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FDA Foia Log Fy2015
FDA Foia Log Fy2015
2014-8965 11/07/2014 VU
2014-8966 11/07/2014 UNIVERSITY OF BIRMINGHAM
2014-8967 11/07/2014 STRYKER INSTRUMENTS
2014-8968 11/07/2014 Watkins, Lourie, Roll & Chance, PC
2014-8969 11/07/2014 MDC RegAffairs GmbH
LINZESS - AER
SONNEBORN INC, PETROLIA, PA - EIR 6/1/14-8/1/14
STEM CELL RECS
MEDWATCH 139521
GVK BIOSCIENCES, INDIA - 483
ALBENZA - NDA
NDA 021038 S020
IPCA LBARATORIES, INDIA - EIR 2014
NDA 205060
INAD I-008476
APPROVAL LETTERS ANDA 78043 78466 65392 ETC
Materials Submitted by Organogenesis for 01/16/2014
Meeting with FDA
K143244
NDA 020649
ANDA 075896, ANDA 075998
NDA 020379
VENLAFAXINE - AERS
INDIVIDUAL RECS
AUROBINDO PHARMA, TARO - EIR, 483 01/01/2010 -
12/24/2014
KIMBERLY-CLARK MICROCOOL SURGICAL GOWNS, SURGICAL
DRAPES - FORM 3500, 3500A, 3500B 01/22/2011 -
12/22/2014
RECKITT BENCKISER, SALT LAKE CITY, UT - 483
01/01/2014 - 10/14/2015
BIOTRONIK - MOST RECENT ANNUAL REPORT FOR
IMPLANTABLE CARDIOVERTER DEFIBRILLATORS 12/01/2012
- 12/24/2014
BIOTRONIK - MOST RECEN T ANNUAL REPORT FOR LEADS
12/01/2012 - 12/24/2014
P050053
ST JUDE MEDICAL MOST RECENT ANNUAL REPORT SUBMITTED
FOR LEADS 12/01/2012 - 12/24/2014
K942583, K971048, K040415 ETC
BOSTON SCIENTIFIC MOST RECENT ANNUAL REPORT FOR
LEADS 12/01/2012 - 12/24/2014
ST JUDE MEDICAL MOST RECENT ANNUAL REPORT FOR
IMPLANTABLE CARDIOVERTER DEFIBRILLATORS 12/01/2012
- 12/24/2014
ANDA 075998 CHEMISTRY REVIEW
SHIRE HUMAN GENETIC THERAPIES - BIOLOGICAL
DEVIATION REPORTS
BOSTON SCIENTIFIC MOST RECENT ANNUAL REPORT FOR
IMPLANTABLE CARDIOVERTER DEFIBRILLATORS 12/01/2012
- 12/24/2014
AMGEN, WEST GREENWICH, RI - EIR, INVESTIGATOR NOTES
07/20/2014 - 08/20/2014
HAPPY APPLES OF WASHINGTON, MO - CORR WITH FDA
10/01/2014 - 12/26/2014
K113008, K112997, K102599 ETC
MW5029909
BLOOD CENTER OF WISCONSIN - 483 MOST RECENT
FCN 1240, 818, 297 TOXICOLOGY RECS
FCN 1239, 823, 300 - CHEMISTRY, TOXICOLOGY RECS
CFSAN FOIA REQUESTS 11/25/2014 - 12/30/2014
SYNSEPALUM DULCIFICUM FRUIT, MIRACULIN - NON
APPROVAL RECS 01/02/1974 - 12/31/1974
K091760
K993107
IDE G940178
CHARTER MEDICAL LTD - 483 10/16/2004 - 10/16/2014
ANTIEPILEPTIC DRUGS & SUICIDALITY - STATISTICAL
RVWS & EVALUATION 5/23/08 (CERTIFIED)
ANTIEPILEPTIC DRUGS & SUICIDALITY - PATIENT SAFETY
NEWS SHOW #89 8/09
SUICIDAL THOUGHTS & BEHAVIOR - ANTIEPILEPTIC DRUGS
L FDA PODCAST FULL VERSION 12/12/08
C R BARD INC - HICKMAN HEMODIALYSIS APHERESIS DUAL
LUMEN CATHETER MDRS
PFIZER LABS - CHANTIX MEDICATION GUIDE12/12 TO
PRESENT
K934440
RICE BRAN WAX - FAP
K122288
HESPERIDIN - AERS
K082761 - ACCESSION NUMBER, DEVICE LISTING NUMBER
BONIVA - AERS
K130847
K133725
CLINICAL SPECIALTIES COMPOUNDING PHARMACY, AUGUSTA,
GA ATHENS RETINA CENTER, ATHENS, GA - LAB RESULTS
03/01/2013 - 09/30/2013
TRIFEXIS - COMPREHENSIVE CLINICAL DETAIL REPORT
LISTINGS
K032753
Mindray DS USA, Inc Panorama Wireless Telemetry
System - APPROVAL RECS
DATASCOPE CORP PANORAMA WIRELESS TELEMETRY SYSTEM -
APPROVAL RECS
FDA-SOL-13-1118990
K060662
Substantial Equivalence tobacco information for
Camel products
10429529, 10432205, 10433312 ETC
K133725
IRDC, MATTAWAN, MI - EIR 01/04/1984 - 12/31/1992
UNILIFE MEDICAL SOLUTIONS - 513(G) REQUEST RECS
CORR WITH CANADA RE SHIRE PHARMACEUTICALS ALLEGED
IMPROPER MARKETING AND PROMOTION OF DRUGS
LUTREPULSE - OOPD RECS 01/01/1987 - 01/01/1988
K072412
IPCA LABORATORIES, INDIA - 483 10/13/2014 -
10/25/2014
DRUG SHORTAGE RECS - 1990 T0 2014
SPECIALTY COMPOUNDING - RESPONSES, TESTING
01/01/2013 - 10/25/2014
CONTINGENCY PLANS FOR EBOLA OUTBREAK - RECS
INULIN DERIVED FROM AGAVE TEQUILIANA - FDA CORR RE
GRAS STATUS
INSPECTION IN FACTS 2005 TO 2006 WITH INSPECTION
BASIS COMPLIANCE AND WITH COMPLAINT NUMBER 1000 TO
1800 ETC
ALERE SAN DIEGO, INC - 483 2012
STATINS - AERS
ANDA 091589 SBA
K090850
K103277
MONUROL - SBA
CETYL PYRIDINIUM - FAP
K103214
SANOFI PASTEUR, INC, SWIFTWATER, PA - 483, EIR
05/09/2014 - 05/09/2014
BEN VENUE LABORATORIES, BEDFORD, OH - 483, EIR
06/06/2014 - 06/06/2014
PFIZER IRELAND PHARMACEUTICALS, DUBLIN, IRELAND -
483, EIR 06/17/2014 - 06/17/2014
TOPAMAX - MEDICATION GUIDE 3/14 (CERTIFIED)
TOPAMAX - CORR FROM RUSSELL KATZ 4/23/09
(CERTIFIED)
TOPAMAX - MEMO FROM TODD SAHROOT PHD 12/11/96
(CERTIFIED)
TOPAMAX- APRVL LTR 12/24/96 (CERTIFIED)
TOPAMAX - LBLG 4/09 (CERTIFIED)
TOPAMAX - MEMO FROM PAUL LEBER MD 12/18/98
(CERTIFIED)
TOPAMAX - LBLG REVISED 4/08 (CERTIFIED)
TOPAMAX - STATISTICAL RVWS 5/13/98 (CERTIFIED)
MEDWATCH RPTS CODED AS MEDICATION ERRORS 9/1/14-
10/31/14
DR MOHAMED S RABBOT, ST JOSEPH'S REGIONAL MEDICAL
CENTER, CLIFTON, NJ - DEFICIENCY CODES, INADEQUATE
PATIENT CONSENT FORM
NDA 204096
SIHUAN PHARMACEUTICALS - INSPECTIONS, APPROVALS
11/11/2011 - 11/10/2014
REPORT SUBMITTED RE TECFIDERA 11/04/2014 -
11/04/2014
CIPLA - 483 MOST RECENT 11/01/2014 - 11/10/2014
CYCLOBENZAPRINE - AERS
MED AWARENESS DBA GENESIS TISSUE SERVICES, POWAY,
CA - 483
IPCA LABORATORIES, INDIA - 483 10/01/2014 -
11/12/2014
Agency Information Collection Activities Proposed
Collection Comment Request Establishment of a
Tobacco User Panel - PROTOCOLS, BACKGROUND
SCANADU SCOUT - 510K 01/01/2011 - 11/12/2014
K140853/S003
OFF LABEL DRUG PROMOTION INVESTIGATIONS,
SETTLEMENTS, WARNING LETTERS ETC
RESTAURANT RECYCLING SERVICES LLC, ROANOKE MILLING
CO, NEW FASHION PORK, ETC - RESULTS OF SPLS TESTED
1/14 TO PRESENT
ZIMMER - TRABECULAR METAL PRIMARY HIP FEMORAL STEM
ISSUES OF HIGH COBALT, CHROMIUM OR TITANIUM LEVELS
IN THE BLOOD CORR, WARNINGS, ETC
SWEDISH MATCH NORTH AMERICA - FDA AUTHORITY TO
REVISE SMOKELESS TOBACCO WARNING LABELS,
ATTACHMENTS
ISSUANCE OF WRITTEN REQUESTS FOR PEDIATRIC STUDIES,
DECLINING OF WRITTEN REQUESTS, SUBMISSION DATES,
ETC
ELIQUIS (APIXABAN), PRADAXA (DABIGATRAN ETEXILATE
MESYLATE), XARELTO (RIVAOXABAN) - AERS, MEDICATION
ERROS LAST FIVE YRS
INDIVIDUAL RECS
ZXPREXA ZYDIS - RECS
PEGASUS LABORATORIES, INC - PROFILE CLASS CODES
01/01/2006 - 11/30/2014
VITALHEALTH TECH, INC, CLIFTON, NJ - 483 06/01/2014
- 07/31/2014
JEFFREY SOSMAN MD, VANDERBILT UNIVERSITY MEDICAL
CENTER, NASHVILLE, TN - EIRS, 483S, CORR, ETC
9/29/10, 6/13/11, 2/12/07
PERCEPTUAL DEVELOPMENT CORP AND/OR IRLEN INSTITUTE
- IRLEN SPECTRAL FILTERS CMPLNTS 1/90 TO PRESENT
DOCUMENT NUMBER CPT1400751 - RECS, WEBSITES
K122288
K930564
LIST OF HOSPITAL, CRO ANNUAL HISTOPATHOLOGY TESTS
PER YEAR
2014-8510
K122894
Records related to any order issued by the FDA
under 21 CFR 814.45 denying FDA Approval of Augment
Bone Graft
K022894
K040324
K930348
K924104
K101298
2012 REVIEWER GUIDE DRAFTED BY CTP, REVISIONS,
ADDITIONAL GUIDES
WELLNESS TORE COMPOUNDING PHARMACY, CLEVELAND, TN -
AERS, MEMOS, REPORTS, ETC 01/01/2014 - 10/01/2014
NDA 020314 - SBA
DEVICE REPORT - FACILITY NAME
K103437
K093128
COLOPLAST MANUFACTURING US LLC, MINNEAPOLIS, MN -
EIR 9/28/11
FCN 956
XENAZINE - AERS
IND BB-6195
K131509
K130393
K062163
BVO - TESTING, RESEARCH
SUN PHARMACEUTICALS, INDIA - 483 11/01/2013 -
12/02/2013
DR REDDY'S LABORATORIES, LIMITED, INDIA - 483
11/01/2014 - 12/01/2014
K141860
JOSEPH LEONARD LILLO, DO - EIR, CORR 02/03/2014 -
02/13/2014
SNEEZE, WHEEZE, AND ITCH ASSOCIATES - EIR, CORR
12/03/2012 - 12/10/2012
FDA ENFORCEMENT REPORTS CVS FORMAT 01/01/2004 -
12/08/2014
BIOSENSORS INTERNATIONAL PTE, LTD SINGAPORE - EIR
08/02/2010 - 08/05/2010
K111201
K130689, K033981
PRIME PACKAGING INC, MIAMI, FL - EIR 7/11/04
LOUISIANA STATE UNIV HEALTH SCIENCE CENTER
DEPARTMENT OF RHEUMATOLOGY, NEW ORLEANS, LA - 483
OR WARNING LTR 8/04 TO 12/04
YALE NEW HAVEN HOSP NEONATAL UNIV - SOLGAR ABC
DOPHILUS CONTAMINATED ABC COPHILIUS POWER RECS
SUBPOENA
NEW ENGLAND COMPOUNDING CENTER (AMERIDOSE) - EIRS,
AUDITS, EVALUATIONS, ETC 9/05 TO PRESENT
ACTOS (PIGOLITAZOLE) - RPTS
NADA 141147
NDA 020064
RB MANUFACTURING LLC, SALT LAKE CITY, UT - EIR
06/01/2014 - 12/18/2014
EDGE SYSTEMS CORP - EIR 05/17/2010 - 05/25/2010
K130143
OXYHEALTH LLC - WARNING LETTER RECS 08/01/2013 -
04/30/2014
VERTELLUS HEALTH AND SPECIALTY PRODUCTS, ZEELAND,
MI - EIR 01/01/2012 - 12/17/2014
K955168 K000470 Q131322
SONAR PRODUCTS, INC, CARLSTADT, NJ - 483
K123459
K082848, K111119, K100889 ETC
K010336
K032104
K071964
1998 ORANGE BOOK
BLA 125432
BLA 125413
K041521
2012 ORANGE BOOK
ACE-MEDICAL CO - EIR 01/01/2013 - 12/18/2014
THE PROMETHEUS GROUP - CPT 1400805 09/23/2014 -
12/18/2014
UAS LABS, WAUSAU, WI - EIR 01/01/2010 - 12/18/2014
ZIMMER 510K RE KINEMATIC DISTAL REFERENCING GUIDE,
KINEMATIC SURGICAL TECHNIQUE FOR PERSONA KNEE
SYSTEM
PROTEC LABORATORY, QUITMAN, TX - EIR 01/01/2010 -
12/18/2014
DR MANUEL LAVADOS, SANTIAGO, CHILE - EIR, 483
01/01/2010 - 12/31/2010
MEGLUMINE - SUMMARY DATA RE SAFETY AND
BIOAVAILABILITY
TOXICITY OF DIETHYLENE GLYCOL DIBENZOATE,
DIPROPYLENE GLYCOL DIBENZOATE, PROPYLENE GLYCOL
DIBENZOAT ETC
RAYOS (PREDNISONE) NDA 02-020 APRVL, MEDICAL RVW,
SUMMARY RVW
LIST OF IMPORT ALERTS
SOVALDI (SOFOSBUVIR) APRVL
LIST OF APPROVED DRUGS LATER FOUND WITH AER
IMBRUVICA - ICR 1056496, 10565010, 10565019, ETC
MEDTRONIC, NORTHRIGDGE, CA MEDTRONIC, PR TANDEM,
SAN DIEGO, CA ETC - EIR, EXHIBITS 01/01/2009 -
12/19/2014
ZYDELIG - ICR 10561655, 10563217, 10564235 ETC
ADVERSE EVENT REPORTER INFORMATION
K131252
NDA 021526 S 004
ROCEPHIN IV PUSH - AERS
K133521
K141480
K103480
K142037
K121517
K062386
K063877
K033374
K131447
K121916
K121213
DR STEPHAN A GRUPP, PHILADELPHIA, PA - 483, CORR
01/01/2005 - 12/29/2010
K111250
K101769
K071876, K111266, K112794, ETC
METHYLPHENIDATE - AERS
IMATINIB MESYLATE - TENTATIVE APPROVAL LETERS TO
SUN PHARMA INDUSTRIES 11/01/2009 - 11/01/2014
TOMOPHASE 510K SUBMISSION
ANDA 078936
2014-9430
LUPIN LIMITED - 483 01/01/2015 - 01/31/2015
K132028
PROPOFOL - AERS
INTUITIVE SURGICAL, INC - CORR, WARNING LETTERS RE
DA VINCE SURGICAL SYSTEM 01/01/2007 - 12/31/2014
ANDA 075074 SBA
CELLTRION - 483 01/01/2015 - 03/10/2016
TECFIDERA LABEL CHANGES
MEDICAL COMPONENTS, INC - 483 01/01/2012 -
12/30/2012
EMEND - STABILITY TEST INFORMATION 03/25/2002 -
09/28/2012
K901202
8-4-(1-aminocyclobutyl)phenyl-9-phenyl-1,2,4-
triazolo3,4-f1,6naph-thyrin-3(2H)-one mono-
hydrochloride - COMPLETE RESPONSE LETTER RE ORPHAN
DESIGNATION 9/3/2009
DIAGNOSTICA STAGO, INC, MOUNT OLIVE, NJ
PARSIPPANY, NJ - INVESTIGATOR DIARIES 10/22/2013 -
11/29/2013
LETERMOVIR - COMPLETE RESPONSE LETTER RE ORPHAN
DESIGNATION 12/12/2011
DINACICLIB - COMPLETE RESPONSE LETTER RE ORPHAN
DESIGNATION 8/25/2011
K143314
K102456
K071246
HARVONI - AERS
SHIPMENTS REGULATED BY FDA 12/15-31/14
K120831
SPATZ LABS, OXNARD, CA - EIR, 483, WARNING LETTER
01/01/2012 - 03/01/2015
ANDA 079217 001 ANDA 079217 002 ANDA 079217 003 -
SBA
K130847
NDC 61703-0243-53 DATE PRODUCT DISCONTINUED
WRIGHT MEDICAL TECHNOLOGY - RECS RE NUMBER OF
POSTMARKET SURVEILLANCE STUDIES 01/03/2011 -
03/19/2015
IND 070484
K883346
NDA 018760
23ANDME - CLOSE OUT LETTER RECS 09/13/2012 -
03/25/2014
K083580, K090042, K120500 ETC
PROVECTUS BIOPHARMACEUTICALS INC - DOCS
2014-6520
2014-6754
2014-5542
2014-7630
2014-7627
2014-3503
2014-7826
2014-7098
2014-6735
2014-7839
OVESCO ENDOSCOPY AG - OVER-THE-SCOPE CLIP SYS SET
K101428
2014-7830
2014-5872
2014-6381
2014-3516
2014-2698
K053655
2014-3539
2014-3131
2014-3839
2014-4986
TESTOSTERONE SUPPLEMENTS - AGGREGATED DATA OF
VENOUS BLOOD CLOT EVENTS 01/01/2010 - 12/31/2014
K820622
SHANDONG FREDO BIOPHARM CO LTD, CHINA - EIR
01/01/2013 - 01/31/2015
GENERAL MILLS, BRAZIL - EIR, 483, RESPONSE
02/08/2014 - 03/20/2015
NDA 10515 S 23, 24, 31
K954311
GRAS 5G0046
GENZYME CORP, FRAMINGHAM, MA APLICARE INC,
MERIDEN, CT VERICHEM LABORATORIES INC, PROVIDENCE,
RI, ETC - 483S 11/1-30/14
COATING PLACE INC, VERONA, WI ANYBATTERY INC,
ROSEMOUNT, MN - 483S 11/1-30/14
BACHEM AMERICAS INC, TORRANCE, CA CARLSBAD
TECHNOLOGY INC, CARLSBAD, CA PRIMA PHARM UNC, SAN
DIEGO, CA, ETC - 483S 11/1-30/14
B & G LABS INC, SAINT LOUIS, MO MERIDIAN MEDICAL
TECHNOLOGIES (PFIZER CO), BRENTWOOD, MO CATALENT
CTS LLC, KANSAS CITY, MO - 483S 11/1-30/14
New Yung Wah Trading Co. - CUSTOMER LIST 01/02/2014
- 12/31/2014
ENCOMPAS UNLIMITED INC, SARASOTA, FL BELCHER
PHARMACEUTICALS LLC, LARGO, FL INOVO INC, LEIGH
ACRES, FL, ETC - 483S 11/1-30/14
NEOTERIC COSMETICS INC, DENVER, CO CONMED
ELECTROSURGERY, CENTERNNIAL, CO - 483S 11/1-30/14
NELSON ENVIRONMENTAL TECHNOLOGIES INC, STAFFORDX,
TX WALGREENS INFUSION SERVICES, HOUSTON, TX - 483S
11/1-30/14
APTALIS PHARMATECH INC, VANDALIA, OH CELSUS
LABORATORIES INC, CINCINNATI, OH GOLDEN TOUCH LLC,
BENTON, KY - 483S 11/1-30/14
SIMVASTATIN - AERS
GLAND PHARMA, INDIA - 483
PRAVASTATIN - AERS
ST JUDE MEDICAL, INC, MINNETONKA, MN - INSPECTION
RECS 01/01/2008 - 12/31/2010
ADVANCED NEUROMODULATION SYSTEMS, INC, PLANO, TX -
INSPECTION RECS 01/01/2009 - 12/31/2010
MONSANTO, DOW, DUPONT - FOOD SAFETY & GMO BREAKDOWN
ON STAFF
NDA 020746 S 21 OTC LABELING UNREDACTED
MONSTER, RED BULL, ROCKSTAR, ETC - AERS 10/24/2012
- 03/31/2015
IMMUNOTEK BIOCENTERS - EIR 01/05/2012 - 03/30/2015
LIST OF FOOD PROCESSING AND PHARMACEUTICAL
INSPECTIONS 01/01/2013 - 03/31/2015
BENZONATE ORAL CAPSULES - LITERATURE CITATIONS FOR
PHASE THREE CLINICAL TRIALS
K141825, K150009, K142418, ETC
ANDA SPREADSHEET
522 STUDY ORDER PS140001 ARGO MEDICAL TECHNOLOGIES,
INC.
GLAND PHARMA, INDIA - 483 07/29/2013 - 08/05/2013
12/27/2010 - 01/07/2011 03/24/2006 - 04/01/2006
LEAD, MERCURY, ARSENIC, ETC - STANDARDS FOR FOOD,
BEVERAGES, AND DRINKING WATER
2014-9798
ROUVASTATIN - AERS
ANNUAL REPORT SUBMITTED BY NDA APPLICANTS TO FDA RE
LABELING CHANGES
VERTEPORFIN - EFFICACY, SAFETY, FORMULATIONS ETC
K001773, K001334, K032232 ETC
FLUVASTATIN - AERS
ATORVASTATIN - AERS
LOVASTATIN - AERS
FLUOROQUIONLONES - AERS
SAFETY DATA FROM CYSTIC FIBROSIS PATIENTS TAKING
KALYDECO, LUMACAFTOR, VX-661 ETC 01/01/2011 -
03/31/2015
AUTOMATED ENDOSCOPE REPROCESSORS - CONSENT DECREES,
RECALLS, 483 ETC 01/01/2006 - 01/01/2015
PRP TRADING CORP - ENTRY #D05-01247080 NOTICES
PITAVASTATIN - AERS
RACHEL RAY NUTRISH CAT FOOD INV858657, INV858658,
INV878138 TEST RESULTS
K141929
K880450
NDA 019806
ANDA 078292 SBA
RHEOS HIGH BLOOD PRESSURE PIVOTAL TRIAL, CVRX RHEOS
BAROREFLEX HYPERTENSION THERAPY SYSTEM - APPROVAL,
CORR, EMAIL ETC 01/01/2001 - 03/26/2015
K070582
K042709
K941578
CV FOR HIRED INDIVIDUAL
K023805
NDA 203976 TENTATIVE APPROVAL LETTER
K861401
K933048
AKORN, DECATUR, IL - EIR 05/01/2014 - 12/31/2014
K131044
K070793
NADA 097037 FOIA SUMMARY
RELIABLE BIOPHARMACEUTICAL CORPORATION - EIR
01/14/2013 - 01/25/2013
K113351
ZOMETA NDA 21-386 - MEDICAL RVW PART 1 AND PART 2
EFFEXOR - AERS
SHARP CORPORATION, CONSHOHOCKEN, PA - EIR
05/01/2012 - 08/31/2012
INVO BIOSCIENCE INVOCELL - APPROVAL RECS
NCT00123487 - CFR
ANDA 080819
K123822
NADA 055-099 - FOIA SUMMARY
SANOFI, TORONTO, CANADA - 483, EIR, CORR 01/05/2012
- 04/07/2015
DRUG COMPANIES, MEDICAL DVC MFRS, BLOOD
ESTABLISHMENTS, ETC - FOREIGN AND DOMESTIC INSPS
9/14 TO 12/14
GUARANA - COLA REVIEW, LABEL APPROVALS ETC
INTEGRA NEUROSCIENCES PR, INC, ANASCO, PR - 483,
EIR, RESPONSE 11/01/2013 - 12/01/2013
PHARMACEUTICAL INNOVATIONS, INC, NEWARK, NJ - 483,
EIR, RESPONSE 02/01/2012 - 03/01/2012
MCNEIL-PPC, INC, SKILLMAN, NJ - 483, EIR, RESPONSE
04/01/2013 - 05/01/2013
HYDROYCUT SX-7 - AERS, MEDWATCH
COOPER VISION CARIBBEAN CORP, JUAN DIAZ, PR - 483,
EIR, RESPONSE 12/01/2013 - 01/31/2014
CR BARD, INC, UROLOGICAL DIVISION, COVINGTON, GA -
483, EIR, RESPONSE 07/01/2012 - 07/31/2012
COVIDIENT, PLC, BOULDER, CO - 483, EIR, RESPONSE
05/01/2014 - 06/30/2014
ADVANCED RENAL TECHNOLOGIES, INC, BELLEVUE, WA -
483, EIR, RESPONSE 03/01/2014 - 04/01/2014
KEVIN B FRICKA, MD, ALEXANDRIA, VA - 483, EIR,
RESPONSE 02/01/2014 - 02/28/2014
CAERS 176429,176524, 177048, ETC
BECTON DICKINSON AND COMPANY, COLUMBUS, NE - 483,
EIR, RESPONSE 09/01/2013 - 09/30/2013
3M UNITEK CORPORATION, MONRAVIA, CA - 483, EIR,
RESPONSE 03/01/2014 - 03/31/2014
K081238
K100786
K122982
K042616
K952737
K141139
K081151
NDA 205053
NSPIRED FOODS - ALMOND BUTTER RECALL RECS
GLAUKOS ISTENT TRABECULAR MICRO-BYPASS STENT SYS
P080030/S012
HARVONI - AERS
K141785
XCELIENCE, TAMPA, FL - EIR, 483 12/01/2008 -
01/30/2009
PACLITAXEL - AERS
ROCA LABS, INC., ROCA LABS PHARMACEUTICALS, ROCA
LABS USA - COMPLAINTS, REFUSAL, INSPECTION ETC
01/01/2009 - 04/15/2015
PENICILLIN G SODIUM ANDA 065068
BIORELIANCE CORPORATION, ROCKVILLE, MD - 482, 483,
EIR 01/01/2011 - 04/08/2015
WIL RESEARCH, ASHLAND, OH - 482, 483, EIR
03/01/2011 - 04/08/2015
P900056 S026
ANDA 202348
BIOFER SPA, MEDOLIA, ITALY - 483 1/31/14-2/4/14
CORDIS CORPORATION - WARNING LETTERS 01/01/2004 -
12/31/2004
2nd Quarter DMF file (Excel format) 2nd Quarter VMF
file (PDF format)
GENERIC METHYLPHENIDATE HYDROCHLORIDE ER - ADVERSE
EVENTS EXCEL, CVS FORMAT 12/28/2012 - 02/27/2015
MPI RESEARCH, INC, MATTAWAN, MI - 483, EIR,
RESPONSE 08/01/2012 - 08/31/2012
SRI INTERNATIONAL, MENLO PARK, CA - 483, EIR,
RESPONSE 02/01/2012 - 02/28/2012
CHARLES RIVER PATHOLOGY ASSOCIATES, CHICAGO, IL -
483, EIR, RESPONSE 06/01/2012 - 07/30/2012
LOVELACE RESPIRATORY RESEARCH INSTITUTE,
ALBUQUERQUE, NM - 483, EIR, RESPONSE 03/01/2012 -
03/31/2012
CORR FROM UCLA OR DR GARY SMALL TO FDA RE WARNING
LETTER 01/01/2015 - 04/08/2015
PHARMANET USA, PRINCETON, NJ - 483, EIR, RESPONSE
08/01/2012 - 09/30/2012
REPLAGAL - RECS RE EXPANDED ACCESS, COMPASSIONATE
USE 06/16/2009 - 03/01/2012
SHARP GLOBAL LTD, GUJRANWALA TOWN, NEW DELHI, INDIA
- 483 3/14
COVANCE LABORATORIES, INC, CHANDLER, AZ - 483, EIR,
RESPONSE 06/01/2012 - 07/30/2012
CONAGR FOODS, AFFTON, MO - EIR 01/27/2014 -
09/24/2014
US ARMY MEDICAL RESEARCH INSTITUTE OF INFECTIOUS
DISEASES, FORT DETRICK, MD - 483, EIR, RESPONSE
03/01/2012 - 03/30/2012
FCN 178
K063517
RICERCA BIOSCIENCES, LLC, CONCORD, NH - 483, EIR,
RESPONSE 04/01/2012 - 04/30/2012
PPD DEVELOPMENT, LP, RICHMOND, VA - 483, EIR,
RESPONSE 02/01/2012 - 02/28/2012
ORTHO EVRA - AERS
FCN 475
LURPON - AERS
NOVACYL WUXI PHARMACEUTICAL CO LTD, JIANGSU, CHINA
- 483 10/14-18/13
EXELIXIS, SOUTH SAN FRANCISCO, CA - 483, EIR,
RESPONSE 09/01/2012 - 09/30/2012
CORR SENT TO CANADA DRUGS LTD, WINNIPEG, MANITOBA,
CANADA RE EXPORT OF PRESCRIPTION MEDICATION TO THE
US 03/01/2012 - 04/08/2015
RECALL Z-0006-04 RECS
K012677
K100341
K133705
K111773
2014-3015
ANDA 090379 SBA
DMF 1201, DMF 17157, DMF 18963 ETC
PAUL D MINTZ MD, CHARLOTTESVILLE, VA - EIR, 483, CO
RESP 2/24/14-3/28/14
2015-2528, 2015-2463, 2015-2261 ETC
MONOSOL RX, PORTAGE, INDIANA - 483, WARNING LETTER,
RESPONSES 01/03/2013 - 04/09/2015
K041867
BK140191
BK130065
K110582
K123468
K130163
K142024
FK140337
MCNEIL-PPC INC, SKILLMAN, NJ - EIR, 483, CO RESP
3/21/13-4/10/13
K081042
SHIRE HUMAN GENETIC THERAPIES, NORTH READING, MA -
EIR, 483, RESPONSE 01/01/2014 - 01/31/2014
FOREST RESEARCH INSTITUTE, FARMINGDALE, NY - EIR,
483, RESPONSE 03/01/2012 - 04/30/2012
ALBANY MOLECULAR RESEARCH, ALBANY, NY - EIR, 483,
RESPONSE 12/01/2013 - 12/31/2013
DILANTIN - COMPLAINT RECS
WACKER CHEMIE AG MUNICH, GERMANY PHARMAZELL,
CHENNAI, INDIA - 483, EIR LAST FIVE YEARS
USA CONTAINER CO, INC, HILLSBOROUGH, NJ - EIR
01/03/2012 - 01/05/2015
FDA minutes with Seattle Genetics regarding the
AETHERA study, from 01/01/2014 to the present
FDA meeting minutes with Teva Pharmaceuticals
discussing generic EpiPen from 01/01/2014 to the
present
DASETTA - AERS
PI PHARMA INC, CAMPTON, KY - EIR, 483, CO RESP
2/10-19/14
FDA meeting minutes with Prosensa (now BioMarin)
discussing drisapersen from 01/01/2014 to the
present
FDA meeting minutes with Sarepta Therapeutics
discussing Eteplirsen 10/01/2014 to the present
03/2015 meeting minutes between FDA & Amicus
FDA meeting minutes with Alkermes discusing ALKS
9070 from 01/01/2014 to the present
FDA meeting minutes with industry discussing HP
Acthar Gel (respository corticotropin gel) from
01/01/2012 to the present
LIST OF FDA CLEARED OR APPROVED VERTEBRAL BODY
REPLACEMENT DEVICES FOR USE IN THE CERVICAL SPINE
04/04/2001 - 04/09/2015
PFIZER, AUSTRALIA - 483 11/01/2014 - 04/09/2015
COSMETIC VOLUNTARY REGISTRATION PROGRAM -
INGREDIENT DATA
ACELRX PHARMACEUTICALS ZALVISO - COMMUNICATIONS
WITH FDA RE DEVICE PORTION 03/01/2014 - 07/31/2014
2014-2991
NEW HOPE FERTILITY CENTER, NEW YORK, NY - EIR, 483,
CO RESP 8/26/14-9/15/14
2014-4430
2014-4497
TECFIDERA - AERS
2014-4460
2014-4605
2014-4255
2014-4297
2014-4291
2014-4289
2014-4298
K080079, K120035, K042455
2014-4824
2014-4302
2014-4315
2014-4830
2014-4917
2014-4867
2014-4847
SUBSYS - AERS
WUXI APPTEC, PHILADELPHIA, PA - EIR 12/17/2002 -
04/10/2015
FOI DAILY LOG 3/16-20/15
ADENOSCAN AERS
FOI DAILY LOG 3/2-6/16
FOI DAILY LOG 3/9-13/15
FOI DAILY LOG 3/23-27/15
FOI DAILY LOG 2/23-27/15
FOI DAILY LOG 3/16-20/15
FOI DAILY LOG 3/2-6/15
FOI DAILY LOG 3/9-13/15
CLOSED FOIA REQUESTS 3/23-27/15
CLOSED FOIA REQUESTS 3/2-6/15
CLOSED FOIA REQUESTS 3/9/13/15
ANDA 200675 - SUMMARY OF REVIEW COMMENTS
A H ROBINS - SKELAXIN (METAXALONE) NDA 13-217 APRVL
LTR
K001962, K002099
CLOSED FOIA REQUESTS 3/16-20/15
CLOSED FOIA REQUESTS 2/23-27/15
FOI DAILY LOG 3/23-27/15
FOI DAILY LOG 3/16-20/15
FOI DAILY LOG 3/2-6/15
FOI DAILY LOG 3/9-13/15
CLOSED FOIA REQUESTS 2/23-27/15
CLOSED FOIA REQUESTS 3/2-6/15
CLOSED FOIA REQUESTS 3/9-13/15
CLOSED FOIA REQUESTS 3/16-20/15
TEXAS APPLIED BIOMEDICAL SERVICES, HOUSTON, TX -
EIR, 483, CO RESP 4/16-25/12
CLOSED FOIA REQUESTS 3/23-27/15
FOI DAILY LOG 2/23-28/15
FOI DAILY LOG 3/16-21/15
FOI DAILY LOG 3/2-7/15
FOI DAILY LOG 3/9-14/15
FOI DAILY LOG 2/23-28/15
CLOSED FOIA REQUESTS 3/2-7/15
CLOSED FOIA REQUESTS 3/9-14/15
CLOSED FOIA REQUESTS 3/16-21/15
CLOSED FOIA REQUESTS 3/23-28/15
APPLIED LABORATORIES INC, CLOUMBUS, IN - EIR, 483,
CO RESP 2/11-18/14
CLOSED FOIA REQUESTS 2/23-27/15
CLOSED FOIA REQUESTS 3/2-6/15
CLOSED FOIA REQUESTS 3/9-13/15
CLOSED FOIA REQUESTS 3/16-20/15
CLOSED FOIA REQUESTS 3/23-27/15
FOI DAILY LOG 3/23-27/15
FOI DAILY LOG 3/16-20/15
FOI DAILY LOG 3/2-6/15
FOI DAILY LOG 3/9-13/15
FOI DAILY LOG 3/23-27/15
CENTURY PHARMACEUTICALS INC, INDIANAPOLIS, IN -
EIR, 483, CO RESP 1/13-14/14
K143182, K023254
MW5017940
INDIVIDUAL RECS
NDA 206538
2014-7062
ARROW PHARMACEUTICALS LTD, AUSTRALIA - INSPECTION
RECS JUNE 2008
OSE reviews related to oxymorphone (Opana ER) and
the medical complication thrombotic microangiopathy
(TMA)
WOCKHARDT LIMITED, INDIA - EIR, 483 09/02/2014 -
04/28/2015
YSI INCORPORATED, YELLOW SPRINGS, OH - EIR
03/01/2014 - 12/31/2014
SBA 202608
Process Validation study submitted to FDA for HPP-
High Hydrostatic Pressure Processing for packaged
as Pouched or Cup Applesauce
NDA 21214 S 6, S 7 - SBA
ANDA 90218
ANDA 062349
ONDANSETRON - AERS
DELEGATION AGREEMENT BETWEEN FDA AND COMMONWEALTH
OF PENNSYLVANIA FOR ENFORCEMENT OF FSMA 01/01/2011
- 04/30/2015
NDA 20430, NDA 000552, NDA 013304 ETC - CMC
SUPPLEMENT UNREDACTED
FACT SHEET RE TATTOOS 01/01/1995 - 01/01/1996
DEN140019
FOI DAILY LOG 4/1-30/2015
CLOSED FOIA REQUESTS 4/1-30/2015
VAERS RECS
NDA 203159 GENERIC BE GUIDANCE
ESSURE FIVE YEAR REVIEW
ZOFRAN - AERS
HALOPERIDOL NON INJECTABLE - MONOGRAPH
K090224
AEK-0186764-4
DOW CHEMICAL CO - FCN 1095 MALEIC ANHYDRIDE GRAFED
POLYROYLENE
MTG BETWEEN FDA AND ORGANOGENESIS - EMAIL, MINUTES,
PRESENTATIONS
THIRD TRILATERAL MEETING ON TOBACCO AND REGULATION
- AGENDA, ROSTER, NOTES ETC
K150017, K150714
K110878
XALATAN - SBA
K143646
K140575
K960777
K100049
BLUE BELL CREAMERIES - 483 01/01/2005 - 05/01/2015
FDA AERS 8967754 9186133 9314001 9513408 9513490
K140980
K142988
ALIMTA, AVASTIN, GILOTRIF ETC - AERS 10/01/2014 -
05/01/2015
NDA 21919, NDA: 22200 GENOTOXICITY STUDIES
NATURE'S PRODUCT INC, SUNRISE, FL - EIR, 483, CORR
ETC 06/01/2007 - 12/21/2014
MAGUET CARDIOPULMONARY SET - JOSTRA HLM TUBING SET
K053025
IVAN BUNGANIC, GASTROENTEROLO AMBULANCIA MUCO,
PRESOV, SVK - 483 9/12 TO 4/15
NICLOSAMIDE - PHARMACOLOGY, TOXICOLOGY STUDY
BLA 125477/S-007
PUGET SOUND BLOOD CENTER - 483, CORR 01/01/2014 -
05/05/2015
MORTON GROVE PHARMACEUTICALS, MORTON GROVE, IL -
EIR 03/26/2014 - 05/05/2015
ICLUSIG - AERS
CUSTOMED - MEETING MINUTES, NOTES 03/12/2015 -
04/17/2015
FORFIVO XL - AERS
ADVAIR - AERS
AVANDIA - AERS
PAXIL CR - AERS
OASIS MEDICAL INC - EIR 04/11/2014 - 09/30/2014
PAXIL - AERS
ZOLPIDEM - AERS
PROPRANOLOL - AERS
AMBIEN - AERS
AMBIEN CR - AERS
BUPROPION - AERS
WELLBUTRIN - AERS
WELLBUTRIN SR - AERS
WELLBUTRIN XL
ST JOHN'S WORT - AERS
POLYETHYLENE GLYCOL - ADVERSE EVENTS
DEKA RESEARCH & DEVELOPMENT CORP, MANCHESTER NH -
AMIA AUTOMATED PD SYS K124018
TOPAMAX (TOPIRAMATE) - ISRS 4502937-1, 6120398-6,
7161594-9, ETC
AFLURIA, ERBITUX - PROD MOLNOGRAPH, AERS 2/12/13 TO
2/13/15
UNCLE JESTER'S FINE FOODS LLC - EIRS 3/15 TO 4/15
CORE PHARMA LLC, MIDDLESEX, NJ - MSDS SHEETS,
ACCIDENTS, INVESTIGATIONS, ETC 2014, 2015
IOVATE, HYDROXYCUT, SMARTBURN, ETC - CAERS 2/\3/15
TO PRESENT
MOLNSANTO'S SEPTEMBER 2 SUBMISSION PAGE 49
FRAUNHOFER INSTITUT VERFAHRENSTECHNIK UND
VERPACKUNG (LUIGI BANDERA SPA) - POLYETHYLENE
TEREPHTHALATE (PET) FCN 119
CPT1400457, GEN1400371, CPT1400361
GENERAL MILLS, CARLISLE, IA MURFREESBORO, TN -
EIR, 483, ETC
RADIANT RESEARCH, CINCINNATI, ON - EIR 02/01/2014
- 12/31/2014
IMPORT DATA 4/16/15 - 4/30/15
K063304
CANAGLIFLOZIN, DAPAGLIFLOZIN, EMPAGLIFLOZIN - AERS
2014-9550
2015-312
2015-1455
2014-5840
2014-7820
2014-9024
2012-4168
ANDA AWAITING OGD ACTION
2012-4230
2013-10022
2014-2190
2014-5803
2014-4624
2014-8639
2014-8640
2014-8475
2014-5549
2012-2028
KERYX BIOPHARMS - AURYXIA (FERRIC CITRATE) TABS 210
MG NDA 205-874 SBA
2014-8210
2015-877
2015-984
2014-9023
ENTRY 277-0143296-8
K864492
LANOXIN - AERS
K050174, K060846
K120296
DOMESTIC FOOD FACILITY REGISTRATION
10069989, 10283699, 10353121 ETC
ICE CREAM INSPECTIONS 01/01/2010 - 05/15/2015
OLYMPUS - DUODENOSCOPE MDRS
DR REDDY'S LABS, ANDHRA PRADESH, INDIA - FTO 7 ORAL
SOLID INJ FROMULATIONS 483
JANSSEN PIIARMS - LEVAQUIN (LEVOFLOXACIN) NDA 020-
634/.004,012.013, ETC LABELS CERTIFIED
NDA 205747
HOUCHIN COMMUNITY BLOOD BANK, BAKERSFIELD, CA - EIR
01/01/2013 - 06/01/2015
K143022, K100985, K093321 ETC
AERS DATA
K142919
K925699
MEGESTROL ACETATE - AERS
K974280, K961381, K961382 ETC
K971861
MINDRAY DS USA, INC, MAHWAH, NJ - EIR 06/01/2012 -
03/10/2015
K132612
WOCKHARDT, INDIA - 483 01/01/2015 - 05/29/2015
CLOSED FOIA REQUESTS 5/4-9/15
CLOSED FOIA REQUESTS 5/11-16/15
CLOSED FOIA LOG 5/18-23/15
CLOSD FOIA REQUESTS 5/11-15/15
FOI DAILY LOG 4/20-25/15
K033333
FOI DAILY LOG 4/27/15-5/2/15
CLOSED FOIA REQUESTS 5/4-8/15
CLOSED FOIA REQUESTS 5/11-15/15
CLOSED FOIA REQUESTS 5/18-22/15
FOI DAILY LOG 4/20-24/15
FOI DAILY LOG 4/27/15-5/1/15
FOI DAILY LOG 4/20-24/15
FOI DAILY LOG 4/27/15-5/1/115
FOI DAILY LOG 4/20-24/15
FOI DAILY LOG 4/27/15-5./1/15
FAP 9A3441
CLOSED FOIA REQUESTS 5/4-8/15
CLOSED FOIA REQUESTS 5/11-15/15
CLOSED FOIA REQUESTS 5/18-22/15
FOI DAILY LOG 4/20-24/15
FOI DAILY LOG 4/27/15-5/1/15
CLOSED FOIA REQUESTS 4/27/15-5/1/15
CLOSED FOIA REQUESTS 5/4-8/15
CLOSED FOIA REQUESTS 5/18-22/15
FOI DAILY LOG 4/20-24/15
FOI REQUESTS 4/20-24/15
YOUNG VETERINARY RESEARCH SERVICES, TURLOCK, CA -
483 02/19/2013 - 03/18/2013
FOI DAILY LOG 5/4-9/15
FOI DAILY LOG 5/11-16/15
FOI DAILY LOG R5/18-23/15
FOI DAILY LOG 4/20-25/15
FOI DAILY LOG 4/27/15-5/2/15
FOI DAILY LOG 5/4-8/15
FOI DAILY LOG 5/11-15/15
FOI DAILY LOG 5/18-22/15
FOI DAILY LOG 5/4-8/15
FOI DAILY LOG 5/11-15/15
FAP 6A4763
FOI DAILY LOG 5/18-22/15
CLOSED FOIA REQUESTS 4/27/15-5/1/15
FOI DAILY LOG 5/4-8/15
FOI DAILY LOG 5/11-15/15
FOI DAILY LOG 5/18-22/15
FOI DAILY LOG 4/27/15-5/1/15
FOI DAILY LOG 5/4-8/15
FOI DAILY LOG 5/11-15/15
FOI DAILY LOG 5/18-22/15
FOI DAILY LOG 5/4-8/15
K874106
FOI DAILY LOG 5/11-15/15
FOI DAILY LOIG 5/18-22/15
CLOSED FOIA REQUESTS 4/20-24/15
CLOSED FOIA REQUESTS 4/27/15-5/1/15
FOI DAILY LOG 4/27/15-5/1/15
FOI DAILY LOG 5//4-8/15
FOI DAILY LOG R5/11-15/15
FOI DAILY LOG 5/18-22/15
CLOSED FOIA REQUESTS 4/20-24/15
CLOSED FOIA REQUESTS 4.20-24/15
BIRTH CONTROL DRUGS - AERS DATA
ALLI, XENICAL - AERS
COOK UROLOGICAL INC, KARL STORZ, FEMRX/JOHNSON &
JOHNSON - POWER MORECELLATOR 510K, ADVERSE EVETNS
01/01/1991 - 05/31/2015
VAERS RECS
FOIA LOG 01/01/2006 - 06/30/2015
ZARBEE'S INC - WARNING LETTER RECS, LABELING RECS
TOTAL NUMBER OF FORMS 2253 RECEIVED BY OPDP BY YEAR
2012-2014
CEMPRA PHARMACEUTICAL INC CEM-101 - AERS
ZARBEE'S - COMMUNICATIONS WITH FDA RE WARNING
LETTER, LABELING
2015-2719
REPORTS OF UNDECLARED ALLERGENS IN FOODS 01/01/2013
- 05/29/2015
LIST OF INSPECTIONAL OBSERVATIONS DATA 01/01/2005
- 05/30/2015
K041269
SUN PHARMACEUTICALS INDUSTRIES LTD - CORR WITH FDA
01/02/2014 - 06/01/2015
2015-3974
EVOTAZ (ATAZANAVIR, COBICISTAT), GLYXAMBI
(EMPAGLIFLOZIN, LINAGLIPTIN), ETC AERS
K142458
510K SUBMISSIONS FOR AUTOMATED ENDOSCOPE
REPROCESSORS REFERENCED IN FDA EXECUTIVE SUMMARY
01/01/2009 - 05/31/2015
2015-2801
2015-2883
2015-3266
2015-2890
2015-2913
K053340
2015-2920
2015-2694
2015-315
2015-1520
2015-2966
2015-1526
2015-2698
2015-1744
2015-2116
2015-2114
FINAL REPORT OF CFSAN NUTRITION REVIEW 12/01/2014 -
12/31/2014
2015-2566
2015-2204
2015-2203
ICLUSIG - AERS
TECFIDERA - 5 YEAR NEW CHEMICAL ENTITY EXCLUSIVITY
RECS
JACOBS TOBACCO COMPANY - SE REPORTS
IND 47776
ANDA 203967 APPROVAL LETTER
FLUOROURACIL - AERS
NDA 20272
HOSPIRA, MCPHERSON, KS - 483, WARNING LETTERS,
RESPONSE LETTERS 01/02/2014 - 06/03/2015
2015-3644
K030802
ST JUDE MEDICAL INC OR ADVANCED NEUROMODULATION
SYSTEMS INC - ANS'S TRIPOLE 16 LAMITRODE PADDLE
LEAD P010032/S026 APRVL, LBLG CHANGES
ANDA 203005
K100786
PACIRA PHARMS - EXPAREL APRVL MTG MINS 3/15, 4/15
IND 45228
GANAXOLONE IND RECS
VONNIE'S GREENS - COMPLAINT 140664
K042228
NDA 020622, ANDA 090218
OTSUKA PHARMACEUTICAL CO LTD - ABILIFY NDA 202-
971/S003 SBA
ANDA APPROVAL LETTERS
VELOXIA PHARMS - ENVARSUS XR (TACROLIMUS) TABS NDA
206-406 3 YR EXCLUSIVITY DECISION
PALL BIOMEDICAL PRODUCTS CO - BLOOD TRANSFUSION
MICROFILTER K960993
PSYCHEDELIC AND MIND ALTERING SUBSTANCES - RECS
K943272
K030834
FULL LIST OF HUMAN DRUG SUBSTANCES REFERENCED IN
CFR TITLE 21 I a
TURKANA FOOD, KENILWORTH, NJ - INSP 3/31/15 TO
6/18/15
DICLOFENAC SODIUM ANDA
ELITE MEDICAL SUPPLY, NY - INSP 8/8-14/14,
INVESTIGATIONS
VELOXIS PHARMACEUTICALS - ENVARSUS XR NDA 06-406
OTSUKA PHARMACEUTICAL COMPANY LTD - ABILIFY
MAINTENA KIT (ARIPIPRAZOLE) NDA 02-971/S-003 SBA
CFSAN FOIA REQUESTS 05/22/2015 - 06/22/2015
MIRENA REPORT 68420195
PYRAMID LABORATORIES - 483 05/22/2015 - 06/08/2015
COLOR ADDITIVE PETITION FOR CHROMIUM-COBALT-
ALUMINUM OXIDE
GILEAD SCIENCES, INC, FOSTER CITY, CA - 483 OCT
2013
CAPTEK SOFTGEL INTERNATIONAL, CERRITOS, CA - 483
11/01/2014 - 02/28/2015
LIST OF ICE CREAM MANUFACTURERS 01/01/2015 -
06/22/2015
PROPOSED TEMPLATE FOR PACKAGE INSERTS FOR
IMMUNOHISTOCHEMISTRY PRODUCTS 01/01/1994 -
12/29/1994
METHOTREXATE - AERS
K121765
2015-4489
BLA 125084 APPROVAL RECS
ZOLL LIFECOR CORPORATION - RESPONSE TO WARNING
LETTER 10/02/2014 - 06/26/2015
GILENYA - AERS
AARTI DRUGS LTD, PAN DRUGS LTD - IMPORT ALERTS
01/01/2015 - 06/01/2015
K030254
TOPIRAMATE - AERS
SYNACTHEN (TETRACOSACTIDE) - IND OR NDA RECS
K082057
FCN 1440
K130802
INVESTIGATION RECS 02/18/2015 - 06/26/2015
NADA 065178
INDIVIDUAL RECS 01/01/2014 - 06/26/2015
PHOTOMEXEX, CARLSBAD, CA - 483 06/16/2015 -
06/16/2015
BNF0035
INTEGRA LIFE SCIENCES, VISTA, CA IRVINE, CA - 483,
WARNING LETTER, CORR ETC WITH FDA 01/01/2012 -
06/26/2015
510K SUBMISSIONS RE BONE CEMENT, POLY (METHYL-
METHACRYLATE), CALCIUM PHOSPHATE, PMMA 01/01/2002 -
06/25/2105
HP ACTHAR GEL (REPOSITORY CORTICOTROPIN INJ)/ACTH -
SAFETY OR EFFICACY RECS
CLOSED FOIA rEQUESTS 6/8-12/15
FOI DAILY LOG 6/8-12/15
FOI DAILY LOG 6/8-12/15
CLOSED FOIA REQUESTS 6/8-12/15
FOI DAILY LOG 6/8-12/15
FOI DAILY LOG 6/8-12/15
FOI DAILY LOG 6/8-12/15
CLOSED FOIA REQUESTS 6/8-12/15
FOI DAILY LOG 6/8-12/15
CLOSED FOIA REQUESTS 6/8-13/15
ACTHAR GEL-SYNTHETIC NDA 17-861 - SBA
FOI DAILY LOG 6/8-13/15
TOPAMAX NDA 20-505, 20-844 - ISR 10343305,
10264856, 10193000, ETC
MEDTONIC SOFAMOR DANEK - BONE FRAGMENTOR Z-0176-
2007 (CERTIFIED)
MEDTRONIC INC (MEDTONIC SOFAMOR DANEK) - BONE
FRAGMENTOR LTR 11/21/06 (CERTIFIED)
IMIQUIMOD - AERS
STUART PRODUCTS INC - VITAL E-A+D - DENIAL OF
RECONDITIONING PROPOSAL
GERRESHEIMER - USE OF GLASS TUBING IN
PHARMACEUTICAL PARENTERAL PREPARATIONS CORR, MTG
MINS, REGULATORY OPINIONS, ETC 1/10 TO PRESENT
USE OF GLASS TUBING IN PHARMACEUTICAL PARENTERAL
PREPARATIONS - CORR, MTG MINS, REGULATORY OPINIONS,
ETC 1/10 TO PRESENT
CPT 1500317, CPT 1500035
ENTRY D01-0850007-1
AMERICAN SUGAR REFINING, BALTIMORE, MD - EIR, 483
DAPAGLIFLOZIN ETC - APPROVAL RECS
K142335
K131402
ANDA 203399 APPROVAL LETTER
CONCERTA - PRESCRIBER INFORMATION CERTIFIED
ETHICON - MORCELLATOR HYSTERECTOMY SURGICAL TOOLS
TRANS, RPTS, MDRS, ETC
KARL STORZ ENDOSCOPY OF AMERICA KARL STORZ GMBH -
MORCELLATOR HYSTERECTOMY SURGICAL TOOLS TRANS,
MDRS, COMM, ETC
BELMORA LLC, ARLINGTON, VA - LIDOCAINE 5% ANDA 80-
210 APRVD APPL
COUGH & COLD PREPARATIONS - ISRS 91691343,
94455812, 96810154, ETC
ATEECO INC - AUDITS 2000 TO PRESENT
K131799
FINASTERIDE, PROSCAR, PROPECIA - CITIZEN'S
PETITIONS , RESP 2010-2011
BASIC BOX - SE00009416 BASIC SOFT PACK -
SE00009424 MARLBORO BOX - SE00009412, ETC
SUBSTANTIAL EQUIVALENCE REVIEVER'S SUMMARIES
DR LAURA JAMES - INSPECTION RECS 05/27/2008 -
05/27/2008
AZATHIOPRINE/IMURAN - AERS
MAESTRO RECHARGEABLE SYSTEM - FDA SPONSORED PATEINT
PREFERENCES SURVEY 01/01/2014 - 01/14/2015
IND VX-770
787625 855170 855171 ETC - SAMPLE RECS
RECS RE MACROBIOTIC DIET 01/01/1950 - 01/01/1980
KETOROLAC - AERS
CITRULLINE - AERS
SUN PHARMA FACILITY, INDIA - 483 06/01/2015 -
07/14/2015
870302 SAMPLE RECS
Tobacco listings & registrations 08/01/2014 to
present
K142946
EMCURE PHARMACEUTICALS LIMITED, INDIA - 483
02/01/2014 - 02/10/2014
FAP 2267
SUN PHARMA INDUSTRIES, INDIA - 483 05/19/2015 -
07/14/2015
ABILIFY - APPROVAL RECS
K063873
SYNGENE INTERNATIONAL, LTD, INDIA - EIR 09/16/2013
- 07/11/2014
FDC LIMITED, INDIA - 483, WARNING LETTER 01/01/2012
- 07/14/2015
K033998
K101128
ROCK STAR, ROCKSTAR - ADVERSE EVENTS 01/01/1997 -
12/31/2013
MSN LABORATORIES PRIVATE LIMITED, INDIA - 483,
WARNING LETTER 01/01/2012 - 07/14/2015
SUPRIYA LIFESCIENCES LTD, INDIA - 483, WARNING
LETTER 01/01/2012 - 07/14/2015
CHEMPRO PHARMA PRIVATE LIMITED, INDIA - 483,
WARNING LETTER 01/01/2012 - 07/14/2015
TMJ SOLUTIONS, INC TMJ MEDICAL BIOMET, LLC
MICROFIXATION LLC - 483
REPORTABLE FOOD REGISTRY RECS 01/01/2014 -
07/01/2015
CELECOXIB - AERS
INDOMETHACIN - AERS
IBUPROFEN - AERS
KETORLAC - AERS
COMM BTWN FDA OFFICALS WHICH CONTAIN DISCUSSIONS
MENTIONING OR REFERRING TO AN EXPEDITED PATHWAY TO
A PRVL FOR ALS DRUGS 5/15 TO PRESENT
MELOXICAM - AERS
METHYENE BLUE - AERS 6/1/14 TO PRESENT
LUPIN PHARMA, GOA, INDIA - 483 JULY
ELAN CZELSER NEW YORK UNIV- CORR 1/14 TO PRESENT
RHONE-POULENC - TAXOTERE NDA 20-449 SBA
K071513
ENCHANEMENT MEDICAL LLC - EXPRESSION DVC LISTINGS,
DVC ESTABLISHMENT REGISTRATIONS, MDRS, ETC
WIL RESEARCH, ASHLAND, OH - EIR, 483 3/15 NON-
REDACTED
FLORIDA HOSP - TRANSFORM (NCT 01700439) STUDY
FOLLOW-UP RPT 7/28/14-8/1/14
TIANJIN JIANFENG NATURAL PRODUCT R&D - POLYONUM
CUSPIDATURM EXTRACT CUSTOMS ENTRY NUMBER, NOTICES
OF ACTION, ANALYTICAL RPT, ETC
DKT FDA-2010P-0091 - TRANS, MINS, RPTS, ETC
INCIDENTS OF FATAL ENCOUNTERS INVOLVING OCI 1/00 TO
PRESENT
INDIVIDUAL RECS
INDIVIDUAL RECS
FCN 1490
HUMAN BIOLOGICS OF TEXAS LTD, SAN ANTONIO, TX - EIR
02/25/14, 05/25/12
K083227
DIAGNOSTIC TEST WORKING GROUP - MTG MINUTES, MEMOS,
CORR ETC 10/01/2014 - 07/23/2015
FOIA REQUESTS RE CATALENT, INC, CATALENT PHARMA
SOLUTIONS, LLC, CATALENT PHARMA SOLUTIONS APRILLA
ETC 07/01/2014 - 07/22/2015
ENTRY 916-2707562-4
BLOOD BANK OF ALASKA - COOR WITH FDA RE
DEFICIENCIES IDENTIFIED IN 1994 DIOR SUBMITTED TO
BBOA 07/01/1993 - 07/22/2015
DIETARY SUPPLEMENT FIRMS - STATUS OF INJUNCTIONS
ENTRY 916-2708251-3
LT CMDR COLBURN - RECS RE SERVICE ON OUTSIDE BOARDS
OF DIRECTORS 01/01/2012 - 07/22/2015
RECALLS, MARKET WITHDRAWALS, SAFETY ALERTS -
01/01/2000 - 07/22/2015
DAVID BRANCATO - RECS RE DEBARMENT, TERMINATION OF
DEBARMENT, ETC Date Range: 01/01/1988 - 07/22/2015
BELVIQ - AERS
K022013
K882802
ANDA 204403 TENTATIVE APPROVAL
AURYXIA - AERS
K073023
LAMPRENE - NDA RECS
BELVIQ - AERS
TEKTURNA, VALTURNA - AERS
SYNGENE INTERNATIONAL LTD, INDIA - EIR 06/23/2014 -
07/17/2015
NDA 20629
BLINATUMOMAB - MEDWATCH REPORTS
EKOSONIC MACH 4 ENDOVASCULAR DVC, EKOSONIC CONTROL
UNIT K140151
TESAMORELIN - AERS
HESPERIDIN AERS
A copy of any decisions or memoranda issued by the
CDER Exclusivity Board in calendar year 2015
Company Response Letter to the FDA's warning letter
to Innovative BioDefense, which was issued June 30,
2015
LABS IN CHINA, INDIA - INSPECTION REPORTS SHOWING
VIOLATIONS AT CANADIAN PHARMACEUTICAL COMPANIES
07/01/2013 - 07/30/2015
ANDA 08606
RESTAURANT RECYCLING SERVICES, FREMONT, MI - 483,
EIR, CORR
AIR LIQUIDE HEALTHCARE AMERICA CORP,
PLUMSTEADVILLE, PA - 5/18-16/15 ULTRA SONICS INC,
IVYCAND, PA 49-25/15, ETC 483S -
NORTHWEST LOUISIANA EYE BANK - WARNING LETTER, 483
01/23/2012 - 01/23/2015
NDA 18790
CINCINNATI EYE BANK FOR SIGHT RESTORATION - WARNING
LETTER, 483 01/23/2012 - 01/23/2015
NDA 020599
QUINCY BIOSCIENCE - ATTACHMENTS, EXHIBITS CITED IN
CORR WITH FDA I
PERIPHERAL & CENTRAL NERVOUS SYSTEM DRUGS ADVISORY
COMMITTEE TRANSCRIPT FOR RILUTEK 9/18/95
GAZYVA - AERS
K061855
K143236
GAS-X ULTRA AERS
LE-VEL - NEW DIETARY INGREDIENT APPLICATIONS FOR
THRIVE
K14228
K052931, K070173
THE IMPORT ALERT LETTER SENT TO IPCA LABORATORIES
FOR RATLAM FACILITY, INDIA
K14228
LUPIN, GOA, INDIA - 483 07/01/2015 - 07/31/2015
NOVARTIS VACCINES AND DIAGNOSTICS LIMITED, UK -
483, EIR 6/11/15
CATALENT PHARMA SOLUTIONS, BELGIUM - 483, EIR
5/28/15
PATHEON ITALIA SPA, ITALY - EIR, 483 6/4/15
INVENTIV HEALTH CLINIQUE, QUEBEC CITY, CANADA - EIR
12/15-19/14
PHARMA NET CANADA INC, QUEBEC, CANADA - EIR 8/6-
10/12
ARC CLEANER - PURPOSE, USE
ENTRY NO 13-054459700
94P-0208-CP, PAV,CI
ANDA A202044
MIRTAZAPINE - AERS
LIFESHARE BLOOD CENTERS - EIR 01/03/2013 -
07/31/2014
MAUDE REPORT RECS 1219930-2012-00737
ANDA 040630
2015-5498
K141219
K133858
K984550
K12297 K132423
K083070
K043248
XARELTO - AERS
ALCON RESEARCH LTD, LAKE FOREST, CA - EIR 9/10-
16/14
FDA-ORA-15-DE-1226627EW, FDA-ORA-15-MP-1226649WW
GLYCERIN TRADERS OF LAPORTE, IN - 483, EIR, WARNING
LETTERS ETC 08/01/2014 - 08/12/2015
CARTER COUNTY, KY INVESTIGATION OF TAMPERING -
INVESTIGATION RECS 01/05/2012 - 08/12/2015
INTUITIVE SURGICAL - WARNING LETTERS 01/01/1996 -
08/12/2015
ZIMECTERINE GOLD - AERS
AVINZA - AERS
916-2707794-3
SUBSYS - AERS
PROPECIA - AERS
CPT1500543
DAVIDOFF CIGARETTE BRANDS - RECS RE GRANDFATHERED
DETERMINATION
BLOOD CENTERS, SHREVEPORT, LA - EIR 01/01/2011 -
12/31/2015
LES IMPORTATIONS HERBASANTE INC, MONTREAL, CANADA -
EIR
INTUITIVE SURGICAL DEVICES INC - ROBOTIC SURGICAL
SYS CMPLNTS, AER
SWISS MEDICAL CARE - CT EXPRESS III K062265
ENTRY NO 9P3-0012713-7
INDIVIDUAL RECS
2015-5955
LUPIN BIORESEARCH CENTER, PUNE, INDIA - EIR
E Z EM INC - EMPOWER CTA INJECTOR SYS K031571
E Z EM INC - EMPOWER CTA INJECTOR SYS K071378
BRACCO INJENEERING SA - BROCCO INJENEERING TRANSFER
SET K133147
K080816, K081162
NAVILYST MEDICAL INC - NAMIC RCS SYRINGE K140194
CANONICA VERDE ITALIAN HONEY, BOSTON, MA -
INSPECTIONS, CMPLNTS, RPTS 2010-2014
IMPAX LABORATORIES, HAYWARD, CA - EIR 5/15
2015 DIETARY GUIDELINES A/C - AMERICAN EGG BOARD
AND THE EGG NUTRITION CENTER RECS
FOOD AND DRUG ADMINISTRATION MODERNIZATION ACT
(FDAMA) NUTRIENT CONTENT OR HEALTH CLAIM
NOTIFICATIONS THAT HAVE BEEN REJECTED
WONTON FOODS INC - MUNG BEAN SPROUT SALMONELLA
ENTERIDITIS OUTBREAK 9/30/14-12/15/14 RECS
SANOFI, SWIFTWATER, PA - 483S 2008, 2009
INFED (IRON DEXTRAN) - AERS, HEALTHCARE FACILITIES
INNOVATIVE OPHTHALMIC PRODUCTS INC - MOLTENO
IMPLNAT K890598, MOLTENO GALUCOMA IMPLANT K902489
SUMMERLIN HOSPITAL MEDICAL CENTER, LAS VEGAS, NV -
TUBERCULOSIS OUTBREAK RECS, RPTS, INVESTIGATION,
ETC 2013
K100272, K012349
DOCTOR-FREE DIAGNOSTICS SYSTEMS - APRVL,
PROCEDURES, POLICIES, ETC
ETHICON MORCELLATOR - RECORDS PREVIOUSLY RELEASED
UNDER FOIA
GYRUS ACMI MORCELLATOR - RECS PREVIOUSLY RELEASED
UNDER FOIA
FAERS DATA
FOODSERVICE PARTNERS, SOUTH SAN FRANCISCOM CA - EIR
08/05/2015 - 08/06/2015
OXYELITE - MEDWATCH REPORTS 01/01/2013 -
08/31/2015
DRUG MASTER FILE SPREADSHEET 01/01/2010 -
12/31/2012
UNION QUIMICO FARMACEUTICA SA, SPAIN - EIR
NEWBORN BLOOD BANKING INC - CORRECTION OF
VIOLATIONS 02/23/2010 - 08/03/2015
INTUITIVE SURGICAL ENDOSCOPIC INSTRUMENT CONTROL
SYSTEM - ADVISORY COMMITTEE TRANSCRIPT 11/01/2000 -
11/30/2000
K900770
K881577
BRAVECTO - AERS
SCHWARTZBERG, LEE S, MEMPHIS, TN - 483 02/18/2005 -
03/08/2005
K930933
CYNTHIA STROUT, COASTAL CAROLINA RESEARCH CENTER,
PLEASANT, SC - EIR, 483, RESPONSE 04/27/2015 -
04/30/2015
BAXTER HEALTHCARE CORPORATION, CLEVELAND, MS - EIR,
483, RESPONSE 01/07/2014 - 01/23/2014
NOELLE FREY, UNIVERSITY OF PENNSYLVANIA,
PHILADELPHIA, PA - EIR, 483, RESPONSE 11/03/2014 -
11/12/2014
LI NYI CITY KANGFA FOODSTUFF DRINKABLE CO LTD,
LINYI CITY, CHINA - ENTRY F5-9326871-1 UNREDACTED
INFIXIMAB - AERS
NDA 18276 CLINICAL TRIAL DATA
2015-6229 & 2015-6230 - REQUEST LETTER(S) ONLY
2015-6368 - REQUEST LETTER ONLY
ANDA 090962, ANDA 091314, ANDA 200298
2015-6239 - REQUEST LETTER ONLY
ANDA 040557 ANDA 078711 NDA 014901 ETC
DKT FDA-2015-P1090
FCN No. 1370, FCN No. 1400, FCN No. 1421
23 AND ME - LIST OF PREVIOUS FOIA REQUESTS
DORYX TABS NDA 50-795/S019 - RECS
WALGREENS INFUSION SERVICES - MEDWATCH REPORT
01/01/2015 - 08/17/2015
FLYING FOOD GROUP, 121 INFLIGHT CATERING, EXECUTIVE
CUISINE, ETC - EIRS, 483S 1/15 TO 8/15
SODIUM THIOPENTAL - IMPORT RECS, CORR, RPTS, ETC
DRUG LISTINGS NOT CURRENTLY POSTED ON THE NATIONAL
LIBRARY OF MEDICINE (NLM) WEBSITE - LABELER CODES,
ESTABLISHMENT REGISTRATIONS
USPLABS LLC - 1,3-DIMETHYLAMYLAMINE HCI (DMMAA),
AEGELINE INSPS, TEST RESULTS, INVESTIGATIONS, ETC
FENWAL INTERNATIONAL INC, HAINA SAN CRISTOBAL,
DOMINICAN REPUBLIC - EIR 2/26/01-3/2/01
NATIONAL BIOLOGICAL CORP, BEACHWOOD, OH - EIR 3/26-
13-4/4/13
ASHFIELD POLICE DEPT #1394767 DUNS #968259601
CMPLNT #138430
CYTORI THERAPEUTICS - PREVIOUS FOIA REQUESTS
01/03/2013 - 01/20/2015
CLOSED FOI REQUESTS 8/3-7/15
CLOSED FOI REQUESTS 8/3-7/15
CLOSED FOI REQUESTS 8/3-7/15
CLOSED FOI REQUESTS 8/3-7/15
FOI DAILY LOG 8/3-7/15
FOI DIALY LOG 8/3-7/15
FOI DIALY LOG 8/3-7/15
FOI DAILY LOG 8/3-7/15
FOI DIALY LOG 8/3-7/15
FOI DIALY LOG 8/3-7/15
CORBION CARAVAN, LENEXA, KS - EIR, 483, RESPONSES
ETC 01/01/2010 - 01/27/2015
FOI DAILY LOG 8/3-7/15
INTUITIVE SURGICAL, INC - 483 PREVIOUSLY RELEASED
UNDER FOIA 01/01/1996 - 08/12/2015
INTUITIVE SURGICAL, INC - EIR PREVIOUSLY RELEASED
UNDER FOIA 01/01/1996 - 08/12/2015
INTUITIVE SURGICAL, INC - 510K PREVIOUSLY RELEASED
UNDER FOIA 01/01/1996 - 08/12/2015
K981916
2015-6301 - REQUEST LETTER ONLY
2015-6002 - REQUEST LETTER ONLY
2015-5892 - REQUEST LETTER ONLY
2015-6366 - REQUEST LETTER ONLY
2015-6280 - REQUEST LETTER ONLY
COMPLAINT FOR FORENSIC USE ONLY - PREMIER BIOTECH
01/01/2014 - 01/11/2015
2015-6238 - REQUEST LETTER ONLY
2015-6060 - REQUEST LETTER ONLY
2015-6184 - REQUEST LETTER ONLY
2015-6034 - REQUEST LETTER ONLY
2015-6345 - REQUEST LETTER ONLY
2015-6038 - REQUEST LETTER ONLY
2015-6365 - REQUEST LETTER ONLY
2015-6281 - REQUEST LETTER ONLY
2015-6017 - REQUEST LETTER ONLY
2015-5841 - REQUEST LETTER ONLY
PHARMACYCLICS, INC, SUNNYVALE, CA - CORR 07/01/2014
- 01/27/2015
2015-5886 - REQUEST LETTER ONLY
2015-6420 - REQUEST LETTER ONLY
2015-5890 - REQUEST LETTER ONLY
STAR OF THE WEST MILING CO, VASSAR, MI - 483, EIR,
WARNING LETTER ETC 08/01/2014 - 08/17/2015
CARGILL INCORPORATED, HERSEY, MI - 483, EIR,
WARNING LETTER ETC 08/01/2014 - 08/17/2015
WALCOTT ELEVATOR, ALLENDALE, MI - 483, EIR, WARNING
LETTER ETC 08/01/2014 - 08/17/2015
OCEANA COUNTY FREEZER STORAGE, INC, SHELBY, MI -
483, EIR, WARNING LETTER ETC 08/01/2014 -
08/17/2015
MEIJER DISTRIBUTION INC, LANSING, MI MEIJER
DISTRIBUTION INC, HOLLAND, MI - 483, EIR, WARNING
LETTER ETC 08/01/2014 - 08/17/2015
ADM GRAIN CO, GRAND LEDGE, MI - 483, EIR, WARNING
LETTER ETC 08/01/2014 - 08/17/2015
CONAGRA FOODS, BATTLE CREEK, MI - 483, EIR, WARNING
LETTER ETC 08/01/2014 - 08/17/2015
NDA 203629 LABEL
KRUGER COMMODITIES, HAMILTON, MI - 483, EIR,
WARNING LETTER ETC 08/01/2014 - 08/17/2015
LIST OF INSPECTIONS 3/15/15 THROUGH 8/15/15
AIRGAS MERCHANT GASES, LAWTON, OK - EIR 08/01/2014
- 08/31/2014
BLOODCENTER OF WISCONSIN, INC, MILWAUKEE, MN - EIR
09/08/2014 - 09/19/2014
NOVEN THERAPEUTICS, LLC --DAYTRANA PATCH
(METHYLPHENIDATE TRASDERMAL SYS) ISR 596412,
6016219, 6717714, ETC
NOTIFIER HEUBACH COLOUR PVT LTD - FCN 1231
SUDARSHAN CHEMICAL INDUSTRES LTD - FCN 1280 SUN
CHEMICAL CORP - FCN 1311
INDIVIDUAL RECS (CERTIFIED)
STRYKER INSTRUMENTS SYSTEM 6 ASEPTIC HOUSING - HHE
STRYKER INSTRUMENTS FLYTE TOGA - HHE
STRYKER INSTRUMENTS UNIVERSEAL CHARGER - HHE
K150271
GREEN VALLEY HERBS, SAN MARCOS, MA - INSPECTION
RECS 06/02/2014 - 08/26/2015
RAPID IDENTIFICATION OF COLOR ADDITIVES, USING THE
C18 CARTRIDGE, COLLABORATIVE STUDY
ANDA 062305, ANDA 062364
UNITED PARCEL SERVICE, LIPOMED AG - SODIUM
THIPENTAL IMPORT RECS 8/13 TO 1/14
DR JAMES PEARLE, FULLER, CA 5/19/15-6/11/15 DR
LEONARD DUNN, CLEARWATER, FL 7/2-10/15 - 482S,
483S, EIRS, ETC
INDIVIDUAL RECS
UNETTE CORPORATION, WHARTON, NJ - EIR, 483
01/01/1995 - 01/01/2009
TRASTUZUMAB EMTANISE - AERS
ACTIVE PHARMACEUTICAL INGREDIENTS IDENTIFIED IN
WARNING LETTERS 10/01/2012 - 08/23/2015
K050418, PS130035, PS130035
MEFLOQUINE - ORPHAN DESIGNATION RECS
MELALEUCA - AERS
2014-9406 - REQUEST LETTER
K142827
EIR FOR TISSUE ESTABLISHMENTS IN STATE OF ILLINOIS
LAST FIVE YEARS
OSTOSPRAY - AERS
JEFFREY LEVINE - DEBARMENT RECS
HOSPIRA - RESPONSE TO WARNING LETTER
LIST OF ESTABLISHMENTS 07/01/2015 - 08/15/2015
ADVANCE PHARMACEUTICALS INC - RECALL RECS RE
FERROUS SULFATE TABLETS 09/01/2012 - 09/01/2013
DRUGS WITHDRAWN, DISCONTINUED 01/01/2004 -
08/24/2015
ANDA 202161 SBA
STRIDES ARCOLAB, GLENMARK - WARNING LETTERS, 483
08/01/2010 - 08/24/2015
2014-9617 - REQUEST LETTER
AMERICAN RED CROSS NEW YORK-PENN REGION - EIR
09/09/2013 - 09/13/2013
MIRALAX - AERS
IBUPROFEN - AERS
CEPHALEXIN - AERS
TRILLIUM FARMS, LLC, LA RUE, OH - 483, EIR, WARNING
LETTER 08/01/2014 - 08/24/2015
886961 SAMPLE RECS
884177 SAMPLE RECS
787625 SAMPLE RECS
884180 SAMPLE RECS
884179 SAMPLE RECS
2014-9654 - REQUEST LETTER
MEGA ELECTRONICS LTD, KUOPIO, FINLAND - EIR 2013,
2015
MINOCYCLINE HYDROCHLORIDE - AERS
ADVANCED TESTING LABORATORY INC, CINCINNATI, OH -
INSP RECS, CORR, WARNING LTR 10/12/10, ETC
ASTRAZENECA PHARMS - NDA 21-153, NDA 21-957, NDA
22-101, ETC RPTS, STUDIES, MEMOS, ETC
CONNAUGHT - LYMERIX PHASE I, II, III, IV TRIALS,
AERS, INDIVIDUAL RECS, ETC
CIPRO - AUTOIMMUNE DISORDERS RECS
GROCERY MANUFACTURERS ASSN - FAP FOR USES OF
PARTIALLY HYDROGENATED VEGETABLE OILS (PHO) IN OR
ON SELECT FOODS
IRSOGLADINE MALEATE - APRVL RECS, AERS, COMPLIANCE
HISTORY, ETC
K022156
K021875
2014-9796 - REQUEST LETTER
HOG SLAT, INC, CAMDEN, IN - EIR, 483, WARNING
LETTER 08/01/2014 - 08/24/2015
PMA P050052
DR ELLEN MARMUR, NEW YORK, NY - 483, EIR 12/29/2014
- 01/08/2015
PROLIA - AERS
K873996, K873996
K002488
FCN 116
NDA 202806
RECS RE REMOVAL OF THE IMPORT REFUSAL REPORTS FOR
ENTRIES 417-0297648-5/1/1, 417-0297648-5/2/1, 417-
0297648-5/3/1, and 417-0297648-5/4/1
ATIQ ABUBAKAR DURRANI, MD - REPORTS, WARNING
LETTERS ETC 01/01/2005 - 01/29/2015
NDA 204114
NDA 206995
RECALL AUDIT CHECK REPORT CALCIUM CHLORIDE 10%
09/10/2015 - 09/10/2015
GILENYA - AERS
SE0003441, SE0003442, SE0003443, ETC
K103540
IND068391
K991926
K091757, K122744
CMS STUDY
PEG 3350 - AERS
CPT1400952
FIFTY SHADES OF GREY COME ALIVE PLEASURE GEL, LOVE
HONEY - RECS, 510K 01/01/2010 - 01/30/2015
CERNER CORP, KANSAS CITY, MO INDIA CANADA - 483S
2009 TO PRESENT
K974187
DRUG MANUFACTURING FACILITIES IN INDIA - EIR
01/01/2012 - 12/31/2013
SNOQUALMIE GOURMET ICE CREAM, SNOHOMISH, WA - LAB
RESULTS, COLLECTION REPORTS, CORR ETC 12/01/2012 -
12/30/2014
DE NOVO - DEXCOM SHARE DIRECT SECONDARY DISPLAYS
RECLASSIFICATION ORDER, DECISION SUMMARY
INVERSINE (MECAMYLAMINE HCL) NDA 10-251 - APRVL
RECS, DESI RVVS
IPCA LABORATORIES LTD, RATLAM (MADYA PRADESH),
INDIA - IMPORT ALERT
SCHERING LABORATORIES - NORMODYNE INJ (LABETOLOL)
NDA 18-686 PHARMACOKINETICS RECS
RESPIRE BLUE SERIES K111207 RESPIRE PINK SERIES
K131138
OTC VOLUME 070168, 070126, 070099, ETC
INDIVIDUAL RECS
TAXOL, TAXOTERE (DOCETAXEL) - AUTHORIZATION LABELS
ENDO PHARMS - AVEED (TESTOSTERONE UNDECANOATE) NDA
22-219 - ARPVL RECS
SADDLE CREEK CORPORATION - INSPECTION RECS, RECALL
RECS, REPORTABLE FOOD REGISTRY ETC 01/05/2012 -
01/05/2015
LUPRON INJ, MICRO-DOSE FLAIRE LUPRON INJ - AERS
HUMAN CHORIONIC GONADOTROPIN (HCG) INJ - AERS
REPRONEX, PERGONAL INJ - AERS
GONAL F INJ - AERS
ESTROGEN/ESTRADIOL INJ, VIVELLE ESTRADERM PATCHES -
AERS
MEDROL TABS - AERS
PROGESTERONE IN OIL, INJ, LOZENGES, SUPPOSITORIES -
AERS
ARIAD PHARMACEUTICALS, CAMBRIDGE, MA - EIR
09/01/2014 - 01/30/2015
AROMATHERAPY UNITED - COMPLAINTS, WARNING LETTER
RECS
CADILA HEALTHCARE LIMITED INDIA - 483 12/01/2014 -
12/07/2014
CIALIS - AERS
CADILA HEALTHCARE LIMITED, INDIA - 483 08/28/2014 -
09/05/2014
K133665
K991938
K141769
K141453
K093857
K141456
K133573
K133444
BENDAMUSTINE - AERS
K943250 SUMMARY
BENDAMUSTINE - AERS
I GAUGIN TRIAL - START DATE
CHENZHEN WOWTOU TECH CO LIMITED - LASER POINTER
REPORT 08/01/2014 - 02/01/2015
DR REDDY'S, ZYDUS CADILA - 483 01/01/2014 -
12/31/2014
RELIABLE PHARMACEUTICALS, ST LOUIS, MO - 483
03/02/2010 - 02/02/2015
2014-8455
2014-8392
2014-7238
2014-8301
K033761, K042231, K083091 ETC
K002154
2014-3411
2013-149
2014-8644
2014-8537
2014-7842
ZYDUS PHARMA - 483 09/02/2014 - 02/02/2015
FOI DAILY LOG 1/1-31/2015
2014-7821
A list of all FOIA requests closed 1/1-31/2015
NDA 020503
K002154 SUMMARY
CORTEF - NDA, CORR, SBA LETTER
CITALOPRAM - AERS 08/24/2011 - 12/31/2014
NATHAN BASS, UNIV OF CALIFORNIA, SAN FRANCISCO, CA
- EIRS, 483S, CO RESP 4/28/14-5/9/14
VILAVICIENCIO ALAN T, BOULDER, CO - EIRS, 483S, CO
RESP 5/21-6/05/14
MARK POLHEMUS, SUNY MEDICAL UNIV, SYRACUSE,, NY -
EIRS, 483S, CO RESP 5/28/14-6/11/14
AIRGAS USA LLC, EAST GREENWICH, RI - EIRS, 483S, CO
RESP 2/26/14
ALAN NIEDERMAN MD, FT LAUDERDALE, FL - EIRS, 483S,
CO RESP 9/15-10/16/09
K130874
BRAINLAB AG, GERMANY - EIR 06/21/2013 - 02/04/2015
K132560
FCN1169
ANNUAL PERFORMANCE RPT 2014
IND BB-6195
SYNEPHRINE - AERS, MEDWATCH 01/01/2011 -
02/03/2015
STAAR SURGICAL, MONROVIA, CA - EIRS 2/14 TO 3/14,
11/14 TO 12/14 COMM 11/14 TO 12/14
INDIVIDUAL RECS
PROZAC NDA 18-936 - RVWS, CORR
DCK 2014N-0168