listed below, 3/1/22-present. The facilities makes biologics. Alvotech Reykjavik, Iceland -- Ivers-Lee CSM
Marie-Curie-Str.8 79539 Lörrach Germany
Please provide unredacted copies of all documents, data, information, and materials related to PreserVision AREDS 2,
including but not limited to any reports of injury caused by low levels of copper, copper insufficiency, and/or copper
deficiency to consumers taking PreserVision AREDS 2.
Seeking all laboratory records related to Earache Ear Drops Recall Lot# G11639.
Summary basis of approval for ANDA# 214585 for the generic equivalent to Pentasa.
1. All communications between March 1, 2022, and the date you process this request, with covered FDA offices about
“Gender-Affirming Care and Young People,” a guidance document issued by the Office of Population Affairs in the
Department of Health and Human Services dated March 2022.
All documents concerning Arimistane (also called “ANDROSTA-3,5-DIENE-7,17-DIONE”) that have been composed,
created, produced, sent, or received, between the dates of May 10th, 2016, and May 17th, 2022.
All documents concerning 1 Androstene-3b-ol,17-one, 4-Androstene-3b-ol,17-one, and

19-NorAndrost-4-ene-3b-ol, including but not limited to the Redcon1 products containing
them: SOMAL-1, SOMAL-4, and SOMAL-NOR, that have been composed, created,
produced, sent, or received, between the dates of January 1st, 2012, and May 17th,
2022.
I am seeking all records held by this agency concerning the dietary supplement company Redcon1, LLC, founded in May
of 2016 and still in operation. The range for which I am seeking records is May 10, 2016 through May 16, 2022.
The tentative (where applicable) and final approval routing summaries for the following Abbreviated New Drug
Applications (ANDAs): 1. ANDA Application No. 200268, filed by Aurobindo Pharma Ltd. 2. ANDA Application
No. 078670, filed by Sandoz.
I hereby request a copy of the Action Package (Approval Package) for Tyvaso DPI (treprostinil) inhalation powder
Request for summary basis of approval NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE - A062423
Requesting the Pharmaceutical usage data and national contract usage data from last year for the following products:
Bupropion HCl Tablets USP 75 mg, Bupropion HCl Tablets USP 100 mg, Terazosin Capsules 1mg, Terazosin Capsules 2mg,
Terazosin Capsules 5mg, Terazosin Capsules 10mg, Hydrocortisone Acetate Suppositories 25mg, Hydrocortisone Acetate
Suppositories 30mg, Hydroquinone USP 4% (Skin Bleaching Cream) and Lidocaine 5% Anorectal Cream.
Copies of any letters, presentations, correspondence or e-mail from either Empower Pharmacy or Hyman, Phelps and
McNamara to the Office of Regulatory Affairs, the Center for Drug Evaluation and Research or the Center for Biologics
Evaluation and Research describing the unlawful marketing and sale of formulations including biologics by Revive Rx
Pharmacy or any requests to investigate or schedule a manufacturing inspection due to alleged insanitary conditions at
Revive Rx Pharmacy. ETC
Form 483 from October 2021 regarding a CMC-inspection of WuXi Biologicals (WuXi, China) as a contract manufacturer
of commercial-scale drug substance and drug product of GMP certification.
Form 483 from November 2021 regarding a CMC-inspection of WuXi Biologicals (WuXi, China) as a contract
manufacturer of commercial-scale drug substance and drug product of GMP certification.
Form 483 from December 2021 regarding a CMC-inspection of WuXi Biologicals (WuXi, China) as a contract
manufacturer of commercial-scale drug substance and drug product of GMP certification.
Form 483 from January 2022 regarding a CMC-inspection of WuXi Biologicals (WuXi, China) as a contract manufacturer
of commercial-scale drug substance and drug product of GMP certification.
I hereby request a copy of the Action Package (approval package) for Tyvaso DPI (treprostinil) inhalation powder
A copy of all documents and other memoranda, including but not limited to those prepared by the CDER Exclusivity
Board, documenting the Agency’s decision whether to award three-year exclusivity to Tyvaso DPI (treprostinil)
inhalation powder (NDA 214324).
Correspondence related to complaints regarding high potency probiotics being sold as medical food. See attached
request.
Please consider this a request for a copy of the 4/15/2022 tentative approval letter for ANDA No. 215762 for Colchicine
(generic drug).
memo to government agencies to notify them of the impact to the US infant formula supply. The memos may have
come from or been copied to Susan Mayne or Frank Yiannas at FDA
Copy of the 483 for the Jan 16, 2017 - Jan 18, 2017 (3 days) inspection of Shandong Analysis and Test Center [Jinan Shi /
China] 19 Keyuan Rd, Lixia Qu, Jinan Shi, Shandong Sheng, China, 250010. This inspection pertains to human drugs.
Copy of the 483 for the Jan 16, 2017 - Jan 19, 2017 (4 days) inspection of Euro Diagnostica AB [- / Sweden] Box 50117,
Lundavagen 151 Malmo Sweden. This inspection pertains to medical devices.
I would like all FAERS reports for Janssen/Legend Biotech’s cilta-cel (brand name Carvykti).
I kindly request a copy of all documents including but not limited to memos or minutes of meetings, telephone
discussions, submission and FDA correspondence related to brazzein sweetener or brazzein protein from January 2017
to current.
Please provide a copy of the disclosable portions of any meeting minutes, meeting agendas, or decision logs created by
the “FDA Nicotine Steering Committee” from February 16, 2022 - May 2022.
I kindly request a copy of all documents including but not limited to memos or minutes of meetings, telephone
discussions, submission and FDA correspondence related to monellin sweetener or monellin protein from January 2017
to current.
Importer of Record, or Consignee; for entry-lines with submission or arrival dates between May 1 and May 31, 2022: 1)
DUNS Number / Unique Facility Identifier (UFI) of: 080801169 ETC
for Foods & Cosmetics inspection of National Meat & Provisions Co., Inc. ending 08/08/2002 at the location in Reserve
LA, United States. Please send documents as email attachments.
Food Additive Petition 8B3394
Hello, I am requesting the same records released in 2013-9068, Rec'd Date 11/13/2013, Requestor: Hogan Lovells US
LLP, Action Offices: FDA/OMPT/CDHR/OCER/DFOI/OC/OES. I am also requesting appeal information related to this
request if it exists since only partial records were released here. Thank you,
Hello, I am requesting the information previously released in Previous Control #: FOIA: 2013-2618 Rec’d Date
04/05/2013, Due Date 05/03/2013, Requestor Andrews Thornton, Action Offices FOIA involved were:
FDA/OMPT/CDRH/OCER/DFOI, FDA/OC/OES/DFOI, FDA. Thank you.
Original human clinical trial information on SSRI Prozac, aka LY110140 (made by Eli Lilly) from 1972-1985. Not available
via Lilly’s website clinical trial information, clinicaltrials.gov, NIH, or PubMed.
Form FDA 483: Adamson Analytical Laboratories, Inc.

Corona, California End Dates of inspection: 23 March 2021 Project Area: Drug Quality
Assurance
483: Aerie Pharmaceuticals Ireland Limited
Athlone, Ireland End Dates of inspection: 29 July 2021 Project Area: Drug Quality Assurance
Global Medical Production Co Ltd Jiaxing, China End Dates of inspection: 30 July 2021 Project Area: Compliance: Devices
FEI: 3006897899 Classification: OAI I confirm that Clarivate Analytics will be charged accordingly by FOI for this request,
483: Hetero Labs Limited Sangareddy
District, India End Dates of inspection: 12 August 2021 Project Area: Drug Quality Assurance
Please provide Form 483 for Aurobindo Pharma Unit 4 inspection ongoing
Please note that we have tried to submit this request online as well as via fax last week, but failed. Please may we order
the following 25 Individual case safety reports. All have anakinra as suspect product. Case IDs: 7534581 7843675
8299138 8418820 8547981 9631304 7225477 18599331 20636095 20608729 20608664 20596448 20214304 20001430
19981335 etc
Hello, I am requesting the same records released in 2015-2228, 3/18/2015, DEPUY ORTHOPEDICS MASTER FILE MAF-
610. Thank you.
The 483 (in electronic format) for Foods & Cosmetics inspection of United Exchange Corporation ending 02/14/2018 at
the location in Cypress CA, United States. The EIR (in electronic format) for Foods & Cosmetics inspection of United
Exchange Corporation ending 02/14/2018 at the location in Cypress CA, United States. etc.
The EIR (in electronic format) for Animal Drugs & Feeds inspection of Altaire Pharmaceuticals, Inc. ending 02/11/2022
at the location in Aquebogue NY, United States. The Response (in electronic format) for Animal Drugs & Feeds
inspection of Altaire Pharmaceuticals, Inc. ending 02/11/2022 at the location in Aquebogue NY, United States.
Please provide approval letter for ANDA # 216375. Thanks
The following two (2) CSV files: 1) Listing of all INSPECTIONS since Tuesday, June 1, 2021 (in CSV format) with the
Code, Zip Code, Country Name, FDA483, Full Name, District, Center, INSPECTION REASON etc
for Medical Devices & Rad Health inspection of Excellus Holdings LLC ending 04/23/2022 at the location in San Diego CA,
for Medical Devices & Rad Health inspection of Quadm Technologies, Llc ending 04/25/2022 at the location in Hamilton
NJ, United States. Please send documents as email attachments.
for Medical Devices & Rad Health inspection of Flextronics International USA, Inc ending 04/19/2022 at the location in
Buffalo Grove IL, United States. Please send documents as email attachments.
for Medical Devices & Rad Health inspection of Dental Choice Holding Llc ending 04/26/2022 at the location in Louisville
KY, United States. Please send documents as email attachments.
for Medical Devices & Rad Health inspection of Ximedica Llc ending 04/13/2022 at the location in Providence RI, United
2021-7870, 2022-2205, 2022-2315, 2022-2323, 2022-2346.
CVs Dmitry Gazarian, Evelyn Baez Colon, Michele Gottshall, James Keller, etc
Hello, Please provide me with the same information released in: 2016-1148, 2/11/16, LETTER FROM FDA TO STRYKER RE
TRIDENT HEMISPHERICAL, TRIDENT PSL CUPS. Thank you,
Hello, Please provide me with the same information released in: 2016-4335, 5/24/16, HOWMEDICA OSTEONICS CORP-
RESTORATION ADM SYSTEM, K072020 Thank you,
Hello, Please provide me with the same information released in: 2017-7352, 8/25/17, STRYKER MODULAR HIP STEM
SYSTEM- URGENT PRODUCT CORRECTION, PRODUCT CORRECTION ACKNOWLEDGEMENT FORM, URGENT UPDATE,
PRODUCT RECALL Thank you,
Hello, Please provide me with the same information released in: 2017-906, 2/1/17, STRYKER CORP, PORTAGE, MI-
WARNING LETTER 3/13 Thank you,
Copy of the disclosable portions of the 510(k) for K131282, Nexus Hemorrhoid Ligator, by INX Medical
Complete 510(k) filing for 510(k)# BK030040, Sponsor Medtronic Sofamor Danek USA, Inc., Device Name: Magellan
Autologous Platelet Separator System, Class II, Device Code: FMF.
Information regarding adverse experiences for several tobacco STNs. Please see attached for details.
A list of tobacco products containing non-tobacco nicotine (“synthetic nicotine”) that were on the market as of May 14,
2022, and their manufacturers, for which premarket authorization applications were timely submitted as required by
H.R. 2471, the Consolidated Appropriations Act, 2022.
Copy of the disclosable portions of the MedWatch forms for the following 2 molnupiravir cases: 20850771, and
20849382.
Please provide Summary Basis of Approval (Including CMC, Biopharmaceutics and Dissolution review) for
Fludrocortisone Acetate Tablets ORAL 0.1mg for the following mentioned Applicants: 1. CASPER PHARMA LLC -
FLORINEF N010060 2. IMPAX LABORATORIES INC- A040431 3. BARR LABORATORIES INC-A040425
I am interested in the agency's approval package for Dermavant's VTAMA® (tapinarof) cream 1% for the topical
treatment of plaque psoriasis in adults. I am particularly interested in the long-term safety / toxicity non-clinic study
results. In the published label, the statement is too simple without detail descriptions.
1) Letter from William Chatoff, owner of Edge Pharma, to FDA on December 21, 2021 2) Reply from FDA to William
Chatoff on January 15, 2022
483: Allen Y. Hu, M.D. Hagerstown,
Maryland, United States End Dates of inspection: 27
September 2021 Project Area: Bioresearch Monitoring FEI: 3019853004 Classification: VAI I confirm that Clarivate
K210971
483: Blink Device Company, LLC Seattle,
Washington, United States End Dates of inspection: 15
October 2021 Project Area: Compliance: Devices FEI: 3014447708 Classification: VAI I confirm that Clarivate Analytics
will be charged accordingly by FOI for this request, however please contact me if the charges exceed $ 200.
483: CellEra LLC Monroe, Ohio,
United States End Dates of inspection: 08 July 2021 Project
Area: Compliance: Devices FEI: 3007594734 Classification: OAI I confirm that Clarivate Analytics will be charged
I would like to receive a full copy of the product 510k submission for Pediametrix SoftSpot (K212045) in order to
understand the need and purpose behind the new product classification this product prompted. Thanks in advance.
COMPANY: East Tennessee Clinical Research, ADDRESS: 80 Copper Ridge Farm Road, Rockwood, TN 37854, CLINICAL
INVESTIGATOR: Craig Reinemeyer REQUEST INFO: Any FDA 482, FDA 483, FDA GLP Inspections, EIRs, All Inspections
K220195
483: Compass Health Brands (Corporate Office)
Middleburg Heights, Ohio, United States End Dates of
inspection: 07 October 2021 Project Area: Compliance: Devices FEI: 3012316249 Classification: VAI I confirm that
$ 200
Hi, I am an investment professional for an asset management firm and would like to request all forms 483 issued to the
following site from September 2021 to present: Respironics California, LLC, 2271 Cosmos Ct, Carlsbad, CA 92011-1517.
FEI 3002470603 Please send 483s via email or Box if possible; otherwise a CD would suffice. Thank you!
1. ANDA Application No. 078472, filed by Synthon; 2. ANDA Application No. 076801, filed by Mylan; and, 3.
ANDA Application No. 204133, filed by Annora Pharma.
Hi, I am an investment professional for an asset management firm and would like to request UCB Pharma’s response to
the 483s issued facility with FEI 3003909356 and FEI 1000291122 for February 2022-March 2022? Please send via email
or Box if possible; otherwise a CD would suffice. Thank you!
K162128 - Scope Buddy Plus 510k, full report Date Prepared: December 12, 2016 Manufacturer: Medivators Inc., a
Cantel Medical Company Address: 14605 28th Avenue North Minneapolis, MN 55447 (800) 328-3345 Official Contact:
Kristin Bergeson Padilla Regulatory Affairs Associate, Medivators Inc.
We kindly request a copy of all documents including but not limited to memos or minutes of meetings, telephone
discussions, submission and FDA correspondence related to Amai proteins and sweeteners from January 2017 to
current.
.ALL FORM 483, EIR, RESPONSE LETTERS, AND ANY OTHER COMMUNICATIONS WITH THE FDA BY/FOR STRATUS
PHARMACEUTICALS, LLC LOCATED AT 12379 SW 130TH ST, MIAMI, FL 33186.
483: DDC Technologies Inc. Oceanside,
New York, United States End Dates of inspection: 22
October 2021 Project Area: Compliance: Devices FEI: 3002757272 Classification: VAI I confirm that Clarivate Analytics
will be charged accordingly by FOI for this request, however please contact me if the charges exceed $ 200
483: Fertility Center of Dallas Dallas,
Texas, United States End Dates of inspection: 25 August
2021 Project Area: Human Cellular, Tissue, and Gene Therapies FEI: 3009081566 Classification: VAI I confirm that
$ 200.
483: GENIAL DAY INC Orland Park,
Illinois, United States End Dates of inspection: 03 August
All controlled substances transactions reported by Walgreens from January 1, 2015 to
December 31, 2021 etc
Can you please provide a list of company names (in the cell and gene therapy space) that have received a 483.
In view of submission of our proposed ANDA for Oxcarbazepine Tablets, 150mg, 300mg, 600mg please provide us all the
available data/SBOA for the following products (RLD/RS/Approved Generics) listed below- RLD: Trileptal
(Novartis) 021014 Generics: Annora Pharma 215939 Breckenridge 078069
Glenmark 077802 Rubicon 077747 Sun 077794
In view of submission of our proposed ANDA for Carbidopa and Levodopa Orally Disintegrating Tablets 10 mg, 100 mg;
25 mg, 100 mg; 25 mg, 250 mg, please provide us all the available data/SBOA for the following listed RLD/RS/Approved
Generics- RS: Sun 078690 Generics: Impax 090631 Rising 078893
UCB Inc 076699
In view of submission of our proposed ANDA for Indapamide Tablets 1.25mg/2.5mg, please provide us all the available
data/SBOA for the following listed RLD/RS/Approved Generics- RLD: Lozol (Sanofi Aventis) 018538 RS:
ANI 074299 Generics: Actavis 074722 Chartwell 074594 Mylan
075105 Rising 074461 Teva 074665
In view of submission of our proposed ANDA for Pimozide Tablets 1 mg and 2 mg, please provide us all the available
data/SBOA for the following listed RLD/RS- RLD: Orap (Teva) 017473 RS: Par 204521
In view of submission of our proposed ANDA for TERAZOSIN HYDROCHLORIDE Capsules, please provide us all the
available data/SBOA for the following product- ANDA # 075317
We are requesting a copy of a memo that the FDA sent to agencies signaling a risk to the baby formula supply chain.
all contacts or binding agreements relating to the following Award IDs (Mod#s):
1) 75F40120P00388
2) 75F40120P00150
Copies of FOIA Requests By Specific Requestors: I am requesting copies of all FOIA request submitted to your agency by
the following parties (listed below) from January 1, 2022, to February 1, 2022. • Margaret Kwoka • FOI Services,
Inc • FDA News • Washington Information Source • Thomson Reuters • Merck & Co., Inc. • Eli Lilly & Co. • EAS
Consulting • etc
I am requesting an unredacted copy of the Boston Scientific owned premarket notification records K083292 and
K180165 and the associated reviews. The 510(k) applicant was EMcision, Ltd. Boston Scientific acquired EMcision, Ltd. in
March 2018.
Pursuant to the Freedom of Information Act, I am writing on behalf of the Democratic National Committee to request
the following records in the possession of the United States Food & Drug Administration, • All correspondence,
including – but not limited to – emails, letters and faxes, between any official or employee in the Center for Biologics
Evaluation and Research and Benjamin “Ben” Carson or representatives from Vaccinogen, Inc or OncoVAX. This request
extends from October 1, 2013 through May 31, 2015. etc
We request a spreadsheet identifying the firms that received FDA Warning Letters between October 1, 2011, and June
1, 2022
FDA publishes weekly Enforcement Reports on its website

(http://www.fda.gov/Safety/Recalls/EnforcementReports/default.htm) identifying all recalls monitored by FDA once
they are classified according to the level of hazard involved. These reports are available as a downloadable CSV file
which includes the following data fields: 1. Product Type 2. Event ID 3. Status etc
We request a spreadsheet which includes the 23 publicly available data points for all entries that led to Delicias Import,
Inc.'s inclusion in this list for the last 2 years (June 1, 2020 - June 1, 2022).
I am seeking all emails sent or received by FDA commissioner Dr. Robert Califf from email accounts ending in:
"@who.eop.gov" - this is the email server for the Executive Office of the President.
2020-2265 2020-4990 2020-8549 2021-1054 2021-6287 2022-1879 2022-2007
1. OS Memorandum Update to Premarket Tobacco Product Application (PMTA) Review Process: Deficiency Letters and
Major Amendments memorandum, dated August 12, 2020 etc
F-0958-2022, F-0957-2022, F-0955-2022, etc
ANDA 085070 for Hydrocortisone Tablet, 20 mg FDA approved May 7, 1976
ANDA 080694 for Cortisone Acetate Tablet, 25 mg FDA approved October 17, 1974
Investigator site audits performed for Study C4591001
For the time period January 1, 2022 to present, the FDA health hazard evaluation supporting FDA’s recall classification
for the following recall numbers: F-0958-2022, F-0957-2022, F-0955-2022, etc
Copies of all documents, slide sets, tables, reviewer guides, job aids, checklists, questions common to all manufacturing
facilities and unit operations, spreadsheets, algorithms, risk criteria and risk assessment tools and scoring mechanisms,
notes and memoranda from the OPQ KASA steering committee etc
Copies of all contracts awarded to all vendors for the development of the Knowledge Aided Assessment and Structured
Application (KASA) project for the product quality (CMC) review for generic drugs and new drugs.
Information regarding May 26th Closure of Greenwood Ice Cream by Either FDA and/or Ga. Dept. of Agriculture 19
Martin Luther King Jr. Dr. Atlanta, Ga etc
Any Form 483 / inspection report relating to the Laupheim, Germany plant of Rentschler Biopharma SE that relates to
the manufacture of the biological active substance for bimekizumab
inspection, Investigator name(s), product(s) being inspected, and whether or not a 483 was issued.
Requesting Meeting Minutes of the below: Regulatory Meeting Agenda Osteolife Biomedical LLC FEI: 3014623896 May
24, 2022 Time: 1:00PM-2:30PM EST Via Zoom
I'm seeking the Form FDA 483 and Establishment Inspection Report for the inspection (Inspection End Date:
01/21/2022, Inspection ID: 1161948, Product Type: Drugs, Classification: VAI) of the firm Gemini PharmChem
Mannheim GmbH (FEI Number: 3014000756, Firm Address: Sandhofer Str. 96, Mannheim, Baden-Wurttemberg 68305,
Germany).
for Foods & Cosmetics inspection of Weeks & Leo Co Inc ending 03/29/2018 at the location in Clive IA, United States.
The EIR (in electronic format) for Foods & Cosmetics inspection of Weeks & Leo Co Inc ending 03/29/2018 at the
location in Clive IA, United States. etc
for Human Drugs inspection of Element Materials Technology Oakland-Concord ending 03/22/2022 at the location in
Concord CA, United States. The EIR (in electronic format) for Human Drugs inspection of Element Materials Technology
Oakland-Concord ending 03/22/2022 at the location in Concord CA, United States.
for Medical Devices & Rad Health inspection of Med Pen Concepts, Llc ending 04/13/2022 at the location in Woburn
MA, United States. etc
for Medical Devices & Rad Health inspection of Aggredyne, Inc. ending 04/14/2022 at the location in Houston TX, United
format) for Medical Devices & Rad Health inspection of Becton Dickinson & Company ending 07/06/2017 at the location
in Franklin Lakes NJ, United States. Please send documents as email attachments.
The redacted premarket tobacco applications submitted to FDA by Swedish Match for ZYN-branded tobacco products
(STNs PM0000593 - PM0000612) (“the ZYN PMTAs”). Specifically, Swedish Match submitted to FDA versions of the ZYN
PMTAs that were redacted of confidential, trade secret, and/or personally identifiable information.
All submissions, files, and communications between Venostat and FDA regarding the Breakthrough Designation granted
by FDA on or about May 17, 2022 for Venostent’s SelfWrap® Bioabsorbable Perivascular Wrap.
since Saturday, April 30, 2022.
Records that are releasable to the public and related to the 2018 and/or 2019 inspection/ examination of
manufacturing processes at the following dietary supplement manufacturer: Vit-Best Nutrition, Dow Ave., Tustin, CA;
and the inspector’s findings, including FDA Form 483, and related or subsequent correspondence between the FDA
/inspectors and Vit-Best.
FDA GLP Inspection reports and the responses from Joinn Laboratories Co. Ltd. and JOINN Laboratories (Suzhou).
Communications sent or received by Rochelle Walensky, Mitchell Wolfe, Peter Marks, and/or
Jay C. Butler that include the term “DeSantis” and/or “Florida” dated between January 1, 2020
through date of search. (IR#0657)
for Human Drugs inspection of P & L Development, LLC ending 11/13/2018 at the location in Westbury NY, United
States. The EIR (in electronic format) for Human Drugs inspection of P & L Development, LLC ending 11/13/2018 at the
location in Westbury NY, United States.etc
FDA recently inspected Nephron Sterile Compounding Center, LLC (NSCC), West Columbia, SC. This inspection was
concluded on 04/20/2022. I would like to receive a copy of Form FDA-483 associated with this inspection as well as and
any other additional forms/letters issued by the FDA associated with this inspection.
for Animal Drugs & Feeds inspection of Nova-Tech Inc. ending 03/15/2022 at the location in Grand Island NE, United
States. The EIR (in electronic format) for Animal Drugs & Feeds inspection of Nova-Tech Inc. ending 03/15/2022 at the
location in Grand Island NE, United States. etc
for Medical Devices & Rad Health inspection of EINSTEIN WORKS, LLC ending 03/23/2022 at the location in Houston TX,
United States. etc
format) for Animal Drugs & Feeds inspection of Denison Pharmaceuticals, LLC ending 10/25/2017 at the location in
Lincoln RI, United States. Please send documents as email attachments.
The policy and procedures, published on November 18, 2019, and any updated policies and procedures thereafter, for
the transfer, adoption, retirement, or other handling of research animals that have completed their assigned study.
Hello FDA officer, I'm looking for the food facility inspection report (483) the inspection was done on June 10, 2013 in
New Taipei City, TW. The facility name is HAHN SHYUAN FOOD FACTORY CO., LTD. Best Regards!
Biologic License Application (BLA): 125360 Request: FDA review record for approval of SUPPL-66
All submissions, files, and communications between Laminate Medical and FDA regarding the Breakthrough Designation
granted by FDA on or about June 7, 2020 for Laminate Medical’s VasQ External Support for the creation of
arteriovenous fistulas.
For the time period listed, please provide copies of all complaints and related correspondence submitted to CDRH
regarding NeilMed Pharmaceuticals, Inc., 601 Aviation Blvd., Santa Rosa, CA 95403.
All internal or external communications sent to or received by the FDA related to the Sturgis plant, from July 1, 2021, to
the present; All records related to the FDA’s inspections of the Sturgis plant, from September 1, 2021, to the present,
including but not limited to communications, reports, findings, audits, memoranda, or summaries, etc
Hi, I am an investment professional for an asset management firm and would like to request the Medwatch case reports
for the following FAERS Case IDs: 20557475 20691717 20713885 20618280 20557475 20428196 Please send via email
or Box if possible; otherwise a CD would suffice. Thank you!
Please provide a list of all sites where the FDA conducted GMP and GLP inspections during the requested dates.
Drug summary basis of approval (SBA) documentation for Somatuline Depot (lanreotide) Injection, NDA 22074: review
of supplement 11 for new indication submitted on Jun23, 2014 and approved on Dec16, 2014; and review of
supplement 17 submitted on Aug 15, 2016 and approved on Sep 15, 2017.
2014-9659 Recd Date:12/08/2014 Requester: Bloomberg News FDA Control # 2014-9660 Recd Date:12/08/2014
Requester: Bloomberg News FDA Control # 2016-5690 Recd Date:07/11/2016 Requester: Merchant, Brian
483 inspection reports, or other documents specific to the work of Emergent BioSolutions in filling and finishing
Ryplazim (plasminogen, human-tvmh) a plasma-derived human plasminogen manufactured by Kedrion Biopharma.
All emails sent to or received by any personnel from the Center for Biologics Evaluation and Research and the McKinsey
& Company Inc. and/or the “@mckinsey.com” domain name, from January 1, 2020, to the time of the search.
internal Center for Tobacco Products (CTP) memorandum “Update to Premarket Tobacco Product Application (PMTA)
Review Process: Deficiency Letters and Major Amendments,” dated August 12, 2020.
internal Center for Tobacco Products (CTP) memorandum "Bundling and Bracketing Approach for Review of ENDS Open
E-liquid PMTAs," dated August 19, 2020.
assessment from the Center for Tobacco Product's Office of Science's Evaluation Branch that identified the top market
share ENDS manufacturers as of June 13, 2020, dated August 7, 2020.
Center for Tobacco Product's Office of Science's internal Briefing memos, dated April 23, 2020 and May 5, 2020.
INDIVIDUAL RECS
INDIVIDUAL RECS
INDIVIDUAL RECS
INDIVIDUAL RECS
I'm requesting all scientific review and risk records and documents for Sec. 690.800
https://www.fda.gov/downloads/iceci/compliancemanuals/compliancepolicyguidancemanual/ucm361105.pdf
I am requesting this complaint: FDA received a complaint of two kitten deaths, including one death which was
confirmed to be caused by Salmonella septicemia. Subsequent testing by the FDA of Kitten Grind Lot#GA1102 revealed
the presence of Salmonella and Listeria monocytogenes. This is in regards to blue ridge beef 03.01.18 recall
Scientific review and risk records and documents for Sec. 690.800
https://www.fda.gov/downloads/iceci/compliancemanuals/compliancepolicyguidancemanual/ucm361105.pdf
All email records for FDA CVM employees David Edwards, Charlotte Conway, Steven Solomon, and Tracey Forfa
containing the key search term: AAFCO 11.01.2020-05.31.2022 All calendar records for FDA CVM employees David
Edwards, Charlotte Conway, Steven Solomon, and Tracey Forfa 11.01.2020-05.31.2022
Pursuant to the Freedom of Information Act, 5 U.S.C. Section 552 et seq.("FOIA"), I request inspection reports from the
past year of Bluebird Bio’s facility at 60 Binney St Cambridge, MA 02142. I am further requesting that the Records be
provided to me on computer files or, if not maintained on computer files, in the same format as they are currently
maintained at the Food and Drug Administration.
for Biologics inspection of Wyeth Pharmaceutical Division of Wyeth Holdings LLC ending 11/26/2019 at the location in
Sanford NC, United States. The Response (in electronic format) for Biologics inspection of Wyeth Pharmaceutical
Division of Wyeth Holdings LLC ending 11/26/2019 at the location in Sanford NC, United States. Please send documents
for Human Drugs inspection of United Exchange Corporation ending 12/04/2019 at the location in Cypress CA, United
States. The EIR (in electronic format) for Human Drugs inspection of United Exchange Corporation ending 12/04/2019
at the location in Cypress CA, United States. The Response (in electronic format) for Human Drugs inspection of United
Exchange Corporation ending 12/04/2019 at the location in Cypress CA, United States. Please send documents as email
attachments.
for Human Drugs inspection of Young Dental Manufacturing I, LLC ending 03/25/2022 at the location in Earth City MO,
United States. The EIR (in electronic format) for Human Drugs inspection of Young Dental Manufacturing I, LLC ending
03/25/2022 at the location in Earth City MO, United States. etc
for Human Drugs inspection of Fresh Farms LLC ending 11/11/2021 at the location in Montebello CA, United States. The
Response (in electronic format) for Human Drugs inspection of Fresh Farms LLC ending 11/11/2021 at the location in
Montebello CA, United States. Please send documents as email attachments.
Hello, I would like to request all supporting data for two 510(k) forms submitted by Dr. Collins, Inc. K181965 and
K200077. The supporting data should include performance data, biocompatibility data, and any other data submitted by
the applicant. Thank you (Date Range for Record Search: From 07/20/2018 To 11/09/2020)
We request the FDA's discipline-specific standard NDA/BLA refuse to file templates.

All correspondence between PepsiCo and the US FDA related to infant formula, documents and any applications for
temporary approval to sell infant formula in the US
Requesting a copy of the FDA Form 483 or EIR from inspection at TEVA Parenteral Medicines, Inc. (FEI# 2027158)
occurring around June-July-August 2021 time frame.
All records related to the Premarket Notification 1 submitted by Ceramatec, Inc.

(“Sponsor”), located at 2425 South 900 West, Salt Lake City, UT 84119, for its Rugged Ozone
Sterilization System Model M1 (ROSS M1) (“Product”).
This inspection of McGuff Compounding Pharmacy Services, Inc., (CPS) a producer of human sterile, topical, and oral
drugs, PAC Code 56D015, FACTS ID 11976001, Op ID 130150, was a for cause assignment from the Office of Unapproved
Drugs and Labeling Compliance (OUDLC)
Please provide the Form 483 associated with the FDA’s inspection of Sovereign Pharmaceuticals, LLC's (FEI #:
3003229412) Fort Worth, TX facility that concluded on 4/22/2022. Facility address: 7590 Sand St, Fort Worth, TX, 76118-
6977.
Request for FDA 483 for the inspection of the facility Bioiberica, SAU (FEI #1000418405). The inspection ended on
02/04/2022 and the Inspection ID# is 1162922. The facility manufactures Human Drugs (APIs). Please also include any
responses to FDA 483 if available.
I request all documents and emails that contain the following terms: "Danco" "GenBioPro" "Mifepristone" I request
these documents be sent to me via email. I request a waiver on all fees, as I am a member of the media seeking
information for the benefit of the public. Thank you.
Copy of the non-confidential portions of Prenotification Consultations (PNCs) 2633 and 2696, No Objection Letters
(NOLs) 253 and 263, and all FDA internal review memoranda associated with these filings. These submissions relate to
Zhenjiang Ceville Recycled Fiber Co., Ltd.’s secondary recycling process for post-consumer recycled polyethylene
terephthalate (PCR-PET).
OPKO Biologics_MOD4023_Pediatric HGH_CP-4-006_Steelman. The FDA audited this study at our site in January 2021.
They say the report was sent to the primary and secondary points of contact, however neither individual received the
document. We are requesting a copy of the audit report.
Request for Fast Track designation of Edge Therapeutics, Inc. ("Company") for its product EG-1962, and any FDA review
of the Company's Request
Report and/or the MDSAP Noncomformity Grading and Exchange Form (NC) for the inspection of Delta Med SpA,
Viadana, Italy, end date 01-25-2018. FEI# 3006846316. This inspection pertains to medical devices.
Report and/or the MDSAP Noncomformity Grading and Exchange Form (NC) for the inspection of LIOFILCHEM SRL,
Abruzzi, Italy, end date 11-09-2018. FEI# 3012389632. This inspection pertains to medical devices.
Report and/or the MDSAP Noncomformity Grading and Exchange Form (NC) for the inspection of Cosmed S.R.L., Pavona
Di Albano, Roma, Italy, end date 12-12-2018. FEI# 2995. This inspection pertains to medical devices.
Report and/or the MDSAP Noncomformity Grading and Exchange Form (NC) for the inspection of Mdt-Micro Diamond
Technologies Ltd, Afula Eliteafula Elite, Israel, end date 06-21-2018. FEI# 3005615993. This inspection pertains to
medical devices.
Regulatory Assessment of CSL Plasma, Inc Located at Harlingen TX United States FEI Number: 3013450966 held on
06/28/2021.
Regulatory Assessment of BioLife Plasma Services LP Located at Pasco WA United States FEI Number: 3012981516 held
on 06/28/2021.
Regulatory Assessment of Biomat USA, Inc. Located at Bakersfield CA United States FEI Number: 1000135246 held on
06/28/2021.
Regulatory Assessment of Biomat USA, Inc. Located at Las Vegas NV United States FEI Number: 2976605 held on
06/28/2021.
2017-4646
Report and/or the MDSAP Noncomformity Grading and Exchange Form (NC) for the inspection of Delta Med SpA,
Viadana, Italy, end date 01-25-2018. FEI# 3006846316. This inspection pertains to medical devices.
Report and/or the MDSAP Noncomformity Grading and Exchange Form (NC) for the inspection of LIOFILCHEM SRL,
Abruzzi, Italy, end date 11-09-2018. FEI# 3012389632. This inspection pertains to medical devices.
Report and/or the MDSAP Noncomformity Grading and Exchange Form (NC) for the inspection of Cosmed S.R.L., Pavona
Di Albano, Roma, Italy, end date 12-12-2018. FEI# 2995. This inspection pertains to medical devices.
Report and/or the MDSAP Noncomformity Grading and Exchange Form (NC) for the inspection of Mdt-Micro Diamond
Technologies Ltd, Afula Eliteafula Elite, Israel, end date 06-21-2018. FEI# 3005615993. This inspection pertains to
medical devices.
Copy of the 483 for the 01/27/2022 - 02/02/2022 inspection of L M Manufacturing Limited [Weedon Bec / United
Kingdom of Great Britain and Northern Ireland] Sandretto Building Cavalry Hill Industrial Park, Northampton,
Northamptonshire NN7 4PP, United Kingdom (GBR). This inspection pertains to HUMAN DRUGS
Copy of the 483 for the 01/12/2022 - 01/24/2022 inspection of Manish Jain, M.D. [Chicago / United States of America]
5149 N Ashland Ave, Chicago, IL 60640, USA. This inspection pertains to HUMAN DRUGS
Copy of the 483 for the 01/18/2022 - 01/24/2022 inspection of Ann R. Woodbridge, M.D. [Dallas / United States of
America] 8160 Walnut Hill Ln #215, Dallas, TX 75231, USA. This inspection pertains to HUMAN DRUGS
Copy of the 483 for the 01/04/2022 - 01/15/2022 inspection of CRONUS PHARMA SPECIALITIES INDIA PRIVATE LIMITED
[Mamidpally / India] Sy No: 99/1, M/s GMR Hyderabad Aviation SEZ Limited Mamidipalli Village, Shamshabad Mandal,
Ranga Reddy, Hyderabad, Telangana 501218, India (IND). This inspection pertains to VETERINARY DRUGS
Request to provide the Summary basis of approval (SBOA) for Rasagiline
Copy of ANDA Approval letter for SODIUM PHOSPHATES injection held by FRESENIUS KABI USA LLC and approved under
ANDA # A209997 on Mar 30, 2022.
2022-1662, 2021-8741, 2022-1391, 2022-1766, 2022-1957.
The FDA Form 483 (in electronic format) for the FDA inspection of FDA-registered (Reg. No. 3016808907) establishment
Texas Medical Technology, Inc. ending 03/03/2022 at the location in Houston TX, United States. Please send documents
as email attachments. Additionally, please include any response(s) to the Form 483 report filed by Texas Medical
Technology, Inc.
Freedom of Information Act (FOIA): Requesting the Agency to provide last five years inspected Form 483 (Notice of
Inspectional Observations) of Analytical Solutions, with FDA establishment identifier # 3005658262
Inspectional Observations) of Choksi Laboratories Limited, with FDA establishment identifier # 3006091736.
Inspectional Observations) of Aragen Life Sciences Private Limited, with FDA establishment identifier # 3011573185.
Inspectional Observations) of Megsan Labs Private Limited, with FDA establishment identifier # 3010960741
Inspectional Observations) of Shiva Analyticals (India) Private Limited, with FDA establishment identifier # 3006192929
Inspectional Observations) of Vimta Labs Limited, with FDA establishment identifier # 3006587427
I request the meeting minutes, notes, materials (including presentations) and transcript if available from a meeting on
March 10, 2022, between Frank Yiannas and the Safe Food Coalition. Specifically, I request FDA’s assessment of the
infant formula supply presented to the meeting participants.
INSPECTIONS, CITATIONS DATA
PREVIOUSLY RELEASED INSPECTION RECS
STEM CELL THERAPY
K211222
1. Emails sent by Susan Mayne, Director Center for Food Safety and Applied Nutrition (CFSAN), to any individual using
the email domain address @michigan.gov during the specified time period. 2. Emails sent by Frank Yiannas, Deputy
Commission for Food Policy and Response (OFPR), to any individual using the email domain address @michigan.gov
during the specified time period. etc
FAERS database for VABYSMO (faricimab-svoa). Please search for records under both drug names.
FDA FAERS database for (lonapegsomatropin-tcgd) (brand name SKYTROFA).

All applications, documents, correspondence and emails between the FDA and the Nature's One facility in Heath, Ohio
regarding their certification to make infant formula
Hello, I am requesting all information and correspondence/communications related to: Recall Number Z-0336-2020
Recall Event ID 83962 Thank you-
Copy of ANDA Approval letter for Sodium Bicarbonate Injection, USP held by EXELA PHARMA SCIENCES LLC and
approved under ANDA # A211091 on Jun 20, 2019.
K092219
I would like any documents available pertaining to the approval process of Fabryzyme in April of 2003.
Any and all adverse events reporting for the following:

Stryker Orthopedics
Triathlon Knee System
CSINS
FDA's response letter to NDI 264 subsequent to the response letter issued by FDA on February 9, 2005
Regulatory Assessment of Pfizer Manufacturing Deutschland GmbH Located at Freiburg im Breisgau Germany FEI
Number: 3002807097 held on 01/04/2021.
Regulatory Assessment of Novo Nordisk A/S Located at Kalundborg Denmark FEI Number: 3002807751 held on
12/30/2020.
Regulatory Assessment of PAREXEL International GmbH, Early Phase Clinical Unit Berlin Located at Berlin Germany FEI
Number: 3005921529 held on 09/25/2020.
All releasable forms 3542 for NDA No. 211288, including forms 3542 for NDA No.211288 that list patent information for
US Patent No. 7,772,243; US Patent No. 8,623,883; US Patent No. 10,596,162; and US Patent No 10,603,314.
Regulatory Assessment of FRESENIUS KABI SWISSBIOSIM GMBH Located at Eysins Switzerland FEI Number: 3016540422
held on 08/19/2020.
Electronic listing (preferably csv format) of all RRAs conducted since March 1, 2022.
Copy of the 483 for the 01/31/2022 - 02/11/2022 inspection of Muhammad Y. Sheikh, M.D. [Fresno / United States of
America] 7055 N Maple Ave, Fresno, CA 93720, USA. This inspection pertains to HUMAN DRUGS
Copy of the 483 for the 02/07/2022 - 02/11/2022 inspection of Samuel J. Maiser, M.D., Clinical Investigator
[Minneapolis / United States of America] 701 Park Ave, Minneapolis, MN 55404, USA. This inspection pertains to
HUMAN DRUGS
Copy of the 483 for the 01/31/2022 - 02/11/2022 inspection of Maropack AG [Zell / Switzerland] Industriestrasse
Briseck 4, 6144 Zell, Switzerland. This inspection pertains to HUMAN DRUGS
Copy of the disclosable portions of all premarket tobacco product applications, including amendments, deficiency letters
with responses and all relevant meeting correspondences. Excluding any scientific literature and raw/full clinical and
behavioral data between the manufacturer and CTP relating to the following Logic products: PM0000529, PM0000530,
PM0000531, PM0000535, PM0000536, PM0000537, PM0000540, and PM0000541.
All premarket tobacco product applications, including amendments, deficiency letters with responses and all relevant
meeting correspondences. Excluding any scientific literature and raw/full clinical and behavioral data between the
manufacturer and CTP relating to the following Vuse Vibe & Vuse Ciro products: PM0000635, PM0000636, PM0004287,
PM0000646, PM0000712, and PM0004293.
All premarket tobacco product applications, including amendments, deficiency letters with responses and all relevant
meeting correspondences. Excluding any scientific literature and raw/full clinical and behavioral data between the
manufacturer and CTP relating to the following NJOY products: PM0000613, PM0000614, PM0000615, and PM0000616.
I would like to request a copy of the FDA 510(K) Application K192731. This filling is for the ZIDA Wearable
Neuromodulation System by Exodus Innovations. The FDA received the filing on 9.27.2019 and made it's decision on
03.19.2021 based upon the summary documentation available online.
Re: Clinical pharmacology & Biopharmaceutics approval package for HYZAAR (Losartan Potassium and
Hydrochlorothiazide Tablets)
Copy of the disclosable portions of FDA's chemistry and toxicology review memoranda relating to the following Food
Contact Notifications: FCN 333, FCN 462, and FCN 592.
Copy of any and all correspondence between FDA and Motif Foodworks, including GRAS GRN No. 1001
Under the U.S. Freedom of Information Act, I am requesting electronic copies of all inspection findings and/or reports--
including 483 reports--of the FDA's follow up observations from Abbott Nutrition's Sturgis, Michigan baby formula
production facility. The request is specifically for all inspection findings up until the date the request is fulfilled. Thank
you.
for Biologics inspection of Pfizer Ireland Pharmaceuticals ending 11/12/2019 at the location in Dublin 22, Ireland.
for Human Drugs inspection of Cs Bio Company ending 02/17/2022 at the location in Menlo Park CA, United States.
for Human Drugs inspection of Lilly del Caribe, Inc ending 02/25/2022 at the location in Carolina PR, United States. The
Response (in electronic format) for Human Drugs inspection of Lilly del Caribe, Inc ending 02/25/2022 at the location in
Carolina PR, United States. Please send documents as email attachments.
for Human Drugs inspection of Guardian Drug Co. Inc. ending 02/17/2022 at the location in Dayton NJ, United States.
The EIR (in electronic format) for Human Drugs inspection of Guardian Drug Co. Inc. ending 02/17/2022 at the location
in Dayton NJ, United States. The Response (in electronic format) for Human Drugs inspection of Guardian Drug Co. Inc.
ending 02/17/2022 at the location in Dayton NJ, United States. Please send documents as email attachments.
for Human Drugs inspection of United Exchange Corporation ending 12/19/2019 at the location in Cypress CA, United
States. The EIR (in electronic format) for Human Drugs inspection of United Exchange Corporation ending 12/19/2019
at the location in Cypress CA, United States. etc
A list of the dates and the topics and REMS programs discussed at REMS Oversight Committee Meetings held from
06/01/2021 – present. If such a list is not able to be created, please send the minutes for all REMS Oversight Committee
Meetings from 06/01/2021 - Present.
Report and/or the MDSAP Noncomformity Grading and Exchange Form (NC) for the inspection of BioFire Diagnostics,
LLC, Salt Lake City, UT , end date 10-23-2017. FEI# 3002773840. This inspection pertains to medical devices.
Report and/or the MDSAP Noncomformity Grading and Exchange Form (NC) for the inspection of Bard Access Systems
Inc., Salt Lake City, UT , end date 09-15-2017. FEI# 3006260740. This inspection pertains to medical devices.
Report and/or the MDSAP Noncomformity Grading and Exchange Form (NC) for the inspection of FujiFilm SonoSite, Inc.,
Report and/or the MDSAP Noncomformity Grading and Exchange Form (NC) for the inspection of Liposonix Inc, Bothell,
WA , end date 06-26-2018. FEI# 3004106598. This inspection pertains to medical devices.
Copy of the 483 for the 01/31/2022 - 02/04/2022 inspection of Takeda Ireland Ltd [- / Ireland] Grange Castle Business
Park, Nangor Road Dublin 22 Ireland. This inspection pertains to HUMAN DRUGS
I am requesting a copy of the inspection report (EIR) for Dr. John DeVincenzo. The FEI # 3005495146. This was a NAI
inspection per the FDA auditor. The investigator is no longer at the site and the site requests a copy for our records to
go with our study file.
A copy of all correspondence, documents, recall notices, investigation pertaining to Aziyo Biologics, Inc. FiberCel Fiber
Viable Bone Matrix Lot #NMDS210011 including, but not limited to, all correspondence provided to Advocate Sherman
Hospital in Elgin, Illinois.
A copy of all correspondence, including emails, to and from the National Chicken
Council that were sent or received by FSIS employee Gamola Fortenberry.
Hello, please provide all emails, instant chat messages, and texts to or from Tom Shimabukuro
mentioning "myocarditis" or "pericarditis" and "vaccine" and "covid" or "covid-19"
CDC EMAILS RE Palantir ETC
ALL FORM 483, EIR, RESPONSE LETTERS, AND ANY OTHER COMMUNICATIONS WITH THE FDA BY/FOR APNAR PHARMA
LP LOCATED AT 4820 LANIER ROAD, CHINO, CA - 91710 USA AND 10 Lake Dr, East Windsor, NJ - 08520 USA AND Block
No. – 102, At & Post –Gavasada, Padra – Jambusar Road, Ta. Padra, Dist. Vadodara, Gujarat, India – 391430.
Inspectional Observations) of Syngene International Limited, with FDA establishment identifier # 3007907068
I would like to request details of every FDA user fee paid by pharmaceutical companies to the FDA. I would specifically
like to see the dates of payments, the company names and the amount paid in dollars of each fee paid.
All emails, letters, correspondence, social media posts, contracts with outside firms, PR infortmation, call logs and any
other material regarding Ivermectin and Covid-19. Please include all discussions, emails, letters, correspondence,
contracts with outside firms regarding social media and Ivermectin.
1. Reproductive toxicology report #20256343 submitted by Pfizer/BioNTech for approval of its COVID-19/SARS-CoV-2
vaccine. 2. Reproductive toxicology report #20248897 submitted by Moderna for approval of its COVID-19/SARS-CoV-2
vaccine.
No Objection Letter (NOL) provided to Veolia Huafei Polymer Technology Co. Ltd. Group (Veolia), NOL #264, on March
14, 2022 regarding the company’s process for producing post-consumer recycled (PCR) plastic to be used in the
manufacturing of food-contact articles
The brand name and establishment company name of any FDA medical devices with a code FRO (wound care gels)
which contain the following ingredients: Iron Hectorite Bentonite Smectite Kaolin Aluminum Laponite Pangel
all research backing the statement that polio vaccination protects against different mutations of the polio vaccine virus.
Hello, Please provide all emails to and from Abby Capobianco, Alison Hunt, and Veronika Pfaeffle mentioning
"myocarditis" and "vaccine" or "vaccines."
BIOLOX® delta Option (GUDID# 00887868271380) model# 650-1056 [Biomet UK D-U-N-S® Number*: 219322575] This
request is for: 510(K), Product Label, Device Record/ Product Life Cycle and Recall information [*This GUDID#
00887868271380 component applies to 8 Regulatory Product Codes: LPH, LZO, OQH, LWJ, OQG, JDI, MAY, OQI ]
Hi, Please provide all emails to or from the following people that mention the words "infant formula" or "baby formula"
and "Abbott" or "Michigan." Carrie Assar, Leila Beker Cheryl Issa Tova Jacobovits Megan Kulas Jeanne Rader Gillian
Robert-Baldo Shawne Suggs-Anderson Linda Tonucci Stephan Torres Krista Viau Suzanne Wolcoff
in the month of May 1 to 31, 2022, including for any inspections dated before May 1, for: • Pharmaceutical, biologics
and medical device manufacturing facilities, including premarket approval inspections; AND • Clinical research
facilities, investigators and IRBs.
ASON Medsystems Inc, existence of company; registration wit FDA
PMA P050018& Supplements, P190019 & supplements; 510k K142983, K193576 and K183636
I am requesting copies of the original requests associated with the following control numbers (listed below): •
2020-8183 • 2021-8872
etc
A copy of the complete 510(k) for the Olympus ALT-Y0003 Endoscope Leak Tester, K123704 and a copy of the complete
501(k) for the Zutron Medical Endoscope Leak Tester, K093718.
I would like the Form 483s for the 2020-2022 inspections for Advanced Accelerator Applications in Milburn, NJ (FEI
3012484129).
All contents of K181038, Device Name: CorMatrix® Cor Patch, Manufacturer: CorMatrix, Product code: PSQ
Copy of the disclosable portions of the MedWatch reports for the following 2 molnupiravir cases: 20877019, and
20873105.
Requesting the most recently approved labeling for RLD ANDA 088316, for Dexamethasone Tablets.
All contents of K201977, Device Name: TempTraq, Model: TT_100, TT-200, TT-300, Manufacturer: Blue Spark
Technologies Inc., Product code: FLL
Request for MedWatch Report for Product Case ID 20577800 • Suspect Product: Benlysta; Lupkynis • Reaction: Malaise
• Male of unspecified age • Country of occurrence: US • Manufacturer Control Number: US-GLAXOSMITHKLINE-
US2022AMR043272
IDE submission G190206 and 510(k) Number K220641 submitted by Palette Life Sciences (device name: Barrigel
Injectable Gel) decision date May 26, 2022
for Biologics inspection of Doris V. Quon, M.D. ending 08/03/2020 at the location in Los Angeles CA, United States.
ANY AND ALL documents, relating to "Dermaglove," including registration application, renewals or FDA inactivation.
Dermaglove is a hand sanitizer product. The applicant/individual owner is Lisa Levison a/k/ Lisa Turner Levison.
Attached is a sample image showing the product name.
483s, EIRs, all correspondences including company response to 483/EIR, any warning letters, for Mead Johnson
Nutritional infant formula plant in Evansville, IN. Would prefer PDFs to be emailed.
for Biologics inspection of Nigel S. Key ending 06/04/2020 at the location in Chapel Hill NC, United States. Please send
for Biologics inspection of Adam S. Giermasz, M.D., Ph.D. ending 07/17/2020 at the location in Sacramento CA, United
States. The EIR (in electronic format) for Biologics inspection of Andrew D. Leavitt MD ending 07/02/2020 at the
location in San Francisco CA, United States. Please send documents as email attachments.
for Biologics inspection of Elaine M. Majerus, MD, PhD ending 06/17/2020 at the location in Saint Louis MO, United
The 483 (in electronic format) for Medical Devices & Rad Health inspection of Tender Corporation ending 10/26/2018
at the location in Littleton NH, United States. The EIR (in electronic format) for Medical Devices & Rad Health inspection
of Tender Corporation ending 10/26/2018 at the location in Littleton NH, United States. ETC
I request access to and copies of Recordings of the Center for Drug Evaluation and Research (CDER) webcast of the May
10, 2012, meeting of the Antiviral Drugs Advisory Committee, linked here:
https://web.archive.org/web/20141225190039/http:/www.fda.gov/downloads/AdvisoryCommittees/Committ
eesMeetingMaterials/Drugs/AntiviralDrugsAdvisoryCommittee/UCM303519.pdf.
Final report for the Remote Regulatory Assessment of Viant Upland Inc completed January 18, 2022 - February 1, 2022.
Address: 2052 West 11th St., Upland, CA 91786 Registration Number: 2027487
Emergency Use Authorization ("EUA") submission cover letters and approval/clearance letters, including revisions,
related to all EUA's issued to Curative Labs, Inc. granting curative limited or unlimited authority to provide COVID-19
testing services.
PREVIOULSY RELEASED INSPECTION RECS
NDA 019734 LABEL
Copy of 483 for FDA inspection of Aperteryx located in Akron, OH. Inspection end date 2/23/2018. Inspection ID:
records and emails relating to Abbott's requests for reinspection of the Sturgis, MI formula plant after 03-18-2022. We
know the plant was found deficient on 03-18-2022. I am trying to determine if, and when Abbott remedied the defaults
and notified the FDA it was ready for re-inspection to open the plant for operations
All documents concerning McKinsey contract 75F40120P00388
All documents concerning McKinsey contract 75F40120P00150
The EIR (in electronic format) for Human Drugs inspection of Charles Stephen Foster, M.D. ending 05/21/2018 at the
location in Waltham MA, United States. The Response (in electronic format) for Human Drugs inspection of Charles
Stephen Foster, M.D. ending 05/21/2018 at the location in Waltham MA, United States.
All current FDA approved labeling for the drug product AUBAGIO which was approved as part of NDA 202992/S-013 and
S-015 on April 30, 2021. We would also like to request any AUBAGIO labeling that has been revised since April 30, 2021.
RLD container label with PRILOSEC as proprietary name on it

The name, address, contact information, and a copy of the application for FDA registration number 18309678280 which
should belong to a supplier of dietary supplement ingredients.
Any internal communications related to the issuance of the warning letter. • Any internal communications predating
or postdating the issuance of the warning letter comparing Vanda’s descriptions of FANAPT® with conduct in other cases
in which FDA did or did not issue warning letters. • Any internal communications postdating the issuance of the
warning letter that relate to the warning letter, including those relating to any response from Dr. Polymeropoulos,
Vanda, the public, or any other entity.
Any discipline reviews (including clinical and statistical reviews) created during FDA’s evaluation of the original
applications for Dramamine (dimenhydrinate). • Any discipline reviews (including clinical and statistical reviews)
created during FDA’s evaluation of subsequent dimenhydrinate applications: ANDAs 040519, 080615, 080715, 080841,
083531, 084316, 084767, 085166, and 085985.
Please see attached FOIA letter. • Any discipline reviews (including clinical and statistical reviews) created during FDA’s
evaluation of the original applications for Antivert (meclizine hydrochloride): NDA 010721.
Please see attached FOIA letter. Any discipline reviews (including clinical and statistical reviews) created duringFDA’s
evaluation of the original applications for Scopolamine: NDA 017874. •Any discipline reviews (including clinical and
statistical reviews) created duringFDA’s evaluation of original abbreviated new drug applications for
Scopolamine:ANDAs 078830, 203753, 208769, or 212342.
BK110061 BK120066 etc
2015-7984
Scope Buddy Plus 510(k), K213833. Full report.
Pursuant to the Freedom of Information Act (FOIA), 5 U.S.C. § 552, as amended, and the regulations promulgated by
the U.S. Food and Drug Administration (“FDA”) in 21 C.F.R. Part 20, I hereby request a report of all FOIA requests filed
with FDA’s Center for Food Safety and Applied Nutrition (“CFSAN”), including related offices, from May 1, 2022 through
May 31, 2022.
K213606, EvoEndo Single-Use Endoscopy System.
PHILIPS RESPIRONICS 124 DEATH REPORT NUMBERS PE-PUR FOAM BREAKDOWN
All records related to any and all FDA investigations of Valisure, LLC in New Haven, Connecticut or Emery Pharma in
Alameda, California.
I would like information relating to any and all on-site FDA Inspections, Audits, visits, to the Lonza Biologics Site (14905
Kirby Dr, Houston, TX 77047) From January 1, 2022- June 1, 2022.
Any complaints or other communications received by FDA from outside individuals or entities concerning Vanda’s
descriptions of FANAPT® (iloperidone) and/or HETLIOZ® (tasimelteon) made on its website or in any other marketing
material, including but not limited to any communication or correspondence that played any role in FDA’s action. ETC
Any record, data, database, or statistics illustrating or discussing the number of formal meetings between the FDA and
drug sponsors over the past three fiscal years. • Any record, data, database, or statistics illustrating or discussing the
number of Type A meetings between the FDA and drug sponsors over the past three fiscal years. • Any record, data,
database, or statistics illustrating or discussing the number of Type B meetings between the FDA and drug sponsors over
the past three fiscal years. ETC
Any record, data, database, or statistics illustrating or discussing the number of Expanded Access applications received
by FDA in the last three fiscal years. • Any record, data, database, or statistics illustrating or discussing the number of
Expanded Access applications that FDA approved in the last three fiscal years. ETC
ANDA 087859
Hello, I am requesting the same information released in 2018-6147.
ANI Pharmaceuticals, Inc. is requesting a copy of all comments made to “Docket Numbers 98P-1041 and FDA-1998-P-
0083 (formerly 76N-0377)” for DESI 7661 Estrogen-Androgen Fixed-Combination Drug Products; Syntest D.S. and
Syntest H.S. Tablets as these documents are not available on Regulations.gov.
Please provide all scientific research available to the FDA proving that the polio vaccines in the childhood schedule
protect against MUTATIONS of the VACCINE DERIVED POLIO virus. Thank you
Hello, Please provide records previously released in 2013-7937. Thank you,
Hello, Please provide records released in 2020-8070. Thank you,
Hello, Please provide documents previously released in 2018-7421. Thank you,
I am requesting an un-redacted copy of my 510(k)/PMA, and I am the 510(k) holder/ PMA applicant.
Please provide the full text of the following food-related complaints re: FEI 1815692 172425 172435 172443 172450
172457 172477 172533 172607 172632 172636 172651
Please provide the full text of the food-related complaints re: FEI 1815692 from the March 4, 2022 to the date of
processing this request. A summary spreadsheet would fulfill this request in .xls or .csv format. Thank you.
I would like the 510K submission for Promisemed Safety Heal Lancet submission number K193009. The summary is
attached.
Hello, I wanted to know if it is possible to get the genome sequences for the different Bacillus subtilis strains that were
published as GRAS Notices. Here is the list of records: GRN No. 974 Date Feb 2, 2022, GRN No. 969 etc
Original approval package from 1997 for GONAL-F (FOLLITROPIN ALFA/BETA) | BLA #020378 |
INJECTABLE;SUBCUTANEOUS | Prescription | EMD SERONO-
Please provide all complaint documentation related to the FDA inspection performed by Stephanie Mangigian between
the dates of May 16, 2022 - May 27, 2022 at Temple University (FEI Number 3022435070).
I am interested in receiving the FDA approval package (including medical and statistical review): NDA 20-243/S-006.
Approval date is March 25, 1997 This concerns the approval of fluvoxamine in the treatment of Obsessive-Compulsive
Disorder (OCD) in the pediatric population.
FDA EIR Report for Duke University Medical Center in Durham, NC.
Original approved USPI labeling for BLA 020378 under submission ORIG-1 (approval date 9/29/1997) for GONAL-F
(follitropin alpha-EMD SERONO) Original approved USPI labeling for BLA 020582 under submission ORIG-1 (approval
date 9/29/1997) for FOLLISTIM (follitropin beta-ORGANON USA INC)
I am requesting a copy of the Quality Assurance Profile (QAP) for Galephar Pharmaceutical Research Inc. Humacao Site
with FDA establishment number 3008206797.
shell egg proof of registration for Chikad LLC.,15100 Stratton Rd., West Salem Ohio 44287
483’s issued to the Philips Healthcare manufacturing site (FEI #1525965) located at 595 Miner Rd, Cleveland OH 44143
during the period Jan 1, 2019 to Jun 8, 2022. Electronic copy is preferred.
483’s issued to Revance Therapeutics, Inc. (FEI #3007772056) located at 7555 Gateway Blvd, Newark CA 94560 during
the period Jan 1, 2022 to Jun 9, 2022. Electronic copy is preferred.
TRIDENT SEAFOODS CORPORATION EIR
Philips Respironics PE-PUR Test Plan Summary dated April 26, 2022 and the Philips Respironics Summary of PE-PUR
Testing Results and Conclusions Available to Date dated April 25, 2022. These two documents were cited in the Philips
518(b) Notice of Opportunity for Hearing dated May 2, 2022.
Summary Basis of Approval for Setraline Hydrochloride Capsules, 150mg and 200mg reference NDA# 215133.
Emails sent or received by FDA employees regarding hydroxychloroquin
483 issued to Kyowa Hakko Bio Co., Ltd, Japan on FDA CDER inspection.
Seeking FDA Form 483 for: Manufacturer: UCB, Inc Facility: Europe Product: bimekizumab
Salmonella Newport Outbreak in Summer 2020 Recall Numbers: F-1272-2020; F-1273-2020; F-1274-2020; F-1275-
2020 Confirmation # FDA2070729
I would like to request the review summaries from each division involved in the review and approval of two
supplements to BLA 125057 (Humira, adalimumab).
All contents of K183635, Device Name: CryoLife Inc, Manufacturer: PhotoFix Decellularized Bovine Pericardium, Product
code: PSQ
PM0000529.PD1, PM0000530.PD1, PM0000531.PD1, PM0000535.PD1, PM0000536.PD1, PM0000537.PD1,
PM0000540.PD1, and PM0000541.PD1. (Marketing Granted Order was issued on March 24, 2022.)
All records pertaining to Consumer Complaint #174113 submitted to the Office of Regulatory Affairs U.S. Food and Drug
Administration, 1 Montvale Avenue, Stoneham, MA 02180 on 5/10/2022.
510K documents Philips MCOT (Mobile Cardiac Outpatient Telemetry)
Copy of the disclosable portions of the pediatric drug development plan submitted on 06/12/2006 by Banner
Pharmacaps in support of their pediatric post marketing study commitment for NDA 21-920.
Solicitamos amablemente el informe de la evaluación remota extranjera realizada en fecha del 22 al 25 de febrero del
2022 con la oficial Edith Gonzales a nuestra empresa COMEXPROM de Honduras.
The previous owner of vascular logistics (Dr. Brannon) had exchanged letters with the FDA regarding not needing to file
for a new 510k number. In those letters, Dr. Brannon used data to prove the products were similar. We are trying to
obtain that data and the letters that correspond with them. the 510K numbers are K965030, K960047, and K960049
INVESTIGATION RECS
I-natal developmental toxicity study (cited in Label for NDA 016267 "Desferal®", section "Precautions", Novartis,
12/16/2011) etc
AUROMEDICS INC - SUBMISSIONS, AUDITS, ETC
I am requesting the SIS scores for each plant (which the FDA calls "firms"; I mean establishment/manufacturing facility),
each year they have been created. SIS stands for "Site Inspection Score". Specifically, a data set that includes: FEI
number, DUNS number (if easy to include), firm name, firm address, date first created, date updated, SIS score.
INFANT FORMULA COMPLAINTS/ADVERSE EVENTS
Freedom of Information Act (FOIA): Requesting the Agency to provide most recent 3 Form 483 (Notice of Inspectional
Observations) of Vimta Labs Limited, with FDA establishment identifier # 3006587427
FDA review records for K212871.
FDA Review Records for K212871/S001
TEVA EPINEPHRINE (AUTOINJECTOR) ANDA #090589
The 483 (in electronic format) for Human Drugs inspection of Veridian Healthcare ending 11/28/2018 at the location in
Gurnee IL, United States. The EIR (in electronic format) for Human Drugs inspection of Veridian Healthcare ending
11/28/2018 at the location in Gurnee IL, United States. The Response (in electronic format) for Human Drugs inspection
of Veridian Healthcare ending 11/28/2018 at the location in Gurnee IL, United States. Please send documents as email
attachments.
The EIR (in electronic format) for Human Drugs inspection of Tender Corporation ending 09/23/2021 at the location in
Littleton NH, United States. The Response (in electronic format) for Human Drugs inspection of Tender Corporation
ending 09/23/2021 at the location in Littleton NH, United States. Please send documents as email attachments.
format) for Foods & Cosmetics inspection of National Meat & Provisions Co., Inc. ending 08/08/2002 at the location in
Reserve LA, United States. Please send documents as email attachments.
for Human Drugs inspection of The Procter & Gamble Manufacturing Company ending 02/18/2022 at the location in
Browns Summit NC, United States. Please send documents as email attachments.
format) for Human Drugs inspection of Janssen Ortho LLC ending 08/28/2018 at the location in Gurabo PR, United
for Medical Devices & Rad Health inspection of Menarini Silicon Biosystems ending 06/25/2020 at the location in
Huntingdon Valley PA, United States. Please send documents as email attachments.
for Human Drugs inspection of Servier Pharmaceuticals LLC ending 03/24/2022 at the location in Boston MA, United
Copy of the disclosable portions of the 510(k) for K220596, Wearable Breast Pump (Model S9) by Shenzhen TPH
Technology.
Copy of the disclosable portions of the 510(k) for K220596, Wearable Breast Pump (Model S9) by Shenzhen TPH
Technology.
I am an investment professional for an asset management firm and would like to request the Filing Communication,
Mid-Cycle Communication, and Memorandum of Late-Cycle Review Minutes for IND 103217. Thank you!
2022-1675, 2021-7038, 2022-943, 2022-1821, 2022-1839.
Copy of the disclosable portions of the 510(k) for K212564, Electric Breast Pump, by Guangdong Horigen Mother & Baby
Products.
Copy of the disclosable portions of the 510(k) for K212773, Ardo Alyssa, by ARDO Medical AG.
Copy of the disclosable portions of the 510(k) for K212955, Fit Pro Breast Pump, by Hygeia II Medical Group.
K211024, Electric Breast Pump, by Shantou Huihengqi Electronic Technology
K212180, Wearable Breast Pump (Model S12), by Shenzhen TPH Technology
Copy of the disclosable portions of the original request letter and complete FDA response for File Number 2022-2877.
Copy of the disclosable portions of all records regarding Contract Number GS-35F-0156R, CTP IT System Lifecycle
Development and Management Support BPA, between CTP and Dovel Technologies.
Any records of communications relating to infant formula between officials from the Food and Drug Administration and
officials from the White House Domestic Policy Council and White House National Economic Council from Jan 15, 2022
and June 10, 2022
(1) All establishment inspection reports from the past ten (10) years from FDA inspections of Matrixx Initiatives, Inc., the
manufacturer of Zicam® Cold Remedy brand homeopathic zinc products, and (2) All establishment inspection reports
from the past ten (10) years from FDA inspections of Mylan Consumer Healthcare, Inc., the manufacturer of Cold-Eeze®
Cold Remedy brand homeopathic zinc products.
Form 483 for Panacea Biotech Baddi facility issued 8 observations
2022-1921, 2022-1956, 2022-2366, 2022-2369, 2022-2596.
The Department of Health is requesting the investigation report for agency case #22-MIF-701-0208
Melissa Simanton, Fonda Olsen, Daniel Skirvin, Kristine Mantaring, Nilantha Bandara, CVs
Copies of Label for NORMODYNE (RLD# 018686) between SUPPL-5 to SUPPL-26.
Please send me the copy of the following section of the ANDA. We are the first party owning this ANDA. Oxaprozin
Tablets, 600 mg (ANDA-075842) Approved: 12th April, 2001 Drug Substance Documents Sections: • 3.2.S.2.1
Manufacturer • 3.2.S.4.1 Specifications • 3.2.S.4.2 Analytical Procedure Drug Product Documents Sections: • 2.7
Clinical Summary-comparative dissolution • etc
I am seeking any and all consumer complaint records wherein an infant became sick or died after consuming powdered
infant formula manufactured at Abbott Nutrition's Sturgis, Michigan plant, received from September 20, 2021 to
February 24, 2022, of infant illness. Thank you.
CDER ADVERSE EVENT DATA
1) List of all applicants to the FDA to import infant formula sold in other countries under new guidance aimed at
alleviating the shortage on a temporary basis 2) Applications, emails and all other correspondence and documents
between the FDA and Health & Happiness International Holdings Ltd, Bellamy Organics, the A2 Milk Company, Fonterra,
Holle, HiPP, Nature's One, Kendamil and Bub's Australia
Internal communications involving specified custodians relating to any aspect of Vanda’s tradipitant development
program.
External communications involving specified custodians relating to any aspect of Vanda’s tradipitant development
program.
Date Range: 09/01/2018 - 12/31/2018; I'm requesting all calendar records for Tracey Forfa of FDA CVM
Date Range: 08/01/2019 - 08/31/2019; I'm requesting all calendar records for Eric Nelson (FDA-CVM)
Date Range: 09/01/2019 - 09/30/2019; I'm requesting all calendar records for Eric Nelson (FDA-CVM)
Date Range: 09/01/2019 - 09/30/2019; I'm requesting all calendar records for Robin Rivers
Date Range: 07/28/2019 - 08/12/2019; I'm requesting all e-mails exchanged between Robin.Rivers@fda.hhs.gov (FDA-
ORA) and the email address davdressle@pa.gov
Date Range: 01/01/2018 - 12/31/2018; I'm requesting all text message records for Nathan Moon
Date Range: 01/01/2018 - 12/31/2018; I'm requesting all cell phone bills for Nathan Moon
I'm requesting all documents pertaining to FOIA request 2019-3449. I am requesting that all requested records please
be sent digitally.
be sent digitally.
be sent digitally.
For my FOIA request assigned control #2022-3025, FDA denied via FOIA access to "eight draft email attachments". For
these eight attachments that were in draft, I am requesting the FDA's final, non draft version for each of the these
documents.
I would like a report made by the FDA regard an inspection on a synthetic caffeine plant in china that supplies Coca-Cola
and Dr Pepper. This factory is referenced in
"https://www.decadentdecaf.com/blogs/decadent-decaf-coffee-co/174589383-ever-wondered-where-the-caffeine-
comes-from-in-soda-or-energy-drinks-answer-synthetic-caffeine"
1. Any correspondence between the FDA and manufacturers of cleaners for CPAP, Bi-PAP, or ventilation machines
using UV light. 2. All protocols, data, and results from tests of cleaners for CPAP, Bi-PAP, or ventilation machines using
UV light. 3. Any correspondence between the FDA and manufacturers of CPAP cleaners using UV light in connection
with applications for premarket notification or approval of UV cleaner devices.ETC
2020-2542 2021-4062
1. Any protocols, data, and results of tests of ozone based Devices. 2. Any documents created or reviewed by the FDA
to evaluate the safety and efficacy of ozone based Devices or to assess the veracity of claims made in promotional
materials or advertisements for Devices. etc
Eli Lilly and Company is requesting the review package for Dupixent which was approved for adult and pediatric >=12 yrs
old, weighing at least 40kg (BLA 761055/S-40). The action date was 5/20/2022. Thank you!
2020-2542 2021-808
Full 510(k) Premarket Notification for the following device: 510(k) Number: K140023 Device Name: ELEVATION
Applicant: PDG PRODUCT DESIGN GROUP, INC. Date Received: 01/06/2014 Decision Date: 10/16/2014
for Human Drugs inspection of Aphena Pharma Solutions-Maryland LLC ending 05/06/2022 at the location in Easton
MD, United States. Please send documents as email attachments.
The 483 (in electronic format) for Human Drugs inspection of Tanvex BioPharma USA, Inc ending 05/04/2022 at the
location in San Diego CA, United States. The 483 (in electronic format) for Human Drugs inspection of Richard H. Hass,
M.D. ending 05/13/2022 at the location in La Jolla CA, United States. The 483 (in electronic format) for Human Drugs
inspection of Maynard R. Rasmussen, M.D ending 05/06/2022 at the location in San Diego CA, United States. Please
The 483 (in electronic format) for Human Drugs inspection of Mobeen Mazhar, M.D. ending 04/28/2022 at the location
in Houston TX, United States. The EIR (in electronic format) for Human Drugs inspection of Mobeen Mazhar, M.D.
ending 04/28/2022 at the location in Houston TX, United States. etc
The EIR (in electronic format) for Human Drugs inspection of KBI Biopharma, Inc. ending 12/03/2021 at the location in
Boulder CO, United States. The Response (in electronic format) for Human Drugs inspection of KBI Biopharma, Inc.
ending 12/03/2021 at the location in Boulder CO, United States. Please send documents as email attachments.
Individual case reports of human adverse events from rofecoxib initially sourced from the FAERS Public Dashboard.
All documents, communications and/or records related, in any way, to FDA's2022 inspection of Hikma Injectables
located in Cherry Hill, NJ.
2021-808 2021-4062
NBC NEWS IS REQUESTING ANY AND ALL INSPECTIONS, 483'S OR EIR'S FOR ANY RECKITT OR GERBER INFANT FORMULA
PLANT FROM JAN 1, 2019 THROUGH JUNE 13, 2022.
I am requesting a copy of any and all Establishment Inspection Reports (EIRs) conducted at the Best Harvest Bakeries
facility located 530 S. 65th Street, Kansas City, KS 66111 from January 1, 2021 to December 31, 2021.
VAERS report
VAERS report
I am seeking any and all FDA warning letters, 483s, 483 responses, and any other correspondence between the FDA and
the following infant formula manufacturers: Mead Johnson; Danone; Reckitt; Nestle/Gerber. et
Hello, I'm looking for the FDA's latest inspection report (Form 483) of Beyond Meat's facilities in Missouri. Thank you,
Deena
located in Dayton, New Jersey.
I am requesting the following information: FAERS case reports with the following IDs: 20463171 and 19787426.
VAERS report
VAERS report
VAERS report
VAERS report
VAERS report
VAERS report
VAERS report
VAERS report
I am requesting the following information (also in attached letter): Adverse events reported to FAERS from April 9, 2022
through today (June 13, 2022) for Aduhelm, aducanumab and/or aducanumab-AVWA. Please provide the information in
an Excel/CSV file and in a PDF file. Please send electronically to the email provided. Thank you.
Prevagen safety study data, Prevagen FDA notification for dietary supplement
Complete 510(k) PMN for K980298, Flowable Hybrid.
A request for FDA meeting minutes pertaining to the primary endpoint change of the avapritinib trial in indolent
systemic mastocytosis (PIONEER, NCT03731260).
We are requesting the 483, EIR, and 483r for the following inspection: Inspection Site Name: Serum Institute of India
Inspection Site Address: Soli Poonawalla Rd, Pune, Maharashtra 411028, India Inspection Site FEI Number: 3004211038
All internal and external correspondence regarding FOIA Request No. 2022-3335, including any records released to the
requester.
Please provide solicitation documents for the below contract, including Section C (Statement of Work), Section L
(Instructions), and Section M (Evaluation Criteria), and any attachments.
Contract ID: 5F40119F80440
Referenced IDV: GS07F0547U
Solicitation ID: FDA19RFQ1210271
Awardee: MEDIAFORCE, LLC
Source:FPDS (Date Range for Record Search: From 09/17/2017 to 09/17/2022)
We would like to request copy of the latest version of the Package insert, pouch label and pouch carton of
Cholestyramine for Oral Suspension, USP (ANDA # 074557) of EPIC PHARMA.
Any and all FDA CDER or CDER Exclusivity Board documentation [memorandum, letter, statement, report, etc.], whether
in electronic or hardcopy form, supporting or documenting FDA’s determination to attach 3-year “New Product” or “NP”
exclusivity to NDA 208088 for TLANDO (Testosterone Undecanoate oral capsules) (Orange Book listing attached).
Copies of contracts awarded to Booz Allen Hamilton for Knowledge Aided Assessment and Structured Application
(KASA). First contract award ID is 75F40119F19003, start date 9/25/2019 and end date 9/29/2020. Second contract
award ID is 75F40121F19010, start date 3/16/2021 and end date 11/24/2021.
Copies of any for cause inspection memoranda or other documents or communications created by either the Office of
Regulatory Affairs or the Center for Drug Evaluation and Research regarding for-cause inspections of Revive Rx
Pharmacy in Houston, FEI number 3016710945.
All records related to the warning letter sent out on January 18, 2012 to Almased USA, Inc. for the promotion of an
unapproved drug.
This request is made under the Freedom of Information Act, pursuant to 5 U.S.C. § 552 and 21 C.F.R. 20.40(a), and seeks
the Patent Certifications for the following Abbreviated New Drug Applications (ANDAs): 1. ANDA Application No.
200044, filed by Accord Healthcare; and 2. ANDA Application No. 076800, filed by Ranbaxy Laboratories Limited.
Unedacted copy of Assessment Reports of Liposomal Amphotericin B for Injections, 50mg/vials - ANDA212514
Copies of Form 483s issued to the following CLINICAL INVESTIGATOR from April 1-30, 2022:
Have there been any form 483s issued for the below facility for the period January 1st 2022 – June 13th 2022? Revance
Therapeutics FEI Number: 3007772056 Located at 7555 Gateway Blvd. Newark CA 94560
Summary basis of approval for ANDA No. 212416; summary basis for approval for ANDA No. 209358
Summary basis of approval for ANDA No. 203900
Summary basis of approval for ANDA No. 207719
Establishment Inspection Report (Including Exhibits and Attachments) of Aziyo Biologics, Inc. located at 880 Harbour
Way S, Suite 100 Richmond, California 94804-3650. FEI: 1000100754. EI Start 6/17/2021 EI End 6/25/2021. FDA
Investigators Shelley H. Beausoleil and Ka L. Wong.
Please produce inspection records, including but not limited to Form 483s, for Abbott Laboratories' Sturgis, Michigan
facility between 2019 through today. Please also produce any whistleblower complaints regarding problems at the
facility during the same time period, including but not limited to those referenced within the Wall Street Journal article
about Abbott published on June 8, 2022.
for Human Drugs inspection of Ferndale Laboratories, Inc. ending 03/04/2022 at the location in Ferndale MI, United
States. The EIR (in electronic format) for Human Drugs inspection of Ferndale Laboratories, Inc. ending 03/04/2022 at
the location in Ferndale MI, United States. etc
for Human Drugs inspection of Mikart LLC ending 04/26/2022 at the location in Atlanta GA, United States. The EIR (in
electronic format) for Human Drugs inspection of KBI Biopharma, Inc. ending 01/13/2022 at the location in Durham NC,
K791307 K072002
for Human Drugs inspection of Vantage Specialty Ingredients ending 05/02/2022 at the location in Linden NJ, United
for Human Drugs inspection of Shuo Ma, M.D. ending 05/06/2022 at the location in Chicago IL, United States. Please
for Human Drugs inspection of Skyless LLC ending 05/04/2022 at the location in Ponce PR, United States. Please send
for Human Drugs inspection of Antares Pharma, Inc ending 05/13/2022 at the location in Minnetonka MN, United
513g submission information
Copies of all Center for Tobacco Products Office of Science memoranda regarding plans for prioritization of review or
review order of Premarket Tobacco Product Applications.
for Human Drugs inspection of Brock Andersen, M.D. ending 05/20/2022 at the location in Fruitland ID, United States.
Pursuant to the federal Freedom of Information Act, 5 U.S.C. § 552 et seq., I request access to all adverse event and
product complaint reports submitted to FDA related to infant formula produced by Abbott Laboratories at the
company’s plant in Sturgis, Michigan from January 1, 2021 to the latest available date.
Communications between FDA representatives and Cosmetic Ingredient Review related to prostaglandins.
Hello, have there been any form 483s issued for the period January 1st 2021 – June 13th 2022 for any of the below
facilities operated by Polpharma? Facility #1 Pharmaceutical Plant Polpharma S.A. in Starogard Gdanski. Ul. Pelplinska
19. 83-200 Starogard Gdanski Facility #2 Pharmaceutical Plant Polpharma S.A. in Nowa Deba ul. Metalowca 2. 39-460
Nowa Deba etc
Copies of Form 483s issued to the following DEVICE companies from April 1-30, 2022:
Copies of Form 483s issued to the following DRUG companies from April 1-30, 2022:
Copies of Form 483s issued to the following DRUG companies from April 1-30, 2022:
Copies of Form 483s issued by the CDER Office in April 1-30, 2022
Copies of Form 483s issued by the CDER Office (Complex ) in April 1-30, 2022
Copies of Form 483s issued by the CDRH Office in April 1-30, 2022.
I request the Establishment Inspection Report from an inspection ending 10-22-2010 of Abbott’s Sturgis, Michigan,
manufacturing facility.
Freedom of Information Act Request: Records of Applications and Related Materials Submitted Pursuant to Premarket
Tobacco Product Applications and Recordkeeping Requirements, 86 Fed. Reg. 55300 and the Consolidated
Appropriations Act of 2022
The request is for the FDA Drug Approval Package (review documents) for NDA 214324 Tyvaso DPI (treprostinil)
inhalation powder approved May 23, 2022.
Please provide tentative approval letter for ANDA#203640
Philosys, Korea response' document for 'attached 483' submitted within the period
all releasable records from January 1, 2021 to the present relating to premarket notification K210478, including but not
limited to any emails or other communications to or from Intuitive Surgical, Inc. or other third parties and documents
referring or relating to communications with Intuitive Surgical, Inc. or other third parties
FDA Form 483 from manufacturing facility inspection around June 10, 2022 at Seagen Inc, located at 450 Monte Villa
Pkwy, Bothell, WA 98021. Please cancel request if this form otherwise becomes publicly available.
Full 510k submission K162627 from EnsoSleep of Madison, WI
All records pertaining to NDA 202331, IND 077278, and PRE-IND 77,278
PEANUT BUTTER OUTBREAK ROOT CAUSE ANALYSIS
Copy of the disclosable portions for the following two MedWatch reports for molnupiravir: 20899641, and 20880076.
for Medical Devices & Rad Health inspection of Concord Biomedical Science and Emerging Technologies, Inc. ending
05/23/2019 at the location in Lexington MA, United States. Please send documents as email attachments.
VAERS Report
for Animal Drugs & Feeds inspection of Strem Chemicals, Inc. ending 01/27/2020 at the location in Newburyport MA,
for Human Drugs inspection of Omid Tehrani, M.D. ending 04/14/2022 at the location in Fresno CA, United States.
The Response (in electronic format) for Foods & Cosmetics inspection of DSM Nutritional Products, Inc. ending
03/14/2019 at the location in Belvidere NJ, United States. The EIR (in electronic format) for Foods & Cosmetics
inspection of MOL LOGISTICS (USA) INC. ending 10/20/2021 at the location in Fairview NJ, United States. Please send
for Human Drugs inspection of Hugo Llanes JR, M.D. ending 05/19/2022 at the location in Hialeah FL, United States.
for Human Drugs inspection of Cambrex Charles City Inc ending 05/02/2022 at the location in Charles City IA, United
for Biologics inspection of Kearney, Susan L., M.D., Clinical Investigator ending 05/10/2022 at the location in
for Biologics inspection of University of Texas MD Anderson Cancer Center ending 05/12/2022 at the location in
Houston TX, United States. Please send documents as email attachments.
for Biologics inspection of Intermountain Medical Center ending 05/12/2022 at the location in Murray UT, United
I would like to request FDA483's affiliated with Aurobindo Pharmaceuticals manufacturing from the past 10 years, most
importantly those in more recent years. Subsequently, if possible, please also send the inspection reports. Thank you,
Angela
Copy of the disclosable portions of all disciplinary and scientific review documents as well as full technical Project Lead
memos for the MGOs issued by CTP for the following NJOY Daily products: PM0000630, and PM0000631.
Dear Sir/Madam, We are working on Nilotinib Tablets 50 mg, 150 mg and 200 mg ANDA. We would like to request
Agency the Tentative approval letter received by Apotex Inc for ANDA 203640. Thanks for your kind attention and
Support.
We request all documents related to FAP Document ID FDA-2021-F-0564-0001 (Biomin Holding GmbH FAP proposal to
amend food additive regulations to provide the safe use of fumonisin esterase to degrade fumonisins in poultry feed.)
Please provide the narratives associated with the following FAERS individual case reports in the attached file for Nurtec
ODT (rimegepant). These case reports were identified using the FAERS quarterly data files.
period. Please include derivations such as Wegmans, Wegman's, Wegman, Wegmans Warehouse, etc.
We request all documents related to FAP Document ID FDA-2020-F-1275-0001 (Biomin Holding GmbH FAP proposal to
amend food additive regulations to provide the safe use of fumonisin esterase to degrade fumonisins in swine feed.)
The FDA Memorandum "BCP Consult Request Memo for SE0015386 (April 29, 2021),” which was cited in the TPL for
SE0015386, dated June 21, 2021. This memorandum was also requested through another FOIA request in November
2021, FOIA control number 2021-8104.
EXACTECH INC-OPTETRAK TOTAL KNEE REPLACEMENT SYSTEM CORR, RECALLS, ETC
We request the Summary Basis of Approval for PENICILLIN G BENZATHINE (N050141) attached as a PDF to the email
address found on the request letter.
Freedom of Information Act (FOIA): Request for detailed Summary Basis of Approval (SBOA) of IMITREX (sumatriptan)
injection (NDA 020080) held by Glaxosmithkline
Observations) of Analytical Solutions, with FDA establishment identifier # 3005658262.
Freedom of Information Act (FOIA): Request for FDA Label (Prescribing Information) of Lidocaine Hydrochloride Jelly
(ANDA 081318) held by Cosette Pharmaceuticals INC
Complete 510(k) packages for K191804 and K133209.
Freedom of Information Act (FOIA): Request for detailed Summary Basis of Approval (SBOA) of IMITREX (sumatriptan)
injection (NDA 020080) held by Glaxosmithkline
Pursuant to the Freedom of Information Act (FOIA), I hereby request the 483 forms of Zhejiang Tianyu Pharmaceutical
Co Ltd. The FEI number is 3010972581. The product area of following inspections are drugs. Thank you.
Any adverse events reported to the FDA Adverse Event Reporting System (FAERS) related to mavacamten (brand name:
Camzyos) over the dates detailed above (Jan 1, 2021 to June 20, 2022)
Human Adverse Drug MedWatch Reports for the following Case IDs: 19353073 19628758 18588534 18554081
18299452 18084050
1. A copy of any and all releasable documents including but not limited to the Multi-Discipline Reviews, Summary
Reviews, or discipline-specific reviews of the clinical data for the 14 January 2022, approval of Rinvoq (upadacitinib),
NDA 211675/S-004. etc
Any FDA submissions/applications/correspondence on 3-nitrooxypropanol (3-NOP, brand name Bovaer®).
Pursuant to the Freedom of Information Act (FOIA), I hereby request the following: All records furnished pursuant to
the following requests: 2021-8090 2022-2347 2022-3563 2022-1131 2020-8296 2021-7896 Please see the
attached request letter.
Please provide the application for IOSAT, NDA 018664. In addition, please provide all submissions and/or supplements
filed with the FDA by or on behalf of ANBEX for IOSAT, including, but not limited to the following: (1) SUPPL-18 with
action date of 12/20/2016 etc
Copy of the disclosable portions of the complete FDA response for the following two File Numbers: 2022-2877, and
2022-3609.
All consumer complaints relating to the manufacture of infant formula by the following companies: Abbott Nutrition
Mead Johnson Nutrition Gerber Product Company Perrio Company In the period of Jan. 1, 2019, to the date this
request is processed.
Inogen, Inc.’s Inogen One G3 Generator portable oxygen concentrator, Model 10-300, Serial Number 19083531
(hereinafter, the “Inogen One® G3, Model 10-300, Serial Number 19083531”), including but not limited to: (a) A list of
all reports and/or complaints made to the FDA regarding the Inogen One® G3, Model 10-300, Serial Number 19083531;
etc
Any/all Forms 483, Warning Letters, sponsor correspondences, and/or other records pertaining to this facility: FEI
Number: 3003909356 Name/address: UCB Pharma S.A., Chemin Du Foriest, Braine-l'alleud, Brabant Wallon 1420,
Belgium
Copy of all releasable records created between September 29, 2020, and the present relating to CPT2000125 and
CPT2000126, including but not limited to, internal FDA correspondence, minutes of FDA meetings and teleconferences,
correspondence between FDA and others, minutes of meetings and teleconferences between FDA and others,etc
Pursuant to the Freedom of Information Act, I am hereby requesting any and all communications between The U.S.
Food and Drug Administration (FDA) and Johnson & Johnson (J&J) regarding product labeling for Tylenol® (the subject
label). See attached correspondence for additional information, specific to my request.
I would like to request an electronic copy of the Establishment Inspection Report from FDA's inspection of Abbott's
infant formula plant in Sturgis, Michigan, that ended Sept. 24, 2019. I would also like an electronic copy of Abbott's
response to the 483 from the same inspection ending Sept. 24, 2019.
WOODCOCK, RICHARDS, MCNEILL EMAILS
for Human Drugs inspection of Bell Pharmaceuticals, Inc ending 04/06/2018 at the location in Belle Plaine MN, United
States. The Response (in electronic format) for Human Drugs inspection of Bell Pharmaceuticals, Inc ending 04/06/2018
at the location in Belle Plaine MN, United States. Please send documents as email attachments.
Under FOIA, I would like these records provided to me. This is a request to the US Food and Drug Administration, under
6 CFR Part 5. I request you provide me with the following information: 1. All reports of adverse events and/or
reactions dog and/or cats have had to dog and cat food and dog and cat treats from May 1, 2022-May 31, 2022. ETC
For the feed ingredient, Whole Grain Wheat, approved for use in animal feeds "regulated" by FDA. I request the
following documents this approved feed ingredient: - All documents associated with AAFCO Ingredient Definition
Request Process of the above listed ingredient - Associated Feeding Trial submissions for the above listed ingredient
The 483 (in electronic format) for Biologics inspection of NYC Health + Hospitals/Bellevue ending 05/06/2022 at the
location in New York NY, United States. The 483 (in electronic format) for Biologics inspection of New York Fertility
Medical Practice, PLLC ending 05/12/2022 at the location in New York NY, United States. Please send documents as
email attachments.
for Foods & Cosmetics inspection of Cardinal Health ending 05/19/2022 at the location in Stafford TX, United States.
format) for Human Drugs inspection of Wells Pharma of Houston LLC ending 06/17/2021 at the location in Houston TX,
for Foods & Cosmetics inspection of Jody's Inc. ending 01/20/2022 at the location in Norfolk VA, United States. Please
All email records containing the keyword “AAFCO” for FDA ORA employee Daniel Rice for the date range of January 01,
2021-January 31,2021
for Biologics inspection of Vitalant ending 05/02/2022 at the location in Yuba City CA, United States. Please send
1. Any correspondence between the FDA and SoClean, Inc. 2. All protocols, data, and results from tests of SoClean,
Inc.’s ozone cleaners. 3. Any correspondence between the FDA and SoClean, Inc. in connection with SoClean’s
applications for premarket notification or approval of its ozone cleaner devices. ETC
I request that a copy of the following documents be provided to me: meeting minutes, memos, and presentations
related to the Cannabis Products Council.
According to the most recent pIV certification list (https://www.fda.gov/media/133240/download), there was a single
paragraph IV FTF applicant for fenfluramine (Fintepla NDA No. 212102). Applicant seeks information on the total
number of ANDA applicants for this drug product. We understand that the identity of the applicants is confidential but
we believe that the total number of ANDA applicants referencing NDA No. 202102 is public information and respectfully
request that it be made available.
for Biologics inspection of University Reproductive Associates, P.C. ending 05/10/2022 at the location in Hasbrouck
Heights NJ, United States. Please send documents as email attachments.
I request consumer complaints/adverse event reports related to Abbott’s Sturgis, Michigan, facility that makes infant
formula from January 1, 2010 to August 31, 2021.
Clairity, Inc., requests the following data for all MQSA certified mammography facilities that are operating as of
06/14/22 (or most recent date available): - Facility name - Facility location address - Facility mailing address - Facility
certification date - Employer Identification Number (EIN) - Facility owner - etc
I request consumer complaints/adverse event reports related to Reckitt Benckiser’s (Mead Johnson) facilities that make
infant formula in Michigan, Indiana and Minnesota from September 1, 2021 to present date.
Copies of all FOIA requests submitted to the Food and Drug Administration by BioNTech on or after December 1, 2020,
The Justification and Approval (J&A) document for sole source purchase order 75F40120P00388 awarded to McKinsey &
Company, Inc. for the COVID-19 Pandemic Mid-Action Review Project.
On July 25, 2019 Steven Solomon (FDA CVM) sent an email to Anne Norris with the attachment
CVMU_MedFeed_ADAFDA.docx. I am requesting that attached document.
I am requesting the final document for the CVM Key Initiave Plan 2019-2020. This record would be located at FDA-CVM.
Employees who could possibly maintain the final version or at least point to where the final document's location at CVM
would be Steven Solomon, Shera Moxley, Roxanne Schweitzer, Almas Azeem.
I'm requesting all e-mail records for Dianne Milazzo containing key word; AAFCO. Employee works at FDA-CVM
03.01.20-03.31.20
I would like a copy of any communications or memoradums of understanding between T-Mobile US, Inc and staff or
leadership of the FDA for June 2021-June 26, 2022 concerning COVID vaccines.
Hello, please provide all emails, text messages, and instant chat messages to and from Dr. Califf mentioning "Covid-19"
or "covid" and "Fauci"
Hello, please provide all memorandums, reports, and other materials outlining the FDA's return to work pilot program,
which was mentioned by Dr. Califf during the Senate Health panel hearing on June 16.
Hello, please provide the written plan to get a "super supply" of baby formula on store shelves, as referenced by Dr.
Califf during testimony before the Senate Health Committee on June 16.
We are requesting a copy of the complete 510(k) submission for K170974. Please also include any responses to requests
for additional information supplied by the 510(k) holder, all internal FDA review memorandum, as well as any other FDA
correspondence related to the review of this 510(k), including any deficiency letters.
The 483 (in electronic format) for Foods & Cosmetics inspection of Ford Gum & Machine Company Inc ending
05/07/2019 at the location in Akron NY, United States. The Response (in electronic format) for Foods & Cosmetics
inspection of Ford Gum & Machine Company Inc ending 05/07/2019 at the location in Akron NY, United States.
We are requesting a copy of the complete 510(k) submission for K141932. Please also include any responses to requests
for additional information supplied by the 510(k) holder, all internal FDA review memorandum, as well as any other FDA
correspondence related to the review of this 510(k), including any deficiency letters.
75F40120D00009
Inspection details, including date and nature of inspection (on-site or remote), and any associated inspection-
observation reports including 483 reports and FMD-145 cover letters, should they exist, from January 1, 2022 to
present, for: Lonza located in Houston, Texas and Minaris Regenerative Medicine locations in both Allendale, New
Jersey and Mountain View, California
I request the Form 483 associated with the Agency's September 17, 2021 inspection of Acella Pharmaceuticals, LLC in
Alpharetta, Georgia. FEI No. 3006691461. Inspection ID No. 1152922.
for Fujifilm Diosynth Biotechnologies USA, Inc. ending 04/21/2021 at the location in Morrisville NC, United States.
Please provide Summary Basis of Approval of Trandolapril and Verapamil Hydrochloride Extended-Release Tablets ORAL
2MG;180MG, 2MG;240MG, 4MG;240MG and 1MG;240MG for the following mentioned Applicant Holders: 1. ABBVIE
INC (Proprietary Name of Drug Product: TARKA): N020591 2.GLENMARK GENERICS LTD: A079135
Natalia Hegedosh, MD; Global Research Solutions, 8300 W Flagler Street, Suite 252A, Miami, FL 33144 form 483
Copy of the disclosable portions of the VAERS forms for the following 5 case numbers for Vaxneuvance: 2259926;
2272993; 2284646; 2292227; and 2297243.
Please provide the full text of the following medication adverse event reports with the following Case ID numbers:
19826595, 18499909, 16058040, 14203615, 14827209, 19752284, 19989098, 19028737
Copy of the disclosable portions of the 510(k) for K220426, Fiber Dust Pro.
Copy of the disclosable portions of the 510(k) for K211517, Optica XT Thulium Fiber Laser.
for Animal Drugs & Feeds inspection of Westwood Laboratories, Inc. ending 04/05/2022 at the location in Azusa CA,
CA, United States. Please send documents as email attachments.
for Human Drugs inspection of Advanced Cosmetic Research Laboratories, Inc. ending 04/27/2022 at the location in
Chatsworth CA, United States. The 483 (in electronic format) for Human Drugs inspection of Lynn Oaks Compounding
Pharmacy ending 04/15/2022 at the location in Thousand Oaks CA, United States. Please send documents as email
attachments.
for Medical Devices & Rad Health inspection of The See Clear Company ending 05/24/2022 at the location in Peachtree
Corners GA, United States. Please send documents as email attachments.
for Medical Devices & Rad Health inspection of Ultimate F/X Lasers and Pyrotechnics LLC ending 05/05/2022 at the
location in Marengo IL, United States. Please send documents as email attachments.
for Medical Devices & Rad Health inspection of Tepha Incorporated ending 05/13/2022 at the location in Lexington MA,
for Medical Devices & Rad Health inspection of NYSARC, Columbia County Chapter, Inc. ending 05/13/2022 at the
location in Mellenville NY, United States. Please send documents as email attachments.
for Human Drugs inspection of Kappa Laboratories, Inc. ending 04/22/2022 at the location in Miami FL, United States.
The 483 (in electronic format) for Human Drugs inspection of Natalia S. Hegedosh, M.D. ending 04/21/2022 at the
location in Miami FL, United States. Please send documents as email attachments.
All contents of Import Alert 89-04, Company Name: Kawamoto Corporation, Date Published: 09/16/2009
ALL COMMUNICATIONS, EMAILS, AND ANY WRITTEN CORRESPONDENCE PRODUCED (INCLUDING ATTACHMENTS)
BETWEEN FDA EMPLOYEE VIRGINIA RAMOS (Virginia.Ramos@fda.hhs.gov) AND CFSAN and FDA EMPLOYEE Ashley
Campbell .RELATED TO Notice of Detention and Hearing OF ENTRY NUMBER BJG-0122361-8. .
The 483 (in electronic format) for Medical Devices & Rad Health inspection of BioMed Holdings LLC ending 05/06/2022
at the location in White City OR, United States. The 483 (in electronic format) for Human Drugs inspection of
Providence Health and Services Washington Dba Providence Inf ending 04/13/2022 at the location in Tukwila WA,
2022-3601, 2022-3613, 2022-3614, 2022-3615, 2022-3708.
2022-3776, 2022-3808, 2022-3830, 2022-3864, 2022-3897
The EIR (in electronic format) for Medical Devices & Rad Health inspection of Apothecary Products, LLC ending
09/03/2019 at the location in Burnsville MN, United States. The Response (in electronic format) for Medical Devices &
Rad Health inspection of Apothecary Products, LLC ending 09/03/2019 at the location in Burnsville MN, United States.
format) for Human Drugs inspection of Noven Pharmaceuticals, Inc. ending 02/14/2011 at the location in Carlsbad CA,
On behalf of Lupin Pharmaceuticals, Inc. I request you to please provide The summery of Approval (SBOA) for RLD
[VIBRAMYCIN ® (doxycycline hyclate for injection), 100 mg per vial]. The Application N050442 has been Approved Prior
to Jan 1, 1982.
for Human Drugs inspection of Filltech USA, LLC ending 04/14/2022 at the location in Rockwell NC, United States.
The 483 (in electronic format) for Human Drugs inspection of Pharmacyclics LLC ending 04/27/2022 at the location in
South San Francisco CA, United States. The 483 (in electronic format) for Human Drugs inspection of Omid Tehrani,
M.D. ending 04/14/2022 at the location in Fresno CA, United States.
for Human Drugs inspection of Wheeling Hospital IRB ending 04/12/2022 at the location in Wheeling WV, United States.
The 483 (in electronic format) for Human Drugs inspection of Akorn, Inc. ending 04/08/2022 at the location in Decatur
IL, United States. The 483 (in electronic format) for Human Drugs inspection of Accugen Laboratories, Inc. ending
04/28/2022 at the location in Addison IL, United States. etc
Any memoranda or other correspondence documenting FDA's decision with respect to the disposition (non-forfeiture)
of 180-day exclusivity in related to Dasatinib Tablets, 80 mg and 140 mg. Such correspondence may be contained in
ANDA No. 203180, approved on November 23, 2021, or another application.
Any memoranda or other correspondence documenting FDA's decision with respect to the disposition (forfeiture or
non-forfeiture) of 180-day exclusivity in related to Dasatinib Tablets, 20 mg, 50 mg, 70 mg, and 100 mg. Such
correspondence may be contained in ANDA No. 202103, approved on June 10, 2016, or another application. FDA's PIV
List indicates that a 180-day exclusivity decision was posted on or about 10/19/2021.
of the 180-day exclusivity in relation to Albuterol Sulfate Inhalation Aerosol, 90 mcg (base)/actuation. Such
correspondence may be contained in ANDA 203760, approved on February 4, 2020. FDA's PIV list indicates that the 180-
day decision posting date was on or about August 24, 2020.
of the 180-day exclusivity in relation to Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution, 17.5
g/3.13 g/1.6 g per bottle. Such correspondence may be contained in ANDA 202511, approved on 02/23/2017. FDA's PIV
list indicates that the 180-day decision posting date was on or about 11/17/2020.
of 180-day exclusivity in relation to Abacavir and Lamivudine Tablets USP, 600 mg/300 mg. Such correspondence may
be contained in ANDA No. 079246, approved on 9/29/2016. FDA's PIV list indicates that the 180-day decision posting
date was on or about 2/11/2020.
of 180-day exclusivity in relation to Clofarabine Injection, 20 mg/20 mL (1 mg/mL), Single-use Vial. Such correspondence
may be contained in ANDA No. 204029, approved on 5/9/2017. FDA's PIV list indicates that the 180-day decision posting
date was on or about 4/7/2020.
of 180-day exclusivity in relation to Imiquimod Cream, 5%. Such correspondence may be contained in ANDA No. 78548,
approved on 2/25/2010. FDA's PIV list indicates that the 180-day decision posting date was on or about 6/29/2020.
of 180-day exclusivity in relation to Zolpidem Tartrate Extended-release Tablets USP, 6.25 mg. Such correspondence
may be contained in ANDA No. 78179, approved on 10/13/2010. FDA's PIV List indicates that the 180-day decision
posting date was on or about 7/27/2020.
of 180-day exclusivity in relation to Zolpidem Tartrate Extended-release Tablets USP, 12.5 mg. Such correspondence
may be contained in ANDA No. 78148, approved on 12/3/2010. FDA's PIV List indicates that the 180-day decision
posting date was on or about 7/27/2020.
May we please request a FOIA copy of a Letter of No Objection (NOL) #185, held by Company MAS Maschinen-und
Anlagenbau Schulz GmbH.
510K records: K220411, K202554, K201806, K190610
Copy of the disclosable portions of all mystery shopper age verification compliance check data with tobacco retailers
from FY 2011 - FY 2022 when no violation occurred. The data sets provided at
https://www.accessdata.fda.gov/scripts/oce/inspections/oce_insp_searching.cfm only list the product type and brand
when a violation occurs. We would like the product type and brand shopped when violations were not observed.
2022-2832 •2022-3607 •2022-3610 •2022-3652 •2021-8719 •2022-3607 •2022-3685
Please provide the original Emergency Use Authorization application and supporting materials (including any application
amendments and revisions) submitted to FDA by iHealth Labs Inc. for Covid-19 Antigen Rapid Test (EUA210470).
All records pertaining to the Remote Regulatory Assessment that was conducted starting 01/11/22 at Fresh Test LLC, FEI
Number 3017544399, by Sarah Hassas. The site is located in Los Angeles, CA, USA.
Dear Sir/Madam, Medtronic, Inc. is submitting this request for two 510(k)s under the Freedom of Information Act.
Below are the 510(k)s of interest: 1) K142870, Penumbra Embolectomy Aspiration System 2) K121917, Penumbra
Embolectomy Aspiration System Please find the attached cover letter for this request with more details for your
reference.
for Human Drugs inspection of American Distilling Inc. ending 04/26/2022 at the location in East Hampton CT, United
for Human Drugs inspection of Contract Pharmacal Corporation ending 04/14/2022 at the location in Hauppauge NY,
United States. The 483 (in electronic format) for Human Drugs inspection of Positive Promotions ending 04/25/2022 at
the location in Hauppauge NY, United States. The 483 (in electronic format) for Human Drugs inspection of SLV
Pharmaceuticals LLC ending 04/14/2022 at the location in Hauppauge NY, United States. Please send documents as
email attachments.
A copy of the Original 510K Application (K181661) and corresponding FDA Request for Additional Information and
Correspondences
Full EIR and FDA 483 for inspection of : LyoContract GmbH Ilsenburg (Harz) Germany conducted on 9/20/2019 FEI #
3014034890
Full EIR and FDA 483 for inspection of : LyoContract GmbH Ilsenburg (Harz) Germany conducted on 9/20/2019 FEI #
3014034890
1274-2020; F-1275-2020 Confirmation # FDA2070729
Redacted 510K for K182887

We are requesting the feedback to control numbers 2021-8799 and 2021-8805 concerning the drug approval package
for NDA 215395.
SpecGx LLC went through a upgrade to our publishing system and the XML file for DMF 030985 sequence 0000 is
missing. We would like FDA to send us the electronic full XML file for this DMF that was submitted on 12/19/2016 to
CDER in eCTD format
Under the provisions of the Freedom of Information Act, I hereby request records or portions thereof pertaining to food
safety complaints regarding Daily Harvest’s products.
I am reaching out to request some information about the datasets used to train and validate
each of the 7 market-approved algorithms (detailed below).
11997460, 19463117, 20626836, 20827372, 20833982, 20924286, 20908011, 20758383, 20638335, 20633877,
20766193, 20797927, 20520521. Please send electronically to sroberts@dal.ca or by mail to the provided address.
Thank you.
2021 & 2022 Baby Formula monthly US demand 2021 & 2022 Baby Formula monthly production amounts by producer
and location 2022 Operation Fly Formula monthly import amounts of Baby Formula (actual and planned) Acceptable
formats are excel (.xls/.xlsx) or PDF. If the information is summarized in a presentation such as .ppt, that would also be
acceptable.
Letters, emails or other communications between: A) Richard Pazdur, director of Office of Hematology and Oncology
Products (OHOP), and any or all of the following in which the drug Ibrance (palbociclib) is discussed: 1) employees or
officials of the pharmaceutical company Pfizer 2) Deborah Armstrong, head of Oncologic Drugs Advisory Committee
ETC
FEI Insp Start Date Inspn End Date Program Area FD483 WL Y/N WL ISSUED DATE Employee(s) District Firm Name Firm
Address City ST ZIP Country For the above date. In addition, please add all WL letters issued during the period with the
same info as above (FEI, Issued Date, Employee(s). District, etc).
the detailed data of cases of disseminated tuberculosis caused by adalimumab for psoriasis retrieved from FAERS Public
Dashboard. The case ID numbers are: 16917151 17088528 17219085 17517543 17600724 18436607 19068738
19079084 19159204 19566240 19632232 19766548
Observations) of Megsan Labs Private Limited, with FDA establishment identifier # 3010960741
Entry Number: SCS-1244337-3 Notice of Refusal
for Medical Devices & Rad Health inspection of Halo Medical Technologies ending 05/23/2022 at the location in
Bethlehem PA, United States. Please send documents as email attachments.
for Medical Devices & Rad Health inspection of Nu Dimension Tech Ventures, Llc ending 05/04/2022 at the location in
Huffman TX, United States. The 483 (in electronic format) for Human Drugs inspection of Sovereign Pharmaceuticals,
LLC ending 04/22/2022 at the location in Fort Worth TX, United States. etc
All inspection reports and establishment inspection reports pursuant to the following inspection ID numbers: •
937923 • 740836 • 565052
Materials regarding Request No. 2020-2584; all complaints, recalls, investigations, inquiries, and correspondence
regarding medical devices more specifically detailed in the attached letter.
Pharmaceutic Labs, LLC 15 Walker Way Albany, NY 12205 I am seeking for inspection records after this facility received
a warning letter in May 3rd 2017.
Sterigenics Establishment Inspection Report from inspection ID 1108874 which concluded 29 Oct 2019 at Sterigenics Salt
Lake City (FEI #1721676).
for Animal Drugs & Feeds inspection of Inovat Industria Farmaceutica Ltda. ending 08/14/2018 at the location in
Guarulhos, Brazil. Please send documents as email attachments.
Copy of all releasable records created between January 31, 2020 and the present relating to CPT2000125 and
CPT2000126. See attached for further details. Please note that this is in reference to FOI 2020-6908.
Copies of Form 483s issued to New Vision Pharmaceuticals on May 7, 2019.
for Human Drugs inspection of Weeks & Leo Co Inc ending 04/07/2022 at the location in Clive IA, United States. The
483 (in electronic format) for Human Drugs inspection of Legacy Pharmaceutical Packaging LLC ending 04/27/2022 at
the location in Earth City MO, United States. etc
Requesting details of the six observations issued under Form 483 on inspection of Glenmark Pharmaceuticals'
formulation manufacturing facility based out of Baddi, India between June 13, 2022 and June 22, 2022. The
information is being requested in public interest.
Please share Glenmark Pharma Baddi facility Form 483
I would like to receive the Orphan Drug Designation request for [Lu-177]-DOTA-Tyr3-Octreotate. The designation date
was 12/01/2009. The Sponsor of the Orphan Designation was Advanced Accelerator Applications. The Designation was
for treatment of gastro-entero-pancreatic neuroendocrine tumors.
[Lu-177]-dotatate (LUTATHERA, Advanced Accelerator Applications, USA) was approved for treatment of
gastroenteropancreatic neuroendocrine tumors (GEP-NETs) by the FDA on January 26, 2018.
Registrar Corp is the authorized regulatory consultant for Conchita Foods, Inc. (FEI 1000113523, DUNS 044031847).
Conchita Foods, Inc. has waived confidentiality between FDA and Registrar Corp for the purposes of this request (see
attached waiver). Pursuant to the FSVP regulation under 805(g) of the Federal Food, Drug, and Cosmetic Act, FDA
provided a link to a list of FSVP importers that have been identified at entry.
Company: Wright Medical Technology Inc. FDA Clearance #K193067 - The INBONE™ Total Ankle System, the INFINITY™
Total Ankle System and the INVISION™ Total Ankle Revision System
available. ETC
All records for pet foods tested for aflatoxin in 2020
PM0000630 and PM0000631
I am requesting all investigative documents and final reports related to the investigation of Miller's Organic Farm and
any successive businesses, run by the proprietor of Miller's Organic Farm, Amos Miller, for the production of raw milk.
Request for Copy of Drug Approval..of generic drug, aliskiren, made by PAR Pharmaceutical (India), showing whether
aliskiren made by PAR was analyzed by FDA for quality of ingredients, especially the active ingredient.
FDA 483 for FDA inspection of Trifarma S.p.A.. - FEI: 3002807260 Category: Drug Quality Assurance, Ending on
02/28/2019. Location: via Pavese 2, Rozzano, Milan, 20089, Italy (ITA). Including any previously FOIA released
documents related to this inspection. If not available, then just the FDA 483.
All communications between FDA Media Affairs Leadership (including Michael

Felderbaum, Daniel Hetlage, Stephanie Caccomo, Shannon P. Hatch, Tara Rabin,
Jeremy Kahn, and their predecessors) OR Center for Tobacco Products Press
Officers (including Cherie Duvall-Jones, Alison Hunt, Courtney Rhodes and their
predecessors) and Jennifer Maloney (Jennifer.maloney@wsj.com)
The time period for this request is January 1, 2022 to June 20, 2022
Copies of MedWatch Reports (FORM FDA 3500/3500A/3500B) and any and all other available case narratives related to
the postmarketing adverse events reported to the FDA Adverse Event Reporting System identified by Case ID as follows:
11948576; 17436585; 17437243; 17440174; etc
Please provide full reports for the following 5 case reports in the FAERS system for product pegcetacoplan: Case ID
19353149, 19630663, 19685262, 19939906, 20102463
All documents related to SBOA of Prohance (gadoteridol) Injection by Bracco Diagnostics
Please provide Summary Basis of Approval of PENTOXIFYLLINE TABLET, EXTENDED RELEASE ORAL 400MG for the
Applicant APOTEX INC-A075191
Hello, We would like to request a copy of 510k K171626 for the trufreeze system.
A copy of the Patent Listing Dispute documents submitted to FDA pursuant to 21 C.F.R. § 314.53(f)(1), including the
statement of dispute and the NDA-holder’s response(s) to the statement of dispute for: (1) U.S. Patent No. 10,960,004,
listed in the Orange Book for Lonsurf (tipiracil HCL; trifluridine) Tablets (NDA 207981); etc
The Isomedix Operations, Inc Chester site located at 23 Elizabeth Drive N., Chester, NY 10918-1367, FEI # 1000136478,
was inspected by the FDA on February 14-18, 2022. The inspection resulted in zero form 483 observations. Our firm did
not receive a copy of the Establishment Inspection Report (EIR) prepared following the conclusion of the inspection. We
are requesting a copy of the EIR at this time.
1. A list of all Bargaining Unit Employees (BUE) that are assigned to any FDA Headquarters component that have as
their official duty station any of the following locations: FDA Headquarters White Oak Campus located at 10903 New
Hampshire Ave, Silver Spring, MD 20993, Office of Regulatory Affairs (ORA) located at 12420 Parklawn Drive, Rockville,
MD 20852, etc
I am seeking all records pertaining to the FDA interactions with the People with AIDS Health Group (PWA Health Group).
Any and all records relating to or concerning communications between the Department of Commerce and/or the FDA
(including those communications where Commerce and/or the FDA is copied or blind copied) and Abbott, Mead
Johnson, Nestle, or Perrigo, related to any of their baby formula products. etc
Documentation on FDA’s justification to release guidance titled: Guidance for Industry: Infant Formula Enforcement
Discretion Policy, All applications and supplemental materials to applications for enforcement discretion related to
infant formula submitted to FDA, Justifications of approved applications and justifications of denied applications etc
All email communications (including emails, complete email chains, email attachments, calendar invitations, and
calendar invitation attachments), from the below listed individuals sent or received from the following domains (1)
senate.gov (2) mail.house.gov (3) ama.org (4) ocsotc.org (5) acog.org (6) aafp.org (7) kff.org concerning over-the-counter
oral contraceptives. (a) Robert M. Califf, M.D (b) Janet Woodcock (c) Julia (Julie) Tierney, J.D (d) Dr. Kaveeta Vasisht
Please provide records from February 1, 2021, to present.
investigation reports, correspondence, memorandums, interviews or any other documents concerning AMARC
Enterprises, Inc. and/or Albert Lee Sanchez, Jr., including, but not limited to, the documents that support the Complaint
for Permanent Injunction that was filed December 2, 2020 in the United States District Court, District of Southern
California as case number 20CV231 MMA-AGS
All records produced in response to the records requests that are the subject of Judge Rotenberg Educational Center,
Inc. v. U.S. Food and Drug Administration, filed as No. 17-2092 in the United States District Court for the District of
Columbia. This includes the records produced in response to the following FOIA requests ETC
FDA Bioequivalence Review for ANDA 211526 (Difluprednate Ophthalmic Emulsion 0.05% - Amneal)
Form 483 issued to Immacule Lifesciences Private Limited (FEI 3014210753)
ODT (rimegepant). These 12 case reports were identified using the FAERS quarterly data files.
The routing summary for each of the following approved ANDAs: - ANDA No. 203180 (Dasatinib Tablets, 80 mg and 140
mg, approved on November 23, 2021) - ANDA No. 203760 (Albuterol Sulfate Inhalation Aerosol, 90 mcg
(base)/actuation, approved on February 4, 2020) ETC
I am seeking all records pertaining to the FDA interactions with the Healing Alternatives Foundation (HAF).
participating in the FDA Foreign Supplier Verification Programs from approximately March 17, 2022 - June 16, 2022. We
request a modified version of this same list to include the Firm's FDA FEI Number. This is the same request as our
previous FOI request with control number 2021-1456 (fulfilled by CFSAN), but, with a different date range.
Observations) of Aragen Life Sciences Private Limited, with FDA establishment identifier # 3011573185
NADA 046-592 Bacitracin methylene disalicylate NADA 048-761 Chlortetracycline pre-mix approval NADA 094-975 etc
Freedom of Information Act (FOIA): Request for Summary Basis of Approval (SBOA) of GLYDO (Lidocaine Hydrochloride)
jelly 2% (NDA A201094) held by Sagent Pharmaceuticals INC
Meeting minutes of Type C meeting (08-Jan-2010) for NDA#201635.
FDA 482s, 483s and EIRs by Arsen Karpetyan issued for PAI inspections conducted between 06/06/2022 - 06/30/2022
for... Laboratorios Farmacicos ROVI, S.A. dba ROVI Pharma Industrial Services Avda. Catalunya N1, 28703, San Sebastian
de los Reyes (Madrid) and, Julian Camarillo, 35, 28037 Madrid
Any and all records maintained by the Center for Drug Evaluation and Research (CDER), U.S. Food and Drug
Administration including memoranda, draft memoranda, investigative reports, email communications, email chains, and
other communications or data concerning complaints or alleged violations involving Vestavia Research Group while
performing work on Pfizer's Phase III trial for the COVID-19 vaccine. Please provide records from August 1, 2020, to
present.
I respectfully request the technical project lead review (TPL) and any related documents for the mid-cycle review of the
following JUUL Labs, Inc. Premarket Tobacco Product Applications (FDA Submission Tracking Numbers (STN):
PM0000864.PD1, PM0000872.PD1, PM0000874.PD1, PM0000876.PD1, PM0000878.PD1, PM0000879.PD9).
Marketing Denial Orders issued to JUUL Labs Inc. for all of their products currently marketed in the United States,
including the JUUL device and four types of JUUL pods: Virginia tobacco flavored pods at nicotine concentrations of
5.0% and 3.0% and menthol flavored pods at nicotine concentrations of 5.0% and 3.0%.
Premarket Approval Application, including all appendices, exhibits, addenda and other materials submitted in relation to
the following device: NEVRO SENZA SPINAL CORD STIMULATION (SCS) SYSTEM Stimulator, Spinal-Cord, Totally
Implanted For Pain Relief Applicant: Nevro Corporation PMA Number P130022
"Addendum to February 24, 2017, Equivalence Testing for SE Evaluations Memo," dated April 16, 2019
Respectfully request the request the disciplinary review documents for the following JUUL Labs, Inc. Premarket Tobacco
Product Applications (PM0000864.PD1, PM0000872.PD1, PM0000874.PD1, PM0000876.PD1, PM0000878.PD1,
PM0000879.PD9).
I am attempting to obtain some older documents regarding the medication Fludara, NDA 020038.
I'm requesting all e-mail records for Eric Nelson containing key word; AAFCO. Eric Nelson works at FDA-CVM (04.01.20-
05.31.22). All email records for FDA CVM employee David Edwards containing the key search term: AAFCO (09.01.2021-
05.31.2022). All email records for FDA CVM employee Eric Nelson containing the key search term: AAFCO (08.01.2021-
05.31.2022)
In FY 2020, FDA reviewed over 50,000 products at the International Mail Facilities (IMF) and identified 215 opioids, with
97% being either destroyed, refused, or referred to FDA's Office of Criminal Inspections and the U.S. Customs and
Border Protection (CBP)" (DHHS, 2022). If possible I would like a comprehensive dataset including what products were
contained in each of the 50,000 packages reviewed and what was done with each of the packages after review.
Observations) of Choksi Laboratories Limited, with FDA establishment identifier # 3006091736
Please provide all available FDA Review documents supporting the regulatory approval of BLA 761197, SUSVIMO?
(ranibizumab injection) for intravitreal use via SUSVIMO ocular implant . The product was approved on 22 October 2021.
The drugs@FDA website does not provide these documents, yet. Thank you
All Technical Project Lead Summary Memoranda for all Marketing Denial Orders issued by the Center for Tobacco
Products to JUUL Labs Inc.
Redacted 510k submissions for -Diagnostica Stago Inc. STA-R K111822 - chromogenic - 10/26/2011 Instrumentation
Laboratory HemosIL K090209 - 06/02/2009 Siemans Innovance - K162540 - 08/22/2017 STA® Liquid Anti-Xa
k111822 -06/28/2011 K010455 ROTACHROM HEPARIN AND STA -ROTACHROM HEPARIN K010455 06/07/2001
Inspection reports and any compliance actions for SpectronRx contract manufacturing organization. Two Manufacturing
Locations: 17490 Dugdale Drive, South Bend, IN 46635-1572; 9550 Zionsville Rd, Suite 1, Indianapolis, IN 46268.
Copy of the disclosable portions of all marketing denial orders (MDOs) issued to Juul Labs in June 2022, as well as all
underlying review documents.
Nephron Pharmaceuticals Corporation: 4500 12th Street Extension, Columbia, SC 29172
Inspection reports and any compliance actions.
Nephron is a supplier for RayzeBio and we would like further details on recent inspections finding.
The Technical Project Lead Review and all FDA disciplinary review documents for JUUL Labs Inc. Premarket Tobacco
Product Applications for the JUUL device and JUUL Virginia tobacco flavored pods at nicotine concentrations of 5.0%
and 3.0% and menthol flavored pods at nicotine concentrations of 5.0% and 3.0%.
All “483” forms issued to the following organizations between Jan. 1, 2010, and the date this request is processed:
Mead Johnson Nutrition, Reckitt Mead Johnson Nutrition, and/or Mead Johnson Nutritionals, LLC. Gerber, Gerber
Products Company, and/or Gerber Products Company dba Nestle Infant Nutrition PBM Nutritionals LLC, Perrigo, L.
Perrigo Company, Perrigo New York, Inc., Perrigo Company PLC
Human Adverse Drug MedWatch reports for the following case IDs: 10951822 11044075 17695149 17758591
17808572 17965625 17965675 17965747 17686430
1274-2020; F-1275-2020 Confirmation # FDA2070729
I would like to see IND filing package of Trikafta and/or any other approved drugs for the treatment of cystic fibrosis
FDA 483 for FDA inspection of AGON PHARMA PRIVATE LIMITED - FEI: 3007481629 Category: Drug Quality Assurance,
ending 13 June 2019, Location: New Gat No. 837 & Old Gat No. 142, Milkat No. 1252, Pune, Maharashtra 412214, India
(IND). Including any previously FOIA released documents related to this inspection. If not available, then just the FDA
483.
(1) The Technical Project Lead (TPL) memorandum and any and all related documents associated with JUUL’s PMTA
submissions for the following products for which FDA issued marketing denial orders on June 23, 2022: Virginia tobacco
flavored pods at nicotine concentrations of 5.0% and 3.0% and menthol flavored pods at nicotine concentrations of
5.0% and 3.0%. ETC
Premarket Tobacco Product Applications (PMTAs) related to 06/23/22 Marketing Denial Orders for all JUUL Labs Inc’s
products currently marketed in the US, including: 1. The PMTAs submitted by JUUL Labs Inc. between January 1, 2020
and September 9, 2020 for all products that they currently marketed or wished to market in the United States,
including, but not limited to, the JUUL device and four types of JUUL pods: ETC
All clinical trial documentation related to P-IND 101,672 submitted to the FDA or received from the FDA by DiaMedica
Inc. formerly located at 4-1250 Waverly Street, Winnipeg, Manitoba, Canada R3T 6C6
Azelex, NDA 020428 - current package insert and primary container labeling. Drugs@FDA indicates new labeling
We are requesting an electronic copy (Acrobat PDF version) of the (1) Environmental Assessment submitted by NJOY,
LLC for the product NJOY DAILY Rich Tobacco 4.5% (PM0000630); ETC
Electronic listing (preferably csv format) of all inspections conducted by FDA since February 1, 2022. The list should
Copy of the 483 for the 02/15/2022 - 02/22/2022 inspection of Dennis Marcus, M.D. [Augusta / United States of
America] 3685 Wheeler Rd # 201, Augusta, GA 30909, USA. This inspection pertains to HUMAN DRUGS
Copy of the 483 for the 02/07/2022 - 02/18/2022 inspection of Cangene BioPharma LLC [Baltimore / United States of
America] 1111 S Paca St, Baltimore, MD 21230, USA. This inspection pertains to HUMAN DRUGS
Copy of the 483 for the 02/14/2022 - 02/18/2022 inspection of St. Cloud Hospital [St. Cloud / United States of America]
St Cloud Hospital, 1406 6th Ave N, St Cloud, MN 56303, USA. This inspection pertains to HUMAN DRUGS
Copy of the 483 for the 02/07/2022 - 02/18/2022 inspection of Sterling Pharmceutical Svcs [Dupo / United States of
America] 109 S 2nd St, Dupo, IL 62239, USA. This inspection pertains to VETERINARY DRUGS
Report and/or the MDSAP Noncomformity Grading and Exchange Form (NC) for the inspection of Seirin Corporation,
Shizuoka-Shi, Japan, end date 04-27-2018. FEI# 3003135788. This inspection pertains to medical devices.
Report and/or the MDSAP Noncomformity Grading and Exchange Form (NC) for the inspection of OLYMPUS TERUMO
BIOMATERIALS CORP, Shibuya, Japan, end date 08-30-2016. FEI# 3012251296. This inspection pertains to medical
devices.
Report and/or the MDSAP Noncomformity Grading and Exchange Form (NC) for the inspection of Quanta System, S.p.A.,
Solbiate Olona, Italy, end date 12-01-2017. FEI# 3004378299. This inspection pertains to medical devices.
Report and/or the MDSAP Noncomformity Grading and Exchange Form (NC) for the inspection of Asa Srl, Vicenza, Italy,
end date 12-07-2017. FEI# 3007359670. This inspection pertains to medical devices.
All emails relating to the letter from The Satanic Temple (TST) demanding the FDA permit TST access to Mifepristone
and Misoprostol for use under medical supervision as part of TST's religious abortion ritual.
Altadis U.S.A. LLC (“AUSA LLC”), as owner of EX0002041.PD1 and as U.S. Agent for Tabacalera de Garcia S.A.S. (aka
Tabacalera de Garcia), requests the following records: a. Unredacted Technical Project Lead (TPL) Review documents
relating to EX0002041.PD1. ETC
relating to EX0002042.PD1. etc
I seek to obtain copies of the following records referenced in the multiple site clinical trial published in 2019 in JCO
(Ambrosone CB, Zirpoli GR, Hutson AD, et al. Dietary Supplement Use During Chemotherapy and Survival Outcomes of
Patients With Breast Cancer Enrolled in a Cooperative Group Clinical Trial (SWOG S0221). J Clin Oncol. 2020;38(8):804-
814.doi:10.1200/JCO.19.01203): 1. The institutional review board (IRB) final approval with all associated documents
including informed consent (IC) for each trial site. 2. The investigational new drug (IND) final approval with all associated
documents. 3. All documents and correspondence related to the early closing of the trial.
FDA 483 for FDA inspection of HUBEI GEDIAN HUMANWELL PHARM. - FEI: 3004117486 Category: Drug Quality
Assurance, ending 28 June 2019, Location: Gedian Economic Development District,, Ezhou, Hubei 436070, China (CHN).
Including any previously FOIA released documents related to this inspection. If not available, then just the FDA 483.
Any documents relating to inspection activities or inspections of Porton Biopharma Limited, Manor Farm Road, Porton
Down, Salisbury, Wiltshire, United Kingdom.
We would like to request a copy of the 510(k), K041007 under the FOIA.
All internal FDA and Center for Tobacco Products correspondence—including, but not limited to, emails,
memorandums, and meeting records—related to the PMTA application filed by Juul Labs.
Vacancy announcement for position number 00438074.
relating to EX0002043.PD1.etc
relating to EX0002044.PD1.etc
Pre-Notification Consultation (PNC) 002723 and all FDA internal review memoranda associated with it, including
chemistry review memorandum and/or toxicology review notes. This PNC relates to hydrogenated castor oil (HCO) (CAS
Reg. No. 8001-78-3) and 12-hydroxystearic acid (CAS Reg. No. 106-14-9).
We request all information relating to any medical device reports (MDRs) submitted by mandatory reporters
(manufacturers, importers and device user facilities) or voluntary reporters, such as health care professionals, patients,
and consumers, between the dates of January 1, 2015 and March 31, 2020, regarding malfunctions of Baxter’s Spectrum
Infusion System etc
Please provide copies of the disclosable portions of the Center for Tobacco Products (CTP), Office of Science (OS)
marketing denial orders (MDOs) and any associated supporting CTP memoranda and correspondence related to the
NJOY LLC Daily e-cigarette products that received MDOs on June 10, 2022.
Please provide copies of the disclosable portions of the Center for Tobacco Products (CTP), Office of Science (OS)
deficiency letter(s) related to the NJOY LLC Daily e-cigarette products that were the subject of the June 10, 2022
marketing order.
Searching for records or evidence of an FDA investigation into Axsome Therapeutics Inc. for clinical trial and/or data
fraud/manipulation with regards to their drug AXS-05 (dextromethorphan-bupropion).
FDA Order on Juul Ban
TRIAL DATA FROM MERCK TRIALS OF MOLNUPIRAVIR FOR TREATMENT OF COVID
TOBACCO STATEMENTS
FAERS 20102463; 19939906; 19630663; 19685262; 19353149
marketing denial orders (MDOs) to JUUL Labs Inc. for an electronic nicotine delivery
a copy of the Premarket Tobacco Product Applications (PMTAs), including any

supplements and supporting communications, submitted by JUUL Labs Inc. for an electronic nicotine
delivery system (ENDS) device and four types of JUULpods. FDA issued marketing denial orders
(MDOs) for these products, which was announced on June 23, 2022
2022-3434, 2022-3453, 2022-3472, 2022-3505, 2022-3506.
2022-3586, 2022-3594, 2022-3595, 2022-3597, 2022-3598
CVs Tamara A Brey, Roberta W Cunningham, Gary L Zaharek, etc
Report and/or the MDSAP Noncomformity Grading and Exchange Form (NC) for the inspection of OLYMPUS TERUMO
BIOMATERIALS CORP. MISHIMA FACTORY, Sunto-Gun, Japan, end date 08-25-2017. FEI# 3007738819. This inspection
Report and/or the MDSAP Noncomformity Grading and Exchange Form (NC) for the inspection of MIZUHO IKAKOGYO
CO., LTD. Chiba Factory, Ota, Japan, end date 12-05-2017. FEI# 3010594257. This inspection pertains to medical
devices.
Copy of the disclosable portions of the MedWatch reports for the following 2 molnupiravir cases: 20974437, and
20967391.
for Medical Devices & Rad Health inspection of Compass Health Brands (Corporate Office) ending 10/07/2021 at the
location in Middleburg Heights OH, United States. etc
for Foods & Cosmetics inspection of Prolacta Bioscience Inc ending 05/01/2014 at the location in City Of Industry CA,
United States. The 483 (in electronic format) for Foods & Cosmetics inspection of Prolacta Bioscience Inc ending
10/20/2015 at the location in City Of Industry CA, United States. etc
for Foods & Cosmetics inspection of Grimmway Enterprises, Inc. dba Grimmway Farms ending 05/04/2022 at the
location in Arvin CA, United States. etc
Report and/or the MDSAP Noncomformity Grading and Exchange Form (NC) for the inspection of Right Manufacturing
Co Ltd, Itabashi, Japan, end date 03-09-2018. FEI# 3004438257. This inspection pertains to medical devices.
Report and/or the MDSAP Noncomformity Grading and Exchange Form (NC) for the inspection of Topcon Corporation,
Itabashi, Japan, end date 04-20-2018. FEI# 1000175127. This inspection pertains to medical devices.
Copy of the 483 for the 02/14/2022 - 02/25/2022 inspection of Saima Jehangir, M.D. [Austin / United States of America]
3407 Glenview Ave, Austin, TX 78703, USA. This inspection pertains to HUMAN DRUGS
Copy of the 483 for the 02/14/2022 - 02/24/2022 inspection of Mikell Jaratt, M.D. [Gastonia / United States of America]
1010 X Ray Dr, Gastonia, NC 28054, USA. This inspection pertains to HUMAN DRUGS
Copy of the 483 for the 02/14/2022 - 02/22/2022 inspection of Nikolaos T. Pyrsopoulos, M.D. [Newark / United States
of America] 90 Bergen St 2 2100, Newark, NJ 07103, USA. This inspection pertains to HUMAN DRUGS
Copy of the 483 for the 02/01/2022 - 02/22/2022 inspection of Frank Sciurba, M.D. [Pittsburgh / United States of
America] 3471 Fifth Ave #1211, Pittsburgh, PA 15213, USA. This inspection pertains to MEDICAL DEVICES
Emails, memos, letters, and all internal and external communication regarding the source of the cronobacter bacteria
and/or salmonella and other harmful bacteria found in baby formula manufacturer ( such as Abbott) products in 2021-
2022.
Product at Issue: Belumosudil Case ID: 20411858
Request to acquire the FDA 483 for FDA inspection of M9084 Menadiona SL - FEI: 1000242648 Category: Drug Quality
Assurance Inspection, ending 11 July 2018, Location: Poligono Industrial Mas Puigver, Palafolls Barcelona, 08389, Spain
(ESP). Including any previously FOIA released documents related to this inspection. If not available, then just the FDA
483.
FDA 483 for FDA inspection of Aarti Industries Limited - FEI: 3005256484 Category: Drug Quality Assurance, ending 20
February 2020, Location: Unit–IV, Plot . E 50, M.I.D.C Tarapur Tal- Palghar, Palghar, Maharashtra 401506, India (IND).
Including any previously FOIA released documents related to this inspection. If not available, then just the FDA 483.
New Drug Application (NDA): 019758; supplements: SUPPL-2, SUPPL-5, SUPPL-6, SUPPL-11, SUPPL-14, SUPPL-21,
SUPPL-23, SUPPL-25, SUPPL-27, SUPPL-33, SUPPL-32, SUPPL-34, SUPPL-36, SUPPL-41
I am interested in the Terumo BCT original FDA submission and approval for the Spectra Optia Apheresis System. The
submission identifier is K071079 but the full submission was not available on the FDA's website.
510k Submission: K180908, Company: New Deantronics
510(k) K161487 - ResMed Ltd. S9 VPAP Tx
Please provide the epidemiology review, toxicology review and health effects summary for the PMTA/MDO process re:
the JUUL device and Juul Labs Inc. Virginia tobacco flavored pods at nicotine concentrations of 5.0% and 3.0% and
menthol flavored pods at nicotine concentrations of 5.0% and 3.0%.
Please provide the marketing denial order (MDO) summary for Juul Labs Inc. Virginia tobacco flavored pods at nicotine
concentrations of 5.0% and 3.0% and menthol flavored pods at nicotine concentrations of 5.0% and 3.0%.
Any and all reports, studies, and other analyses leading to or in support of FDA’s June 2022 decision to issue marketing
denial orders (MDO) to JUUL Labs Inc. for all of their products in the United States as well as the company’s premarket
tobacco product applicants (PMTAs).
Please see attached PDF for FDA case ID numbers retrieved from FAERS dashboard. This request includes 161 cases
between 2012 and 2022. Please advise if the cases prior to 2014 will delay request. Kind regards, Laura Bunn, MSN,
RN SafetyCall International
Request to acquire the FDA 483 for FDA inspection of M9049 Changzhou Tianhua Pharmaceutical - FEI: 3003895439
Category: Human Drugs Inspection, ending 19 Apr 2019, Location: Jintan, China. Including any previously FOIA released
documents related to this inspection. If not available, then just the FDA 483.
1. The Certificate of Sanitary Construction (CSC) for Vessel "American Song" (VIN 1282656) that was issued on
8/22/2018. 2. Any index or listing of documents that FDA reviewed in the process of determining to issue that
Certificate. (not all those documents, just any one listing or index of them) 3. Any Inspection assignment to inspect
that Vessel. 4. Any Establishment Inspection Report (or similar document for a vessel inspection) for that vessel. 5.
Any FD-483 List of Observations (or similar document for a vessel inspection) for that vessel. 6. If there are no
responsive document to requests 4 or 5 above, then the most recent two such documents with respect to any of these
American Cruise Line vessels of the same class: American Serenade American Symphony American Melody
American Jazz American Harmony (this request #6 seeks only the most recent two documents for any of these
vessels, not more than two documents, total) I will work with any responding FDA person to clarify or refine these
requests to reduce the time, burden or nuisance for FDA to respond. The locations of these inspected facilities vary, as
vessels move. They are all operated by American Cruise Lines, of 741 Boston Post Rd. Suite 200, Guilford, CT 06437 US
1. The first page (i.e., Face Page) of the current contract award, and first 15 pages of the Performance Work Statement
or Statement of Work for the existing contract # HHSM500201600051I/75F40120F80520 etc
I am requesting the full 510(k) submission for the following devices, as only summaries are available online: The
Sherlock 3CG TCS (K113808) The Sherlock 3CG TCS (K113808) VPS System Console (K103260) PICC Tip Positioning Aid
(K152261) VPS Rhythm with TipTracker (K160925) Celerity System (K140799) Celerity PICC Tip Confirmation System
(K142889) C3 Wave (K143238) C3 Wave System (K170934) etc
I respectfully request copies of any and all information related to Philips Respironics’ (FEI # 2518422) response to the
518(a) Notification Order that was issued to Philips Respironics on March 10, 2022.
I would like all records of the inspection or investigation of Acella Pharmaceuticals located in Georgia.
I hereby request a copy of the evaluation report (inspection) from Productos Marinos c.a, a blue crab meat processing
company; located in San Francisco, Zulia state; Venezuela. The evaluation was carried out by Lisa Bowden, from March
28 to April 1 of this year.
FDA rejected de novo diagnostic device application by Resapp Health Ltd. I am seeking the application by the company
and the rejection document by the FDA. The company applied for "Resapp’s respiratory diagnostic" device.
Requesting a copy of K212871, device description: Aliya(TM) System, Aliya(TM) Generator, Aliya(TM) Needle, Aliya(TM)
Electrode
Can we please request additional information for a case reporting compartment syndrome and rhabdomyolysis - VAERS
ID 2284986, AER 20220560207
Infant formula submissions from January 1, 2019 to present for (1) Similac Pro-Sensitive; and (2) Gerber Good Start
Gentlepro.
K140560
for Foods & Cosmetics inspection of Prolacta Bioscience Inc ending 11/22/2019 at the location in City Of Industry CA,
United States. The EIR (in electronic format) for Foods & Cosmetics inspection of Prolacta Bioscience Inc ending
07/30/2021 at the location in City Of Industry CA, United States. etc
Hello, I would like to request the Form 483 and EIR issued during any FDA inspection of the Revance Therapeutics
manufacturing facility located in Fremont, CA, since April 1, 2022. Thank you
Hello, I would like to request the Form 483 and EIR issued during any FDA inspection of the Berkshire Sterile
Manufacturing plant located in Lee, MA during 2022. Thank you,
for Animal Drugs & Feeds inspection of Zhejiang Jinhua Conba Bio-Pharm. Co., Ltd. ending 09/13/2007 at the location in
Jinhua, China. Please send documents as email attachments.
FDA’s Technical Project Lead (TPL) Review of PMTAs (Toxicology) for Juul Labs Inc. products that were subject to MDO in
June 2022.
Hello, This is a request under the Freedom of Information Act. We are looking to retrieve the report that Philips
Respironics has sent to the FDA in the month of December 2021, in response to the aforementioned FDA 483 Form (FEI
number 2518422), about the ongoing class 1 medical device recalls of various models of Philips Respironics ventilators,
CPAP and BPAP devices, due to foam degradation issues. ETC
for Human Drugs inspection of Camco Chemical Company ending 03/02/2022 at the location in Florence KY, United
format) for Foods & Cosmetics inspection of Puris Proteins, LLC. ending 06/12/2017 at the location in Dawson MN,
This pertains to Acella Pharmacuitacals located in Georgia and their drug NP Thyroid. I would like all the records that
shows why they were inspected, and discovery of inspection, documents on reports of adverse effects (I reported mine
to Acella on 9-11-2018) any or all reports.
All written communications between FDA and Novavax, Inc., regarding Novavax's pending request for Emergency Use
Authorization of its vaccine against Covid-19.
Correspondence with members of the press regarding MDOs for Juul products. Please see attached for details.
Correspondence regarding market denial orders for Juul products. Please see attached for further details.
for Foods & Cosmetics inspection of Medolac Laboratories, A Public Benefit Corporation ending 11/15/2018 at the
location in Boulder City NV, United States. etc
Unabridged copies of the following research items: o FDA. U. S. Food and Drug Administration. “Inspection, Collection
and to Analysis of Powdered Infant Formula for Enterobacter sakazakii (E. sakazakii)”¿–¿High Priority. (2002). (DOEP
#02-18¿–¿FACTS #33044”). o Zink D. FDA Field Survey of Powdered Formula Manufacturing, U. S. Food and Drug
Administration, Food Advisory Committee, Meeting. (2003). Available from:
http://www.fda.gov/ohrms/dockets/ac/03/slides/3939s1.htm etc
I’m seeking the report made by FDA Inspector Stephen D. Eich, for the Remote Regulatory Assessment (RRA) he
conduction on 2-16 March 2022, for Advalight ApS, located in Denmark. I hereby confirm, that we are willing to pay the
fee in connection with receiving above RRA from FDA.
Request Review Memoranda and Correspondence Related to NJOY LLC's PMTA
Correspondence to/from Michele Mital and/or Robert Califf regarding Juul MDO press leak. Please see attached for
further details.
I respectfully request copies of any and all information related to Philips Respironics’ (FEI # 2518422) response to the
518(b) Notice of Opportunity for a Hearing that was issued to Philips Respironics on May 2, 2022.
Orhan Drug Designation review and decision making documents for Tarpeyo/budesonide for the indication of
immunoglobulin A nephropathy. As per the OOPD database, orphan designation is given to slow the progression of
immunoglobulin A nephropathy & delay kidney failure in patients affected by the disease in 2010.
for Foods & Cosmetics inspection of Medolac Laboratories, A Public Benefit Corporation ending 09/14/2017 at the
location in Lake Oswego OR, United States. Please send documents as email attachments.
All form 483 inspection reports regarding the company Procept Biorobotics, headquartered at 900 Island Drive,
Redwood City, CA 94065.
Documents and communications related to consumer complaints and facility (Sturgis, MI) health and safety complaints
related to infant baby formula manufactured and/or sold by Abbott Laboratories dba Abbott Nutrition
We would like to request a copy of the summary report and associated documentation of the traditional 510(k)
clearance; K181454 (Device name: DAILIES AquaComfort Plus, DAILIES AquaComfort Plus FreshTech, DAILIES
AquaComfort Plus Toric and DAILIES AquaComfort Plus Multifocal ).
I would like to request all documents issued to Dr. Opada Alzohaili located in Dearborn, Michigan related to the
inspections that were completed on 8/14/13 and 3/29/16. Please include any Establishment Inspection Report, Warning
Letter, 482 or 483 forms issued
for Biologics inspection of Kite Pharma, Inc. ending 10/22/2021 at the location in El Segundo CA, United States. Please
for Human Drugs inspection of MALLONEE, WILLIAM ending 09/21/2015 at the location in WICHITA KS, United States.
Hello, Please provide all emails to and from Dr. Rochelle Walensky containing
the words "myocarditis" and "vaccine" or "vaccination" between 12.29.21 and
1.6.22. Exclude spam and attachments.
To Whom It May Concern: This is a request under the Freedom of Information Act. I request that a copy of any
documents from between Sept. 2020 and April 2021, including but not limited to, memos, reports, meeting minutes,
emails and other internal communications containing the following search terms: Merck AND OncoImmune; Merck AND
“CD24Fc”; Merck AND “MK-7110”;etc
I am requesting all calendar records from employees Eric Nelson [CVM], Steven Solomon [CVM], Timothy Schell [CVM].
Please ensure the calendar records are provided in the format that shows each full day with all entries for each day.
Date Range: 01/01/2019 - 08/06/2019; I'm requesting all e-mail records for Charlotte Conway Division Director
CVM/OSC/Division of Animal Feeds pertaining to the key words pertaining to these key words; AAFCO, Answers Pet
Food, Lystn LLC, Louisville Kentucky, zero tolerance policy, compliance policy
I'm requesting all e-mails exchanged between Robin.Rivers@fda.hhs.gov and davdressle@pa.gov 01.01.19-07.28.19
All vacancy announcements for the Office of Operations, Office of Human Capital Management, for a GS-13
Management Analyst.
Listing of vacancies within the Office of Operations, Office of Human Capital Management, Immediate Office.
Listing of vacancy numbers within Office of Operations, Office of Human Capital Management, for a GS-13 Management
Analyst.
All documents in the biological product file for the product NUWIQ, that contain the term “HEK”.
All documents in the biological product file for the product Luxturna (Voretigene neparvovec), that contain the term
“HEK”.
All documents in the biological product file for the product Yescarta (Axicabtagene Cilolucel), that contain the term
“HEK”.
All documents in the biological file for the product Kymriah (Tisagenlecleucel), that contain the term “HEK”.
I am requesting all FDA records to cases where humans have been known to have died from salmonella by handling pet
food. I’m requesting all FDA records to cases where humans have been known to have become sick or hospitalized from
salmonella by handling pet food 01/01/1980 - 12/16/2018
All documents in the biological product file for the product Zolgensma (Onasemnogene abeparvovec), that contain the
term “HEK”.
All documents in the biological product file for the product Breyanzi (Liscocabtagene maraleucel), that contain the term
“HEK”.
All documents in the biological product file for the product Abecma (Idecabtagene vicleucel), that contain the term
“HEK”.
Observations) of Syngene International Limited, with FDA establishment identifier # 3007907068
Observations) of Shiva Analyticals (India) Private Limited, with FDA establishment identifier # 3006192929.
Request to acquire the FDA 483 for FDA inspection of M9088 Fuzhou Fuxing - FEI: 3006772356 Category: Drug Quality
Assurance, ending 03 Aug 2018, Location: No. 8 Nangang Road, Jiangyin Industrial Concentration Zone, Fuqing, Fuzhou,
Fujian 350309, China (CHN). Including any previously FOIA released documents related to this inspection. If not
available, then just the FDA 483.
Request to acquire the FDA 483 for FDA inspection of M9157 Antibiotice - FEI: 3003489017 Category: Drug Quality
Assurance, ending 11 October 2019, Location: 1 Valea Lupului Street, Iasi, Iasi 707410, Romania (ROU). Including any
previously FOIA released documents related to this inspection. If not available, then just the FDA 483.
Bioequivalence Review for ANDA 210876
Approval letter for Cosmegen (Dactinomycin) NDA 05682, approval date December 10th, 1964.
A copy of the summary basis of approval for ANDA 214585, approved on May 11, 2022, for mesalamine extended
release oral capsules, 500 mg.
A copy of the Approval Package (Summary Basis of Approval) for ANDA 214585, for Mesalamine Extended-release
Capsules, 500 mg, approved on May 11, 2022.
ANDA# 205894 MYLAN Summary Review Cross Discipline Review Chemistry Review Clinical Pharmacology and
Biopharmaceutical Review
Please see attached Request Letter. Generally, we are requesting all files, documents, correspondence, emails, etc. that
relate to all names of and/or references to any licensed homeopaths, homeopathic physicians, or homeopathic
pharmacists who have been employed by the FDA since 1938, including but not limited to such employee’s title,
position, general description of duties and dates of employment. Also requesting the same information for any
representative of any homeopathic organization or manufacturer who has worked with or for the FDA in any capacity
since 1938. (please see attached Request Letter for further details)
I request that a copy of any and all documents—internal memos, emails or other correspondences—be provided to me
that contain information related to FDA policy and guidance on emerging cannabinoids including, but not limited to,
delta-8 THC.
The summary basis for approval for ANDA 214585.
Please provide Safety Report # 9686436. This safety report appeared in the MAUDE database and came up as a search
result when searching for safety reports submitted to FDA by our company, Pinnacle, from 01/01/2020 to present. I
uploaded screenshots for further details.
483: Piramal Healthcare UK Limited
Morpeth, United Kingdom End Dates of inspection: 18 June 2021 Project Area: Drug Quality
483: SGS Lab Simon Bierges, Belgium
End Dates of inspection: 22 March 2021 Project Area: Drug Quality Assurance FEI: 3004186644
Classification: VAI I confirm that Clarivate Analytics will be charged accordingly by FOI for this request, however please
483: Upjohn Manufacturing Ireland Unlimited Company
Cork, Ireland End Dates of inspection: 02 July 2021 Project Area: Drug Quality
As permitted by the Freedom of Information Act (FOIA), I am hereby requesting a copy of the EIR released on 6/10/2022
resulting from FDA inspection at Rentschler Biopharma SE Erwin-Rentschler-Str. 21 Laupheim, Baden-Wurttemberg
88471 Germany FEI# 1000291122. I confirm that CytomX Therapeutics will be charged accordingly by FOI for this
request.
I would like to see the non-clinical data that Translate Bio has submitted in order to advance to human clinical trial for
the MRT-5005, an mRNA therapeutic for cystic fibrosis.
Please consider this a request for a copy of the 6/10/2022 tentative approval letter for ANDA No. 203640 for Nilotinib
(generic drug).
I am an investment professional for an asset management firm and would like to request all 483s issued for inspections
occurring from 01/01/2022 to 06/29/2022 for Interquim S.A. The facility’s FEIN is 3002807304 and it is located at Calle
De Joan Buscalla 10, Sant Cugat del Valles, 08173, Spain. Thank you!
Please provide the MedWatch form for Case ID 20538342
We need the eCTD submission for our Type III DMF no. 032350 "Collapsible Aluminium Tubes for Pharma Packaging"
FOIA RESPONSES CONFIRM OR DENY ETC

Our company committed the Foreign Remote Regulatory Assessment (FRRA) on 25th - 29th April with FDA. 2 months
has passed and we would like to request a copy of the report for the assessment.
All documentation related to the FDA inspection conducted between 22 Dec 2021 - 29 Jul 2022., at DPT Laboratories,
Ltd (FEI: 1628114) and Interquim, S.A. (3002807304)
483: Artemis Bio-Solutions Wood Dale,
Illinois United States End Dates of inspection: 01 December 2021 Project Area: Drug Quality Assurance FEI: 3009620743
483: Ataia, Inc Silver Spring,
Maryland United States End Dates of inspection: 07 March 2022 Project Area: Compliance: Devices FEI: 3016096197
Establishment Inspection Report (EIR) for Emerald Kalama (1296 Nw 3rd St., Kalama, WA 98625-9701, United States)
Inspection 961641, performed on 1/15/2016.
CONTROLLED SUBSTANCE REGULATION
I request you provide me with the following information: 1. All reports of adverse events and/or reactions dog and/or
cats have had to dog and cat food and dog and cat treats from 05.01.2022-06.30.2022. a. Please include the type of
animal, the reaction, the brand name and the product name of the food item to which the dog or cat reacted, the
symptoms displayed and the outcome, if available. etc
483: Broncus Medical Inc. San Jose,
California United States End Dates of inspection: 30 July 2021 Project Area: Compliance: Devices FEI: 3007867778
483: CASAD Company Inc Coldwater,
Ohio United States End Dates of inspection: 18 August 2021 Project Area: Drug Quality Assurance FEI: 3013014383
483: Colgate-Palmolive Company
Morristown, Tennessee United States End Dates of inspection: 15 July 2021 Project Area: Postmarket Assurance:
483: DMD Medical Group Chesterfield,
South Carolina United States End Dates of inspection: 25 August 2021 Project Area: Compliance: Devices FEI:
483: DuPont Nutrition USA, Inc Newark,
Delaware United States End Dates of inspection: 15 December 2021 Project Area: Drug Quality Assurance FEI:
483: Fertility Center of San Antonio San
Antonio, Texas United States End Dates of inspection: 24 May 2021 Project Area: Blood and Blood Products FEI:
483: Hammond & Co, Inc DBA Pacific Coast Spirits
Carlsbad, California United States End Dates of inspection: 18 August 2021 Project Area: Drug Quality Assurance
FEI: 3016690411 Classification: OAI I confirm that Clarivate Analytics will be charged accordingly by FOI for this request,
483: IEC Electronics Newark, New York
United States End Dates of inspection: 03/11/2022 Project Area: Compliance: Devices FEI: 1000474105 Classification:
the charges exceed $ 200
483: James W. Findling, M.D. Milwaukee,
Wisconsin United States End Dates of inspection: 26 August 2021 Project Area: Bioresearch Monitoring FEI: 3015358337
483: Little Sparrows Technologies, Inc. Newtonville, Massachusetts
United States End Dates of inspection: 20 October 2021 Project Area: Compliance: Devices FEI: 3013424071
483: Kaleido Biosciences, Inc. Lexington,
Massachusetts United States End Dates of inspection: 03 March 2021 Project Area: Bioresearch Monitoring FEI:
3012884265 Classification: OAI I confirm that Clarivate Analytics will be charged accordingly by FOI for this request,
A list of all FDA warning letters since 2000, including (1) posted date (2) letter issue date (3) company name (4) issuing
office (5) subject (6) closeout letter. A list contains information similar to that in FDA warning letters' website.
483: Magnolia Medical Technologies, Inc. Seattle, Washington United
States End Dates of inspection: 15 July 2021 Project Area: Compliance: Devices FEI: 3009976527 Classification: OAI I
483: Medtronic MiniMed. Northridge, California United States End
Dates of inspection: 07 July 2021 Project Area: Compliance: Devices FEI: 3003166194 Classification: OAI I confirm that
$ 200.
483: Mohammed Ansari Lubbock, Texas United States End Dates of
inspection: 16 September 2021 Project Area: Bioresearch Monitoring FEI: 3017424523 Classification: VAI I confirm that
$ 200.
the FDA FAERS database for efgartigimod alfa-fcab (brand name VYVGART).
I kindly request the administrative records for the following BNFs: BNF#135; BNF# 162 and BNF#157. Please include the
original submission, any questions from the agency and any additional information the developers provided.
All emails exchanged from February 15, 2022, to June 22, 2022, between Michele Mital and the office of Senator Dick
Durbin. Please limit the FOIA production to emails mentioning or referring to Juul, nicotine, e-cigarette, ENDS, and
vaping.
All emails exchanged from February 15, 2022, to June 22, 2022, between Michele Mital and the office of Congressman
Raja Krishnamoorthi.
All emails exchanged from February 15, 2022, to June 22, 2022, between Commissioner Robert Califf and the office of
Congressman Raja Krishnamoorthi.
All emails exchanged from February 15, 2022, to June 22, 2022, between Commissioner Robert Califf and the office of
Senator Dick Durbin.
-All investigative records produced or gathered by the FDA related to the investigation into Nephron Pharmaceuticals
(FEI: 3011158388) which resulted in the Applied 508 document issued on April 20, 2022 -All investigative records
produced or gathered by the FDA related to the investigation into Nephron Pharmaceuticals (FEI: 3011158388) which
resulted in the Warning Letter on Sept. 22, 2020 regarding Budesonide etc
Wondfo Product Involved in Import Alert 89-08
The 2020 annual report for the approved drug product Sotalol Hydrochloride Injection (NDA 022306) which was
AltaThera's 2020 annual report for the approved drug product Sotalol Hydrochloride Injection (NDA 022306) which was
Any and all records, documents, product warnings, complaints, or recalls regarding Parent's Choice unscented and
scented baby wipes that were previously sold at Walmart's nationwide. Walmart removed select lot numbers from their
stores due to a quality issue and provided refunds to purchasers.
I'd like to receive the form 483 document that Spok, Inc. received from the FDA for the inspection date 4/29/2022
(district: BLT-DO). I noticed that this was a recently requested form 483, so hopefully it is easily accessible now. Thank
you.
1) Listing of all INSPECTIONS since Thursday, July 1, 2021 (in CSV format) with the following fields: FEI Number,
FACTS database) for each company since Thursday, July 1, 2021 in CSV format with the following columns: etc
I would like a copy of the each government contract the US has with Pfizer to purchase Covid-19 vaccines. Including the
most recent one for $3.2 billion for 105 million doses of the Covid-19 vaccine that they say was signed on Wednesday,
June 29th, 2022.
Zoll Manufacturing Corporation - 121 Gamma Drive, Pittsburgh, PA 15238 Zoll LifeCor Corporation - 121 Freeport Road,
Pittsburgh, PA 15238 A) With respect to PMA P010030 / S011, the authenticated copy of the applicant’s submission
starting from “Table of Contents” and ending with “Marketing History”, totaling approximately seven (7) pages. ETC
The 2018 annual report for the approved drug product Sotalol Hydrochloride Injection (NDA 022306) which was
approved on 7/2/2009.
All information submitted to the FDA on the chemicals with the CAS Registration Number 69991-62-4.
Requesting a copy of Form 483 with respect to Cipla Ltd.'s ANDA filed for the product to be manufactured at its Indore
plant. The Pre-Approval Inspection was conducted from 27th June 2022 to 1st July 2022 and was closed with two
observations. Requesting a copy of the said observations.
Please may we order the following 12 Individual case safety reports. All have anakinra as suspect product. Please may
we receive only the database outputs of these reports, i.e. the ”FOIA Case Report Information”. We do not need any
other case data or source data etc. Case IDs: 9119377 9179360 10343212 11124713 ETC
Detention #1018682, which resulted in a seizure of all commodities listed on Entry 9L5-00493445.
Sartorius Korea Biotech Inspection Report The inspection was performed on May 18. 2022 ~ May 20. 2022 The name of
the investigator was Junho Pak
Importer of Record, or Consignee; for entry-lines with submission or arrival dates between June 1 and June 30, 2022:
1) DUNS Number / Unique Facility Identifier (UFI) of: 080801169 2) Federal Tax ID Number (EIN) of: 822349285 ETC
I'm looking for (1) establishment reports and (2) Form 483's issued as a result of inspections of facilities operated by
Bavarian Nordic in Denmark from the beginning of 2019 up through the date that your records search is conducted. If
it helps with your search, I think I am looking for records on FEI # 3008318564 and any other sites operated by the same
firm -- the manufacturer of the Jynneos vaccine -- in that country.
I request any all all records and correspondence associated with Adverse Event Report 3011011193-2019-00009
concerning an Endometrial Ablation Device (Model Number: MIN9770) that resulted in patient injury. Other identifying
information consists of: MDR Report Key 8725298 and MDR Text Key 148916493.
RE: J.M. Smucker Company, Lexington KY: Please supply FDA Form 483 (if issued), consumer complaints, incident
reports, lab results, and Establishment Inspection Report (if available) for inspection of this location pursuant to
investigation of Salmonella Senftenberg outbreak associated with Jif peanut butter products manufactured at the
above-specified facility.
All documents relating to P200040
all documents relating to 510(k) Number K190442 Device Name Koios DS for Breast
All records relating to 510k files for K212616 K212616 Trade/Device Name: Koios DS Regulation Number: 21 CFR
892.2060 Regulation Name: Radiological computer-assisted diagnostic software for lesions suspicious of cancer
Regulatory Class: Class II Product Code: POK, QIH
All files and documents relating to K213620 Trade/Device Name: ATUSA™ Automated 3D Breast Ultrasound System
Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulatory Class: Class
II Product Code: IYO, ITX
All documents & files for Device ID K202406 510k Number K202406 Device Name: Butterfly IQ Ultrasound
System Classification System, Imaging, Pulsed Doppler, Ultrasonic Applicant Butterfly Network, Inc. 530 Old
Whitfield Street Guilford, CT 06437
All files and docs for DEN170022 Trade/Device Name: QuantX Regulation Number: 21 CFR 892.2060 Regulation Name:
Radiological computer-assisted diagnostic (CADx) software for lesions suspicious for cancer Regulatory Class: Class II
Product Code: POK Dated: April 7, 2017
All files and records relating to K211678 Trade/Device Name: Lunit INSIGHT MMG Regulation Number: 21 CFR
892.2090 Regulation Name: Radiological computer assisted detection and diagnosis software Regulatory Class: Class II
Product Code: QDQ
All records on K173574 Trade/Device Name: DenSeeMammo Regulation Number: 21 CFR 892.2050 Regulation Name:
Picture Archiving And Communications System Regulatory Class: Class II Product Code: LLZ
All “Automated tables” including the VAERS daily table and VAERS weekly tables identified in Section 2.2 (2.2.1 and
2.2.2) of the VAERS Standard Operating Procedures for COVID-19.
All records concerning “Empirical Bayesian data mining” and “Empirical Bayesian Geometric Means” pursuant to Section
2.3 (2.3.2) of the VAERS Standard Operating Procedures for COVID-19. This should include, but not be limited to, any
communications between FDA and CDC “shar[ing] and ‘discuss[ing] results of data mining analyses and signals.” (See
Section 2.3.2)
All records related to Proportional Reporting Ratio (PRR) analyses performed “to identify AEs that are disproportionately
reported relative to other AEs” pursuant to Section 2.0, 2.3., and 2.3.1 of the VAERS Standard Operating Procedures for
COVID-19.
All “reports of possible concern based on the data mining results” the FDA shared with the CDC pursuant to section 2.5
of the VAERS Standard Operating Procedures for COVID-19.
All records (including, but not limited to, spreadsheets, emails, memoranda, slide decks, call or meeting transcripts or
recordings, etc.) related to any “Signal assessment” including but not limited to initial assessments, coordinated
response plans, and/or investigations conducted by the agency pursuant to Section 2.5 of the VAERS Standard
Operating Procedures for COVID-19.
All documents concerning crude reporting rates and calculations of same pursuant to Section 2.3.3 of the VAERS
Standard Operating Procedures for COVID-19. Information helpful to fulfilling the request: The FDA’s Center for
Biologics Evaluation and Research is the likely custodian of responsive records.
All Daily Priority Reports sent to the agency from the VAERS contractor “with a list of VAERS ID numbers for all serious
and non-serious reports of adverse events of special interest after COVID-19 vaccines” pursuant to Section 2.1 of the
VAERS Standard Operating Procedures for COVID-19.
All records concerning the investigation and identification of clusters of reports and of unexpected AEs as well as the
“list of lot numbers of vaccines that may be of concern” that were requested by the FDA, and the “summary of the data
review” provided to pertinent stakeholders as referenced in Section 2.4 of the VAERS Standard Operating Procedures
for COVID-19.
All records concerning meetings and conference calls referenced in Section 3.0 of the VAERS Standard Operating
Procedures for COVID-19. This should include but not be limited to calendar entries, audio or visual recordings,
transcripts, notes, and/or meeting minutes.
Copy of the disclosable portions of the MedWatch forms for the following 2 molnupiravir cases: 20993882, and
20987728.
483: NDAL Mfg Inc. Monterey, California United States End Dates
of inspection: 20 September 2021 Project Area: Drug Quality Assurance FEI: 3011219618 Classification: OAI I confirm
exceed $ 200.
483: Opus KSD, Inc. Pembroke, Massachusetts United States End
Dates of inspection: 12 November 2021 Project Area: Compliance: Devices FEI: 3011301103 Classification: VAI I confirm
exceed $ 200.
483: Packaging On Demand Inc San Clemente, California United States
End Dates of inspection: 18 October 2021 Project Area: Drug Quality Assurance FEI: 3004758248 Classification: OAI I
483: Q'apel Medical, Inc. Fremont, California United States End Dates of
inspection: 08 March 2022 Project Area: Compliance: Devices FEI: 3015614180 Classification: VAI I confirm that
$ 200.
483: RAY VISION INC. Lake Forest, California United States End Dates
of inspection: 17 December 2021 Project Area: Compliance: Devices FEI: 3013436538 Classification: VAI I confirm that
$ 200.
483: Sciegen Pharmaceuticals Inc Hauppauge, New York United States End
Dates of inspection: 20 December 2021 Project Area: Drug Quality Assurance FEI: 3008298016 Classification: VAI I
charges exceed $ 200
Copy of the disclosable portions of the Food Contact Notifications, including all correspondence and releasable FDA
chemistry, toxicology, and environmental review memoranda, for FCNs 38 and 419.
Information regarding Dr. Allan Bailey's 06/08/2022 presentation at the 2022 Spring Food Packaging Conference of
PLASTICS' Food, Drug & Cosmetic Packaging Materials Committee (see attached for details).
Correspondence regarding the FDA’s official issuance of its marketing denial order for Juul Labs, Inc.’s premarket
tobacco product applications, and documents related to any communications regarding the same. Please see attached
for details.
Requesting a copy of Form 483 issued to Glenmark Pharmaceuticals Ltd.'s formulation manufacturing facility based out
of Aurangabad, India. The inspection was conducted between June 27 to July 1, 2022 and was closed with one
observation.
2022-3089, 2022-3096, 2022-3108, 2022-3195, 2022-3230.
2022-3263, 2022-3344, 2022-3346, 2022-3353, 2022-3398.
483: Macleods Pharmaceuticals Limited
Tehsil Baddi, District Solan, India End Dates of inspection: 01 November 2021
Project Area: Drug Quality Assurance FEI: 3007517881 Classification: OAI I confirm that Clarivate Analytics will be
483: Lupin Limited Vasco Da Gama
India End Dates of inspection: 18 Sep 2021 Project Area: Drug Quality Assurance
FEI: 3004819820 Classification: VAI I confirm that Clarivate Analytics will be charged accordingly by FOI for this request,
FCN 2149 Chemistry & Toxicology Review Memoranda.
Information regarding certain food sample collection reports and analytical results from the FDA Office of Regulatory
Affairs (ORA). Specifically, please provide such information for all samples of the meal replacement drink identified as
“Reference #1060” on the Coordinated Outbreak Response and Evaluation (CORE) Investigation Table.
We request a spreadsheet identifying the firms that received FDA Warning Letters between October 1, 2011, and July 1,
2022 or the most recently available date, to include the following: Company FEI; Company Name; etc
violation and the frequency in which they were observed between December 20, 2017 and June 30, 2022 (or the most
recently available date for 2022).
Address (Line 1), and Address (Line 2) for each inspection that occurred between October 1, 2011 and June 30, 2022 (or
the most recent available date).
Enforcement Reports
We request a spreadsheet which includes the 23 publicly available data points for all entries that led to our company's
inclusion in this list as of 6/30/2022 or the most recently available date.
all TJX Brands - HomeGoods, HomeSense, Marshalls, Sierra, TJ Maxx, on FDA's list. If possible, please include the FEI
number for each of the 9 entities above as a column in the spreadsheet.
We request a spreadsheet which includes the 23 publicly available data points for all entries that led to the inclusion
of the following companies in this list in 2019: Nestle USA, Inc (DUNS number 00-825-6224), Nestle Professional (DUNS
number 09-014-5707), etc
Inc.'s inclusion in this list for the last 60 days.
since Monday, May 30, 2022. If the zipped files do not exceed 25 Megabytes, please send to support@fdazilla.com,
otherwise please send these on CD or DVD media to: Govzilla Inc., 9800 Dunmore Circle Johnston, IA, 50131
Please feel free to contact us (support@fdazilla.com, 1-844-332-3320) to discuss any questions or issues which may
result prior to or during the processing of this request.
Request for form 483 issued with respect to recent USFDA inspection at Pithampur (FEI: 3008581988) site of Cipla
Any records pertaining to the FDA approved feed assay methods for drugs with a bentonite cautionary statement in 21
CFR 558 (amprolium, carbadox, decoquinate, morantel, pyrantel, robenidine, thiabendazole, tilmicosin, and tylosin)
including assay methods for specific species and type of feed (i.e., Type B and Type C medicated feed) if more than one
method exists per drug.
LIST OF INSPECTIONS APIs
Please see attached letter. The audio recording of the May 27, 2011, oral history interview of Robert Temple and
Robert O’Neill.
Please see attached letter. • Any internal or external FDA guidance concerning FDA’s standard of review for evaluating
whether proposed drugs have a clinically meaningful therapeutic effect. • etc
Please see attached letter. • Any internal training materials (or other documents prepared for use by FDA reviewers)
concerning or discussing evaluation of a proposed drug’s clinically meaningful therapeutic effect. • Any internal training
materials (or other documents prepared for use by FDA reviewers) concerning or discussing evaluation of a proposed
drug’s clinically and/or statistically significant beneficial effect. • etc
This is a request under the Freedom of Information Act. I request that a copy of the following documents [or documents
containing the following information] be provided to me: 1. All records for ENTRY ASE-0010855-5 including images,
videos, emails, notes, phone logs, warehouse visit logs, List of FDA personnel providing examination and expert
opinions, and the complete Official FDA records. etc
Hi there, I'm looking for all records of inspections at Beyond Meat facilities, including notes, emails, appointments,
reports, etc. within these dates. I'd like Form 483s as well as Establishment Inspection Reports. I am looking for records
regarding the company's plants in Missouri and Pennsylvania. Please be in touch ASAP. Thank you, Deena
Hi, I am requesting all inspection records for Beyond Meat facilities, including in Missouri and Pennsylvania, in the above
timeframe. I am looking for emails, notes, reports, and anything else that might inform the public about why inspections
were performed and what was found. I am look for Forms 483 and Establishment Inspection Reports, as well as any
other records that describe what was found. Thank you, Deena
“Design of Clinical Trials,” authored by Robert Temple on November 12, 2013 removal from website
2021-2041
Oxbryta, Ingrezza, Nuplazid, Lupkynis, Orladeyo, Onpattro, Wakix, Tyvaso, Tavneos, Voxzogo, Pyrukynd, Skytrofa,
Vyvgart AERS
prescribing information for extended-release oxycodone from 1995.

Can you please provide FDA's unredacted review reports for Dayvigo (lemborexant), which was approved on 20
December 2019
Taylor Research Group (“TRG”) herby requests a copy of the transparency summary issued by the U.S. Food and Drug
Administration (“FDA”) in connection with the De Novo approval of the Hominis Surgical System.
Inspections of the Nutra Solutions USA, Inc. facility located at 1019 Grand Blvd, Deer Park, New York in 2017, 2018,
2020, and 2021, including all FDA Form 482, FDA Form 483, and any affidavits that may have been issued as a result of
these inspections; ETC
Dear Madam/Sir, We are seeking the 510k submission documents for K172044.
Medical Device Master File #1330 t
Under CFSAN, please provide the consumer complaint on June 10, 2022 related to cronobacter and a situation that
resulted in an infant death in January 2022 that is referenced here: https://www.fda.gov/news-events/press-
announcements/fda-provides-update-efforts-increase-supply-and-availability-safe-and-nutritious-infant-formula
Please see attached PDF for case identifiers. We are requesting individual case reports for twelve Case ID numbers
retrieved from the FAERS dashboard. Thank you.
1. Records relating to Florida’s SIP proposal. 2. Records relating to Canadian drug importation programs, including SIP
proposals, for the following states: Colorado, New Mexico, New Hampshire, Vermont, and Maine ETC
Please provide CSV files with the following information: (1) Listing of all inspections between January 1, 2000 and
December 31, 2021 in CSV format that includes the following fields: FEI Number, Inspection Start Date, Inspection End
Date, Legal Name, Address, City Name, State Code, Zip Code, Country Name, FDA483, Full Name, District, Center,
Inspection Reason, Inspection ID ETC
The US House Committee on Energy and Commerce (CEC) letter to the FDA on 20-May, asking questions on drug
applications from China and data quality from China sites.
I wish to receive a copy of the current version of the Blood Establishment Registration Database maintained by the FDA
(https://www.fda.gov/vaccines-blood-biologics/biologics-establishment-registration/find-blood-establishment,
https://www.accessdata.fda.gov/scripts/cber/CFAppsPub/). Thank you.
FAERS REPORT
Documents related to Custom Pet SAS salmonella products in Import Alert 72-03 ETC
We require list of ALL products approved under DESI (Drug Efficacy Study Implementation) Program with application
number and Company name. Kindly send us in an excel file.
Any/all inspection reports (including issued citations) for Big Olaf Creamery LLC dba Big Olaf (FEI Number 3004654033)
from 01/01/2012 to present. Any/all environmental inspections and assessments stemming from the 2022 outbreak of
Listeria moncytogenes.
FDA Reviews for March 2022 MRGO for IQOS 3.0 sMRTPA MR 0000192. Please see attached.
124 voluntary reports and the Manufacturer Report Numbers for the reports submitted by Philips
Copy of 510(k)# K031799, Miele Dental Thermal Disinfector, Model G7881
McGuff Compounding Pharmaceutical Services (CPS) hereby requests: Copies of the FDA Closeout Letter from a
Warning Letter that was issued to McGuff CPS on November 13th, 2015(attached), and all FDA Closeout Letters
resolving Form 483 Notifications issued in 2014 (attached).
Copies of Form 483s issued by the CDER Office in May 1-31, 2022.
The 483 (in electronic format) for Human Drugs inspection of ZENG, XIAOFENG ending 03/11/2013 at the location in
BEIJING, CHN. The EIR (in electronic format) for Human Drugs inspection of ZENG, XIAOFENG ending 03/11/2013 at the
location in BEIJING, CHN. The Response (in electronic format) for Human Drugs inspection of ZENG, XIAOFENG ending
03/11/2013 at the location in BEIJING, CHN. Please send documents as email attachments.
The EIR (in electronic format) for Human Drugs inspection of Aetna Felt Corporation ending 05/13/2021 at the location
in Allentown PA, United States. The Response (in electronic format) for Human Drugs inspection of Aetna Felt
Corporation ending 05/13/2021 at the location in Allentown PA, United States. The EIR (in electronic format) for Human
Drugs inspection of Gateway Analytical, LLC. ending 01/15/2015 at the location in Gibsonia PA, ETC
Outset Medical Inc shipment hold on home hemodialysis device, Tablo - any documents, including email
correspondences within the FDA and with Outset related to Tablo's shipment hold and human factors testing.
The EIR (in electronic format) for Human Drugs inspection of OraLabs, Incorporated ending 07/13/2018 at the location
in Parker CO, United States. The Response (in electronic format) for Human Drugs inspection of OraLabs, Incorporated
ending 07/13/2018 at the location in Parker CO, United States. Please send documents as email attachments.
The EIR (in electronic format) for Medical Devices & Rad Health inspection of OraLabs, Incorporated ending
05/28/2019 at the location in Parker CO, United States. The Response (in electronic format) for Medical Devices & Rad
Health inspection of OraLabs, Incorporated ending 05/28/2019 at the location in Parker CO, United States. Please send
in the month of June 1 to 30, 2022, including for any inspections dated before May 1, for: • Pharmaceutical, biologics
and medical device manufacturing facilities, including premarket approval inspections; AND • etc
Copies of Form 483s issued by the CDER Complex Office in May 1-31, 2022.
Copies of Form 483s issued by the CDRH Office in May 1-31, 2022.
Copies of Form 483s issued by the CBER Office in May 1-31, 2022.
(Rq#1) Copies of Form 483s issued to the following CLINICAL INVESTIGATOR from May 1-31, 2022:
(Rq#2) Copies of Form 483s issued to the following CLINICAL INVESTIGATOR from May 1-31, 2022:
(Rq.#1) Copies of Form 483s issued to the following DEVICE companies from May 1-31, 2022.
(Rq.#1) Copies of Form 483s issued to the following DRUG companies from May 1-31, 2022.
(Rq.#2) Copies of Form 483s issued to the following DRUG companies from May 1-31, 2022.
Report and/or the MDSAP Noncomformity Grading and Exchange Form (NC) for the inspection of Eizo Corporation,
Hakusan, Japan, end date 08-03-2017. FEI# 3000237660. This inspection pertains to medical devices.
Report and/or the MDSAP Noncomformity Grading and Exchange Form (NC) for the inspection of TORAY INDUSTRIES,
INC. SETA PLANT, Otsu, Japan, end date 07-21-2017. FEI# 3002808331. This inspection pertains to medical devices.
510(k) submission for K002970 for device named "SUBDURAL EVACUATING PORT SYSTEM, MODEL 11-9901" We are
seeking to identify the animal model/testing used to determine substantial equivalence.
Report and/or the MDSAP Noncomformity Grading and Exchange Form (NC) for the inspection of Boditech Med, Inc.,
Chuncheon, Korea, end date 07-14-2017. FEI# 3009491259. This inspection pertains to medical devices.
Report and/or the MDSAP Noncomformity Grading and Exchange Form (NC) for the inspection of SD Biosensor,
Chungcheongbuk-du, Korea, end date 12-09-2016. FEI# 3008959428. This inspection pertains to medical devices.
Copy of the 483 for the 02/21/2022 - 02/25/2022 inspection of Robert Joseph Jeanfreau, MD [Metairie / United States
of America] 3800 Houma Blvd #345, Metairie, LA 70006, USA. This inspection pertains to HUMAN DRUGS
Copy of the 483 for the 02/22/2022 - 02/25/2022 inspection of Adam Sun, M.D [Rosemead / United States of America]
7403 Hellman Ave, Rosemead, CA 91770, USA. This inspection pertains to HUMAN DRUGS
Copy of the 483 for the 02/24/2022 - 03/03/2022 inspection of Lucky Flores, M.D. [Miami Lakes / United States of
America] 8181 NW 154th St #290, Miami Lakes, FL 33016, USA. This inspection pertains to HUMAN DRUGS
Copy of the 483 for the 02/22/2022 - 03/04/2022 inspection of HMS Veterinary Development Inc [Tulare / United States
of America] 3346 Ave 248, Tulare, CA 93274, USA. This inspection pertains to ANIMAL HEALTH
5066.
3406.
On behalf of Lupin Pharmaceuticals, Inc. I request you to please provide me with the latest Tentative approval (TA)
letter” of Apotex’s ANDA #203640 for Nilotinib hydrochloride capsules which is approved on 06/10/2022.
510(k) for K152848, Autolap System, by MST Medical Surgery Technologies.
all inspection related documents (483, EIR, company correspondence) for Miller's Pharmacy (FEI: 3004600183) Millers
of Wyckoff, Inc. 678 Wyckoff Avenue Wyckoff, NJ 07481-1430
Any and all publicly available documents regarding 510(k) No. BK190317 (PurePRP Supraphysiologic Concentrating
System, EmCyte Corp., decision date 02/12/2020), including but not limited to the complete premarket notification
submission and all attachments.
Hello, Please provide all preliminary, interim, and finalized memorandums and reports from CBER regarding COVID-19
vaccine administration to children under the age of 5.
Center for Devices and Radiological Health, Office of Regulatory Affairs, and/or Office of the Commissioner: Records &
correspondence with Michael Mina regarding SARS-CoV-2 Testing. Please see attached for details.
Center for Devices and Radiological Health, Office of Regulatory Affairs, and/or Office of the Commissioner: Records
regarding SARS-CoV-2 testing. Please see attached for details.
Please provide all documents, including e-mails, relating to the FDA's decision that it will not require companies to
submit clinical trial data on COVID-19 vaccines modified to protect against the BA.4 and BA.5 versions of Omicron in
order to authorize those shots.
For reference, this issue was reported by Reuters in its conversation with Dr. Peter Marks.
Link: https://www.reuters.com/legal/government/fda-will-not-require-clinical-trial-data-authorize-redesigned-covid-
boosters-2022-06-30/
Center for Devices and Radiological Health, Office of Regulatory Affairs, and/or Office of the Commissioner:
Correspondence with media regarding Covid testing, etc. Please see attached.
Purple Book information about patents and exclusivities of biologics.
All information concerning FDA inspections conducted at any ASPIRUS KEWEENAW ENTERPRISES, INC. facility in the
state of Michigan for the period January 1, 1998 through present, including, without limitation, any Form 483
Inspectional Observations, Establishment Inspection Reports and/or Warning Letters.
ALL FORM 483, EIR, RESPONSE LETTERS, AND ANY OTHER COMMUNICATIONS WITH THE FDA BY/FOR QUAGEN PHARMA
LOCATED AT 11 PATTON DRIVE, WEST CALDWELL, NJ 07006 AND 34 FAIRFIELD PLACE, WEST CALDWELL, NJ 07006 AND
35 FAIRFIELD PLACE, WEST CALDWELL, NJ 07006 AND 37 FAIRFIELD PLACE, WEST CALDWELL PLACE 07006
All records provided by the FDA in response to FDA FOIA Requests #2021-6767 and #2021-8418.
We hereby request the releasable portions of Food Additive Master File (FAMF) 137 as well as the U.S. Food and Drug
Administration’s (FDA) review memoranda and correspondence associated with FAMF 137, including all Toxicology and
Chemistry memoranda associated with this file.
I would like all records provided for 2022-3220, which is all inspection documents for FDA inspection of OC Raw Dog LLC,
located at 1500 Commerce St., Ste. A #101 Corona, CA 92880-1715 01.01.21-12.31.21
Premarket approval (PMA) P200044, LungFit PH, nitric oxide generator and delivery system, decision date June 28, 2022
(applicant—Beyond Air, Inc.)
All transcripts, exhibits, and agency decisions or guidance that relates to the Part 15 public hearing held on September
11, 1997. in "Benzodiazepines and Related Substances; Criteria for Scheduling Recommendations Under the Controlled
Substance Act; Notice of Public Hearing Modification" described at 62 Fed. Reg. 33418 and 62 Fed. Reg. 45667.
1. Any and all correspondence or communications between the FDA and Medtronic relating to manufacture, design,
safety, defects, recalls, CAPAs, field safety notifications, medical device corrections, or labeling of Medtronic’s 630G and
670G infusion pump systems (P150001 and P160017), from 2018 to present. ETC
I would like to request any additional documentation available for GRAS Notice No. GRN 000976 - Sodium hyaluronate.
Specifically, I seek all correspondence between the U.S. FDA and the Notifier (Bloomage Biotechnology Corp., Ltd.) or
their Agent GRAS Associates LLC, such as email correspondence, meeting minutes etc. that are not currently posted in
the GRAS Notices Inventory.
I would like to request the Establishment Inspection Report from the most recent Inspection of the Medtronic, Inc.
Philadelphia Distribution Center 1130 Commerce Blvd facility registration number 3007026906. The inspection started
on 17 August 2021 and concluded on 18 August 2021.
the FDA’s evaluation of AbbVie’s Rinvoq sNDAs;

• the FDA’s evaluation of Pfizer’s Xeljanz;
• the FDA’s evaluation of Eli Lilly’s Olumiant; ETC
all investigative records concerning Outliers, Inc. (dba Thesis), located at 902 Broadway, Floor 6, New York, New York,
from January 1, 2017 to today. This company sells nootropics supplements through the website takethesis.com.
Requesting FOI for Sodium phosphates Injection RLD: Sodium phosphates injection in plastic containers NDA no: 018892
Applicant holder: Hospira
Full K201758 submission Q-submissions related to K201758 AI requests related to K201758

Request ORPHAN DESIGNATION Application (FORM 4035), review and all amendments for Trade Name Amondys 45
from Sponsor Sarepta Therapeutics with date designated 6/4/2019.
Copies of all documents, such as e-mail communications, memoranda, and notes, and other material in the
administrative record which describe or are the subject of the FDA assessment by ORA, CDER and CBER of complaints
received that Revive Rx Pharmacy (FEI 3016710945) is operating under insanitary conditions ETC
We hereby request the following documentation and appreciate your support: Original Investigational New Drug
Application (Serial No. 0000) for Sponsor British Biotech Inc. for the use of Marimastat (BB-2516) for the treatment of
cancer and all associated amendments and annual reports during the requested time.
Full K201832 submission Q-submissions related to K201832 AI requests related to K201832
Full K023984submission Q-submissions related to K023984 AI requests related to K023984
Looking for all EIRs and 483s for the following potential manufacturers regarding Arcutis Biotherapeutics' ARQ-151
(topical roflumilast). The possible manufacturing facilities are: 1.) DPT Laboratories - Possible addresses are 5303
Distribution Drive, San Antonio, TX 78218 (FEI:1000117684); 307 E. Josephine Street, San Antonio, TX 78215
(FEI:1628114); or 3300 Research Plaza, San Antonio, TX, 78235 (FEI:832224690). 2. Interquim, S.A. - possible address is
C/ Joan Buscalla 10, Sant Cugat del Valles (BA), 08173, Spain (FEI:3002807304)
Looking for all EIRs and 483s for the following potential manufacturers regarding Veru Inc's sabizabulin (VERU-111): 1.)
CoreRx in Clearwater, FL (possible street addresses: 14501 58th St, 5733 Myerlake Circle, 5777 Myerlake Circle, or 14205
Myerlake Circle) (FEI: 3007209985); 2.) Olon Ricerca Biosciences at 7528 Auburn Rd, Painesville, OH (possible FEI:
3013648152); 3.) Safetec of America at 887 Kensington Ave, Buffalo, New York (FEI: 1319744); 4.) Patheon
Pharmaceuticals at 2110 E Galbraith Rd, Cincinnati, Ohio (FEI: 1510437)
We are requesting the approved labels for NDA 020449, Taxotere, Docetaxel under Action DAte 04/27/2022, SUPPL-85,
and Labeling-container/carton labels. Labels are needed to keep our ANDA updated to date with the changes made
under this supplement. Please provide the labels via email due to remote working conditions.
Requesting a copy of form 483 with two observations issued to Dr Reddy's Laboratories Ltd post completion of a
completed a Pre-Approval Inspection (PAI) at their formulations manufacturing facility FTO 11 in Srikakulam, Andhra
Pradesh between 30th June, 2022 to 7th July, 2022.
I request you to send please me form 483 for the Inspection held for company name CIPLA located in India Indore
I request you to send please me form 483 for the Inspection held for company name Dr.Reddys located in India Andhra
Pradesh Srikakulam plant
Product name: Nexium 24HR; ANDA Number: 204655, Applicant: ASTRAZENECA LP Manufacturing (CMC): All
supplements; CLINICAL PHARMACOLOGY AND BIOPHARMACEUTICS REVIEW(S); CHEMISTRY REVIEW(S)
Please release the records for Class 1 IVD device by Trajan Scientific Australia PTY LTD for Hemapen (D254956) in order
to determine substantial equivalence of the device. I am seeking all the records pertaining to device (D254956)
including substantial equivalence rationale, SE comparison, and summary Thank you.
1.The first page (i.e., Face Page) of the current contract award, and first 15 pages of the Performance Work Statement
or Statement of Work for the existing contract # 75F40121C00197
https://www.fpds.gov/ezsearch/search.do?
q=75F40121C00197&s=FPDS.GOV&templateName=1.5.2&indexName=awardfull&sortBy=SIGNED_DATE&desc=Y
ETC
Any records pertaining to the food additive petition filed by Phillips Petroleum Co. regarding Pichia Pastoris Dried Yeast
as an additive in animal feeds (FAP 2207) and any other relevant records related to promulgation of 21 CFR §573.750
Pichia pastoris dried yeast [58 FR 59170, Nov. 8, 1993].
I'm looking for all EIRs and 483s for the Serum Institute of India Private Limited (SIIPL) at either of the following
addresses: 1.) 212/2 Hadapsar, Pune, Maharashtra 411028, India (FEI: 3004211038); or 2.) S. No. 105-110, Manjari BK,
Pune Zone 3, Pune, Maharashtra 412307, India (FEI:3020223359), with regards to Novovax's Covid Vaccine (NVX-
CoV2373).
format) for Human Drugs inspection of Excell Research ending 01/31/2020 at the location in Oceanside CA, United
for Human Drugs inspection of Clario Inc. ending 01/10/2022 at the location in Princeton NJ, United States. The EIR (in
electronic format) for Human Drugs inspection of Clario Inc. ending 03/04/2022 at the location in Princeton NJ, United
States. The Response (in electronic format) for Human Drugs inspection of Clario Inc. ending 03/04/2022 at the location
in Princeton NJ, United States. Please send documents as email attachments.
I am an investment professional for an asset management firm and would like to request any 483s issued for inspections
occurring from 04/01/2022 to 07/08/2022 for Ivers-Lee AG located at Kirchbergstrasse 160, Burgdorf, BE 3400,
Switzerland
for Human Drugs inspection of Massachusetts General Hospital RDRC ending 08/16/2013 at the location in Boston MA,
for Foods & Cosmetics inspection of Lyne Laboratories, Inc. ending 09/08/2021 at the location in Brockton MA, United
The EIR (in electronic format) for Human Drugs inspection of LNK International, Inc. ending 02/08/2019 at the location
in Hauppauge NY, United States. The Response (in electronic format) for Human Drugs inspection of LNK International,
Inc. ending 02/08/2019 at the location in Hauppauge NY, United States. The EIR (in electronic format) for Human Drugs
inspection of LNK International, Inc. ending 07/01/2021 at the location in Hauppauge NY, United States. The Response
(in electronic format) for Human Drugs inspection of LNK International, Inc. ending 07/01/2021 at the location in
Hauppauge NY, United States. Please send documents as email attachments.
I'm looking for all EIRs and 483s for the Novovax manufacturing facilities at either of the following addresses: 1.) 700
Quince Orchard Road, Gaithersburg, MD; 2.) 21 Firstfield Road, Gaithersburg, MD with regards to Novovax's Covid
Vaccine (NVX-CoV2373).
I am interested in any and all information regarding magnetic resonance spectroscopy, when it was approved, and its
FDA-approved uses (FDA reference No. E-2009-011).
Seeking records on the medical device approval of a dental appliance known as an Anterior Growth Guidance Appliance.
Also any records related to seeking approval for this device, or the rejection or withdrawal of approval for the device.
We believe the device was designed by and would have been submitted by Steve Galella, DDS and/or OrthoMatrix
Corporation. We also believe the device to be manufactured by John's Dental Laboratory, Inc.
FDA NDC product and package files from CDER
Please provide the results for the following CV/Resumes from 01-01-2010 to current, in electronic pdf format as email
attachments delivered to mandy.haacker@redica.com. May each CV/Resume be delivered in individual pdfs. If the files
are too large for delivery as email attachments, then please send in a ZIP file, Box.com.
2022-2457, 2022-3185, 2022-3999
2021-7151, 2022-2732, 2022-2751, 2022-2780, 2022-2850.
2022-2856, 2022-2857, 2022-2858, 2022-2859, 2022-2884.
2022-2995, 2022-3001, 2022-3002, 2022-3079, 2022-3083.
Form 483 for -Dr Reddys Srikaukulam Formulation plant -Glenmark Aurgangabad Facility
K191272
I am seeking the Establishment Inspection Report (EIR) for an inspection conducted from 3/21/2022 to 4/21/2022. The
inspected entity was Natalia S. Hegedosh, M.D., Clinical Investigator (Global Research Solutions, 8300 W Flagler St, Ste
252A, Miami, FL 33144-6002)
ALL FOREIGN SUPPLIER VERIFICATION PROGRAM (FSVP) RECORDS RELATED TO SPROUT’S FARMERS MARKET, SPROUTS
FARMERS MARKET, AND SPROUTS FARMERS MARKET LLC ARIZONA WAREHOUSE.
K212981
Summary Basis of Approval for NDA 022388, ACUVUE THERAVISION WITH KETOTIFEN.
FDA 483s for PAI inspection conducted between 06/06/2022 - 06/30/2022 for... Laboratorios Farmacicos ROVI, S.A. dba
ROVI Pharma Industrial Services Avda. Catalunya N1, 28703, San Sebastian de los Reyes (Madrid) and, Julian Camarillo,
35, 28037 Madrid
COVID VACCINE ADVERSE EVENT REPORTS
COPY OF 7/1/22 LETTER, COPY OF 2022-3137, ORGANIZATIONAL CHART
I am looking for a Citizen's Petition filed by Theresa McGovern, Martha Davis, and Alma Gomez
on December 15, 1992 regarding the Clinical Evaluation of Drugs.
E. coli outbreak associated with Josie’s Organics baby spinach
LIST OF COMPANIES PUTTING NANO CHIPS IN FOOD
RECS FROM MEETING WITH AIDS BUYERS CLUBS
I'm looking for all EIRs and 483s for the Novovax manufacturing facilities at any of the following addresses: 1.) Fujifilm
Diosynth Biotechnologies (FDB) at either 100 Discovery Dr, Suite 200 NCTM, College Station, TX 77845
(FEI:3011948449), 6051 George Watts Hill Drive, Research Triangle Park, North Carolina 27709 (FEI:3000718852), or
Belasis Avenue, Billingham TS23 1LH, UK (FEI:3007182567);ETC
Subject: REVEX (Nalmefene Hydrochloride) Injection Artworks – NDA 020459
Approval package for Avapritinib in AdvSM

We request a copy of the Approval package for Avapritinib in AdvSM, from the sNDA of AYVAKIT (avapritinib) in
Advanced Systemic Mastocytosis (AdvSM) that received full approval on Jun 16, 2021.
We request a copy of the Orphan Drug Application for Avapritinib in AdvSM, from the sNDA of AYVAKIT (avapritinib) in
Advanced Systemic Mastocytosis (AdvSM) that received full approval on Jun 16, 2021.
We request copies of Administrative Correspondences associated with the Avapritinib in AdvSM submission, from the
sNDA of AYVAKIT (avapritinib) in Advanced Systemic Mastocytosis (AdvSM) that received full approval onJun 16, 2021.
483 issued to Schott AG by CDRH Medical Device in Germany Previous FOIA request 2019-9586
All documents pertaining to Conagen and lactoferrin. These pertaining documents may include but are not necessarily
limited to: communications and materials between Conagen and the agency in the form of a consultation or pre-
submission meeting, any follow-up or additional communications or materials, and any information developed by FDA
regarding Conagen and lactoferrin such as FDA review memoranda.
Full submission of K972699
Copy of the disclosable portions of the following three attachments for HHSF223201510022B: ATTACHMENT 03- RPS
Implementation Roadmap, CTP date unknown; ATTACHMENT 14- End to End MRTPA Review Process Model; and
ATTACHMENT 15- PMTA-MRTPA-SE Exemption Review Process Model. Please see attached for document these
attachments were referenced in.
Tentative approval letter for ANDA 214547, lisdexamfetamine dimesylate, by Norwich, tentatively approved on
6/21/2022.
Fluid Milk Produced in PA Fluid Milk Processed in PA Fluid Milk Sold in PA Fluid Milk Exports I hope to obtain the data
that meets the above criteria combined, individually, or in any combination Seeking fluid Milk Supply chain in and out
of the Commonwealth.
Regarding the marketing denial orders (MDOs) issued by FDA Center for Tobacco Products 6/23/2022 to JUUL Labs Inc.
for all of their tobacco products currently marketed in the United States (see https://www.fda.gov/news-events/press-
announcements/fda-denies-authorization-market-juul-products), I request: 1) copy of the decision summary supporting
FDA's 6/23/2022 MDO letter. ETC
1. All documents, reviews, correspondence, and adverse evert reports relating to and supporting the information
provided in FDA's Drug Safety Communication, dated January 9, 2015, regarding possible risks of pain medicine use
during pregnancy. ETC
Records of Emergency Use Authorizations that fit any of the below criteria: Related to ADHD treatments Blind case
studies Relevant to a single, or two individuals only
I request all data regarding the safety and efficacy of the Moderna vaccine leading to its emergency use approval.
All EIR reports for Nephron Pharmaceuticals (FEI # 3011158388) for responsive timeframe. This submission is in
response to the note sent regarding request FDA22084757 asking for a timeframe.
Hello, I am requesting a copy of your abbreviated new drug application and or letter for Betaxolol Hydrochloride
Tablets USP, 10 mg and the Label for the Betaxolol Hydrochloride Tablets USP, 10 mg for Amide Pharmaceutical and or
EPIC PHARMA. etc
Pursuant to FOIA, please provide the following records in electronic form to johnbyrnefoia@gmail.com: Emails received
by or sent by HHS Secretary Xavier Barcera containing the search term "monkeypox," redacted only as permissible by
law. Emails received by or sent by HHS Assistant Secretary for Public Affairs Sarah Lovenheim containing the search
term "monkeypox," redacted only as permissible by law. etc
Emails sent or received by FDA Commissioner Robert M. Califf the search term containing the search terms
"monkeypox," "JYNNEOS," or "Bavarian Nordic" redacted only as permissible by law. Emails sent by FDA media relations
staffers Michael Felerbaum, Daniel Hetlage, etc
I would like information on the data that was used by the FDA to approve Sequential Compression Devices for home use
for the treatment of clotting disorders. Specifically, I would like the data that shows the effectiveness of the product in
reducing clotting events.
All records and documents associated with review and clearance of pre-market notification K213037
We are the new holder of the NADA 141217, submission history was not transferred from the former owner to us, we
hereby request for a copy of the application for NADA 141217 from FDA's files.
Privacy Act Reports
for Human Drugs inspection of OraLabs, Incorporated ending 01/10/2020 at the location in Parker CO, United States.
The Response (in electronic format) for Human Drugs inspection of OraLabs, Incorporated ending 01/10/2020 at the
location in Parker CO, United States. Please send documents as email attachments.
for Human Drugs inspection of Humco Holding Group, Inc ending 03/13/2020 at the location in Texarkana TX, United
States. The Response (in electronic format) for Human Drugs inspection of Humco Holding Group, Inc ending
03/13/2020 at the location in Texarkana TX, United States. Please send documents as email attachments.
for Foods & Cosmetics inspection of Naturally Nutty Foods, Inc. ending 01/27/2022 at the location in Williamsburg MI,
United States. The EIR (in electronic format) for Foods & Cosmetics inspection of Naturally Nutty Foods, Inc. ending
01/27/2022 at the location in Williamsburg MI, United States. The Response (in electronic format) for Foods &
Cosmetics inspection of Naturally Nutty Foods, Inc. ending 01/27/2022 at the location in Williamsburg MI, United States.
format) for Foods & Cosmetics inspection of Stir Foods, LLC. Dba Pacifica Foods LLC ending 07/26/2019 at the location in
Corona CA, United States. The Response (in electronic format) for Foods & Cosmetics inspection of Stir Foods, LLC. Dba
Pacifica Foods LLC ending 05/06/2022 at the location in Corona CA, United States. Please send documents as email
attachments.
2022-1725, 2022-1726, 2022-1727, 2022-1728
A full copy of all of the records provided in response to FOIA requests with the following control numbers: 2022-2925,
2022-4370, 2022-2485.
Under FOIA, I am requesting all correspondence (the initial request and any responsive documents provided by FDA) for
closed FOIA case numbers 2022-3677 and 2020-6536. Please let me know if you have any questions.
JUUL MDO
REG LOGIC PM0000529
NJOY PM0000613
NJOY PM0000630-31
Thompson Hine LLP, on behalf of its client Shenzhen YouMe Information Technology Co. (“the company”) is requesting
the entirety of the following premarket tobacco applications previously submitted by the company: PM0000881;
PM0000884; PM0000885; and PM0000886.
On behalf of the notifier, we are seeking unredacted copies of the U.S. Food and Drug Administration’s (FDA) review
memoranda and related correspondence for Food Contact Notification (FCN) 2223 (a reactive mixture of ethylene
acrylic acid copolymer (EAA; CAS Reg. No. 9010-77-9) and N,N,N',N'-tetrakis(2- hydroxypropyl)adipamide (HAA; CAS Reg.
No. 57843-53-5)).
VUSE PM0000551-53-60
VUSE PM0000635
RECS RE JOHNSTON COUNTY HAMS OUTBREAK
For RLD Cabenuva NDA#212888, Chemistry reviews, Medical reviews, pharmacology reviews, clinical pharmacological
biopharmaceutics reviews, administrative correspondence documents. More specifically, information to understand the
function of excipients in drug product.
I request all records that were released in response to the previous request 2022-4512 filed on June 21. Thanks
a log of all FOIA requests received by the Food and Drug Administration since Jan. 1, 2021.
K183230 K190225
Any and all documents pertaining to the premarket notification K201418 for the Sunset Heated CPAP Tube marketed by
Sunset Healthcare Solutions, Inc.
the postmarketing adverse events reported to the FDA Adverse Event Reporting System as follows: 17467751;
17469779; 17470526; 17470530; 17470612; 17479490; 17480668; 17480669; 17480684; 17480685; 17482246;
17483850;
K190898, copy of 510(k) for K190898, Sight OLO Hematology Analyzer, manufactured by Sight Diagnostics Ltd.
K143577, copy of 510(k) for K143577, Sysmex XW-100 Hematology Analyzer, manufactured by Sysmex America Inc.
CW170012, Copy of CLIA Waiver application for Sysmex XW-100 Automated Hematology Analyzer, manufactured by
Sysmex America Inc.
Request for complete application for ANDA 088786 for Sodium Polystyrene Sulfonate USP (Powder), 453.6 GM/Bot
INAD 013-347, INAD 011-911 and several submissions related to seeking a sponsor fee waiver for use in cattle (no
INAD).
We are requesting the 483, EIR, and 483r for the following inspection: Inspection Site Name: Novo Nordisk (FEI
Number: 1000158576) Inspection Site Address: 3612 Powhatan Rd, Clayton, NC 27527, USA Inspection Dates: May 9,
2022 - May 13, 2022 (5 days); 483 issued etc
ANDA 212296; Company: SLAYBACK PHARMA LLC Can you provide me any information on this approval? I am
particularly interested in the chemistry review. At a minimum, I would like to receive the approved label. Thanks!
1. 1654271881654271882020062911etc
Request for complete application for ANDA 088312 for Fluocinolone Acetate Topical Solution, 0.01%
Request for complete application for ANDA 071985 for Propranolol Hydrochloride Oral Solution, 40 mg/5 mL
Request for complete application for ANDA 071984 for Propranolol Hydrochloride Oral Solution, 20 mg/5 mL
I am requesting copies of FOIA requests #2022-4330, #2022-4562, and #2022-4732, as well as any and all records
provided in response to these requests.
Please provide disclosable portions of FDA’s final FOIA response letter for File Number 2022-2864. If there is no final
response letter, please send any correspondence indicating the closure of the request.
Copy of the disclosable portions of the MedWatch reports for the following 2 molnupiravir cases: 21008783; and
21008781.
483s issued for the below facility for the period January 1st 2022 – June 13th 2022 Revance Therapeutics FEI Number:
3007772056 Located at 7555 Gateway Blvd. Newark CA 94560
BASF is requesting a letter of No Objection issued by CVM for Mazu 4141 a defoamer used in the production of lysine
for animal feed. The request for the letter was made by Keller & Heckman on behalf of BASF corp. The date of the
request was May 2, 2003. Thank you for your help in this matter.
Any and all correspondence, reports, written findings, letters, or other documents related to the FDA CTP Potential
Tobacco Product Violation Reporting against Throwbacks cigars, and any investigation related thereto.
Revance Therapeutics, Inc. facility in Newark, California (7555 Gateway Blvd., Newark, CA 94560-1152) for the
manufacture of DaxibotulinumtoxinA (Daxi).
Documents sufficient to show FDA Commissioner Robert Califf's meetings, both internal and external, from June 12,
2022 to July 12, 2022, including, but not limited, to calendar entries, whether electronic or physical, that track Califf's
schedule.
K112030
Dear Food & Drug Administration Officer: Under the Freedom of Information Act (FOIA), I am requesting access to any
records and emails on Celsius Holdings, Inc. from 2016 to present. I am willing to pay up to $100 for search and review
fees. Thank you for your time. Sincerely, Grace Huh
We are writing to request copies of any records, compiled between March 1, 2022 and today, July 11, 2022, on file at
the FDA regarding the investigation of this outbreak. We specifically request: • all health department summary reports
(NORS reports) of any investigations conducted for this outbreak; • ETC
Please produce all studies considered by the CDC in making these assertions which expressly test, examine, discuss or
address the benefits or detriments, if any, of providing a SECOND dose of vaccine to persons who have recovered from
an actual or suspected prior Covide 19 infection
We request the bottle label of 30's counts for 100 mg and 150 mg strength of RLD. LUVOX CR (fluvoxamine maleate)
capsule, extended release 100 mg and 150 mg, Application No. N022033 held by Jazz Pharmaceuticals Inc. This is
required for ANDA submission planned on 10th August 2022.
The following FAERS reports for the product pegcetacoplan: 20102463, 19939906, 19630663, 19685262, and 19353149.
All records regarding the letter FDA sent to Protagonist Therapeutics in April 2022 indicating "an intent to rescind" the
breakthrough designation of their product Rusfertide. Here is a link to the SEC filing referencing the letter:
https://d18rn0p25nwr6d.cloudfront.net/CIK-0001377121/61deefe7-452a-425c-aed3-1b95d36df2ec.pdf.
Adagrasib (MRTX849) breakthrough designation. - The completed CDER Breakthrough Therapy Designation
Determination Review Template (BTDDRT) and BTD determination review presentation (likely published 3/1/21-
6/24/21) -etc
Amgen’s Lumakras (sotorasib) approval package. -Preliminary Meeting Comments - Type B Pre-NDA Meeting
(conducted around 9/1/2020-12/31/2020) -Appendix 2_Sotorasib RTOR Pre-submission Plan for submission timelines
(submitted around 9/1/2020-12/31/2020) -NDA Filing Communication Sent at Day 60 (sent around 1/1/2021-3/1/2021)
Or, in the alternative, all records sent in response to request FDA FOIA Request 2022-3174.
All FAERS records referencing lumakras (sotorasib), which is being developed by Amgen.
All records regarding the FDA Application Review Files (i.e. Multi-Discipline Review) for the approval of AYVAKIT™
(avapritinib) for the Treatment of Adults with Advanced Systemic Mastocytosis on June 16, 2021.
All records regarding the Type B Pre-NDA meeting between Blueprint Medicines Corporation and the FDA regarding the
supplemental new drug application for AYVAKIT™ (avapritinib) for the treatment of adult patients with advanced
systemic mastocytosis (SM)? The sNDA was submitted on December 17, 2020.
Any Form 483 (or other inspection records) for Seagen Inc (manufacturing facility), located in Bothell, WA.
I’m requesting the 483 associated with Integrated Commercialization Solutions (FEI #3002478693) in Brooks, Ky, USA.
The inspection was performed on 15Jul2019.
Requesting the Drug Approval Package for Amvuttra (vutrisiran), NDA 215515 from Alnylam Pharms Inc. which was
approved on 13 June 2022. Would like the full package including the summary review, chemistry review, medical
review, etc.
Copy of the disclosable portions of information submitted that resulted in No Objection Letter (NOL) 270 issued on June
1, 2022 to Veolia Huafei Polymer Technology Co. Ltd. Group on its post-consumer recycled polypropylene, as well as a
copy of all releasable FDA chemistry and toxicology review memoranda written related to NOL 270.
NDA No. N050790 - CYCLOSPORINE (RESTASIS MULTIDOSE) EMULSION 0.05% (Product 002) submitted to the FDA after
January 31, 2020. •All communications between FDA and the NDA holder of NDA No. N050790 relating to U.S. Patent
Nos.: o 8629111 o 8633162 o 8642556 o 8648048 o 8685930 o 9248191 o 8292129 o
8561859 o 9669974 o 9676525 etc
Please provide a copy of the 518(a) order and the 518(b) order the FDA filed re: Philips respironics during the above
noted dates and any response from Philips.
All documents created or maintained by the FDA, including but not limited to all Establishment Inspection Reports and
Form 483s, related to inspections or enforcement actions pertaining to the following USA-based facilities, from
1/01/2007 through 07/13/2022: 1. Lonza Walkersville 8830 Biggs Ford Rd Walkersville, MD 21793-8415 United States
etc.
Please provide the letter from lawmakers in the FDA/OC/OPLIA/OL/ log of lawmaker correspondence with the following
numbers: 2021-2638, 2021-2801, 2021-2447, 2022-1067 and the letter back to the lawmaker from the FDA.
All documents related to "pulse oximeter" and "skin pigmentation" including presentations, email correspondence,
medical device approval records, PMAs, 510Ks, and De Novo Classifications. I request that you release this on a rolling
basis as records become available.
All files, reports, and records related to inspections, inspection schedules and any investigations (including Form 483s)
issued to WuXi Biologicals with the following physical address: WuXi, Mashan 108 Meiliang Road W, MaShan Binhu
District Wuxi, 214092 FEI: 3010606982 DUNS: 421298354 The product at issue is a human drug. Form 483 issued
between September 2021-January 2022. Thank you!
This request is for all records related to Complaint number 174196.
I am requesting all calendar records, digital and physical calendars, for Robin Rivers (FDA ORA) for the following date
ranges: 10.01.2018-10.31.2018; 08.01.19-08.31.19 ; 09.01.19-09.30.19
[0807C] All communications of David Kim, M.D., M.S., M.H.A. from June 7, 2022 through the date of search, concerning
the letter signed by 18 members of Congress, available here
https://posey.house.gov/uploadedfiles/fdalettercovidvaxquestionsjune82022.pdf
All communications of FDA Commissioner Robert M. Califf, M.D., Prabhakara Atreya, Ph.D., and/or Sussan Paydar, Ph.D.
from June 7, 2022 through the date of search, concerning the letter signed by 18 members of Congress, available here
https://posey.house.gov/uploadedfiles/fdalettercovidvaxquestionsjune82022.pdf
The Memorandum of Understanding (MOU) referenced in the CDC’s final response to FOIA Request #22-00536, dated
February 14, 2022, as follows: “CDC has a Memorandum of Understanding (MOU), with the Food and Drug
Administration (FDA), stating that all VAERS inquires, FOIAs, and congressional inquiries are addressed by FDA.” (See
Exhibit A.).
Hello, Please provide all Empirical Bayesian data mining analyses performed by the FDA for the COVID-19 vaccines.
ACCELLA PHARMACEUTICALS EIR
Please provide any form 483s issued to Stira Pharmaceuticals LLC, FEI 3017224277 located in Fairfield, NJ 070004-3026,
since its inception in 2019
We request the bottle label of 100's counts for 2mg and 3mg strength of RLD.LUNESTA® (Eszopiclone) Tablets 1 mg, 2
mg and 3 mg NDA # 021476 held by Sunovion Pharmaceuticals Inc. This is required for ANDA submission planned on
30th July 2022.
Any and all communications from third parties to the FDA related to compounding sodium thiosulfate and all
communications provided by FDA to third parties in response to the same.
All correspondence, no matter the form, including letters, e-mails, memos, whether external or internal, to/from or
concerning the International Hyperbarics Association, Inc., whether as a sender/recipient or subject in such record, as
well as any records to, from, or pertaining to Shannon Kenitz or Justin Shrenger.
ENTRY RECS
for Human Drugs inspection of Medline Industries, Inc./Medline Laboratories ending 05/22/2018 at the location in
Mundelein IL, United States. The EIR (in electronic format) for Human Drugs inspection of Medline Industries,
Inc./Medline Laboratories ending 05/22/2018 at the location in Mundelein IL, United States. etc
for Medical Devices & Rad Health inspection of MHC Medical Products LLC ending 02/02/2018 at the location in
Cincinnati OH, United States. The Response (in electronic format) for Medical Devices & Rad Health inspection of MHC
Medical Products LLC ending 02/02/2018 at the location in Cincinnati OH, United States.
for Foods & Cosmetics inspection of Stello Foods Inc ending 08/03/2021 at the location in Punxsutawney PA, United
States. The EIR (in electronic format) for Foods & Cosmetics inspection of Stello Foods Inc ending 08/03/2021 at the
location in Punxsutawney PA, United States. etc
for Foods & Cosmetics inspection of Blue Chip Group, Inc ending 02/13/2019 at the location in Salt Lake City UT, United
States. The EIR (in electronic format) for Foods & Cosmetics inspection of Blue Chip Group, Inc ending 02/13/2019 at
the location in Salt Lake City UT, United States. etc
All internal FDA and/or CTP reviewer guidance, manuals, templates, memoranda or
similar documents for review of premarket tobacco product applications (“PMTAs”);
2. Any memorandum, directive, handbook, or other guidance available to agency employees
regarding the evaluation of PMTAs; etc
The premarket tobacco product applications for PM0000626-PM0000627,

PM0000630-PM0000631, and PM0000632-PM0000633 (collectively, the
“PMTAs”);
Copy of the disclosable portions of Unilever's response to the 08/23/2010 Warning Letter, as well as any subsequent
response from FDA to Unilever, including the closing letter.
INSPECTION RECORDS
SARASOTA ARTHRITIS INSPECTION RECS MAY 10-14, 1999
Please provide documents that identify the brand, manufacturer of the product, supplier name, source/geography of
where the products were harvested, can codes, universal product codes (or UPC), Stock-keeping unit (or SKU), best
before dates, and labels of seafood products that were sampled and tested in FDA’s July 2022, “PFAS in Seafood Survey”
Inspection reports ( form 483) for: Scientech Laboratories South Plainfield, New Jersey
UNREDACTED DISCLOSURE RE ABBOTT
1) I am requesting the complete FDA Premarket Approval P850022 (OrthoPak Bone Growth Stimulator). 2) I am
requesting specific information out of FDA Premarket Approval P850022: a) Summary of Safety and Effectiveness Data
(SSED); b) device description with physical, performance, and electrical characteristics of the device with minimum and
maximum values where applicable. ETC
All reports submitted by Philip Morris Products S.A. pursuant to Marketing Granted Orders issued by the Center for
Tobacco Products and assigned Submission Tracking Numbers PM0000424, PM0000425, PM0000426, PM0000479, and
PM0000634.
All reports submitted by Swedish Match North America, Inc., pursuant to Marketing Granted Orders issued by the
Center for Tobacco Products and assigned Submission Tracking Numbers PM0000010-PM0000017.
Records provided in response to requests 2019-6050, 2022-2971, 2022-3293, 2022-3649, 2022-4241, 2022-4258.
We request the bottle label and blister label of 100's counts for 2.5 mg, 5 mg, 10 mg and 20 mg strength, carton label
for 10 mg and 20 mg strength of RLD. Bystolic® (nebivolol) tablets 2.5 mg, 5 mg, 10 mg and 20 mg, Application No.
N021742 held by Allergan Sales LLC. This is required for ANDA submission planned on 22nd August 2022.
2018-6189
2019-9790
2019-10981
2019-10019
All contents of K080950, Device Name: STIWELL med4, Manufacturer: Otto Bock, Austria GmbH, Product code: IPF, GZI,
KPI, GZJ, HCC
All contents of K201290, Device Name: Medline DeNovo 4Pro Electrical Stimulation Device, Manufacturer: Medline
Industries Inc, Product code: IPF, GZJ, HCC, GZI, KPI
All contents of K101889, Device Name: Decompression of Choice and AAAR 2K10, Manufacturer: Pivotal Health
Solutions, Product code: ITH
All contents of K131036, Device Name: Yamahachi Denture Base Resins, Manufacturer: Yamahachi Dental
Manufacturing Co., Product code: EBI
All contents of K103081, Device Name: COVAORTHO-NERVE RESORBABLE COLLAGEN MEMBRANE, Manufacturer:
BIOM'UP SAS, Product code: JXI
All contents of K983007, Device Name: NEUROTUBE, Manufacturer: NEUROREGEN, L.L.C., product code: JXI
All contents of K142461, Device Name: VASCU-GUARD Peripheral Vascular Patch, Manufacturer: Synovis Life
Technologies Inc., product code: DXZ
All contents of K011168, Device Name: NEUROGEN NERVE GUIDE, Manufacturer: INTEGRA LIFESCIENCES CORP.,
product code: JXI
All contents of K162741, Device Name: AxoGuard Nerve Connector, Manufacturer: COOK BIOTECH INCORPORATED,
product code: JXI
All contents of K152967, Device Name: NERBRIDGE, Manufacturer: TOYOBO CO., LTD., product code: JXI
483s from Alvotech's Reykavik facility
Copy of the disclosable portions of the original request letter and complete FDA response for File Number: 2022-4435
(regarding peanut butter outbreak root cause analysis; and also for the following File Numbers regarding JM Smucker
Co: 2022-3772; 2022-3778; 2022-3780; 2022-3781; and 2022-3783.
Report and/or the MDSAP Noncomformity Grading and Exchange Form (NC) for the inspection of DePuy Orthopedics,
Raynham, MA ending on 2021-10-15. This inspection pertains to Medical Devices.
All reports submitted by R.J. Reynolds Vapor Company pursuant to Marketing Granted Orders issued by the Center for
Tobacco Products and assigned Submission Tracking Numbers PM0000551, PM0000553, PM0000560, PM0000635,
PM0000636, PM0004287, PM0000646, PM0000712, and PM0004293.
All reports submitted by Logic Technology Development LLC pursuant to Marketing Granted Orders issued by the Center
for Tobacco Products and assigned Submission Tracking Numbers PM0000529, PM0000530, PM0000531, PM0000535,
PM0000536, PM0000537, PM0000540, and PM0000541.
Forms 483 (Notice of Inspectional Observations) for inspections regarding Blending, Labeling, Manufacturing, Packaging,
Reconstituting, Saucing (or Casing), Storing, Testing of tobacco products at Avanti a/k/a Parodi Holdings L.L.C., 200
Keystone Industrial Park, Dunmore, PA, US, 18512, FEI #3012132146. etc.
Re:Vaccine Adverse Event Reporting System Report -
Request for the following records: NDA 021248/S-015 sNDA Review packet for the new indication: Trisenox in
combination with tretinoin NDA 021248 Review of Post-Marketing Commitment 1162-7 Analyze data from all the
pharmacokinetic studies conducted as Phase 4 commitment to evaluate the influence of age, gender, and race on the
pharmacokinetics of arsenic trioxide. NDA 021248 Review of Post-Marketing commitments identified in the approval
letter for NDA 021248 from 25 Sep 2000
Please provide the full and complete case reports for the following Pegcetacoplan FAERS cases: Case IDs 19353149,
20102463, 19630663, 19685262, 19939906.
All records that refer or relate to orders or other communications between any governmental entity and Michael
Andrew Robinson and/or Grabba Leaf, LLC regarding the wording on or labelling of "Grabba Leaf" products, and/or the
contents of "Grabba Leaf" products sold by said individual or company.
All documents, emails, texts, instant messages, electronic chats, memos, notes, and letters regarding FDA’s definition of
PFAS.
All evidence relied upon to support the FDA's decision to issue Import Alert 66-41 (see document)
All contents of K021827, Device Name: Accu-Chek Active System, Manufacturer: Roche Diagnostics Corporation, product
code: NBW; LFR
Report and/or the MDSAP Noncomformity Grading and Exchange Form (NC) for the inspection of Vascular Solutions,
Minneapolis, MN ending on 2021-01-15. This inspection pertains to Medical Devices.
All contents of PMA Number: P990004, Device Name: SURGIFOAM Absorbable Gelatin Sponge, SURGIFLO® Hemostatic
Matrix, SURGIFOAM® Absorbable Gelatin Powder, SURGIFOAM® Absor, Manufacturer: Ferrosan Meidcal Devices A/S,
product code: LMF
All contents of PMA number: P990009, Device Name: Floseal Hemostatic Matrix, Fast Prep, Floseal Hemostatic Matrix,
RT5, Floseal NT And Floseal Hemostatic Matrix, Floseal, Manufacturer: BAXTER HEALTHCARE CORP., product code: PMX
All contents of K160136, Trade/Device Name: Flowable Wound Matrix, Product Code: KGN, Manufacturer: Cook Biotech
Incorporated
All contents of K140510, Device Name: MIROMATRIX WOUND MATRIX, Manufacturer: MIROMATRIX MEDICAL INC.,
product code: KGN
All contents of K072113, Trade/Device Name: INTEGRA Flowable Wound Matrix, Product Code: KGN, Manufacturer:
Integra LifeSciences Corporation
Report and/or the MDSAP Noncomformity Grading and Exchange Form (NC) for the inspection of Boston Scientific,
Marlborough, MS ending on 2021-02-04. This inspection pertains to Medical Devices.
Report and/or the MDSAP Noncomformity Grading and Exchange Form (NC) for the inspection of Cadwell Industries,
Kennewick, WA ending on 2021-02-10. This inspection pertains to Medical Devices.
Report and/or the MDSAP Noncomformity Grading and Exchange Form (NC) for the inspection of Medtronic Minimed,
Northridge, CA ending on 2019-06-06. This inspection pertains to Medical Devices.
510(k) #K210851 510(k) #K182540 510(k) #K162428
Copy of the disclosable portions of the original request letters and complete FDA response for the following File
Numbers: 2022-3491, 2022-3492, 2022-3476; and 2022-3606.
All Review Documents for Supplement-81 to BLA 125554, Opdivo (nivolumab), sponsored by Bristol Myers Squibb and
approved on June 10, 2020.
2022-4117 2022-4441
An electronic copy of all documents, including all communications (no matter the form), regarding the 510(k) premarket
submission for the medical device product called "Revitalair® 430F" by Oxavita S.R.L., 510(k) number K171899. Please
include CDRH Premarket Review Submission Cover Sheet (Form FDA 3514) and "Declaration of Conformity" to
consensus standards (if one was submitted).
submission for the medical device (hyperbaric chamber) called "FLEXI-LITE" by applicant PRESSURE-TECH, INC.,
K101262. Please include CDRH Premarket Review Submission Cover Sheet (Form FDA 3514) and "Declaration of
Conformity" to consensus standards (if one was submitted).
submission for the medical device name (hyperbaric chamber) "DIVE AND SHALLOW AND GRAND DIVE" by applicant
SUMMIT TO SEA., K072757. Please include CDRH Premarket Review Submission Cover Sheet (Form FDA 3514) and
"Declaration of Conformity" to consensus standards (if one was submitted).
The 483 (in electronic format) for Biologics inspection of BioReliance Limited ending 01/14/2014 at the location in
Glasgow, United Kingdom. The Response (in electronic format) for Biologics inspection of BioReliance Limited ending
01/14/2014 at the location in Glasgow, United Kingdom. The Response (in electronic format) for Biologics inspection of
BioReliance Limited ending 03/15/2019 at the location in Glasgow, United Kingdom. Please send documents as email
attachments.
The EIR (in electronic format) for Medical Devices & Rad Health inspection of STERITECH, INC. ending 02/10/2021 at
the location in Salinas PR, United States. The Response (in electronic format) for Medical Devices & Rad Health
inspection of STERITECH, INC. ending 02/10/2021 at the location in Salinas PR, United States. Please send documents as
email attachments.
format) for Foods & Cosmetics inspection of The Procter & Gamble Manufacturing Company ending 02/26/2020 at the
location in Phoenix AZ, United States. Please send documents as email attachments.
for Human Drugs inspection of Spaulding Clinical Research, LLC ending 05/31/2019 at the location in West Bend WI,
INTERSCOPE RRA 2/2/22
REPORT FROM PANEL ON DRUGS USED IN RHEUMATIC DISEASES, FEDERAL REGISTER NOTICES
ENTRY W96-3599166-9
IND 10903
All testing records for this voluntary recall published by FDA on July 6, 2022: https://www.fda.gov/safety/recalls-market-
withdrawals-safety-alerts/primal-pet-foods-voluntary-recalls-single-lot-raw-frozen-patties-beef-formula-due-potential
I am requesting all records and response letters for 2022-2620
I am requesting a full and complete copy of the April 20, 2017, letter from CDR Steven Porter (Director, from the Los
Angeles District Office) regarding Thiopental Sodium imported by Arizona of Corrections. The letter is 26 pages in length.
If the responsive document indicates that it was submitted via electronic mail, please include a full and complete copy
of the email it was associated with.
Records of Approval: I am requesting copies of records within the FDA’s custody documenting the approval of sale or
use of pentobarbital sodium salt for the Arizona Department of Corrections in 2020. Records of Purchase: I am
requesting copies of records within the FDA’s custody documenting the purchase of pentobarbital sodium salt by (or for
the benefit of) the Arizona Department of Corrections in 2019 and 2020.
Solis’ Emails Regarding The Death Penalty: I am requesting releasable/redacted copies of incoming-and-outgoing email
correspondence (including attachments) between Dan R. Solis (Assistant Commissioner for Import Operations) and the
following individuals (listed below as Email Recipients/Senders) from August 1, 2020, to December 31, 2020 which
included the following terms (listed below as Key Terms). Email Recipients/Senders • Mark Brnovich • Rachelle Lumpp
• Joe Kanefield • etc
: I am requesting releasable/redacted copies of incoming-and-outgoing email correspondence (including attachments)

between Ted Poplawski (Acting Director – Division of Import Operations) and the following individuals (listed below as
Email Recipients/Senders) from August 1, 2020, to December 31, 2020 which included the following terms (listed below
as Key Terms). Email Recipients/Senders • Mark Brnovich • Rachelle Lumpp •etc
I am requesting releasable/redacted copies of incoming-and-outgoing email correspondence (including attachments)

between Stacy Below (DIB - Division of Southwest Imports) and the following individuals (listed below as Email
Recipients/Senders) from August 1, 2020, to December 31, 2020 which included the following terms (listed below as Key
Terms). Email Recipients/Senders • Mark Brnovich • Rachelle Lumpp • Joe Kanefield • etc
between Adrian H. Garcia (Import Supervisor – Arizona) and the following individuals (listed below as Email
Recipients/Senders) from August 1, 2020, to December 31, 2020 which included the following terms (listed below as Key
Terms). Email Recipients/Senders • Mark Brnovich • Rachelle Lumpp • Joe Kanefield • Allyson Flanagan • Jason Isaak •
Angie Paton • Rick Medina • Joshua Kredit • Edith Lefevre • Daniel Stefanski • Leslie Heathcotte • Lizette Morgan • John
Johnson • Beau Roysden • Lacey Gard • Linley Wilson • Michael Catlett • Charles Ryan (aka: Chuck Ryan) • David Shinn
• Joseph Profiri • Frank Strada • Brad Keogh • Valerie Murtha Key Terms • Pentobarbital • Sodium • capital
punishment • lethal injection • execution • death row Bowen’s Emails Regarding The Death Penalty: I am requesting
releasable/redacted copies of incoming-and-outgoing email correspondence (including attachments) between Patrick
Bowen ( Branch Chief, Import Operations) and the following individuals (listed below as Email Recipients/Senders) from
August 1, 2020, to December 31, 2020 which included the following terms (listed below as Key Terms). Email
Recipients/Senders • Mark Brnovich • Rachelle Lumpp • Joe Kanefield • Allyson Flanagan • Jason Isaak • Angie Paton •
Rick Medina etc

between Andrew Seaborn (Branch Chief, Import Program Development) and the following individuals (listed below as
Email Recipients/Senders) from August 1, 2020, to December 31, 2020 which included the following terms (listed below
as Key Terms). Email Recipients/Senders • Mark Brnovich • Rachelle Lumpp • etc
I am inquiring into inspection records for Boehringer Ingelheim’s Biopharmaceuticals Manufacturing site called 'Oasis' in
Shanghai, China.
I am seeking a list of all combinations that combine drug(s) OR biologic with a device / implant. I am not looking for drug
combined with biologic. I would like to know approval data, company/sponsor, indication, description of approved
product.
Copy of Orphan Drug Application of Avacopan for indication of "Treatment of anti-neutrophil cytoplasmic
autoantibodies associated vasculitides (granulomatosis with polyangiitis or Wegener's granulomatosis, microscopic
polyangiitis, and Churg-Strauss syndrome)". Designation given on 06/02/2014 and the drug approved on 10/7/2021
with trade name "Tavneos"
Freedom of Information Act (FOIA): Requesting the Agency to provide most recent three Form 483 (Notice of
Inspectional Observations) of Immacule Life sciences Private Limited, with FDA establishment identifier # 3014210753.
Copy of the (8) documents associated with Dockets Management ID numbers FDA-2000-N-0112-DRAFT-0840 through
FDA-2000-N-0112-DRAFT-0847.
All records relating to the following Import Refusal: Manufacturer FEI: 2150117 / Manufacturer Name: Pharmaceutical
Specialties, Inc. / Manufacturer Address: 1620 Industrial Dr NW / Manufacturer City: Rochester / Manufacturer
Province/State: MN / Manufacturer Country/Area: United States / Product Code: 62WBY99 / FDA Product Description:
etc
2022-4363, 2022-4370, 2022-4447, 2022-4503, 2022-4600.
2022-4148, 2022-4276, 2022-4282, 2022-4289, 2022-4327.
Copy of IND 19884
Full document for K020608
May we request USFDA approved human drugs related manufacturing data (name of establishment and location) for
each USFDA approved human drug?
Inspection records for UMCG Hematology department, BIMO ZUMA 7 inspection date 24 jan 2022 through 28 jan 2022,
Groningen, the Netherlands. We have not yet received any feedback regarding our inspection which took place in
January. We therefore would like to kindly ask you if we could receive the inspection report.
2022-4637
RECS RE HRPP USAF University of South Alabama medical center Human research protected program. 1998-1999.
CMC Review of NDA 022544, SUPPL-27 approved on 09/16/2021
I am requesting the current approval status of the root canal filling material commonly known by the name N2 Universal
as well as RC2B, RC2W, sargenti paste, sargenti cement and others. The company responsible for attempting to obtain
approval is N2 Products, president Alvin Arzt.
I am seeking digital copies of all CAERS, consumer complaints and other consumer communications filed with the FDA
regarding foods from the firm Daily Harvest.
[Reference FGI# 22-78953] Relevant to FDA we seek a copy of the disclosable portions of all releasable records related
to (1) Complaints received from February 2019 through July 2022 by the FDA limited to the following FDA CAERS report
id numbers: 2019-CFS-002432, 2020-CFS-006817, 2020-CFS-007337, 2020-CFS-008484.
All materials related to submission and approval of submission no. P920046/S012, "Approval for revisions to the
Instructions for Use to clarify symptomatic versus asymptomatic clip migration rates for the Filshie Clip (Mark VI)
System." Please provide materials submitted by Femcare Ltd. as well as decision by FDA. Thank you.
IDE application (https://www.fda.gov/medical-devices/investigational-device-exemption-ide/ide-application) submitted

by Establishment Labs to receive this 2018 investigational device exemption
(https://investors.establishmentlabs.com/news-releases/news-release-details/establishment-labs-receives-ide-
approval-us-fda-initiate).
ALL RECS RE ZESTY PAWS, HEALTH AND HAPPINESS INTERNATIONAL HOLDINGS, ETC
Please provide the EIR for the inspection dated 01/28/2022 (Y.Dezan & J.Estriplet) for: Sharp Packaging Services, LLC
7451 Keebler Way, Allentown, PA 18106 USA FEI Number: 3004161147
I request all records and communications associated with the FDA’s December 21, 2016, letter asking for enhanced
pharmacovigilance (ePV) concerning GnRH agonists from AbbVie and Endo Pharmaceuticals.
Copy of the disclosable portions of the 510(k) for K220481, Remanufactured LigaSure Exact Dissector without Nano-
coating (LF2019).
Copy of the disclosable portions of the VAERS reports for the following 2 cases for Vaxneuvance: 2307839, and
2307852.
[Reference FGI# 22-78946] Relevant to FDA and “SIMILAC” we seek a copy of the disclosable portions of all releasable
recor ds related to (1) Complaints received from October 2021 through July 2022 by the FDA including but not limited to
the Similac Pro Advance Batch: 36667X8, Similac Pro Advance Batch: 38753X8, Similac Pro Advance Batch: 37724X800
Similac Pro Advance Batch 37706X800, Similac NeoSure Batch 36361RE and Similac NeoSure Batch 37568RE.
[Reference FGI# 22-78947] Relevant to FDA and “SIMILAC” we seek a copy of t he disclosable portions of all releasable
records related to (1) Complaints received from September 2021 through July 2022 by the FDA limited to the following
complaint id numbers: 170177, 171087, 171222, 171771, and 172377.
complaint id numbers: 172424, 172435, 172450, 172457, 172477.
[Reference FGI# 22-78954] Relevant to FDA we seek a copy of the disclosable portions of all releasable records related
to (1) Complaints received from February 2019 through July 2022 by the FDA limited to the following FDA CAERS report
id numbers: 2020-CFS-009955, 2020-CFS-010953, 2021-CFS-011732, 2021-CFS-002365.
for Medical Devices & Rad Health inspection of B. Braun Melsungen AG ending 02/15/2018 at the location in
Melsungen, Germany. Please send documents as email attachments.
for Human Drugs inspection of Olon Ricerca Bioscience LLC ending 01/22/2019 at the location in Painesville OH, United
for Human Drugs inspection of Donald J Garcia, Jr. M.D. ending 09/03/2015 at the location in Austin TX, United States.
The EIR (in electronic format) for Human Drugs inspection of Donald J Garcia, Jr. M.D. ending 09/03/2015 at the location
in Austin TX, United States. etc
for Human Drugs inspection of Mark A. Hernandez, M.D. ending 09/11/2020 at the location in Miami FL, United States.
The EIR (in electronic format) for Human Drugs inspection of Mark A. Hernandez, M.D. ending 04/30/2021 at the
location in Miami FL, United States.
format) for Human Drugs inspection of Bend Research Inc ending 07/27/2018 at the location in Bend OR, United States.
I'm requesting the report from FDA's inspection of Bavarian Nordic's facility in Denmark from this year. Thank you!
A list of any closed FDA investigations into thermal imaging systems, solutions, or devices used to detect COVID-19,
detect fevers, or otherwise measure human temperatures, including the names of the entities and/or individuals
investigated. Such thermal imaging systems are also known as infrared thermographs (IRTs), thermal cameras, thermal
kiosks, thermal tablets, fever cameras, fever kiosks, or fever fever tablets.
Documents from any closed FDA investigations into thermal imaging systems, solutions, or devices used to detect
COVID-19, detect fevers, or otherwise measure human temperatures, including the names of the entities and/or
individuals investigated. Such thermal imaging systems are also known as infrared thermographs (IRTs), thermal
cameras, thermal kiosks, thermal tablets, fever cameras, fever kiosks, or fever fever tablets.
483 to Catalent Belgium for the inspection date 10/26/2021
I am an investment professional for an asset management firm and would like to request all form 483’s issued to
Revance Therapeutics, Inc. (FEI #3007772056) located at 7555 Gateway Blvd, Newark CA 94560 during 2022. Electronic
copy is preferred.
Copy of the disclosable portions of the 510(k) for K212658, CloudCath Peritoneal Dialysis Drain Set Monitoring System.
Human Adverse Event Drug MedWatch Reports for the following Case IDs: 8086716 8148479 8247164 8594966
8761615 9024611 9222660 9240497 9407996 9462181 9553614 9559358
Product Approval Package of DESYREL (Trazodone Hydrochloride Tablets)

We want to appply for the technique documents or technical parameter of Freeprint denture which K number is
K200461, becasue it is our predicate device, we want to conduct predicate comparison with them when prepare 510k
submission documents
All transcripts and presentations from the March 2003 meeting of the Contaminants and Natural Toxicants
Subcommittee of the Food Advisory Committee
Please advise whether the following devices seth forth in the attached medical records were recalled by the FDA in 2015
or 2016:
Requesting a copy of the inspection report for a FDA inspection conducted by Investigator Anetra Wyatt on April 8, 2022
at PMC Biogenix, Inc., 1231 Pope St., Memphis, TN 38108
Complete 510k submission files for Wuhan Greentek Pty Ltd Disposable EEG Electrodes (K200162)
To Whom it May Concern, We are seeking all public records related to FCN 2219, effective date May 25, 2022. Thank
you, Evan
Allegation submitted to the FDA related to FDA "Attention" Letter - CPT1900639 and outcome of the investigation.
Non-eCTD (Paper) Documents Request for ANDA 075894; Fluvoxamine Maleate Tablets 25 mg, 50 mg, and 100 mg
SIX ALTRIA STUDIES
Request for a Copy of all Disclosable Communications, Correspondence, Minutes of Meetings, Emails and All
Information Regarding the Mitre Contracts and Performance Goals and Achievements with the Center for Devices and
Radiological Health (“CDRH”).
I would like the vaccine trial data for all COVID-19 vaccinations PRIOR to and AFTER FDA approval.
Hello, Please provide all daily-email alerts (Daily Priority Reports) from the VAERS contractor to the FDA, as described
in this document https://www.cdc.gov/vaccinesafety/pdf/VAERS-COVID19-SOP-02-02-2022-508.pdf
Hello, Please provide all reports the FDA shared with the CDC "of possible concern" based on results of data mining
from VAERS data.
Requesting inspectional report for Malcolm MacComara-UT Southwestern audit conducted between 3/15-3/18/2021
Per Program Division Director, Eric Pittman. The inspectional report for Malcom MacConmara was sent to him on
08/06/2021, however he has since left the institution and require a copy of the report for recordkeeping.
All communications (including memoranda, records of meetings, records of telephonic or in-person discussions, etc.)
between FDA and Inimmune (or any of its agents or representatives) concerning or relating to toxicity studies—
including non-rodent toxicity studies—with respect to Inimmune’s proposed intranasal treatment for allergic rhinitis,
including INI-2004. etc
NDA 17-117 / S-006 approval letter or summary -

To whom it may concern, we are looking for information for the below: Award ID: 75F40119F19003 Reference ID:
75F40118D10055 Vendor : Translation Excellence Inc
All 483 reports for Nephron Pharmaceuticals (now located in West Columbia, South Carolina). FEI # 3011158388
MedWatch Forms for 5 Molnupiravir Cases: 21047112, 21047073, 21042529, 21042524, and 21042466
MedWatch Reports for the following 11 FAERS cases: 19928518, 19942925, 20015968, 20131809, 20081745,
20126428, 19949643, 20016702, 19928315, 19977386, and 20015421
Requesting to know if a complete response letter has been issued or not to Axsome Therapeutics for their drug AXS-05
(dextromethorphan and bupropion).
Request for complete application for ANDA 088786, ANDA 071984, ANDA 071985 and ANDA 088312
Hello, Please provide all emails between Dr. Peter Marks and any of the following addresses
DeanofPublicHealth@brown.edu ajha@hsph.harvard.edu ashish_jha@brown.edu.
Copy of the disclosable portions of the tentative approval letter for Lumryz, NDA 214755, tentatively approved
07/18/2022.
12 CAR-T-related PML cases which are listed in the attached request letter.
GSK is seeking cases which have niraparib as a suspect product and an even preferred term of
lymphangioleiomyomatosis. Please provide the MedWatch forms from FAERS for the following case report IDs:
14869582, 14915366, 14987775, 15017724, 15192012, 18429944.
Requesting a copy of the Establishment Inspection Report (EIR) and Form 483 if applicable for White Labs, Inc located at
172 South Charlotte Street, Asheville NC 28801
Tentative Approval Letter for NDA 216338 (Paclitaxel Injection 100mg)
K070198
We request you to provide the Labelling Information of BREVITAL SODIUM i.e Vial and Carton label.
Annual reports submitted to FDA in 2021 and 2022, and six-month reports submitted to FDA in 2020, 2021 and 2022, by
22nd Century Group Inc. as part of its PMTA post-marketing obligations for all Moonlight and Moonlight Menthol
tobacco products.
Electronic listing (preferably csv format) of all inspections conducted by FDA since March 1, 2022. The list should cover
I am requesting for the list of recalls, market withdrawals, safety alerts, as well as any weekly enforcement reports
mentioning the HyperRAB, HyperRAB S/D, HyperTET, HyperTET S/D, HyperRHO, HyperRHO S/D human immunoglobulin
products since 2008.
483 (in electronic format) for Human Drugs inspection of Berkshire Sterile Manufacturing, LLC ending 05/23/2022 at the
location in Lee MA, United States. The EIR (in electronic format) for Human Drugs inspection of Berkshire Sterile
Manufacturing, LLC ending 05/23/2022 at the location in Lee MA, United States. The Response (in electronic format) for
Human Drugs inspection of Berkshire Sterile Manufacturing, LLC ending 05/23/2022 at the location in Lee MA, United
States.
for Biologics inspection of Baxter Healthcare Corporation ending 05/12/2022 at the location in Marion NC, United
States. The EIR (in electronic format) for Biologics inspection of Baxter Healthcare Corporation ending 05/12/2022 at
the location in Marion NC, United States. Please send documents as email attachments.
for Human Drugs inspection of Levlad, LLC ending 05/19/2022 at the location in Chatsworth CA, United States. Please
for Animal Drugs & Feeds inspection of The Micro Connection Enterprises, Inc. DBA Personal Care Per ending
05/13/2022 at the location in City Of Industry CA, United States. Please send documents as email attachments.
for Human Drugs inspection of Glenmark Pharmaceuticals Inc USA ending 05/19/2022 at the location in Monroe NC,
for Human Drugs inspection of Howard University Institutional Review Board ending 05/19/2022 at the location in
Washington DC, United States. The 483 (in electronic format) for Human Drugs inspection of Safe Chain Solutions, Llc
ending 05/10/2022 at the location in Cambridge MD, United States.
Test results related to the Daily Harvest product recall.
For the date range listed above, please provide all complaints submitted to CFSAN or CDER regarding the entity listed
below or any of its products: Fairy Tales Hair Care 4 Just Road Fairfield, NJ
1.) proposal and information submitted to FDA by Lundbeck Pharaceutical in process of thier applying for orphan drug
status and FDA approval for clobazam (Onfi) 2.) Details of FDA's consideration of and response to the above and
reasoning for the drug qualifying under the orphan drug law
Request for 9 Case Records pertaining to mucormycosis following CAR-T Cell therapy. Please see the attached request
letter which contains all the information required and Case IDs obtained from the FAERS Public Dashboard.
In the FAERS database record for pegcetacoplan, two cases of uveitis and two cases of vitiris are reported. I am seeking
these individual case safety report submissions, including any attached supporting information (e.g. hospital discharge
summaries if they have been submitted with the case reports).
LIST OF INSPECTIONS
All correspondence, communications, and documents exchanged between the FDA and ChemoCentryx (or the
Company’s third-party agents) concerning the Phase III clinical trial - referred to as ADVOCATE - testing the efficacy and
safety of avacopan ETC
DNAe Breakthrough Device Designation to DNAe’s LiDia-SEQ sequencing device

Hello, I would like to request the results of a query showing the final classification of the May 2022 FDA inspection of
the Berkshire Sterile Manufacturing facility located in Lee, MA. Thank you
The EIR (in electronic format) for Human Drugs inspection of TriRx Huntsville Pharmaceutical Services, LLC ending
04/01/2022 at the location in Huntsville AL, United States. The Response (in electronic format) for Human Drugs
inspection of TriRx Huntsville Pharmaceutical Services, LLC ending 04/01/2022 at the location in Huntsville AL, United
The 483 (in electronic format) for Human Drugs inspection of Novo Nordisk Pharmaceutical Industries LP ending
05/13/2022 at the location in Clayton NC, United States. The EIR (in electronic format) for Human Drugs inspection of
Encompass Pharmaceutical Services Inc. ending 06/03/2022 at the location in Peachtree Corners GA, United States. etc
for Human Drugs inspection of Ferring Production Inc. ending 05/12/2022 at the location in Parsippany NJ, United
for Animal Drugs & Feeds inspection of Akorn Operating Company LLC ending 05/17/2022 at the location in Somerset
for Human Drugs inspection of Omega & Delta Co., Inc. ending 05/06/2022 at the location in Carolina PR, United States.
The 483 (in electronic format) for Human Drugs inspection of Skyless LLC ending 05/16/2022 at the location in Ponce PR,
for Human Drugs inspection of Founders Science Group, LLC ending 05/17/2022 at the location in Taunton MA, United
Hello, Please provide agendas, participant lists, audio recordings, transcripts, notes, summaries, presentations, and
other documents from the CDC/FDA COVID-19 Safety Coordination Meetings.
K161623, Prontosan
K202071, BD Surgiphor.
K202222, Irrisept.
K210536, Irrisept.
K161165, Bactisure.
K192349, Bactisure.
All first cycle disciplinary/scientific reviews for Vuse Solo (PM0000551, PM0000553, PM0000560)
Copy of the disclosable portions of the first cycle toxicology review for myBlu (PM0000720, PM0000721, PM0000725,
PM0000726, PM0000742-744).
Copy of the disclosable portions of the first cycle toxicology review for NJOY Daily (PM0000630, PM0000631), and NJOY
Ace (PM0000613-615, PM0000622)
Copy of the disclosable portions of the first cycle toxicology review for Logic (PM0000529-531, PM0000535-537,
PM0000540, PM0000541).
First cycle toxicology review for 22nd Century (PM0000491, PM0000492)
First cycle toxicology review for Vuse Solo (PM0000551, PM0000553, PM0000560).
I am requesting records from FDA-CVM for the FDA regulation for the term "beef short rib" (for use in animal feed and
pet foods)
All e-mail records for FDA employee Darla Bracy [OHAF-West Division 5] for the date range of 05.20.17-06.30.2017
containing the key terms; Small Batch, Michael Vogel
All email records for FDA CVM employee David Edwards for the date range of 04.01.2022-06.30.2022 containing the key
search term: AAFCO. All email records for the date range of 04.02.2022-06.30.2022 for FDA CVM employee Charlotte
Conway containing the key search term: AAFCO. All email records for the date range of 04.01.2022-06.30.2022 for FDA
CVM employee Steven Solomon containing the key search term: AAFCO.
Date Range: 09/01/2019 - 09/30/2019; all calendar records for Mark Raza
All FDA memoranda, guidance documents, or directives regarding the infant formula
shortage etc
E-mail records from Mark Guerra (Mark.Guerra@fda.hhs.gov) and Virginia Ramos (VIRGINIA.RAMOS@fda.hhs.gov)
pertaining to keywords (included in the document)
E-mail records from Emilio Escobar Supervisory Consumer Safety Officer Division of Southwest Imports Pharr TX
(Emilio.Escobar@fda.hhs.gov) pertaining to keywords (included in the document).
I'm requesting all phone records and calendar records for Emilio Escobar Supervisory Consumer Safety Officer Division
of Southwest Imports (emilio.escobar@fda.hhs.gov)
I'm requesting all phone records and calendar records from Michael Morgan Investigator/Consumer Safety Officer,
Division of Southwest Imports (michael.morgan1@fda.hhs.gov)
All email records between FDA Officer Juan D. Garza III Compliance Officer, DSWI ( juan.garza@fda.hhs.gov ) and FDA’s
Center for Food Safety and Applied Nutrition (CFSAN) for their review to determine admissibility.for entries (see
attached document):
Copies of all HHS 717-2 Reports of Prohibited Financial Interests submitted by employees of the FDA who are Public SF
278 filers between Dec. 31, 2017 and today.
I am requesting 3 Certified Copies of the FMD 145 also know as the EIR "Establishment Inspection Report" for the FDA
inspection of Johnson Matthey Pharmaceutical Services, Inc. The inspection ended on January 31st, 2019. The
inspection report was signed on February 25th, 2019. Please see the attached signed release form by Veranova
(Formerly Johnson Matthey Pharmaceutical Services, Inc.)
1. All documents released for FOI 2019-285 and subsequently released for FOI 2022-3181 All documents released for
FOI 2016-10102 and subsequently released for FOI 2022-2629.
Hello - I would like to place a FOIA request for the following documents: P180008 P140015
FOIA request for records about cellulose related to selected generally recognized as safe (GRAS) notifications, including
but not limited to GRN No. 954, 470, 213 and 190. For the 4 GRAS notification (GRNs) listed below and posted on its
website at https://www.cfsanappsexternal.fda.gov/scripts/fdcc/?set=GRASNotices. etc
Hello - I would like to place a FOIA request specifically for Table one in K133593. I am specifically interested in the exact
material of the polyethylene insulin bag from a biocompatibility with insulin concern.
Please provide a copy of all Med Watch and adverse drug reaction reports for brand name AMPYRA™ (dalfampridine)
and 4-aminopyridine (4-AP, fampridine) in all dosage forms. Please include all such reports for pharmacy-compounded
Aminopyridine, The report documents provided can be in an electronic format.
Records in support of medical device premarket clearance request for K212947, Trinity Plus Wrinkle Reducer by Carol
Cole Company dba NuFACE.
Records in support of medical device premarket clearance request for K201782, NuFace Trinity Plus Device by Carol Cole
Company dba NuFACE.
SBOA for ANDA # 212416 (Calcitonin Salmon) from Custopharm, Chemistry review for ANDA # 212416 (Calcitonin
salmon) from Custopharm
SBOA for ANDA # 209358 (Calcitonin salmon) from Par. Chemistry review for ANDA # 209358 (Calcitonin salmon) from
Par.
VAERS report
VAERS Report
In the FAERS database record for pegcetacoplan, two cases of uveitis and two cases of vitiris are reported. I am seeking
these individual case safety report submissions, including any attached supporting information (e.g. hospital discharge
summaries if they have been submitted with the case reports). The case ID numbers are: 19685262, 19353149,
20102463, 19630663.
I request any readily available records for current, approved blister pack label, wallet card label and bottle label for the
Reference Listed Drug, AUBAGIO, 7mg and 14mg strengths. The blister pack, wallet card and bottle labels are not
available on the Drugs@FDA.gov website.
Analytical method and its validation for determining free iodine content in any of the below dossiers: ALLEGIANCE
HEALTHCARE CORP: POVIDONE IODINE 1% SOLUTION; CLINIPAD CORP: E-Z PREP N019382 SOLUTION TOPICAL
10%
Form 483 for Biocon's Biologics Unit in Bengaluru
1. Communications during the period 2/1/20 - 3/31/20 with Biomarin Pharmaceuticals, Inc. ("Biomarin") personnel
regarding Biomarin's drug "valrox". 2. Communications during the period of 2/1/20 - 3/31/20 with Biomarin personnel
regarding a Preapproval Inspection of Biomarin's Novato facility. etc
Requesting a copy of the three observations issued on Biocon Ltd's Hyderabad facility, Site 3, during a pre-approval
inspection on July 20, 2022. The same is requested in public interest.
483 issued to Mylan Laboratories Limited Bommasandra-Jigani Link Road Anekal Taluk, Bangalore India
I would like to request for the individual case reports for the following case numbers, taken from the FDA FAERS Public
Dashboard for the Human Rabies Virus Immune Globulin products. 20208330 20127111 20127094 20127371 etc
Report and/or the MDSAP Noncomformity Grading and Exchange Form (NC) for the inspection of K-C AFC
Manufacturing SA de RL de CV, Heroica Nogales, Mexico, end date 12-07-2018. FEI# 3011109575. This inspection
Copy of the 483 for the 03/01/2022 - 03/04/2022 inspection of Troy Hounshell, D.O. [West Des Moines / United States
of America] 5880 University Ave, West Des Moines, IA 50266, USA. This inspection pertains to MEDICAL DEVICES
Copy of the 483 for the 02/22/2022 - 03/04/2022 inspection of Max Health, Subsero Health [Sarasota / United States of
America] 2055 Wood St #100, Sarasota, FL 34237, USA. This inspection pertains to HUMAN DRUGS
Copy of the 483 for the 02/28/2022 - 03/10/2022 inspection of Maria L. Colavincenzo, M.D. [Chicago / United States of
America] 676 N St Clair St Suite 1600, Chicago, IL 60611, USA. This inspection pertains to HUMAN DRUGS
Report and/or the MDSAP Noncomformity Grading and Exchange Form (NC) for the inspection of Teleflex Medical Sdn.
Bhd., Kamunting, Malaysia, end date 05-21-2018. FEI# 3009271244. This inspection pertains to medical devices.
Copy of the 483 for the 03/07/2022 - 03/11/2022 inspection of Charles Redfern, MD [San Diego / United States of
America] 7930 Frost St #300, San Diego, CA 92123, USA. This inspection pertains to HUMAN DRUGS
Report and/or the MDSAP Noncomformity Grading and Exchange Form (NC) for the inspection of SD Biosensor Inc,
Suwon-si, Korea, end date 12-07-2016. FEI# 3012133212. This inspection pertains to medical devices.
Report and/or the MDSAP Noncomformity Grading and Exchange Form (NC) for the inspection of Inmed Mfg. Sdn. Bhd,
Kamunting Perak, Malaysia, end date 05-25-2018. FEI# 3005946224. This inspection pertains to medical devices.
Copy of the disclosable portions of the toxicology review for myBlu (PM0000720, PM0000721, PM0000725,
PM0000726, PM0000742-744).
Copy of the disclosable portions of the toxicology reviews for NJOY Daily (PM0000630, PM0000631), and NJOY Ace
(PM0000613-615, PM0000622).
Copy of the disclosable portions of the toxicology reviews for Logic (PM0000529-531, PM0000535-537, PM0000540,
PM0000541).
Copy of the disclosable portions of the toxicology reviews for 22nd Century (PM0000491, PM0000492).
Copy of the disclosable portions of the toxicology reviews for Vuse Solo (PM0000551, PM0000553, PM0000560).
for Foods & Cosmetics inspection of Gerber Products Company dba Nestle Nutrition ending 04/14/2022 at the location
in Eau Claire WI, United States. The EIR (in electronic format) for Foods & Cosmetics inspection of Gerber Products
Company dba Nestle Nutrition ending 04/14/2022 at the location in Eau Claire WI, United States. Please send
for Human Drugs inspection of Premier Brands Of America Inc. ending 05/16/2022 at the location in Orangeburg NY,
United States. The EIR (in electronic format) for Human Drugs inspection of Premier Brands Of America Inc. ending
05/16/2022 at the location in Orangeburg NY, United States. etc
for Human Drugs inspection of Aero Healthcare ending 05/06/2022 at the location in Valley Cottage NY, United States.
for Human Drugs inspection of MD Pharmaceutical Supply, LLC ending 05/09/2022 at the location in Hanover PA, United
The 483 (in electronic format) for Human Drugs inspection of Shahrukh A. Kureishy, MD ending 05/09/2022 at the
location in Mckinney TX, United States. The 483 (in electronic format) for Human Drugs inspection of Revive Rx LLC dba
Revive Rx Pharmacy ending 05/04/2022 at the location in Houston TX, United States. Please send documents as email
attachments.
for Human Drugs inspection of Nukemed Inc ending 05/12/2022 at the location in South Bend IN, United States. Please
Copy of the FDA response only to the following file numbers 2021-5746 2021-5686 2021-5666 2021-5066 2021-4376
Dear Sir/Madam, Could we please get a copy of the 510(k) submission documents for the follow KZK device codes: -
K991473 - K944319 - K932122 for the purpose of establishing a predicate for a new submission. Thank you for your
time.
All reviews associated with CDER Tracked Safety Issue 259
Request to issue a copy of EIR of 'Ortin Laboratories Limited Unit-II' FEI No.3015264798, FDA Inspection was done from
2-6th September 2019 at Sy.No.300, Malkapur Village, Choutuppal Mandal, Yadadri-Bhuvanagiri District - 508252,
Telangana State, India.
CVs Michele C Murray-Schrade, Vivian Garcia, Kim M Downing, Richard D Manney, Laishan L Lam, Philip J Boston,
Colleen M Damon, Robert J Maffei, Debra L Pagano, Carol A Llewellyn, Charlie P Booker, etc
Request for records that have led to SCHNUCK MARKETS INC, SCHNUCK MARKETS, INC., SCHNUCKS MARKETS, INC. and
SCHNUCKS MARKETS INC-ST LOUIS -NORTH PARK DRY on page 381 of the Foreign Supplier Verification Programs - List of
Participants (Name and State Only) March 17, 2022 - June 16, 2022.
Jardiance AERS
All communications (including, but not limited to, emails, phone call transcripts, video call transcripts, and meeting
transcripts) between FDA officials and representatives of both Pfizer and Moderna pertaining to the companies’
vaccines for children under 5. For Pfizer, this would begin in January 2022, and for Moderna, this would begin in March
2022.
All records and documents (letters, emails, electronic files, reports, transcripts, audio) between the FDA and Reagan-
Udall Foundation relating to the engagement of the Reagan-Udall Foundation as an advisor to fda for a proposed review
of the Center For Tobacco Products.
Recs re Philips Respironics’ (FEI # 2518422) request for a meeting with FDA in the Second Quarter of 2022 and its
presentation of data regarding the effectiveness of various changes that the Philips Respironics has implemented
following FDA’s issuance of the Form FDA 483 (“Form-483”) on November 9, 2021, which detailed FDA’s inspectional
observations of the facility located in Murrysville, Pennsylvania.
We request the following records and information: 1. All documents concerning the FDA’s requests in or around early
2021 for AbbVie to submit updated assessments of the benefit-risk profile for Rinvoq in atopic dermatitis, psoriatic
arthritis, and ankylosing spondylitis. etc
Any and all documents collected or created related to the FDA's requested voluntary recall of Buzzagogo's Allergy Bee
Gone for Kids, lot # 2006491. We are specifically requesting, but are not limiting this request, to all documents related
to sample selection and gathering, testing methods, testing results and application of standards to the results.
We are interested in the following three items for CDRH Master File MAF#622 for Nusil MED-2000 Silicone.
1.Verification that the MAF#622 exists and is recognized by CDRH. 2. Cover letter and any other releasable info for the
original submission. 3. FDA/CDRH letter acknowledging/accepting/approving the master file.
All documents (i.e., FDA internal memoranda, review notes, reviewer guidance,
manuals, templates, and similar documents) related to EX0002078.PD1,
EX0002078.PD3, and EX0002078.PD5
Please provide Summary basis of Approval of CUVRIOR (TRIENTINE TETRAHYDROCHLORIDE) TABLET;ORAL 300MG for
the Applicant ORPHALAN SA-N215760
The 483 (in electronic format) for Human Drugs inspection of Dr. Reddy's Laboratories, Inc. ending 05/26/2022 at the
location in Princeton NJ, United States. The EIR (in electronic format) for Human Drugs inspection of Dr. Reddy's
Laboratories, Inc. ending 05/26/2022 at the location in Princeton NJ, United States. The Response (in electronic format)
for Human Drugs inspection of Dr. Reddy's Laboratories, Inc. ending 05/26/2022 at the location in Princeton NJ, United
Copy of the disclosable portions of the toxicology reviews for Vuse Ciro/Vibe (PM0000635, PM0000636, PM0000646,
PM0000712, PM00004287, PM00004293).
Any and all communications, correspondence, documents,

memorandums, and information consisting of or relating to the FDA inspection of Elixinol Wellness’ facility that took
place on or around April 18, 2022, including but not limited to FDA’s internal memorandum detailing FDA’s overview of
such inspection.
The 483 (in electronic format) for Biologics inspection of Emergent BioSolutions Canada Inc. ending 05/10/2022 at the
location in Winnipeg, Canada. The EIR (in electronic format) for Biologics inspection of Emergent BioSolutions Canada
Inc. ending 05/10/2022 at the location in Winnipeg, Canada. Please send documents as email attachments.
LABORATORIES LOCATED AT 11111 M STREET, SUITE 110, NE 68137 AND 5036 S. 33rd ST. OMAHA, NE 68107
Thompson Hine, on behalf of its client Shenzhen First Union Technology Co., LTD. is seeking a complete copy of their
Tobacco Product Master File (“TPMF”) STN: MF0000443, and premarket tobacco application (“PMTA”), STN:
PM0000892 PD6-11.
: The EIR (in electronic format) for Animal Drugs & Feeds inspection of Akorn, Inc. ending 09/17/2010 at the location in
Decatur IL, United States. The Response (in electronic format) for Animal Drugs & Feeds inspection of Akorn, Inc. ending
09/17/2010 at the location in Decatur IL, United States. Please send documents as email attachments.
for Human Drugs inspection of GCP Laboratories ending 05/13/2022 at the location in Gulfport MS, United States.
ALL FORM 483, EIR, RESPONSE LETTERS, AND ANY OTHER COMMUNICATIONS WITH THE FDA BY/FOR RLC LABS LOCATED
AT 1850 E RIVERVIEW DR, PHOENIX, AZ 85034.
Freedom of Information Act (FOIA): Requesting the Agency to provide the latest Form 483 (Notice of Inspectional
Observations) for Stelis Biopharma Limited, with FDA establishment identifier # 3017501030
MicroPort Prophecy is requesting the 510(k) records of MindMotion GO by MindMaze. Its 510(k) number is K173931.
Premarket notification [510(k)] K212815 for My3D® Personalized Pelvic Reconstruction by Onkos Surgical, 77 East Halsey
Rd., Parsippany, NJ 07054.
ALL FORM 483, EIR, RESPONSE LETTERS, AND ANY OTHER COMMUNICATIONS WITH THE FDA BY/FOR WESTMINSTER
PHALOCATED AT 1321 Murfreesboro Pike Suite 607, Nashville, TN 3721 AND 3550 Buschwood Park Drive, Suite 295
Tampa, Florida 33618.
Copy of the disclosable portions of the MedWatch forms for the following 4 molnupiravir cases: 21093681, 21076793,
21075236, and 21065638.
1. FDA Lot Release Letter

and 2. The manufactured locations of the below lot numbers from Comirnaty labeled vials:
FW1330
FW1331
FW1333
Please let me know if you have any questions and thank you for your time and attention to this matter. I can be reached
by email or my cell: 850-449-5793. Thank you again.
Respectfully,
Josh Hoppe
- FDA-approved labeling for Xofluza (Baloxavir Marboxil Tablets, NDA 210854): - 40 mg and 80 mg container and
carton labeling (S-008) - Prescribing information and patient information labeling (S-008)
Official request for the agency to disclose information regarding the methodology of testing used for the testing of two
API lots: Sample Number 1156095, Sample Number 1174935.
ALL FORM 483, EIR, RESPONSE LETTERS, AND ANY OTHER COMMUNICATIONS WITH THE FDA BY/FOR BIOFAC A/S
EJBYVEJ 44, LILLE SKENSVED, SJAELLAND 4623, DENMARK.
ALL FORM 483, EIR, RESPONSE LETTERS, AND ANY OTHER COMMUNICATIONS WITH THE FDA BY/FOR SPECIALTY
PROCESS LABS LLC LOCATED AT 1030 E LONE CACTUS DR, PHOENIX, AZ 85024
ALL FORM 483, EIR, RESPONSE LETTERS, AND ANY OTHER COMMUNICATIONS WITH THE FDA BY/FOR NORDMARK
PHARMA GMBH LOCATED AT PINNAUALLEE 4, UETERSEN, SCHLESWIG-HOLSTEIN D-25436, GERMANY
ALL FORM 483, EIR, RESPONSE LETTERS, AND ANY OTHER COMMUNICATIONS WITH THE FDA BY/FOR SCIENTIFIC LIFE
SOLUTIONS LOCATED AT 1010 DALE ST N, ST.PAUL, MN 55117 AND 8101- 34TH AVENUE SOUTH, SUITE 400
BLOOMINGTON, MN 55425
Methods of the Allergenic Products Testing Laboratory. Rockville, MD: Laboratory of Immunobiochemistry, Division of
Allergenic Products and Parasitology, Center for Biologics Evaluation and Research, Food and Drug Administration;
October 1993. 59 FR - Methods of the Allergenic Products Testing Laboratory; Availability - Content Details - 94-28858
(govinfo.gov) https://www.govinfo.gov/content/pkg/FR-1994-11-23/html/94-28858.htm
2022-2749, 2022-3821, 2022-4027, 2022-4032, 2022-4034.
2022-4035, 2022-4078, 2022-4119, 2022-4122, 2022-4123.
Any and all written communications between the Food and Drug Administration (“FDA”) and General Mills, Inc. (“the
company”) related to the warning letter issued by FDA on May 5, 2009 to the company, including, but not limited to, a
copy of the close-out letter issued to the company in connection with the warning letter.
Request for Individual Case Report. Total Number: 1 (one). Suspect Product Name: Vyvgart. Suspect Product Active
Ingredient: Efgartigimod Alfa-Fcab. Source of case number: FAERS Public Dashboard. Case number: 20654879.
The requested documents are copies of all correspondence in releasable format for the period
1/31/2022 to 6/10/2022, between the Office of Laboratory Animal Welfare (OLAW), Division
of Compliance Oversight (DCO) and the following institutions
510(k) Submission K032514 for the AC APPLICATOR, AURORA AC submitted by SYNERON MEDICAL LTD.
All documents sufficient to identify the total dollar amount of the Fiscal Year 2023 FDA budget allocated specifically for
responding to Freedom of Information Act (FOIA) requests and other FOIA-related activities.
All documents sufficient to identify the total number of Full Time Equivalents (FTEs) who respond to Freedom of
Information Act (FOIA) requests and perform other FOIA-related activities for the FDA in Fiscal Year (FY) 2022; and the
budgeted number of FTEs for same in FY 2023.
All records (including, but not limited to, spreadsheets, emails, memoranda, slide decks, call or meeting transcripts or
recordings, etc.), dated between January 1, 2022 through date of search, related to a review of Vaccine Adverse Events
Reporting System and any planned and/or pending changes thereto.
All reports related to defects or functional failures in the DePuy Synthes Corail Hip Implant System.
K111377: STERRAD(R) 100NX STERILIZER DUO CYCLE We would like the access to the entire 510(k) files submitted to the
FDA
K160818: STERRAD® NX Sterilizer with ALLClear™ Technology We would like the access to the entire 510(k) files
submitted to the FDA
for Human Drugs inspection of AndersonBrecon Inc. ending 06/10/2022 at the location in Rockford IL, United States.
for Medical Devices & Rad Health inspection of Innovative Sterilization Technologies LLC ending 12/22/2014 at the
location in Dayton OH, United States. Please send documents as email attachments.
K172754: V-PRO maX 2 Low Temperature Sterilization System We would like the access to the entire 510(k) files
K172319: AMSCO V-PRO 1 Low Temperature Sterilization System, AMSCO V-PRO 1 Plus Low Temperature Sterilization
System, V-PRO maX Low Temperature Sterilization System, V-PRO 60 Low Temperature Sterilization System We would
like the access to the entire 510(k) files submitted to the FDA
K160433: V-PRO® 1 Plus and V-PRO® maX Low Temperature We would like the access to the entire 510(k) files
K183419: EVIS EXERA III Bronchovideoscope Olympus BF-XT190 We would like the access to the entire 510(k) files
K201758: EVIS EXERA III Bronchovideoscope Olympus BF-XP190, EVIS EXERA III Bronchovideoscope Olympus BF-P190
We would like the access to the entire 510(k) files submitted to the FDA
K133538: VISERA CYSTO-NEPHRO VIDEOSCOPE OLYMPUS CYF TYPE V2, VISERA CYSTO-NEPHRO VIDEOSCOPE OLYMPUS
CYF TYPE VA2, VISERA CYSTO-NE We would like the access to the entire 510(k) files submitted to the FDA
K181451: URETERO-RENO VIDEOSCOPE OLYMPUS URF-V3/V3R, URETERO-RENO FIBERSCOPE OLYMPUS URF-P7/P7R We
would like the access to the entire 510(k) files submitted to the FDA
K182102: RHINO-LARYNGO VIDEOSCOPE OLYMPUS ENF-VH2, RHINO-LARYNGO VIDEOSCOPE OLYMPUS ENF-V4 We
K183416: Rhino-Laryngo Videoscope Olympus ENF-VT3 We would like the access to the entire 510(k) files submitted to
the FDA
redacted records for 510K for K182887 Masimo’s Co-Oximter application and should make mention of hemoglobin
levels.
K181240: Rhino-Laryngo Fiberscope Olympus ENF-GP2 We would like the access to the entire 510(k) files submitted to
the FDA
We request the full FCN for FCN No. 1083 and FCN No. 1180.
I'm requesting copies of all correspondence between Dr Matthew R. Holman, Director of the Office of Science at the
FDA's Center for Tobacco Products, and representatives of Philip Morris International. Searches of Dr Holman's email
inbox should be conducted for the email prefix "@pmi.com".
Establishment Inspection Report for Catalent Maryland Inc. FEI: 3015434301 conducted Inspection ID 1156961 for
Human Cellular, Tissue, and Gene Therapies.
For this FOIA request, we would like to request the following: -Any FDA inspection-related observations (associated with
a human-drugs pre-approval inspection) related to inspections completed between Apr ’22 and Aug ’22 at RVNC’s
Newark, CA facility (7555 Gateway Blvd, Newark, CA, 94560-1152). This would include any (if available) Form 483s or
Establishment Inspection Reports (EIR) Thanks!
Please produce the following documents relating to the 2020-2021 outbreak of non-viral hepatitis associated with the
alkaline water called "Real Water": 1. Any PowerPoint presentations or other slides in your possession relating to the
outbreak (or any investigation of the outbreak); 2. Any video or sound recordings of any presentations on the outbreak.
We request pre-submission correspondence between the FDA and potential notifiers regarding GRN No. 1056 (ß-
lactoglobulin produced by Komagataella phaffii strain “yRMK-66”). We also request GRAS Notice No. 1056.
for Human Drugs inspection of Curia New Mexico, LLC ending 04/11/2022 at the location in Albuquerque NM, United
States. The EIR (in electronic format) for Human Drugs inspection of Curia New Mexico, LLC ending 04/11/2022 at the
location in Albuquerque NM, United States. Please send documents as email attachments.
for Human Drugs inspection of Airgas USA, LLC ending 06/17/2022 at the location in Dover NH, United States. Please
The 483 (in electronic format) for Medical Devices & Rad Health inspection of Neurotronics, Inc. ending 05/05/2022 at
the location in Gainesville FL, United States. The 483 (in electronic format) for Medical Devices & Rad Health inspection
of Legend Aerospace, Inc. ending 05/27/2022 at the location in Medley FL, United States. The 483 (in electronic format)
for Medical Devices & Rad Health inspection of ULTRAVISION CORPORATION ending 05/20/2022 at the location in North
Palm Beach FL, United States. Please send documents as email attachments.
The 483 (in electronic format) for Medical Devices & Rad Health inspection of Pyrexar Medical, Inc. ending 05/18/2022
at the location in West Valley City UT, United States. The 483 (in electronic format) for Medical Devices & Rad Health
inspection of Tf Health Corp. DBA Breezing Co. ending 05/06/2022 at the location in Tempe AZ, United States.
Redacted copy of the EIR from the CSL Behring Bradley, IL location Inspection beginning on September 13, 2021 and
ending on September 24, 2021.
We request FDA's plant inspections data, which may contain the following data fields: (1) FDA establishment
identification (FEI) number, (2) firm name, (3) DUNS number, (4) inspection ID, (5) inspection date, (6) inspection
outcome (classification), (7) product type / program area, (8) inspector ID (for all inspectors involved in one inspection).
I would like to request access to the FDA 483 from December 2021 for Phoenix Formulations and for the August 2021
483 for Good Health Manufacturing
-All documents generated by the FDA related to the recall Event ID #90512 related to Nephron Pharmaceuticals and its
voluntary recall on 6/30/22. -This includes all 483 documents, letters or EIR documents -If some records cannot be
released, please continue to process those that can
K994393, K994392, K990804 ETC FIRST PARTY
1. All emails sent to and from Center for Biologics Evaluation and Research Director Marion Gruber regarding Shanghai
Medicilon Inc., also known as Medicilon Preclinical Research, LLC and Medicilon. 2. All emails sent to and from Center
for Biologics Evaluation and Research Director Peter Marks regarding Shanghai Medicilon Inc., also known as Medicilon
Preclinical Research, LLC and Medicilon. ETC
Copy of the disclosable portions of the following information for Nova-Tech, located in Grand Island, Nebraska: (1) the
483 for the 03/15/2022 inspection; and (2) the EIR, 483 and Company Response for the 04/22/2016 inspection. Please
note these inspections relate to Animal Drugs and Feeds.
Records regarding dockets FDA-2019-P-1534 ad FDA-2002-P-0364. Please see attached for details.
Resume, CV, and job application for Brian A. King's appointment as CTP Director in 2022.
Complaint # 169064 Date 7/16/2021 Complaint # 171774 Date 12/13/2021 Complaint # 175068 Date 6/27/2022
Inspection Records for Western Group Packaging, LLC 3330 E. Gowan Road N. LV, NV 89030
Nellcor OxiFirst PMA
HYDROCHLORTHIAZIDE APPROVAL
HYDROCHLORTHIAZIDE RECALL RECSS PFIZER
FDA INSPECTION REPORT FOR THE COMPANY ALLWAYS FRESH PRODUCTS INC ADDRESS : 465 VEIT RD, UNIT B,
HUNTINGDON VALLEY, PA 19006 WE NEED copy of the Commonwealth of Pennsylvania Department of Agriculture
Bureau of Food Safety and Laboratory Service Inspection LATEST Report
RECS RE FAMILY DOLLAR - STATEMENTS, NOTES, TESTS, ETC
I would like to request a copy of the FDA cleared 510(k) Submission : K200500 Trade/Device Name: Molekule Air Pro RX
Regulation Number: 21 CFR 880.6500 Regulation Name: Medical Ultraviolet Air Purifier Regulatory Class: Class II Product
Code: FRA Dated: February 27, 2020 Received: February 28, 2020 Thank you in advance Tim Lawton
I am requesting the 483(s) received by this company, some time in june 2022. Encompass pharmaceutical services,
located at 150 technology pkwy peachtree corners GA 30092. Thank you.
We would like to request all FDA findings for Allure Labs 30901 Wiegman Road, Hayward, CA 94544
We are requesting any FDA findings for NaturTech 350 Apache Trail Terrell, TX 75160 from 2018-current.
RE: J.M. Smucker Company, Lexington, KY. Please supply the Establishment Inspection Report and results of all lab
analysis for the inspection(s) conducted pursuant to the outbreak of Salmonella Senftenberg linked to consumption of
Jif Peanut Butter products manufactured at this location.
CORR AND COMM RE MARCH 3-4 CRYOGENIC TANK FAILURE THAT OCCURRED AT UNIVERSITY HOSPITALS - AHUJA
MEDICAL CENTER FERTILITY CLINIC, BEACHWOOD, OH ETC
for Human Drugs inspection of AmbioPharm, Inc ending 07/05/2017 at the location in Beech Island SC, United States.
K092622: STERRAD 100NX STERILIZER EXPRESS CYCLE We would like the access to the entire 510(k) files submitted to
the FDA
K131120: AMSCO V-PRO 1 LOW, V-PRO 1 PLUS, V-PRO MAX LOW TEMPERATURE We would like the access to the entire
510(k) files submitted to the FDA
K061313: EVIS EXERA 180 SYSTEM We would like the access to the entire 510(k) files submitted to the FDA
K172726: EVIS EXERA III BRONCHOFIBERVIDEOSCOPE OLYMPUS BF-MP190F, Single Use Biopsy Forceps FB-433D We
K032092: OLYMPUS XCYF-TP3 CYSTOFIBERSCOPE/NEPHROFIBERSCOPE We would like the access to the entire 510(k)
files submitted to the FDA
K062049: EVIS EXERA II 180 SYSTEM We would like the access to the entire 510(k) files submitted to the FDA
K172246: OLYMPUS URF-V2/V2R We would like the access to the entire 510(k) files submitted to the FDA
K140464: STERILUCENT PSD-85 HYDROGEN PEROXIDE STERILIZER We would like the access to the entire 510(k) files
K190005: Sterilucent HC 80TT Hydrogen Peroxide Sterilizer We would like the access to the entire 510(k) files submitted
to the FDA
K111391: STERRAD (R) 100NX DUO CYCLE TEST PACK We would like the access to the entire 510(k) files submitted to
the FDA
for Medical Devices & Rad Health inspection of Heartware, Inc. ending 09/30/2021 at the location in Miami Lakes FL,
for Human Drugs inspection of Mylan Pharmaceuticals Inc ending 05/26/2022 at the location in Morgantown WV,
for Biologics inspection of Csl Plasma ending 03/18/2022 at the location in Columbus OH, United States. The EIR (in
electronic format) for Biologics inspection of CSL Plasma Inc. ending 05/12/2022 at the location in Springfield OH,
for Biologics inspection of Csl Plasma ending 03/18/2022 at the location in Columbus OH, United States. The EIR (in
electronic format) for Biologics inspection of CSL Plasma Inc. ending 05/12/2022 at the location in Springfield OH,
The 483 (in electronic format) for Medical Devices & Rad Health inspection of Moldex-Metric, Inc. ending 05/20/2022 at
the location in Culver City CA, United States. etc
for Medical Devices & Rad Health inspection of B-ONE ORTHO, CORP. ending 05/18/2022 at the location in Cedar Knolls
We respectfully request all entry-line records that contain any of the following data points in reference to an entry’s
FSVP Importer, Importer of Record, or Consignee; for entry-lines with submission or arrival dates between July 1 and
July 31, 2022: 1) DUNS Number / Unique Facility Identifier (UFI) of: 080801169 2) Federal Tax ID Number (EIN) of:
822349285 3etc
for Medical Devices & Rad Health inspection of Alyk Inc. ending 05/20/2022 at the location in New York NY, United
All documents (i.e., FDA internal memoranda, review notes, reviewer guidance, manuals, templates, and similar
documents) related to SE0017151.PD1 (Backwoods Honey Berry Cigar Single Pouch), SE0017152.PD1 (Backwoods Honey
Cigar Single Pouch), SE0017153.PD1 (Backwoods Honey Berry Cigars 3 Pouch), SE0017155.PD1 (Backwoods Sweet
Aromatic Cigar Single Pouch), SE0017158.PD1 (Backwoods Sweet Aromatic Cigars 5 Pouch), and SE0017162.PD1
(Backwoods Original Cigars 5 Pouch), (collectively, the “SEs”):
Any correspondence between the FDA and Sarepta Therapeutics regarding SRP-9001 (delandistrogene moxeparvovec).
the postmarketing adverse events reported to the FDA Adverse Event Reporting System identified by Case ID as follows:
17488380; 17492822; 17498024; 17498939; 17501070; 17501450; 17505073; 17505126; 17509187; 17510969;
17511591; 17511602.
NDA 19807 Statistical Reviews/Letters/Memos
Please provide Summary Basis of Approval of BUDESONIDE CAPSULE, DELAYED RELEASE (TARPEYO) ORAL 4MG for
the Applicant CALLIDITAS THERAPEUTICS AB-N215935
Please see attached PDF for case identifiers. We are requesting individual case reports for twelve Case ID numbers
retrieved from the FAERS dashboard. Thank you, Laura Bunn
Hello, please provide the complete response and records for request 2022-3649
I would like to receive copies of the pharmacology and toxicology sections of IND 62160 - Sivelestst. I am attaching a
copy of a letter of authorization from the current IND holder - Mariushi Pharma
On behalf of Lupin Pharmaceuticals, Inc. I request you to please provide me the summary of ANDA - CMC and BE
reviews for the product FERUMOXYTOL SOLUTION; INTRAVENOUS (ANDA# 206604).
summary basis of approval (SBOA) for MEBENDAZOLE.
1. Establishment Inspection Report (EIR) provided to Medicilon Preclinical Research (Shanghai) LLC, as mentioned in a
letter from the FDA to Chun-Lin Chen, PhD, EMBA at Medicilon Preclinical Research, in a letter dated April 19, 2018.
Requesting an unredacted copy of the Product Quality Review for NDA 215152
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2022/215152Orig1s000,215153Orig1s000ChemR.pdf
Copies of emails sent between "kristen.haslam@fda.hhs.gov" and email correspondents using the email address domain
“@dsm.com” between 10/01/2019 and the date this records request is fulfilled. Any attachments to those emails.
Request a report on Adverse or Serious Adverse Events associated with the topical usage of copper containing product
including, Copper Carbonate Hydroxide, Copper Hydroxide and Cupric Oxide.
Hi, I was looking to see if this facility has been inspected, and for all 483s issued to this facility, for the period September
2021-July 2022 and was hoping you could help? Thank you! Revance Therapeutics, Inc, FEI 3007772056, located at
7555 Gateway Boulevard, Newark, CA 94560
I would like to request the complete case reports for the following FAERS cases involving the drug pegcetacoplan. The
case numbers are from the FAERS public dashboard. 19685262 19353149 19630663 20102463 19986134 Thank you
Please consider this a request for a copy of the 7/11/22 tentative approval letter for ANDA No. 215572 for
Spironolactone (generic drug).
Memorandum from the Division of Petition Control (HFS-215) to the Executive Secretary, Quantitative Risk Assessment
Committee (QRAC) (HFS-308) entitled "Estimation of upper-bound limit of lifetime risk from ethyleneimine (EI),
epichlorohydrin (ECH), ethylene oxide (EO), and 1,4-dioxane (DX), FAP 5B4452," dated October 5, 1999.
Copy of the disclosable portions of the REMS reviews for the following two supplements for NDA 020687, Mifeprex:
Supplement 22 (approved 04/11/2019), and supplement 24 (approved 05/14/2021); and for the following supplement
for ANDA 091178, mifepristone: Supplement 3 (approved 05/14/2021).
• FDA Test results for heavy metals including lead, cadmium, mercury, arsenic and inorganic arsenic, in any and all
baby and toddler food products from Jan. 1, 2021 to July 27, 2022. • Any and all test results received by the FDA from
states for testing of heavy metals including lead, cadmium, mercury, arsenic and inorganic arsenic in any and all baby
and toddler food products from Jan. 1, 2021 to July 27, 2022.
The data underlying the U.S. Food and Drug Administration’s (“FDA”) FDA Total Diet Study (TDS): FY2018-FY2020 TDS
Element Report, dated July 2022, including but not limited to data sufficient to identify the 307 foods sampled and
analyzed in Appendix A, Table 5.
Please share Form 483 of Aurobindo Pharma Unit 11 Inspection
Freedom of Information Act (FOIA): Request for Summary Basis of Approval (SBOA) of FML® (Fluorometholone
ophthalmic suspension, USP) 0.1% (NDA 016851) held by Allergan.
Certified copies of the Approval Packages for the following Atorvastatin Calcium Tablets ANDAs: 1. 076477 (sponsor:
Ranbaxy); 2. 077575 (Sandoz); 3. 078773 (Teva); 4. 090548 (Apotex); 5. 091226 (Mylan); 6. 091624
(Kudco); and 7. 202357 (Dr. Reddy’s).
Colgate is requesting import records of Colgate Palmolive S.A. de C.V. between January 2022 and July 2022.
On behalf on Lupin Pharmaceuticals, Inc. I request you to please provide me with latest container and carton label of
Dermotic (FLUOCINOLONE ACETONIDE) (NDC 019452) supplement-40 approved on 01/29/2020 . I would like to have
final Package insert as it is only available as draft labeling.
11 MedWatch Reports for Welireg. Please see attached for case numbers.
Close-Out letter related to warning letter (Ref. KAN 2012-11) issued July 30, 2012, to Jesse E. Rettig, Chief Executive
Officer Grato, Inc. 312 Lowery Drive Woodbine, lA 51579
Tentative and (where applicable) final approval routing summaries for the following ANDAs: 1. ANDA No. 078-383 filed
by Dr. Reddy's Laboratories; and, 2. ANDA No. 078-038 filed by Wockhardt.
Warning Letter 320-19-27. This warning letter was issued to Aurobindo Pharma Limited Plot No. 2, Maitrivihar,
Ameerpet, Hyderabad-500038, Telengana India. This warning letter pertains to a human drug manufacturing facility
located at Aurobindo Pharma Limited (APL), Unit XI at Sy. No. 61-66, IDA, Pydibhimavaram, Ranasthalam (Mandal),
Srikakulam District, AP, From Febuary 4-9 2019.
Hi, I would like to request the CMC section from the Summary Basis of Approval of ANDA 212025; APOMORPHINE
HYDROCHLORIDE approved 2/23/22. Thank you
Hi, I would like to request the Form 483 and the EIR from the 2022 FDA inspection of the Revance Therapeutics
manufacturing facility located in Fremont, CA. Thank you
All releasable forms 3542 for NDA No. 021361 that list patent information for U.S. Patent No. 8,642,573; U.S. Patent
No. 8,741,904; U.S. Patent No. 8,829,017; U.S. Patent No. 8,946,252; U.S. Patent No. 8,969,398; U.S. Patent No.
9,421,195; U.S. Patent No. 9,629,828; U.S. Patent No. 10,314,828; U.S. Patent No. 10,335,397; U.S. Patent No.
10,703,763; and U.S. Patent No. 10,709,694.
I would like inspection records from Acella Pharmaceutical located in Gerogia USA. Of their facility and any complaints
by consumers and all findings.
looking for documents & correspondences concerning Apothecare of Cape Cod ETC
The Complete Response Letter (CRL) the FDA sent to the biopharmaceutical company UCB in May 2022 regarding the
BLA for bimekizumab for the treatment of adults with moderate to sever plaque psoriasis.
The EIR (in electronic format) for Human Drugs inspection of Fisher Clinical Services, Inc. ending 08/31/2017 at the
location in Allentown PA, United States. The Response (in electronic format) for Human Drugs inspection of Teva
Branded Pharmaceutical Products R&D, Inc. ending 05/15/2017 at the location in West Chester PA, United States.
for Biologics inspection of CSL Plasma Inc. ending 02/24/2022 at the location in Port St Lucie FL, United States. Please
for Biologics inspection of CSL Plasma ending 02/16/2022 at the location in Champaign IL, United States. Please send
for Human Drugs inspection of PetNet Solutions Inc ending 04/08/2022 at the location in Elk Grove Village IL, United
for Medical Devices & Rad Health inspection of VALENCIA NATURALS, INC ending 05/11/2022 at the location in
Chatsworth CA, United States. The 483 (in electronic format) for Medical Devices & Rad Health inspection of Maxkron
Machine, LLC ending 05/13/2022 at the location in Valencia CA, United States. Please send documents as email
attachments.
t: The 483 (in electronic format) for Medical Devices & Rad Health inspection of Surgical Appliance Industries Inc
ending 05/10/2022 at the location in Cincinnati OH, United States. The 483 (in electronic format) for Medical Devices &
Rad Health inspection of Carefusion 2200 Inc ending 05/23/2022 at the location in Middleburg Heights OH, United
States.
for Medical Devices & Rad Health inspection of Verichem Laboratories, Inc. ending 05/24/2022 at the location in
Providence RI, United States. Please send documents as email attachments.
483: Alembic Pharmaceuticals Limited Panchmahal, India End Dates of
inspection: 13 Mar 2020 Project Area: Drug Quality Assurance FEI: 3004956904 Classification: VAI I confirm that
$ 200.
483: 21st Century Scientific Inc Coeur d Alene, Idaho United States End
Dates of inspection: 17 September 2021 Project Area: Compliance: Devices FEI: 1000125727 Classification: VAI I confirm
exceed $ 200.
483: Ajinomoto Althea, Inc. San Diego, California United States End
Dates of inspection: 25 May 2021 Project Area: Drug Quality Assurance FEI: 3004575449 Classification: VAI I confirm
exceed $ 200.
483: Apollo Care Columbia, Missouri United States End Dates of
inspection: 08 September 2021 Project Area: Drug Quality Assurance FEI: 3013927023 Classification: OAI I confirm that
$ 200.
483: Bruce Henry Properties, LLC DBA Bonadent Seneca Falls, New York
United States End Dates of inspection: 25 Mar 2022 Project Area: Compliance: Devices FEI: 3009659896 Classification:
483: Cogmedix, Inc. West Boylston, Massachusetts United States End
Dates of inspection: 07 Mar 2022 Project Area: Compliance: Devices FEI: 3007712511 Classification: VAI I confirm that
$ 200.
483: McGuff Company Inc. Santa Ana, California United States End
$ 200.
483: North Hudson IVF Center for Fertility & Gynecology P.C. Englewood Cliffs,
New Jersey United States End Dates of inspection: 03 Mar 2022 Project Area: Blood and Blood Products FEI:
483: RMA Long Island IVF Melville, New York United States End Dates of
inspection: 01 Mar 2022 Project Area: Blood and Blood Products FEI: 3007067646 Classification: VAI I confirm that
$ 200.
483: Zoll Medical Corporations Rumford, Rhode Island United States End
$ 200.
483: Ximedica LLC Providence, Rhode Island United States End Dates
of inspection: 13 Apr 2022 Project Area: Compliance: Devices FEI: 3006463947 Classification: VAI I confirm that
$ 200.
483: Vaupell Midwest Molding and Tooling Constantine, Michigan United
States End Dates of inspection: 04 Mar 2022 Project Area: Compliance: Devices FEI: 3003595343 Classification: VAI I
483: Taurus Engineering and Manufacturing, Inc. Saint Paul, Minnesota
United States End Dates of inspection: 10 Mar 2022 Project Area: Compliance: Devices FEI: 3010236732 Classification:
483: rms Surgical. Anoka, Minnesota United States End Dates of
inspection: 1 Apr 2022 Project Area: Compliance: Devices FEI: 3010009693 Classification: VAI I confirm that Clarivate
483: Revolutionary Science Shafer, Minnesota United States End
Dates of inspection: 06 Apr 2022 Project Area: Postmarket Assurance: Devices FEI: 3009519707 Classification: VAI I
483: POM Medical LLC Moorpark, California United States End Dates of
inspection: 08 Mar 2022 Project Area: Compliance: Devices FEI: 3010411911 Classification: VAI I confirm that Clarivate
483: Mid-Continent Packaging, Inc Enid, Oklahoma United States End
Dates of inspection: 07 Mar 2022 Project Area: Drug Quality Assurance FEI: 3003218007 Classification: VAI I confirm
exceed $ 200.
483: Medstrat, Inc. Downers Grove, Illinois United States End Dates
of inspection: 10 Mar 2022 Project Area: Compliance: Devices FEI: 3003574171 Classification: VAI I confirm that
$ 200.
Request to acquire the FDA 483 for FDA inspection of M9169 Flamma S.p.A. - FEI: 3001168779 Category: Drug
Quality Assurance, ending 17 March 2017, Location: Via Bedeschi 22, Chignolo d'Isola, Bergamo 24040, Italy (ITA)
For SUPPL-4 of NDA 211243, New indication granted 7/31/2020.
We are the agent for Amcol Health And Beauty Solutions. Amcol Health And Beauty Solutions does not have a copy of
the entire Drug Master File 12738 that it has submitted to FDA. We are requesting the files. Please provide a copy of the
submission files for Drug Master File 12738 that have been submitted to FDA in paper and eCTD format.
Hello, please provide all communications - emails, text messages, and instant chat messages - to or from any of the
following people mentioning "Judicial Watch", "gruber", or "krause" Peter Marks Janet Woodcock Dorian Fink
K063654
1) Listing of all INSPECTIONS since Sunday, August 1, 2021 (in CSV format) with the following fields: FEI Number,
FACTS database) for each company since Sunday, August 1, 2021 in CSV format with the following columns:
since Thursday, June 30, 2022
2022-1392, 2022-1828, 2022-1905, 2022-2156, 2021-6898.
2021-7619, 2022-1964, 2022-2800, 2022-2878, 2022-3114.
The following two (2) CSV files: 1) Listing of all INSPECTIONS since Sunday, August 1, 2021 (in CSV format) with the
following fields: FEI Number, Inspection Start Date, Inspection End Date, Legal Name, Address, City Name, State Code,
Zip Code, Country Name, FDA483, Full Name, District, Center, INSPECTION REASON 2) Listing of releasable inspection
CITATIONS (from FDA's FACTS database) for each company since Sunday, August 1, 2021 in CSV format with the
following columns: INSPECTION_ID, YEAR, INSPECTION_START_DATE, INSPECTION_END_DATE, FEI_NUMBER,
Complete Response Letters, Form 483 issuances and Establishment Inspection Report Documents issued to Alvotech
since Thursday, June 30, 2022. If the zipped files do not exceed 25 Megabytes, please send to support@fdazilla.com,
otherwise please send these on CD or DVD media to: Govzilla Inc., 1905 Marketview Drive, Suite 205 Yorkville, IL 60560
Please feel free to contact us (support@fdazilla.com, 1-844-332-3320) to discuss any questions or issues which may
result prior to or during the processing of this request.
Copy of the 483 for the 03/22/2022 - 04/01/2022 inspection of Benjamin A. Gartrell, M.D. [- / -]. This inspection pertains
to HUMAN DRUGS
Copy of the 483 for the 03/14/2022 - 03/17/2022 inspection of Wanzhu Hou, CMD, MD (CN) [Rockville / United States
of America] 4801 Randolph Rd, Rockville, MD 20852, USA. This inspection pertains to HUMAN DRUGS
Report and/or the MDSAP Noncomformity Grading and Exchange Form (NC) for the inspection of Avent S. de R.L. de
C.V., Tijuana, Mexico, end date 07-20-2017. FEI# 3007596547. This inspection pertains to medical devices.
Report and/or the MDSAP Noncomformity Grading and Exchange Form (NC) for the inspection of Merit Maquiladora
Mexico S De Rl De CV, Tijuana, Mexico, end date 10-06-2017. FEI# 3011642792. This inspection pertains to medical
devices.
for Human Drugs inspection of Ari Baron MD ending 09/18/2020 at the location in San Francisco CA, United States.
Report and/or the MDSAP Noncomformity Grading and Exchange Form (NC) for the inspection of NxStage Medical, Inc.,
Tijuana, Mexico, end date 12-14-2017. FEI# 3014193096. This inspection pertains to medical devices.
for Animal Drugs & Feeds inspection of TRS Labs Inc. ending 04/22/2022 at the location in Athens GA, United States.
for Human Drugs inspection of Institute for In Vitro Sciences, Inc. ending 06/01/2022 at the location in Gaithersburg
MD, United States. Please send documents as email attachments.
The 483 (in electronic format) for Medical Devices & Rad Health inspection of Medin Technologies, Inc. ending
02/16/2022 at the location in Totowa NJ, United States. The EIR (in electronic format) for Medical Devices & Rad Health
inspection of Medin Technologies, Inc. ending 02/16/2022 at the location in Totowa NJ, United States. Please send
Report and/or the MDSAP Noncomformity Grading and Exchange Form (NC) for the inspection of Internacional
Farmaceutica S.A. de C.V, Pueblo Infonavit Lerma, Mexico, end date 03-08-2018. FEI# 3014273254. This inspection
for Medical Devices & Rad Health inspection of Karl Storz Endoscopy America Inc ending 05/24/2022 at the location in
Auburn MA, United States. The 483 (in electronic format) for Medical Devices & Rad Health inspection of BK Medical
Holding Company ending 05/27/2022 at the location in Burlington MA, United States. Please send documents as email
attachments.
for Medical Devices & Rad Health inspection of Devon Orthopaedic Implants LLC., ending 05/19/2022 at the location in
King Of Prussia PA, United States. Please send documents as email attachments.
for Biologics inspection of Saint Bernards Medical Center IRB ending 05/26/2022 at the location in Jonesboro AR, United
States. The 483 (in electronic format) for Medical Devices & Rad Health inspection of Kenneth J Maverick, M.D. ending
05/20/2022 at the location in San Antonio TX, United States. Please send documents as email attachments.
records containing the data the FDA used to determine that that ivermectin presents a greater potential health risk,
despite evidence showing its success in treating COVID-19, than the COVID-19 vaccines that have been associated with
vastly more adverse events and deaths. etc
1. Please provide records of any studies and data that informed the FDA's determination in June 2020 that giving
hydroxychloroquine (HCQ) or (chloroquine) CQ to COVID-19 infected outpatients within seven days from the onset of
symptoms, under a doctor's supervision, will have no clinical effect and may be harmful to the patient. etc
Records of the daily email alerts/Daily Priority Reports received by FDA and/or CBER from CDC’s VAERS contractor,
including but not limited to any lists of VAERS ID numbers for reports of adverse events of special interest (AESIs) after
COVID-19 vaccines;10 2) Records of any manual review of serious ASEI reports conducted by FDA and/or CBER etc
GRN No. 001020 (“Protein from Helianthus annuus [sunflower protein]”), to specifically include the following
communications described in the U.S. FDA’s response letter to GRN No. 001020 (dated June 14, 2022)
Firm compliance inspection database in the pharmaceutical and medical device industries, from 10/1/1999 to present
email communications or otherwise from Peter Heimlich to the FDA regarding LifeVac LLC.
I am looking for any and all records related to Gray Barker, a resident of West Virginia. I have found documents in
Barker's archive suggesting that he was investigated or subject to inspection by agents of the FDA in or around 1970-
1971; it is possible that there may be further records from later. Barker died in 1984.
I request all 5 attachments (listed on p 59.) to the Establishment Inspection Report FEI 3012144557 of Berkshire Sterile
Manufacturing, 480 Pleasant St., Lee, MA 01238 conducted 8/26/20 through 10/27/20
1. Any and all documentation and correspondence related to Lannett Company Inc.’s December 18, 2019 voluntary
recall for the product described below, including but not limited to the health hazard evaluation, meeting notes, and
internal communications between the Health Hazard Evaluation Board and those who made the recall class
determination. Levetiracetam Oral Solution 100mg/mL NDC: 54838-548-80 etc
FDA testing results and other documents related to Real Water samples taken from Nevada Beverage Company
warehouses at 4250 E. Cheyenne Ave, Las Vegas, NV 89115 and 3940 W. Tropicana Ave, Las Vegas, NV 89103, including
FDA sample numbers 1158172 to 1158182; 1159389 to 1159390; and 1159391 to 1159399.
483 BSV Bioscience Gmbh Mar 2016 FDA investigators audited the BSV Bioscience Gmbh - Baesweiler, Germany facility
and issued inspectional observations (via FDA 483) on 11 Mar 2016. We request electronic copies be sent to
evan@granata.bio
K071553
This request under the Freedom of Information Act seeks the tentative (where applicable) and final approval routing
summaries for the following generic drug companies: Apotex and Hetero.
I'd like to request an adverse report for Mounjaro (tirzepatide) in PDF and Excel from Jan 2022 to present.
I'd like to request an adverse report for Wegovy (semaglutide) in PDF and Excel from Jan 2021 to present.
I'd like to request an adverse report for Fintepla (fenfluramine) in PDF and Excel from Jan 2020 to present.
I'd like to request an adverse report for Empaveli (pegcetacoplan) in PDF and Excel from Jan 2021 to present.
I'd like to request an adverse report for Opzelura (ruxolitinib) in PDF and Excel from Jan 2021 to present.
I'd like to request an adverse report for Amvuttra (vutrisiran) in PDF and Excel.
All records created by or in the possession of the Food and Drug Administration in connection with any investigation of
Western Milling LLC, Kruse-Western, Inc., and any known affiliated business entities concerning animal feed production
or monesin contamination from 2005 forward.
ALL FORM 483, EIR, RESPONSE LETTERS, AND ANY OTHER COMMUNICATIONS WITH THE FDA BY/FOR EYWA PHARMA
INC. LOCATED AT 2 RESEARCH WAY, FL PRINCETON, NJ 08540, USA AND 1 DUNCAN DR CRANBURY, NJ 08512, USA
Our organization is requesting all NDA 020355 filings and supplemental filings for Desmopressin Acetate 1.5 mg/mL
nasal spray. 03/07/1994 - ORIG-1 10/02/1995 - SUPPL-1 03/29/1996 - SUPPL-2 03/21/2000 - SUPPL-3 08/21/2002 -
SUPPL-4 10/24/2007 - SUPPL-7 09/16/2011 - SUPPL-13 01/25/2013 - SUPPL-18 05/24/2013 - SUPPL-17 06/10/2013 -
SUPPL-20 12/18/2013 - SUPPL-19 Please include any other supplemental filings that may not be included on FDA
accessdata.
We are interested in obtaining any Form 483s related to Braeburn Pharmaceuticals Inc. manufacturing activities at
Pharmaceutics International Inc., in Hunt Valley, MD. Please also include any additional documentation available related
to the BRIXADI pre-approval inspections at this facility.
We are interested in obtaining any Form 483s or inspection reports related to Sharp Packaging Services (d/b/a Sharp
Packaging solutions).
All records from plant inspections of Bush Brothers food manufacturing plants at 600 S Bush Brothers Dr Augusta, WI,
54722-7205 AND 3304 Chestnut Hill Rd. Dandridge, TN 37725
Enforcement Reports
August 1, 2022
1. A list of Docket ID numbers for citizen petitions submitted for therapeutic equivalence rating determinations for drugs
approved under 505(b)(2) of the Food, Drug, and Cosmetic Act (FDCA) since January 1, 2012. 2. A list of Docket ID
numbers for suitability petitions submitted for petitioned ANDAs under 505(j)(2)(C) of the FDCA since January 1, 2012.
Please provide this information in an Excel spreadsheet.
Can you send me all available records for the orphan approval of: Setanaxib treatment of primary biliary cholangitis
10/16/2020 Designated bis-choline tetrathiomolybdate Treatment of primary biliary cholangitis 04/06/2020
Designated If you can send the results via email that would be best. Thanks!
summaries, TPLs, and any associated supporting CTP memoranda or reviewer guides for the following STNs: SE0017370,
SE0018754, SE0017335, and SE0015415.
Please provide the full text of the following medication adverse event reports with the following Case ID numbers:
10450397, 10482140, 10483868, 10668363, 11049151, 11100448, 11319266, 11864318, 12395565, 12550256,
13156261, 13210670, 13210855, etc
A copy of the Approval Package (Summary Basis of Approval) for ANDA 208086, for Glucagon Injection, 1 mg/Vial,
approved on December 28, 2020.
Food Contact Substance:1,2-Cyclohexanedicarboxylic acid, calcium salt (1:1), (1R, 2S)-rel- (CAS Reg. No. 491589-22-1)
Looking for the EIR for FEI #3018815311 (Axsome Therapeutics, New York).
Requesting records of US FDA's inspection of Aurobindo Pharma's Unit XI - API non-antibiotic manufacturing facility
situated at Pydibhimavaram, Srikakulam District, Andhra Pradesh, from July 25 to August 2, 2022. A form 483 was
issued with 3 observations. Please share the information in public interest
This request seeks the tentative (where applicable) and final approval routing summaries for ANDA No. 076800, filed by
Ranbaxy Laboratories, Inc., and ANDA No. 076799, filed by Alphapharm Pty. Ltd.
BROADMASTER BIOTECH CORP, EIR of FDA inspection from 05/02/2016 - 05/05/2016
1. The Certificate of Sanitary Construction (CSC) for Vessel "American Song" (VIN 1282656) that was issued on or about
8/22/2018. 2. Any index or listing of documents that FDA reviewed in the process of determining to issue that
Certificate. (not all those documents, just any one listing or index of them) etc
VAERS report
VAERS report
VAERS report
We are requesting information on any reported cases of E. Coli on or near the date of 05/21/2022 in the Brooklyn, NY
11226 area. In addition, any reported cases of E. Coli at the Dominos, 775 Flatbush Avenue, Brooklyn, NY 11226 on or
near the date of 05/21/2022. We are Insight Service Group, a private investigation firm working on behalf of Alexis-Jaye
Mullane at Liberty Mutual Insurance Company in Boston, MA. This request is regarding an insurance claim. The client’s
file number is 24028369.
VAERS report
Any “simple notifications” provided to FDA under section 802(g) of the FDC Act (since 2007) identifying “Russia” as the
country to which products are being exported.
RE: Arrow Reliance Inc. (dba Darwin's Natural Pet Products), Tukwila, WA (REI #3007652252). Please supply all available
details on any consumer complaints, veterinarian-filed complaints, and/or Adverse Event reports relating to products
manufactured at this location. Please include lab results, where available.
(1) Any and all comments and complaints relating to Daily Harvest, Inc.’s French Lentil + Leek Crumbles from January 1,
2022, through the present. (2) Any and all documents reflecting or relating to the Food and Drug Administration’s
investigation of Daily Harvest, Inc.’s French Lentil + Leek Crumbles from January 1, 2022, through the present, including
correspondence, testing, data, reports, and logs. etc
Copy of the disclosable portions of the following 4 MedWatch reports for molnupiravir: 21118921, 21110635,
21105925, and 21096253.
Respectfully request Quality Assurance Profile (QAP) information for Almac Pharma Services LLC (Audubon, PA),
inclusive of all files, reports, and records related to inspections (including CDER inspection records and Establishment
Inspection Reports), inspection schedules and investigations (including Form 483s)..
Records of any investigation, audit, or inquiry relating to California-based BioCorRx, Inc. , Brady Grainer, or Andrew
Mallon. Food and Drug Administration (FDA) documents related to California-based BioCorRx, Inc., including but not
limited to all correspondence between the FDA and BioCorRx, as well as any other emails, letters, reports, and
memoranda.
Alternative Summary Reports (ASRs) for Intuitive Surgical's DaVinci Surgical Robot and accessories. They were not
included in the CDRH ASR data release in June 2019 but I need them to evaluate the safety of this device before my
mom gets surgery in early fall.
I am seeking inspection records for Lyons Magnus East, LLC, FEI number 1034904, in 2019. FDA's Dashboard indicates
there was an inspection on 10/08/2019, Inspection ID 1106243, classification VAI. I am seeking any and all records from
that particular inspection, as well as correspondence between FDA and Lyons Magnus East during and after the
inspection.
A list or spreadsheet of all products that have applied for PMTA authorization for synthetic nicotine, as of the May 14,
2022 deadline, as required under the new Congressional statute passed in March giving FDA authority over synthetic
nicotine.
EIR and Form 483 regarding the inspection for Catalent Pharma Solutions LLC,ended on 09/28/2020 (Inspection ID #
1131607) EIR and Form 483 regarding the inspection for Amgen Manufacturing Ltd, ended on 04/11/2019 (Inspection
ID # 1085900)
We are requesting all adverse reactions reported to the FDA between 2/22/22 and 7/8/22 on the two drugs listed
below: ciltacabtagene autoleucel CARVYKTI
2022-4579
Current Package insert of Minocycline for Injection,100 mg base/vial approved under ANDA # 214934 and held by
NEXUS PHARMACEUTICALS INC.
Request for the entire database of cosmetic products registered under the Voluntary Cosmetic Registration Program
(VCRP) in a digital format (CSV or excel preferably) with all registered products, their ingredients, and other publicly
available pertinent information. Proprietary business information, if any, may be redacted.
1) All FDA intake, routing, and/or tracking forms associated with: 1) AbbVie’s citizen petition, docket no. FDA-2011-P-
0610, and 2) Auxilium’s citizen petition, docket no. FDA-2013-P-0371. 2) The glossary or definitions provided for the
footnoted terms on the CDER Clearance Sheet, as updated on 08/23/12.
for Human Drugs inspection of Laura Kooienga, M.D. ending 05/21/2021 at the location in Denver CO, United States.
[Reference FGI# 22- 79252] Relevant to GS35F0553P Order 75F40122F19006, we seek copies of the following: (1)
Awarded contract with Statement of Work/Performance Work Statement, (2) Complete and original RFP with all
amendments, exhibits, attachments and Q&A’s (3) Labor rates/categories
[Reference FGI# 22- 79253] Relevant to GS35F0553P Order 75F40121F19005, we seek copies of the following: (1)
[Reference FGI# 22-79286] Relevant to GS35F0553P Order 75F40121F19004, we seek copies of the following: (1)
[Reference FGI# 22-79287] Relevant to GS35F0553P Order 75F40119F19001, we seek copies of the following: (1)
for Biologics inspection of PAR Sterile Products LLC ending 10/22/2021 at the location in Rochester MI, United States.
Please provide the following 1 inspection-related document in electronic PDF format: The Establishment Inspection
Report (in electronic format) for inspection of K.C. Pharmaceuticals, Inc. (Sterile OTC Drug (Eye Drop) Manufacturer)
ending 01/30/2020 at the location in 3201 Producer Way Pomona, CA 91768.
for Foods & Cosmetics inspection of Idaho Natural & Organic Foods LLC ending 03/07/2022 at the location in Mountain
Home ID, United States. Please send documents as email attachments.
for Biologics inspection of Children's Hosp Of WI Institutional Review Board ending 05/23/2022 at the location in
Milwaukee WI, United States. Please send documents as email attachments.
for Medical Devices & Rad Health inspection of Allied Healthcare Products Inc ending 05/20/2022 at the location in Saint
Louis MO, United States. The 483 (in electronic format) for Medical Devices & Rad Health inspection of Zutron Medical
LLC ending 05/24/2022 at the location in Lenexa KS, United States.
for Medical Devices & Rad Health inspection of Reliance Mobility, LLC ending 05/09/2022 at the location in Columbia
located in Cherry Hill, NJ.
Hello, I am requesting the "1996-current: PMN96CUR.ZIP" (Downloadable 510k dataset) but with the establishment
registration number added as a column in the CSV file. Thank you. (The PMN96CUR.ZIP downloadable dataset from this
page: https://www.fda.gov/medical-devices/510k-clearances/downloadable-510k-files ) (Establishment Registration
Number from Section B of FORM 3514)
Torigen Pharmaceuticals, Inc. respectfully requests the FOIA Drug Summary or any other available information for both
Asparaginase and Dactinomycin.
I would like to receive the Orphan Drug Designation request for Iobenguane I 131.
I would like to receive the Orphan Drug Designation request for lanreotide acetate.
I would like to receive the Orphan Drug Designation request for everolimus.
I would like to receive the Orphan Drug Designation request for Gallium-68 (DOTA0-Phel-Tyr3)octreotide.
I would like to receive the Orphan Drug Designation request for telotristat etiprate.
I would like to receive the Orphan Drug Designation request for Gallium [Ga-68]-N-[(4,7,10-tricarboxymethyl-1,4,7,10-
tetraazacyclododec-1 -yl)acetyl]-D-phenylalanyl-L-cysteinyl-L-tyrosyl-D-tryptophanyl-L -lysyl-L-threoninyl-Lcysteinyl-L-
threonine-cyclic(2-7)disulfide.
I would like to receive the Orphan Drug Designation request for copper Cu 64 dotatate (trade name: Detectnet).
Torigen Pharmaceuticals, Inc. respectfully requests the FOIA Drug Summary for for KinaVet CA-1,
Torigen Pharmaceuticals, Inc. respectfully requests the FOIA Drug Summary for for Paccal Vet,
Any 483 observation or Warning Letter inspection records received by Quality Chemical Laboratory located at 3400
Enterprise Drive, Wilmington NC.
Any 483 observation or Warning Letter inspection records received by Nelson Laboratories, located at 6280 S. Redwood
Road, Salt Lake City, Utah.
Any 483 observation or Warning Letter inspection records received by Alcami Corporation located at 2320 Scientific Park
Dr. in Wilmington NC.
Full 510(k) submission for 510(k) number K162784 received by the FDA on February 21, 2017.
Full 510(k) submission for 510(k) number K170499 received by the FDA on May 12, 2017.
Full 510(k) submission for 510(k) number K203665 received by the FDA on January 28, 2021.
Full 510(k) submission for 510(k) number K181774 received by the FDA on May 9, 2019.
Complete electronic copies of all submissions, responses and other related correspondence between sponsor and CVM
for period noted subject of INAD 013-047. All original submissions were made electronically, however original submitter
is no longer at company and files were not transferred when ownership was transferred to Elanco. Specific submission
reference numbers are included in attached letter.
DOCS AND CORR RE POTENTIAL VIOLATIONS OF THE FDCA BY TRU-D, SURFACIDE, UVDI, ETC.
documents and information relating to Soluciones Cosmeticas’ voluntary recalls of “Berish Hand Sanitizer Gel Fragrance
Free” and “Berish Antiseptic Alcohol 70% Topical Solution Hand Sanitizer"
VAERS report
communications and documents regarding Kim Witczak as a member of the Psychopharmacologic Drugs Advisory
Committee (PDAC).
requesting MAUDE, MDR and legacy device reports through DEN as well as "alternative summary reporting" records for
all dental implant failures and dental bone graft product failures placed in the USA 1990-present.
VAERS report
VAERS report
VAERS report
Sequence 0017 for DMF 025912, STERILE CONTRACT MANUFACTURING FACILITY AS MANUFACTURED IN GRAND
RAPIDS, MI.
All releasable documentation associated with FDA’s list of chemistry and toxicology questions regarding GRN 1020
posed to the notifier in an email dated February 11, 2022.
I request copies of all documents in the possession of FDA from April 1, 2022 to June 30, 2022 regarding products sold
under the brand name "Jamieson" including any: a)Form FDA3500 Voluntary Reporting, b) Form 3500B Voluntary
Reporting for Consumer and c) Form FDA 3500A Mandatory Reporting.
Zydus life sciences cadila moraiya form 483 please send
Zydus Life / Cadila health's Moraiya Facility 4 observations
483 issued to Aurobindo Pharma Ltd, Unit 11, Survey No 61-66, Pydibhimavaram, Ranasthali (M), Srikakulam District,
Andhra Pradesh, India
related petition and documents concerning 25-Hydroxyvitamin D3 submitted by DSM Nutritional Products ? The
documents are related to FAP 2277, FAP 2279 and GRASP 2449.
Torigen Pharmaceuticals, Inc. respectfully requests the FOIA Drug Summary or any additional available information for
Alpha-neurotoxoid Panavira. The Designation date was 7/27/2011. The sponsor was Cygnos Biotech, LLC, P.O. Box
160471, Miami, FL 33316. The indication was for the treatment of local disease in stage II and II oral malignant
melanoma in dogs.
All Premarket Tobacco Product Application (“PMTA”) marketing denial orders (“MDOs”), refuse to accept letters
(“RTAs”), and refuse to file letters (“RTFs”), including, but not limited to, copies of all such MDOs, RTAs, and RTFs; any
documents modifying the PMTA MDOs, RTAs, and RTFs, including, but not limited to, copies of all PMTA MDOs, etc
replication competent amphotropic murine leukemia virus with a cytosine deaminase gene (TOCA 511) and oral
flucytosine (5-FC). The Designation date was 1/25/2011 and the Designation terminated at sponsor’s request
9/25/2017. The sponsor was Tocagen, Inc., 330 Bunker Hill Street #230, San Diego, CA 92109. The indication was for the
treatment of primary malignant brain tumors in dogs.
VDC-597, Designation date 8/16/2018. The sponsor is VetDC, Inc., 320 Vine Drive, Suite 101, Fort Collins, CO 80524. The
indication is for the adjuvant treatment of splenic hemangiosarcoma following splenectomy in dogs.
Hello, I am seeking all documents related to FDA inspections of Uniqure's Lexington gene therapy manufacturing facility.
Copy of the disclosable portions of any review memoranda or other documents associated with FDA's toxicity review of
2-Ethyl-2-oxazoline, CAS Registry Number 10431-98-8, under the FDA Food-Contact Substance Notification Program
Requesting a copy of 510(k) K200596, S.E. 10/13/202: G21 Cement Vader Pedicle System
510k submission FDA correspondence on K220867
510K Submission FDA Correspondence on K212306
510K Submission FDA Correspondence related to K112423

510(K) Summary and correspondence for K220317, commercially known as PuraPly Micronized Wound Matrix (PuraPly
MZ).
Requesting a copy of 510(k) K193423, S.E. 05/22/2020: Vader One Pedicle System MIS and Lightmore Pedicle System 6.0
Requesting a copy of 510(k) K190545, S.E. 06/20/2019: Vader One Pedicle System MIS and Lightmore Pedicle System 6.0
510k submission Correspondence related to K213958
for Medical Devices & Rad Health inspection of Neotech Products, LLC ending 06/09/2022 at the location in Valencia CA,
for Human Drugs inspection of Rafaelito S. Victoria, MD ending 06/10/2022 at the location in La Palma CA, United
for Biologics inspection of American Fertility Medical Center - Genetic Infertility & An ending 06/09/2022 at the location
in Irvine CA, United States. Please send documents as email attachments.
for Human Drugs inspection of Encompass Pharmaceutical Services Inc. ending 06/03/2022 at the location in Peachtree
Corners GA, United States. Please send documents as email attachments.
for Medical Devices & Rad Health inspection of Xintec Corp ending 06/07/2022 at the location in Alameda CA, United
2022-5076
Requesting the summary basis of approval for NDA 018612 for non-commercial scientific research.
for Human Drugs inspection of Akron Coating & Adhesives Inc ending 06/27/2022 at the location in Akron OH, United
States. The 483 (in electronic format) for Human Drugs inspection of Emily K. Curran, M.D. ending 06/03/2022 at the
location in Cincinnati OH, United States. Please send documents as email attachments.
for Medical Devices & Rad Health inspection of ADMI ending 06/03/2022 at the location in East Syracuse NY, United
States. The 483 (in electronic format) for Medical Devices & Rad Health inspection of Electroskip, Llc ending 06/07/2022
at the location in Buffalo NY, United States. Please send documents as email attachments.
for Human Drugs inspection of FARMAKEIO OUTSOURCING LLC ending 06/10/2022 at the location in Southlake TX,
f all documents in the custody and/or control of the U.S. Food and Drug Administration (“FDA”) concerning (1) Natera
Inc. (“Natera”) in connection with the FDA’s April 19, 2022 News Release titled “FDA Warns of Risks Associated with
Non-Invasive Prenatal Screening Tests” and the FDA’s April 19, 2022 Safety Communication titled “Genetic Non-Invasive
Prenatal Screening Tests May Have False Results,” (2) Natera’s noninvasive prenatal tests, including Panorama™, and (3)
Natera’s transplant rejection assessment test, Prospera™.
510k submission FDA correspondence on K122048
PERSONAL RECS
Establishment inspection report (EIR) for Veeda Clinical Research Private Limited. Ahemdabad India FEI 3006355426
Inspection date - 20 to 24 March 2017
Please provide Summary Basis of Approval of EDARAVONE SUSPENSION ORAL (RADICAVA ORS) 105MG/5ML for the
Applicant MITSUBISHI TANABE PHARMA CORP-N215446
I am an investment professional for an asset management firm and would like to request any 483s issued for inspections
occurring from 04/01/2022 to 08/04/2022 for WuXi Biologics Co., Ltd. located at 108 Meiliang Road, Mashan, Binhu
District, Wuxi, Jiangsu 214092, China? The FEIN is 3010606982.
Hi, I would like to request the 15-day response letter sent by Berkshire Sterile Manufacturing to the FDA following the
May 2022 inspection of the facility located in Lee, MA. Thank you
AstraZeneca Pediatric Study 375 IND 063634 See Attached Request Letter
CDRH RECS RE POSTMARKET SURVEILLANCE, ADVERSE EVENTS, HAZARD ANALYSIS, ETC SMARTABLATE RF SYSTEM,
THERMOCOOL SMARTTOUCH
VAERS RECORDS
INFORMATION RE INTRANENOUS FEED SOLUTION PROCALAMINE 1976 - WHEN GLYCEROL REACHES AND STEADY STATE
IN PLASMA ETC
list of drugs and companies identified as complex generics in 2020 and 2021
Student Guide for FD226 Produce Inspections for Regulators, the guide should include all powerpoint slides, notes,
activities, exercises and associated handouts. Should a student manual or other similar manual be available, that would
be responsive to this request.
ECS Brands "Nitro-V" GRAS Certification
Can you send me the record of FDA's April 9, 2008, orphan designation of obeticholic acid for primary biliary cirrhosis?
Please send the results to me via email. Thanks!
Premarket Notification Submission Document 510(k)Number : K212412 Device Name : IRIS-XP Applicant : Medicore Co.,
Ltd.
2015-5556
All food additive petitions for animals records submitted to FDA CVM and FDA Division of Animal Feeds, January 1,
2022-July 31, 2022
All audio recordings from FDA-CVM for the AAFCO 2022 Midyear Meeting 01.18.22-01.24.22
from June 1, 2022-July 31, 2022. a. Please include the type of animal, the reaction, the brand name and the product
name of the food item to which the dog or cat reacted, the symptoms displayed and the outcome, if available. ETC
I would like all records provided for 2022-3220, which is all inspection documents for FDA inspection of OC Raw Dog LLC,
located at 1500 Commerce St., Ste. A #101 Corona, CA 92880-1715 01.01.21-12.31.21
Dear FDA Official, Pursuant to the Freedom of Information Act, I request a copy of the Medical Device Fellowship
Program (MDFP) applicant records.
Hello, please provide all the raw data from the FDA-CMS Medicare and BEST systems regarding post-vaccination
myocarditis, pericarditis, and myopericarditis.
Hello, Please provide all memorandums and other documents on the FDA's decision to accept clinical trial data for the
COVID-19 vaccines that measured efficacy as starting 14 days after a dose.
All requests for certification as an eligible organization under the Intergovernmental
Personnel Act mobility program submitted to your agency since Jan. 1, 2017 ETC
All records concerning the solicitation, award, and/or all modifications of Contract 75F40121P00211 awarded to Active
Health Science, LLC, dated from October 1, 2020 to date of search.
All records and communications maintained by the Center for Drug Evaluation and Research, Food and Drug
Administration concerning (1) Adverse Events (AEs), Serious Adverse Events (SAEs), Serious and Unexpected Suspected
Adverse Reactions (SUSARs), Unanticipated Problems (UPs) AND / OR (2) any finding from animal or in vitro testing
whether or not conducted by the investigator that suggest a significant risk in humans exposed to the drug such as
reports of mutagenicity, teratogenicity, or carcinogenesis or reports of organ toxicity for the following: Proper Name:
Smallpox and Monkeypox Vaccine, Live, Non-Replicating Tradename: JYNNEOS Manufacturer: Bavarian Nordic A/S ETC
Smallpox (Vaccinia) Vaccine, Live Tradename: ACAM2000 Manufacturer: Emergent Product Development Gaithersburg,
Inc. ETC
ST-246 / tecovirimat Tradename: TPOXX Manufacturer: SIGA Please provide records from January 1, 2010 to present.
All electronic correspondence containing any of the following terms ("monkeypox" or "mpox" or "Jynneos" or "Bavarian
Nordic" or "Kvistgaard" or "Denmark") sent or received by the following FDA employees: Peter Marks or Robert Califf or
Jerry Weir.
I request access to and copies of all electronic correspondence containing any of the following terms ("monkeypox" or
"mpox" or "Tpoxx" or “Siga” or “tecovirimat”) sent or received from 5/1/22 to 8/4/22 by the following FDA employees:
Patrizia Cavazzoni or Adam Sherwat.
FDA Foreign Inspection Results (Available Form 483 observations) for: Kyowa Hakko Bio Co. Ltd. (Hofu Plant) 1-1
Kyowa-cho, Hofu-shi Yamaguchi, 747-8522 Japan.
EIR for inspection of Roche Diagnostics, 9115 Hague Rd., Indianapolis, IN 46256-1025 on 6/24/2019 to 6/27/2019. Lead
investigator was Myra K. Casey.
All FOIA requests received, name and organization making the request, and the original date of submission.
Please provide FDA’s Health Hazard Evaluation(s) involving Bumble Bee’s “baby smoked claims in cottonseed oil”
product that FDA tested as part of FDA’s July 6, 2022, Results on PFAS Testing in Seafood (identified as “clam 1-4”).”
Copy of the 483 for the 03/21/2022 - 03/23/2022 inspection of Holodiag Val-de-Reuil, France. This inspection pertains
to HUMAN DRUGS
Copy of the 483 for the 03/09/2022 - 03/11/2022 inspection of Keybio ZAC ATHELIA V, 539 Av. du Mistral, 13600 La
Ciotat, France. This inspection pertains to HUMAN DRUGS
I am an investment professional for an asset management firm and would like to request all whistleblower reports
related to the Philips Respironics CPAP device recall between January 1, 2020 and August 5, 2022.
We would like to request the following Drug Product review records for the application number , RLD - NDA # 017100:
1. Approval Letter(s) 2. Summary Review 3. Chemistry, 4. Administrative 5. Non-Clinical, 6. Clinical
2022-3042, 2022-3220, 2022-3287, 2022-3384, 2022-3385.
2022-3456, 2022-3712, 2022-3770, 2022-3772, 2022-3778.
CVs David R Heiar, Kristen D Evans, Janice K Gardner, Phillip L Toy, Christine M Cerenzio, etc
I am looking for the case reports for deaths associated with Vyvgart that have been added to FAERS. The case IDs are
20986731, 20733649, 20628191, 20661555, 20436365, 20936386, 20773415, 206461192, and 20817585.
Please provide the Establishment Inspection Report (EIR) associated with the FDA's inspection of Bioiberica SAU's (FEI #:
1000418405) Palafolls, Spain facility that concluded on 2/4/2022. Facility address: Carrer Antic Cami de Tordera 109-
119, Palafolls, Barcelona, 08389, Spain.
Need a copy of the 510 (k) that was submitted. The 510 (k) number is k110719.
UCB Pharma SA [FEI: 3003909356] Site Address: Braine-l'Alleaud, Belgium, 1420 Inspection Date: 01/27/2022 -
02/04/2022 483R and any other commentary between UCB and the FDA between the dates of 1/1/2022-2/4/2022
regarding this inspection.
All documents and communications exchanged between FDA and Desktop Metal ("DM") regarding the manufacturing or
product compliance practices and procedures at DM/EnvisionTEC’s Dearborn, Michigan facility. 2. All documents and
communications exchanged between FDA and EnvisionTEC regarding the manufacturing or product compliance
practices and procedures at DM/EnvisionTEC’s Dearborn, Michigan facility. etc
All Technical Project Lead (TPL) Decision Summaries for the Marketing Denial Order actions taken by FDA for JUUL
products. These TPL Decision Summaries reflect FDA's decision rationale for the Marketing Denial Order actions taken
by FDA on June 23, 2022 for JUUL products.
All records pertaining to Consumer Complaint #174113 submitted to the Office of Regulatory Affairs U.S Food and Drug
Administration, 1 Montvale Avenue, Stoneham, MA 02180 on May 10th 2022.
Human Adverse Drug MedWatch Reports for the following case IDs: 20726721 20726764 20805149 20988874
21019614
FOIA request for the full 510K submission for SmartFlow (K123605) and the SurgiVision (K102101) devices
FDA summary and discipline reviews for Tecentriq (atezolizumab) approval of supplement 42 on 15 Oct 2021 for
adjuvant NSCLC.
On behalf of Lupin Pharmaceuticals Inc. I request you to please provide me with Package insert for the product DERMA
SMOOTHE/FS (NDA 019452) approved on 12/13/16 as per supplement-28.
Please provide Summary Basis of Approval of MESALAMINE CAPSULE, EXTENDED RELEASE ORAL 500MG for the
Applicant SUN PHARMACEUTICAL INDUSTRIES LTD-A214585
carboplatin. The Designation date was 9/10/2020. The sponsor is Armada Animal Health, LLC, ert E. 94th Street #PHE,
New York, NY 10128. The indication is for the treatment of non-metastatic squamous cell carcinoma in dogs that have
not received previous chemotherapy or radiotherapy.
doxorubicin. The Designation date was 7/14/2021. The sponsor is Anivive Lifesciences, Inc., 3250 Airflite Way, Long
Beach, CA 90807. The indication is for the treatment of lymphoma in dogs.
An auditor was at our facility in September 2020 and we received a letter dated July 14th 2022 for Lot #21. We would
like the records on the type of test conducted as well as the date the test was conducted.
Hello, I would like to request all supporting data for one 510(k) form submitted by DENTSPLY INTERNATIONAL INC.,
K121698. The supporting data should include performance data, biocompatibility data, safety data/claims, and any
other data submitted by the applicant. Thank you, Andrew
Hi, I would like to request the Form 483 issued to Revance Therapeutics during their Neward, CA manufacturing facility
inspection in 2022. I would also like to know whether the EIR is available. Thank you
chlorambucil. The Designation date was 9/16/2015. The sponsor is EirGen Pharma Ltd., Westside Business Park, Old
Kilmeaden Road, Waterford, Ireland. The indication is for maintenance therapy in dogs with chronic lymphocytic
leukemia following an induction protocol of chemotherapy.
Hi, I would like to request the Form 483 issued to Berkshire Sterile Manufacturing during the August or Sept 2022 FDA
inspection of the facility located in Lee, MA. Thank you
Doxophos Vet (doxorubicin). The Designation date was 6/27/2012 and the Designation terminated at sponsor’s request
11/29/2018. The sponsor was Oasmia Pharmaceutical AB, Vallongatan 1, SE752, 28 Uppsala Sweden. The indication was
for the treatment of lymphoma in dogs.
RC-2B (geroxane). The Designation date was 8/5/2013 and the Designation terminated on 12/18/2018. The sponsor was
Torquin, LLC, 508 Kodiak Trail, Cedar Park, TX 78613. The indication was for the treatment of lymphoma in dogs and the
treatment of nonresectable Grade II and III mast cell tumors in dogs that have no received previous therapy except
corticosteroids.
RV1001 (a PI3Kd inhibitor). The Designation date was 7/29/2015 and the Designation terminated on 5/29/2020. The
sponsor was Rhizen Pharmaceutical, SA, Fritz Courvoisier 40, CH-2300 La Chax-de-Fonds, Swizterland. The indication
was for the treatment of lymphoma in dogs.
for Medical Devices & Rad Health inspection of Zoll Medical Corporation ending 06/13/2022 at the location in Deerfield
for Biologics inspection of The A.R.T. Institute of Washington, Inc. ending 06/08/2022 at the location in Bethesda MD,
I am writing to request the following records under FOIA: All inspection reports from the Office of Regulatory Affairs for
finished drug product or API manufacturers (not compounding pharmacies) in which the Agency downgraded the report
from Official Action Indicated to Voluntary Action Indicated. I also request all associated downgrade memorandums for
the inspections that were changed from OAI to VAI.
I am requesting all syringe-related communications between FDA and the Becton-Dickinson company from the 1930s-
1950s (when BD was a leading force in reusable syringes and sterilizing technologies) and the 1960s-1980s (when BD
shifted to become a leading innovator in disposable syringes and diagnostic devices). I
All Agency documents, correspondence, records, opinions, and other related materials that are related to the legal or
regulatory status of nasal washes and rinses, including those containing sodium chloride or sodium bicarbonate, from
2010 through present. Specifically, we request materials from the Center for Devices and Radiological Health (“CDRH”),
Office of Combination Products (“OCP”), or both.
Please provide all emails or correspondence (with attachments if applicable) containing any of the words "Coxiella",
"Burnetii" or "Q fever" to, from or cc’ing any of the following people: Janet Woodcock
(Janet.Woodcock@fda.hhs.gov) Peter Marks (Peter.Marks@fda.hhs.gov) Celia Witten (celia.witten@fda.hhs.gov) Steven
Hahn Scott Gottlieb etc
Predicate device(s) to which manufacturer of each 510k device claims equivalence: In the requested information, please
include the 510k/PMA number of predicate device(s) and the manufacturer(s) of the predicate device(s) of each 510k
cleared device. (Similar request to 2019-7535 and 2021-7400) Please include records from the earliest available date of
records (1976 if possible) to current day.
for Foods & Cosmetics inspection of Abbott Nutrition, Division of Abbott Laboratories ending 03/25/2022 at the location
in Columbus OH, United States. Please send documents as email attachments.
The 483 (in electronic format) for Foods & Cosmetics inspection of Fruit Of The Earth, Inc. ending 12/22/2021 at the
location in Grand Prairie TX, United States. The EIR (in electronic format) for Foods & Cosmetics inspection of Fruit Of
The Earth, Inc. ending 12/22/2021 at the location in Grand Prairie TX, United States. The Response (in electronic
format) for Foods & Cosmetics inspection of Fruit Of The Earth, Inc. ending 12/22/2021 etc
format) for Human Drugs inspection of BLA Enterprises, LLC dba Green Mountain Pharmaceuticals ending 12/13/2021 at
the location in Lakewood CO, United States. Please send documents as email attachments.
for Human Drugs inspection of Airgas USA, LLC ending 06/08/2022 at the location in Billerica MA, United States. The
483 (in electronic format) for Human Drugs inspection of The General Hospital Corporation ending 06/13/2022 at the
location in Boston MA, United States. Please send documents as email attachments.
for Medical Devices & Rad Health inspection of Infinite Biomedical Technologies ending 06/10/2022 at the location in
Baltimore MD, United States. Please send documents as email attachments.
2022-4833
The EIR (in electronic format) for Human Drugs inspection of United Exchange Corporation ending 04/06/2018 at the
location in Cypress CA, United States. The Response (in electronic format) for Human Drugs inspection of United
Exchange Corporation ending 04/06/2018 at the location in Cypress CA, United States.
The EIR (in electronic format) for Biologics inspection of Bavarian Nordic A/S ending 03/01/2019 at the location in
Kvistgaard, Denmark. The EIR (in electronic format) for Biologics inspection of Bavarian Nordic A/S ending 07/08/2022
at the location in Kvistgaard, Denmark.
for Medical Devices & Rad Health inspection of SpaceBander Corporation ending 06/02/2022 at the location in
Hillsborough NJ, United States. Please send documents as email attachments.
for Human Drugs inspection of Generichem Corporation ending 06/08/2022 at the location in Totowa NJ, United States.
for Medical Devices & Rad Health inspection of Physician Software Systems LLC ending 06/06/2022 at the location in
Lisle IL, United States. Please send documents as email attachments.
for Human Drugs inspection of AltaThera Pharmaceuticals LLC ending 06/17/2022 at the location in Chicago IL, United
for Medical Devices & Rad Health inspection of Vela Operations USA, Inc. ending 06/01/2022 at the location in Salt Lake
City UT, United States. Please send documents as email attachments.
for Medical Devices & Rad Health inspection of Marlen Manufacturing & Development Co. ending 06/08/2022 at the
location in Bedford OH, United States. Please send documents as email attachments.
All e-mail records for FDA employee Darla Bracy [OHAF-West Division 5] for date range of 07.01.2017-09.30.2017
containing the key terms; Small Batch, Michael Vogel
available. etc
All email records for FDA CVM employee Isabel Pocurull containing the key search term: AAFCO 05.01.2021-07.31.2021.
All email records for FDA CVM employee Matthew Lucia containing the key search term: AAFCO 05.01.2021-07.31.2021.
All email records for FDA CVM employee William Burkholder containing the key search term: AAFCO 05.01.2021-
07.31.2021
FDA Stop Sale, Use or Removal Order for Veratour "BioErase" product Product type: Disinfectant wipes
FDA approval or non-pproval of Veratour "BioErase" product Product type: Disinfecting wipes
All data and information for the 12-15-Year-Old Pfizer Vaccine enumerated in 21 C.F.R. § 601.51(e) with the exception
of publicly available reports on the Vaccine Adverse Events Reporting System.
17735804 17795332 18199253 18434993 18648645 18776340 19188143 19664462
Please provide the following documents from Summary Basis of Approval (SBOA) for ACYCLOVIR CREAM;
TOPICAL, 5%, ANDA# 208766: (1) CHEMISTRY REVIEW(S) (2) ADMINISTRATIVE and CORRESPONDENCE DOCUMENTS.
Please provide the following documents from Summary Basis of Approval (SBOA) for Dapsone Gel 7.5%; TOPICAL,
ANDA# 213847:
- BIOEQUIVALENCE REVIEW(S) DOCUMENTS
From the records that are searchable by FOI Branch II (OSPOP), for the time period January 1, 2022 to present, all
correspondence and other related documents regarding FDA’s recall classification for the following recall numbers: F-
0958-2022, F-0957-2022, F-0955-2022, F-0949-2022, etc
Any and all documents (paper or electronic) related to a product called the "Anterior Growth Guidance Appliance", also
known as the "Osseo-Restoration" appliance.
container label and outsert for the following RLD- Active Ingredient: FLUPHENAZINE HYDROCHLORIDE Proprietary
Name: PROLIXIN Dosage Form; Route of Administration: TABLET; ORAL Strength: 5MG
Request for individual case reports. Total Number: 2. Source of case number: FAERS Public Dashboard Case number #1:
17864759 Suspect Product Name: Soliris Suspect Product Active ingredients: Eculizumab;Efgartigimod Alfa;Human
Immunoglobulin G Case number #2: 20797046 Suspect Product name: Soliris Suspect Product Active ingredients:
Eculizumab;Efgartigimod Alfa
All documents, communications and/or records related, in any way, to FDA's 2022 inspection of Quva Pharma Inc. in
Temple, TX.
Hi, we would like to request an electronic copy of the FDA direct report to FAERs for the following case: 21009241
(Zynrelef) in order to assess impact to our Heron marketed product. Many thanks! Audrey
Please provide the disclosable portions of the Establishment Inspection Reports issued to Logic Technology
Development, LLC for the three manufacturing site inspections conducted between 1/6/20 and 1/16/20
VAERS Report
K221834, K221658, and K181205.
Please see enclosed letter. FOIA requests include: 1. Any and all DOCUMENTS relating to the notice published on the
FDA website on August 16, 2021, entitled “Voluntary Recall of Hostess® Hamburger Buns & Hot Dog Buns Due to
Possible Health Risks,” and attached to the enclosed letter as Exhibit A. 2. Any and all DOCUMENTS relating to any
inspection conducted by the FDA regarding the FACILITY from January 1, 2018 to present. etc
The CDER Drug approval database includes the approved label for Immunex entanercept supplement, but the approval
letter is not available. I'm writing to request the approval order/letter. Biologic License Application (BLA): 103795
Company: IMMUNEX 10/06/2017 Amgen Enbrel SUPPL-5561 Supplement Label (PDF)
Please provide the disclosable portions of the Establishment Inspection Reports issued to Logic Technology
Development, LLC for the three manufacturing site inspections conducted between 1/6/20 and 1/16/20 as described in
the Technical Project Lead Review Summary memo for the products that received a PMTA Marketing Granted Order on
3/24/22 (STN: PM0000529-31; PM0000535-37; PM0000540-41)
Please provide the disclosable portions of the Establishment Inspection Report issued to R.J. Reynolds Tobacco
Company for the manufacturing inspection conducted at 7855 King Tobaccoville Road, Tobaccoville, NC 27050 in
February 2020 as referenced in the Technical Project Lead Review Summary memo for the products that received a
PMTA Marketing Granted Order on 10/12/21 (STN: PM0000551, PM0000553, PM0000560)
Please provide the disclosable portions of the Establishment Inspection Report(s) issued to Fontem US, LLC for the post-
market site inspection that occurred at the Charlotte, North Carolina facility that ended February 25, 2020. The
inspection ID is 1121006
Please provide disclosable portions of the original FOIA request letters and complete FDA responses for file numbers
2022-3339 and 2022-3609.
A copy of GRAS notice (GRN) 1056, ß-lactoglobulin produced by Komagataella phaffii strain “yRMK-66,” submitted by
Remilk Ltd. The requested records are maintained at the Center for Food Safety and Applied Nutrition, Office of Food
Additive Safety.
Correspondence and documents regarding Dr. Matt Holman’s recusal and leave from work at the Center for Tobacco
Products and U.S. Food & Drug Administration and his termination of employment.
Hi, I would like to request the EIR from the July 2022 FDA inspection of the Revance Manufacturing Facility Located in
Newark, CA. Thank you.
I am an investment professional for an asset management firm and would like to request the response filed by Revance
Therapeutics to the form 483 that was issued to FEI #3007772056 located at 7555 Gateway Blvd, Newark CA 94560 on
7/15/22. Electronic copy is requested.
DAILY HARVEST - OUTBREAK RECS
Request copy of Order Approving Predicate Product and/or Substantial Equivalence Product Application filed for our
cigarette brand "New York New York Cigarettes"
The 483 (in electronic format) for Human Drugs inspection of Revance Therapeutics Inc ending 07/15/2022 at the
location in Nashville TN, United States. The EIR (in electronic format) for Human Drugs inspection of Revance
Therapeutics Inc ending 07/15/2022 at the location in Nashville TN, United States. The Response (in electronic format)
for Human Drugs inspection of Revance Therapeutics Inc ending 07/15/2022 at the location in Nashville TN, United
format) for Human Drugs inspection of Curia New Mexico, LLC ending 04/11/2022 at the location in Albuquerque NM,
for Foods & Cosmetics inspection of AmerisourceBergen Drug Corporation ending 07/14/2022 at the location in
Amityville NY, United States. Please send documents as email attachments.
for Biologics inspection of Polcz Fertility Lab, LLC ending 06/27/2022 at the location in Boynton Beach FL, United States.
The 483 (in electronic format) for Biologics inspection of Mark S. Denker, M.D., PA ending 06/06/2022 at the location in
Boca Raton FL, United States.
The 483 (in electronic format) for Human Drugs inspection of USpharma Ltd ending 06/23/2022 at the location in
Miami Lakes FL, United States. The 483 (in electronic format) for Human Drugs inspection of U.S. Investigational Review
Board Inc. ending 06/06/2022 at the location in Miami FL, United States. Please send documents as email attachments.
for Medical Devices & Rad Health inspection of Sonoco TEQ Llc ending 06/10/2022 at the location in Fremont IN, United
I request the FDA Form 483 issued to Reckitt Mead Johnson Nutrition at their Evensville facility in Indiana. Our
understanding is that this form 483 was issued to Reckitt Mead Johnson Nutrition in Aug 2021 and that’s what we are
requesting
Product registration information and all subsequent supplements for product application A208766
Product registration information and all subsequent supplements for product application. no. A208702
Product registration information and all subsequent supplements for product application no. A213847
Product registration information and all subsequent supplements for product application no. A214722
please provide the 483 forms for the pre licensure inspection listed below: District:SAN FEI Number:3007772056
Inspection Date:07/15/2022 Commodity:Human Drugs Firm Name:Revance Therapeutics Inc Firm Address:7555
Gateway Blvd City:Newark State:CA ZIP:94560-1152 Country:US
Hi, I would like to request the 15-day response letter sent to the FDA by Berkshire Sterile Manufacturing after its
October 2021 FDA inspection of the manufacturing facility located in Lee, MA. Thank you
testing
Dear Sir/Madam, Par is requesting the FDA FOI for Application NDA#019443, Proprietary Name 'Sodium Bicarbonate in
a Plastic Container, Strength 0.9MEQ/ML & 1MEQ/ML, Approved 06/03/1986'?
in the month of July 1 to 31, 2022, including for any inspections dated before July 1
1. All documents, photographs, videos, correspondence, investigations, claims, and disks that have any and all files
maintained by the FDA indicating that ThermiRF devices and Thermitight procedures have led to burns, injury, or other
undesired results. ETC
I would like to request the following Zilretta case number 20900429.
I would like to request the follow Zenpep and Viokase cases: 20968501 20850236 20857547
Hello, I would like to request the "For Cause Inspection Request" memorandum dated September 24, 2021 issued by the
FDA (under MARCS Op ID No. 207184), regarding the manufacturing inspection of Berkshire Sterile Manufacturing in
Lee, MA. Thank you
Dear Reviewer, Please provide all 510(k) submission related information, notes, memos, communications and
correspondences specific to the following 510(k): K051309
INDIVIDUAL RECS
I. Custodians a. Janet Woodcock b. Rick Bright c. Gary Disbrow d. Denise Hinton II. Requested Records The timeframe
for each request is March 1, 2020, to September 1, 2020: A. For all custodians, all records, including but not limited to
email, texts, memoranda, and handwritten notes including the words “hydroxychloroquine” or “HCQ,” or “early
treatment,” or “early (drug) treatment,” or “remdesivir.” ETC
I am seeking all adverse event reports submitted to the FDA relating to the use of "Miracle Mineral Solution", also
known as "Master Mineral Supplement", "MMS", and "chlorine dioxide".
records regarding a citizen petition submitted to FDA on September 18, 2017 involving the drug Propecia, NDA 020788.
I would like to request Illuccix case number 20910376
We would like to request copy of the latest version of the Package insert and container labels of METROGEL-VAGINAL®
(metronidazole) gel, 0.75% (NDA # 020208) of BAUSCH HEALTH US LLC.
All Establishment Inspection Report or Reports issued to Caito Foods, LLC, including those issued for Establishment
#1824339 and #3013211657 (Indianapolis, Indiana).
K002519 510(k)
Kindly requesting a copy of cleared K192324 for Sheridan Sprial-Flex Endotracheal Tubes. Part of Anesthesiology
specialty with product code BTR (Class 2).
Complete Technical Project Lead (TPL) Decision Summaries for the Marketing Granted Orders for STN PM0000630 (NJOY
Daily Rich Tobacco 4.5% disposable e-cigarette) and PM0000631 (NJOY Daily Rich Tobacco 6% disposable e-cigarette).
All emails sent or received by Janet Woodcock, Acting Commissioner of the FDA, from September 15, 2021 to July 10,
2021, that contain any of the following terms:
1. Senator Ron Johnson

2. Sen. Ron Johnson
3. Senator Johnson
4. Sen. Johnson
5. September 15, 2021 letter
6. Johnson’s letter
7. “Johnson” AND “letter”
All emails sent or received from all directors within the Office of Biostatistics of the Center for Drug Evaluation and
Research (CDER), from September 15, 2021 to July 10, 2021, that contain any of the following terms:
1. Senator Ron Johnson

2. Sen. Ron Johnson
3. Senator Johnson
4. Sen. Johnson
5. September 15, 2021 letter
6. Johnson’s letter
7. “Johnson” AND “letter”
All emails sent or received from all personnel in the Office of Biostatistics and Pharmacovigilance of the Center for
Biologics Evaluation and Research (CBER), from September 15, 2021 to July 10, 2021, that contain any of the following
terms: Senator Ron Johnson etc
All emails sent or received from all directors within the Office of Surveillance and Epidemiology of the Center for Drug
Evaluation and Research (CDER), from September 15, 2021 to July 10, 2021, that contain any of the following terms: 1.
Senator Ron Johnson etc
All records in the possession of the individuals listed below, dated from December 1, 2020 to the date of search, that
include any of the following terms: “VAERS”, “signal”, “medical record”, “blood clot”, “heart inflammation”,
“myocarditis”, “pericarditis”, and/or “Epoch Times.”
• Narayan Nair, MD• Deborah Thompson, MD • Kerry Wesch, MD etc
Product registration information and all subsequent supplements for Application No. A215210
Product registration information and all subsequent supplements for Product Application No. A210225
Product registration information and all subsequent supplements for application No. A205548
FAERS REPORTS
for Human Drugs inspection of Cangene BioPharma, LLC ending 02/18/2022 at the location in Baltimore MD, United
States. The Response (in electronic format) for Human Drugs inspection of Cangene BioPharma, LLC ending 02/18/2022
at the location in Baltimore MD, United States. Please send documents as email attachments.
for Human Drugs inspection of TPM Laboratories, Inc. ending 10/16/2018 at the location in Cherry Hill NJ, United States.
The EIR (in electronic format) for Human Drugs inspection of AptaPharma Inc. ending 06/23/2014 at the location in
Pennsauken NJ, United States. etc
for Biologics inspection of Repro Lab ending 06/24/2022 at the location in New York NY, United States. The 483 (in
electronic format) for Biologics inspection of The Fertility Institutes, Jeffrey Steinberg, MD Incorporated ending
06/23/2022 at the location in New York NY, United States. Please send documents as email attachments.
for Medical Devices & Rad Health inspection of Whele LLC DBA Perch ending 06/06/2022 at the location in Boston MA,
for Human Drugs inspection of Dercher Enterprises, Inc., DBA Gordon Laboratories ending 06/13/2022 at the location in
Upper Darby PA, United States. The 483 (in electronic format) for Human Drugs inspection of ARx LLC ending
06/03/2022 at the location in Glen Rock PA, United States.
The FDA awarded contract 75F40119A10003 for INTEGRATED SERVICES to SUNTIVA, LLC (subsequently purchased by
LOGISTICS MANAGEMENT INSTITUTE (LMI))
All records and response letters provided for 2022-910, 2022-912, 2022-658, 2022-657
available. etc
I am requesting the record/records from FDA-ORA for the formal FDA definition for “Pork Flavor", for use in animal feed
and pet food products. I am not requesting any additional links beyond the records for this formal FDA animal feed
ingredient.
All feed additive petitions received by FDA-CVM for the animal feed/pet food term "Dried Black Soldier Fly Larvae"
01.01.10-12.31.20
I'm requesting all records for all pet foods FDA tested from January 1, 2022 through July 31, 2022 for tularemia
I'm requesting all records for all pet food plants (and manufacturers) FDA inspected from January 1, 2022 through July
31, 2022 for issues relating to tularemia
I'm requesting all records and response letters provided for 2021-494
BLA 761234
Would like a list of all BLA licenses and their respective contact information.
of the food item to which the dog or cat reacted, the symptoms displayed and the outcome, if available etc
Allegation of Regulatory Misconduct sent in August 9 2022. Document Number: CPT2201256.
Dear officer, We are seeking for full FCN information of FCN 832 and FCN 1912, that is, the full dossier of these FCNs.
Thank you! Best regards, Yini Jin
510(k) Premarket Notification for the PHILIPS NM3 MONITOR, MODEL 7900. 510(k) Number: K091459 Device
Classification Name: spirometer, monitoring (w/wo alarm) Device Name PHILIPS NM3 MONITOR, MODEL 7900
Applicant: RESPIRONICS NOVAMETRIX LLC
Product registration information and all subsequent supplements for Product Application No. A212991
I am an investment professional for an asset management firm and would like to request the following supplemental
approvals for NDA # 022264: Supplements #11, 12, 17, and 21 (i.e. SUPPL-11, SUPPL-12, SUPPL-17, and SUPPL-21). I’d
also like to request the Manufacturing (CMC) section from the original approval for NDA # 022264.
We would like to request copy of the latest version of the Package insert and container labels of Cytomel (liothyronine
sodium) tablets (NDA # 010379) of KING PHARMACEUTICALS RESEARCH AND DEVELOPMENT LLC.
I am requesting an un-redacted copy of my 510(k). Our company is the new 510(k) holder. K040911.
Emails, letters and/or other written communications from FDA officials and/or representatives to Felix Huettenbach,
Max Oehme and/or any other representatives of Sameday Health, Sameday Testing and/or Praesidium Diagnostics ETC
Please consider this a request for a copy of the 7/22/22 effective approval letter for ANDA No. 214934 for Minocycline
hydrochloride (generic drug). Please consider this a request for a copy of the 7/19/2022 tentative approval letter for
ANDA No. 213672 for Plerixafor (generic drug). ETC
K211496
Hello -- I'm requesting the Complete Response Letter issued in February 2022 to Mallinckrodt regarding its drug
terlipressin for the treatment of adults with hepatorenal syndrome.
The 483 (in electronic format) for Foods & Cosmetics inspection of Tarrier Foods Corp. ending 01/20/2021 at the
location in Columbus OH, United States. The EIR (in electronic format) for Foods & Cosmetics inspection of Tarrier
Foods Corp. ending 01/20/2021 at the location in Columbus OH, United States. The Response (in electronic format) for
Foods & Cosmetics inspection of Tarrier Foods Corp. ending 01/20/2021 at the location in Columbus OH, United States.
for Human Drugs inspection of AptaPharma Inc. ending 09/25/2019 at the location in Pennsauken NJ, United States.
The EIR (in electronic format) for Human Drugs inspection of Stira Pharmaceuticals LLC ending 11/05/2021 at the
location in Fairfield NJ, United States. Please send documents as email attachments.
for Medical Devices & Rad Health inspection of North American Diagnostics ending 06/23/2022 at the location in Holly
Hill FL, United States. Please send documents as email attachments.
for Animal Drugs & Feeds inspection of Green Roads, Inc. dba Clarity Labs ending 06/17/2022 at the location in Miami
FL, United States. Please send documents as email attachments.
for Human Drugs inspection of Lil' Drug Store Products Inc ending 06/02/2022 at the location in Cedar Rapids IA, United
for Biologics inspection of The Blood Center ending 06/17/2022 at the location in New Orleans LA, United States. Please
for Medical Devices & Rad Health inspection of Mcminnville Workholding Company, Inc. ending 06/03/2022 at the
location in Mcminnville TN, United States. Please send documents as email attachments.
The following two (2) CSV files: 1) Listing of all INSPECTIONS since Sunday, August 15, 2021 (in CSV format) with the
following fields: FEI Number, Inspection Start Date, Inspection End Date, Legal Name, Address, City Name, State Code,
Zip Code, Country Name, FDA483, Full Name, District, Center, INSPECTION REASON etc
2022-3873, 2022-3950, 2022-3990, 2022-4019, 2022-4022.
2022-3780, 2022-3781, 2022-3783, 2022-3870, 2022-3872.
Please send form 483 for Mohali manufacturing facility (Punjab, India) of Sun Pharmaceutical Industries Limited (“the
Company”) from August 3, 2022 to August 12, 2022.
Company: Stryker Corp FDA Clearance K191259-Stryker CrossFlow Integrated Arthroscopy Pump
FDA Case ID: 19921097, 20056281, 20355583, 20528447, 20379809, 20121142, 20219161, 20125085
full 510k package for K200160 740 SafeSAT device
(https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K200160)
N017473A204521
Company: Medos International SARL FDA Clearance: K171237 - FMS VUE II Fluid Management and Tissue Debridement
System
Company:Conmed Corporation FDA Clearance: K182882-CrystalView Pro Irrigation Console, CrystalView Pro
Autoclavable Remote Control
N021014A215939A078069
Company: Smith & Nephew FDA Clearance: K192155-Smith & Nephew DYONICS 25 Fluid Management System
Company: Relign Corporation FDA Clearance: K162770-Relign System
Hi, We would like to request an electronic copy of the of the FDA report to FAERS for the following 5 cases: 21000603
(aprepitant), 20991039 (aprepitant), 20910861 (aprepitant), 20868366 (aprepitant), and 20847447 (aprepitant) in order
to assess impact to Heron marketed products. Many thanks! Audrey
A078690 A090631 A078893 etc
I am requesting the manufacturing location of 6 lots of the Pfizer COMIRNATY vaccine NDC 0069-2025, lots FW1329,
FW1330, FW1331, FW1333, FW1334, FW1336 .
I am looking for Form 483 from the inspection of 2 facilities. FEI #3011910331 & 3010705046 Laboratories
Farmaceutico s Rovi S.A. in the cities of Alcala DeHenares and Madrid, Spain.
FDA Review of BLA 761139 SUPPL-21 dated 11 Aug 2022
INSPECTION DATA
Request for the 2018 Annual Report for NDA 021196 (Xyrem)
Mars Pet Care, Inc.. Everson, PA (FEI #3002319635). Please supply complete Establishment Inspection report for FDA
inspection carried out in December 2007, including lab results for any samples collected during the inspection.
RE: Mars Pet Care, Allentown, PA (FEI #3003611553). Please supply lab results for the following sample numbers,
collected during the inspection of this facility in October-November 2008: Samples #425600-#425614, inclusive.
I am an investment professional for an asset management firm and would like to request the following FAERS Case
Reports for Case IDs: 20908039, 20912941, 20986684, 20824207, 21012585, 20940360, 20663620
N018538 A074299 A074594etc
For the Rosemary Repel product manufactured by Fairy Tales Hair Care, please provide any and all Agency documents
involving any allegation that the product is misbranded or mislabeled. Specifically, we request materials from CDER.
I am requesting to know the physical locations/addresses of the Business Operations regarding the ANALYSIS (NDC
0069-2025), MANUFACTURING LOCATION (NDC 0069-2025), PACK (NDC 0069-2025), and LABEL (NDC 0069-2025) in the
Lot Release Protocols for the Pfizer BioNTech FDA Approved "Comirnaty" COVID-19 Vaccine NDC 0069-2025-10, 0069-
2025-01, Lot number FW1331.
I would like to request the FULL 510(k) submissions for the Sculpsure Device: 510(k) # K182741 510(k) # K171992 510(k)
# K171111 510(k) # K160470 510(k) # K150724 510(k) # K150230
I would like to request a copy of the FULL 510(k) filed for the Ulthera device: 510(k) # K180623 510(k) # K134032 510(k)
# K132028 510(k) # K121700 510(k) # K122528
14029435 14290015 14573429 14914406 14991659 15130059 16042648 16451202
for Human Drugs inspection of GURUNANDA LLC ending 11/10/2021 at the location in Buena Park CA, United States.
for Foods & Cosmetics inspection of Dietary Pro, Inc ending 10/27/2021 at the location in Wausau WI, United States.
This is a request under the Freedom of Information Act. I request that a copy of the following document(s) be provided
to me: the disclosable portion of all findings, correspondence, and records related to the clinical investigator inspections
conducted by the FDA in conjunction with Veru Inc’s application for Emergency Use Authorization for Sabizabulin. Veru
Inc. is currently headquartered at 2916 North Miami Ave, Suite 1000, Miami, FL 33127.
I’m requesting the successful applicant’s qualifications for the followng:

Vacancy Announcement: FDA-OO-MP-22-11357528-LW
Title of the position: Accountant (GS-0510-12/13),
Name of the agency: Food and Drug Administration (FDA)
Requesting a copy of form 483 issued to Sun Pharmaceutical Industries Limited on inspection of its Mohali
manufacturing facility (Punjab, India). The inspection was conducted between August 3, 2022 to August 12 and 6
observations were made.
Copy of 510(k) for K200865, Piccolo Potassium Test System, manufactured by Abaxis Inc.
Copy of 510(k) for K163406, Mission Cholesterol Pro Monitoring System, manufactured by ACON Laboratories Inc.
Form 483 issued to Sun Pharma following the USFDA inspection of the Mohali site between 3 Aug and 12 Aug 2022
Under the Freedom of Information Act, 5 U.S.C. §552, we are requesting an opportunity to inspect or obtain copies of
public records in the possession by the Food and Drug Administration or another designated department. We request
the following information related to a criminal trial in the Southern District of Ohio (U.S. v. Thomas Romano; 2:19-CR-
202).
RECS PREVIOUSLY RELEASED RE DRUG APPLICATIONS
Hel I request copies of any agency documentation or communication with Lyons Magnus located at 2924 Wyetta Drive,
Beloit, WI 53511 between March 1, 2022- Present regarding FDA Warning letter, Form 483 report, site inspection or
product recalls.
Copy of FAP 2311, submitted by Biomin GmBH for fumonisin esterase to degrade fumonisins present in swine feed.
Any memoranda or other correspondence documenting FDA’s decision regarding whether 180-day exclusivity for
Vasopressin Injection USP, 200 Units/10 mL (20 units/mL), Multiple-Dose Vials, has been forfeited.
Copy of the disclosable portions of the MedWatch reports for the following 7 molnupiravir case numbers: 21143823;
21179878; 21173045; 21155206; 21156922; 21154910; and 21154906.
Copies of Form 483s issued by the CDRH Office in June 1-30, 2022.
Copies of Form 483s issued by the CDER Office in June 1-30, 2022. (CDER Complex)
Copies of Form 483s issued by the CBER Office in June 1-30, 2022.
Copies of Form 483s issued by the CDER Office in June 1-30, 2022.
(Rq.#2) Copies of Form 483s issued to the following DRUG companies from June 1-30, 2022.
(Rq.#1) Copies of Form 483s issued to the following DRUG companies from June 1-30, 2022.
(Rq.#4) Copies of Form 483s issued to the following DEVICE companies from June 1-30, 2022.
(Rq#1) Copies of Form 483s issued to the following CLINICAL INVESTIGATOR from June 1-30, 2022:
Summary Basis of Approval Package for NDA 019880 (Orginal-1, S-003, S-004, S-014, S-015, S-017 and S-018) of RLD
drug product held by Corden Pharma. We are specifically looking for Quality (Chemistry, Manufacturing and Controls
and Manufacturing Process) review documents in the Summary Basis of Approval Package.
A copy of the Action Package/Summary Basis of Approval for SUSVIMO (ranibizumab injection), 100mg/mL in a single-
dose vial, licensed under BLA 761197 on October 22, 2021.
for Human Drugs inspection of Boehringer Ingelheim Pharmaceuticals, Inc. ending 07/03/2018 at the location in
Ridgefield CT, United States. Please send documents as email attachments.
Complete Summary Basis of Approval, All Review Disciplines and Approved Labeling: DIAPID LYPRESSIN, Nasal Solution;
0.185 mg/mL; NDA 016755, Date of Approval 1970, Marketing Status Discontinued; Review not available on
Drugs@FDA.
All records submitted by the Applicant and between the Applicant and the FDA, relating to HeartSine Technology Ltd.,
Samaritan 350P (SAM350P), Normal 180-day Track No User Fee supplement, P160008/S017, FDA approval for Change
to the Indications for Use (IFU) from Prescription to Over-the-Counter Use With Associated Labeling Changes, including
FDA’s summary review memo.
1. Correspondence and communications, including all internal or external communications, relating to the cryogenic
tanks in the IVF (invitro fertilization) lab, including the March 3-4, 2018 cryogenic tank failure that occurred at University
Hospitals Cleveland, Ohio or the Beachwood, Ohio facility. 2. Correspondence and communications relating to Dr.
Andrew Bhatnager, Ph.D., who was employed at University Hospitals Cleveland, Ohio at the time of the March 3-4, 2018
cryogenic tank failure. ETC
FAMILY DOLLAR STORES NOTES, TESTS, CORR ETC

VAERS RECS
1. K212361 - PathAI, LLC, device name: Novo
2. K210811 - Inspirata, Inc, device name: Dynamyx DP SW
3. K201005 - Paige.AI, Inc, device name: FullFocus
ETC
Oceana requests copies of all records (including but not limited to, all applicable documents, notes, correspondence,
emails, and electronic records) related to communications with groups representing seafood industry interests,
including but not limited to the National Fisheries Institute, concerning the proposed and final Food Traceability Rules
and the Food Traceability List. ETC
Sequences 0020 through 0039 of the following ANDA: • ANDA 204137 for Omeprazole and Sodium Bicarbonate
Capsule, 20 mg; 1.1 gm, FDA approved July 15, 2016
list of SPL document Ids (UUIDs) of SPL files published by the FDA, because those are necessary to access all published
SPL files on accessdata.fda.gov.
for Human Drugs inspection of Weeks & Leo Co Inc ending 04/07/2022 at the location in Clive IA, United States. The
Response (in electronic format) for Human Drugs inspection of Weeks & Leo Co Inc ending 04/07/2022 at the location in
Clive IA, United States. Please send documents as email attachments.
for Human Drugs inspection of L. Perrigo Company ending 10/16/2019 at the location in Holland MI, United States.
format) for Human Drugs inspection of Catalent Pharma Solutions, LLC ending 02/22/2019 at the location in Saint
Petersburg FL, United States. Please send documents as email attachments.
for Biologics inspection of Valley Biosystems ending 10/08/2021 at the location in West Sacramento CA, United States.
Whistle Blower matter regarding device malfunction
The full text of the letter or letters sent from FDA to JYNNEOS vaccine manufacturer Bavarian Nordic in response to their
questions about the new dose sparing strategy.
Summary Basis of Approval for ADAPALENE AND BENZOYL PEROXIDE GEL (0.3%; 2.5%) , ANDA# A212464; Company:
PADAGIS ISRAEL PHARMACEUTICALS LTD. Kindly contact 800-922-1038 Ext (3454)
We are seeking all inspections and 483 records notices and observations for Elite One Source. We include on this
request form the company name, and location of all EOS manufacturing facilities.
Copy of the disclosable portions of the Bioequivalence Review for Doxorubicin Hydrochloride (Liposomal), ANDA
212299, by Zydus.
Multi-Discipline Review and Administrative and Correspondence Documents for the NSCLC accelerated approval for
Enhertu granted on 08/11/2022
Summary Basis of Approval for Xipere (triamcinolone acetonide), approved under NDA 211950 on October 22, 2021.
Copy of the disclosable portions of the Bioequivalence Review for Doxorubicin Hydrochloride (Liposomal), ANDA
207228, by Ayana Pharma.
Requesting the original clinical data to support the approval of the veterinary drug Re-covr. Original NADA #006-417
Solvay Animal Health (changed to Fort Dodge AH). Generic NADA of 200-167 Phoenix Scientific.
Norgine is seeking inspection records pertaining to FDA inspection ID 1161851 of Jost Chemical Co., FEI 3001239108, at
8150 Lackland Rd., Saint Louis, Missouri, from January 10 to 21, 2022.
The complaint to FDA from Dept of Justice that ultimately led to inspection of Berkshire Sterile Manufacturing FEI
3012144557 on 08/26/2020-10/27/2020. Also all communications between FDA and the Dept of Justice concerning this
inspection.
We are requesting all information and documentation related to any meetings, interactions and communications
between the FDA and Nano-X Imaging from January 1, 2021 to today. We are particularly interested in all meetings,
interactions and communications related to Nano-X's 510(k) application (submitted June 2021) and Q-submission
(submitted January 2022) related to the multi-source Nanox.ARC 3-D tomosynthesis imaging system.
Copy of the disclosable portions of the Chemistry Review for ANDA 091482, Fluvoxamine Maleate, approved
11/18/2013, by Actavis Elizabeth.
Any and all FDA review memos used in the decision making process to clear K191407 (NovaLung System).
Please provide the complete set of labels including bottles and blisters for Trokendi XR Capsules 25 mg, 50 mg, 100 mg
and 200 mg. The legacy blisters are not available for review but we would like to review both the bottles and blisters for
the most recent labels, all strengths. Essentially, I need the labels, cartons, blisters all artwork for all strengths.
We are writing to request copies of any records on file at the FDA, compiled between October 2021 and July 2022,
regarding the investigation of this outbreak (CDC ID: POB2112MLEXK-1). We specifically request: • all health
department summary reports (NORS reports) of any investigations conducted for this outbreak; • complete linelists of
cases, lab specimen, and exposures pertaining to cases in the outbreak; etc
Documents regarding promotional materials for Hologic Novasure.
The 483 (in electronic format) for Human Drugs inspection of VMP COSMETICS ending 07/13/2022 at the location in
Vernon CA, United States. The 483 (in electronic format) for Human Drugs inspection of QYK BRANDS LLC ending
07/01/2022 at the location in Garden Grove CA, United States. etc
for Human Drugs inspection of Fresenius Kabi USA LLC ending 06/30/2022 at the location in Melrose Park IL, United
for Human Drugs inspection of KVK-Tech, Inc. ending 07/08/2022 at the location in Newtown PA, United States. Please
for Human Drugs inspection of Inotiv, Inc ending 07/14/2022 at the location in Mount Vernon IN, United States. The
483 (in electronic format) for Human Drugs inspection of BAMF Health Inc ending 07/01/2022 at the location in Grand
Rapids MI, United States.
for Human Drugs inspection of OFD Foods LLC ending 07/01/2022 at the location in Albany OR, United States. Please
for Human Drugs inspection of Inspec Solutions LLC ending 07/01/2022 at the location in Holly Hill FL, United States.
The 483 (in electronic format) for Human Drugs inspection of Maria A. Rodil, M.D. ending 07/14/2022 at the location in
West Miami FL, United States. Please send documents as email attachments.
We therefore request the data that the FDA uses to draw the conclusion that it is not mandated to regulate
electromagnetic radiation from LED products and the data that the FDA uses to conclude that there are no negative
health effects, including impacts on the eye and nerves, from LED light.
All documents (i.e., FDA internal memoranda, review notes, reviewer guidance, manuals, templates and similar
documents) related to (i) the premarket tobacco product applications for PM0005590.PD1-PM0005590.PD3
(collectively, the “PMTAs”); and (ii) acceptance review of the PMTAs ETC
We hereby request the following documentation and appreciate your support on this: establishment inspection report
and 483s for the FDA inspection in 2022 on Pharmaceutics International Pii3 (FEI 3006503202) in Cockeysville, MD and
Pharmaceutics International Pii (FEI 1000513101) in Hunt Valley, MD
All vacancy announcements for the Office of Operations, Office of Human Capital Management, for a GS-13
Management Analyst.
All vacancy listings for any position (including GS-13 Management Analyst) within the Office of Operations, Office of
Human Capital Management, Immediate Office.
All vacancy announcements for EEO Specialists and/or Reasonable Accommodation Specialists for Office of Operations,
Office of Equal Employment Opportunity.
Enfamil NeuroPro™ EnfaCare® Milk-based discharge formula that supports catch-up growth and brain development in
babies born prematurely or with low birth weight Post-discharge formula for premature infants. Exempt premature
infant formula 90-day FDA infant formula notification likely between Jan, 2003- Dec, 2008
Similac® NeoSure® 22 Cal/fl oz, nutrient-enriched formula for babies who were born prematurely. Designed to be used
as a preterm post-discharge formula. Post-discharge exempt infant formula for premature infants. 90-day FDA infant
formula notification likely between Jan, 1999- Dec, 2005
ALL FORM 483, EIR, RESPONSE LETTERS, AND ANY OTHER COMMUNICATIONS WITH THE FDA BY/FOR METHOD
PHARMACEUTICALS, LLC LOCATED AT 419 Bank St Ste 100, Southlake, Texas (TX) 76092, United States (USA).
Any communications between the FDA and Missouri state government, including Governor Mike Parson regarding the
Missouri house bill 1667, also known as the Missouri Kratom Consumer Protection Act.
The Isomedix Operations, Inc Chester site located at 2 Nucifora Blvd, Chester, NY 10918, FEI # 3013820501, was
inspected by the FDA for five days between March 29, 2022 to April 12, 2022. The inspection resulted in one form 483
observation. Our firm did not receive a copy of the Establishment Inspection Report (EIR) prepared following the
conclusion of the inspection. We are requesting a copy of the EIR at this time.
The Synergy Health AST, LLC Saxonburg site located at 7225 N. Noah Dr. Saxonburg, PA 16056, FEI # 3009882464, was
inspected by the FDA on May 26, 2022. The inspection resulted in zero form 483 observations. Our firm did not receive
a copy of the Establishment Inspection Report (EIR) prepared following the conclusion of the inspection. We are
requesting a copy of the EIR at this time.
format) for Human Drugs inspection of Ajinomoto Althea, Inc. ending 12/20/2019 at the location in San Diego CA,
for Biologics inspection of Patheon Manufacturing Services LLC ending 04/15/2022 at the location in Greenville NC,
for Human Drugs inspection of Patheon Manufacturing Services LLC ending 11/12/2021 at the location in Greenville NC,
for Human Drugs inspection of Agios Pharmaceuticals, INC. ending 09/16/2021 at the location in Cambridge MA, United
for Medical Devices & Rad Health inspection of Global Packaging Systems ending 12/06/2018 at the location in Fort
Worth TX, United States. Please send documents as email attachments.
for Human Drugs inspection of Medical Technical Gases, Inc. ending 07/08/2022 at the location in N Billerica MA, United
for Human Drugs inspection of Grato Holdings, Inc. ending 07/14/2022 at the location in Woodbine IA, United States.
All emails regarding FDA's review of talc, talcum powder, and talc products. Any documents regarding the review of talc,
talcum powder, and talc products. Any investigation of talc by IWGACP and by the FDA generally.
Please provide all FDA483 and any related response letter for the following clinical site (all investigators and all suites
related to the site): Texas Oncology--Charles A. Sammons Cancer Center 3410 Worth Street Dallas, TX 75246
See Attached Request Letter, Dated 8/17/2022. documents concerning communications between FDA and Axsome
Therapeutics, Inc. concerning Complete Response Letter to AXS-07 for the acute treatment of migraine NDA and
deficiencies in Axome's NDA for AXS-05 for the treatment of major depressive disorder.
Requesting a copy of any FDA visit or inspection for White Labs, Inc located at 172 S Charlotte Street, Asheville NC 28801
T.MARZETTI CO/ ALLEN MILK DIVISION 1709 FRANK RD COLUMBUS OH 43223 FRANKLINYogurt desserts
T.MARZETTI CO/ QUALITY BAKERY/ MOUNTAIN TOP FROZEN PIES 50 N GLENWOOD AVE COLUMBUS OH
43222 FRANKLINSalad dressings T.MARZETTI CO 3770 INDIANOLA AVE COLUMBUS OH 43214 FRANKLIN
Salad dressings T.MARZETTI CO/ MARZETTI DISTRIBUTION 5800 N MEADOWS DR GROVE CITY OH 43123
FRANKLINFood warehousing Please provide the following documents for the foregoing facilities: a. All warning letters
and any related “close-out” letters; b. All inspection reports; c. All notices of recalls, violations, penalties, product
seizures, or other enforcement actions; d. All untitled letters.
T.MARZETTI CO/ NEW YORK FROZEN FOODS 25900 FARGO AVE BEDFORD OH 44146 CUYAHOGA Pickles, sauces,
salad dressings For the period from Jan. 1, 2019 thru the date the agency responds to my FOIA request, please provide
the following documents for the foregoing facility: a. All warning letters and any related “close-out” letters; b. All
inspection reports; c. All notices of recalls, violations, penalties, product seizures, or other enforcement actions; d.
All untitled letters.
LANCASTER COLONY CORP/ T.MARZETTI CO 380 POLARIS PKWY STE 400 WESTERVILLE OH 43082 DELAWARE
Salad dressings For the period from Jan. 1, 2019 thru the date the agency responds to my FOIA request, please provide
the following documents for the foregoing facility: a. All warning letters and any related “close-out” letters; b. All
All untitled letters.
T.MARZETTI CO/ INN MAID PRODUCTS DIV 7445 COUNTY ROAD 68 MILLERSBURG OH 44654 HOLMES Pickles,
sauces, salad dressings For the period from Jan. 1, 2019 thru the date the agency responds to my FOIA request, please
provide the following documents for the foregoing facility: a. All warning letters and any related “close-out” letters;
b. All inspection reports; c. All notices of recalls, violations, penalties, product seizures, or other enforcement actions;
d. All untitled letters.
T Marzetti Co/ SISTER SCHUBERT'S HOMEMADE ROLLS 100 CRENSHAW PKWY LUVERNE AL 36049 CRENSHAW
Breads, rolls, and buns T Marzetti Co/ SISTER SCHUBERT'S HOMEMADE ROLLS 100 JACINTOPORT BLVD SARALAND
AL 36571 MOBILE Breads, rolls, and buns For the period from Jan. 1, 2019 thru the date the agency responds to
my FOIA request, please provide the following documents for the foregoing facilities: a. All warning letters and any
related “close-out” letters; b. All inspection reports; c. All notices of recalls, violations, penalties, product seizures, or
other enforcement actions; d.All “untitled letters.”
T Marzetti CO/ NEW YORK FROZEN FOODS/ MAMMA BELLA FOODS 5100 RIVERGRADE RD BALDWIN PARK CA
91706 LOS ANGELES Buns, bread T.MARZETTI COMPANY 876 YOSEMITE DR MILPITAS CA 95035 SANTA
CLARA a. All warning letters and any related “close-out” letters; b. All inspection reports; c. All notices of recalls,
violations, penalties, product seizures, or other enforcement actions; d. All “untitled letters.”
MARZETTI FROZEN PASTA, INC. 803 8TH ST SW ALTOONAIA 50009 POLK Frozen specialties MARZETTI
FROZEN PASTA, INC. 612 ADVENTURELAND DR NE ALTOONAIA 50009 POLK a. All warning letters and any
K211965, K200482, K190047, K142432 - Request for Information Included in Premarket Notification on Safety &
Effectiveness
T.MARZETTI CO/SISTER SCHUBERT'S HOMEMADE ROLLS 1000 TOP QUALITY DR HORSE CAVE KY 42749
HART Food preparations For the period from Jan. 1, 2019 thru the date the agency responds to my FOIA request,
please provide the following documents for the foregoing facility: a. All warning letters and any related “close-out”
letters; b. All inspection reports; c. All notices of recalls, violations, penalties, product seizures, or other enforcement
actions; d. All “untitled letters.”
T.MARZETTI COMPANY/ CHATHAM VILLAGE 15 KENDRICK RD WAREHAM MA 25711 PLYMOUTH Bakery

products For the period from Jan. 1, 2019 thru the date the agency responds to my FOIA request, please provide the
following documents for the foregoing facility: a. All warning letters and any related “close-out” letters; b. All
All “untitled letters.”
I am writing pursuant to FOIA to request records concerning the following food manufacturing facility: Business Name
Street Address City State Zip County Food Products T Marzetti Co/ FLATOUT, INC./ FLATOUT BAKERY 1422
WOODLAND DR SALINE MI 48176 WASHTENAW Retail bakeries For the period from Jan. 1, 2019 thru the
date the agency responds to my FOIA request, please provide the following documents for the foregoing facility: a.
All warning letters and any related “close-out” letters; b. All inspection reports; c. All notices of recalls, violations,
penalties, product seizures, or other enforcement actions; d. All “untitled letters.”
I am writing to request records concerning the following food manufacturing facility: Business Name Street Address
City State Zip County Food Products MARZETTI MFG. CO/ TQ BAKING 2621 FREDDY LN BLDG 7 VINELAND
NJ 83601 CUMBERLAND Bakery products For the period from Jan. 1, 2019 thru the date the agency responds to
my FOIA request, please provide the following documents for the foregoing facility: a. All warning letters and any
I am writing pursuant to request records concerning the following food manufacturing facility: Business Name
Street Address City State Zip County Food Products T MARZETTI CO/ BANTAM BAGELS 283 BLEECKER ST FRNT 2
NEW YORK NY 10014 NEW YORK Bagels For the period from Jan. 1, 2019 thru the date the agency responds
to my FOIA request, please provide the following documents for the foregoing facility: a. All warning letters and any
T MARZETTI CO/ ANGELIC BAKEHOUSE 3275 E LAYTON AVECUDAHY WI 53110 MILWAUKEE Bread For the
period from Jan. 1, 2019 thru the date the agency responds to my FOIA request, please provide the following
documents for the foregoing facility: a. All warning letters and any related “close-out” letters; b. All inspection
reports; c. All notices of recalls, violations, penalties, product seizures, or other enforcement actions; d. All
“untitled letters.”
Hello, I am requesting any and all correspondence, responses, inquiries, and all generated documentation related to the
complaint I filed with CDRH related to DePuy Orthopedics for allegations sent to the FDA-SB-CPT2102099.
510(k) submission #K073482, and De Novo submission # DEN080007; Trade/Device Name: ALLOMAP MOLECULAR
EXPRESSION TESTING. Please provide complete 510(k0 and De Novo (DEN) submissions and all official correspondence
between FDA and the Sponsor.
Hello, I am requesting the full 510k application packets for the following 510k clearances: K214114, K211738, K211798,
K191419, K202345, K212632, K192833, K210911, K213565, K201705, K011056, K130904. This would include all the
testing and documents submitted to support the 510k application. The format can be pdf documents. Thank you,
Michael
All releasable documents related to the following Case ID numbers, as reported in the FAERS Public database, for the
Beractant and Calfactant product active ingredients: 20994992; 20438634; 20438890; 20420896; 20407163; 19438807;
17381218; 16750842; 16750713; 16648728; 16025224; 15323122.
• All internal or external communications sent to or received by the FDA related to the Sturgis plant, from July 1,
2021, to the present; • All records related to the FDA’s inspections of the Sturgis plant, from September 1, 2021, to the
present, including but not limited to communications, reports, findings, audits, memoranda, or summaries, whether in
draft or final format, and any actions discussed, recommended, or taken by the FDA and/or Abbott ETC
All memoranda and other correspondence (other than approval letters) regarding the scope of First Interchangeable
Exclusivity awarded to Semglee (insulin glargine-yfgn) under 42 U.S.C. 262(k)(6), including whether such exclusivity
blocks licensure of subsequent insulin glargine products (including Rezvoglar (insulin glargine-aglr)) as interchangeable
to the Reference Product.
--The Establishment Inspection Report for the November 9, 2021 inspection of AMPAC Fine Chemicals (FEI: 3013791960,
Address: 2820 Normandy Dr Petersburg, VA 23805-9372) --Any Form 483s issued as a result of the November 9, 2021,
inspection of AMPAC Fine Chemicals (FEI: 3013791960, Address: 2820 Normandy Dr Petersburg, VA 23805-9372)
1. Documents sufficient to identify: (1) drug product lot numbers for all Moderna COVID-19 vaccines manufactured;
and (2) the total number of units and/or doses in each such lot. ETC
1. Documents sufficient to identify: (1) drug product lot numbers for all Pfizer/BioNTech COVID-19 vaccines
manufactured; and (2) the total number of units and/or doses in each such lot. ETC
Hi, I would like to request the 90-day facility classification decisional letter (ConOps between CDER and ORA) sent to
Berkshire Sterile Manufacturing (on or about August 23, 2022), following the May 23 FDA inspection of the facility
located in Lee, MA. Thank you.
The Establishment Inspection Report for the December 11, 2021 inspection of OncoImmune, Inc. (FEI: 3017610952,
Address: 9430 Key West Ave Ste 113, Rockville, MD 20850-6345) Any Form 483s issued as a result of the the December
11, 2021 inspection of OncoImmune, Inc. (FEI: 3017610952, Address: 9430 Key West Ave Ste 113, Rockville, MD 20850-
6345)
Inspection records, 483 forms, 483 responses, correspondence related to current recall, test results, RFR submission.
Company/Facility: Lyons Magnus, Inc 3158 E Hamilton Ave Fresno, CA 93702-4163
Unredacted copies of all sections for the original Milophene (clomiphene citrate) ANDA 072196 approved on December
20, 1988. - An unredacted copy of all ANDA 072196 pre-approval and post-approval correspondence between Milex
Products and FDA - An unredacted copy of all post-approval supplements
establishment inspection reports (ERIs), FDA Form 483 inspection observances, and/or warning letters related to Daily
Harvest headquartered: 99 Hudson Street 11th Floor New York, NY 10013. I am seeking all facilities related in the
manufacturing of Daily Harvest product.
Daily Harvest Leek + Lentil Recall: All documents pertaining to the recall, establishment inspection reports (ERIs), FDA
Form 483 inspection observances, and/or warning letters
Kindly provide a FOI report of all commodities that cross into the US border under our enterprise.
Can we please receive names and email addresses for all current FDA employees?
Any and all documentation concerning the results of the Award for Request for Quote # RIVCO-EMARC-RFQ-0000549
(Pharmaceuticals: Doxycycline and Ciproflaxin), including a copy of any relevant Request for Proposal submitted.
Sandoz Private Limited in India 02/27/2020 INSPECTION RECS
I would like to receive a copy of the toxicology and pharmacology sections of NDA 62160 - drug generic name Sivelestat.
The NDA is now owned by Mariushi Pharma of Japan - attached please find a letter of authorization from the company.
The 483 (in electronic format) for Biologics inspection of Newton Implant Systems, Inc. ending 07/19/2022 at the
location in San Diego CA, United States. The 483 (in electronic format) for Biologics inspection of Akyut Bayrak, MD. A
Professional Corporation ending 07/21/2022 at the location in Pasadena CA, United States. The 483 (in electronic
format) for Biologics inspection of Meta Dental ending 06/30/2022 at the location in Northridge CA, United States.
for Biologics inspection of Noble Life Sciences, Inc ending 07/08/2022 at the location in Sykesville MD, United States.
The 483 (in electronic format) for Biologics inspection of Northwell Health Fertility ending 07/20/2022 at the location in
Manhasset NY, United States. The 483 (in electronic format) for Biologics inspection of Stony Brook Community Medical
PC - Island Fertility ending 07/13/2022 at the location in Commack NY, United States. Please send documents as email
attachments.
for Biologics inspection of Main Line Fertility Center ending 06/30/2022 at the location in Bryn Mawr PA, United States.
The 483 (in electronic format) for Biologics inspection of Suncoast Communities Blood Bank, Inc. ending 07/01/2022 at
the location in Bradenton FL, United States. The 483 (in electronic format) for Biologics inspection of LifeLink
Foundation, Inc. dba Lifelink Tissue Bank ending 07/15/2022 at the location in Tampa FL, United States. Please send
for Biologics inspection of Center for Reproductive Health Fertility Laboratory of Nashv ending 06/30/2022 at the
location in Nashville TN, United States. Please send documents as email attachments.
I am requesting the PDF record David Edwards (FDA CVM) sent to Erin Bubb (PA Department Of Agriculture) on March
26, 2019
excel list of all citizen petitions filed with the FDA and their disposition
2022-5446
RECORDS PREVOIUSLY RELEASED TO GOVZILLA JUNE-AUGUST 2022
All “condolence letters” or other correspondence sent to family members (or others who knew the deceased) after any
death report entered into the Vaccine Adverse Events Reporting System.
All records concerning the contract awarded from Solicitation 75D301-22-R-72321. (Exhibit A.)
We request the memorandum of the closure of the FRRA received with the officer Edith Gonzales
All contents of the “‘quarantine’ folder” which contains “potentially or obviously false or ‘hoax’ reports” that were
submitted to the Vaccine Adverse Events Reporting System, and all records concerning the amount/volume of such
reports that have been received.
Any and all drafts and versions, including any final versions of the Vaccine Adverse Event Reporting System (VAERS)
Standard Operating Procedures for COVID-19.
Any and all “instructions” referenced in Solicitation 75D301-22-R-72321 (Exhibit A) on Page 19, Paragraph F:
“Information obtained during follow-up shall be clearly separated from information in the VAERS report when entering
follow-up data into the VAERS database. The Government will provide instructions on how this will be accomplished.
Follow-up information will NOT be included in the VAERS public data” (emphasis added).
Shenzhen Smoore Technology Limited ("Smoore") is requesting copies of all reports, including the written list of
observations, from the RRA performed on Smoore and its subsidiary Shenzhen Vaporesso Technology Limited, by
Carmen Fisher and Christopher Keating from March 22, 2021 to April 8, 2021.
Please produce (1) All documents and communications relating to off-label uses of Apyx Medical Corporation’s
Advanced Energy Products, Renuvion and/or J-Plasma. (2) All Medical Device Reports and related documents and
communications regarding Apyx’s Advanced Energy Products, Renuvion and/or J-Plasma. (3) All documents and
communications relating to Medical Device Safety Communications (“MDSC”) concerning Apyx’s Advanced Energy
Products, Renuvion and/or J-Plasma.
We would like to request all recall records associated with drugs and medical devices.
Complete, unredacted copies of the following Type III Drug Master Files (DMF): • DMF 22701 • DMF 22702 • DMF
24171 • DMF 24894 • DMF 28318 In addition to a copy of the original submission for each DMF, this request includes
copies of all subsequent amendments, letters of authorization, and annual reports filed with the U.S. Food and Drug
Administration (FDA).
Request for ANDA 074901 labeling found in Suppl-20, 07/26/2018, Labeling-Package Insert, Labeling-Container/Carton
Labels. This ANDA is a basis of a submission for Meitheal Pharmaceuticals ANDA and we would like to ensure that our
labels are updated to date. Please send the labels via electronic mail.
FCN #: 52 Notifier: Chr. Hansen A/S Substance: ETC

All submissions and official correspondence between FDA and the Sponsor for De Novo DEN200001, Cell-Free DNA
Blood Collection Tubes (BCT) by Streck, Inc.
Requesting - all e-mails, notes, records, transcripts for VAERS ID 1223941-1 - any and all communications for VAERS ID
1223941-1
We are looking for Exhibits collected during Inspection of facility Second Bite Foods, Inc. located in Shakopee , MN
55379 and listed in Establishment Inspection Report FEI:3003908115. These exhibits are from page 26 to page 28 :
Exhibit number 1 through Exhibit number 35.
Looking for final results and status of samples collected in Second Bite Foods, Inc. related to Daily Harvest French Lentil
Crumbles recall. Multiple testing conducted including Microbiologist, Chemical and toxicology. 1194778, hemp seeds
1194780, tara protein flour 1194782, hemp hearts 1194784, red lentils 1194786, cremini mushrooms 1194788,
butternut squash 1194790, green lentils 1194792, quinoa
Documents and information relating to the New Drug Application submitted by Ardelyx, Inc. to the FDA for the use of
the drug tenapanor for the treatment of hyperphosphatemia in chronic kidney disease patients on dialysis, and any and
all communications between the FDA and Ardelyx in relation to the same.
Subject Device CONTINUOUS GLUCOSE MONITORING SYSTEM Applicant MEDTRONIC MINIMED PMA Number
P980022 Product Codes MDS OYC Docket Number 99M-2169 Labeling (including User Guides and Manuals)
through December 31, 2005, be provided, especially including any such Labeling relating to Supplements and not
accessible on the FDA website
I would like to request a dataset showing the residing city and state of the authors of all medical device reports the Food
and Drug Administration received from April 1, 2021, through August 19, 2022, associated with the PE-PUR foam
breakdown or suspected foam breakdown in Philips Respironics devices. ETC
Available Center for Tobacco Product (CTP) FDA records relating to the marketing granted orders (MGO) and marketing
denial orders (MDO) for the NJOY ACE and NJOY Daily Electronic Nicotine Delivery System (ENDS) products. To include
communication from the FDA to NJOY and letters detailing reasons for MGO and MDO issued, and deficiency letters
provided to NJOY.
Available Center for Tobacco Product (CTP) FDA records relating to the marketing denial orders (MDO) for the JUUL Labs
Inc. Electronic Nicotine Delivery System (ENDS) products. To include communication from the FDA to JUUL Labs and
letters detailing reasons for MDO issued, and deficiency letters provided to JUUL.
Available Center for Tobacco Product (CTP) FDA records relating to the marketing denial orders (MDO) for the Fontem
myblu Electronic Nicotine Delivery System (ENDS) products, and deficiency letters relating to the BLU+ and
bluDisposable PMTA submissions. To include communication from the FDA to myblu and letters detailing reasons for
MDO issued, and deficiency letters provided to Fontem.
Request copy of the summary basis of approval from May 5, 1987 for NDA 019228 MANGANESE SULFATE EQ 0.1MG
MANGANESE/ML INJECTABLE;INJECTION. Also requesting copy of the most recent approved labeling from SUPPL 5
approved on April 25, 1994.
PMA # P200010 Guardant360 CDx - full submission and all correspondence between FDA and the Sponsor.
2022-2308, 2022-2880, 2022-2925, 2022-3165, 2022-3874.
2022-3875, 2021-7136, 2021-8099, 2022-584, 2022-3653.
CV William C Hughes, Bradley J Maunder, Darlene C Plank Turlington, ETC
MEDTRONIC SYSTEM ELIGIBILITY, BATTERY LONGEVITY, SPECIFICATIONS REFERENCE MANUAL

Please provide (if possible by email alison.bascou@bd.com) FDA 483 Warning letter to Catalent located in Brussels in
Belgium issued in August 2022 and January 2022.
FOI Request - Summary Basis Of Approval for TARPEYO (Budesonide) Delayed Release Capsules 4mg, New Drug
Application (NDA): 215935
Under the Freedom of Information Act, 5 U.S.C .§ 552, I am requesting all copies of all 483s during inspections at WuXi
AppTec (Shanghai) Co., Ltd. [FEI Number: 3008361755] in Shanghai, China during the period of August 1, 2022 until
August 22, 2022.
We request certified and authenticated copies of all Forms 3542 and Forms 3542(a) related to U.S. Patent Nos.
8,895,601; 9,464,071; 9,902,714; 10,898,482; 11,077,106 listed in the Orange Book for the drug product ERDAFITINIB
(Balversa) Tablets.
The TRIP (TRG Rapid Inquiry Program) response for the BioStem Technologies amniotic membrane allograft product
VENDAJE.
records pertaining to the Innovative Science and Technology Approaches for New Drugs (ISTAND) Pilot Program: (1)
All formal Letters of Intent (LOI) submitted to the United States Food and Drug Administration (FDA) Innovative Science
and Technology Approaches for New Drugs (ISTAND) Pilot Program that were either a) accepted or b) denied. etc
Children 6 months to 12 years were included in the Pfizer-BioNTech vaccine trials. I would like to know if the FDA,
Pfizer, and/or BioNTech has the following information: 1) If the parents of the children volunteered their children as
trial participants or whether the parents received financial compensation; and ETC
Records and / or communications of the Center for Biologics Evaluation and Research, Food and Drug Administration, to
and / or from Pfizer, inc. concerning Lot # FW1331 of Comirnaty®. Please provide records from November 1, 2021, to
present.
Any and all emails sent to and from FDA officials related to compliance issues with its vendor Advanced Bioscience
Resources, Inc. (“ABR”) and/or the termination by FDA of ABR’s services.
Plavix Package Labels for dates: 05/03/2011 05/24/2013 03/12/2014 05/14/2014 03/24/2016
Inspection Form 483 for Abraxis Bioscience LLC, Phoenix , AZ 85043. Inspection ID 1166508 Date 04/06/22
Good morning FDA. I am requesting all written correspondence (including but not limited to emails) between FDA and
Metro International Biotech LLC (“Metro”) that relate to a Dec. 1, 2021, letter from Metro to the Food and Drug
Administration in docket number FDA-2021-P-0938. The latter letter to FDA was signed by Michael A. Willis, corporate
counsel to Metro.
All data and information for the 12-15-Year-Old Pfizer Vaccine enumerated in 21 C.F.R. § 601.51(e) with the exception
of publicly available reports on the Vaccine Adverse Events Reporting System.
STIMLABS COMPLAINANT
Records listing all summary data related to Adverse Events of Special Interest (AESI) resulting from administration of
COVID-19 vaccines identified through the Rapid Cycle Analysis (RCA) surveillance protocol. Data collected shall includes
types of AESI (eg, heart attacks, thromboses, strokes, et al), number of incidents, locations and dates of incidents, age of
patient, et al.
d: Facility: Alkermes (Wilmington, Ohio) [FEI: 1000142940] Address: 265 Olinger Cir, Wilmington, OH 45177 A copy of
the most recent inspection and a copy of any 483's issued
Copy of 510(k) for K093243, CoaguSense self test Prothrombin Time/INR Monitoring system, manufactured by
CoaguSense Inc.
Copy of 510(k) for K050574, Afinion AS100 Analyzer, manufactured by Axis-Shield PoC AS
Copy of 510(k) for K053597, I-STAT BNP Test, manufactured by i-STAT Corporation
Copy of Dual 510(k) and CLIA Waiver submission, tracked as K181043 and CU180005, StatStrip Glucose Hospital Meter
System, manufactured by Nova Biomedical Corporation
A copy of any and all correspondence or documents relating to any patent for Akynzeo® or NDA No. 210493 in the FDA’s
volume entitled Approved Drug Products with Therapeutic Equivalence
AbbVie, Inc. would like to obtain a copy of the FDA medical/summary/multidisciplinary/statistical review(s) for the
Supplemental New Drug Application (sNDA) for the updates to the United States Prescribing Information (USPI)
describing the impact of Jakafi (ruxolitinib) on fatigue in patients with myelofibrosis (MF). According to the FDA
supplement approval letter, the sNDA dated December 15, 2016 was submitted by Incyte Corporation.
Complete 510(k) premarket notification documents including all applicable attachments for 510(k) number K172284
510(k) Number: K172284 Device Name: NAPA LP-15 Airway Pressure Monitor Applicant: DRW Medical, LLC Regulation
Number 868.2600 Classification Product Code: CAP Date Received: 07/28/2017 Decision Date: 02/09/2018
QUESTIONS RE IMPORTING COSMETICS
I'm looking for records from a John Hopkins warning letter dated Mar 31, 2003 Ref# 02HFD-45-0303 (I have a copy of
this). Requesting: John Hopkins trial protocol: "Mechanisms of Deep Inspiration-Induced Airway Relaxation," and any
associated forms from the protocol any associated records the FDA has on this event. I'd also like the response letter
from John Hopkin's pertaining to the warning letter to FDA.
The 483 (in electronic format) for Human Drugs inspection of EMERY PHARMA ending 04/09/2021 at the location in
Alameda CA, United States. The EIR (in electronic format) for Human Drugs inspection of EMERY PHARMA ending
04/09/2021 at the location in Alameda CA, United States. etc
for Biologics inspection of Seqirus Pty Ltd ending 03/18/2022 at the location in Parkville, Australia. Please send
for Medical Devices & Rad Health inspection of Becton Dickinson Caribe LTD ending 07/29/2021 at the location in Cayey
PR, United States. Please send documents as email attachments.
for Biologics inspection of Spark Therapeutics, Inc. ending 03/04/2022 at the location in Philadelphia PA, United States.
format) for Human Drugs inspection of Plastikon Healthcare LLC ending 11/04/2021 at the location in Lawrence KS,
format) for Human Drugs inspection of Chattem Plant 1 ending 03/13/2020 at the location in Chattanooga TN, United
Inspection report for Indianapolis Fruit, dated March 2nd 2022.
for Human Drugs inspection of PETNET Solutions, Inc ending 06/15/2022 at the location in Portland OR, United States.
I am requesting the container and carton labels for 019627 Diprivan, Propofol found under SUPPL-72, 05/11/2021 for
our ANDA development. We do see that labels are posted on the FDA website but they are not clear, we were hoping
that the FDA has labels that are better legible. Please send the labels via email. Thank you.
Documents relating to: Chehab, M, 2021, Pharmacovigilance Memo: Device Breakage, NDAs 208-224, 206-229, 21-225,
203-159, 18-680, OSE RCM #2018-892. FDA/CDR/OSE. Associated link does not work:
https://darrts.fda.gov/darrts/faces/ViewDocument?documentId=090140af805f973f& afrRedirect=305197636762994
most recent inspection and a copy of any 483's issued for the following record: Facility: Alkermes (Athlone, Ireland)
[FEI: 3002806873] Address: Monksland Industrial Estate Athlone Ireland
The inspection report for Garden Cut, LLC at 4501 Massachusetts Avenue. Indianapolis IN 46218 from September 2021.
- Full text, especially showing the brand name of the products, for 7 reports concerning heat not burn devices. Reports
ID: 459, 403, 935, 863, 2103218, 2087498, 2128650. - Full text, especially showing the brand name of the products, for
10 reports concerning electronic cigarettes reported in 2022. Reports ID: 2127920,etc
Emergency IND #28685
FOI Request and Authorization for FDA to Release a Complete Copy of IND 66111 from the Center for Drug Evaluation
and Research to Mr. David L. Rosen.BS Pharm, JD of Foley & Lardner LLP
All investigation materials and reports, including but not limited to the Establishment Inspection Report (EIR), for the
inspection related to the fatality that occurred May 14, 2019, after a visit to the BioLife Plasma Services L.P. facility
located at 9500 NE 82nd Terrace, Kansas City, Missouri.
Please see attached line listing of cases pulled from the FAERs dashboard for which we are requesting report details.
Thank you,
method for determining the weight average molecular weight to number average molecular weight
I would like to request the review summary from each division involved in the review and approval supplement 400 to
BLA 125057 (Humira, adalimumab).
I would like to request the review summary from each division involved in the review and approval supplement 401 to
BLA 125057 (Humira, adalimumab).
Seeking Information regarding: AMPUTEK Inc. Registration Number: 3015143068 FEI Number*: 3015143068. Registered
Agent, Fred Hernandez. Requesting copies of, Custom Device Annual Filing Report for 2018, 2019, 2020, 2021. Also
seeking any and all inspection records for custom medical devices imported and distributed by AMPUTEK Inc.
Copy of the disclosable portions of the MedWatch report for Molnupiravir case number 21184264.
1. All complaints relating or referring to The Honest Company (also known as Honest or Honest Co.) filed with the
Food and Drug Administration’s Consumer Complaint Coordinator from 01/01/2021 to the present
1. All complaints relating or referring to The Honest Company (also known as Honest or Honest Co.) filed with the Food
and Drug Administration’s Office of Regulatory Affairs from 01/01/2021 to the present
1. All correspondence between officials at the Office of Regulatory Affairs with ranks G-15 and higher and The Honest
Company (also known as Honest or Honest Co.) from 01/01/2021 to the present 2. All correspondence from officials at
the Office of Regulatory Affairs with ranks G-15 and higher relating or referring to The Honest Company (also known as
Honest or Honest Co.) from 01/01/2021 to the present
and Drug Administration’s Center for Devices and Radiological Health from 01/01/2021 to the present n
I request disclosure of the following records: 1. All correspondence between officials at the Center for Devices and
Radiological Health with ranks G-15 and higher and The Honest Company (also known as Honest or Honest Co.) from
01/01/2021 to the present 2. All correspondence from officials at the Center for Devices and Radiological Health with
ranks G-15 and higher relating or referring to The Honest Company (also known as Honest or Honest Co.) from
01/01/2021 to the present
We request all copies of all 483s during inspections at WuXi AppTec Co., Ltd. [FEI Number: 3006336161] in Shanghai,
China during the period of August 1, 2022 until August 22, 2022. Thank you in advance for your time.
and Drug Administration’s Center for Drug Evaluation and Research from 01/01/2021 to the present
2022-5419, 2022-5420, 2022-5454, 2022-5453, 2022-5212, 2022-5213
Copy of the disclosable portions of the complete FDA response for the following file numbers: 2019-2120, 2022-2589,
2022-2612, and 2022-1597.
2022-2389, and 2022-3424.
Our business is looking for the Establishment Inspection Reports (EIR) from the last two audits held with the FDA. These
audits were conducted in August of 2015 and March of 2016. Our facility registration # is 1718850. These reports can be
provided either electronically or in hard copy. Thank you Celeste Kreul Cell: 303-810-4324 Address: 14401 W 65th Way
Arvada, CO. 80004 celeste.kreul@livanova.com
Requesting copy of May 12, 2021 DePuy Synthes Urgent Medical Device Removal notice for Articul/eze femoral heads
distributed with incorrect part number and size etched on the product
Copy of the disclosable portions of the original FOIA request letters and complete FDA responses for the following 4 File
Numbers: 2022-2523, 2022-3491, 2022-3492, and 2022-3606.
Seeking information regarding: OTN Implants B.V., Simon Stevinweg 48, Arnhem Gelderland, NL Custom Device Annual
Filing Reports for 2018, 2019, 2020, 2021. Also requesting any and all inspection records for custom medical devices
imported and distributed by OTN Implants individually or through Amputek Inc. or Fred Hernandez as listed above.
ReVivo INTERNATIONAL GMBH. Address: An Der Hasenkaule 10 Huerth North Rhine-Westphalia, DE 50354 Custom
Device Annual Filing Reports for 2018, 2019, 2020, and 2021. Also requesting any and all inspection records for custom
medical devices imported and distributed in the US by ReVivo International GMBH and affiliations with US based
companies.
Signature Orthopaedic Signature Orthopaedics USA Corp. US address, 3150 Stage Post Drive, Suite 104, Bartlett, TN
custom device annual filing reports for 2018, 2019, 2020, & 2021. Also seeking any and all inspections records for
custom medical devices imported and distributed by Signature Orthopaedics or their known US agents as related to
Osseointegration and the "Patriot" implant. Official Correspondent: Declan P Brazil 7 Sirius Road Lane Cove West, New
South Wales AU 2066 Phone: 61-02-94115514
We are seeking a warning letter from the CDRH to Caliber ID (CMS# 431658) dated January 8, 2015, addressed to
Recipient: L. Michael Hone Chief Executive Officer Caliber Imaging & Diagnostics, Inc. 50 Methodist Hill Drive Suite 1000
Rochester, NY 14623 United States.
All emails, sent or received between January 1, 2022 and the date of the search by any of the individuals listed below,
that contain any of the following terms: “excess death(s)” or “negative efficacy” or “all cause mortality” or “all-cause
mortality” or “ACM” or “Scotland” or “sudden death(s)”: 1) Peter Marks, MD, director of CBER etc
NDA 215430: Qulity (Chemistry) Review, and Biopharmaceitucal Review
I am seeking all FDA 483 records for the following companies within the timeframe noted (01/01/2020 - current):
Monarch PCM, LLC FEI 3012816585 Located Fort Worth, TX Verde Cosmetic labs, LLC FEI 3014015976 Located
Northridge, CA
FDA site facility report of Moderna Therapeutics, One Upland Road, Norwood Mass. 02062 in anticipation of EUA for
Covid Vaccine.
EIR and Forms 483 for FEI 3001236616: Musculoskeletal Transplant Foundation, 125 May St., Edison, NJ 08837.
Hello, Please provide the memorandum of understanding between the FDA and CDC that states all VAERS inquiries,
FOIAs, and congressional inquiries are addressed by the FDA
EIR and Forms 483 for FEI 3000718057, Musculoskeletal Transplant Foundation, 3-A Chestnut St., Albany, NY 12205.
EIR, Forms 483, and firm's response for FEI 3015365441: Vitti Labs LLC, 834 W. Kansas, Suite C, Liberty, MO 64068.
Product Area: Drugs Forms FDA 483 and EIRs for the following sites: Charles River Laboratories, 87 Senneville Road,
Senneville, Quebec H9X 3R3, Canada; BioReliance Corporation, 9630 Medical Center Drive, Rockville, MD 20850, USA;
Covance Laboratories, 9200 Leesburg Pike, Vienna, VA 22182-1699, USA.
Please share form 483 for Glenmark pharma usa facility North Carolina facility
I would like to view results of warning letter issued to American Contract Systems, Inc. on November 6, 2018 for its
Zelionople, PA facility and subsequent same facility audit dated March 25, 2022. I am interested in determining if the
March 25, 2022 audit did in fact close out the warning letter of November 6, 2018.
All documents, communications and/or records related, in any way, to FDA's 2022 inspection of Quva Pharma, Inc. in
Sugar Land, Texas.
510k application and other related documents of Tyto Care Inc. K181612.
Human Adverse Drug MedWatch Reports for the following Case IDs: 9914267 9959791 10364611 10426451 10526968
11097303 11182937 11366204 11694848 11809078 12095594 12557975
510k application and any other related documents from Diacoustic Medical Devices (Pty) Ltd. K131044.
510k application and any other related documents from CSD Labs GmbH. K220766
A PMA Number P120006 PMA Number P120006 Supplement Number S001 PMA Number P120006 Supplement
Number S003 PMA Number P120006 etc
510k application and any other related documents from CSD Labs GmbH. K181988
I am seeking all FDA-produced documents and all correspondence related to foodborne illness investigation number
1064 (dry cereal), posted 4/20/22 on the CORE table.
full-length case reports (including full narratives) for all adverse events related to poppy seeds resulting in overdose,
dependence, death, or any other serious or medically important outcome reported to FDA between December 2021
and August 2022
We request you to provide us the classification of all USFDA approved drugs as per the "Pharmacologic Class" as
described in USP Therapeutic Categories Model Guidelines given under the below link:
https://www.fda.gov/regulatory-information/fdaaa-implementation-chart/usp-therapeutic-categories-model-guidelines
Thanks and regards, Nimish Mehta
WARNING LETTERS
DAILY HARVEST FRENCH LENTIL + LEEK SAME METHODS ETC
K211399
for Human Drugs inspection of BAMF Health Inc ending 07/01/2022 at the location in Grand Rapids MI, United States.
The Response (in electronic format) for Human Drugs inspection of BAMF Health Inc ending 07/01/2022 at the location
in Grand Rapids MI, United States. Please send documents as email attachments.
format) for Biologics inspection of Emergent BioSolutions Canada Inc. ending 05/10/2022 at the location in Winnipeg,
Canada. Please send documents as email attachments.
for Human Drugs inspection of Avantor Inc. ending 08/03/2018 at the location in Phillipsburg NJ, United States. Please
for Foods & Cosmetics inspection of Shandong Xinhua Pharmaceuticals (USA) Inc. ending 06/02/2021 at the location in
South El Monte CA, United States. Please send documents as email attachments.
for Medical Devices & Rad Health inspection of iCRco Inc. ending 07/01/2022 at the location in Goleta CA, United States.
for Medical Devices & Rad Health inspection of Retrofix Screws LLC ending 07/01/2022 at the location in Salisbury NC,
for Medical Devices & Rad Health inspection of RIGHTEYE, LLC ending 07/08/2022 at the location in Bethesda MD,
Please provide the summary basis of approval (especially clinical, chemistry, efficacy and safety review documents) and
administrative correspondence (especially related to regulatory exclusivity) for NDA 216264.
for Medical Devices & Rad Health inspection of Specialty Vision Llc ending 07/07/2022 at the location in Ridgefield Park
for Medical Devices & Rad Health inspection of Faretec Inc ending 07/13/2022 at the location in Painesville OH, United
FOIA Request for 510(k) filing for K123079: Olympic Brainz Monitor
All materials submitted by Allogene to the FDA regarding their RMAT designations for ALLO-715 and ALLO-501A,
including clinical and nonclinical data.
K200148
The USFDA had inspected Gland Pharma's Dundigal Facility at Hyderabad, India from 22nd August, 2022 to 25th August,
2022. It has received 1 (ONE) observation on Form 483 with respect to ANDA filed for the product to be manufactured
at the said Facility. Request you to kindly share a copy of Form 483
We would like any and all reports, documents, pictures, videos, notes, opinions, conclusions, interviews, statements, or
other tangible record of the FDA's inspection(s) of Zachary Confection's (2130 West State Road 28, Frankfort, Indiana
45041) facilities, specifically surrounding the reporting of rodent fecal matter found in a Zachary Confections Cinnamon
Bears container on or around January 4, 2022.
A complete copy of all documents relating to adverse events (including warnings, 483 letters, notices, inspections,
investigations, communications, affidavits, MedWatch reporting, medical records, autopsy reports, recalls, etc.) for the
product Libido-Max, produced by Applied Nutrition and/or Irwin Naturals.
I am writing about licensed issued patent #9,803,176 B2, otherwise known as JadiCell and the clinical phase IIb/IIII study
by Principal Investigator Dr. James Veltmeyer and Therapeutic Solutions International, Inc., administered by BioRASI. It
is the subject of an FDA cleared Phase III trial. It is an Industry Sponsored investigation.
Hello, I would like to request the Form 483 issued in August or Sept 2022 to Berkshire Sterile Manufacturing during any
FDA inspection of their Lee, MA facility. Thank you
I am requesting a copy of any and all documents related to the 1) investigation of Revive smoothie products; 2) copies
of all consumer complaints and documents about Revive smoothie products; 3) all consumer complaints about Tara
flour; 4) FDA’s investigation of Tara flour 5) all materials relating to GRAS status of Tara flour.
Information regarding Motif FoodWorks Color Additive Petition relating to Pichia pastoris. Please see attached for
further details.
I am requesting a copy of any and all records related to 1) FDA's investigation of complaints about recalled Daily Harvest
French Lentil + Leek Crumbles; 2) Copies of consumer complaints and records about Daily Harvest French Lentil + Leek
Crumbles; 3) Investigation of complaints about other Daily Harvest products not part of the French Lentil + Leek
Crumbles recall; etc.
-Letters to the FDA from concerned citizens and consumers regarding Miltown, Librium and Valium and the FDA
responses between 1955 and 1980, and FDA letters in response -Original new drug applications to the FDA for the
following drugs: Miltown, Librium, Valium etc
I am writing to request a full and complete copy of the CFSAN investigation file, including but not limited to a CORE
report related to the 2019 Salmonella Carrau outbreak linked to Caito Foods, LLC's cut melon. Please treat this request
as a first party request.
Inspector Profiles and 483s issued by 1. Dr. Yongmin Liu, OBP - Biologist 2.Yan Wang - Lead Biologist - CDER/OPQ/OBP 3.
Wayne Seifert - Consumer Safety Officer - CDER/OPQ/OPMA/DBM1
I would like a copy of the form 483 observations issued by the US FDA for the following manufacturing plants of
Glenmark Pharmaceuticals: A) Facility at Monroe, North Carolina - inspected between April 4 and May 19, 2022 B)
Facility at Goa, India - inspected between May 12 and May 20, 2022
2022-4024, 2022-4061, 2022-4065, 2022-4203, 2022-4271.
2022-3701, 2022-3813, 2022-3866, 2022-3878, 2022-3943.
All emails from FDA-CVM employee Xin Li for the date of December 7, 2012, with the key search term: PFI
I’d like a copy of all documents including the request in December 2021 for Ark Pharmacy dba Regency Medical
Pharmacy; FEI 3021030637Ark Pharmacy dba Regency Medical Pharmacy; FEI 3021030637 Regency Medical Pharmacy
1000 Newbury Rd Ste 100 Newbury Park CA 91320
Please provide all requested records by electronic format to my email. Any and all information regarding VAERS report
ID: 2294012-1, including but not limited to any correspondence received or sent in relation to this report.
ADVERSE EVENT RECS
1. Any and all information and records regarding Case 20861953 listed in the COVID-19 Emergency Use Authorization
(EUA) FAERS Public Dashboard, a case regarding a 27yo male reporting Dysgeusia after taking Paxlovid. (Also listed as
US-PFIZER INC-202200735619.) 2. Any and all information and records regarding Case 20821187 listed in the COVID-19
Emergency Use Authorization (EUA) FAERS Public Dashboard, a case regarding a 27yo male reporting Dysgeusia after
taking Paxlovid. (Also listed as US-PFIZER INC-202200677312.)
We respectfully request all entry-line records that contain any of the following data points in reference to any entry’s
FSVP Importer, Importer of Record, or Consignee; for entry-lines with submission or arrival dates between August 1 and
August 31, 2022: 1) DUNS Number / Unique Facility Identifier (UFI) of: 080801169 etc
INDIVIDUAL RECS
format) for Biologics inspection of Kamada, Ltd. ending 04/05/2017 at the location in Mobile Post Negev, Israel. Please
for Biologics inspection of ADMA Biologics, Inc ending 08/12/2021 at the location in Boca Raton FL, United States.
for Human Drugs inspection of SHIRE, PLC ending 03/23/2022 at the location in Lexington MA, United States. Please
format) for Human Drugs inspection of Charles River Laboratories ending 12/06/2016 at the location in Woburn MA,
for Medical Devices & Rad Health inspection of Mytrex, Inc. ending 07/19/2022 at the location in South Jordan UT,
for Medical Devices & Rad Health inspection of Optikem International, Inc. ending 07/11/2022 at the location in Denver
CO, United States. Please send documents as email attachments.
for Medical Devices & Rad Health inspection of Huestis Machine Corporation ending 06/30/2022 at the location in
Bristol RI, United States. Please send documents as email attachments.
for Medical Devices & Rad Health inspection of Signifier Medical Technologies, Llc ending 07/15/2022 at the location in
Needham Heights MA, United States. Please send documents as email attachments.
for Medical Devices & Rad Health inspection of Jarvis Surgical, Inc. ending 07/07/2022 at the location in Westfield MA,
for Medical Devices & Rad Health inspection of Kem Medical Products Corp ending 07/21/2022 at the location in
Hauppauge NY, United States. Please send documents as email attachments.
Sample Results for Glucerna Chocolate Shakes
All records related to serious adverse event reports assigned CAERS identification numbers 104496 (submitted
7/3/2008) and 128655 (submitted 12/24/2009).
75F40122D00022 list of bidders
Any 483 reports related to the HeartWare Ventricular Assist Device owned by Medtronic.
Email communication between FDA Human Tissue and Reproduction Branch Chief Ping He and Sean Tipton of the
American Society for Reproductive Medicine. (stipton@asrm.org)
RECS RE PETDINE LLC - COMMUNICATIONS, INSPECTIONS ETC
Copy of the 483 for the 07/08/2022 through 07/14/2022 inspection of Maria A. Rodil, M.D. located at Maria A. Rodil,
M.D. [West Miami / United States of America] 1350 SW 57th Ave Ste 314, West Miami, FL 33144, USA. This inspection
pertains to HUMAN DRUGS.
Report and/or the MDSAP Noncomformity Grading and Exchange Form (NC) for the inspection of Allesee Orthodontic
Appliances, Sturtevant, WI , end date 02-07-2019. FEI# 1000128562. This inspection pertains to medical devices.
Report and/or the MDSAP Noncomformity Grading and Exchange Form (NC) for the inspection of NEUWAVE MEDICAL,
INC., Madison, WI , end date 10-27-2017. FEI# 3008769756. This inspection pertains to medical devices.
Report and/or the MDSAP Noncomformity Grading and Exchange Form (NC) for the inspection of Hamilton Enterprises,
Inc. / dba: Quintron Instrument Co., Milwaukee, WI , end date 06-16-2017. FEI# 2124914. This inspection pertains to
medical devices.
Regulatory Assessment of Providence VA Medical Center Blood Bank Located at Providence RI United States FEI
Number: 1273951 held on 05/12/2021.
Report and/or the MDSAP Noncomformity Grading and Exchange Form (NC) for the inspection of Young Os Llc,
Algonquin, IL , end date 12-20-2018. FEI# 3008875470. This inspection pertains to medical devices.
Regulatory Assessment of TriStar Centennial Medical Center Located at Nashville TN United States FEI Number:
3008138134 held on 05/12/2021.
Regulatory Assessment of Hygeia II Medical Group, Inc. Located at Carlsbad CA United States FEI Number: 3006774448
held on 05/12/2021.
Regulatory Assessment of Cranial Technologies Inc Located at Tempe AZ United States FEI Number: 3000215614 held on
05/12/2021.
for Medical Devices & Rad Health inspection of Sonomed, Inc. ending 07/14/2022 at the location in New Hyde Park NY,
I request a copy of all documents containing information submitted to the Food and Drug Administration (FDA) related
to the 510k application submitted by Visibly in January 2022. The device name is “Visibly Digital Acuity Product.” 510(k)
Number is K220090.
for Medical Devices & Rad Health inspection of Pedia Parents Inc. DBA Pedia Pals ending 07/14/2022 at the location in
Buffalo NY, United States. Please send documents as email attachments.
for Medical Devices & Rad Health inspection of Vee international inc ending 07/15/2022 at the location in Garden City
for Medical Devices & Rad Health inspection of Advanced Facialdontics LLC ending 07/22/2022 at the location in East
Islip NY, United States. Please send documents as email attachments.
for Medical Devices & Rad Health inspection of Wintech Mdedipro LLC ending 07/06/2022 at the location in Katy TX,
Please share any FDA Correspondence as it pertains to Form 483 issuances to Alvotech (parent company) and its
associated subsidiaries at the following Company sites listed below between March 1, 2022 and August 30, 2022.
Alvotech – 1201 Wilson Blvd., Arlington, Virginia, 22209

Alvotech hf – Sæmundargata 15 - 19, 102 Reykjavik, Iceland
Alvotech – Feodor Lynen Str. 35, 30625 Hannover, Germany
Alvotech – Thurgauerstrasse 54, CH-8050 Zurich, Switzerland
Alvotech – Karl-Heinz-Beckurts-Str. 13, 52428 Julich, Germany
for Foods & Cosmetics inspection of Rockwell Medical ending 07/25/2022 at the location in Grapevine TX, United States.
for Medical Devices & Rad Health inspection of Welch Allyn Inc (Baxter affiliate) ending 07/15/2022 at the location in
Milwaukee WI, United States. Please send documents as email attachments.
for Medical Devices & Rad Health inspection of Medical Machining Technologies LLC dba Med Tech LLC ending
06/30/2022 at the location in Millington TN, United States. Please send documents as email attachments.
Technology Sciences Group Inc. (TSG) hereby submits this FOIA request to obtain all physically and electronically
releasable copies of the documentation submitted by Ishizuka Glass Co., LTD in support of Food Contact Notifications:
FCN 1981 and FCN 476.
Flagship Food Group (TJ Farms brand) frozen Cauliflower Listeria monocytogenes Testing, Investigation, and Recall
K111202 Thunderbeat 510k, manufactured by Olympus
Hello, I would like to request any Form 483 issued to Berkshire Sterile Manufacturing during the August 2022 facility
inspection located in Lee, MA. Thank you
K173085, Invendoscopy E210 System
I am requesting a letter delivered to MiMedx Tissue Services, LLC (FEI# 3005897621) located at 1775 West Oak
Commons Court NE, Marietta, Georgia, 30062, OR MiMedx Tissue Services, LLC (FEI# 3009814715) located at 300
TownPark Drive Suite 260, Kennesaw, Georgia, 30144.
Rapid Reboot Recovery Products LLC 2018 Establishment Inspection Report

DEN220006, ProdiGI
Any and all investigation files and/or consumer complaints or injury reports relating to Stonegate Pharmcy, LC located at
2501 w. William Cannon Drive, Suite 203, Austin TX 78745.
Seeking the 510(k) file for RSDL (K023969):
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K023969
Please supply the 510(k) file for M291 (K894455):
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K894455
Please provide the Exclusivity Board Memo for NDA 216264.
05/15/2014 OSE Review for TSI 1355.
Please send usfda form 483 for cipla Goa facility
Form 483 issued to Cipla following the US FDA Inspection at the Goa site in Aug 2022
Requesting a copy of FORM 483 issued to Cipla Ltd's Goa manufacturing facility post an inspection conducted from 16th
- 26th August 2022. The inspection had yielded 6 observations.
Please share form 483 for USFDA inspection of Cipla Ltd manufacturing facility, details of which are as follows: FEI#
3004081307; Formulations manufacturing facility belonging to Cipla Ltd; Location: Goa, India. Inspection: start date :
16th August 2022; Inspection end date: 26th August 2022. Form 483 issued with 6 observations
ANDA 209358
We would like to request the latest (Most recent) Form 483 (Notice of Inspectional Observations) issued for below
referenced facility that was inspected from July 11, 2022 – July 20, 2022. Name of Facility: STELIS BIOPHARMA LIMITED
Address: Plot no.: 2-D1, Obadenahalli, Doddaballapura, 3rd Phase, Industrial area, Doddaballapura Taluk, Bengaluru,
Karnataka 561 203, India (IND) FEI: 3017501030
Recs re Peripheral and Central Nervous System Drugs Advisory Committee sNDA 20-717/S-008, Provigil (modafinil)
Tablets.
Requesting all information associated with Docket # 2005D-0240 and the guidance document titled Draft Guidance for
Industry on Gingivitis: Development and Evaluation of Drugs for Treatment or Prevention. Availability of the guidance
was published in the FR Volume 70, Issue 123 (June 28, 2005) Thank you
NDA# 020165
NDA# 086069
I request the exclusivity summary document and all related documentation used to grant 3 years marketing exclusivity
for NDA 213436 for Trudhesa.
NDA 022503
A full, unredacted copy of the 510K for Promiseb

Investigator’s Brochures related to the 6 FDA approved CAR-T products.
•Request for MedWatch Report for Tebentafusp Case ID 20961330
Data on child-related medication errors

Please may we order the following 12 Individual case safety reports. Case IDs: 11713912 12186273 12187703 12774630
13455885 14785242 14776165 14775861 14929805 17575518 17754393 18504090
2022-5422, 2022-5301, 2022-5282, 2022-4821.
2022-547, 2022-5337, 2022-4391, 2022-4261, 2022-3645, 2022-3605, 2019-8482.
2022-5119, 2022-4714, 2022-4704, 2022-4660, 2022-4641
Form FDA 483: Baxter Laboratories Pty. Ltd. Boronia Australia End Dates
of inspection: 22 July 2022 Project Area: Drug Quality Assurance FEI: 3003945201 Classification: VAI I confirm that
$ 200.
483: Ensign Laboratories Pty Ltd Mulgrave Australia End Dates of
inspection: 15 July 2022 Project Area: Drug Quality Assurance FEI: 3003380641 Classification: VAI I confirm that
$ 200.
I am requesting a letter delivered to MiMedx Tissue Services, LLC (FEI# 3005897621) located at 1775 West Oak
Commons Court NE, Marietta, Georgia, 30062, OR MiMedx Tissue Services, LLC (FEI# 3009814715) located at 300
TownPark Drive Suite 260, Kennesaw, Georgia, 30144.
Aurobindo Pharma Limited Polepally, Mahaboob Nagar India End Dates of inspection: 10 May 2022 Project Area: Drug
Additional documentation on the 45 out-of-specification events referenced in Observation 4 of the FDA’s July 2021 483
for Valisure, located in New Haven, CT, dates of inspection 05/26/2021-07/06/2021 (FEI Number 301206324). Please
note the scope of this request was drugs.
Copy of the disclosable portions of the EIR, 483, and Company Response for the 2018 inspection of Valisure, located in
New Haven, CT. This inspection may relate to drugs or cosmetics, or both.
Any and all records relating to complications, injuries or risks associated with the use of Renuvion/J Plasma
(manufacturer Apyx Medical), including but not limited to reports by physicians, surgical centers, hospitals, distributors,
the manufacturer and consumers.
Copy of the disclosable portions of all FDA Form 3911s submitted by Valisure regarding drugs and/or sunscreens, from
01/01/2015 - present.
Copy of the disclosable portions of the following exhibits to the 483 issued on 07/06/2021 to Valisure, located in New
Haven, CT: Exhibits 2, 3, 4, 5, 55, 100, 101, 102, 106, and 129. Please note this inspection pertained to drugs.
483: Acuity Polymers, Inc. Rochester, New York United States End
Dates of inspection: 03 Aug 2022 Project Area: Compliance: Devices FEI: 3012228452 Classification: VAI I confirm that
$ 200.
483: BioLife Plasma Services L P Rialto, California United States End
Dates of inspection: 27 May 2022 Project Area: Blood and Blood Products FEI: 3018368788 Classification: VAI I confirm
exceed $ 200.
483: Aero Healthcare Valley Cottage, New York United States End
Dates of inspection: 06 May 2022 Project Area: Drug Quality Assurance FEI: 3009540516 Classification: VAI I confirm
exceed $ 200.
483: Continental Dental Ceramics Inc. Torrance, California United States
End Dates of inspection: 15 July 2022 Project Area: Compliance: Devices FEI: 3004146605 Classification: VAI I confirm
exceed $ 200.
483: DICOM Grid, Inc. d/b/a Ambra Health. New York United States End
Dates of inspection: 27 July 2022 Project Area: Compliance: Devices FEI: 3008776294 Classification: VAI I confirm that
$ 200.
483: Dr. Reddy's Laboratories, Inc. Princeton, New York United States
End Dates of inspection: 26 May 2022 Project Area: Bioresearch Monitoring FEI: 3003989912 Classification: VAI I
s permitted by the Freedom of Information Act (FOIA), I am hereby requesting the following document: Form FDA 483:
Electroskip, Llc Buffalo, New York United States End Dates of
inspection: 07 June 2022 Project Area: Postmarket Assurance: Devices FEI: 3017542281 Classification: VAI I confirm
exceed $ 200.
I request a copy of the exclusivity summary document and all related documentation used the determination of 3-year
exclusivity for NDA 20-148 for Migranal nasal spray.
On behalf of Lupin Pharmaceuticals Inc. I request you to please provide me with the Summary Basis of Approval (SBOA)
for the RLD [RADICAVA ORS® (edaravone) oral suspension, 105 mg/5mL]. The Application N215446 has been Approved
Prior to May 12, 2022 and the SBOA is currently not available on Drugs@FDA.
Results of Inspection ID 1081499 of BSV Bioscience Gmbh. Inspection End date 1/25/2019. If applicable, FDA Form
483.
Results of Inspection ID 1048084, and 1050487 of Nanjing King-Friend Biochemical Pharmaceutical Co., Ltd. (FDF Site)
and Nanjing King-Friend Biochemical Pharmaceutical Co., Ltd.. Inspection End date04/03/2018, and 03/23/2018 If
applicable, FDA Form 483.
K213269 APPLICATION STATUS
• All documents laying out Food and Drug Administration (FDA) policies during the period 2008 to present to assess,
prevent, or mitigate, or that governed, personal conflicts of interest (COI) with contractors under 48 C.F.R. § 52.203-16;
• All documents laying out FDA policies during the period 2008 to present to assess, prevent, or mitigate, or that
governed, organizational COI with contractors under 48 C.F.R. Part 9 Subpart 9.5; ETC
Please send form 483 for usfda inspexrion at biocon bangalore bengaluru 2 sites and malaysia
Latest approved insert label (prescribing information) of NDA 017011
Samsung Biologics All 483s for the inspection that took place at Samsung Biologics [FEI: 3010479596] on 06/09/2022.
Facility Address: 300, Songdo Bio Way (Daero), Yeonsu-Gu, Incheon, Republic of Korea
Patheon (relevant for AMX0035 PAI, PDUFA 9/29/2022): Request: All 483s for any inspections that took place at
Patheon FEI: 300026488
Requesting a copy of the Form 483s issued on Biocon Biologic's facilities during the pre-approval inspection conducted
between August 11 to August 30, 2022. The inspection marked 11 observations each for the company's two sites in
Bengaluru and 6 observations for the Malaysia site. Attaching a company disclosure copy for reference.
1) Listing of all INSPECTIONS since Wednesday, September 1, 2021 (in CSV format) with the following fields: FEI
Number, Inspection Start Date, Inspection End Date, Legal Name, Address, City Name, State Code, Zip Code, Country
Name, FDA483, Full Name, District, Center, INSPECTION REASON 2) Listing of releasable inspection CITATIONS (from
FDA's FACTS database) for each company since Wednesday, September 1, 2021 in CSV format with the following
columns: INSPECTION_ID, YEAR, INSPECTION_START_DATE, INSPECTION_END_DATE, FEI_NUMBER, FIRM_Name,
REF_NO, SHORT_DESC, Inspection Classification, Inspection Project Area. Please send CSV file to support@fdazilla.com
Information related to RLD: NDA#018044 ROCALTROL Capsules, 0.25mcg & 0.5mcg 1. Agency reviews for the original
drug product approval dated on August 17,1978. 2.The latest approved labeling-package insert and container/carton
labels dated Feburary 22, 2010.
IBSA would like to receive a copy of the Establishment Inspection Report (EIR) for the Inspection conducted on February
10 through February 13, 2020 by FDA Investigator Phillip M. Pontikos at IBSA Farmaceutici Italia Srl in Lodi, Italy (FEI
3008280916).
I would like to request both Form 483s associated with recent inspection of manufacturing facility in Bengaluru,
Karnataka, India, belonging to Biocon Biologics, Details furnished below: Facility FEI #: 3003981475; Bangalore SEZ
(Biologics facility) Inspection start date (inspection startyed at copmany's facilities in Bangalore): 11th August 2022;
Inspection end date (eneded in Malaysia): ETC
I would like to request Form 483 associated with recent inspection of manufacturing facility in Malaysia belonging to
Biocon Biologics, Details furnished below: Facility FEI #: 3011248248; in Johor, Malaysia Inspection start date (inspection
started at company's facilities in Bangalore): ETC.
Requesting a copy of Form 483 issued on Alembic Pharmaceuticals’ Injectable Facility (F-3) located at Karkhadi. The
inspection was conducted between 18th August, 2022 to 30th August, 2022 and 2 observations were made.
since Sunday, July 31, 2022.
The following two (2) CSV files: 1) Listing of all INSPECTIONS since Wednesday, September 1, 2021 (in CSV format)
with the following fields: FEI Number, Inspection Start Date, Inspection End Date, Legal Name, Address, City Name,
State Code, Zip Code, Country Name, FDA483, Full Name, District, Center, INSPECTION REASON 2) Listing of
releasable inspection CITATIONS (from FDA's FACTS database) for each company since Wednesday, September 1, 2021
in CSV format with the following columns: INSPECTION_ID, YEAR, INSPECTION_START_DATE,
INSPECTION_END_DATE, FEI_NUMBER, FIRM_Name, REF_NO, SHORT_DESC, Inspection Classification, Inspection Project
Area. Please send CSV file to support@fdazilla.com
We request a copy of any and all documents pertaining to the premarket notification K132431 for the Thermage CPT®
System (TG-28) manufactured by Solta Medical, Inc. Please produce responsive documents in their entirety, including
all attachments, enclosures, and exhibits, as well as all related communications between FDA and the applicant.
Establishment Inspection Report (EIR) for FDA Inspection conducted at Midwest Sterilization Corporation, 1204 Lenco
Avenue, Jackson, MO 63755 from Aug 30 - Sept 2, 2021
Any and all reviews, associated drafts, and other communications regarding the abstract/presentation by FDA for the
Society for Research on Nicotine & Tobacco (“SRNT”) on menthol during the 2017 Annual Meeting on March 8-11, 2017:
POS4-111, “Scientific Review of The Effects of Menthol in Cigarettes on Addition,” Kia Jackson, Olga Rass, Megan
Schroeder (CTP).
Spontaneous reports from the FDA's FAERS database reporting certain adverse events for Implanon/Nexplanon; the
3500A forms from the AERs for Implanon/Nexplanon.
All inspection reports for “Mead Johnson & Company, LLC,” “Mead Johnson Nutrition Company,” or “Mead Johnson,”
conducted at any of their facilities in Glenview, IL; Chicago, IL; and Evansville, IN between January 1, 2014 through
August 31, 2022. ETC
1) Job Aids a. PMTA Acceptance and Filing Reviewer’s Job Aid b. PMTA Secondary Reviewer’s Check List c.
TPMF Job Aid d. All other “Job Aid” documents not specifically mentioned 2) Guides a. PMTA Discipline Review
Template b. ENDS State of Science (SoS) c. OS Decision Making Principles d. All other discipline-specific review
guides ETC
On behalf of Lupin Pharmaceuticals, Inc. I request you to please provide me the summary of ANDA - CMC for the
product FERUMOXYTOL SOLUTION; INTRAVENOUS (ANDA# 206604).
Copy of the disclosable portions of the Food Contact Notification for FCN 2211, as well as all releasable FDA chemistry
and toxicology review memoranda and any relevant correspondence.
Please provide the Form 483 associated with the FDA’s inspection of Smithfield Bioscience Inc's (FEI #: 1527761)
Cincinnati, OH facility that concluded on 7/15/2022. Facility address: 12150 Best Pl, Cincinnati, OH, 45241-1569.
Human Adverse Drug MedWatch Reports for the following Case IDs: 8996934 9826211 12862262 20892066 16910550
17648549 17702818 14264317 13796371 11473143 10787176 17588365
re: Donor Network of Arizona FEI 3003374197, 2010 W. Rio Salad Parkway, Tempe, AZ 85281. EIR, Form 483, and firm
response(s) for any inspection(s) occurring between June 1, 2021 and September 1, 2022.
since Sunday, July 31, 2022.
I am requesting the FDA's filed documents in response to the FOIA request 2020-6993 by the SYNGAP Research Fund.
I would like to get case-reports (narratives) of pneumonitis (reaction) induced by Olaparib. Please find attached
(document WORD) the 63 cases of interest identified in the FEARS DashBoard.
I would like to see the scientific data about the safety and health effects of HIGH FRUCTOSE CORN SYRUP; I would like to
see the data regarding the approval of HIGH FRUCTOSE CORN SYRUP by the federal office that approved of this
substance.
We request agency to provide CDER of THORAZINE TABLET-ORAL, GLAXOSMITHKLINE, New Drug Application (NDA):
009149
Copy of the 483 for the 05/09/2022 through 05/20/2022 inspection of Clive Ballard, M.D. located at Clive Ballard, M.D.
[- / United Kingdom of Great Britain and Northern Ireland] Tower Wing, Floor 16, Great Maze Pond London United
Kingdom. This inspection pertains to HUMAN DRUGS.
Copy of the 483 for the 06/06/2022 through 06/20/2022 inspection of ROVI PHARMA INDUSTRIAL SERVICES S.A. located
at ROVI PHARMA INDUSTRIAL SERVICES S.A. [San Sebastián de los Reyes / Spain] P.º de Europa, 50, 28702 San Sebastián
de los Reyes, Madrid, Spain. This inspection pertains to HUMAN DRUGS.
I am requesting to receive the 510(k) Premarket Notification K212525 for Advcare Vial Direct to Bag (VDB) Needle-free
Admixture Devices
Copy of the 483 for the 06/15/2022 through 06/24/2022 inspection of Ophtec USA, Inc. located at Ophtec USA, Inc.
[Sunrise / United States of America] 400 Sawgrass Corporate Pkwy STE 220, Sunrise, FL 33325, USA. This inspection
pertains to MEDICAL DEVICES.
To whom it may concern, I am Nguyen Nguyen, an Assistant Professor of Finance at Minnesota State University
Mankato. I am working on a research project that needs data for food, drug, and medical device recalls from the weekly
enforcement reports published by the FDA. The time period is from 01/01/2002 to 12/21/2013. Could you provide the
data? Thank you in advance.
Please provide any email correspondence and/or meeting notes related to the applicability of hyperbaric oxygen
therapy to traumatic brain injury and/or post-traumatic stress disorder.
I would like the Universe Data Dictionary for data stored by the FDA, with information about which fields are publicly
accessible and which require a FOIA request
Complete Response Letter for the Biologics License Application for Somatrogon (Ngenla) once weekly long acting HGH to
Pfizer Inc.
All documents related to a request for approval to treat people with COVID using hyperbaric chambers at Extivita - RTP,
a company founded by Edward di Girolamo. This includes, but is not limited to, documents submitted as part of Di
Girolamo's application, emails, meeting notes, calendar invites, memos and letters indicating a decision.
Please provide any quarterly report regarding Armour Thyroid submitted by AbbVie as committed to in AbbVie's 483
response letter (dated 7/15/2021).
K220090
FDA Data Integrity Inspection Report, Inspection occurred 20-22 Oct 2020 at the US Army Institute of Surgical Research,
Joint Base San Antonio, Fort Sam Houston, Texas
Supplement Approval Letter dated September 14, 2021 for ANDA 210536, Doxycycline Hyclate Tablets, 50 mg and 100
mg held by Alembic Pharmaceuticals Ltd. which provides for the approval of the 50 mg strength product (Product
Number 002).
Supplement Approval Letter dated October 5, 1983 for ANDA 062269, Doxycycline Hyclate Tablets, 50 mg and 100 mg
held by Caribe Holdings Cayman Co. Ltd. (DBA Puracap Caribe) which provides for the approval of the 50 mg strength
product (Product Number 003)
Supplement (CMC) Approval Letter dated July 27, 2021 for ANDA 062505, Doxycycline Hyclate Tablets, 50 mg and 100
mg held by Chartwell Scheduled LLC which provides for the approval of the 50 mg strength product (Product Number
002).
ANDA Approval Letter dated March 31, 1983 for ANDA 062392, Doxycycline Hyclate Tablets, 50 mg and 100 mg held by
Watson Laboratories Inc.
All Form 483s and Establishment Inspection Reports issued by the FDA to Sterling Pharmaceuticals Services, LLC from
June 2020 to the present related to the inspection of any of its facilities, including any correspondence between Sterling
and the FDA regarding these reports and/or remediation efforts, as well as any notice that the FDA recommends or will
take regulatory action (such as classification of the facility as “OAI status").
All Form 483s, Establishment Inspection Reports, correspondence, and/or communications issued by the FDA to Verrica
Pharmaceuticals, Inc. from June 2020 to the present related to the inspection of any facility that produces Verrica’s
product candidate, VP-102, including the facilities owned by Sterling Pharmaceuticals Services, LLC that produce VP-102.
ETC
Documents Regarding Bovine Colostrum in Dietary Supplements & Food. Please see attached for details.
For the medication Aquasol A, there were two documents -- "SUPPL-18" on 11/11/2014 and "SUPPL-19 on 9/18/2015"
-- that were in the category of Manufacturing-CMC. I have attached a copy of the page from the FDA website listing
these documents. I am requesting a copy of both "SUPPL-18" and "SUPPL-19." Thank you very much for your help.
Resume, CV, and job application of Mitchell Zeller, for the position of Director of Center for Tobacco Products (MARCH
2013 - APRIL 2022).
The full (non-summarized) 510(k) clearance reports for the following 510K numbers: K121623, K113053, K111610,
K093416, K083526, K103167, K092818, K082660, K070328.
Any and all records concerning any FDA inspection of Eli Lilly's drug manufacturing facility located in Branchburg, New
Jersey.
FDA IMPORT ALERT 452 & IMPORT ALERT 21-07 (PASCUAL BOING) plus importation records for products from
Sociedad Cooprativa Trabajadores de PAscual S.C.L. (a Mexico shipper). A third party has been importing these products
illegally that has caused the above alerts.
I am requesting copies of all adverse event reports associated with white mulberry leaf.
FDA 483 report on Medpace (Cincinnati, OH) by Victoria Daddeo, April 2018 - FEI Number: 3009316555 ("FDA
investigators audited the Medpace - Cincinnati, OH, United States facility and issued inspectional observations (via FDA
483) on 20 Apr 2018.")
Pursuant to the Freedom of Information Act I am requesting copy of FDA inspection documents related to any
inspections of Jost Chemical Company, 8150 Lackland Rd, St. Louis, MO 63114, for any relevant Project Area (Drug
Quality Assurance, Food Composition, Standards, Labeling, Econ) for calendar year 2022 (from 01/01/2022 to current
date).
I would like to make FOI request for K153485
I would like to make request for K143072
I would like to make a request for K143459
I would like to make request for K130649
Copy of the 483 for the 04/11/2022 - 04/25/2022 inspection of David F. Jativa, M.D. Pensicola, FL. This inspection
inspection, Investigator name(s), product(s) being inspected, and whether or not a 483 was issued
Copy of the 483 for the 07/05/2022 through 07/14/2022 inspection of BAS Evansville, Div Of Bioanalytical Systems, Inc.
located at BAS Evansville, Div Of Bioanalytical Systems, Inc. [Mount Vernon / United States of America] 10424 Middle Mt
Vernon Rd, Mt Vernon, IN 47620, USA. This inspection pertains to HUMAN DRUGS.
Copy of the 483 for the 07/08/2022 through 07/14/2022 inspection of Maria A. Rodil, M.D. located at Maria A. Rodil,
M.D. [West Miami / United States of America] 1350 SW 57th Ave Ste 314, West Miami, FL 33144, USA. This inspection
2022-5568, 2022-5562
All email records for FDA CVM employee David Edwards containing the key search term: AAFCO 07.01.2022-08.31.2022.
08.31.2022. etc
Officials [she works at /DHHS/FDA/ORA/ORA/OHAFO/OHAFOW/DHAFOWVI] 12.01.2021-12.31.2021. Additionally, I
request all records provided for FDA FOIA Appeal 22-0063AA
All documents released under FOIA request 2021 - 5779
All records released for FOIA # 2021-3659.
Any and all Plavix Packet Inserts for dates 05/12/1998 through 11/12/2009. Would like these inserts to have a
certificate of authentication included with them. Also need certificate of authentication for Plavix Packet Inserts Dates:
02/01/2011, 05/06/2011, 12/20/2011, 09/12/2013, 12/12/2013, 07/16/2015, 09/16/2016, 07/10/2017, 10/31/2017,
05/25/2018, 10/11/2018, 5/17/2019, 03/01/2021
Form 483 for Cipla Goa Facility Glenmark Goa Facility Biocon Biologics - Bengaluru, Malaysia sites
all records FDA-CVM reviewed for the approval of the AAFCO definition for "Ground Juniper"
All epidemiology reviews or memorandums related to NDMA OR ranitidine OR n-nitrosodimethylamine OR Zantac

all toxicology reviews related to ranitidine OR Zantac OR NDMA or n-nitrosodimethylamine.
All communications to or from Florian regarding ranitidine or NDMA
all previously produced FOIA productions regarding ranitidine or Zantac or NDMA
All memorandum by or to Joyce Korvick, Janet Woodcock, or Joel Weissfeld regarding ranitidine or NDMA or Zantac
Any communications to or from Gao or Spalding regarding ranitidine or NDMA
I request the Form 483 for the inspection that ended Sept. 1, 2022, of the Catalent drug factory in Bloomington, Indiana.
for Medical Devices & Rad Health inspection of Braemar Manufacturing, LLC ending 04/28/2006 at the location in San
Diego CA, United States. Please send documents as email attachments.
for Medical Devices & Rad Health inspection of Invivo Corporation ending 01/16/2019 at the location in Orlando FL,
for Human Drugs inspection of UAB Cyclotron PET Production Facility ending 08/23/2019 at the location in Birmingham
AL, United States. Please send documents as email attachments.
for Human Drugs inspection of Patheon API Services Inc. ending 08/28/2015 at the location in Florence SC, United
FOIA Request for Documents Related to Synthetic Nicotine Products and Registrations, and Inspection Assignment
Memoranda
FDA presentation materials from the Arthritis Advisory Committee meeting for NDA 021042 held on 4/20/1999 and
4/21/1999
Letters from Medtronic in response to the FDA Form 483 arising from the June 2021 inspection of Medtronic's
Northridge, California facility. Those response letters are dated July 28, September 3, October 8, November 5, and
December 3, 2021.
CMC / Quality review summary ANDA 209358
Dear Sir/Madam, We would like to request the CMC / Quality review summary ANDA 211538
Copy of the disclosable portions of the 510(k) for K172047, Riva Star by SDI Limited.
Copy of the disclosable portions of the 510(k) for K102973, Silver Dental Arrest by Cooley Consulting.
2022-5592 2022-5725 2022-5780 2022-5782 2022-5833 2022-5850 2022-5859 2022-6007 2022-6066 2022-6223 2022-
6281
Please provide both Form 483s (1. Human Drugs; 2. Animal Drugs & Feeds) and applicable Establishment Inspection
Reports (EIR) associated with the FDA’s inspection of Custom Industrial Analysis Laboratories' (FEI #: 1927976) Saint
Joseph, MO facility that concluded in August 2021. Facility Address: 301 S 7th St, Saint Joseph, MO 64501-2203.
Notice of FDA Action File to Wondfo regarding Import Alert 89-08
“International Conference on Harmonisation; Guidance on M3(R2) Nonclinical Safety Studies for the Conduct of Human
Clinical Trials and Marketing Authorization for Pharmaceuticals.” 75 Fed. Reg. 3,471. • Any public comments received
by FDA concerning the final guidance since its publication. • Any public comments received by FDA concerning the draft
guidance. See 73 Fed. Reg. 51,491.
Looking for consumer complaints or adverse event reports about any Isotonix (distributed by Market America Inc)
dietary supplement products. No details are needed. Just need the total number of complaints/reports filed.
I am looking for any Form 483/observation letters/FDA communication for Alvotech S.A., specifically with respect to
their Iceland manufacturing facility.
CV/Resume Jean Brewer, Elizabeth A Sheller, Jocelyn M Muggli, etc
2022-4278, 2022-4283, 2022-4288, 2022-4304, 2022-4328.
2022-4366, 2022-4432, 2022-4462, 2022-4472, 2022-4568.
1. The first page (i.e., Face Page) of the current contract award, and first 15 pages of the Performance Work Statement
or Statement of Work for the existing contract # 47QTCB21D0325/ 75F40122F80015
Any communications between FDA (including any FDA official) and the International Council for Harmonisation of
Technical Requirements for Pharmaceuticals for Human Use (ICH), or any representative, officer, or agent thereof. etc
“International Conference on Harmonisation; Guidance on M3(R2) Nonclinical Safety Studies for the Conduct of Human
Clinical Trials and Marketing Authorization for Pharmaceuticals.” Any records—including emails, memorandum, reports,
or any other records—discussing the development of the Guidance’s technical requirements. etc.
Hi, I would like to request the Form 483 and EIR issued during the March 17, 2022 inspection of the Alvotech facility
located in Reykjavik, Iceland. Thank you.
Any communications external from FDA to or from Dr. Robert Temple discussing, concerning, or in any way relating to
the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) or any
publication, recommendation, or published standard thereof.
Any internal communications to or from Dr. Robert Temple discussing, concerning, or in any way relating to the
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) or any
publication, recommendation, or published standard thereof.
Please provide records relating to Sodium Nitrite -- including the following brands of Sodium Nitrite: HIMedia, Loudwolf,
Duda Energy, ImTimeCuisine. Including Sodium Nitrite sold on Amazon. Including incidents of Sodium Nitrite used for
suicide, homicide. including ingestion of Sodium Nitrite Including the (on or about) February 2021 report filed by our
client (authorization enclosed) Nick McCarthy relating to Loudwolf Sodium Nitrite
PHILIPS NORTH AMERICA COMMUNICATIONS, REQUESTS, SUBMISSIONS RE IST, SCIP, CT, MRI ETC
Seeking communication from the FDA (Complete Response Letter, ext.) detailing its assessment of the March inspection
of Alvotech's manufacturing facility in Reykjavik, Iceland and Alvotech's subsequent written responses to the FDA.
Requesting a copy of the FDA EIR from an FDA Inspection that was conducted in our CSL Plasma, Inc. - Augusta , GA
location (3015462403) March 7, 2022 - March 9, 2022.
Public Records Request Salmonella Newport Outbreak in Summer 2020 Recall Numbers: F-1272-2020; F-1273-2020;
F-1274-2020; F-1275-2020 Confirmation # FDA2070729
A compilation of all the approved emergency investigative new drug (e-IND) requests for Hemopure [HBOC-201] ever.
Any information that is available for release is welcome but hopefully, at least: 1) Date of request, 2) Requesting
institution/physician, 3) Contact information of physician, 4) Reason for request
K203503
VAERS Report
VAERS report
All records related to FDA’s refusal of Entry No. CHQ-0897503-1 and Entry No. CHQ-0879873-0.
VAERS report
Please provide the EIR for the latest inspection(s) conducted at: Catalent Pharma Solutions 1300 S Patterson Dr
Bloomington, IN 47403 FEI Number: 3005949964
VAERS report
VAERS report
Entire unredacted IND filing and correspondence for EP-5C7, also known as EP5C7, huEP5C7, or SMART-anti-E/P-
selectin, from Protein Design Labs, Inc and related materials (e.g. safety data, Phase 1 updates, etc.).
Copy of the disclosable portions of the MedWatch reports for the following 5 molnupiravir cases: 21247165, 21233649,
21233637, 21232308, and 21223953.
Copy of the disclosable portions of the Food Contact Notification for FCN 2201
Requesting a copy of the 07/16/2015 Plavix Packet Label including a Certificate of Authentication. Please contact me
back ASAP on when I can expect to receive this, it is needed for a trial beginning September 17th.
VAERS report
EDF is requesting the petitions, any toxicology, chemistry, or environmental assessment reports prepared by FDA in its
evaluation of the notices, and any correspondence between FDA and the petitioners regarding FDA’s approvals and
amendments of mica-based pearlescent pigments at 21 C.F.R. § 73.350.
Our 3 containers has been examined by FDA. The arrival location of shipment was in Detroit/MI Compliance Officer of
FDA Christinaé R. Hudson did let us know that the laboratory analysis records of our shipments has been released.
Please see containers' numbers 8V6-0017624-3 / 8V6-0017623-5 / 8V6-0017622-7
I am requesting OSE Review #2019-1466.
An electronic database of all the Pet Food Safety Report submitted to the FDA from January 1st, 2019 - Present (Sept.
6th, 2022).
Hi, I would to request the results of the query showing the final classification of the May 2022 manufacturing inspection
of the Berkshire Sterile Manufacturing facility in Lee, MA. Thank you
Request for additional information on VAERS ID 2210778
Requesting a copy of the FDA EIR from an FDA inspection that was conducted in our CSL Plasma, Inc. - Lackawanna, NY
location (3016247266) February 10, 2022 - February 16, 2022.
INDIVIDUAL RECS
We are looking for end of year data, from 12/31 of each year, for all thirteen datasets at this link:
https://www.fda.gov/medical-devices/device-registration-and-listing/establishment-registration-and-medical-device-
listing-files-download
PLEASE provide if FDA A TYPE MEETING has been scheduled BY PMCB Pharmacyte Biotech Inc
Request for product labeling for Differin Gel (adapalene gel, 0.1%) for RLD update posted on Drugs@FDA for
Supplement Approval on June 14, 2022. Drugs@FDA lists "Label is not available on this site." Label is also not available
on DailyMed site.
This request is for a copy of the recently issued Food and Drug Administration (FDA) Letter of No Objection (LONO) for
Berry Global Inc’s post-consumer recycled (PCR) polypropylene, designated as CleanStream® recycling technology.
We are requesting a complete list for the time period where Target Corporation is listed as FSVP importer for any
commodity. Target DUNS number (006961700) is used for import entry, however, Target DUNS number should not be
listed for FSVP importer (FSVP FEI Number 3004613289).
Would like to get a copy of the Complete Response Letter recently issued to Alvotech which was following the
assessment of the March 2022 inspection of Alvotech’s manufacturing facility in Reykjavik, Iceland and Alvotech’s
subsequent written responses to the FDA
As permitted by the Freedom of Information Act (FOIA), I am hereby requesting the following document(s): Drug Master
File (DMF) no. 29463 with subject “PACKAGING MATERIAL, PLASTIC CONTAINER AND APPLICATOR”
Copy of the disclosable portions of all whistleblower reports in relation to the June 2021 Philips Respironics CPAP device
recall.
I request a copy of documents containing information related to the following: Feds4MedFreedom Feds for Medical
Freedom Feds4MedFreedom.org F4MF Feds4MedFreedom.com Feds4MedFreedom Fed Workers for Freedom Marcus
Thornton James Erdman. James Edward Erdman, James Edward Erdman III etc
Pneumonitis induced by Olaparib.
As a Psychology major, I aim to focus of researching how drug usage can effect adult everyday life and routine. I would
like to seek more information regarding the data and evidence found about drugs found in family households and hold
many minors have been exposed. If possible, any examples including news articles of the issue help.
Requesting you to send the US FDA observation report (6 observations) of the facility inspection that took place at
Jubilant Generics' Roorkee facility (FEI Number - 3006895982) in Uttaranchal, India.
Request you to kindly share a copy of USFDA's inspection on Jubilant Pharmova Limited's Solid Dosage Formulations
facility at Roorkee, India. of Jubilant Generics is a subsidiary of its wholly owned subsidiary Jubilant Pharma Limited. The
US FDA has issued six observations pursuant to the completion of the audit.
Hello, I would like to obtain the adverse events related to beta-lactam use in children from 2019 to 2021.
Hello, Please provide all communications - emails, texts, instant chats - to and from the following individuals
mentioning -"data mining" or "Empirical Bayesian" -"vaccines" and "COVID-19" -"results" and "mining" Individuals:
Bethany Baer, Jane Baumblatt, Kerry Welsh, Narayan Nair, Brendan Day, David Menschik, Deborah Thompson,
Christopher Jankosky, Craig Zinderman, Melvyn Okeke
Any releasable drug master file information and drug master file amendments for the following substances: DuPont™
Duolite™ AP143 . DuPont™ AmberLite™ IRP69
We would like to get redacted X-tack 510(k): K201808. Thank you!
tentative (where applicable) and final approval routing summaries (or tentative approval letters, if that is all that is
available) for the generic Actos (pioglitazone) ANDAs submitted by the following companies: 1. Apotex 2. Hetero
I'm looking for documentation of the Pfizer test results for their Omicron variant vaccine that was tested on mice. I
understand the FDA approved them to proceed on to the CDC for review; however, I cannot find any documentation of
test results accordingly.
I am requesting electronic databases of any and all reports of adverse events for animal drugs and devices; both reports
regarding FDA approved animal drugs and devices and unapproved animal drugs and devices.
1) The emergency use authorization filing made by Moderna for its updated Omicron BA.5 bivalent booster to the FDA
in August 2022.
2) Correspondence between Dr. Peter Marks and the Office of Vaccines Research and Review about the above EUA
filing.
I would like to request a copy of the form 483 and/or CRL (complete response letter) that was issued to Alvotech
regarding its proposed biosimilar to Humira.
the data for all product recalls with a Recall Initiation Date between 01 January 2007 and 31 December 2007.
Seattle Children’s Hospital EIR ETC
Hi Please advise if we can get the classification outcome documental evidence to submit to customers of the inspection
done at Chemeca Drugs Private Limited, located at Plot No. 7, Tadi Revenue (Village) J N Pharma City, Parawada
(Mandal), Visakhapatnam, Andhra Pradesh 531019, India (IND) with FEI # 3010630993. This inspection was in june 2022.
regards raghuram Pannala US Agent
Descriptive summaries of observed rates of AESIs, described in section 4.5 on pages 12-13 of the BEST Protocol; B)
Records of the sequential analyses of AESIs described in section 4.6 on pages 13-24 of the BEST Protocol (including both
PMaxSPRT and BMaxSPRT); etc
Sekisui XenoTech, LLC etc inspections dates
I am looking for all Good Laboratory Practice related 483 and warning letters as they pertain to 21 CFR Part 58. I'd love
to learn and see what has been written. I have read through all the ones posted online.
2022-5088
2022-5249
2022-5509
2022-5780
2022-5849
records of the Empirical Bayesian data mining described on pages 9-10 of the article, “Reporting Rates for VAERS Death
Reports Following COVID-19 Vaccination, December 14, 2020-November 17, 2021.”
Records of lines of entries in which Topco Associates LLC or similar variations of its name are listed as the FSVP importer.
Records of lines of entries in which U.S. Food Imports LLC or similar variations of such name, is listed as the FSVP
importer
NOL for food grade post-consumer recycled polypropylene, obtained by mechanical recycling - Berry Global
Inc.'s inclusion in this list for the last 2 months (July 1, 2022 - September 1, 2022).
We request a spreadsheet which includes the 23 publicly available data points for all entries that led to Conchita Foods,
Inc.'s inclusion in this list for the last 2 months (July 1, 2022 - September 1, 2022)
Enforcement Reports
September 8, 2022
the companies listed in the attached document. This request is identical to the request we previously submitted with
control number 2020-3947, but with a different time frame. Lipari Foods requested that each shipment should be
""connected"" to the relevant importer in FDA's resulting spreadsheet. We are providing DUNS numbers for the Lipari
importers relevant to our request below. Please link each entry to the DUNS number that was transmitted along with it
at entry in the response spreadsheet (where available). 1. Market Distributing Market Distribution, Inc. 25 West Cliff
Road Suite 115 Burnsville, MN 55337 DUNS: 08-014-6545 FEI: 3012030144 2. Lipari Foods Lipari Foods Operating
Company, LLC 26661 Bunert Rd Warren, MI 48089 DUNS: 00-640-2820 FEI: 1818487 3. KLT Global PO Box 718 Warren,
MI 48089-0718 4. Lipari/Tut’s Lipari Foods Operating Company, LLC 4900 Stecker Ave Dearborn, MI 48126 FEI
3018728560
Establishment Inspection Reports; Fisher Clinical Services; Allentown, PA. Inspection ID 991558 (10/28/2016) and
Inspection ID 1027720 (08/31/2017)
Please share any Form 483 issuances to Alvotech (parent company) and its associated subsidiaries as it relates to
Biosimilar Adalimumab. The FEI Number is 3013702557 and the Address is Sæmundargata 15 - 19, 102 Reykjavik,
Iceland. Please send for dates between February 1, 2022 and September 1, 2022.
I am requesting the list of cosmetics manufacturers and packagers registered with the FDA. Include all the 50 states and
send the list in excel format please. Only interested in the company name and the state its located in. Thank you.
I would like to request the Form 483 from the March 2022 inspection of Alvotech's manufacturing facility in Reykjavik,
Iceland.
le. We request a spreadsheet which includes the 23 publicly available data points for all entries that led to Fourstar's
inclusion in this list for the last 2 years (July 1, 2020 - July 1, 2022).
Meeting minutes of Type C meeting for NDA#201635.
Information related to Ergocalciferol 50,000 IU Capsules with NDA#003444: FDA's reviews on clinical study for the
original drug product approval dated January 11, 1941
Hello, I would like to obtain relevant data on adverse events related to the use of beta-lactam drugs in children from
2011 to 2021. If possible, I hope to obtain these data as soon as possible. Thank you very much!
All letters, memorandums, correspondence, reports, emails, documents, spreadsheets and the like reviewed, received,
sent, or obtained by the FDA and/or Exactech pertaining to the recalls Z-0024-2022, Z-0023-2022, Z-0021-2022, Z-0019-
2022, Z-0025-2022, Z-0026-2022, Z-0020-2022, Z-0022-2022, and Z-0027-2022. All letters, emails, correspondence, and
documents submitted to the FDA by Exactech relating to the aforementioned recalls. All documents, correspondence,
letters, and emails from the FDA to Exactech.
Request: Establishment Inspection Report for Laboratory Corporation of America ViroMed Laboratories. The inspection
took place 3/2020. FEI: 0002183472. Located at Burlington, North Carolina 27215
Please provide any and all correspondence between FDA and Alvotech of Reykjavík, Iceland related to an FDA inspection
that occurred at the company's manufacturing facility from 3/10/2022 to 3/17/2022 with an FEI number of
3013702557.
Alvotech deficiencies that were identified at the Reykjavik facility and the specified required remediations that are
required in order for the FDA to move forward with the approval of Alvotech's BLA for AVT02.
Regards,
All communications sent or received by Telisha A. Wilson between April 1, 2021 and the date of search that contain any
of the following terms: “Active Health Science”, “75F40121P00211,” and/or “75F401-21-P-00211.”
All deliverables submitted by Active Health Science LLC between June 1, 2021 and the date of search, as required by
page 7 of Contract 75F40121P00211. (Exhibit A.)
EIR and FDA 483 issued for the 4/1 - 4/4/22 inspection of Curia New Mexico, LLC located at: 4272 Balloon Park Road NE
Albuquerque, NM 87109 FEI # 1643045 Note that the FDA 483 was issued on 8/9/22.
2021-7192
Any communications between the FDA and the American Kratom Association ("AKA") regarding kratom importation,
kratom exports from Indonesia, and FDA standards for purity and quality of kratom imported into the United States. I
am attaching a copy of an AKA correspondence that states the AKA is communication with the FDA regarding such
topics. Thank you.
Hi we are requesting for 483 citations AND EIR report issued for Chromo Laboratories India Private Limited, Plot No: 43
& 44 Phase II, IDA, Pashamylaram, Sangareddy District, Telangana 502307, India (IND), FEI # 3008771562. This is for
audit held in January 2020. regards Raghuram P
Legacy Pharmaceutical Services LLC FEI number 3004453700 13333 Lakefront Drive, Earth City, MO 63045 Inspection
483 report from April 12-27, 2022 inspection of facility.
general advice letter that FDA sent to Axsome on July 30th 2021 highlighting that deficiencies preclude labeling.
2021-7946
We are looking to FOIA the case reports from FAERS for the drug Pegcetacoplan
Case numbers:19685262, 19353149, 1960663, 20102463 from the FAERS website
Sequences 0010 through 0016 of the following ANDA 207128

unredacted copies of the Chemistry, Manufacturing, and Controls (CMC) and Annual Reports relating to ANDA
078046 for Ciclopirox Topical Solution, 8%, (Nail Lacquer)
Sequences 0009 through 0012 of the following ANDA 213530 for Chlordiazepoxide Hydrochloride and Clidinium
Bromide Capsules, USP, 5 mg / 2.5 mg, FDA approved October 20, 2020
Sequences 0013 through 0023 ANDA 075900 Fluvoxamine Maleate Tablets, USP, 25 mg, 50 mg, and 100 mg, FDA
approved February 23, 2006
We would like to receive copies, via email, of the latest approved tube/carton labeling (60g and 120g) for the RLD
product Dovonex® (calcipotriene ointment), 0.005% NDA #020273
2022-4580, 2022-4629, 2022-4633, 2022-4641, 2022-4660.
2022-4704, 2022-4714, 2022-4715, 2022-4802, 2022-4809.
the 483 copy of FDA Audit at Centrient, India site that was concluded in July'2022
Luohe Nanjiecun Pharmaceutical Group Pharmacy Co.,Ltd. No.7 Renmin Road East Luohe City, Henan, 462000 China EIR
FEI3010164381
PLease send form 483 for USFDA inspection of Ajanta Pharma DAhej facility
2022-3443
483 issued to Biocon Biologics Limited, Bengaluru India
All records related to any and all Empirical Bayesian1 (EB) data
mining with VAERS data concerning COVID-19 vaccines
documents relating to labeling of chocolate products. Specifically, declaration of added flavoring, spices, etc. to
chocolate regardless of the form.
Date Range: 01/01/2018 - 12/31/2018; I'm requesting all calendar records for William Burkholder
All records and response letters provided for 2022-910, 2022-912, 2022-658, 2022-657
483s and Establishment Inspection Reports (EIR) for Teleflex and Arrow (3015 Carrington Mill Blvd, Morrisville, NC
27560).
in the month of August 1 to 31, 2022, including for any inspections dated before August 1, for: • Pharmaceutical,
biologics and medical device manufacturing facilities, including premarket approval inspections; etc
(Rq.#1) Copies of Form 483s issued to the following DEVICE companies from July 1-31, 2022.
for Biologics inspection of Crystal Laboratory LLC ending 12/12/2006 at the location in Luther OK, United States. Please
for Foods & Cosmetics inspection of L'Oreal USA Products Inc ending 12/04/2012 at the location in Somerset NJ, United
(Rq.#1) Copies of Form 483s issued to the following DRUG companies from July 1-31, 2022.
Copies of Form 483s issued by the CDER Office in July 1-31, 2022.
for Human Drugs inspection of Samuel N. Lederman, M.D. ending 06/03/2013 at the location in Palm Springs FL, United
Copies of Form 483s issued by the CDER Office in July 1-31, 2022. (Complex)
Copies of Form 483s issued by the CDRH Office in July 1-31, 2022.
Copies of Form 483s issued to Green Wave Analytical, LLC on March 7, 2022. FEI Number: 3016367069 Inspection
Date: 3/7/2022
for Human Drugs inspection of LEDERMAN, SAMUEL ending 05/10/2013 at the location in LAKE WORTH FL, United
for Human Drugs inspection of Pennington Biomedical Research Center IRB ending 02/01/2010 at the location in Baton
Rouge LA, United States. Please send documents as email attachments.
K210009, K191163, K192782, K191560, K180797
21273562, 21273554, 21273546, and 21266282.
Copy of the disclosable portions of all establishment registrations and accreditations by Valisure, LLC, to be an FDA
pharmaceutical quality control lab and an analytical lab. Please include all exhibits/attachments included in the
applications, as well as all related correspondence, from 2015 to the present.
Copy of the disclosable portions of the EIRs for the following inspections of Nutricia, located in Cedar Knolls, IA:
05/14/2019, and 07/14/2021. Please note that these inspections related to Foods.
Hi, I would like to obtain data on adverse events related to ibuprofen and acetaminophen use in children from 2001 to
2021. Thank you.
Establishment Inspection Report (EIR) by FDA for - North American Science Associates Inc, (NAmSA) 2261 Tracy Road
Northwood, Ohio USA 43619-1397 FDA Registration # 1521876 Date of Inspection January, 21, 1994
483: Generation Next Fertility New York United States End Dates of
inspection: 25 May 2022 Project Area: Blood and Blood Products FEI: 3013676494
DEVICE: Biolox® delta (GUDID # 00889024430396) DEVICE: Biolox® delta (GUDID# 00889024430402) DEVICE: Biolox®
delta (GUDID# 00889024430419) DEVICE: Biolox® delta (GUDID# 00889024430426) 510K; Recall Information; 483s;
CAPAs; all Urgent Medical Device Correction letter(s) for Biolox Delta
Dear Sir/Madam, Could we please get a copy of the 510(k) submission documents for the follow KZK device codes: -
K991473 - K944319 - K932122 for the purpose of establishing a predicate for a new submission. Thank you for your
time.
01/17/2019 OSE for TSI 1355.
Please provide solicitation documents for the below contract, including Section C (Statement of Work), Section L
(Instructions), and Section M (Evaluation Criteria), and any attachments. Contract ID: 75F40120F80615 Referenced IDV:
GS23F0270L Awardee: PALLADIAN PARTNERS, INC. Source:FPDS (Date Range for Record Search: From 09/29/2018 to
09/30/2020.
Hi Please help in providing EIR for inspection at SLV Pharmaceuticals, LLC (SLV) located at 320 Oser Ave Unit B,
Hauppauge, NY, 11788, and satellite site, on various dates between 29MAR2022 and 14APR2022. It s FEI number is
3014479175 regards raghuram P
Records related to an FDA inspection that occurred at Vapor Vapes Inc.'s premises located at 1801 Catalina St, Suite D,
Sand City CA 93955, which occurred on or about January 17, 2022, as outlined in detail in the submitted full FOIA
request attached. Please see attached for completed request.
Please send us a copy of CLEW Medical Inc's 510(k) entitled CLEWICU with 510(k) number K200717. Thanks.
Full 510(k) submission for: K192109 KOALA and K202487 HealthJoint Note: I believe this was previously requested per
Alpha Intelligent Manifolds, Inc ref# 2021-3112
I am looking for a list of NDC codes that have been deprecated from 2015 through the current day, along with the name
of the drug and the date the drug was made inactive. Looking for the format to be similar to the current format of the
downloadable list of FDA active NDC codes
We are looking to FOIA the case reports from FAERS for the drug Pegcetacoplan
Case number: 19939906
Complete 510k file for Belmont Rapid Infuser RI2 K141654, inclusive of initial 510k submission, formal AINN letters and
AINN responses, and all FDA and applicant correspondence regarding K141654.
(Rq#1) Copies of Form 483s issued to the following CLINICAL INVESTIGATOR from July 1-31, 2022:
I am requesting a listing of individuals with the last name Kamal, who were/are subject to human subject research
under the FDA’’s amended “Final Rule” for waiver of informed consent requirements for emergency research,
Food Contact Notification No. 480, Food Contact Substance Alpha alkene (C20-C24)
SPREADSHEET OF RULEMAKING PETITIONS

Letters to and from the manufacturer's of Dr. Reade's Slim Sense regarding the FDA's detection of lorcaserin in Slim
Sense.
LIST OF INSPECTIONS
LIST OF INSPECTIONS
Rubicon requesting - 483's - FDA inspection observations of the CTX facility details mentioned below for inspection
completed from Aug 25 to Sept 2, 2022. Facility Details: CTX Life Sciences Private Limited, Block No. 251-252, Sachin -
Magdalla Road GIDC, Surat, Gujarat, India, 394230 FEI Number- 3006254924 DUNS Number- 676190180 Product Type-
Human Drugs
510(k) submission document K143563 for Inari Medical Infusion Aspiration Catheter System
Dear Sir/Madam, I would like to request the complete Establishment Inspection Report (EIR) for the facility STELIS
BIOPHARMA LIMITED inspected by FDA during June 11, 2022 to June 19, 2022
Request RLD pack insert of N016418 INDERAL(Propranolol Hydrochloride) Tablets for ANDA submission.
I am looking for all cases with adverse affects from the Hyland's Baby Teething Tablets in the above date range post
2017 recall.
ADVESRE EVENT NARRATIVES
FDA inspection list information request under the Freedom of Information act.
Please see the attached letter. I am requesting all records related to FDA PLA 96-0350:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/96/altegen061896r2.pdf
FCN 1884 chemistry & toxicology review memoranda
Freedom of Information Act (FOIA) Request for FDA’s Unredacted Review Memoranda and Correspondence related to
Mighty Vapors, LLC’s Premarket Tobacco Product Application (PMTA) for Open-System E-Liquid Products; FDA
Submission Tracking Number (STN) PM0002975
All documents and communications, including all photographs, concerning the November 9, 2021 MAUDE Adverse
Event Report for “ENVISIONTEC GMBH FLEXCERA BASE RESIN, DENTURE, RELINING, REPAIRING, REBASING” (MDR
Report Key: 12804286; MDR Text Key: 280836217; Report Number: MW5105283), a copy of which is attached hereto.
AUTO ACCIDENT FOOTAGE
I am requesting the first 500 pages of the Pfizer vaccine licensing data for educational purposes.
I would like to see all the data on reported adverse events for patients using the drug Tepezza (Teprotumumab-trbw)
from February 2020 till today.
all documents, contracts and agreements relating to the development, and distribution of vaccines against COVID-19.
Ivermectin Case ID 20869671
Records of email communication between Food and Drug Administration and HireVue employees, dating from January
1, 2020 to the present date regarding the following two contract numbers: 75F40120P00403 75F40121P00148 Food
and Drug Administration employees who I believe communicated with HireVue employees regarding the above contract
numbers include the following: Tracy Bellamy-Anderson Steven Chang: Tzeleong.Chang@fda.hhs.gov Tiffany Hatcher:
Tiffany.Hatcher@fda.hhs.gov Jacquita Johnson-House: Jacquita.Johnsonhouse@fda.hhs.gov Natalie Mitchell:
Natalie.Mitchell@fda.hhs.gov Sherelle Neal Jennifer Ofsthun Amanda Prophet: etc
copies of all electronic communication between FDA Commissioner Robert Califf and staff of the Executive Office of the
President (emails ending in @who.eop.gov and all other methods of electronic messaging, including texts) containing
any of the following terms (“abortion” or “reproductive” or “contraception” or “contraceptive” or “Mifeprex” or
“misoprostol” or “mifepristone” etc
Please provide the Health Hazard Evaluation, toxicological assessments, laboratory test results, and other documents
that include the levels of cadmium in and/or risk of “De La Rosa Chocolate bars” imported by Mazapan de la Rosa S.A.
de C.V., which is subject to Import Alert 99-42 on 7/21/2022.
Requesting a copy of the Form 483 issued during a pre-approval inspection at Alkem Laboratories Limited's
manufacturing facility in St. Louis, USA. The inspection was concluded with 2 observations and conducted from 6th
September, 2022 to 14th September, 2022.
1. The names and locations (addresses) of any facility owned by USDA or a private facility that supplies the
USDA/FDA/NIH with beagles for research or experiments.
all information that describes FDA’s efforts over the past year to encourage the packaged food and restaurant
industries to lower sodium levels and meet the targets, as well as efforts to encourage consumers to lower their sodium
intake.
LIST OF REMOTE REGULATORY ASSESSMENTS
We are requesting the Latest Pack Insert of Hydrochlorothiazide Oral Solution, 50MG/5ML; ANDA #088587
We are requesting Pack Insert of Hydrochlorothiazide Oral Solution, 50 mg/mL; ANDA # 089661
EIR and Form 483 regarding the inspection for Catalent Indiana, LLC ended on 05/19/2017 (Inspection ID # 1030478).
1) Please provide all Approval Letters for with STN #'s 125742/0-175 (or whatever is the most current update to the
STN) with the original and verifiable signatures. The only STN Approval Letters that are available on the FDA page
(https://www.fda.gov/vaccines-blood-biologics/comirnaty) currently are 125742/0 (23 Aug 21), 125742/36 (16 Dec 21),
125742/45 (8 Jul 22), and 125742/175 (25 Aug 22). etc
Observations) inspection conducted by CDRH for combination product manufacturer Stelis Biopharma Limited, with FDA
establishment identifier # 3017501030.
Observations) inspection conducted by CDRH for combination product manufacturer Gland Pharma Limited, with FDA
establishment identifier # 3002647489
Dr. Philip R. Kennedy FDA warning letter close out; research https://www.fda.gov/inspections-compliance-
enforcement-and-criminal-investigations/warning-letters/kennedy-philip-r-597587-02272020
Requesting the EIR for the inspection at Olympus Corporation located at 2400 Ringwood Ave, San Jose, California.
Inspection dates were Feb 22, 2022 - March 10, 2022.
RECALL DATA
We'd like to request the full 510(k) submission for K212896, Visible Patient Suite, System, Image Processing,
Radiological, Visible Patient.
Under FOIA, I am requesting all records and response letters provided for previous FOIA requests 2021-8167, 2021-
8164, 2021-8163, 2021-8161, 2021-8159, 2021-8158. I request the records be provided to me electronically, via email.
We would like to request the full 510(k) submission for K173274,Ceevra Reveal 2.0, Ceevra, Inc.
We would like to request the full 510(k) submission for K103720, SYNAPSE 3D LUNG AND ABDOMEN ANALYSIS,
FUJIFILM MEDICAL SYSTEMS U.S.A., INC.
Please see the attached letter requesting "Table of Final Conclusions" (plasma donor fatalities) for FY20 (span:
10/1/2019-9/30/2020)
Inspection Records including but not limited to: 483s, warning letters, recalls, investigations for the company ARL BIO
PHARMA (FEI 3003644883) located in Oklahoma City, Oklahoma.
We request the following records and information: 1. FDA meeting minutes or notes from meetings between the FDA
and individuals from AbbVie concerning or referencing Rinvoq. 2. FDA meeting minutes or notes from internal FDA
meetings concerning or referencing Rinvoq. etc
FDA's response to Lexicon Pharmaceuticals, Inc.'s request for a hearing on FDA's proposal to refuse Lexicon's new drug
application for Zynquista (sotagliflozin) for use as an adjunct to insulin therapy to improve glycemic control in adults
with type 1 diabetes.
FDA's response to Intarcia Therapeutics, Inc.'s request for a hearing on FDA's proposal to refuse Intarcia's new drug
application for ITCA 650 (exenatide implant).
Copy of the entire file entitled “Evaluation of the Safety and Efficacy of CosmetaLife™ for the Correction of Nasolabial
Folds” having a ClinicalTrials.gov Identifier (NCT Number) of NCT00414544 and an IDE Number of G060045. The request
should include, but not be limited to all formal correspondence between applicant and the FDA, meeting and
correspondence notes, reviewer emails, submissions and acknowledgments and any other correspondence related to
the clinical trial.
I would like the drugs/prescriptions that are FDA approved for a 2-4 yr old that has been diagnosed with ALL-B
Leukemia. etc
Grocery.
Form 483 related to the pre-approval inspection of a foreign facility in Belgium of UCB S.A. The inspection happened
between the 12 January 2022 and the 24 February 2022
Form 483 and Establishment Inspection Report for a human or animal drug pre-approval inspection performed from
August 20, 2002 through September 6, 2002 at NextPharma Oy Niityhaankatu 20 FIN-33720 Tampere, Finland.
all documents, including but not limited to laboratory test results, certification, approval letters, etc. relating to the
release of all lots of HyperRAB S/D Rabies Human Immunoglobulin products authorized for release in the United States
during the specified period (01 Jan 2008 - 01 May 2013).
KETAMINE ADVERSE EVENTS
Based on my request, my initial question to ask about more information on illicit stimulants like Methamphetamine. I
would like evidence as well as event reports regarding the use of it in appropriate environments, concerning medicinal
practice, as well as in inappropriate environments, leading to crime. ETC
Hi, FDA. I am seeking the number of metronidazole (Flagyl) prescriptions--all variations, including capsules, tablets,
vaginal gel and IV drip--for the year 2021, from January 1st, 2021 to December 31st, 2021.
Information related to RLD ZARONTIN syrup 250mg/5ml (ANDA#080258) held by PARKE-DAVIS DIVISION OF PFIZER INC:
FDA's complete reviews for this drug product's original approval dated on February 13, 1974.
Information related to RLD ZARONTIN capsules 250mg(NDA#012380) held by PARKE DAVIS DIV WARNER LAMBERT CO:
FDA's complete reviews for this drug product's original approval dated on November 2, 1960.
Best of Boston located at 4334 Washington St. Roslindale, MA - Inspection Violations
Documents related to a Biologics License Application and associated FDA actions related to that application submitted
by Revance Therapeutics, Inc. (FEI No. 3007772056) for DaxibotulinumtoxinA for injection as detailed fully in the
attached request letter.
Dear FDA: I am making a request under the Freedom of Information Act for documents related to the Philips
Respironics June 2021 recall of millions of its BiBAP and CPAP obstructive sleep apnea devices. Specifically, I am
requesting any communications between the FDA and Philips that relate to the inspection of the company’s Murrysville,
PA facility between August 2021 and October 2021 – and any communications related to the subpoena the DOJ served
Philips on April 8. I am also requesting any other correspondence between the FDA ETC
The following records relating to the usaspending.gov Unique Award Key

"CONT_AWD_75F40121F19002_7524_75F40121A00009_7524": 1) contract with SOW/PWS, all modifications; (2)
agency source selection statement/memorandum and scoring matrix; (3) all task orders with the applicable scope of
work, modifications and (4) complete and original RFP with all attachments and amendments
INDIVIDUAL RECS
All visits by the FDA to review the manufacturing capability of Berkshire Sterile (Lee, MA) and any resultant inspection
records, including CRLs, Form 483, OIAs or VAIs.
I would like to receive any and all information pertaining to the use of BeLiv - dietary supplement. Supports Healthy
Blood Sugar, 2 fl. oz. dropper bottle. Distributed by: BeLiv, 19655 E. 35th Dr, Suite 100, Aurora, CO 80011. This product
has not been evaluated by the FDA.
Freedom of Information Act (FOIA) Request for Juul Labs Inc.’s 21 C.F.R. § 10.75 Request for Supervisory Review of the
Company’s Marketing Denial Order; STNs PM0000864, PM0000872, PM0000874, PM0000876, PM0000878 and
PM0000879
AUTOPSY REPORT
PEG 1500 APPROVED USES, DRUG PROFILE, LIST OF COMPANIES SEEKING APPROVAL
for Human Drugs inspection of Granules Pharmaceuticals Inc ending 07/22/2022 at the location in Chantilly VA, United
States (3011585184). Please send documents as email attachments.
for Medical Devices & Rad Health inspection of Maquet Cardiopulmonary GmbH ending 06/24/2022 at the location in
Hechingen, Germany (3009649876). Please send documents as email attachments.
for Biologics inspection of CSL Plasma Inc. ending 03/21/2019 at the location in Linden NJ, United States (3014744187).
for Foods & Cosmetics inspection of Gemini Pharmaceuticals, Inc. ending 07/26/2022 at the location in Commack NY,
United States (2432926). Please send documents as email attachments.
for Medical Devices & Rad Health inspection of Robert Busse & Co. Inc ending 04/13/2018 at the location in Hauppauge
NY, United States (2433012). Please send documents as email attachments.
for Human Drugs inspection of U.S. Continental Marketing, Inc. ending 07/21/2022 at the location in Corona CA, United
for Human Drugs inspection of Ultra Chem Labs Corp ending 07/27/2022 at the location in Ontario CA, United States
(3011622931). Please send documents as email attachments.
for Human Drugs inspection of Auto-Chlor System LLC ending 07/18/2022 at the location in Hapeville GA, United States
for Human Drugs inspection of AnazaoHealth Corporation ending 07/29/2022 at the location in Las Vegas NV, United
for Human Drugs inspection of Dental Technologies Inc. ending 07/26/2022 at the location in Lincolnwood IL, United
Copy of the 483 for the 06/13/2022 through 06/17/2022 inspection of TAIRGI TREAD-LIA BAILE NA SCEILGE TEORANTA
(DbA Ballinskelligs Veterinary Products [BVP]) located at TAIRGI TREAD-LIA BAILE NA SCEILGE TEORANTA (DbA
Ballinskelligs Veterinary Products [BVP]) [- / Ireland] Dungeagan, Ballinskelligs, Co. Kerry V23 XR52, Ireland (IRL). This
inspection pertains to ANIMAL HEALTH
Copy of the 483 for the 05/03/2022 through 05/09/2022 inspection of Shahrukh Kureishy, MD located at Shahrukh
Kureishy, MD 4833 Medical Center Dr #6b, McKinney, TX 75069, USA. This inspection pertains to HUMAN DRUGS.
Copy of the 483 for the 04/11/2022 through 04/15/2022 inspection of Inci B. Yildirim, M.D. located at Inci B. Yildirim,
M.D. [New Haven / United States of America] 2 Church Street South, 2 Church St S #401, New Haven, CT 06519, USA.
This inspection pertains to BIOLOGICS
Copy of the 483 for the 04/04/2022 through 04/12/2022 inspection of Bracco The Bracco Group Family Tree located at
BRACCO IMAGING SPA [Samone / Italy] Via Ribes, 5, 10010 Samone TO, Italy. This inspection pertains to HUMAN
DRUGS.
Report and/or the MDSAP Noncomformity Grading and Exchange Form (NC) for the inspection of Sparton Medical
Systems Colorado, Frederick, CO , end date 04-19-2018. FEI# 3008557675. This inspection pertains to medical devices.
Report and/or the MDSAP Noncomformity Grading and Exchange Form (NC) for the inspection of EZ Pedo Incorporated,
Loomis, CA , end date 04-13-2018. FEI# 3009133627. This inspection pertains to medical devices.
Report and/or the MDSAP Noncomformity Grading and Exchange Form (NC) for the inspection of Teratech Corporation,
Burlington, MA , end date 04-12-2018. FEI# 3002315840. This inspection pertains to medical devices.
Report and/or the MDSAP Noncomformity Grading and Exchange Form (NC) for the inspection of Bard Brachytherapy,
Inc., Carol Stream, IL , end date 04-06-2018. FEI# 3002942387. This inspection pertains to medical devices.
Request RLD container labels of N016418 INDERAL(Propranolol Hydrochloride)Tablets for ANDA submission.
CV James D Romero, Nathaniel R Esaw, Bruce E Kummer, Cheryl A Fuhs, Matthew M Henciak, ETC
2022-5338, 2022-5356, 2022-2061, 2022-3265, 2022-3806.
2022-4969, 2022-4998, 2022-5102, 2022-5134, 2022-5275.
DEN200080
DEN200080
Full submission for K201066

Please send 2 form 483s of Mylan Bangalore and Mylan unit 7 hyderabad

I am an investment professional and would like to request any 483s issued for inspections occurring in 2022 for
uniQure, Inc. located at 113 Hartwell Ave, Lexington, MA 02472, USA? The FEIN is 3011357564.
We are seeking all reports, records, and documents relating to the FDA's Investigation of Cronobacter Infections in
Abbott Powdered Infant Formula from February, 2022. Specifically, we are seeking the reports, documents, and records
on Abbott Nutrition's Sturgis, Michigan facility.
Freedom of Information Act (FOIA) Request for PNC 2780 Unredacted FDA Review Memoranda.
We are requesting all communications between DOJ; FDA; Cipla Limited, Cipla USA Inc.; and Akorn Operating Company
LLC regarding United States ex rel. Albermarle, LLC V Cipla Limited, Cipla USA Inc., and Akorn Operating Company LLC
(Case 1:21-cv-11060-ADB) and correspondence regarding the conversion of the brand names of Diclofenac, Olopatadine
and Azelastine from Rx-to-OTC.
Ivermectin Use for COVID-19 Treatment.

K040383 - DePuy TriFlange II Acetabular Cup System - entire 510k submissions, RAI responses and all correspondences
related to this clearance
K040383 - DePuy TriFlange II Acetabular Cup System - entire 510k submissions, RAI responses and all correspondences
related to this clearance
K201348, DePuy 3D Additive TriFlange Acetabular Cup - - entire 510k submission, RAI responses and all
correspondences related to this clearance please
K001277, DePuy, Triflange Acetabular Cup System - entire 510k submission, RAI responses and all correspondences
related to this clearance please
K030861, Biomet Inc., HA PMI FLANGED ACETABULAR COMPONENT - entire 510k submission, RAI responses and all
correspondences related to this clearance please
All emails, memos or other correspondence either to or from the FDA Office of Prescription Drug Promotion that relates
to advertising for Covid 19 vaccines or boosters including social media.
All files, reports, and records related to inspections, inspection schedules and any investigations (including Form 483s)
issued to Bachem Americas, Inc at the Torrance CA site. The product at issue is a human drug.
Data for FDA FCN000443 application.
AXS-05 is now FDA approved under the brand name Auvelity. Can we please obtain the Axsome Therapeutics response
to the FDA’s deficiency notice related to analytical methods in the Chemistry, Manufacturing, and Controls section of
the Company’s New Drug Application (the “NDA”) for AXS-05 in the first half of January 2022? It would have been
submitted by the company Axsome to the FDA.
510ks, DeNovo, 483s, Warning Letters, CAPAs (Corrective Action), Recalls, Removals, Field Safety, Product Labels for
Articul/eze (DePuy International) and compatibility chart(s) for pairing the "Articul/eze Head Alumina Ceramic" (models
#s 9111121, 9111122, 9111123, 9111131, 9111132, 9111133) with REEF implants/femoral stems (DePuy Ireland).
Manufacturer listing of the balls is on page 11/14 (REEF Surgical Technique p.10 of DePuy Synthes/ JnJ 107293-190211
published 2019). etc
483: ADMI East Syracuse, New York United States End Dates of
inspection: 03 Jun 2022 Project Area: Compliance: Devices
483: Airgas USA, LLC Miami, Florida United States End Dates of inspection: 22 Jul 2022 Project Area: Drug
Quality Assurance
for Human Drugs inspection of Gilead Sciences, Inc. ending 10/18/2011 at the location in Foster City CA, United States
for Human Drugs inspection of Gilead Sciences, Inc. ending 12/09/2011 at the location in Foster City CA, United States
for Medical Devices & Rad Health inspection of Isomedix Operations Inc ending 07/25/2022 at the location in Groveport
OH, United States (1526711). Please send documents as email attachments.
for Biologics inspection of Organogenesis, Inc. ending 06/08/2018 at the location in Canton MA, United States
for Human Drugs inspection of Genzyme Corporation ending 07/25/2022 at the location in Framingham MA, United
for Human Drugs inspection of Cosmax USA, Inc. ending 07/22/2022 at the location in Solon OH, United States
for Human Drugs inspection of Smithfield Bioscience Inc ending 07/15/2022 at the location in Cincinnati OH, United
for Human Drugs inspection of EMS Contract Packaging ending 07/22/2022 at the location in Hatfield PA, United States
for Human Drugs inspection of Renu Laboratories, Inc. ending 07/27/2022 at the location in Warminster PA, United
for Human Drugs inspection of Giles Chemical ending 07/27/2022 at the location in Greendale IN, United States
Communications, whether in electronic or hard copy format, between any representative of the Food and Drug
Administration and any individual or entity representative listed below that relates to the data, methodology, analysis,
or conclusions set forth in the following article: “Clinical Outcomes and Cost Associated With an Intravascular Microaxial
Left Ventricular Assist Device vs Intra-aortic Balloon Pump in Patients Presenting With Acute Myocardial Infarction
Complicated by Cardiogenic Shock”
or conclusions set forth in the following article: “The Evolving Landscape of Impella Use in the United States Among
Patients Undergoing Percutaneous Coronary Intervention With Mechanical Circulatory Support”, Circulation.
or conclusions set forth in the following article: “Association of Use of an Intravascular Microaxial Left Ventricular Assist
Device vs Intra-aortic Balloon Pump With In-Hospital Mortality and Major Bleeding Among Patients With Acute
Myocardial Infarction Complicated by Cardiogenic Shock”, JAMA. 2020;323(8):734-745 (published February 10, 2020)
K220624
[Reference FGI# 22-80043] Relevant to FDA we seek all records mentioning “colostral whey protein concentrate” for
Sterling Technology, Inc. related to ingredient/GRAS between March 2012 through December 2012.
Requesting the inspection report (EIR) and FDA 483 for : Hybio Pharmaceutical Co. Ltd Shenzhen, China FEI
#3010165930. The inspection end date is 3/30/2018 (inspection ID 1051143). I am not sure of the inspection start
date. Please provide these documents even if it will take an inordinate amount of time.
Requesting copy of Approval letter for Dexlansoprazole Capsules Delayed Release,30mg and 60mg strength Applicant
Number: A202666 Applicant Holder: TWI Pharmaceuticals Inc. Market Status: Prescription
I would like to request the inspection report (EIR) for the inspection of: Curia New Mexico, LLC 4272 Balloon Park Road
NE Albuquerque, NM 87109 FEI # 1643045 In a separate FOIA request, I requested the FDA 483 for this inspection, but
now I would like to obtain the full EIR even if it will take a long time to receive this.
Please provide the inspection report (EIR) and FDA 483 for the inspection of: Hybio Pharmaceutical Co. Ltd Shenzhen,
China FEI #3010165930 The inspection end date was 6/26/2015 (inspection ID 936556); I am not sure of the inspection
start date. Please provide these records even if it will take an inordinate amount of time to provide them.
Lowey Ent. DBA Sunrise Produce Co. 500 Burning Tree Rd Fullerton, CA 92833 Hello, I am Gerson Depaz I am requesting
a copy of a FDA inspection that was done at our facility on 4/19/2019. Inspection #1089575 FEI # 3003179742.
From your « Submissions on post consumer recycled plastics for food contact articles » list on your web site, the NOL
letters issued by FDA for the following « Recycle number »: 154, 203, 207, 212, 231 and 250
Please send Form 483 for Torrent Pharma Indrad Chatarpur facility
Full CareSideTM Analyzer Safety and Effectiveness application K980056 and decision and all associated correspondance.
Note that CareSide is now a defunct company, so I believe there is no need to redact any information from the
application.
Requesting Premarket approval application for the following of Intuitive Surgical, Inc.: Re: K212747 Trade/Device Name:
Da Vinci SP Surgical System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope And Accessories
Regulatory Class: Class II Product Code: NAY Dated: August 26, 2021 Received: August 30, 2021
I am an investment professional and would like to request the 483 issued under inspection ID # 1162959 occurring in
February 2022 for Cangene BioPharma, LLC located at 1111 South Paca Street, Baltimore, MD 21230, USA (FEIN is
1000512361).
Any and all correspondence — including but not limited to emails, texts and letters — between the U.S. Food and Drug
Administration and Koninklijke Philips N.V, which goes by other names, including, but not limited to, Philips, Philips
Respironics and Royal Philps, using the search criteria specified below.
11371924 11472937 11473066 11473329 11487593 13244742 13752251 16864022
Administration and various members of the U.S. Congress specifically with the search keywords: “Philips" and/or
“respironics” and/or “cpap” or “bipap” and/or “ventilator” and: The office of U.S. Sen. Bob Casey Jr. etc
Correspondence post- or pre-submission between FDA and potential notifiers regarding brazzein and/or monellin.
Establishment Inspection Report for 151 Gallagher Crest Road Henderson, NV 89074 Inspection performed by Grant L.
Davis in June 2021. Have received the records for the inspection of 188-190, but not 151. Would like to have to keep on
file.
Copy of the disclosable portions of all EIRs, 483s, and Remote Audit Reports or any other sort of inspection report for
Pharmaceutics International (PII), located in Hunt Valley, MD, and Cockeysville, MD, from 10/01/2021 - Present. Please
note that these inspections relate to drugs.
Under FOIA, I am requesting all calendar records from Edward Potter (FDA-ORA OC/OPLIA/OGPS/OGO. He is a consumer
safety officer, Baltimore, MD. His email address is Edward.Potter@fda.hhs.gov). I request the records be provided to me
electronically, via email. 07.01.22-08.31.22
BLA 761166 - Unredacted BLA Reviews for Approval: Product Quality Review, Clinical Pharmacology Review, Clinical
Review, Non-Clinical Review, Proprietary Name Review, Officer/Employee List, Other Review(s), Risk Assessment and
Risk Mitigation Review, Statistical Review, Summary Review, Administrative and Correspondence Documents.
Office of Generic Drugs Approval Routing Summary for both tentative and final approvals for lenalidomide ANDAs.
The full (non-summarized) 510(k) application, clearance reports, and any other documentation of the FDA’s decision
and sign-off for the following 510(K) numbers: K121623, K113053, K111610, K093416, K083526, K103167, K092818,
K082660, K070328. ETC
Please provide a listing of all sites where the FDA conducted GMP and GLP inspections during June 1, 2022 through
August 31, 2022. Request letter is attached.
21303234, 21299621, and 21296949.
Copy of the disclosable portions of the approval information for the following two supplemental BLAS: (1)
Atezolizumab/bevacizumab, BLA 761034/S25, approved 05/29/2020; and (2) Durvalumab/gemcitabine/cisplatin BLA
761069/S35, approved 09/02/2022.
A copy of any audits / reviews and results since 2016 Caney Agri Services
Please provide us with the summary basis of approval (SBOA) for the following item: CORTIFOAM (Hydrocortisone
Acetate AEROSOL, METERED; RECTAL ) NDA# N017351
We are looking for investigational device exemption-related communication between the FDA and Mayo Clinic or its
representative related to a Tinnitus Implant System. The device was given investigational device exemption (IDE) and we
want the communication that led to the granting of IDE.
Thus, I would like to request a dataset that would include the official counts of all inspections made by the FDA for all
clinical and nonclinical labs for biologics and drugs from 2010-2015 available in the FDA database, if possible. The
variables that I would like to request include: (1) FEI Number, (2) Legal Name, (3) City, (4) State, (5) Fiscal Year, (6)
Posted Citation,etc
I am seeking the participant guide (unit 1-7) part 1 and two as well as participant activity guide from the course FDA 107
in PDF format. I asked the course leader Traci Kelm for a pdf version, however they have been advised not to share PDFs
of the materials, but that I could submit a FOIA request as stated in the program guide. Course:-FDA 107 Egg Safety
Inspection- Participant guide unit 1-7 in pdf And Participant activity guide in pdf
All emails, memos or other correspondence either to or from the Advertising and Promotional Labeling Branch (APLB)
that relates to advertising for Covid 19 vaccines or boosters including ads run on social media.
I am an investment professional for an asset management firm and would like to request the response filed by Alvotech
Hf to the form 483 that was issued to FEI # 3013702557 located at Sæmundargata 15-19, Reykjavík, Iceland, 101 on
Please provide ALL documents regarding Pharmacyte Biotech's records for the lifting of the clinical hold on file with the
FDA on cell in a box. This would include FDA responses, guidelines, and all meetings previously had and currently
scheduled. In addition, please provide the remaining requirements needed to be met for clinical hold to be lifted.
Hi, I would like to request the 90-day classification letter ConOps (CDER and ORA) sent to FEI 3012144557 following the
May 2022 inspection of facility in Lee, MA. Thank you
483: B-ONE ORTHO, CORP. Cedar Knolls, New Jersey United States End Dates of inspection: 18 May 2022
Project Area: Compliance: Devices
All items of any kind (e.g., documents, photographs, recordings, videos, or anything else) attached to the Report ID
Numbers in the attached document, all of which relate to injury or death that occurred from the use of drug Kratom (or
the name of the plant from which it is derviced, Mitragyna speciosa).
Q7A edition 2001 see: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-

industry-q7a-good-manufacturing-practice-guidance-active-pharmaceutical-ingredients Button [PDF version of the
document] leads to Q7 (2016) and not Q7A (2002)!
On the withdrawal of Zantac from the market, I would like the relevant documents to what levels of NDMA were
detected in the study.
Individual Case Reports
sequence 0015 of Application IND157853
NDI 705 Zembrin
FDA review package for Tarpeyo, NDA 215935
FDA FAERS database for pegcetacoplan (brand name EMPAVELI).

K202079
Hello FDA FOIA Team, I would like to request all complaints from the past 5 years regarding dog food products that
have caused illness/health problems in dogs.
May I have an electronic copy of the most up to date carton label and container (vial) label for Novartis Zofran Injection
2mg/mL 20mL ?
Copy of the disclosable portions of all releasable information related to New Dietary Ingredient Notification 308 (ASI
Complex), and New Dietary Ingredient Notification 786 (Nitrosigine), both submitted by Nutrition21.
2021-4362
Hi, I would like to request the Form 483 issued to Catalent during their Bloomington, IN manufacturing facility
inspection in August 2022. I would also like to know whether the EIR is available. Thank you The inspection was
referenced in this article: https://www.washingtonpost.com/health/2022/09/20/moderna-boosters-fda-inspection-
indiana-plant/
Written communication between FDA (Peter Marks) and Sarepta Therapeutics on the potential BLA submission for
accelerated approval of the SRP-9001 gene therapy for ambulatory Duchenne patients.
https://investorrelations.sarepta.com/news-releases/news-release-details/sarepta-therapeutics-announces-second-
quarter-2022-financial
Any applications and/or petitions submitted by Terumo Cardiovascular Systems Corporation, which sought relief from
the Consent Decree of Permanent Injunction entered on 3/29/2011. Any documents submitted by Terumo
Cardiovascular Systems Corporation that in any way reference relief from the Consent Decree.
Specifically we are requesting the 2nd Chemistry review of Exemption Requests EX0001328 dated October 16, 2020. I
am US Agent and Authorized Representative for Empresas Victor Sinclair for the Exemption Requests at issue and we
are requesting them in connection in denial of AP0000086. I have attached the original acknowledgement letter
demonstrating I am US Agent for the company.
All responsive and disclosable records pertaining or referencing Potential Tobacco Violation Report ID 22F00154
Please provide the FDA483's for Catalent Maryland Inc. located at 7555 Harmans Road, Harmanss Maryalnd. FEI No.
3015558590. Inspection dates were on 6/19/2020 and 11/17/2021. If redacted EIR's are available for the two site
visits, we will accept those as well. Let me know if you have any questions. T
We are writing to request, via FOIA, the FDA FOIA request log for 2022.
Any Form 483s related to Braeburn Pharmaceuticals Inc. manufacturing activities at Pharmaceutics International Inc., in
Hunt Valley, MD. Please also include any additional documentation available related to the BRIXADI pre-approval
inspections at this facility.
Administration and members of the public regarding their concerns over specific medical devices manufactured by
Koninklijke Philips N.V, which goes by other names, including, but not limited to, Philips, Philips Respironics and Royal
Philps.
The application and any and all documentation showing the U.S. Food and Drug Administration’s review, decision, and
sign-off approving the April 8, 2020 Emergency Use Authorization (EUA) of the Philips Respironics E30 ventilator.
Administration and the U.S. Department of Veterans Affairs, using the search criteria specified below. This request
covers the period between January 1, 2019 and today. For your search, please use the following keywords: philips,
respironics.
Any and all correspondence — including but not limited to emails, texts and letters — between U.S. Food and Drug
Administration and any representatives of the following lobbying groups on behalf of Koninklijke Philips N.V. (which
goes by other names, including but not limited to: Philips, Philips Respironics and Royal Philips): Philips North America
LLC Political Action Committee Philips Electronics North America Advanced Medical etc
Hello, Please provide the following information: The number of FDA employees working full-time on VAERS data
monitoring The number of FDA employees working part-time on VAERS data monitoring etc
K221131
Tasso+
Tasso, Inc.
08/12/2022
Substantially Equivalent
I am an investment professional and would like to request any 483s issued for inspections occurring in 2022 for the
following facilities: • Lonza Biologics, Inc. located at 101 International Drive, Portsmouth, NH 03801, USA (FEI # is
3001451441) • Catalent Indiana, LLC located at 1300 S Patterson Drive, Bloomington, IN 47403, USA (FEI # is
3005949964) etc
I am an investment professional and would like to request any 483s issued for inspections occurring in 2022 for
Moderna, Inc. located at One Moderna Way, Norwood, MA 02062, USA (FEI # is 3014937058). If no 483s are found,
please confirm if the site has been inspected or not in 2022
K820723
for Human Drugs inspection of SpecGx LLC (DBA: Mallinckrodt Inc.) ending 01/25/2019 at the location in Greenville IL,
for Foods & Cosmetics inspection of Bainbridge Beverage West, LLC ending 06/29/2022 at the location in W Sacramento
CA, United States (3012225047). Please send documents as email attachments.
for Human Drugs inspection of Partner Therapeutics Inc ending 07/22/2022 at the location in Lynnwood WA, United
for Human Drugs inspection of Airgas USA, LLC ending 07/22/2022 at the location in Miami FL, United States (1025636).
for Human Drugs inspection of Tropical Seas, Inc. ending 07/15/2022 at the location in Holly Hill FL, United States
for Human Drugs inspection of Wilfrido A. Benitez, M.D. ending 07/21/2022 at the location in Hialeah FL, United States
I am an investment professional and would like to request the day 15 response(s) filed by Moderna and Catalent to the
form 483 that was issued to FEI # 3005949964 located at 1300 S Patterson Drive, Bloomington, IN 47403, USA on
We would like to submit a request for inspection reports for WuXi Biologics at their following locations
Shanghai
WuXi
Suzhou
Hangzhou
Chengdu
Shijiazhuang
Singapore
I am requesting access to all FDA email correspondence and minutes from 01/01/2021-09/01/2022 with Pharvaris
relating to drug candidates PHA121 and PHVS416 (PHA121 in soft gel capsule formulation).
I request copies of any agency documentation or communication with Catalent Indiana, LLC (FEI Nr. 3005949964)
regarding the FDA 483 inspection letter issued to their facility located at 1300 S Patterson Dr, 47403 Bloomington, IN
since July 1, 2022 through present day.
483 for Inspection of Aarti Industries, Dombivli (Thane), Maharashtra, India site, conducted by Investigator - Gam,
during June'2022.
ANDA 088312 for Fluocinolone Acetonide Topical Solution, 0.01%; ANDA 071984 for Propranolol Hydrochloride Oral
Solution, 20 mg/5 mL; and ANDA 071985 for Propranolol Hydrochloride Oral Solution, 40 mg/5 mL. WITHDRAWAL
NOTICES
Evanger's Dog & Cat Food Company, Wheeling, IL (FEI #1480280). Please supply the Emergency Operating Permit issued
by FDA to the above-cited canned pet food manufacturer pursuant to the FDA's April 2008 Order Requiring Emergency
Permit.
Interested in obtaining any FDA documentation / Form 483s related to Fennec Pharmaceuticals manufacturing of
PEDMARK. Please also include any additional documentation available from the PEDMARK pre-approval inspections.
2022-3445
Copy of the disclosable portions of the original request letter and page count for the entire fulfillment of File Number
2022-352; and the original request letter and complete FDA response for File Numbers 2022-890 and 2022-4097.
new drug application (NDA) 211875, for PACLITAXEL
K180220 FIRST PARTY

75F40118F01001 HHSF22301003T 75F40118F01001 75F40118F01001 75F40121P00211 75F40119F80363
75F40121F80303 75F40119P10232
Copy of the disclosable portions of the supplemental approval packages for the following three products: Dupixent, BLA
761055/S20 (approved 05/26/2020) and BLA 761055/S42 (approved 06/07/2022); Olumiant, NDA 207924/S7 (approved
06/13/2022).
FDA Form 483 issued to Medtronic on July 7, 2021. District: LOS; FEI Number: 3003166194; Inspection Date:
07/07/2021; Commodity: Med Dev & Rad Health; Firm Name: Medtronic MiniMed; Firm Address: 18000 Devonshire
Street; City: Northridge; State: CA; Zip: 91325-1219; Country: US
Form FDA 483: Lil' Drug Store Products Inc Cedar Rapids, Iowa United States End Dates of inspection: 02 Jun
2022 Project Area: Drug Quality Assurance FEI: 3003491851 Classification: VAI
Form FDA 483: New York Fertility Medical Practice, PLLC New York United States End Dates of inspection: 12
May 2022 Project Area: Vaccines and Allergenic Products FEI: 3016689391 Classification: VAI
I request access to and a copy of the full report prepared by Steven M. Solomon evaluating FDA’s infant formula
response (not just the top-line findings published here https://www.fda.gov/media/161689/download?
utm_medium=email&utm_source=govdelivery but the information undergirding those findings), and copies of any
transcripts of interviews for the review conducted by Mr. Solomon or his assistants.
for Medical Devices & Rad Health inspection of iRhythm Technologies, Inc. ending 08/12/2022 at the location in Cypress
CA, United States (3021769057). Please send documents as email attachments.
for Medical Devices & Rad Health inspection of Fora Care, Inc ending 08/17/2022 at the location in Moorpark CA, United
for Medical Devices & Rad Health inspection of Hill-Rom Inc. ending 07/29/2022 at the location in Cary NC, United
for Medical Devices & Rad Health inspection of Sonablate Corporation ending 08/02/2022 at the location in Charlotte
NC, United States (3007126306). Please send documents as email attachments.
for Medical Devices & Rad Health inspection of National Cancer Institute Central IRB ending 08/09/2022 at the location
in Rockville MD, United States (3011142166). Please send documents as email attachments.
for Medical Devices & Rad Health inspection of Lingraphicare America, Inc. ending 08/04/2022 at the location in
Princeton NJ, United States (1000123978). Please send documents as email attachments.
for Medical Devices & Rad Health inspection of Alkaline Corp. ending 08/16/2022 at the location in Eatontown NJ,
for Medical Devices & Rad Health inspection of Minxray Inc ending 08/02/2022 at the location in Northbrook IL, United
for Medical Devices & Rad Health inspection of Polar Products Inc. ending 08/04/2022 at the location in Stow OH,
for Medical Devices & Rad Health inspection of Allison Medical, Inc. ending 07/29/2022 at the location in Littleton CO,
FDA Form 483 issued to Medtronic on March 14, 2018 District: LOS FEI Number: 3003166194 Inspection Date:
03/14/2018 Commodity: Med Dev & Rad Health Firm Name: Medtronic MiniMed Firm Address: 18000 Devonshire St.
City: Northridge State: CA Zip: 91325-1219
FDA Warning Letter issued to Medtronic on February 15, 2019. District: LOS FEI Number: 3003166194 Commodity:
Med Dev & Rad Health Firm Name: Medtronic MiniMed Firm Address: 18000 Devonshire St. City: Northridge State: CA
Zip 91325-1219
Responses to Investigator Observations noted on Form FDA 483 issued to Medtronic on July 7, 2021, from Sean
Salmon, Executive Vice President and President Diabetes Operating Unit at Medtronic and Chirag Tilara, Vice President,
Quality Management Representative at Medtronic. I am requesting 4 Responses dated as follows: July 28, 2021
September 3, 2021 October 8, 2021 December 3, 2021
Please send form 483 for Torrent Pharma Indrad facility
Requesting the records associated with K962587, CONCEPTUS FALLOPIAN TUBE CATHETERIZATION WITH
MICROENDOSCOPY SYSTEM.
Please provide all registration file documents and suspension or termination of registration related to Owner/Operator
10066554, Jiangmen Mei Fang Biotechnology Co., Ltd (Manufacturer/Exporter); Agent Thomas Weast (Attached is a
"certification" with the above information)
a listing of ALL INSPECTIONS available and releasable from the FACTS database to the CURRENT DATE, in particular,
please include the following fields if available: "Inspection Reason", "Lead Investigator Name", "Start Date", "FEI", etc
Certificates of Transfer, Attestation Forms, and invoices received by FDA for RECs (renewable energy certificates) from
Jan 1. 2020 to the present. Note: Award ID 75F40122P00043 and Award ID 75F40121F80015 (attached) show that FDA
purchased Renewable Energy Certificates from Sterling Planet in 2020 and 2022.
I would like to request form 483 records for the Catalent Manufacturing Facility in Bloomington IL.
Any and all documents related to consumer risks of aerosol spray sunscreen products, including any and all Heath
Hazard Evaluations (HHE), investigations, testing data and anything received from manufacturers regarding their own
investigations of risks for aerosol spray sunscreen products.
Any and all documents related to risks of Isobutane Propellant in aerosol products.
Please provide the Summary Review and Medical Review from the Summary Basis of Approval for the following:
REXULTI (NDA 205422) Supplemental (S-001); FDA Approval on 23 September 2016
Final Approval Letter for ANDA No. 215444.
RE: Nutripack LLC, Markham, IL (FEI #1480280): Please supply FDA Form 483, complete Establishment Inspection Report,
and any associated sample analysis results and correspondence pursuant to FDA Inspection ID #1149809 (Inspection
end date 08/18/2021)
I'm requesting the Summary Basis of Approval (SBA), or any other approval documents, for NDA #216387. I am
particularly interested in the clinical pharmacology report. It does not seem to be available on Drugs@FDA. Thank you!
All internal FDA emails, communications, notes specifically referring to the comments or letters received pertaining to
the Ag Water section of the 2013 Proposed Rule for the Growing, Harvesting, Packing and Holding of Produce, (the
Subpart E Standards Directed to Agriculture Water.)
ANDA Approval Letter dated May 4, 1982 for ANDA 087833, Prednisone Tablets, 25 mg held by Roxane Laboratories Inc.
Establishment Inspection Report and Form 483 dated 10/10/19 for Supernus Pharmacuticals, Inc,, 9715 Key West Ave.,
Rockville, MD 20850-3900.
Establishment Inspection Report and Form 483 dated 1/6/2020 for: Island Kinetics, Inc.d.b.a. CoValence, 460 S. Benson
Lane, Ste. 1-3, Chandler, AZ 85224-5663
FDA's 483 of CTLT's Bloomington, IL facility from September 2022.
ll documents, emails, communications, notes to or from (between) the FDA and any members of Congress, the U.S.
House or Representatives or the U.S. Senate, specifically referring to the Ag Water section of the 2013 Proposed Rule for
the Growing, Harvesting, Packing and Holding of Produce, (the Subpart E Standards Directed to Agriculture Water.)
all documents, emails, communications, notes to or from (between) the FDA and any members of the White House
staff or the Office of the President of the U.S., specifically referring to the Ag Water section of the 2013 Proposed Rule
for the Growing, Harvesting, Packing and Holding of Produce, (the Subpart E Standards Directed to Agriculture Water.)
Hello, Please provide all emails, texts, and instant chat messages to and from the following FDA officials: Peter Marks,
Doran Fink, Celia Witten, Konstantin Chumakov ...sent to and received from any of the following addresses:
mberkovitch@shamir.gov.il, emilia.anis@moh.gov.il, sharon.alroy@moh.gov.il
From the log of legislative comms from FDA/OC/OPLIA/OL/ please provide letters 2020-4128 and 2020-1473 and the
FDA response to those letters.
EIR Cochlear October 2021 BIMO Lone Tree, Colorado

A copy of any and all alerts, whistleblower complaints, internal reports, external reports, and any other notifications
filed with the FDA concerning manufacturing conditions, manufacturing violations, contamination, unsanitary
conditions, or other issues at the Abbott Nutrition manufacturing facility located in Sturgis, Michigan, leading up to the
Abbott Nutrition voluntary recall of infant formula in February 2022.
Data for FDA FCN001609 application.
Testing, inspections, recommendations regarding raw milk purported to be from Swan Bros. Dairy, Inc., located in 938 E
5th St, Claremore, OK 74017, conducted since 2010, or that are otherwise in your possession; any reports regarding
Swan Bros. Dairy sent to in and out of state governmental agencies and/or federal agencies made since 2010; and any
communications regarding Swan Bros. Dairy between you and any third party and/or governmental agency since 2010.
We request a spreadsheet which includes the 23 publicly available data points for all entries that led to International
Food Distributors DBA APB & M Corp's inclusion in this list for the last 2 years (September 1, 2020 - September 1, 2022).
Please include both the legal name and dba name in the search results.
Form 483s and inspection-related correspondence for the registered outsourcing facility (compounding pharmacy)
Empower Pharmacy in Houston, Texas.
I am requesting records from the FDA's FAERS (FDA Adverse Event Reporting System)
regarding a drug called "Empaveli", also known as "pegcetacoplan". Specifically, I am
requesting any and all information (such as case report forms, correspondence, etc.) for Case
ID numbers 19353149, 19630663, 19685262, 19939906, 20102463.
We are requesting copies of the warning letters that have been issued by FDA to the firms listed in the document that I
will send by email with this request's confirmation number (will send to FDAFOIA@fda.hhs.gov).
Requesting the FDA's Complete Response Letter (CRL) and any additional documents regarding the FDA's CRL to Teva
Pharmaceuticals and MedinCell that was filed in April 2022 regarding the New Drug Application (NDA) for
TV-46000/mdc-IRM (risperidone extended-release injectable suspension for subcutaneous use) for the treatment of
schizophrenia.
all documents, emails, communications, notes to or from (between) the FDA and any members of Congress, the U.S.
House or Representatives or the U.S. Senate, specifically referring to the Ag Water section of the 2013 Proposed Rule for
the Growing, Harvesting, Packing and Holding of Produce, (the Subpart E Standards Directed to Agriculture Water.)
All internal FDA emails, communications, notes specifically referring to the comments or letters received pertaining to
the Ag Water section of the 2013 Proposed Rule for the Growing, Harvesting, Packing and Holding of Produce, (the
Subpart E Standards Directed to Agriculture Water.)
Electronic listing (preferably csv format) of all inspections conducted by FDA since May 1, 2022. The list should cover all
Copy of the 483 issued 09/16/2022, for Gilead in La Verne, CA. FEI #3013189568. This inspection pertains to human
drugs.
Request to acquire the FDA EIR for FDA inspection of M9151 Melody Healthcare - FEI: 3009118300 Category: Drug
Quality Assurance, ending 24 Aug 2018, Location: Plot No. J-73, M.I.D.C. Tarapur Boisar, Palghar, Maharashtra 401506,
India (IND)
Request to acquire the FDA EIR for FDA inspection of M9151 Melody Healthcare - FEI: 3009118300 Category: Drug
Quality Assurance, ending 24 Aug 2018, Location: Plot No. J-73, M.I.D.C. Tarapur Boisar, Palghar, Maharashtra 401506,
India (IND)
Copy of the 483 for the 03/28/2022 through 04/07/2022 inspection of Creighton University IRB located at Creighton
University IRB [Omaha / United States of America] 2500 California Plaza, Omaha, NE 68178, USA. This inspection
Copy of the 483 for the 04/04/2022 through 04/08/2022 inspection of Robin Cornelissen located at Robin Cornelissen
[Rotterdam / Netherlands] 's-Gravendijkwal 230, 3015 GH Rotterdam, Netherlands. This inspection pertains to HUMAN
DRUGS.
Copy of the 483 for the 04/04/2022 through 04/08/2022 inspection of Merck KGaA Merck KGaA Family Tree located at
Merck, S.A. de C.V. [Naucalpan de Juárez / Mexico] C. 5 7, San Andres Atoto, 53500 Naucalpan de Juárez, Méx., Mexico.
This inspection pertains to HUMAN DRUGS.
Copy of the EIR for the 01/24/2022 through 01/28/2022 inspection of Granules Pharmaceuticals Inc located at Granules
Pharmaceuticals Inc [Chantilly / United States of America] 3725 Concorde Pkwy #3701, Chantilly, VA 20151, USA. This
inspection pertains to HUMAN DRUGS.
Report and/or the MDSAP Noncomformity Grading and Exchange Form (NC) for the inspection of Centinel Spine, Inc.,
West Chester, PA , end date 04-05-2018. FEI# 3007494564. This inspection pertains to medical devices.
Report and/or the MDSAP Noncomformity Grading and Exchange Form (NC) for the inspection of Persyst Development
Corporation, Solana Beach, CA , end date 04-05-2018. FEI# 3014350097. This inspection pertains to medical devices.
Report and/or the MDSAP Noncomformity Grading and Exchange Form (NC) for the inspection of Persyst Development
Corp, Prescott, AZ , end date 04-03-2018. FEI# 3002624053. This inspection pertains to medical devices.
Report and/or the MDSAP Noncomformity Grading and Exchange Form (NC) for the inspection of Osi Optoelectronics
Inc., Hawthorne, CA , end date 03-22-2018. FEI# 3006713849. This inspection pertains to medical devices.
Request to acquire the FDA EIR for FDA inspection of S6712 HUNAN DONGTING PHARMA - FEI: 3004753289 Category:
Drug Quality Assurance, ending 06 March 2015 Location: No. 16 Dongyan Road, Deshan, Changde City, Hunan 415001,
China (CHN)
Regulatory Assessment of CED Analytical Laboratory, Inc. Located at Irving TX United States FEI Number: 3011756373
held on 05/12/2021.
Regulatory Assessment of Eastern Maine Medical Center Located at Bangor ME United States FEI Number: 1271577 held
on 04/12/2021.
I am seeking inspection records for a cell bank called American Cell Technology, located in Sunrise, FL (Address: 13794
NW 4th St STE 212, Sunrise, FL 33325).
[Reference FGI# 22-80061] Relevant to FDA we seek copies of the following: (1) complete Orphan Drug Designation
Application for product called Yescarta for diffuse large B cell lymphoma.
Application for product called Kymriah for diffuse large B cell lymphoma
Application for product called Zylonta for diffuse large B cell lymphoma
1. All recordings, transcripts, and notes taken by participants of an April 12, 2021 Zoom meeting held from 9:30am-
10:00am by FDA, CDC and other government officials, hosted by CBER Director Peter Marks, on the subject of
"coordination on adverse events" (as referenced in the attached email excerpt provided by NIH), or if re-scheduled, then
on the rescheduled date/time. etc
I am looking for redacted report(s) for the most recent PAI and general inspections of the Kimball Electronics a
Indianapolis Site performed in 2022
PMA # P960058 and any supplements for the HIRES ULTRA IMPLANT, including but not limited to S117 and S 129. Any
and all documents associated with recall # 85141.
A copy of all line entries for which Pepper Source is declared the FSVP importer. Locations include: 1. Pepper Source,
Ltd. - UFI: 883892622, 5800 Alma Hwy Van Buren, AR 72956 2. Pepper Source, LLC - UFI: 124761946, 11103 N Old Wire,
Rogers, AR 72756 3. Pepper Source, Ltd. - Fort Smith Warehouse - UFI: 118706791, 1301 N 4th St., Fort Smith, AR 72901
The latest form 483 for Pharmaceuticals International Inc. located at 10819 Gilroy Rd., Hunt Valley, MD 21031
Bidi Vapor FOIA Request re RRA Materials PM0003460.PD2
Copies of all memoranda (including meeting memos), and correspondence pertaining to the issue of arsenic organic and
inorganic analysis and safety assessment from GRAS Notification GRN 000609 (Rice Protein Concentrate) and GRN
000478 (Rice Hull Fiber) that are not presently available on FDA’s website.
483: Zynex Medical, Inc Englewood, Colorado United States End Dates of inspection: 15 Jun 2022 Project
483: Skyless LLC Ponce, Puerto Rico United States End Dates of inspection: 16 May 2022 Project Area: Drug
Quality Assurance FEI: 3020256087 Classification: OAI I confirm that Clarivate Analytics will be charged accordingly by
483: University Reproductive Associates, P.C. Hasbrouck Heights, New Jersey United States End Dates of
inspection: 10 May 2022 Project Area: Vaccines and Allergenic Products FEI: 3005187588 Classification: VAI I confirm
exceed $ 200
483: NYC Health + Hospitals/Bellevue New York United States End Dates of inspection: 06 May 2022 Project
Area: Blood and Blood Products FEI: 2473466 Classification: VAI I confirm that Clarivate Analytics will be charged
for Medical Devices & Rad Health inspection of B & D Dental Corporation ending 08/16/2022 at the location in West
Valley City UT, United States (3008190898). Please send documents as email attachments.
for Human Drugs inspection of Tech Group Scottsdale dba West ending 08/19/2022 at the location in Scottsdale AZ,
for Medical Devices & Rad Health inspection of ASD Sleep, LLC dba American Sleep Dentistry ending 09/09/2022 at the
location in Cedar City UT, United States (3008313791). Please send documents as email attachments.
for Medical Devices & Rad Health inspection of CardioFocus, Inc. ending 08/11/2022 at the location in Marlborough MA,
for Medical Devices & Rad Health inspection of Myriad Fiber Imaging Technologies, Inc. ending 07/29/2022 at the
location in Dudley MA, United States (3002516162). Please send documents as email attachments.
for Medical Devices & Rad Health inspection of Praxis Powder Technology, Inc. ending 07/29/2022 at the location in
Queensbury NY, United States (3007304202). Please send documents as email attachments.
for Medical Devices & Rad Health inspection of Crane Dental Laboratory, Inc. ending 09/01/2022 at the location in
Rochester NY, United States (3010324114). Please send documents as email attachments.
2022-4838, 2022-4873, 2022-4877, 2022-4966, 2022-5208.
2022-4811, 2022-4957, 2022-5108, 2022-3871, 2022-4774.
for Medical Devices & Rad Health inspection of Cognivue Inc. ending 08/15/2022 at the location in Victor NY, United
for Medical Devices & Rad Health inspection of Asim R. Piracha, M.D. ending 07/29/2022 at the location in Jeffersonville
IN, United States (3017984620). Please send documents as email attachments.
for Medical Devices & Rad Health inspection of Cytophil, Inc. ending 07/29/2022 at the location in East Troy WI, United
Please provide the FDA-483 documents pertaining to Medical Device Inspections for the following 2 firms: Assecibility
Services, Inc 6241 S Tex Pt, Homosassa, FL, dated 3/31/22 - 3/25/22 and for Klocke of america, Inc. 14201 Jetport Loop
W, Fort Myers, FL, dated 3/28/22 - 3/20/22
All Foreign Suppliers Verification Programs (FSVP) records for "Shamrock" or "Shamrock Foods"
Copy of the disclosable portions of the 510(k) for K220309, Wearable Breast Pump (Model S10), by Shenzhen
Lutejiacheng Technology.
Please provide the FDA-483 documents pertaining to Human DRUG Inspections for the following 3 firms: Gordon
Laboratories Inc. 751 Artesla Blvd, Carson, CA, dated 2/8/22-3/10/22; Green Wave Analytical LLC 10366 Roselle St, Ste
B, San Diego, CA, dated 2/15/22-3/7/22 and West Coast Cosmetics, Inc. 21050 Superior St., Chatsworth, CA, dated
2/23/22-3/9/22
Please provide the FDA-483 document pertaining to Medical Device Inspection for: Medical Chemical Corp. 19430 Van
Ness Ave., Torrance, CA, dated 3/21/22-3/25/22
Please provide the FDA-483 document pertaining to Human DRUG inspections for: Centrix, Inc. 770 River Rd., Shelton,
CT, dated 2/9/22-3/2/22
Please provide the FDA-483 document pertaining to Medical Device Inspections for: Pajunk Medical Systems, L.P. 4575
Marconi Dr., Alpharetta, GA, dated 3/10/22-3/18/22
Please provide the FDA-483 document pertaining to Human DRUG Inspections for: Camco Chemical Company, 8145
Holton Dr., Florence, KY, dated 2/23/22-3/2/22
Please provide the FDA-483 documents pertaining to Medical Device Inspections for the following 2 firms: Litron LLC,
207 Bowles Rd., Agawam, MA, dated 3/9/22-3/22/33 and Phoenix Diagnostics, Inc., 8 Tech Cr., Natick, MA, dated
3/15/22-3/17/22
Please provide the FDA-483 document pertaining to Human DRUG Inspections for: Ferndale Laboratories, Inc., 780 W. 8
Miled Rd., Ferndale, MI, dated 2/22/22-3/4/22
Please provide the FDA-483 document pertaining to Medical Device Inspections for: Dane Technologies, 10400
Fountains Dr., Maple Grove, MN, dated 3/16/22-3/18/22
Please provide the FDA-483 documents pertaining to Medical Device Inspection for the following 2 firms: Custom Smiles
Sleep Department, 2530 Lane St., Kannapolis, NC, dated 3/14/22-3/18/22 and Safeguard US Operating LLC, 5555
Harrisburg Ind Pk Dr. Harrisburg, NC, dated 3/21/22-3/25/22
FDA FORM 483 inspection report of Catalent's Bloomington Indiana manufacturing facility.
WARNING LETTERS
Wanted to request any and all 483s that Catalent (CTLT) has received in last 10 years at any Catalent facilities either in
the US or internationally
Request you to send the US FDA observations at Zydus' Moraiya facility (FEI - 3007834858). The inspection was
conducted between 26th July to 5th August, 2022 with four Form 483 observations.
Please send form 483 for USFDA inspection at Zydus Cadila Moriaya inspection
Please provide FDA 483 letter for Catalent located in Bloomington, Indiana US, issued in September 2022.

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Control # Recd Date From

2021-6479 10/01/2021 Alicia Antiri

2021-6484 10/01/2021 Alicia Antiri

2021-6485 10/01/2021 Alicia Antiri

2021-6486 10/01/2021 Alicia Antiri

2021-6487 10/04/2021 L, Paul

2021-6491 10/04/2021 Evans, Shasta

2021-6492 10/04/2021 Evans, Shasta

2021-6493 10/04/2021 Evans, Shasta

2021-6494 10/04/2021 Evans, Shasta

2021-6496 10/04/2021 Evans, Shasta

2021-6497 10/04/2021 Evans, Shasta

2021-6498 10/04/2021 Evans, Shasta

2021-6499 10/04/2021 Evans, Shasta

2021-6500 10/04/2021 Evans, Shasta

2021-6501 10/04/2021 Duty, Harry

2021-6503 10/04/2021 Bathen, Benjamin

2021-6504 10/04/2021 FOI Services, Inc.

2021-6505 10/04/2021 FDAZILLA

2021-6506 10/04/2021 Medytox Inc.

2021-6507 10/04/2021 Medytox Inc.

2021-6508 10/04/2021 MIDI, Inc.

2021-6512 10/04/2021 NBC NEWS

2021-6513 10/04/2021 STAT News

2021-6515 10/04/2021 Hudson, Jonathan C

2021-6517 10/04/2021 Schmidt & Copeland LLC

2021-6518 10/04/2021 smart, tammy l

2021-6519 10/04/2021 Litzher, Paul

2021-6520 10/04/2021 Litzher, Paul

Spark Capital Advisors (I)

2021-6522 10/04/2021 Mandava Associates, LLC

2021-6523 10/04/2021 John DeBeer

2021-6525 10/04/2021 Acella Pharmaceuticals, LLC

2021-6530 10/04/2021 INGENIO PICHICHÍ S.A.

2021-6531 10/04/2021 FOLEY & LARDNER LLP

2021-6535 10/04/2021 Pearce Legal Services, PLLC

2021-6536 10/04/2021 TORRENT PHARMA INC

2021-6537 10/04/2021 TORRENT PHARMA INC

2021-6539 10/04/2021 BloombergQuint

Columbia Graduate School of

2021-6543 10/04/2021 Wilshire Law Firm, PLC

2021-6545 10/04/2021 Berge, Beau

2021-6548 10/04/2021 SCA Pharmaceuticals, LLC

2021-6549 10/04/2021 SCA Pharmaceuticals, LLC

2021-6550 10/04/2021 SCA Pharmaceuticals, LLC

2021-6551 10/04/2021 SCA Pharmaceuticals, LLC

2021-6552 10/04/2021 SCA Pharmaceuticals, LLC

2021-6553 10/04/2021 SCA Pharmaceuticals, LLC

2021-6555 10/04/2021 SCA Pharmaceuticals, LLC

2021-6556 10/04/2021 SCA Pharmaceuticals, LLC

2021-6558 10/04/2021 FDAZILLA

2021-6559 10/04/2021 FDAZILLA

2021-6560 10/04/2021 FDAZILLA

2021-6561 10/04/2021 FDAZILLA

2021-6562 10/04/2021 FDAZILLA

2021-6563 10/04/2021 FDAZILLA

2021-6564 10/04/2021 FDAZILLA

Hyman Phelps & McNamara

2021-6566 10/04/2021 Fresenius Kabi USA, LLC

2021-6569 10/04/2021 Biocomposites Ltd

2021-6570 10/04/2021 HOLLAND & KNIGHT LLP

2021-6571 10/04/2021 REACH24H USA INC.

2021-6572 10/04/2021 REACH24H USA INC.

2021-6573 10/05/2021 George W Kraus