FDA Foia Log Fy2015

Control# Recd Date Requester
2014-10000 12/23/2014 HURLEY, WENEEKE

2014-10001 12/23/2014 MORGAN LEWIS & BOCKIUS LLP
2014-10002 12/23/2014 GILMORE #344879, PERRY
2014-10003 12/24/2014 Vice News

2014-10004 12/24/2014 Invado Pharmaceuticals
2014-10005 12/24/2014 Keefe, Lynn
2014-10006 12/24/2014 Nivagen Pharmaceuticals, Inc.
2014-10007 12/24/2014 Newtyn Management

Fellers, Snider, Blankenship, Bailey &
2014-10008 12/24/2014 Tippens, P.C.
2014-10009 12/24/2014 FOI Services, Inc.
2014-10010 12/24/2014 FOI Services, Inc.
2014-10011 12/24/2014 IIFL Institutional Equities
2014-10012 12/24/2014 Powers Medical Devices (Pat Palmer, CEO)
2014-10013 12/24/2014 FOI Services, Inc.
2014-10014 12/24/2014 Medtronic Sofamor Danek USA
2014-10015 12/24/2014 Govzilla, Inc.
Eli Lilly and Company - Global Patient
2014-10018 12/24/2014 Safety
2014-10019 12/24/2014 BLOOMBERG NEWS
2014-10020 12/24/2014 Zydus Pharmaceuticals USA Inc.
2014-10021 12/24/2014 InnoPharma Licensing LLC
2014-10022 12/24/2014 AMBIT CAPITAL PVT LTD
2014-10023 12/24/2014 ACASTI PHARMA INC
2014-10024 12/24/2014 Mark Anderson & Associates, Inc.
2014-10025 12/24/2014 Kotak Securities
2014-10026 12/24/2014 FOI Services, Inc.

2014-10027 12/24/2014 ResMed Corp.
2014-10028 12/24/2014 CANARA ASSOCIATES INC.
2014-10029 12/24/2014 Malca, Joseph
2014-10030 12/24/2014 CANARA ASSOCIATES INC.
2014-10031 12/24/2014 Center for the Study of Empathic Therapy
2014-10032 12/24/2014 Doe J
2014-10034 12/29/2014 Eagan Avenatti

2014-10035 12/29/2014 Schidd Company
2014-10036 12/29/2014 Medtronic, Inc.
2014-10037 12/29/2014 Medtronic, Inc.

2014-10038 12/29/2014 Meyerson, Jack
2014-10039 12/29/2014 Medtronic, Inc.

2014-10040 12/29/2014 Boston Children's Hospital
2014-10041 12/29/2014 Medtronic, Inc.
2014-10042 12/29/2014 Medtronic, Inc.

2014-10043 12/29/2014 Malca, Joseph
2014-10044 12/29/2014 Prirista, Inc.
2014-10045 12/29/2014 Medtronic, Inc.
2014-10046 12/29/2014 Prirista, Inc.
2014-10047 12/30/2014 The Seattle Times

2014-10048 12/30/2014 OCT Medical Imaging Inc
2014-10049 12/30/2014 Doe J
2014-10050 12/30/2014 Immucor GTI Diagnostics, Inc.
2014-10051 12/30/2014 North Star Coating
2014-10052 12/30/2014 North Star Coating
2014-10053 12/31/2014 BEVERIDGE & DIAMOND PC
2014-10054 12/31/2014 Woodland Gardens LLC

2014-10055 12/31/2014 FOI Services, Inc.
2014-10056 12/31/2014 BIO-RAD LABORATORIES, INC.
2014-10057 12/31/2014 MMJ Labs

2014-10058 12/31/2014 Withings
2014-10059 12/31/2014 McDermott Will & Emery LLP

2014-7952 10/01/2014 FOI Services, Inc.
2014-7953 10/01/2014 JOHNSON MATTHEY
2014-7954 10/01/2014 MERCK & CO., INC.
2014-7955 10/01/2014 MERCK & CO., INC.
2014-7956 10/01/2014 MERCK & CO., INC.
2014-7957 10/01/2014 DOUGLAS C. ROGERS
Ferdic Inc. -- Publisher of Dickinson's
2014-7958 10/01/2014 FDA Webview
2014-7959 10/01/2014 MERCK & CO., INC.
2014-7960 10/01/2014 MERCK & CO., INC.
2014-7961 10/01/2014 Celltrion, Inc.
2014-7962 10/01/2014 BURGESS, BERNIE

2014-7963 10/01/2014 Soha & Lang, P.S.
2014-7964 10/01/2014 MERCK & CO., INC.
2014-7965 10/01/2014 HEALTHCOR MANAGEMENT LP
2014-7966 10/01/2014 Choate Hall & Stewart LLP

2014-7967 10/01/2014 MERCK & CO., INC.
2014-7968 10/01/2014 MERCK & CO., INC.
2014-7969 10/01/2014 MERCK & CO., INC.
National Institute of Securities Markets,
2014-7970 10/01/2014 Mumbai, India
2014-7971 10/01/2014 FOI Services, Inc.
2014-7972 10/01/2014 Young Dental Manufacturing
2014-7973 10/01/2014 East Bridge Capital Management Limited

2014-7974 10/01/2014 John Chapman
2014-7975 10/01/2014 FOI Services, Inc.
2014-7976 10/01/2014 MERCK & CO., INC.
2014-7977 10/01/2014 MERCK & CO., INC.
2014-7978 10/01/2014 Jing, Jimmy
2014-7979 10/01/2014 AbbVie, Inc.

2014-7980 10/01/2014 United States Endoscopy Group, Inc.
2014-7981 10/01/2014 PUBLIC CITIZEN

2014-7984 10/01/2014 ROBINS KAPLAN MILLER & CIRESI LLP
2014-7985 10/01/2014 ROBINS KAPLAN MILLER & CIRESI LLP
2014-7986 10/01/2014 MERRILL LYNCH
2014-7987 10/01/2014 MERRILL LYNCH

2014-7988 10/01/2014 CRUSER & MITCHELL LLP
2014-7989 10/01/2014 Doe J
2014-7990 10/01/2014 RIED GOODWIN
2014-7991 10/01/2014 GISKIT B V - RCRI INC
2014-7992 10/01/2014 SANOFI PASTEUR

2014-7993 10/01/2014 Toronto Star
2014-7994 10/01/2014 WILLS MD, STEPHEN L
2014-7995 10/01/2014 ROPES & GRAY
COLUMBIA UNIV GRADUATE SCHOOL OF

2014-7996 10/01/2014 JOURNALISM
2014-7997 10/01/2014 HARVIN, PETER
2014-7998 10/01/2014 SHOOK HARDY & BACON LLP

2014-7999 10/01/2014 NOVARTIS PHARMACEUTICAL CORP
2014-8000 10/01/2014 SANDERS, SANDERS & BLOCK
2014-8001 10/01/2014 ORLY ENTERPRISES

2014-8002 10/01/2014 GRIFFIS, WILLIAM P
2014-8003 10/01/2014 HOUSTON, RYAN
2014-8004 10/01/2014 KING & SPALDING
2014-8005 10/01/2014 ARMAS, MIVHSRL A
2014-8006 10/01/2014 MASSACHUSETTS GENERAL HOSPITAL
2014-8007 10/02/2014 ORANGE COUNTY REGISTER

2014-8008 10/02/2014 Medstar Georgetown University Hospital
2014-8009 10/02/2014 Island Health
2014-8010 10/02/2014 NORTHWEST COSMETIC LABS LLC
2014-8012 10/02/2014 Cote Orphan Consulting
2014-8013 10/02/2014 James Alexander Corporation

2014-8015 10/02/2014 FOI Services, Inc.
2014-8016 10/02/2014 Kline & company Inc.
2014-8017 10/02/2014 Jamieson Laboratories Ltd.

Penn State Milton S. Hershey Medical
2014-8018 10/02/2014 Center
2014-8019 10/02/2014 RANGARAJAN, R
2014-8020 10/02/2014 WICKER SMITH ET AL
2014-8021 10/02/2014 Doe J
2014-8022 10/02/2014 GENENTECH INC
2014-8023 10/02/2014 Govzilla, Inc.
2014-8024 10/02/2014 MEDTRONIC

2014-8025 10/02/2014 ODOM & DES ROCHES LLP
2014-8026 10/02/2014 Keller and Heckman LLP
2014-8030 10/02/2014 IOVATE HEALTH SCIENCES INTERNATIONAL INC
2014-8031 10/02/2014 Doe J
2014-8032 10/02/2014 WILSON SONSINI ET AL
2014-8033 10/02/2014 DAILY SIGNAL
2014-8034 10/02/2014 Tom Rhodes Law Firm, P.C.
2014-8035 10/02/2014 Tom Rhodes Law Firm, P.C.
2014-8036 10/02/2014 CLINICAL RESEARCH SERVICES MANHEIM GMBH
2014-8037 10/03/2014 South College School of Pharmacy
2014-8038 10/03/2014 Steptoe & Johnson LLP

WILSON ELSER MOSKOWITZ EDELMAN & DICKER
2014-8039 10/03/2014 LLP
2014-8040 10/03/2014 Bennett, Michael F

2014-8041 10/03/2014 FOXKISER
2014-8042 10/03/2014 Ming-Zher Poh
2014-8043 10/03/2014 Ming-Zher Poh
2014-8044 10/03/2014 Ming-Zher Poh
2014-8045 10/03/2014 PROCTER & GAMBLE
2014-8046 10/03/2014 Kane Kessler, P.C.

2014-8047 10/03/2014 Foston, Rene
2014-8048 10/03/2014 Ming-Zher Poh
2014-8049 10/03/2014 Ming-Zher Poh
2014-8050 10/03/2014 Ming-Zher Poh
2014-8051 10/03/2014 Ming-Zher Poh
2014-8052 10/03/2014 Ming-Zher Poh
2014-8053 10/03/2014 FOI Services, Inc.
2014-8054 10/03/2014 Law Office of Matthew Strugar

2014-8055 10/03/2014 Trimingham, Terry
2014-8056 10/03/2014 LexisNexis CourtLink Document Retrieval
2014-8057 10/03/2014 WTI QA

2014-8059 10/03/2014 BABST CALLAND CLEMENTS ET AL
2014-8060 10/03/2014 Valeant Pharmaceuticals North America LLC

2014-8061 10/03/2014 Smith, Adrian
2014-8062 10/03/2014 RICHARDSON PATRICK ET AL
2014-8063 10/03/2014 FARUQI & FARUQI LLP
2014-8064 10/03/2014 WEBB, HUNTLEY

2014-8066 10/03/2014 BIOMET 3I
2014-8067 10/03/2014 BIOMET 3I

2014-8069 10/03/2014 HEWITT 303283, STEVEN
2014-8070 10/03/2014 COUNTRY LIFE LLC

2014-8071 10/03/2014 SMITH, THOMAS LEE
2014-8072 10/03/2014 EDWARDS, S ALBERT

2014-8073 10/03/2014 COVINGTON & BURLING LLP

2014-8075 10/03/2014 NATIONAL INSTITUTE OF HEALTH
2014-8076 10/03/2014 MONTGOMERY CHAPIN & FETTEN PC

2014-8077 10/03/2014 FOI Services, Inc.
2014-8078 10/03/2014 FOI Services, Inc.
2014-8079 10/03/2014 FOI Services, Inc.
2014-8080 10/03/2014 FOI Services, Inc.
2014-8081 10/03/2014 FOI Services, Inc.
2014-8082 10/03/2014 FOI Services, Inc.

2014-8083 10/06/2014 Cooper Union - c/o Eric Forkosh
2014-8084 10/06/2014 FOI Services, Inc.

2014-8086 10/06/2014 Compliance Specialists, LLC
2014-8087 10/06/2014 SKADDEN ARPS SLATE MEAGHER & FLOM
2014-8088 10/06/2014 ST. ELIZABETH'S MEDICAL CENTER OF BOSTON

2014-8089 10/06/2014 Quintiles Research Pvt. Ltd.

2014-8091 10/06/2014 FOI Services, Inc.
2014-8092 10/06/2014 MERCK & CO., INC.
2014-8093 10/06/2014 Friend, Levinson & Turner, Ltd.

2014-8095 10/06/2014 NOVARTIS
2014-8096 10/06/2014 Ceeable
2014-8098 10/06/2014 Kline & Company, Inc.

2014-8099 10/06/2014 STRYKER BIOTECH
2014-8100 10/06/2014 THOMPSON, T

2014-8101 10/06/2014 Thibault, Andrew
2014-8102 10/06/2014 Catalent Pharma Solutions
2014-8103 10/06/2014 Leydig, Voit and Mayer, Ltd
2014-8105 10/06/2014 Nestle HealthCare Nutrition, Inc.
2014-8106 10/06/2014 LED Dental Inc.
2014-8107 10/06/2014 APOTEX CORP

2014-8108 10/06/2014 FOI Services, Inc.
2014-8109 10/06/2014 Sucampo Pharma Americas, LLC
2014-8110 10/06/2014 anopy Medical
2014-8111 10/06/2014 CANOPY MEDICAL INC
2014-8112 10/06/2014 Self

2014-8113 10/06/2014 Jackson Commodities
2014-8114 10/06/2014 BRIGHAM AND WOMEN'S HOSPITAL

2014-8115 10/06/2014 ASHCRAFT & GEREL, LLP
2014-8116 10/06/2014 FOI Services, Inc.

2014-8118 10/06/2014 WELLS FARGO SECURITIES
2014-8119 10/06/2014 ANI Pharmaceuticals, Inc.
2014-8120 10/07/2014 Biomedical Development Corporation
2014-8121 10/07/2014 Medtronic Spine and Biologics
2014-8123 10/07/2014 Ken Tong
2014-8124 10/07/2014 FOI Services, Inc.
2014-8125 10/07/2014 FOI Services, Inc.
2014-8126 10/07/2014 FOI Services, Inc.
2014-8127 10/07/2014 FOI Services, Inc.
2014-8128 10/07/2014 FOI Services, Inc.
2014-8129 10/07/2014 FOI Services, Inc.

2014-8130 10/07/2014 FOI Services, Inc.
2014-8131 10/07/2014 FOI Services, Inc.
2014-8132 10/07/2014 FOI Services, Inc.
2014-8133 10/07/2014 Toronto Star

2014-8134 10/07/2014 CALAVO GROWERS, INC.
2014-8135 10/07/2014 Ken Tong
2014-8136 10/07/2014 REMS Logic, LLC
2014-8137 10/07/2014 FOI Services, Inc.
2014-8138 10/07/2014 GENERAL PHYSIOTHERAPY, INC.
2014-8139 10/07/2014 SEATTLE GENETICS INC

2014-8140 10/07/2014 SIDLEY AUSTIN LLP
2014-8141 10/07/2014 FOI Services, Inc.
2014-8142 10/07/2014 WALLACE, JOSEPH EM3049
2014-8143 10/07/2014 SCOTT & SCOTT LLP
2014-8144 10/07/2014 DELPOR INC

2014-8145 10/07/2014 AMAZON
2014-8146 10/07/2014 Cash, Krugler & Fredericks LLC
2014-8147 10/07/2014 SECOND HARVEST FOOD BANK OF EAST TENNESSEE

2014-8148 10/07/2014 CONWAY HOMER & CHIN-CAPLAN PC
2014-8149 10/07/2014 CAMPAIGN FOR TOBACCO-FREE KIDS

2014-8150 10/07/2014 CHEATWOOD, DARICI
2014-8151 10/07/2014 IMBESI CHRISTENSEN

2014-8152 10/07/2014 Doe J
2014-8154 10/07/2014 JOHNSON & WEAVER LLP

2014-8155 10/08/2014 ARIAD Pharmaceuticals, Inc.
2014-8156 10/08/2014 FOI Services, Inc.
Ferdic Inc. -- Publisher of Dickinson's
2014-8157 10/08/2014 FDA Webview
2014-8158 10/08/2014 FOI Services, Inc.
2014-8160 10/08/2014 GIBSON DUNN & CRUTCHER LLP
2014-8161 10/08/2014 Cincinnati Sub Zero
2014-8162 10/08/2014 Polymed Therapeutics, Inc.
2014-8163 10/08/2014 Ken Tong
2014-8165 10/08/2014 Pelican Therapeutics, Inc.
2014-8166 10/08/2014 Joseph Malone
2014-8167 10/08/2014 Akerman LLP
2014-8168 10/08/2014 Snyder & Wenner, P.C.
2014-8169 10/08/2014 Akerman LLP

2014-8170 10/08/2014 Duval & Associates
2014-8171 10/08/2014 WASHINGTON STATE UNIVERSITY
2014-8172 10/08/2014 INC RESEARCH CONSULTING & SUBMISSIONS

2014-8173 10/08/2014 FOI Services, Inc.
2014-8174 10/08/2014 ORA
2014-8175 10/08/2014 HSBC

2014-8176 10/08/2014 Markopollo, Inc.
2014-8178 10/08/2014 Markopollo, Inc.
2014-8179 10/08/2014 LINCARE INC
2014-8180 10/08/2014 PUBLIC CITIZEN
2014-8181 10/08/2014 FDA NEWS

2014-8182 10/08/2014 FDA NEWS
2014-8183 10/09/2014 GLOBAL TRADE INTELLIGENCE INC
2014-8184 10/09/2014 SHOOK HARDY & BACON LLP

2014-8185 10/09/2014 ON POINT INVESTIGATIONS
2014-8186 10/09/2014 HENKEL BREUER & PARTNER

2014-8187 10/09/2014 BABST CALLAD CLEMENTS ET AL
2014-8188 10/09/2014 HARRISON PENSA LLP

2014-8189 10/09/2014 BOSTON ANALYTICAL
2014-8190 10/09/2014 Gentry Law, LLC
2014-8191 10/09/2014 Snyder & Wenner, P.C.
2014-8192 10/09/2014 Blood Bank of Delmarva

2014-8193 10/09/2014 Genovi Pharmaceuticals, Inc.

2014-8195 10/09/2014 Mallinckrodt PLC
2014-8196 10/09/2014 FOI Services, Inc.

2014-8197 10/09/2014 Deborah Heart and Lung Center
2014-8198 10/09/2014 FOI Services, Inc.
2014-8199 10/09/2014 NxStage Medical, Inc.
2014-8200 10/09/2014 Mark Supple

2014-8201 10/09/2014 Lhasa OMS, Inc.
2014-8202 10/09/2014 The Weinberg Group
2014-8204 10/09/2014 SRA Developments Ltd
2014-8206 10/09/2014 University of Michigan - Michael Smietana

2014-8207 10/09/2014 Dr. Melvyn Rubenfire
2014-8208 10/09/2014 SR-Bio, Inc
2014-8209 10/09/2014 MARS & CO
2014-8210 10/09/2014 Bennett, Melissa

2014-8218 10/09/2014 Sirius Engineering LLC
2014-8219 10/09/2014 Sirius Engineering LLC
2014-8220 10/09/2014 AdverseEvents, Inc.
2014-8222 10/09/2014 The Financial Express

2014-8228 10/10/2014 LAW OFFICE OF CHRISNA D JONES LLC

2014-8229 10/10/2014 Morris Polich & Purdly, LLP
2014-8230 10/10/2014 Benesch, Friedlander, Coplan & Aronoff LLP

2014-8231 10/10/2014 CBS NEWS
2014-8232 10/10/2014 BENNETT BIGELOW & LEEDOM PS

2014-8233 10/10/2014 Isaac Peter
INVESTIGATIVE REPORTING PROGRAM UC
2014-8235 10/10/2014 BERKELEY
2014-8237 10/10/2014 FOI Services, Inc.

2014-8239 10/10/2014 CBS NEWS

2014-8241 10/10/2014 University of Toronto Mississauga
2014-8243 10/10/2014 Research Delta

2014-8244 10/10/2014 O'BRIEN FIRM PL
2014-8246 10/10/2014 Doe J
2014-8247 10/10/2014 HIGHBRIDGE CAPITAL MANAGEMENT LLC
2014-8248 10/10/2014 CENTER FOR FOOD SAFETY
2014-8249 10/10/2014 none

2014-8250 10/10/2014 COHEN, WILLIAM M
2014-8251 10/10/2014 HOGAN LOVELLS LLP
2014-8252 10/10/2014 KING, JORDAN D
2014-8253 10/14/2014 NORAMCO INC

2014-8254 10/14/2014 Kenny Nachwalter P.A.
2014-8255 10/14/2014 Kitchen Table Bakers

2014-8256 10/14/2014 Vascular Insights, LLC
2014-8260 10/14/2014 Medisca Inc.
2014-8261 10/14/2014 Eagle Pharmaceuticals, Inc.

2014-8262 10/14/2014 N/A
2014-8263 10/14/2014 Cassandra Sanchez
2014-8264 10/14/2014 Win-US Technology Company Limited
2014-8265 10/14/2014 Verrica Pharmaceuticals Inc
2014-8266 10/14/2014 FOI Services, Inc.
2014-8268 10/14/2014 PDI PHARMACEUTICALS INC

2014-8269 10/14/2014 FOI Services, Inc.
2014-8270 10/14/2014 FOI Services, Inc.
2014-8271 10/14/2014 N/A
2014-8273 10/14/2014 Bennett, Michael
2014-8274 10/14/2014 Innocoll, Inc.
2014-8275 10/14/2014 Bennett, Michael
2014-8276 10/14/2014 Bennett, Michael

2014-8277 10/14/2014 THE ASSOCIATED PRESS
2014-8278 10/14/2014 Perkin Elmer Inc.
2014-8279 10/14/2014 Langford Infection Control Systems, Inc.
2014-8280 10/14/2014 Graematter, Inc.
2014-8281 10/14/2014 Sanders, Phillips, Grossman, LLC
2014-8282 10/14/2014 BioPorto Diagnostics A/S
2014-8283 10/14/2014 GREENBERG TRAURIG LLP

2014-8284 10/14/2014 MSquared Associates
2014-8285 10/14/2014 Ken Tong
2014-8286 10/14/2014 Aristotle Capital Management

The Dartmouth Institute for Health Policy
2014-8287 10/14/2014 and Clinical Practice
2014-8288 10/14/2014 THOMSON REUTERS (SCIENTIFIC) SAS
2014-8289 10/14/2014 EMC Insurance Company
2014-8290 10/14/2014 Sanders, Phillips, Grossman, LLC
2014-8291 10/14/2014 THOMSON REUTERS

2014-8305 10/14/2014 CENTER FOR INVESTIGATIVE REPORTING

2014-8306 10/14/2014 LITCHFIELD CAVO LLP
2014-8307 10/14/2014 ADAMS, DALE B
2014-8308 10/14/2014 SOMMERMAN & QUESADA
2014-8309 10/14/2014 P & L Development, LLC
2014-8310 10/15/2014 PEPPER HAMILTON LLP
2014-8311 10/15/2014 Spinalight Inc.

2014-8312 10/15/2014 NOVARTIS ANIMAL HEALTH
2014-8313 10/15/2014 NOVARTIS ANIMAL HEALTH
2014-8314 10/15/2014 Alexander R. Priest
2014-8315 10/15/2014 Donahue, Carol

2014-8316 10/15/2014 Alexander R. Priest
2014-8317 10/15/2014 Advanced Sterilization Pruducts
University of Texas MD Anderson Cancer
2014-8318 10/15/2014 Center (Division of Pharmacy)
2014-8319 10/15/2014 Informa Exhibitions LLC

2014-8320 10/15/2014 Value Plastics, Inc., A Nordson Company
2014-8321 10/15/2014 Brooks Childs
2014-8322 10/15/2014 Denny Darnell

2014-8324 10/15/2014 FRANK MACY
2014-8325 10/15/2014 ALDER BIOPHAMACEUTICALS
2014-8326 10/15/2014 Wong, Wong & Associates, P.C.
2014-8327 10/15/2014 none
2014-8328 10/15/2014 ASSOCIATED STUDENTS OF MADISON (ASM)
2014-8329 10/15/2014 Weir, Kenneth

2014-8330 10/15/2014 MILLER, GERALDINE
2014-8331 10/15/2014 TARO PHARMACEUTICALS USA INC

2014-8332 10/15/2014 Santana McMurrey
2014-8333 10/15/2014 The Dunn Group Inc.

CALIFORNIA PHARMACY AND COMPOUNDING
2014-8334 10/15/2014 CENTER
2014-8335 10/15/2014 ConMed Corporation
CALIFORNIA PHARMACY AND COMPOUNDING

2014-8338 10/15/2014 CENTER
2014-8340 10/15/2014 THOMSON REUTERS
2014-8341 10/16/2014 Hyman, Phelps & McNamara P.C.

2014-8342 10/16/2014 GOLDWATER INSTITUTE
2014-8344 10/16/2014 Immusoft Corporation
2014-8345 10/16/2014 Immusoft Corporation
2014-8346 10/16/2014 FOI Services, Inc.
2014-8347 10/16/2014 Douglass Oeller Consulting, Inc.

2014-8348 10/16/2014 The Dow Chemical Company
2014-8349 10/16/2014 ZEE MEDICAL INC
2014-8350 10/16/2014 Lynn Hadaway Associates, Inc
2014-8351 10/16/2014 MERCK & CO., INC.
2014-8352 10/16/2014 MERCK & CO., INC.
2014-8353 10/16/2014 MERCK & CO., INC.
2014-8354 10/16/2014 Thomas V. Montgomery, III, Ed.D.
2014-8355 10/16/2014 Douglass Oeller Consulting, Inc.
2014-8356 10/16/2014 Woman Advocating Reproductive Safety
2014-8357 10/16/2014 FOI Services, Inc.

2014-8358 10/16/2014 Doe J
2014-8359 10/16/2014 The Indianapolis Star
2014-8360 10/16/2014 Tarsa Therapeutics Inc.

2014-8361 10/16/2014 UNIVERSITY OF VIRGINIA
2014-8362 10/16/2014 FDA NEWS
2014-8364 10/16/2014 FDA NEWS
2014-8365 10/16/2014 FDA NEWS
2014-8366 10/16/2014 FDA NEWS
2014-8367 10/16/2014 FDA NEWS
2014-8368 10/16/2014 FDA NEWS
2014-8369 10/16/2014 FDA NEWS
2014-8370 10/16/2014 FDA NEWS

2014-8371 10/16/2014 FDA NEWS
2014-8372 10/16/2014 FDA NEWS

2014-8373 10/16/2014 FDA NEWS
2014-8374 10/16/2014 FDA NEWS
2014-8375 10/16/2014 FDA NEWS
2014-8376 10/16/2014 FDA NEWS
2014-8377 10/16/2014 Kythera Biopharmaceuticals, Inc.

2014-8378 10/16/2014 FDA NEWS
2014-8379 10/16/2014 FDA NEWS
2014-8380 10/16/2014 FDA NEWS

2014-8381 10/16/2014 NEUROMAGNETICS SA
2014-8382 10/16/2014 FDA NEWS
2014-8383 10/16/2014 FDA NEWS
2014-8384 10/16/2014 FDA NEWS
2014-8385 10/16/2014 FDA NEWS

2014-8386 10/17/2014 BRIGHAM AND WOMEN'S HOSPITAL
2014-8387 10/17/2014 Elba Laboratories
2014-8388 10/17/2014 Mercatus Center at George Mason University

2014-8389 10/17/2014 Katecho, Inc
2014-8390 10/17/2014 Doctors's Best Viaminms
2014-8391 10/17/2014 Rawls McNelis + Mitchell, PC
2014-8392 10/17/2014 MedAssets

2014-8393 10/17/2014 FOI Services, Inc.
University of Kansas Drug Information
2014-8394 10/17/2014 Center
2014-8395 10/17/2014 GCA Law Partners LLP

2014-8396 10/17/2014 CHICAGO TRIBUNE
2014-8397 10/17/2014 Accuray Attn: John McCauley at Reed Smith

2014-8398 10/17/2014 Bemis Manufacturing Company
2014-8399 10/17/2014 FINKELSTEIN & PARTNERS
2014-8402 10/17/2014 CLINE FARRELL ET AL
2014-8403 10/17/2014 LAFOLLETTE JOHNSON
2014-8404 10/17/2014 Wilson Sonsini Goodrich & Rosati
2014-8405 10/17/2014 GRAY RITTER & GRAHAM ATTYS
2014-8406 10/17/2014 Isabel, Catherine
2014-8407 10/17/2014 HATTON #1529223, ROLAND
2014-8408 10/17/2014 TIME INC

2014-8409 10/17/2014 TORRENT PHARMA INC
2014-8410 10/17/2014 Zetetic, Inc.
2014-8411 10/17/2014 TORRENT PHARMA INC

2014-8412 10/17/2014 KOMYATTE LAW FIRM LLC
2014-8413 10/17/2014 AL-SHERRI, SARAH
2014-8414 10/17/2014 Doe J

2014-8415 10/20/2014 Hologic, Inc.
2014-8416 10/20/2014 Hologic, Inc.
2014-8417 10/20/2014 Hologic, Inc.
2014-8418 10/20/2014 Zoetis Inc.
2014-8419 10/20/2014 Hologic, Inc.
2014-8420 10/20/2014 Zoetis Inc.

2014-8421 10/20/2014 FOI Services, Inc.
2014-8422 10/20/2014 Hayden, Rebecca R
2014-8423 10/20/2014 CBR INTERNATIONAL CORP
2014-8425 10/20/2014 FOI Services, Inc.
2014-8426 10/20/2014 FOI Services, Inc.
2014-8427 10/20/2014 FOI Services, Inc.
2014-8428 10/20/2014 The Rose Sheet

2014-8429 10/20/2014 FOI Services, Inc.
2014-8430 10/20/2014 CALAVO GROWERS, INC.
2014-8431 10/20/2014 Harris Penn Lowry LLP
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2014-8441 10/20/2014 ARMBRECHT JACKSON LLP
2014-8442 10/20/2014 ECOR1 CAPITAL LLC
2014-8443 10/20/2014 BUCCI BAILEY & JARVIS LC

2014-8444 10/20/2014 BARIATEC CORP
2014-8445 10/20/2014 WILMER CUTLER PICKERING ET AL

2014-8446 10/20/2014 GARDEZI, WALID
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2014-8448 10/20/2014 NEUROMAGNETICS SA
2014-8449 10/21/2014 Point of Care Decision Support
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2014-8470 10/21/2014 ERIC F GREENBERG PC

2014-8472 10/21/2014 PFIZER
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2014-8476 10/21/2014 LACHMAN CONSULTANT SERVICES INC
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2014-8478 10/21/2014 PERRIGO COMPANY

2014-8479 10/22/2014 Freelance Journalist
2014-8480 10/22/2014 Dynavax Technologies Corporation

2014-8481 10/22/2014 Thar Pharmaceuticals
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2014-8493 10/22/2014 ARENT FOX LLP

2014-8497 10/22/2014 CENTER FOR SCIENCE IN THE PUBLIC INTEREST
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2014-8500 10/22/2014 Stifel Nicolaus & Co
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2014-8505 10/22/2014 NTEU CHAPTER 282
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2014-8543 10/24/2014 BIOTEX INC
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2014-8609 10/27/2014 BBI Solutions OEM Limited
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2014-8614 10/27/2014 BENJAMIN L ENGLAND & ASSOCIATES LLC
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2014-8633 10/28/2014 MASSACHUSETTS INSTITUTE OF TECHNOLOGY
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2014-8649 10/28/2014 NOVARTIS
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2014-8657 10/29/2014 Cliniqa Corporation
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2014-8702 10/29/2014 THOMPSON, RAY
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2014-8791 11/03/2014 SCHROFF, JUDY
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2014-8915 11/06/2014 Kleinfeld, Kaplan & Becker LLP

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2014-8918 11/06/2014 Dianne's Fine Desserts
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2014-9057 11/12/2014 K&L Gates LLP
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2014-9060 11/12/2014 Piramal Enterprises Limited
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Subject
LINZESS - AER
SONNEBORN INC, PETROLIA, PA - EIR 6/1/14-8/1/14
STEM CELL RECS
Guayaquil-based Star Company, S.A., Crimasa

Criaderos De Mariscos, S.A., Gialmar-Produtos
Alimentares S.A. etc - Warning Letter, Inspection
Records, Emails
K062795
BRACCO DIAGNOSTICS, PRINCETON, NJ - EIR, 483
04/01/2014 - 06/30/2014
LIST OF PHARMACEUTICAL INSPECTIONS LAST THREE YEARS

BIOMIMETIC THERAPEUTICS, WRIGHT MEDICAL -
INSPECTION RECS 01/01/2010 - 12/22/2014
CORIN CORMET ADVANCED HIP RESURFACING SYSTEM -
MANUFACTURING STANDARDS
K112605
K080595
IPCA LABS, INDIA - 483 12/08/2014 - 12/17/2014
K010388
K141681
K000073
LISTING OF INSPECTIONS 03/15/2014 - 12/22/2014
K112231
K102566
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
- 12/24/2014
ANDA 075998 CHEMISTRY REVIEW
SHIRE HUMAN GENETIC THERAPIES - BIOLOGICAL
DEVIATION REPORTS
BOSTON SCIENTIFIC MOST RECENT ANNUAL REPORT FOR
- 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
MMJ LABS, ATLANTA, GA - EIR 05/01/2014 - 12/30/2014

K132148
Any Reportable Food Reports related to caramel

apples filed by Safeway, Happy Apples, Bidart
Brother, Pacific Coast Fruit and California Snack
Foods
ROHN & HASS, CHAUNCY, FRANCE - 483 MARCH 2012
RECKITT BENCKISER - EIR 01/01/2011 - 09/25/2014
2014-7046
2014-7026
2014-7018
ENBREL - AERS
PROWL-1, PROWL-2 - FINAL REPORT, SURVEY INSTRUMENT
2014-6377
2014-6476
HERCEPTIN - PHARMACOLOGY, TOXICOLOGY, CLINICAL
STUDY REPORT
CDER BIMO COMPLAINTS ENTERED INTO FACTS 9/06 TO
7/07
2014-3957
2014-4994
LDR Holding Corporation - APPROVABLE LETTER
Date on which Form 3542 was submitted to FDA to
requesting to list US Patent No. 8,759,350 in the
Orange Book
2014-3990
2014-5980
2014-4596
AUROBINDO PHARMA, INDIA - 483 09/15/2014 -
09/26/2014
K023087
K062166
09/29/2014
BK100066, BK130068, BK110040
K811276
CLOSED FOIA REQUESTS 9/1-30/2014
FOI DAILY LOG 9/1-30/2014
K103227
JOHN PAGEL, MD, SEATTLE, WA - 483, EIR 01/30/2008
- 09/30/2014
K113119
FDA POLICY THAST ALLOWS AN EXPERT WHO SERVES AS A

TEMPORARY VOTING MEMBERS OF AN FDA A/C ON A
RECURRING BASIC TO ASSUME THE ROLE OF PAID SPEAKER,
ON BEHALFL OF A SPONSOR, AT A MTG OF THE A/C MTG
ALIVECOR INC - HEART MONITOR CLASS II DVC 510K
SMITH & NEPHEW, ST PETERSBURG, FL - EIR 11/13
VIAGRA (SILDENAFIL) - COMM REGARDING WHETHER TO ADD
LANGUAGE CONCERNING MELANOME OR SKIN CANCER TO THE
LBLG
ABILIFY (ARIPIPRAZOLE) - COMM REGARDING WHETHER TO
ADD LANGUAGE CONCERNING GAMLING TO THE LBLG
SUN PHARMACEUTICAL INDUSTRUES LTD (HALOL FACILITY),
GUJARAT, INDIA - 483 9/19//14
AUROBINDO PHARMA, ANDHRA PRADESH, INDIA - 483
9/19/14
MDRS 1980686, 2007711, 2072674, ETC
INDIVIDUAL RECS
CUT-N-UP SALON, KING GEORGE, VA - TRANS, AUDIO,
VIDEO, ETC 6/15/14
GISKIT B V (FARCO-PHARMA GMBH) - LUBRICANO
ULTRASOUND K083358 UN-REDACTED
SANOFI PASTEUR - MENACTRA LAB TESTS, MEDICAL
HISTORY, HPV MFR, ETC
CANADA HUMAN FOOD INSP - 483S 1/10 TO PRESENT
ARICEPT (DONEPEZIL) - PRE-CLNCL RECS
ORCHID CHEMICALS & PHARMACEUTICALS LTD, INDIA -
EIRS, 483S, REGULATORY CORR 1/14 TO PRESENT
JOHNSON & JOHNSON, PFIZER, ROCHE, ETC - EMAILS BTWN
MEMBERS OF THE DRUG SHORTAGES TASK FORCE 1/10 TO
PRESENT
ZYDELIG (IDELALISB) - AERS
STRYKER - NEPTUNE 2 ULTRA WASTE MANAGEMENT SYS
APRVL & IMPLEMENTATION OF A CERTIFICATE OF MEDICAL
NECESSITY PROGRAM KI122665, K132671, ETC
DR ALICE SHAW, BOSTON, MA - EIRS 2/13-21/14
NSPIRED NATURAL FOODS - MARANATHA ROASTED CREAMY
ALMOND BUTTER RECALL SALMONELLA CONTAMINATION
INVESTIGATIONS 1/14, 8/14
LIST OF APRVD RICE FACTORIES IN CAMBODIA REGISTERD
WITH THE FDA
SPL 835093 - TEST RESULTS
FLINSTONE VITAMINS - CMPLNT 137832, SPL 830934 TEST
RESULTS
APOTEX RESEARCH PRIVATE LTD, BANGALORE, INDIA -
EIRS 6/23/14-7/1/14
LIST OF EVERY MEDICATION & VACCINE RECALLED OR
REMOVED BY FDA
2008 FDA AMENDMENT TO THE CALCIUM & OSTEOPOROSIS &

CALCIUM VITAMIN D OSTEOPOROSIS HEALTH CLAIM
ELIMINATES THE REQUIREMENT THAT THE CLAIM LISTS
RACE AS A SPECIFIC RISK FACTOR
RESEARCH MARIJUANA - IND APPLICATIONS, RESEARCH

PROTOCOLS, LETTTERS TO SPONSORS ETC 1996 TO PRESENT
ENOXAPARIN - AERS
TOTAL AERS, TORSADE DE POINTES, ELECTROCARDIOGRAM
QT PROLONGED, ASSOCIATED WITH ANY DRUG
COLUMBIA COSMETICS MANUFACTURING INC, SAN LEANDRO,
CA - EIR, 483 07/01/2010 - 09/29/2014
CHEMAID, SADDLE BROOK, NJ - EIR, 483 07/01/2010 -
09/29/2014
ENALAPRIL MALEATE - ORPHAN DRUG DESIGNATION RECS
01/02/2013 - 01/31/2014
BEMIS HEALTHCARE PACKAGING, PHILADELPHIA, PA - EIR,
483, PRODUCT RECALLS 09/01/2011 - 09/29/2014
ALLURE LABS, HAYWARD, CA - EIR MOST RECENT
K131337
RR DONNELLEY PLOVER, RR DONNELLEY LODZ, RR
DONNELLEY SINGAPORE - EIR 01/01/2009 - 09/29/2014
JAMIESON LABORATORIES LTD - AERS 01/01/1922 -
09/29/2014
DOMPERIDONE - AERS, DOSING RESTRICTIONS

K941799, K052188, K120494
INDIVIDUAL RECS
INDIVIDUAL RECS
REGENERONS - EYLEA SBA
EIRS 1/1/13 - 8/11/14
GLOBUS VIP ANTERIOR CERVICAL PLATE SYS K081391
SYNTHES VECTRA ONE SYS K071677 LIFE SPINE ANTERIOR
PLATE SYS K070285, K061698, K040844
REQUEST REGARDING PETITION FDA-2012-P-1028
NO OBJECTION LETTERS 65,84
NO OBJECTION LTRS 60, 93
NO OBLIGATION LTRS 54, 83, 89
REQUEST FOR NO OBLIGATION LTRS 43, 75
CAERS 176429, 176524, 177048, 178476
CCSVI PROCEDURE
LINEZOLID ANDA 78-061 - APRVL
2014-4855
PEOPLES PHARMACY - CALCIUM GLUCONATE RECALL
SPECIALTY COMPOUNDING - CALCIUM GLUCONATE RECALL
CRS, MANNNHEIM, GERMANY - EIR
Original package inserts for 25 specific new
molecular entities approved from 1995-1997 for
research purposes.
References in the Indirect Food Additives Final
Rule issued in the Federal Register on May 9, 2000
regarding Polymers
Great Lakes Cheese, St, Adams, NY - INSPECTION
RECS 08/13/2013
Institutional Pharmacy Solutions, LLC, Irwindale,
CA - OUTSOURCING RECORDS, 483 01/30/2014 -
09/30/2014
NDA 201923
K052767
K023238
K130921
Information referenced in: the reference from the

FR Vol 48, No. 27 Tuesday, Feb 8, 1983. External
Analgesic TFM, Comment 7 page 5855. Reference:
(11)Comment Nos. CP, SUP002, CR001, AMD, and
AMD002, Docket No. 78N-0301
Import Detentions of Pyrroloquinoline quinone
01/01/2010 - 10/01/2014
Prednisolone acetate ophthalmic suspension, USP -
AERS
K140933
K121932
K080337
K132206
K122184
Correspondence Between Caryn Cohen at CTP & Members
of TPSAC 07/01/2014 - Present
PHARMACEUTICAL COMPANY V. UNITED STATES FOOD AND
DRUG ADMINISTRATION - SETTLEMENT AGREEMENT
K945271
2014-1904
Comprehensive Clinical Development, Inc., Miramar,
FL - EIR
PHARMACY COMPOUNDING ADVISORY COMMITTEE - NOMINEE
RECORDS
PQ CORP, JOLIET, IL - EIR 12/19/13
MEDICIS PHARMS - PREDNISOLONE SODIUM PHOSPHATE ORAL
SOL ANDA 75-250
MCCALL FOODS - GLORY GREENS RPT
CERTIFIED RECS
Niacin ER Tabs ANDA 90860 Bioeqv, Chemistry
sections
EXELAN PHARMACEUTICALS INC, LAWRENCEVILLE, GA INVA

GEN PHARMACEUTICAL INC, HAUPPAUGE, NY HETRO DRUGS
LTD, HYDERABAD, INDIA - LISINOPRIL APRVL, MFG RECS,
ETC
FCN 1443
STRAUMANN CARES SCREW-RETAINED BRIDGES AND BARS
K140737
NOBEL BIOCARE AB - NOBELPROCERA OVERDENTURE BAR
K132749
HETERO DRUGS LTD, NAKKAPALLY, VISAKHAPATNAM, INDIA
- EIRS, 483S, 1/1/10 TO 9/28/14
CLARITIN, RITALIN, ADDERAL, ETC - AERS, USES, RECS
COUNTRY LIFE LLC, HAUPPAUGE, NY - EIRS, 483S 6/12
TO PRESENT
CMPLNT #138430
SKELAXIN (METAXALONE) NDA 13-217 - APRVL LTRS, LBLG
5/31/02. 6/20/02
HAMPTON CREEK FOODS INC - CFSAN LTR 9/19/14
BAUSCH & LOMB - IPRATROPIUM BROMIDE INHALATION SOL
ANDA 75-835 CROMOLYN SODIUM INHALATION SOL ANDA
75-585
PATENT DATA FOR APRVD FDA DRUGS SINCE 1970
DIAGNOSTICA STAGO INC, PARSIPPANY, NJ - REGULATORY
NON-COMPLIANCE, MISCONDUCT, CMPLNTS, CORR, ETC
Campbell Tobacco Rehandling, Mayfield, KY Heritage
Tobacco Group, Perryville, KY Kentucky
Bioprocessing, Owensboro, KY ETC - 483, EIR,
WARNING LETTER ETC
Global Tobacco, Dallas, TX, Xcaliber International,
Pryor, OK Dosal Tobacco, Opa Locka, FL - EIR, 483,
WARNING LETTER ETC
Sterigenics, Haw River, NC Dry Storage,
Greensboro, NC Top Tobacco, Lake Waccamaw, NC ETC
- EIR, 483, WARNING LETTER ETC
Southern Tobacco, Statesboro, GA Scandinavian
Tobacco Group Lane, Tucker, GA Hail & Cotton,
Springfield, TN - EIR, WARNING LETTER, 483 ETC
Fisher Textiles, Indian Trail, NC US Flue Cured

Tobacco Growers, Timberlake, NC Rock-Tenn
Converting Co, Winston-Salem, NC ETC - 483, EIR,
WARNING LETTER ETC
American Packaging, Story City, IA American
Packaging, Columbus, WI - EIR, 483, WARNING LETTER
ETC
K022834
P020004 S103
Strides Arcolab, Beltapharm SPA, Milan, Italty -
483, Warning Letter
Similasan AG - Corr to FDA
TERUMO CARDIOVASCULAR SYSTEMS - RECS RELEASED UNDER
FOIA RE 2014 INSPECTION
Bioequivalence studies of FDA-approved generic
tacrolimus in healthy volunteers and kidney
transplant recipients
DR RICHARD C DART - EIR 01/01/2005 - 12/31/2005
cyclosporine in healthy volunteers and kidney
Viibryd - WRITTEN REQUEST RE PEDIATRIC STUDIES
NDA 013304
Raphe Healthcare Inc.,Dallas, TX - LICENSING,
COMPLAINTS, INVESTIGATIONS
2014-5468
ORA LABORATORY MANUAL
K121738, K093213
mycophenolate in healthy volunteers and kidney
SANMINA, CHINA - EIR, EXHIBITS 01/01/2009 -
10/02/2014
K133809
MEDICAL DEPOT INC - MAUDE REPORTS 01/01/2008 -
01/01/2014
AERS REPORTS
CATALENT, ST PETERSBURG, FL - EIR JUNE 2012
NDA 019452
2014-6210
DKT FDA-2012-F-0138
K123169
Apotex' Dilitazem XR Capsules, ANDA 074943 -
APPROVAL LETTER
K122202
AMITIZA - SBA
K103110
K113220
CORR TO OR FROM FDA RE ACELRX, ZALVISO, SUBLINGUAL
SUFENTANIL
SAMPLE RESULTS 835926
DR ALVARO OCAMPO, DR JOHN PADRON - 483 01/01/2014 -
09/01/2014
MEDTRONIC P120010, P980022 - RECALL RECS
ZYDELIG - PHARM, TOX
LOT 8 OF PARADIGM INFUSION SETS MEDTRONIC - EMAILS,
COMM 10/01/2001 - 10/01/2014
IMBRUVICA, KALYDECO, SOVALDI ETC
ANDA 62698, 71800, 71801 ETC
K092150
K914362
K810271
IBRUTINIB - AERS
BIO-TISSUE - EIR, 483, WARNING LETTER ETC
BIOD LLC - EIRs, 483s, Warning Letters, ETC
MRF - EIR, 483, WARNING LETTER ETC
Derma Sciences - EIR, 483, WARNING LETTER ETC
ALLOSOURCE - EIR, 483, WARNING LETTER ETC
Bone Bank Allografts - EIR, 483, WARNING LETTER ETC

Liventa - EIR, 483, WARNING LETTER
ACell - EIR, 483, WARNING LETTER ETC
OSIRIS THERAPEUTICS - EIR, 483, WARNING LETTER ETC
EMAIL, MEMOS, REPORTS BETWEEN FDA AND HEALTH CANADA

RE APOTEX IMPORT ALERT 06/23/2014 - 10/06/2014
LAB RESULTS # 692004
KEYTRUDA - AERS
REMS DRUG ERROR REPORTS 2005 TO 2013
AMNIOX MEDICAL - EIR, 483, WARNING LETTER ETC
K122480
SEATTLEL GENETICS - ADCETRIS (BRENTUXIMAB VEDOTIN)
IRS 9836594, 9916423, 10035648, ETC
VALEANT PHARMACEUTICALS INTERNATIONAL INC,
MANITOBA, CANADA 3/1/12 KIK CUSTOM PRODUCTS,
ONTARIO, CANADA 4/27/12 CONTRACT PHARMACUTICALS
LIMITED CANADA, WREXHAM, UK - 483S
MEDWATCH 7177217
RITALIN - LABEL & MEDICATION GUIDE 2000, 2013
TEVA PHARM - AMIODARONE HCL ANDA 74-739 APRVL LTR,
5 MOST RECENT LABEL UPDATES
JANSSEN PHARMS - RISPERIDONE TABS NDA 20-272,
RISPERIDONE ORALLY DISINTERATING TABS NDA 21-444,
ETC SBA
2014-7099. 2014-7206
CLINICAL SPECIALTIES (CLINICAL SPECIALTIES
COMPOUNDING PHARMACY), MARTINEZ, GA - EIRS, 483S,
LAB RPTS, ETC
FOOD RECALLS BY ENFORCEMENT RPT LEADING CAUSES OF
FOOD RECALLS
INDIVIDUAL RECS
STAR SCIENTIFIC CO - DISSOLVABLE TABACCO PRODS
UNREDACTED RVWS
CMPLNT 138494
GATE GOURMENT INC - CMPLNTS, VIOLATIONS, FINES, ETC

INDIVIDUAL RECS
USP LABS - HIGENAMINE WARNING LTR, RESP TO WARNING
LTR, CORR
BIOTA PHARMACEUTICALS INC - LANINAMIVIR OCTANOATE
CORR BTWN HHS, ASPR, BARDA, ETC 3/11 TO PRESENT
ICLUSIG - AERS
ACTERMA - ORPHAN DRUG RECS
510K RESCISSION LETTERS 1/99 TO 9/30/14

ACTEMRA BLA 125276/S64
SUN PHARMACEUTICALS, INDIA - 483 SEPT 2014
2014-6711
K843146
K132834
ZYDELIG - AERS
AMPIO PHARMACEUTICALS - BLA, CMC, CORR ETC
MEDI6383 IND
ORTHO EVRA PATCH, NUVARING, ETHINYL ESTRADIOL ETC
NDA 019941, ANDA 076320, ANDA 076453
SCOTTSDALE HEALTHCARE, SCOTTSDALE, AZ - CLINICAL
TRIALS OF ROBOT ASSISTED MITRAL VALVE REPAIR
SURGERY
LIST OF MANUFACTURER NAMES AND ADDRESSES REGISTERED

TO MANUFACTURE LIDOCAINE, PRILOCAINE, ETC
K131255, K122817, K141573 ETC
ANDA 077239
LONZA BIOLOGICS, INC, PORTSMOUTH, NH - EIR, 483,
RESPONSE
BK140108
BOSTON ANALYTICAL, SALEM, NH - EIR 11/06/2012 -
11/09/2012
SUN PHARMACEUTICALS, INDIA - 483 09/22/2014 -
09/26/2014
K842736
K080275
K842735
CARE MEDICAL INC, VISALIA, CA HOT SPRINGS COUNTY

MEMORIAL HOSP, THERMOPOLIS, WYOMING MINISTRY HOME
CARE SERVICES LLC, RIVER FOREST, IL - 483, WARNNG
LTR, EIR 1/98 TO PRESENT
SAMSCA (TOVAPTEN) ISRS - 7499864, 7861985, 8060244
ETC
LIST OF PHARMACEUTICAL, BIOLOGIC, MEDICAL DVC
MANUFACTURING, CLNCL TRIAL FACILIITES - 483S 9/1-
30/14
DAILY LOG 8/1-9/30/14
FDA IMPORTS 5/26/14 TO PRESENT
STRYKER ORTHOPAEDICS - EIUS UNICOMPARTMENTAL KNEE
SYS K052917, K992287
OVASCIENCE - AUGMENT CORR 2013
COPOLYMER-1 NDA 20-622 - PHARMACOLOGY TOXICOLOGY
DATA
PQ CORP,UTICA, IL - EIR 12/19/13
HOFFMAN-LA ROCHE - ACCUTANE APRVL RECS, REGULATORY
COMPLIANCE, SALE, ETC
BOSTON ANALYTICAL, SALEM, NH - EIR 8/13
KRATOM - CORR, EMAIL, MEETING NOTES ETC
CLINICAL TRIALS OF ROBOT ASSISTED HEART BYPASS
SURGERY AT SCOTTSDALE HEALTHCARE - DATA 01/01/2002
- 01/01/2006
LIST OF FIRMS APPROVED FOR PLATELET ADDITIVE
SOLUTION PLATELETS
NDA 019281 - SBA
California Pharmacy and Compounding Center, Newport
Beach, CA UCSF Home Therapy Services, San
Francisco, CA.- 483, EIR
Mallinckrodt PLC, RALEIGH, NC - EIR
HERBALIFE, LAKE FOREST, CA - EIR, 483, RESPONSE ETC

DR KOVACH - EIR 01/30/2014 - 07/24/2014
K133223
K112314
GUIDANT IMPLANTABLE CARDIAC DEFIBRILLATORS - OCI
INVESTIGATIONS 03/04/2005 - 12/31/2010
K990328
ANDA 201006
ANDA 202077
K900003
2014-7450
Gore-TexTM Cruciate Ligament Prosthesis by W.L.

Gore and Associates approved on October 10, 1986
Stryker Dacrone Ligament Prosthesis by Meadox
Medicals, Inc. approved on December 30, 1988 3M
Kennedy LADTM Ligament Augmentation Device by 3M
which was
STATINS - AERS
K842607
NBTY - EIR MOST RECENT
UNIQUE PHARMACEUTICALS, TEMPLE, TX - WARNING LETTER
RESPONSES
ANDA 200925
ANDA 090887
ANDA 091449
ANDA 077697
K961725
ANDA 076218 APPROVAL LETTER
K103220
K082339
K083833
PROZAC, LEXAPRO, CELEXA - AERS
SOVALDI, ELIQUIS, XARELTO - AERS
SUN PHARMACEUTICALS, HALOL, INDIA - EIR 01/01/2014
- 10/09/2014
K091071
K120092
K133194
K140260
K131547
NORDIC COLD STORAGE LLC, ASTLANTA, GA - EIRS, APPL,
CHANGE IN OWNERSHSIP, ETC LAST 10 YRS
SPINAL SOLUTIONS - RECORDS RELEASED UNDER FOIA
BUTTERFLY BAKERY INC, BRENDA ISAAC, CLIFTON, NJ -
INSPECTIONS, INVESTIGATIONS
NUVISION PHARMACY - AERS
All versions of instructions for use and other

materials submitted by St. Jude Medical / Advanced
Neuromodulation Systems In. for EON Mini IPG
rechargeable neurostimulator model 3788 / product
code 65-3788
HANUTA - RECS, IMPORT ALERTS
K963040
FRESH PACKING CORP, LOS ANGELES, CA - RECS RE
IMPORTS FROM MEXICO
ALK-ABELLO, INC, PORT WASHINGTON, NY EDGE PHARMCY
SERVICES LLC, COLCHESTER, VT JUBILANT HOLLISTER
STIER LLC, SPOKANE, WA ETC - 483, EIR
REPORTS ON SAFETY ISSUES WITH TOBACCO PRODUCTS
SUBMITTED BY CONSUMERS, HEALTH CARE PROVIDERS, ETC
THROUGH PORTAL
ANDA 202077, 201006, 200925, ETC APPROVAL LETTER
NUVISION PHARMACY - RESPONSE TO 483, REQUESTS FOR
RECALLS ETC
K142408
K103785
K112930
SUN PHARMACEUTICALS, HALOL, INDIA - 483 09/01/2014
- 10/09/2014
EDIBLE FOODS - RECS
K111346
Z-0006-04 - BATCH NUMBER RECS
VALEANT PHARMS - 483S 9/1/13 TO 9/30/14
ETHOXYQUIN - RECS RE SAFETY, USE, AND EFFECTS AS AN
ADDITIVE TO ANIMAL FEED
RTI SURGICAL - 483, CLOSEOUT LETTER 01/10/2014 -
09/25/2014
COMPLNT 138376
LIST OF APRVD PAPER NDA'S - MOST RECENT
CHEMICALS USED IN THE FAST FOOD INDUSTRY - LIST OF

BANNED CHEMICALS IN PREPARATION OF FAST FOOD, RPTS
ON AZODICARBONAMIDE, CHEMICALS PROHIBITED IN BREAD
DOUGH
OXYMORPHONE - FIELD ALERT REPORT 09/15/2014 -
10/10/2014
ANDA 040445 , ANDA 203399 CERTIFIED
KALI/JACKS PASTRY SMART PARMESAN CRISP - LAB
RESULTS 09/01/2013 - 10/10/2014
K071468
K092119
IDE G100252
Pre-IDE I100545
JIANGSU JIAERKE PHARMACEUTICALS GROUP CO LTD, CHINA
- EIR 06/01/2014 - 06/30/2014
CIPLA LIMITED - EIR 04/01/2013 - 7/01/2013, ANDA
200540
EEO COMPLAINTS
STATINS - AERS SUMMARY
K040691
CANTHARIDIN - IND
SOP 03-218, for Tiamulin
K110172
ACCU-CHEK INFORM II ROCHE - PLASTIC TYPE AND
COMPOSITION
RTI SURGICAL, ALLENDALE, NJ - INVESTIGATOR DIARIES
RTI SURGICAL, ALLENDALE, NJ - EIR, 483 ETC
TIANSHI HEALTH PRODUCTS INC - CERTIFICATIONS,
K051197, CON1014902
DOWNING LABS - EIR, RESPONSES 01/01/2012 -
10/11/2014
AVELLA, DEER VALLEY - EIR, RESPONSES 01/01/2013 -
10/11/2014
PACIRA PHARMACEUTICALS - WARNING LETTER 09/22/2014
- 10/10/2014
CENTRAL ADMIXTURE PHARMACY SERVICES, IRVINE, CA -
EIR, RESPONSES 01/01/2014 - 10/12/2014
CUSTOM COMPOUNDING CENTERS, LOS ALAMITOS, CA - EIR,
RESPONSES 01/02/2013 - 10/12/2014
CTP FOIA REQUESTS 03/05/2014 - 10/13/2014
SUPPLEMENTAL DEVICE ADVERSE EVENT REPORT
K042648, K063788, K110189
K122137, K120233
PATRIOT PHARMACEUTICALS - APPLICATION,

INVESTIGATION, TESTING ETC 01/01/1998 - 10/13/2014
DEN130031 ASTUTE MEDICAL, INC / NEPHROCHECK TEST
SYSTEM - DECISION SUMMARY, APPROVAL LETTER
5-Methytetrahydrofolate (MTHF), including, but not

limited to, the Administrative Record regarding the
FDA's proposed changes to the Nutrition Facts Label
announced in February 2014 and the discussion of
MTHF as a permissible source of folate or folic
P110006, P130017
IBRUTINIB - CASE REPORTS
ORCHID CHEMICALS AND PHARMACEUTICALS LTD, INDIA -
483 04/01/2014 - 04/30/2014
NDA, NDA SUPPLEMENTS

INFOPIA CO LTD, ANYANG-SI, GYEINGGI-DO, SOUTH KOREA
- 483 2/17-20/14
RESTAURANT RECYCLING SERVICES LLC - INVESTIGATION
RECS 08/01/2014 - 10/14/2014
INVEGA - APPLICATION, INVESTIGATION, TESTING ETC
01/01/1998 - 10/13/2014
HOSPIRA AUSTRALIA PTY LTD, VICTORIA, AUSTRALIA -
483 2/24/14 - 3/1/14
BRAVA, MIAMI, FL - EIR, 483, CO RESP 2/4/14 TO
3/14/14
RTI SURGICAL INC, ALLENDALE, NJ - EIR, 483, CO RESP
12/3/13 TO 1/9/14
WALTER J DOLL PhD, LEXINGTON, KY - EIR, 483, CO
RESP 1/14-17/14
BAYCARE HEALTH SYS IRB - MPM SAH, CLEARWATER, FL -
EIR, 483, CO RESP 2/19/14
MYLAN PHARMACEUTICALS INC, MORGANTOWN, WV - EIR,
483, CO RESP 3/10-21/14
LONZA BIOLOGICS INC, PORTSMOUTH, NH - EIR, 483, CO
RESP 8/26/13 TO 9/30/13
BIOMAT USA INC, SEATTLE, WA - EIR, 483, CO RESP
9/19-23/13
GENENTECH INC, VACAVILLE, CA - EIR, 483, CO RESP
8/26/13 TO 9/6/13
MERCK SHARP & DOHME CORP, ELKTON, VA - EIR, 483, CO
RESP 9/23-30/13
TIMOTHY R. YEKO MD, TEMPLE TERRACE, FL - EIR, 483,
CO RESP 9/10-17/13
SHISHUKA MALHOTRA MD, CANTON, OH - EIR, 483, CO
RESP 1/4-14/13
MEDIMMUNE, SANTA CLARA, CA - EIR, 483, CO RESP
1/30-31/14
EISAI INC, BALTIMORE, MD - EIR, 483, CO RESP 12/9-
17/13
CROWDER MACHINE & TOOL, TEMECULA, CA - EIR 7/30/12

WOLVERINE PACKING CO RECALLL 5/14
ANTI DEPRESSSANTS - DEATHS & SUICIDES
VITROLIFE INC - PERFADEX ALL CORRESPONDENCE
MICRO LABS - 483, EIR, ETC PREVIOUSLY RELEASED
01/01/2012 - 10/13/2014
PROZAC - SAFETY/EFFICACY RECS RE ORIGINAL APPROVAL

SPINALIGHT INC, WOODSTOCK, GA - PHONE, FAX NUMBER
ON SUBMISSIONS
NADA 034267 FOIA SUMMARY
K844918
QUESTCOR PHARMACUETICALS - FOIA REQUESTS AND
RESPONSES 05/09/2014 - 10/14/2014
K902327
K140392
MD ANDERSON CANCER CENTER - AERS REPORTED TO
MEDWATCH 01/01/2011 - 10/15/2014
CRIMINAL COMPLAINTS FILED BY FDA AGAINST DIETARY
SUPPLEMENT COMPANIES 2012-2014
K862653
ADYA CLARITY - INVESTIGATION RECS 01/01/2011 -
12/31/2013
SKELETAL DYNAMICS WRIST ARTHRODESIS NAIL -
COMPLAINTS, INVESTIGATIONS, IMPLANTS ETC
06/01/2014 - 10/14/2014
Any and all documents related to nanoparticles in
animal feed, including FDA's consultations with non
government entities regarding pre-market safety
assessments for nanoparticles in animal feed
P970051
FUJIFILM DIOSYNTH BIOTECHNOLOGIES, BILLINGHAM, UK -
483 7/14
GREEN PHARMACY - COMPLAINTS, REGISTRATION, AERS ETC
09/14/2007 -10/14/2014
AZATHIOPRINE - BLACK BOX WARNING 04/01/2011 -
12/01/2013
UNIV OF WISCONSIN-MADISON, WESTERN IRB -COMMERICAL
IRB COOPERATIVE AMENDMENT 2008
RECS FROM SENATE, HOUSE, LOBBYISTS ON BEHALF OF
UPTAKE MEDICAL CORP TO OBTAIN FDA APPROVAL FOR
MEDICAL DEVICES
MEALS ON WHEELS - FROZEN CHICKEN MEALS
VALEANT INTL - RETIN-A-MICRO NDA 20-475 SBA, MOR,
LBLG, ETC
ZOLOFT - MEDICAL OFFICER REVIEWS FOR INDICATIONS
HUMIRA BLA - CLINICAL TRIAL PROTOCOL PHASE II
STUDY, PATIENT INFORMED CONSENT FORM
FACEY MEDICAL GROUP - BEVACIZUMAB SPL 86634 TEST
RESULTS
K013695, K050344, K011236 ETC
ULTRAMAX ELEMENTS - COMPLAINTS, REGISTRATION, AERS
ETC 09/14/2007 - 10/14/2014
LANDMARK PHARM INTERNATIONAL - COMPLAINTS, AERS,
REGISTRATION ETC 09/14/2007 - 10/14/2014
CALIFORNIA PHARMACY AND COMPOUNDING CENTER, NEWPORT
BEACH, CA - EIR 8/18-25/14, SPL NUMBERS 853516,
853518 TEST RESULTS
GREEN PHARM NY LLC - COMPLAINTS, AERS, REGISTRATION
ETC 09/14/2007 - 10/14/2014
SEPRACOR - XOPENEX (LEVALBUTEROL HCL) NDA 20-
837/S006 APRVL RECS
CORR FROM FDA TO PAR PHARMACEUTICALS RE PREMATURE
NOTIFICATION OF A PARAGRAPH IV CERTIFICATION
EMERGENCY IND RECS EBOLA EMERGENCY USE
ACTIQ, FENTORA - AERS
PROVENGE - IND
RECOMBINANT ALPHA-L-IDURONIDASE - IND
K081285
PRESENTATIONS BY FDA/CVM EMPLOYEES DURING 2013 AND
2014 ANNUAL REGULATOR DAY MTG WITH ANIMAL HEALTH
INSTITUTE WORKING GROUP REPORTS SPEAKERS' NOTES
FCN 608 FORM 3480
ZEE MEDICAL, INDIANAPOLIS, IN - 483, EIR
10/01/2014 - 10/31/2014
VANCOMCYIN - AERS
CASE 9592323, 9723219, 9758264 SOURCE DOCUMENTS
CASE NUMBER: 9651982 SOURCE DOCUMENTS
CASE NUMBERS 9752947, 9790061 SOURCE DOCUMENTS
INTERCHANGE BETWEEN FDA AND NPS RE HIRING DATE OF
TENTATIVE AND OFFICIAL DATE OF JOB OFFER POSITION
ETC
DESOXYCORTICOSTERONE PIVALATE, DESOXYCORTICOSTERONE

ACETATE - ANIMAL STUDY REPORTS EVALUATING NO
OBSERVABLE ADVERSE EFFECTS LEVEL 01/01/1930 -
10/15/2014
JAY M COOPER, PHOENIX, AZ, DEC 2002 FEB 2001 - 483
NASAL MUPIRICIN OINTMENT - SUPP APPROVAL APRIL 1996

ULTRASLIM, LUXURIAN 150 RECS
TRIFEXIS - AERS, DEATHS
PHARMACEUTICALS INTERNATIONAL INCORPORATED, HUNT
VALLEY, MD - INSPECTION REPORTS 06/01/2013 -
10/15/2014
CITIZEN PETITION DATA 01/01/2000 - 12/31/2013
UCSF HOME THERAPY SERVICES , SAN FRANCISCO, CA
INCUMEDX LLC, FREMONT,CA CARDICA INC, REDWOOD,
CITY, CA - 483 9/1-30/14
AEDES AEGYPTI MOSQUITOS - RECS RE TEST IN FLORIA,

CONSULT BETWEEN FDA AND FLORIDA KEYS MOSQUITO
CONTROL DISTRICT, FDA COMMUNICATIONS BETWEEN FDA
AND OXITEC ETC
MEDONE SURGICAL INC, SARASOTA, FL OMEGA MEDICAL
IMAGING INC, SANFORD, FL MAGUIRE ENTERPRISES INC,
SUNRISE, FL - 483 9/1-30/14
L PERRIGO CO, ALLEGAN, MI THERAMETRIC TECHNOLOGIES
INC, NOBLESVILLE, IN L PERRIGO CO, HOLLAND, MI -
483 9/1-30/14
CONTINENTAL MANAUFACTURING CHEMIST INC, MADRID, IA
- 483 9/1-30/14
ULTRADENT PRODUCTS INC, SOUTH JORDAN, UT - 483 9/1-
30/14
3D IMAGING DRUG DESIGN, LITTLE ROCK, AR GOODIER
COSMETICS LP, DALLAS, TX VOSS MEDICAL PRODUCTS,
SAN ANTONIO, TX - 483 9/1-30/14
WESTERN SCOTT FETZER CO, WESTLAKE, OH SONOGAGE
INC, CLEVELAND, OH STERIS CORP, MENTOR, OH - 483
9/1-30/14
NANOPHASE TECHNOLOGIES, ROMEOVILLE, IL - 483 9/1-
30/14
ACTION MEDICAL SYS, HAGERTOWN, MD OTSUKA AMERICA
PHAMACEUTICAL INC, ROCKVILLE, MD - 483 9/1-30/14
BEST VASCULAR INC, NORCROSS, GA ENDO CHOICE INC,
ALPHARETTA, GA PATHEON MANUFACTURING SERVICES LLC,
GREENVILLE, NC - 483 9/1-30/14
BENTLEY LABS LLC, EDISON, NJ - 483 9/1-30/14
KEYSTONE LABS INC, MEMPHIS, TN TOTAL PHARMACY
SERVICES INC, HOUMA, LA - 483 9/1-30/14
BRISTOL MYERS SQUIBB INC, EAST SYRACUSE, NY - 483
9/1-30/14
MEDTRONIC PUERTO RICO OPERATIONS CO, VILLALBA, PR
COMBE PRODUCTS INC, NAGUABO, PR - 483 9/1-30/14
AMRI RENSSELAER, INC, RESSELAER, NY - INSPECTION
RECS 2014
HERON BOTANICALS, KINGSTON, WA - 483 9/1-30/14
ENVOY MEDICAL CORP, SAINT PAUL, MN BRENNTAG GREAT
LAKES LLC, MENOMONEE FALLS, WI PENRAD TECHNOLOGIES
INC, BUFFALO, MN - 483 9/1-30/14
LABORATORIO MAGNACHEM INTL SA, HAINA, DR ISHIHARA

SANGYO KAISHA LTD, YOKKAICHI SHI, JAPAN CADILA
HEALTHCARE LTD, AHMEDABAD CITY, INDIA - 483 9/1-
30/14
BRAINSWAY INC - 510K
HIGH CHEMICAL CO, LEVITTOWN, PA ACCUTOME
ULTRASOUND INC, MALVERN, PA MERCK SHARPE & DOHME
CORP, WEST POINT, PA - 483 9/1-30/14
LIFETECH RESOURCES LLC, CHATSWORTH, CA MINH CONG

VU DBA AURORA MEDBIOCHEM CO, ESCONDIDO, CA MICRO
CONNECTION ENTERPRISES, SANTA FE SPRINGS, CA - 483
9/1-30/14
UNFORS RAYSAFE AB, BILLDAL, SWEDEN COMBO AG,
LOMMISWIL, SWITZERLAND CONKIN SURGICAL INSTRUMENTS
LTD, TORONTO, CANADA - 483 9/1-30/14
GREGORY MANUFACTURING INC, HOLYOKE, MA
PHARMALUCENCE INC, BEDFORD, MA MALRBOROUGH
HOSPITAL, MARBOROUGH, MA - 483 9/1-30/14
3229036 3396290 3430678 ETC
ELBA LABORATORIES, TROY, MI - EIR 01/01/2011 -
10/15/2014
SPREADSHEET TO CALCULATE ESTIMATE OF BENEFITS FOR
STANDARDS FOR THE GROWING, HARVESTING, PACKING, AND
HOLDING OF PRODUCE FOR HUMAN CONSUMPTION
K954504
CAERS CONTACT INFORMATION
VAERS REPORT
LIFENET HEALTH, VIRGINIA BEACH, VA - EIR MOST
RECENT 01/01/2013 - 10/16/2014
3M, ST PAUL, MN - EIR
BETAPLACE, BETAPLACE AF - APPROVAL RECS
COMM BETWEEN FDA AND MARK POLHEMUS, STATE
UNIVERSITY OF NY UPSTATE MEDICAL FACILITY
01/04/2012 - 10/16/2014
LAMICTAL - AERS
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
METOCLOPRAMIDE HCL ER TABS 80 MG, 105 MG ANDA 202-

191 - FORFEITED ELIGIBILITY FOR 180 DAY
EXCLUSIVITY, MINOCYCLINE HCL ER TABS 80 MG, 105 MG
ANDA 091-118 - FORFEITED ELIGIBILITY FOR 180 DAY
EXCLUSIVITY
INVESTIGATION OF NON-FDA APRVD PRESCRIPTION DRUGS -
BILLS SHIPPING LOGS, INVOICES, ETC
MEDICAL DEVICES - TESTED OVERSEAS, WHERE OVERSEAS,
OVERSIGHT BY ANYONE OVERSEAS OR US
MIRAPEX (PRAMIPEXOLE) - INTERNAL & EXTERNAL COMM
1997 TO PRESENT
ROCKSTAR, 5-HOUR ENERGY, RED BULL,ETC - CAERS 1/12
TO PRESENT
MICRO LABS LTD, VERNA, GOA, INDIA - 483 RECENT
SHIPMENTS REGULATED BY US FDA 9/20/14 -10/15/14
SUN PHARMACEUTICAL INDUSTRIES LTD, HOLOL, GUJARAT,
INDIA - 483 9/8/14
GLUCOMANNAN, KONJAC, KONYAKU, ETC - CAERS
NATIONAL CENTER FOR NATURAL PRODUCTS RESEARCH
(NCNPR), OXFORD, MS - GRANT BUDGET 2004-2014
MEDICAL MARIJUANA LAW SUIT FILED AGAINST FDA 1994-
RECS
K132270, K140887
K984631, K012351
K121710
EXPERIMUR, CHICAGO, IL - 483, EIR
K080739, K092704
MPI RESEARCH, MATTAWAN, MI - EIR, 483 10/15/2004 -
10/15/2014
2014-4423
3I MINI IMPLANTS - APPROVAL RECS
XEOMIN - SUPPLEMENTAL APPROVAL RECS
K122356
2013-9594
2014-4656
2014-4604
VOLUNTARY COSMETIC REGISTRATION PROGRAM DATA LAST
FIVE YEARS
2014-4458
SAMPLE 692001 - LAB RESULTS
TORADOL - DRUG INSERT CERTIFIED 01/01/2003 -
04/30/2004
BACKER'S POTATO CHIP FACTORY, FULTON, MO -
INSPECTION RECS LAST FIVE
ANDA 203263 DOXORUBICIN HYDROCHLORIDE - SBA, CMC
SF 1012
K112909
Status letters related to grandfathered tobacco

product status determination issued by the Center
for Tobacco Products, OCE from May, 2013 through
July, 2013
Status letters related to grandfathered tobacco

product status determination issued by the Center
for Tobacco Products, OCE from March, 2013 through
September, 2014
ABILIFY - AERS
DKT 20014D-0758
NOVARTIS PAHRMS, EAST HANOVER, NJ 2/3-2814,
7/15/14-8/4/14 - EIRS, 483S, CORR, ETC
FLOSEAL - AERS, WARNINGS, DEAR DOCTOR LTRS, ETC
ALDER BIOPHARMS, BRISTOL MYERS SQUIBB -
CLAZAKIZUMAB RECS, COMM
MYLAN PHARMS, PFIZER INC - DILANTIN KAPSEALS,
PHENYTEK BLACK BOX WARNINGS, RPTS, STUDIES, ETC
1995 TO 2008
BENTEC MEDICAL INC, WOODLAND, CA - EIR
INVIVO - PLGA POLY-L-LYSINE SCAFFOLD IDE APPL
G110119 LTR 3/29/13
AASTROM BIOSCIENCES - INSP CORR LAST 4 YRS
MAYA OVERSEAS FOOD INC, MASPETH, NY - COMPLIANCE
AND STANDING RECS
BRAINSWAY INC - K122288
WARFARIN - AERS
MSM BLOOD DONOR BAN RECS
MIRACLE EAR HEARING AID
ZIAC - CLINICAL TRIAL RECS
K020802
ANDA 091019 SBA
ILLUMINA INC - RECS RE COMPLIANCE
EXPAREL - MEDWATCH REPORTS
QVAR - AERS
K090244
CH GUENTHER & SON INC, DUNCAVILLE, TX - EIR, SAMPLE
RESULTS 09/28/2014 - 10/25/2014
K132028, K134032
BACTOLAC PHARMACEUTICALS, HAUPPAUGE, NY - 483
11/05/2010 - 10/20/2014
K901348
ABC DOPHILUS - AERS
AMIODARONE WARFARIN - MEWATCH REPORTS

DSM NUTRITIONAL PRODUCTS - SCHIZOCHYTRIUM FAP
INDIAN DRUG FACILITIES - EIR RELEASED UNDER FOIA
GRN00449
BLACK LICORICE - AERS
ICLUSIG - ISR 10469062
QUESTIONS & ANSWERS FROM FD-578 ADVANCED MILK
PROCESSING COURSES HELD IN FY 05 REGIONAL MILK
SEMINARS HELD IN FY 06 (M-I-06-15) - ITEM 29 C
QUESTIONS & ANSWERS FROM FD-578 ADVANCED MILK
PROCESSING COURSES HELD IN FY05 REGIONAL MILK
SEMINARS HELD IN FY 06 (M-I-06-15) - ITEM 29 C
VALEANT, BRIDGEWATER, NJ - EIRS, 483S 6/13-26/14
OM REALITY ENTERPRISES INC, MASPETH, NY -
COMPLIANCE & STANDING RECS
NEIMENGGU FUFENG BIOTECHNOLOGIES CO LTD - XANTHAN
GUM CORR, MEMOS, RPTS, ETC
LIST OF ALL PAID CONSULTANTS USED TO RVW, ADVISE,

GUIDE OR RECOMMEND ANY AND ALL BIOSMILAR
EVALUATION METHODS & PROCESSES FOR APPL, RVW,
ANALYSES INTERPRETATION & THRESHOLD FOR APRVL
LIST OF DOMESTIC & FOREIGN INSP 8/1-31/14
FOOD PROCESSING FACILITIES - LIST OF LOCATIONS
ALTAIRE PHARMACEUTICALS, INC, AQUEBOGUE, NY - 483,
EIR, RESPONSE ETC 01/01/2011 - 10/16/2014
CREATINE NITRATE - NDI RECS
RHEIN BIOTECH GMBH - INSPECTION REC 08/03/2012 -
08/31/2012
BLA 125320/7
K141520
NADA 91-467, NADA 91-513
IMBRUVICA - SUPPLEMENTAL NDA
GRAS 2G0391
ALKERMES INC - EIR 05/01/2012 - 08/31/2012
49 FOREIGN VAERS REPORTS - COUNTRY OF ORIGIN
K113358
XARELTO - AERS
ANMEAL PHARMS - APRVL LTR 6/21/13, ROUTING SHEET
6/21/13 (CERTIFIED)
INDIVIDUAL RECS
AUROBINDO FACILITY UNIT VIII, HYDERABAD, INDIA -
EIR 5/23-26/11
BO YING COMPOUND - AERS
EMD MILLIPORE CORP - COLOR ADDITIVE PETITION 4C0299

INDIVIDUAL RECS
INDIVIDUAL RECS
FLAVOR AND EXTRACT MANUFACTURERS ASSOCIATION (FEMA)
- GRAS DETERMINATIONS 1960 TO PRESENT
POWDERED PURE CAFFEINE - CAERS 2005 TO PRESENT

CALIFORNIA SHELLFISH AND SHIPPING PROGRAM - PROGRAM
ELEMENT EVALUATION RPT (PEER)
SELINEXOR - AERS
CARDIIOVASCULAR AND RENAL DRUGS A/C - BRIEFING
RECS, PRESENTATION SLIDES, ETC 1/28/99
ORGANIC SPROUTED CHIA SEED - SALMONELLA OUTBREAK
RECALL RECS 7/14
CONTRAVE (NALTREXONE HCI, BUPROPION HCI) NDA 200-
063 - APRVL RECS
JEFFREY ROSEN, CLINL RES S FLORIDA, CORAL GABLES,
FL - 483S 4/02 TO PRESENT
INVESTIGATION RECS
K060745, K051772, K111338, ETC
ESTRACE (ESTRADIOL VAGINAL CREAM) ANDA 86-069 IND
AMENDMENTS
LIST OF INSPECTIONS 03/15/2014 - 10/20/2014
PHARMCO-AAPER PRODUCTS, INC. - EIR, 483, RECALL
RECS
ARAVA - NDA, SUPPLEMENTS
K934440
RICE BRAN WAX - FAP
K122288
BIOMERIEUX - WARNING LETTER 09/01/2014 - 10/22/2014

LOUISIANA STATE UNIVERSITY HEALTH SCIENCES CENTER,
SHREVEPORT, LA - EIR 07/01/2006 - 10/01/2014
K1212215, DEN120016
K123795
K141865
CUBIST PHARMACEUTICALS, LEXINGTON, MA - 483
05/01/2014 - 07/31/2014
NILOTINIB HYDROCHLORIDE MONOHYDRATE - STUDY
PROTOCOL 2101
1988 Tentative Final Monograph FR Vol 53, No 221
IMBRUVICA, ZYDELIG, TECFIDERA ETQ - AERS
K081442
PMA 130024
ANDA 202857 SBA
K121700
RECKETT BENCKISER, SALT LAKE CITY, UT - EIR
06/01/2014 - 10/22/2014
ISR 7023409 7097426 7179247 ETC
K061072
K042253
K053025
ANDA 200653 EFFECTIVE APPROVAL LETTER
MEDXPERT GMBH, ESCHBACH, GERMANY - EIR 1/20-21/14
NSPIRED NATURAL FOODS - MARANATHA ROASTED CREAMY
ALMOND BUTTER - RECALL 1/14
LO PROFILE EXTENSION SET K920788 BLOOD
ADMINISTRATION SET K920788 DOUGLAS MEDICAL
PRODUCTS INC IRRIGATION SET K922318
PREDNISOLONE SODIUM PHOSPHATE ORAL SOL ANDA 075-250
- APRVL
IMPAX LABORATORIES INC - RYTARY EIR, 483, WARNING
LTR, APRVL 1/13 TO PRESENT
APOTEX RESEARCH PRIVATE LTD, BANGALORE, INDIA -

GENETIC FACTORS IN TASTE PERCEPTION AND TOBACCO
USAGE STUDY REAL-TIME MEASURMENT AND UPTAKE OF
CARCINOGENS BY MENTHOL CIGARETTS SMOKERS STUDY, ETC
K080613
K082391 K121481 K963204 ETC

K103758
ULTRA PURE SOLUTIONS, INC, CASTROVILLE, CA - EIR,
483, RECALL RECS 10/01/2011 - 10/23/2014
K091641
K131948
GAMMA-AMINOBUTYRIC ACID (GABA) - AERS

K132317
K112181
EZ FLU A+B RAPID FLU DIAGNOSTIC CLEARANCE RECS
K112226
K140104
K103305
K041551
K001678
SIRONA DENTAL SYSTEMS GMBH, HESSEN, GERMANY -
ORTHOPHOS-XG-3D/CEDH K990528, VARIANCE RPT
VATECH CO, GYEONGGIDO, REPUBLIC OF KOREA - PAX-I3D
VARIANCE RPT K132983
IMAGING SCIENCES INTL, HATFIELD, PA - I-CAT SLX
K051980, VARIANCE RPT
MEDICINAL LEECHES - K040187
MEDICINAL LEECHES - K132958
THE SARAH CANNON RESEARCH INSTITUE, NASHVILLE, TN,
DENISE YARDLEY- 483S 3/27/12
GUSTAVO LUGO-ZAMUDIOHOSPITAL JUAREZ, MEXICO CITY-
483S 7/7/08
PETER MERKEL UNIV OF PENN MEDICAL CENTER,
PHILADELPHIA, PA - 483S
KATHY MILLER,INDIANA CANCER PAVILION, INDIANAPOLIS,
IN,- 483S 12/6/11
SOUTHEAST REGIONAL RESEARCH GROUP, COLUMBUS, GA,
JEFFREY KINGSLEY - 483S 1/13/14, 2/24/14
JOHN HAINSWORTH,THE SARAH CANNON RESEARCH INSTIUTE,
NASHVILLE, TN, - 483S 2/23/11
SCOTT LEE,UNIVERSITY OF WASHINGTON MEDICAL CENTER,
SEATTLE, WA - 483S 9/3/3
RONALD FOGEL,HENRY FORD HOSPITAL, DETROIT, MI -
483S 9/5/07
TOTAL SPENT ON STUDENT LOAN REPAYMENT LAST FISCAL
YR
LIST OF ENFORCEMENT RPTS LAST FISCAL YR
TOTAL COST TO PROCESS FOA/PA REQUESTS - LAST FISCAL
YR
LIST OF ALL MOU IN WHICH FDA ENTERED INTO
RPT SUBMITTED TO CONGRESS REGARDING FDA - MOST
RECENT
FOIA LOG - LAST FISCAL YR
BUDGET - CURRENT FISCAL YR
QIAGEN GMBH, HILDEN, GERMANY - EIRS 3/4-5/14
TOPICAL PARAMOMYCIN WITH OR WITHOUT GENTAMICIN FOR
CUTANEOUS LEISHMANISIS - RECS 6/13/13
OREGON COMPOUNDING CENTER INC (CREATIVE
COMPOUNDINGS, AN OREGON PHARMACY) - EIRS, WARNING
LTRS, RECALLS, ETC 1/13 TO PRESENT
NDA 203684
AQUABOUNTY - CORR RE CONSIDERATION OF APPROVAL
LASERS SOLD AS POINTERS - CDRH RECS RE REGULATION,
LETTERS TO MANUFACTURERS, PUBLIC NOTICES
UBIQUINOL - MEDWATCH REPORTS

CINAMOMUN VERUM, CINAMOMUN CASSIA - MEDWATCH
REPORTS
ENDOPHTALMITIS AT RETINA & VITREOUS - RECS AND LAB
RESULTS ETC
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
SIMULATIONS PLUS INC - MODELING AND SIMULATION FOR

OCULAR DOSAGE FORMS PROJECT #1U01FD005211-01
SIMCYP LTD - DEVELOPMENT AND VALIDATION OF DERMAL
PBPK PROJECT #1U01FD005225-01
INDIVIDUAL RECS
INDIVIDUAL RECS
ETHICON INC - GYNECARE LAPAROSCOPIC MORCELLATOR

K993801 COOK UROLOGICAL INC - COOK TISSUE
MORCELLATOR K910939, K925851 LUIMENIS INC -
VERSACUT AND TISSUE MORCELLATOR K133272, ETC
BULK INGEDIENT DRUG PROD LISTING 1/11 TO PRESENT
ALEMBIC PHARMACEUTICALS LTD, GUJARAT, INDIA - EIR
8/27-30/12
NOVARTIS PHARMS - NEORAL (CYCLOSPORINE CAPS, ORAL

SOL) NDA 50-715, NDA 50-716 LTR 5/8/00 DUPONT MERK
PHARMACEUTICAL CO - COUMADIN (WARFRIN SODIUM TABS)
NDA 9-218 LTR 8/26/97
DKT 2001P-0481, DKT 2001P-0122, DKT 2002P-0059, ETC

EBOLA OUTBREAK PLANNING OR DECISION-MAKING - MEMOS,
EMAILS, ANALYSES, ETC 6/14 TO PRESENT
TOTAL AMOUNT SPENT ON RECRUITMENT INCENTIVES LAST
FISCAL YEAR
LIST OF GRANT RECIPIENTS, AMOUNT GIVEN BY FDA LAST
FISCAL YEAR
BIOTENE, BIOTENE PBF DRY-MOUTH MOUTHWASH K101477
BIOTENE ORAL BALANCE, DRY MOUTH ORALRINSE,
MOISTURIZING MOUTH SPRAY K123731
DR FRESH'S DRY MOUTH MOUTHWASH K111250
IMPORT REFUSAL AFJ-1917797-6/932/1, 9BM-0025994-
8/1/1 - IMPORTER
ANDA 090656 SBA
ANDA 078007 SBA
HIGH ERUCIC RAPESEED MEAL AS FEED OR FOOD
INGREDIENT IN LIVESTOCK OR HUMAN FOOD 01/01/2010 -
10/27/2014
GARDISIL - BLA
ROSCOE MEDICAL SOUNDCARE PLUS - COMPLAINT RECS
01/01/2014 - 08/31/2014
K100820
ORAMED PHARMACEUTICALS, INC - RECS FILED WITH FDA
RE DRUG APPLICATIONS 01/01/2008 - 10/21/2014
BIOSIMILARS DATA 01/01/2006 - 01/01/2013
K093565
NDA 20-599 supplements 2-011, S-012 and S-013
K101458
FINASTERIDE, PROPECIA, PROSCAR - REVIEWS, FAERS
2004 MOU LETTER BETWEEN FDA AND SEC

Novartis Vaccines and Diagnostics GmbH & Co. KG
Emil-Von-Behring-Str. 76 Marburg, Germany - EIR MAY
6 2014
NOVARTIS VACCINES AND DIAGNOSTICS, MARBURG, GERMANY
- EIR 06/30/2014 - 06/30/2014
NDA 18723 S017 - APPROVAL LETTER (CERTIFIED)
BEACON HILL MEDICAL PHARMACY PC, SOUTHFIELD, MI -
EIR, 483, CO RESP 7/1-19/13
NEPHRON PHARMS ORLANDO, FL - EIR, 483, CO RESP
2/10-21/14
BAXTER SA, LESSINES, BELGIUM - EIR, 483, CO RESP
6/10-18/13
CHINA RESOURCES SANJIU MEDICAL & PHARMACEUTICAL CO

LTD, SHENZHEN, CHINA - EIR, CO RESP, 483 3/24-28/14
CHONGQING XINFENG MEDICAL INSTRUMENTS CO LTD -
K043558
ANGIO DYNAMICS - NANOKNIFE SAFETY REPORT
DR FENG GU, BEIJING, CHINA - 5/12-16/14 DR MONICA
GADELHA, RIO DE JANEIRO, BRAZIL 5/19-23/14, ETC -
482S, 483S, EIRS, ETC
DR KIM PAPP CANADA 4/28/14-5/9/14 JACEK
SZEPIETOWSKI, POLAND 5/5-15/14 - 482S, 483S, EIRS,
ETC
SYNE QUA NON LTD, NORFOLK, UK 3/5-10/14 - 482,
483, EIR, ETC
VASCULAR SOLUTIONS INC - DUETT PRO CLOSURE MDRS
(CERTIFIED)
MISOPROSTOL (CYTOTEC) - APRVL, NDA 19268/S037
12/27/88 TO PRESENT
PHOENIX MEDICAL DEVICES LLC - EIRS, MDRS, CMPLNTS,
ETC
ELITE MEDICAL SUPPLY, WEST SENECA, NEW YORK - EIRS,
REGULATORY ACTIONS, 510K APRVLS, ETC
CASE 2014-23720 - TRIFEXIS AER
MINSA CORPORATION, MULESHOE, TX - 483, RESPONSES
01/01/2012 - 10/28/2014
K944486
11-1F4 - ORPHAN DRUG DESIGNATION RECS
K121610
K050574
K093548
NAME AND ADDRESS OF ALL SWITZERLAND CHEESE
EXPORTERS WHO HAVE RECEIVED AN LACF REGISTRATION
LACF 01/02/2013 - 10/28/2014
HYDROCHLOROTHIAZIDE 12.5 - AERS 10/28/2004 -
10/28/2014
ECLIPSE, ECLIPSE MENTHOL - SUBSTANTIAL EQUIVALENCE
RECS
K051321, K090413
ANDA 091449, ANDA 076218 - APPRVAL LETTERS
NELSON WATTS, MD, CINCINNATI, OH - 483 03/03/2014 -
04/30/2014
MICRO LABS LIMITED, INDIA - 483 01/02/2013 -
10/28/2014
ATENOLOL - AERS
ANDA 084110
ANDA 203395, 076826, 076616, ETC APPROVAL LETTERS
JOHN BILEZIKIAN, NEW YORK, NY - 483 03/03/2014 -
04/30/2014
2014-7884 - REQUEST LETTER ONLY
AMERICAN SNUFF COMPANY LLC, CLARKSVILLS, TN -
PREVIOUSLY RELEASED INSPECTION RECS 01/01/2011 -
12/31/2012
ABBOTT MOLECULAR, DES PLAINES, IL 6/23/14-7/11/14,

AKORN INC, DECATUR, IL 5/28/2014-662014, BMC 1092
INC (SOLO LABS INC), BROADVIEW, IL 2/18/14-
3/13/2014, ETC - 483S
MIKART INC, ATLANTA, GA 4/16-23/14, PFEIFFER

PHARMACEUTICAL INC, ATLANTA, GA 3/27-31/14, STRADIS
HEALTHCARE LLC, LAWRENCEVILLE, GA 3/17-26/14, ETC -
483S
AAA PHARMACEUTICAL INC, LUMBERTON, NJ 3/5-14/14,

AAIPHARMA ANALYTICAL SERVICES, EDISON, NJ 6/25/14-
7/17/14, AKORN INC, SOMERSET, NJ 4/7/14-5/29/14,
ETC - 483S
ALAZA CORP, VACAVILLE, CA 3/4/14/14, BIOGENEX

LABORATORIES INC, FREMONT, CA 6/5/14-7/1/14,
BIOMARIN PHARMACEUTICAL INC, NOVATO, CA 4/8-17/14,
ETC - 483S
API RESOURCES LLC, SAN ANTONIO, TX 3/4-7/14, CBI

LABORATORIES INC, FORT WORTH, TX 1/15/14-2/14/14,
CEUTICAL LABORATORIES INC, FARMERS BRANCH, TX 2/5-
24/14, ETC - 483S
ACME MONACO CORP, NEW BRITAIN, CT 2/18/14-3/7/14,
MAREL CORP, WEST HAVEN, CT 5/30/14-6/24/14, CITRA
LABS LLC, BRAINTREE, MA 6/2-13/14, ETC - 483S
3M UNITECK CORP, MONROVIA, CA 3/17-27/14, BAUSH &
LOMB INC, IRVINE, CA 7/21-25/14, GILEAD SCIENCES
INC, SAN DIMAS, CA 5/7-16/14, ETC - 483S
AMERICAN FAMILY PHARMACY LLC, INDIANAPOLIS, IN

6/11/14-7/8/14, BIOMET INC, WARSAW, IN 6/16-30/14,
COVANCE LABORATORIES INC, GREENFIELD, IN 6/2-6/14,
ETC - 483S
AMYLIN OHIO LLC, WEST CHESTER, OH 7/7-22/14,
MIDMARK CORP, VERSAILLES, OH 5/19/14-6/9/14,
PROCTER & GAMBLE CO, CINCINNATI, OH 5/28/14-6/2/14,
ETC - 483S
TARO PHARMACEUTICALS, BRAMPTON, CANADA 2/24-28/14,
VALEANT PHARMACEUTICALS INTERNATIONAL, LAVAL,
CANADA 6/11-15/14 483S
ABBOTT HEALTHCARE (PUERTO RICO) LTD, BARCELONETA,

PR 5/12-20/14, BAXTER HEALTHCARE CORP, JAYUYA, PR
1/15/14-2/11/14, ABBVIE BIOTECHNOLOGY LTD,
BARCELONETA, PR 7/1-16/14, ETC - 483S
SIEMENS HEALTHCARE DIAGONSITICS INC, NEWARK, DE

3/31/14-4/23/14, CARDIAC ASSIST INC, PITTSSBURGH,
PA 1/24/14-2/7/14, AUXILIUM PHARMACEUTICALS INC,
HORSHAM, PA 4/14-22/14, ETC - 483S
PHARMACEUTICS INTERNATIONAL INC, COCKEYSVILLE, MD
7/7-17/14, MYLAN PHARMACEUTICALS INC, MORGANTOWN,
WV 3/10-21/14 - 483S
AVEVA DRUG DELIVERY SYSTEMS INC, MIRAMAR, FL

3/31/14-4/11/14, BELCHER PHARMACEUTICALS LLC,
LARGO, FL 1/15-14/2/3/14 PRIME PACKAGING INC,
MEDLEY, FL 4/16-29/14, ETC - 483S
ALTAIRE PHARMACEUTICALS INC, AQUEBOGUE, NY 7/14-

29/14, AMNEAL PHARMACEUTICALS OF NEW YORK LLC,
HAUPAUGE, NY 1/9/14-2/7/14, AMNEAL PHARMACEUTICALS,
BROOKHAVEN, NY 5/5-16/14, ETC - 483S
COVIDIEN PLC, BOULDER, CO 5/28/14-6/10/14, EDWARDS

LIFESCIENCES LLC, DRAPER, UT 3/3/14-4/11/14,
MEDTRONIC NAVIGATION INC, LOUISVILLE, CO 1/30/14-
2/19/14 - 483S
VERATHON INC, BOTHELL, WA 7/8-23/14 - 483S
HOSPIRA INC, MEPHERSON, KS 4/14-23/14, K C
PHARMACEUTICALS INC, BRENTWOOD, MO 2/21/14 - 483S
AMERICAN MEDICAL SYSTEMS INC, MINNETONKA, MN 2/4-
24/14, SMITHS MEDICAL ASD INC, SAINT PAUL, MN 4/8-
23/14 - 483S
BAYER PHARMA AG, BERLIN, GERMANY 5/5-13/14,

BOEHRINGER INGELHEIM PHARMA GMBH & CO KG, INGELHEIM
AM RHEIN, GERMANY 2/24/14-3/7/14, HOLOPACK
VERPACKUNG STECHNIK GMBH, ABTSGMUND,
UNTERGRONINGEN GERMANY, ETC - 483S
QUALITWEST PHARMS, HUNTSVILLE, AL 7/28/14-8/1/14,
MEDTRONIC SOFAMOR DANEK USA INC, MEMPHIS, TN 3/6-
11/14 - 483S
JANSSEN PHARMACEUTICA - RISPERDAL TABS NDA 20-272
SBA (CERTIFIED)
ACTOS - TEST RESULTS, LIST OF BAD DRUGS, NORMAL
TIME RANGE AN ANTIBIOTIC CAN BE USED ON A HUMAN
BEING
REUMOFAN - RECALLS, WARNINGS, TESTS, ETC
PLUM PBC (PLUM ORGANICS) - RECALL, RPTS, AUDITS,
ETC
MILK BASED POWDER SIMILAC ADVANCES COMPLETE

NUTRITON INFANT FORMULA WITH IRON - SPL 797456 RECS
MENNEN SPEEDSTICK POWER FRESH DEODORANT WITH
ANTIPERSPIRANT - OTC DRUG RVW RECS
HEARTLAND TANNING INC - REPORTS FOR SUNDAZZLER
BEDS, RAVE BULBS
K120187
K133753
K081076
BLUE BIRD MEDICATED FEED LABELS
HHE CFSAN,4/25/86 FDA ENFORCEMENT REPORT 8/23/89
FDA ENFORCEMENT REPORT 5/19/93
JOHN NAGLE CO - EIR 07/11/2013 - 07/11/2013
VETERINARY MEDICINE A/C - CONFLICT OF INTEREST
DISCLOSURE RECS AND WAIVERS 1999, 2002, 2004, 2006
HUNTINGDON LIFE SCIENCE, EAST MILLSTONE, NJ - 483
9/14, 10/14
QUESTCOR PHARMACEUTICALS INC - HP ACTHAR GEL
(REPOSITORY CORTICOTROPIN INJ) FOIA REQUESTS LAST
SIX MONTHS
MALLINCKRODT PHARMS, HAYWARD - RECS
AMERICAN MEDICAL SYSTEMS, ATHLONE, IRELAND - EIR
11/13
KENTUCKY FRIED CHICKEN BREADING RECIPE
SAMPLE COLLECTION REPORT 800107
2014-8188
FAST FOOD RESTAURANT INSPECTION FAILURES
MAUDE FACILITY INFORMATION
TARO PHARMACEUTICALS - EIR, CORR 01/01/2014 TO
10/28/2014
PLEXUS, CHINA - EIR 03/10/2014 - 03/14/2014
TREANDA - FAERS
COMMUNICATIONS BETWEEN LOBBYIST ANTONIO C MARTINEZ
AND FDA 10/10/2010 - 10/28/2014
K093677
K030096
K110097
KEYTRUDA - 10457384, 10329858
NDA 20468 S35
DR ALAN W HELDMAN - EIR, ADDITIONAL REC 01/01/2013
- 05/31/2013
K131603 REVIEW NOTES
K100577
NDA 22535
REVLIMID - AERS
ESOMEPRAZOLE MAGNESIUM DELAYED-RELEASE - FIRST
COMPANY TO SUBMIT ANDA, EXCLUSIVITY
K830755
JUXTAPID - COMPLAINTS IN OFFICE OF PRESCRIPTION
DRUG PROMOTION
NDA 205832
ESSENTIAL PHARMACEUTICALS, LLC - CORR, MEMOS
K132547
TOKAI PICKLING CO, LTD, TAHARA, JAPAN - EIR NOV
2013
PLANTA RIO BRAVO - 483, RESPONSE, EIR ETC
LABELING CHANGE SUPPLEMENTS FOR MEDICAL DEVICES
SUBMITTED BY SPONSORS 1/1/05 TO 10/31/14
EVISTA - AERS
K141321
K102307
ALL RECS RE 10/21/14 COMMUNICATION RE REGISTRAR
CORP, 3/21/08 COMMUNICATION ARCHIVING
BLA 125514/0
K133546, K132833, K120560 ETC
CLOSED FOIA REQUESTS 10/6/11/14
CLOSED FOIA REQUESTS 9/29/14-10/4/14
CLOSED FOIA LOGS 10/6-10/14
SHIPMENTS REGULATED BY THE UNITED STATES FOOD &
DRUG ADMINISTRATION 10/15-31/14
SANOFI PASTEUR LTD, TORONTO ONTARIO CANADA - EIRS
4/10-25/12, 9/9-20/13
PB-241 959/6 - CARBON DIOXIDE GAS SCIENTIFIC
LITERATURE RVW 1920 TO 1974
CHRONOLOGICAL LIST OF PETITIONS 1/97 TO 1/14
CLOSED FOIA REQUESTS OCTOBER 2014
QUALITY PACKING SPECIALISTS INTERNATIONAL LLC,
MACUNGIE, PA - EIRS, 483S, WARNING LTR, ETC
HIKMA FARMACEUTICA, PORTUGAL - 483 MARCH 2014
2012-6593
2013-5968
2013-893
INTERNATIONAL DRUG SCHEDULING: CONVENTION ON

PSYCHOTROPIC SUBSTANCES: WORLD HEALTH ORGANIZATION
SCHEDULING RECOMMENDATIONS FOR SEVEN DRUG
SUBSTANCES - MESCARB STUDIES, RPTS, COMMENTS, ETC
IPCA - 483 07/18/2014 - 11/18/2014
ISR 5933585, 7322363, 8146114, ETC COUGH & COLD
PREPARATION
ROSUASTATIN, PITIVASTATIN, PRAVASTATIN - AERS
UPSHER-SMITH LABORATORIES INC - PACERONE ANDA 75-
315, 5 MOST RECENT LABEL UPDATES, APRVL LTR
FELIODIPINE ANA 75-896 , PROPAFENONE ANDA 75-998 -
REC
ZOMETA - AERS
CYPROHEPTADINE HCI TABS - APRVD LBLG
PROVETUS BROPHARMACETWICALS INC - PV-10 MTG MINS
12/16/13
LABS PVT LTD, NAVI MUMBAI - EIRS 4/28-29/14 NON
REDACTED
BOEHRINGER-INGELHEIM - PYRAMID 5 (VOVINE

RHINOTRACEHETIS-BIRUS DIARRHEA-PARAINFLUEZA3-
RESPIRATORY SYNCYTAL VIRUS VACCINE (MODIFIED LIVE
VIRUS), PRESPONSE HM PRISM 5 & EXPRESS 5 HM VAERS
2009 TO 2014
ERWINAZE IND 125359
ANDA 078007
NADA 102-380
ANDA 090656
K140510
RECS TO AND FROM OLYMPUS, GYRUS RE MORCELLATION,
MORCELLATORS, REQUESTS 01/01/2010 - 10/31/2014
SPECIALTY COMPOUNDING LLC - REPORT, MEMO, STUDIES
ETC 03/01/2013 - 11/01/2014
K932301
K140378
ANDA APPROVAL LETTERS
STATINS - LUNG INJURY RECS
OCCIDENTAL CHEMICAL CORP, OCCIDENTAL PETROLEUM CORP
- WARNING LETTERS, INSPECTION NOTES RE 1999 WARNING
LETTER
DR VAUGHN H MANCHA JR - 483, WARNING LETTER CLOSE
OUT
2014-8396
10/31/2014
GREEN PHARM NY LLC, GREEN PHARMACY INC, ULTRAMAX
ETC -REGISTRATION, ADVERSE EVENTS, CERTIFICATES OF
FREE SALE ETC 09/14/2007 - 10/21/2014
2014-6640
2014-1905
CENTINEL SPINE INC - STALIF CTI, STALIF C K142079
STANDARDS FOR THE GROWING, HARVESTING, PACKING, AND
HOLDING OF PRODUCE FOR HUMAN CONSUMPTION
CERUS CORP - INTERCEPT BLOOD SYS (S-59 TREATED FFP)
ORPHAN DRUG DESIGNATION
OCTAPHARMA USA INC - UNIPLUS ORPHAN DRUG
DESIGNATION
OMEROS CORP - HUMAN MONOCLONAL ANTIBODY INHIBITOR
OF MANNAN-BINDING LECTIN-ASSOCIATED SERINE
PROTEASE-2 (MASP-2) ORPHAN DRUG DESIGNATION
ABLYNX NV - ALX-0081 ORPHAN DRUG DESIGNATION
ARCHEMIX CORP - ANTI-VON WILLEBRAND APTAMER ORPHAN
DRUG DESIGNATION
LFB BIOTECHNOLOGIES SA - COMPLEMENT FACTOR H ORPHAN
DRUG DESIGNATION
CRINOS INTERNATIONAL - DEFIBROTIDE ORPHAN DRUG
DESIGNATION
ALEXION PHARMACEUTICALS INC - SOLIRIS (ECULIZUMAB)
OMEROS CIORP - MASP-2 ORPHAN DRUG DESIGNATION
TEIJIN AMERICA INC - HUMANIZED MONOCLONAL ANTIBODY
BAXTER HEALTHCARE CORP - RECOMBINANT DISINTEGRIN
AND METALLOPROTEASE WITH THROMBOSPONDIN TYPE 1
MOTIFS ORPHAN DRUG DESIGNATION
ALEXION PHARMACEUTICALS INC - SOLIRIS (ECUZILUMAB)
ADIENNE SA - MUBODINA(R) (RECOMBINANT HUMAN
MINIBODY AGAINST COMPLEMENT COMPONENT) ORPHAN DRUG
DESIGNATION
CLOSED FOI REQUESTS 9/22-26/14
CLOSED FOI REQUESTS 9.15-19/14
Releasable records and documents pertaining to the
breakthrough designation requests and approvals for
approved drug products
K070270
NADA 034-478
REGISTRAR - FDA COMM 10/21/14
DEVICE LISTING DATABASE 01/01/1985 - 01/01/2014
RepelCV DMA - CMC Review Report - Pharmacology
Review Report -Toxicology Review Report -
Clinical/Biostatistics Review Report
ANDA 203395, 076826, 076616, ETC APPROVAL RECS
MEDWATCH EVENT
NUBAIN - SBA SUMMARY REVIEW, MEDICAL REVIEW ETC
Approval Packages/Review of Generic Zolpidem

Tartrate Extended Release Tablets 6.25 mg/12.5mg
ANDA No. (a) 200266 (b) 090153 (c) 090107 (d)
078970 (e) 078179 (f) 078148
K050738
COMPAZINE - AERS
K122480
UNICONDYLAR SLED KNEE PROSTHESIS - ADVERSE EVENTS,
APPROVAL RECS 01/01/2003 - 01/01/2014
K111501
BIOGENESIS LABS, HACKENSACK, NJ - EIR, 483
01/01/2010 - 11/01/2014
INDIVIDUAL RECS
ANDA 071961 SBA
GREEN TEA EXTRACT - AERS

K131696 SUMMARY
BLA 103353
K120582
K130341
HARRY J BOSWORTH COMPANY - EIR 2013
BACLOFEN - AERS
LILLY OF THE DESERT, MERCEDES, TX - 483, EIR
01/01/2010 - 11/01/2014
K113231
OSIRIS REGISTRATION OF CARTIFORM HUMAN CELL AND
TISSUE PRODUCT WITH FDA, FORM FDA-3356, AERS ETC
BLA 125294
BLA 125409
2012-7667
K033622
K133718
NUMBER OF REMS DRUG ERROR REPORTS 01/01/2005 -
12/31/2013
K070157
2014-7558
K070964, K120743
IPCA - 483 10/16/2014 - 11/05/2014
IPCA - 483 10/13/2014 - 11/17/2014
IPCA - 483 10/13/2014 - 10/20/2014
IPCA Laboratories, India - 483
IPCA - 483 10/01/2014 - 11/05/2014
FOIA LOG 08/01/2014 - 10/31/2014
HIKMA FARMACEUTICA SA - WARNING LETTER 10/01/2014 -
10/31/2014
EXPEDITOR, CAROLINA, PR - INSP
DAILY LOG 9/22-27/14
DAILY LOG 9/29 - 10/4/14
DAILY LOG 10/13-18/14
DAILY LOG 10/13-17/14
DAILY LOG 9/29 - 10/3/14
DAILY LOG 9/29-10/3/14
DAILY LOG 10/13-17/14
DAILY LOG 9/29-10/3/14
DAILY LOG 10/13-17/14
DAILY LOG 9/29-10/3/14
DAILY LOG 10/13-17/14
DAILY LOG 9/29-10/3/14
DAILY LOG 10/13-17/14
COPIES OF FOIA REQUESTS
MARATHON VENTURES, INC - 483, EIR, RESPONSES
01/01/2014 - 11/03/2014
DEPUY LOT 3247367, 3388543, 249638, ETC -
INVESTIGATION, LETTERS TO PHYSICIANS, FAILURE
REPORTS
DUOBLO ULTRASOUND ABLATION PRODUCTS -
INVESTIGATION RE UNAUTHORIZED IMPORTATION
11/01/2013 - 10/31/2014
ICLUSIG - AERS
ALTERNATIVE BRANDS INC - SUBMISSIONS UNDER CHAPTER
IX OF FDCA, CORR RE SUBMISSIONS
ANDA 200675
JUDGE ROTENBERG EDUCATIONAL CENTER, CANTON, MA -
483 10/3/12
DIANNE'S FINE DESSERTS, LECENTER, MN - EIR
EASTERN PHARMACY, INC, DAOUD A ZAYED, OCALA, FL -
INSPECTION REPORTS, COMMUNICATIONS, VIOLATIONS ETC
06/04/2013 - 11/04/2014
MATTHEW SCOTT TUCKER, STEVEN PRESSMAN, PURETEK
CORPORATION, ETC - WARNING, NOTICE, ADVERSE ACTION
APRIL 28 2011 MEETING BETWEEN FDA AND NATIONAL
REYES SYNDROME FOUNDATION - TRANSCRIPT, PAPERS,
POWERPOINTS 01/02/2000 - 01/02/2014
INDIVIDUAL RECS
CORR BETWEEN FDA AND DK DISTRIBUTOR INC, LIT
DISTRIBUTOR INC, KING MOUNTAIN TOBACCO CO INC RE
TOBACC PRODUCT USER FEES
NDA 020165
NDA 017821
2014-3782
2014-4093
NDA 21928
ESCITALOPRAM - THERAPEUTIC TESTING, EQUIVALENCIES
01/01/2013 - 11/01/2014
SE0000282, SE0000283, SE0000284, ETC
2013-7692
2014-4773
2014-4996
2014-7356
2014-3606
APPLICATIONS FOR MALE CONTRCEPTION 1988 - 2014
FOI DALIL LOGS 9/8-12/14
LIST OF 483S FOR PHARMACUTICAL, BIOLOGICS, MEDICAL

DVC MFG & CLNCL TRIAL FACILITIES 10/1-31/14
F HOFFMANN-LA ROCHE AG, HOFFMANN-LA ROCHE LTD,

HOFFMANN-LA ROCHE INC - CORR BTWN INTERNATIONAL
PROGRAMS & HEALTH CANADA IN REGARDS TO ACCUTANE
(ROACCUTANE)
FORM 3500A - MDRS
DR REDDY'S, SHREVEPORT, LA - CMPLNT
PREMARIN, PREMPRO, PREMPHASE - MEDWATCH RPTS 1964,
1967 TO PRESENT
ZOLOFT (SETRALINE) - AERS
ROCHE PHARMS - KLONOPIN (CLONAZEPAM) AERS
APRVL LTR 204555 (CERTIFIED)
IOVATE, HYDROXYCUT, SMARTBURN ETC -CAERS 8/5/14 TO
PRESENT
SMPLY THICK, SIMPLY THICK LLC - FOI REQUEST LTRS
9/17/14 TO PRESENT
FIRST SHIELD TRIO SPOT-ON CANINE FLEA APPL - CORR
BTWN FEDERAL, STATE GOVERMENT, SCHUYLER LLC, CEVA
ANIMAL HEALTH, ETC APRVL LABEL, EFFECTS, ETC
STATSTICAL RVW & EVALUATION - ANTIEPILEPTIC DRUGS &
SUCIDALITY 5/23/08 (CERTIFIED)
MICROBIOLOGICAL SPLS OF MILK POWDER PLANT

ENIVIRONMENTS FOR TESTTING FOR SALMONELLA AND
CRONOBACTER SAKAZAKII - SAMPLING ASSIGNEMTS ISSUED
IN 2014
UNIVERSITY OF MISISSIPPI NATIONAL CENTER FOR

NATURAL PRODUCTS RESEARCH - GRANT RE SCIENCE BASED
AUTHENTICATION OF DIETARY SUPPLEMENT 06/01/2004 -
09/30/2009
Historical Datafiles of the Orange Book including
expiry dates, market exclusivity dates and approval
dates
THORNE - AERS, CORR 08/05/2013 - 11/01/2014
STRYKER INSTRUMENTS - EIR 10/29/2012 - 11/05/2014
MEDWATCH REPORT RECS
INFLIXIMAB - ORPHAN DESIGNATION RECS
BIOMERIEUX - RESPONSE LETTER 10/10/2014 -
11/15/2014
LEXICON PHARMACEUTICALS - COMMUNICATIONS WITH FDA
RE LX4211 01/01/2010 - 11/05/2014
DEN140019
VALPROATES - INDIVIDUAL CASE REPORTS
GLUCOSAMINE - AERS
FAP 2289
09/25/2014
SHIMADZU SCIENTIFIC, COLUMBIA, MD - INVESTIGATION
RECS
PFIZER - VIAGRA NDA 20-895 STUDY #148-215
FLINTSTONE VITAMINS CMPLNT 137832 & SPL 830934 -
TEST RESULTS, CASE SPL SUMMARY RPT (CSSR)
SEATTLE GENETICS - ADCETRIS (BRENTUXIMAB VEDOTIN)
ISRS 10186245, 10190916, 10191646
HOWMEDICA OSTEONICS CORP - MODULAR DUAL MOBILITY
(MDM) LINER & X3 ACETABULAR INSERT K103233, HIP
SYSTEMS K121308 STRYKER CORP - EXETER X3 RIMFIR
ACETABULAR CUP K090897, ETC
SMITH & NEPHEW - LEGION PRIMARY KNEE SYS K093746
CMPLNTS
ZIMMER INC - VIVACIT-E VITAMIN E HIGHLY CROSSLINKED

POLYRHTYLENE K120370, BIOLOX DELTA CERAMIC FEMORAL
HEAD K130899, BIOLOX OPTION CERAMIC FERMORAL HEAD
SYS K073567, ETC CORR, RECS 12/31/11 TO PRESENT
GLAXOSMITHKLINE BIOLOGICALS, RIXENSART, BELGIUM -
483 2014
GLAXOSMITHKLINE BIOLOGICALS, WAVRE, BELGIUM - 483
2014
CUNNINGHAM & RASKIN, DIAGNOSTIC RADIOLOGY &

MAMMOGRAPHY, TAMARAC, FL - ANNUAL SURVEY FOR
MAMMOGRAPHY QUALTY STANDARDS ACT (MQSA) LTR 2002,
2003
LETTER SUBMITTED TO FDA BY SARAH YOUNG 03/04/2013 -
09/30/2014
ASI MARKETING LLC - EIR, 483, CORR 11/01/2013 -
11/30/2013
HHSF223200950015L
PROLIA - AERS
VF-WORKS, INC, DMX-WORKS, INC - COMPLAINTS,
LETTERS, VIOLATIONS ETC 01/01/1996 - 11/06/2014
04/30/2013
FAP 2289
MINOCIN - AERS, MEDWATCH REPORTS
IDEALISIB - AERS
HHSF223200950016L
IMBRUVICA - AERS
KEYTRUDA - AERS
09/19/2014
VEMMA NUTRITION COMPANY - AERS
MUSTAFA NEVAL ILAC SANAVII, AS, TURKEY - 483, EIR,
INVESTIGATOR DIARY 04/20/2012 - 11/06/2014
John R. Postlethwaite, D.C., Nu-Best Diagnostic

Labs, Inc. and Nu-Best Whiplash Injury Center, Inc.
- COMPLAINTS, INSPECTIONS, LETTERS FROM STATE FARM
ETC
AD-TECH MEDICAL INSTRUMENT CORPORATION, RACINE, WI
- EIR 01/01/2011 - 11/06/2014
K092264
K121593
K121484
K101910
K052128
K004009
NDA 008922
JUXTAPID - AERS
IMITREX - AERS
LIST OF MEDICATIONS WITH BLACK BOX WARNING
K052494
K123546
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
The specification for the process impurity

Chloromethyl isopropyl carbonate (CMIC) in the
Tenofovir disoproxil fumarate USP draft monograph
is NMT 0.15%
SCOTT D SEGAL, NORTH MIAMI, FL - EIR 01/01/2013 -
11/10/2014
NDA 201486
MPI RESEARCH INC, MATTAWAN, MI - EIR 01/01/1999 -
12/31/2013
K082982, K10052, K102525 ETC
K781429
Winning proposal for IGF::OT::IGF CDRH CESUB BPA
EXECUTED CONTRACT FOR CDRH CESUB STEADY STATE TASK
ORDER
K140162
NDA 205488
NDA 203667
GLENMARK, INDIA - 483 07/01/2013 - 08/31/2013
Progressive multifocal leukoencephalopathy FAERS
LONZA - 483, RESPONSE CLOSEOUT LTR 08/01/2013 -
11/10/2014
K141522
K112399
Amlodipine, Aranidipine, Azelnidipine ETC -
SBA
FORM 3542 NDA 020845
K140472
TECFIDERA, IMBRUVICA, ZYDELIG ETC - AERS
NDA 017558
Ortiz, L. G. and P. R. Papa (1978). "Topical

miconazole nitrate therapy in tinea pedis and tinea
versicolor." Clinical Therapeutics 1(6): 444-450
Responses
Last 3 recent Periodic Safety Update Reports
(PSURs) for the multiple sclerosis drug fingolimod
(Brand name: GILENYA)
POTENCY TEST FOR HYDRATION ELASTOMERIC BALLS FOR A
SOLUTION WITH MAGNESIUM SULPHATE 32 MEQ PER 500 ML
OF NORMAL SALINE
OCTEC CORR WITH TEKMIRA PHARMACEUTICALS CORPORATION
07/21/2014 - 11/07/2014
TOMITA PHARMACEUTICAL - 483 10/28/2013 - 11/02/2013

RHEIN BIOTECH - EIR 01/03/2012 - 12/31/2012
K061381
MARTIN AVENUE PHARMACY, NAPERVILLE, IL -
COMPLAINTS, AERS, INVESTIGATIONS 09/01/2010 -
12/31/2012
RECALL D-0041-2015
EIR for Nektar Therapeutics, Huntsville, AL
ACTIQ, FENTORA - REMS
K130943
ABILIFY - AERS 13Q2 SOURCE DOCUMENTS
KMED RESEARCH, ST CLAIRE SHORES, MI - COMPLAINT
LETTER, AUDIT REPORT 11/01/2008 - 11/01/2014
LASER TATTOO REMOVAL
2014-621
2013-9524
ELI LILLY & CO, INDIANAPOLIS, IN - EIR 4/15-19/13
2013-7749
2014-654
MISOPROSTOL - APRVL, 12/27/88 TO PRESENT
FCN 607
FCN 1311
8043053, 8097355, 8130667 - FAERS
6241234, 7252037, 7393389 - FAERS
PNC 1442
PNC 1443
BARNARD CASTLE, CORK, EVREUX ETC - QAP
CONAGRA FOODS, INC - REPORTS, RECORDS, COMPLAINTS
ETC RE ADULATERATED FOOD PRODUCTS 01/01/2013 -
11/01/2014
NDA 021264 ORPHAN DRUG REVIEWS
2007 ORANGE BOOK PLUS FINAL SUPPLEMENT, 2008
ORANGE BOOK SUPPLEMENT PDF
Redacted 510(k)s for October 2014
TIRF REMS INFORMATION
INVESTIGATION RECS RE 2013 MULTISTATE OUTBREAK OF
SALMONELLA SAINTPAUL LINKED TO CUCUMBERS 01/01/2013
- 12/31/2013
FIVE ELANCO METHODS
K012715
SIBUTRAMINE, VICTOZA, ETC - PREVIOUSLY RELEASED
RECORDS, TRANSCRIPTS 01/01/1997 - 11/11/2014
K032821
GENENTECH INC - EIR, 483 08/18/2010 - 10/31/2013
HERCULES INC DIOXATHION RESIDUES IN CITRUS FRUIT,
DIOXATHION RESIDUES IN GRAPES, DIOXATHION RESIDUES
RESULTING FROM APPLICATION TO APPLES
CYCLOBENZAPRINE - AERS
MED AWARENESS DBA GENESIS TISSUE SERVICES, POWAY,
CA - 483
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
RAW MILK DRUG RESIDUE SURVWY - SAMPLING DATA

ABBVIE INC/ABBOTT LABS - ANDROGEL RECS, AERS
RAPTOR PHARMS - PROCYSBI (CYSEAMINE BITARTRATE)
AERS, MEDICATION ERRORS
NOVO NORDISK, KALUNDBORG, DENMARK - SUBPOENA CORR,
RPTS, MFG ISSUES
ISOMER, RESIN, AMPHETAMINE, ETC - DEFINITIONS
JANSSEN PHARMS - RIDPERDAL AERS 1/00 TO PRESENT
2014-7673 DELETIONS
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
ARJO MED AB LTD, GLOUCESTER, UK - WARNING LTR MDR

9617921-2007-00028, MDR 9617921-2008-00017, MDR
9617921-2008-00018 CORR, WARNINGS, CORRECTIVE
ACTIONS, ETC 6/10/09
OMINSONICS MEDICAL TECHNOLOGIES INC - MODIFIED
OMINWAVE ENDOVASCULAR SYS K083335
AMERICAN MEDICAL SYSTEMS (AMS), ATHLONE, IRELAND -
EIRS 10/20-24/14
LUTRONIC CORP - K121481
TISSUE TECHNOLOGIES HOLDINGS LLC, RICHMOND, VA -
TT101 510K
COUGH & COLD PREPARATIONS - ISR 6774174, 8043746,
8293797, ETC
WHAT CONSTITUTES A FOOD ALLERGY
CARU PET FOOD CO - EIRS, COMM, INGREDIENTS VERIFIED
OR APRVD, ETC 1/13 TO PRESENT
Import Alert 89-08
ANDA 090943 SBA
ANDA 091649 SBA
VIVATROL - AERS
TARO PHARMACEUTICALS, BRAMPTON, CANADA - 483
02/01/2014 - 11/14/2014
MORCELLATORS - PREVIOUSLY RELEASED RECS 01/01/2013
- 10/31/2014
FOIA REQUESTS RECEIVED RE EBOLA 10/01/2014 -
10/31/2014
5 HOUR ENERGY - COMPLAINTS 01/01/2012 - 11/14/2014
K122036
PRADAXA - AERS
K140783
K043299, K043590
MERCK & CO, BAYER HEALTHCARE PHARMACEUTICALS - 483
01/01/2014
COMMUNICATIONS BETWEEN FDA AND JAPANESE GOVERNMENT
01/01/2014 - 11/16/2014
Drug-placebo trials for autism
TORRENT PHARMACEUTICALS LTD, INDIA - 483 01/02/2013
- 11/17/2014
ASTRA ZENECA INC - SEROQUEL (QUETIAPINE FUMARATE)
AER 7/29/97 - 6/2/97
DOCKET FDA-2014-F-1669
MAUREEN COOPER, COMM CA CARE, INDIANAPOLIS, IN -
483 7/11 TO PRESENT
LTR SENT TO CUNNINGHAM & RASKIN, DIAGNOSTIC
RADIOLOGY & MAMMOGRAPHY, TAMARAC, FL 2002, 2003
CORR BETWEEN FDA & DSM NUTRITIONAL PRODUCTS
REGARDING FAP FOR SCHIZOCHYTRIUM SP DIRED ALGAE FDA
2014-F-1509
MED ART, COPENHAGEN, DENMARK - EIR
RECORD FOR ALL SHIPMENTS FROM 11/1-15/14
SE0004347, SE0004350
NUTEK DISPOSABLES INC - BABY WIPES RECALL
MEDTRONIC - INFUSE BONE GRAFT & LT CAGE DVC - AER,
CORR, INVESTIGATIONS
SCOUT BOSS K023961
KMEDIC INTERNAL EXTERNAL FIXATION DVC K070561
AXIOM FASCIAL CLOSURE SYS K103412 AXIOM TECHNOLOGY
PARTNERS LLC K103412
CANTON LABORATORIES, INDIA - 483 01/01/2013 -
11/17/2014
CYBER LETTERS 01/01/2000 - 12/31/2009
CUBIST PHARMACUETICALS - 483, RESPONSE, CORR
07/01/2014 - 11/17/2014
K923452, K964395, K970346
NDA 021455 S 016, 017
MCDOUGALL'S RIGHT FOODS, INC, SOUTH SAN FRANCISCO,
CA - EIR, 483, CORRECTIVE ACTION ETC 01/01/2009 -
10/31/2014
NDA 017441
K790738
K053223, K053223, K051938 ETC
K030281
STAAR SURGICAL, MONROVIA, CA - EIR, 483, RESPNSE
ETC
NDA 9859
WINTAC LIMITED, INDIA - 483 01/04/2012 - 11/17/2014

DR GIDEON KOREN, ONTARIO, CANADA - RECS RE
VOLUNTARY ACTION 10/29/2012 - 11/02/2012
LEVAQUIN (LEVOFLOXACIN) - ISR 3108187-8, 3108125-8,
3228995-2, ETC
SURGICAL MESH - INADEQUACY OF LABELS
CALBIOCHEM - TRAZURE (AZARIBINE) - PRE-CLINICAL
RECS
MIRTAZAPINE, DOXEPIN 50MG, PRAZOSIN 2MG, 1MG, ETC -
AERS
IMPAX LABORATORIES INC - EIRS, COMPLIANCE,
ENFORCEMENT INVESTIGATIVE ACTION 1/13 TO PRESENT
GARDASIL, HPV CACCINES - VAERS
SANOFI-AVENTIS - TAXOTERE (DOCETAXEL) POST-
MARKETING RECS, WARNING LTRS, CASE RPTS, ETC
COOPER VISION CARIBBEAN CORP, JUANA DIAZ, PR -
483S, UNTITLED LTRS, WARNING LTRS, ETC
BLUE BUFFALO COMPANY LTD (BLUE BUFFALO) - CHICKEN

BY PROD MEAL, POULTRY BY PROD ARTIFICAL
PRESERVATIVES, SOY, CORN INGREDIENTS NOT RELECTED
ON PROD LABELS BILL BISHOP REGARDING THE ISSUE
PERTAINING TO WILBUR ELLIS TEXAS PLANT LTR
10/14/14, PET FOOD M
ETHINYL ESTRADIOL, NORGESROL,NORETHINDRONE ETC -
DEATH REPORTS
K111695
REVIEW GUIDES FOR TRAINING CTP STAFF ON THE SE
REVIEW PROCESS 01/01/2011 - 11/13/2014
AMERICAN RED CROSS, PHILADELPHIA - EIR 01/01/2012 -
12/31/2013
TECFIDERA - AERS
K130191 - CLEARANCE LETTER CERTIFIED
EXCELSIOR MEDICAL, NEPTUNE, NJ - EIR, 483
07/21/2014 - 08/21/2014
2014-2209
K092381
K062340
ASTAGRAF XL - RECS RE DECISION TO GRANT THREE YEAR
EXCLUSIVITY ETC 07/01/2012 - 11/18/2014
K103059
2014-2735
2014-2601
2014-2462
2014-2944
2014-2754
2014-3376
2014-2206
2014-5562
OXITEC LTD - MTG NOTES, CORR, INTERNAL COMM, ETC
INDIVIDUAL RECS
PROTECT YOUR VISION PIINHOLE GLASSES - MARKETING
RECS
REGULATORY PROCEEDING AGAINST CARL ANDREW DEABATE
MD
INDIVIDUAL RECS
REPUBLIC TOBACCO LP - SMOKER FRIENDLY REAL GOLD
KING SIZE FILTERED PAPER TUBES FOR ROLL-YOUR-OWN
TOBACCO SUBSTANIAL EQUIVALENCE RPT SE0004347
UCB INC - KEPPRA OFF-BRANDING INVESTIGATION RECS
ORPHAN DRUG APPLICATION
10 MG PHENYLEPHRINE - EFFICACY STUDIES
CONCERTA - MEDWATCH FORMS 05/01/2013 - 11/13/2014
K041283
IPCA - 483 09/01/2014 - 11/19/2014
K860858
INDIVIDUAL RECS
ZYDELIG - 10368556, 10391545, 10539211 ETC
K123402
ANDA 091106 APPROVAL LETTER CERTIFIED
ANDA 202485 APPROVAL LETTER CERTIFIED
K911278
DSM ASTAXANTHIN SUBACUTE - STUDY RECS
K101641
IMBRUVICA - MEDWATCH REPORTS
ADCETRIS - AERS
K902329
AMERICAN RED CROSS, TULSA, OK - EIR 01/01/2013 -
12/31/2013
K895159
AMERICAN RED CROSS, CHARLOTTE, NC - EIR 01/01/2012
- 12/31/2013
K914570
EMERGENCY USE IND AND INDIVIDUAL PATIENT IND FOR
DRUG PRODUCT 11/07/2009 - 11/19/2014
LEVAQUIN (LOVOFLOXACIN) - ISR 3108187-8, 3108125-8,
3228995-2
CYANOTECH CORP - HAEMATOCOCCUS PLUVIALIS EXTRACT
NDI CONTAINING ASTAXANTHIN ESTERS NOTIFICATION 717
CARE RITE CLINIC, RIPLEY, TN - JOINT INJECTION
INVESTIGATION 9/5/13 TESTING RESULTS, RPTS, ETC
HYQVIA - VAERS
WELL LEAD MEDICAL INSTRUMENTS LTD - ENDOTRACHEAL
TUBE K042683
HAMPTON CREEK, INC - CORR WITH FDA RE JUST MAYO
09/01/2014 - 11/20/2014
K090696
CONSUMER COMPLAINT REFERENCED IN CIPLA LIMITED EIR
SUMMARY
IPCA LABORATORIES, LTD, INDIA - 483 07/14/2014 -
11/20/2014
ANDA 090756
CUTISPHARMA - EIR 01/01/2014 - 11/20/2014
SOLIRIS, TECFIDERA, OTEZLA ETC - AERS
IMPORT REFUSAL 231-1235318-3
K924018
K0102002
WEIJIE - 483, RESPONSE, EIR 09/08/2014 - 09/12/2014

K020311
IRADIMED CORPORATION - 483, RESPONSES
IMPORT REFULSAL 417-0282777-9
IMPORT REFUSAL FS2-1138289-0

TEVA - OMEGA-3 ACID ETHYL ESTERS ANDA 91-028 APRVL
RECS
K123014
GS-14, GS-15, SES ETC JOB ANNOUNCEMENTS CDER
12/01/2013 - 11/21/2014
DR REDDY VIZAG - 483 11/17/2014 - 11/21/2014
HEALTHPOINT, LTD, SMITH & NEPHEW, INC, ETC - RECS
RE MANUKA HONEY 01/01/2009 - 11/20/2014
AUSPEX PHARMACEUTICALS - OPD REVIEW RECS 01/01/2013
- 11/20/2014 We
K083287
K090949
K022423
K021932, K051296, K080398 ETC
IMPAX LABORATORIES, HAYWARD, CA, TAIWAN - 483,
UNTITLED LETTER 08/01/2014 - 11/20/2014
K984370
HOSPIRA INC, VIZAG, INDA AUSTIN, TX LAKE FOREST,
IL ETC - 483, UNTITLED LETTER 09/01/2014 -
11/20/2014
THERAFLU - AERS
CHIMERIX INC BRINCIDOFOVIR - RECS RE ACCESS TO
PATIENT
K121929
K141708
COMM BETWEEN FDA AND NOVARTIS ANIMAL HEALTH US, INC
RE PROMOTIONAL MATERIALS RE TIAMULIN ETC 01/01/2014
- 11/01/2014
COMM BETWEEN FDA AND SPONSORS OF APPROVED

APPLICATIONS FOR NEW ANIMAL DRUGS AND NEW ANIMAL
DRUG COMBINATION PRODUCUTS RE MISLEADING
PROMOTIONAL MATERIALS ETC 01/01/2010 - 11/01/2014
DR STEPHEN C MILLER, WALTERBORO, SC - WARNING
LETTER, INVESTIGATION RECS 01/01/2012 - 01/01/2013
K080550
ONE LAMBDA, INC - 483 MOST RECENT
LIFE TECHNOLOGIES, MILWAUKEE, WI - 483 MOST RECENT
BIOKIT - 483 MOST RECENT
K033954
K023902
K003277
ANDA 065070 - SBA
ABILIFY - AERS
LIST OF FOOD AND PET FOOD MANUFACTURERS IN US
INFANT BACTERIAL THERAPEUTICS - L REUTERI ORPHAN
PRODUDCT RECS 01/01/2012 - 11/21/2014
ALMA MATTSON, LIQUID HEALTH, MATTSON NUTRTION -
WARNING LETTER RECS, UPDATES 01/31/2013 -
11/21/2014
BIRTH CONTROL DRUGS - AERS
NOVARTIS CONSUMER HEALTH TRIAMINIC THIN STRIPS -
APPROVAL LETTER 01/01/2004 - 12/31/2004
XARELTO - AERS
NEXCYON PHARMACEUTICALS INC - INAD 010-594 CMC
TECHNICAL SECTION APPENDIX 1, APPENDIX 3
ANDREW O SCHREIBER, IRVINE, CA - EIR, 483 6/4/12
2014-5667 - MINOR DELETIONS
WENDY STOCK, CHICAGO, IL - 483S 6/09 TO PRESENT
ZYDUS CADILA HEALTHCARE LTD, GUJARAT, INDIA - EIRS,
483S 6/1/14-8/1/14
SODIUM BUTYRATE RN #156-54-7 - REGULATORY STATUS,
CONSUMPTION, USES, ETC
YUCCA SCIDIGERA FOR NATURAL FLAVORING SUBSTANCES
FOR USE IN ALCOHOLIC BEVERAGES FAP 4A1318 -
REGULATORY STATUS, CONSUMPTION, USES, ETC
KRILL OIL (EUPHASIA SUPERBA) - REGULATORY STATUS,
CONSUMPTION, USES, ETC
NDA 85635 S1, S2
FCN 178
DR REDDY'S LABS, INDIA - 483 11/17/2014 -
11/21/2014
K020399
LIST OF DRUGS FDA REJECTED BREAKTHROUGH THERAPY
DESIGNATION REQUEST 01/01/2012 - 11/23/2014
K141273, K112370, K100066 ETC
NDA 205832
K922052
100208311, 100208311, 79802343 ETC

K050337
K050337
PFC DEVELOPMENTS AKA NEW ALLIANCE PHARMA - OXYGENT
IND BB-6195
XIAFLEX - AERS
MOST CURRENT LIST OF DESIGNATED MEDICAL EVENTS USED
IN ADVERSE EVENT MONITORING AND SIGNALING FOR HUMAN
DRUGS
K070107
LEXISCAN - LABEL CHANGE WARNING LETTER, APPROVAL
2014 09/01/2013 - 09/30/2014
AMIKACIN SULFATE INJECTION - APPROVAL DATES FOR
INDICATIONS 01/01/1970 - 12/31/1996
TECFIDERA - AERS
RANBAXY - LETTER RE VALCYTE, NEXIUM 11/01/2014 -
11/25/2014
GLOBAL RECORDS SYSTEM - CONTRACTS WITH FDA,
INCLUDING RESEARCH COLLABORATION AGREEMENT,
COMMUNICATIONS 01/01/2012 - 11/24/2014
NOVOCURE - EIR PITTSURG, PARIS, LEON ETC
AUROBINDO PHARMA - 483 01/01/2014 - 11/25/2014
DR REDDYS LABS, ANDHRA PRADESH, INDIA - 483
OMNISONICS MEDICAL TECHNOLOGIES INC - MODIFIED
ONMIWAVE ENDOVASCULAR SYS K083335
BOSTON SCIENTIFIC - PROTEGEN SLING ETHICON
GYNEMESH PS 510K
CORR FROM SENATOR TED CRUZ 1/13 TO PRESENT
ABB VIE - HUMIRA (ADALIMUMAB) - APLVL
ACTOS - AER
CARE RITE CLINIC, RIPLEY, TN - MEDWATCH 9/13
BIOSAFETY INCIDENT RPTS FOR CBER LABS
INDIVIDUAL RECS
ALMOTRIPTAN, ELETRIPTAN, NARATRIPTAN ETC - AERS
NDA 205352 SBA
ADAM S FREEMAN, ADEMOLA O DARAMOLA, ALICE S TSAO,
ETC - CV
LONZA BIOLOGICS INC, PORTSMOUTH, NH, NEW ENGLAND
HOME THERAPIES INC, SOUTHBOROUGH, MA ARIAD
PHARMACEUTICALS INC, ETC - 483S 10/1-31/14
ARKRAY FACTORY INC, KOKA-SHI, JAPAN ZIMMER
ORTHOPEDIC MFG LTD, SHANNON, IRELAND MULTIMEDICAL
SRL, VIADANA, ITALY, ETC - 483S 10/1-31/14
R & D ENGINEERING OF EARLHAM INC, EARLHAM, IA
COMMUNITY BLOOD CENTER OF GTR KC, KANSAS CITY, MO -
483S 10/1-31/14
CIVIC CENTER PHARMACY, SCOTTSDALE, AZ PADTEST LLC,
SCOTTSDALE, AZ SSCOR INC, SUN VALLEY, CA, ETC -
483S 10/1-31/14
PROMED PHARMA LLC, PLYMOUTH, MN BLUE BELT
TECHNOLOGIES INC, PLYMOUTH, MN TREYMED INC,
SUSSEX, WI, ETC - 483S 10/1-31/14
TRIS PHARMA INC, MONMOUTH JUNCTION, NJ AMNEAL

PHARMACEUTICALS LLC, PISCATAWAY, NJ PARKER
LABORATORIES INC, FAIRFIELD, NJ, ETC - 483S 10/1-
31/14
GREEN HILLS HEALTH AND WELLNESS PHARMACY,
NASHVILLE, TN - 483S 10/1-31/14
SPA TECHNOLOGIES INTERNATIONAL INC, CONGERS, NY
LUITPOLD PHARMACEUTICALS INC, SHIRLEY, NY TEMREX
CORP, FREEPORT, NY, ETC - 483S 10/1-31/14
BTG INTERNATIONAL LINC, WALES, UK GLAXO
SMITHKLINE-RIXENSART, RIXENSART, BELGIUM - 483S
10/1-31/14
KONTUR KONTACT LENS CO INC, HERCULES, CA STRYKER
ENDOSCOPY, SAN JOSE, CA BIONICA INC, MCCLELLAN,
CA, ETC - 483S 10/1-31/14
STRAIGHT ARROW PRODUCTS INC, BETHLEHEM, PA CIMA
TECHNOLOGY INC, PITTSBURGH, PA ANIMAS CORP, WEST
CHESTER, PA - 483S 10/1-31/14
BAXTER PHARMACEUTICAL SOLUTIONS LLC, BLOOMINGTON,
IN XORAN TECHNOLOGIES LLC, ANN ARBOR, MI DANMAR
PRODUCTS INC, ANN ARBOR, MI - 483S 10/1-31/14
HILL DERMACEUTICALS INC, SANFORD, FL JAS
DIAGNOSTICS INC, MIAMI LAKES, FL INVACARE CORP,
SANFORD, FL, ETC - 483S 10/1-31/14
ALLERGY LABORATORIES INC, OKLAHOMA CITY, OK TWO
OLD GOATS LLC, HALTOM CITY, TX OXYSURE SYSTEMS
INC, FRISCO, TX, ETC - 483S 10/1-31/14
MOU BETWEEN APHIS, NIH, FDA RE LAB ANIMAL WELFARE -
POLICIES TO ENSURE COMPLIANCE, GUIDANCE DOCUMENTS,
PROCEDURES
ELANO ANIMAL HEALTH, ELI LILLY AND CO - REC RE
INTERNAL SAFETY REVIEW OF TRIFEXIS 01/01/2014 -
11/24/2014
BIOMET SPINE LLC, BROOMFIELD, CO WATSON
LABORATORIES INC, SALT LAKE CITY, UT WATER PIK
INC, FORT COLLINS, CO, ETC - 483S 10/1-31/14
RICHARD WOLF MEDICAL INSTRUMENTS CORP, VERNON
HILLS, IL - 483S 10/1-31/14
K121610
SAMPLE 849595 ANALYTICAL REPORT
REIMERS SYSTEMS INC, LORTON, VA - 483S 10/1-31/14
K072619
K121291
FOSTER FARMS - WARNINGS, NOTICES OF SUSPENSION, ETC
01/01/2014 - 11/25/2014
AMBIOPHARMA INC, NORTH AUGUSTA, SC STEWART
COMPOUNDING PHARMACY, FAYETTEVILLE, NC - 483S 10/1-
31/14
PARKING LOT VIDEO FOOTAGE
P810002 S46
SUBMISSION RECS RE CLEANING VALIDATING PROTOCOLS
12/12/2008 - 11/25/2014
BAXTER CORPORATION ABACUS TOTAL PARENTERAL
NUTRITION CALCULATION SOFTWARE RECALL 01/01/2014 -
11/25/2014
K092227, K113273, K101609 ETC
CONTINENTAL DENTAL CERAMICS, INC - INVESTIGATION
RECS 08/18/2012 - 11/26/2014
K113229
K133223
STAT RX USA - EIR 01/01/2012 - 11/21/2014
2013-2534
IMBRUVICA - 10488591, 10494308,10494326, ETC
NDA 021660 S037
KEYTRUDA CASE 10329858
DR REDDY LABORATORIES, VIZAG - 483 11/19/2014 -
11/26/2014
NDA 020472
ANDA 078251
ANDA 076373
DR REDDY, ANDHRA PRADESH, INDIA - 483 11/09/2014 -
11/25/2014
DR REDDY, VIZAG, INDIA - 483 11/01/2014 -
11/26/2014
ANDA 076649
DR REDDY LABORATORIES, ANDHRA PRADESH, INDIA - 483
11/15/2014 - 11/30/2014
DR REDDY'S LABS, ANDHRA PRADESH, INDIA - 483
11/18/2014 - 11/21/2014
NDA - ABILIFY, CLOZARIL, FANAPT ETC
Summary NDA for escitalopram
Summary of Adverse Events sent to FDA for
escitalopram
K121039
Complete Summary of Adverse Event Reports for
venlafaxine
LABCORP INTEGRATED GENETICS, SEQUENOM, ILLUMINA ETC
- AERS, COMPLAINTS 11/28/2004 - 11/28/2014
K121964
BIOTEST MEDICAL CORP, TAIWAN - EIR 01/01/2008 -
11/28/2014
K042970
K061301
DR REDDY, ANDHRA PRADESH, INDIA - 483 11/18/2014 -
11/28/2014
ORPHAN PRODUCT APPLICATIONS FOR TREATMENT OF
PYRIDOXINE DEPENDENT SEIZURES ETC 01/01/2000 -
11/18/2014
K033364
K113111
ZOLPIDEM - AERS 2009 TO PRESENT
HISAMITSU AMERICA INC - SALONPAS RECS, CMPLNTS
INDIVIDUAL RECS
SHUR-GREEN FARMS LLC, ANSONIA, OH HORIZON

ENVIRONMENTAL, GRAND RAPIDS, MI ZOETIS, FLORHAM
PARK, NJ - LASCADOIL/SOYOIL RECALL 69399 TEST
RESULTS 1/14 TO PRESENT
TRANSCRIPTS OF THE FDA-NIMH PSYCHOTOMIMETIC AGENTS
ADVISORY COMMITTEE 01/01/1965 - 12/31/1975
K141325
YALE NEW HAVEN HOSPITAL NEONATAL UNIT - SUPPLEMENT
CONTAMINATED WITH MOLD RECS 10/14
ROCKLINE INDUSTRIES - COMM, LAB TESTS,
INVESTIGATION RECS 2001 TO PRESENT NUTEK
DISPOSABLES INC - COMM 2008 TO PRESENT, ETC
SPETOCAINE INJ, ARTICAINE HCL - ISRS 9320998,
9858336, 9870214, ETC
LIST OF SPECIAL GOVERNMENT EMPLOYEES (SGE) OR OTHER
NON-FDA EXPERTS AND ADVISORS PROVIDING GUIDANCE ON
BIOSIMILAR EVALUATION METHODS
ACTOS - SCIENTIFIC STUDY TEST RESULTS
SPECIALTY MINERALS LIFFORD, BIRMINGHAM, UK 10/1014

NATCO PHARMA LTD, KOTHUR MANDAL, INDIA 10/13/14
IPCA LABORATORIES LTD, PITHAMPUR, INDIA 10/17/14 -
483S
MOLECULAR NEUROIMAGING LLC, NEW HAVEN, CT - EIR
4/2-5/13
DR STANISLAW BURZYNSKI MD PHD - FDA DECISION TO
LIFT THE CLNCL HOLD
METHYLENE CHLORIDE - FAP
A list of all FOIA requests closed 11/1-30/2014 on
CD
ICLUSIG - AERS
DEN130032
K840613, K863539, K893531 ETC
PEG 3350 LAXATIVES IN CHILDREN - GRANT RECS
K062416
VALEANT PHARMACEUTICALS, STEINBACH, MANITOBA - 483,
RESPONSE LETTERS, WARNING LETTERS 01/01/2014 -
12/01/2014
ORANGE BOOK TXT FILES 01/01/2005 - 11/30/2014

VALEANT PHARMACEUTICALS, BRIDGEWATER, NJ - 483,
RESPONSE, WARNING LETTERS 01/01/2014 - 12/01/2014
LANNETT COMPANY, PHILADELPHIA, PA - 483, RESPONSE,
WARNING LETTER 01/01/2014 - 12/01/2014
LANNETT COMPANY, CODY, WYOMING - 483, RESPONSE,
WARNING LETTER 01/01/2014 - 12/01/2014
PACIRA PHARMACEUTICALS, SAN DIEGO, CA - 483,
RESPONSE, WARNING LETTER 01/01/2014 - 12/01/2014
K121771
ABBOTT, SANTA CLARA, TEMECULA, CA - EIR
ACTEMRA - ORPHAN DRUG DESIGNATION APPLICATION
AEGERION - JUXTAPID PROMOTION WARNING LETTER
CLOSEOUT LETTER 01/01/2013 - 12/01/2014
K1410382
NDA 019645, NDA 019698

DESI report prepared by the NAS/CRS on
diphenhydramine hydrochloride
FSMA STANDARDS
LIST OF RECALLS OVERSEEN BY THE FDA LAST FISCAL YR
NUMBER OF AERS RPTS LAST FISCAL YR
NUMBER OF CRIMINAL INVESTIGATIONS CONDUCTED BY FDA
LAST YR
LIST OF FINES IMPOSED BY FDA LAST FISCAL YR
MYRBETRIQ - AERS
ORANGE BOOK 1984-1999
ACCORD HEALTHCARE - DOCETAXEL INJ CONCENTRATE ANDA
201-195 VIAL LABELS
OLIVES - CMPLNT
ELECTRIC POWER REASEARCH INSTITUTE - FAP 0A4721
PARKER'S FARM, MINNEAPOLIS, MN - LISTERIA
CONTAMINATION RECS
INDIVIDUAL RECS
LETTER FROM JOHN BOEHNER TO FDA REGARDING
GRANDFATHER DATE FOR DEEMING REGULATIONS
FDA-2014-N-0595 PUBLIC COMMENTS
K132887
ONCOLOGY, ANESTHESIOLOGY DRUGS - SHORTAGE RECS
12/02/2004 - 12/02/2014
K052267
PROCESS VALIDATION FOR MEDICAL DEVICES - COURSE
MATERIALS
DATA, ANALYSES OF ILLNESS OR DEATH IN HORSES
RELATED TO FORAGE, FEED CONTAMINATION, ILLEGAL FEED
ADDITIVES ETC 01/01/2010 - 12/01/2014
LIST OF DRINKING WATER BOTTLERS
NDA 018081
NDA 020690
FDA-2014-D-0091
DR ALAN W HELDMAN, MIAMI, FL - EIR 01/01/2013 -
12/02/2014
INDIVIDUAL RECS
CAMPTOSAR NDA 20-571 -PHARMACOLOOGY RVW
INDIVIDUAL RECS
FOI DAILY LOG 11-10-14/14
NDA 050442 - SBA
PHILIPS, CLEVELAND, OH - 483 12/31/2013 -
12/01/2014
NDA 016087
NDA 007513
ANDA 062475
ANDA 071583
FOI DIALY LOG 11/3-7/14
CLOSED FOI REQUESTS 10-27-31/14
2013-1452
RECS FDA IMPORT ALERT 98-05
K972706
CAYMAN CHEMICAL, ANN ARBOR, MI - EIR, 483
K091216
PLASMA CARE AKA GRIFOLS, HAMPTON, VA - INSPECTION
RECS 2008
2013-4411
510K RELEASED NOVEMBER 2014
2014-2866
CUSTOM ULTRASONICS, IVYLAND, PA - 483, CORR
01/01/2013 - 12/03/2014
K141967
K142303
CUSTOM ULTRASONICS, IVYLAND, PA - RECS RE RECALL OR
PRODUCT CORRECTION 09/01/2012 - 12/02/2014
2014-2885
K080670
ZIJA INTERNATIONAL INC - COMPLAINTS,

INVESTIGATIONS, VIOLATIONS 06/30/2014 - 12/03/2014
2014-2144
ACTIQ, FENTORA, SUBSYS - AERS
2014-818
K112489
K122129
K070795
HILL-ROM MANUFACTURING INC, CHARLESTON, SC - 483
11/12/2013 - 11/15/2013
HILL ROM MANUFACTURING INC, CHARLESTON, SC - EIR
04/06/2009 - 04/14/2009
AMERIGEN PHARMACEUTICALS INC - SBA ORENITRAM
NDA 050618 SBA
IRIX PHARMACEUTICALS, GREENVILLE, SC FLORENCE, SC
- EIR 01/01/2009 - 12/01/2014
K123789
NDA 16087
NDA 13263
K091131
All FDA reviews, memoranda, communications and

other documents regarding peripheral neuropathy for
the drugs Levaquin, levofloxacin and
fluoroquinolones during the time period between
January 1, 2003 to the present
AMUSA, NASHVILLE, TN - CLOSEOUT LETTER 11/13/2012
- 12/31/2012
LECITHIN HYDROGENATED LECITHIN LYSOLECITHIN ETC -
BIOAVAILABILITY, TOXICITY
ZHEJIANG JINHUA CONBA BIO-PHARM CO LTD, CHINIA -
EIR 03/15/2010 - 03/19/2010
ANALOGIC CORPORATION, PEABODY, MA - EIR 09/02/2014
- 09/30/2014
CENTELIA ASIATICA CENTELIA ASIATICA CALLUS CULTURE
CENTILIA ASIATICA FLOWER/LEAF/STEM EXTRACT ETC -
BIOAVAILABILITY, TOXICITY
MEDSEP CORP, COVINA, CA - PALL CELERIS PC SYS
BK120026
MEDSEP CORP, COVINA, CA - PALL CELERIS PC SYS
BK100058
ALL INSP FOR BIOLOGIC, MEDICAL DVC, CLNCL TRIAL
FACILITIES 11/1-30/14
CMPLNT 136716
LIST OF ALL REGULATED SHIPMENTS 11/16-30/14
PREVIOUSLY RELEASED RECS RE K-V PHARMACUETICAL
COMPANY, ETHEX 01/01/1993 - 12/26/2012
ISSAM RAAD MD, HOUSTON, TX - 483 10/2014
ADCETRIS (BRENTUXIMAB VEDOTIN) - FAERS
ADCETRIS (BRENTUXIMAB VEDOTIN) - AERS 3/1/14 TO
11/30/14
CLOSED DAILY LOG 11/3-7/14
DAILY CLOSED LOG 10/20-24/14
WEEKLY CLOSED LOG 10/27-31/14
DAILY LOG 11/3-7/14
DAILY CLOSED LOG 10/27-11/1/14
DAILY LOG 11/3-7/14
DAILY LOG 10/20-24/14
DAILY LOG 10/27-31/14
DENTAL PRODS PANEL PLAQUE SUBCOMMITTEE - TRANS
1981N-033-P
1981N-033P
DKTD-0800
DKT 2006D-0031, 2014D-0447, 2014D-0903
LIST OF FIRM ISSUED RECALL DATA DEC 2013 TO PRESENT
12/01/2003 - 12/31/2014
DKT 2005N-0404, 2005N-0279
DKT 2014D-0901-0001, 2014D-0902-0001
NDA 018749
ILLUMINA - CORR WITH FDA REGARDING MARKETING AND
PROMOTION OR SALE WITHOUT 510K
DKT 1980N-0042
DKT 2014D-0779
FOREIGN FOOD FACILITY INSPECTIONS 10/01/2011 -
09/30/2014
DKT 2014N-1008, 2014D-1167
DKT 1998N-0583
K133793
DKT 1981N-0033
FOREIGN FOOD FACILITIES THAT RECEIVED A 483
08/01/2014 - 10/31/2014
K050469
DKT 2014N-1108
INDEX OF RECORDS MAINTAINED BY FDA
DKT 1980N-0042
DKT 2014N-168
SYNEPALUM DULCIFICUM (MIRACLE BERRY) - APPROVAL
RECS 01/01/1970 - 12/01/2014
NDA 009190
DKT 2014N-1168
ENDOCHOICE, INC, ALPHARETTA, GA - EIR, EXHIBITS,
CORR RE SEPTEMBER 2014 INSPECTION
GRAS PETITION FOR COCOA BUTTER SUBSTITUTE FROM PALM
OIL - 1988G-0388, 1984G-0384, 1988G-0388, ETC
P860019, P880003 - SUMMARY OF SAFETY AND
EFFECTIVENESS DATA 2014
DKT 2014N-1491, 2014D-1167, 2014D-0902
DKT 2014N-1243-0001, 2010P-0559
CMPLNT - INVESTIGATION, FOLLOW-UP ACTIVITIES
CYANOTHECH CORP - HAEMATOCOCCUS PLUVIALIS EXTRACT
CONTAINING ASTAXANTHIN ESTERS NDI NOTIFICATION
NUMBER 717 PARTS I,11,111
MCNEIL PPC INC, JOHNSON & JOHNSON - TYLENOL,
MOTRIN, MEMOS, ETC AERS
KEPRA, DEAKOTE, LAMICTAL, STEVENS-JOHNSON SYNDROME
REMRUM 15 MG - AERS
DR SEBASTIAN SCHNEEWEISS HARVARD MEDICAL SCHOOL -
ACTOS SCIENTIFIC STUDY
PHENTERMINE - AERS
CANGENE CORP - EIR 10/11-19/11
GE MEDICAL SYSTEM INFORMATION TECHNOLOGIES INC,
WAUWATOSA, WI - MAC 800 RESTING ECG ANALYSIS SYS
K090212
2014-9200
2013-6047
2013-6048
FOI DAILY LOG 11/17/22/14
K083152, K120384
K141742
K013630, K955092, K942120
FOIA LOG 01/01/2014 - 12/06/2014
CAF-DCF, BELGIUM - EIR, RESPONSES MAY 2013
ALLERGAN - EIR 12/12/2013 - 12/23/2013
SANQUIN BLOOD SUPPLY FOUNDATION, AMSTERDAM,
NETHERLANDS - EIR, 483, RESPONSE 10/01/2014 -
11/30/2014
MEASURING CONFLICT OF INTEREST AND EXPERTISE ON FDA
ADVISORY COMMITTEES - SPREADSHEET OF DATA
01/01/2008 - 01/01/2010
IMBRUVICA - AERS 11/01/2014 - 11/30/2014
KEYTRUDA - AERS 11/01/2014 - 11/30/2014
ZYDELIG - AERS 11/01/2014 - 11/30/2014
K093695
K113500
K100669
APPLE MEETING RECS
APPLE INC - MEMO OF MEETING DEC 2013
K124044
HALOPERIDOL, RISPERIDONE - AERS
NDA 50495
CAF-DCF, BELGIUM - EIR, 483, RESPONSE 10/01/2014 -
11/30/2014
K082786
K102029
DKT 2014P-0259
K083415
K102709
REMEL, KANSAS - 483, EIR 03/03/2014 - 10/01/2014
DKT 2014N-1413 - COMMENTS
DERMA PEN - 483 07/01/2014 - 08/01/2014
DKT 2014D-1292-0001, 2014D-0852-0001, 2014N-1110-
0001 - COMMENTS
K922770
DKT 2005D-0340
DRUG FACILITIES IN INDIA - 483 09/01/2014 -
12/05/2014
DKT 1998P-0967
DKT 1981N-0015
NDA 200603 S010, S011
TOTAL NUMBER OF ANDAS FILED SINCE HATCH-WAXMAN
DKT 1975N-0012
K073057
SIEMENS HEALTHCARE DIAGNOSTIC - VISTA VITAMIN B
ASSAY & RELATED COMPONENTS INVESTIGATION,
ASSESSMENT RPTS, RECALLS LAST FIVE YRS
SUN PHARMACEUTICALS HALOL, INDIA - 483, EIR, ETC
01/01/2013 - 12/05/2014
LIST OF DRUG SHORTAGES 12/01/2008 - 12/01/2014
SANQUIN BLOOD SUPPLY FOUNDATION, AMSTERDAM,

NETHERLANDS - EIR, RESPONSE 05/01/2013 - 06/30/2013
GRAHAM EMSLIE, MD - EIR, CLOSEOUT

Analytical HPLC method for impurity xyrem (sodium
oxybate)
EXPAREL - BAD ADS COMPLAINTS, PACIRA
PHARMACEUTICALS RESPONSE TO WARNING LETTER,
LABELING DISCUSSION PRIOR TO WARNING LETTER
CYNERGY LLC - WARNING LETTER COMPLIANCE RECS
02/01/2013 - 12/08/2014
ANDA 077510
CADILA PHARMACEUTICALS, INDIA - 483 03/01/2014 -
03/31/2014
ACTAVIS ODYSSEA, BELGIUM - EIR 08/01/2014 -
12/01/2014
ANDA 220744
FCN 956
XENAZINE - AERS
IND BB-6195
K131509
K130393
K062163
BVO - TESTING, RESEARCH
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
ASTRAL STERI TECH PRIVATE LTD, GUJARAT, INDIA - EIR

EDAP TECHNOMED INC - ABLATHERM INTEGRATED IMAGING
HIGH INTENSITY FOCUSED ULTRASOUND SYS - CLNCL
TRIALS, AER, CORR, 2012 TO PRESENT
ASP EIR EXHIBITS JFI-JF7
THIOLA (TIOPRONIN) - AER 12/17/88 TO 12/5/14
CHENODEOXYCHOLIC ACID (CENODAL) 1/08 TO 12/5/14 -
AERS CHENODAL FIRST, CHENODEOXYCHOLIC ACID
HOSPIRA - ANGIOMAX ANDA 90-816, 90-811 APRVL LTR
2/3/13
SEROVARS FREQUENCIES OF OCCURENCE OF SALMONELLA
ISOLATES
MINOR DELETIONS
JIMMY JOHNS, DENVER, CO - E COLI
HAMPTON CREEK FOODS INC - CORR 11/19/14
HUNTINGDON LIFE SCIENCE, EAST MILLSTONE, NJ - EIR
2014
PRECISION BLEND INC - OXYGEN CYLINDER EXPLOSION
INVESTIGATION 9/11/14
WONTON FOOD INC, BROOKYLN, NY - SALMONELLA
ENTERIDIS INVESTIGATIONS, RECS, LAB TESTS, CASE
RPTS, ETC.
NEURONTIN, TOPAMAX - DRUG CLASSIFICATION, CHEMICAL
COMPOUND, AERS, ETC
FOREST LAB INC - CARAFATE (SUCRALFATE) NDA 18-333
SBA
DR PETER R KOWEY, GEODON, ZIPRASIDONE - CORR,
MEMOS, INVOICES, ETC
BIOFRIEND BIOMASK N95 SURGICAL RESPIRATOR K122702
GLAXOSMITHKLINE CONSUMER HEALTHCARE - ACTIPROTECT
UF N95 RESPIRATOR K093161
DAVID L SPARKS, PROFESSIONAL COMPOUNDING CENTERS OF
AMERICA - DOMPERIDONE WARNING LTRS, CORR, RECS
1/1/02, 1/9/04, 3/5/04
JUST MAYO, JUST COOKIES, HAMPTON CREEK, ETC -
EMAILS
OSIRIS - RECS RE UNTITLED LETTER 09/26/2013
NUSCIENCE CORPORATION, LANCASTER, CA LUMINA HEALTH
PRODUCTS, SARASOTA, FL - INVESTIGATION RECS
01/01/2012 - 12/08/2014
AMLODIPINE - AERS
FY 2013 OCP Performance Report
ADVERSE EVENT REPORT
K133226
FCN 1315
ANDA 076649 S3, 4, 7 ANDA 076373 S4, 5
ADALIMUMAB - AERS
COMPLAINTS, APPLICATIONS, CORR ETC RE CANNABINOID
R&B FEEDS LLC, ATLANTA, IA - CMPLNTS, INSPS,
INVESTIGATIONS, ETC
ZALVISO - OCP CATEGORY CLASSIFICATION, OCP
PERFORMANCE REPORT YEAR
GW PHARMACEUTICALS - RECS RE SATIVEX, EPIDIOLEX
CORR WITH ARENT FOX ETC RE SECTION 361 PRODUCTS
LITHIUM - AERS
K031168
FCN 608
FRABAZYME - SHORTAGE RECS 01/01/2009 - 12/31/2013
K033836
Dietary Supplement Use in America's Military
K032590
SWATI MENTHOL & ALLIED CHEMICALS, LTD, INDIA - EIR,
483, RECALL 12/01/2011 - 12/09/2014
ANDA 201984
K133225
K042257, K041543, K050559
MEDTRONIC INC - 8 LEAD SPINAL CORD STIMULATOR
RECALLS, CMPLNTS LAST 2 YRS
INDIVIDUAL RECS
DR HERBERT YALE MELTZER, GEODON, ZIPRASIDONE -
CORR, MEMOS, INVOICES, ETC
ELIZABETH DICKENSON LTR 12/5/13
PAHL PHARMACEUTICAL RESEARCH, OKLAHOMA CITY, OK -
483, EIR 01/02/2013 - 12/31/2013
ANDA 201894
METHYLPREDNISOLONE - AERS
K852560, K852562
NDA 021526 S 004
NDA 021526 S004
SUN PHARMACEUTICAL INDUSTRIES - 483 11/01/2013 -
12/05/2014
BABYGANICS FOAMING HAND SANITIZER, BABYGANICS
SHAMPOO AND BODY WASH, CETAPHIL RESTORADERM BODY
WASH ETC - MEDWATCH REPORTS, CONSUMER COMPLAINTS
NDA 019821
DEN140019
K121719
DMF17864, TYPE 3
ENCO PHARMACEUTICAL DEVELOPMENT INC - EIR
07/07/2014 - 12/10/2014
K130174
K131290
NDA 206627
SURGICAL BIOLOGICS - RECS RE UNTITLED LETTER
08/28/2013
K103429
FLYING FOOD GROUP, LOS ANGELES, CA, HARBOR CITY,
CA, BURLINGAME, CA ETC - 483
TRIFARMA SPA, MILANO, ITALY - EIR
TRIFARMA SPA, MILANO, ITALY - 483 2/1/14 TO
10/31/14
PHARMA MEDICA RESEARCH INC, MISSISSAUGA, ON - EIR
11/17-21/14
DIFLORASONE DIACETATE - AER
2014-9089
MEGLUMINE - CLNCL STUDY
PHILIPS MEDICAL SYSTEMS, CLEVELAND, OH - INSP CORR,
RECS 9/24/13 TO 1/28/14
QRX PHARMA LTD - MOXDUO (MORPHINSE SULFATE,
OXYCODONE HCL) NDA 203-077 FDA
KENALOG CREAM NDA 11-601 SBA
FORREST LAB INC - CARAFA NDA 19-183 SBA
MIRENA IUD - AERS
INC RESEARCH, TORONTO, CANADA MORGANTOWN, VW
RALEIGH, NC, ETC - EIR 07/01/2009 - 09/30/2014
P130026, P060019 S029
K961088
LAMININE - AERS
CONTRAVE, TRULICITY, ORBACTIV ETC - AERS
CONMED DENVER - 483 10/01/2014 - 12/08/2014
2014-9200
OFFICE OF THE OMBUDSMAN - COMM
STN: BL 125508/0
BIOMET 31, PALM BEACH GARDENS, FL - EIRS 8/4-6/14
FOLGERS BRAND INSTANT COFFEE - ANALYSIS PERFORMED
ON CAFFEINE CONTENT, EFFECTS UPON CONSUMING PROD
OVER SHORT TIME SPAN
2014-8183 - MINOR DELETIONS
K012078
All grandfathered product determination letters

issued by the Center for Tobacco Products to the
R.J. Reynolds Tobacco Company, Reynolds American
Inc., RAI Services or any related entity 06/22/2009
- 12/12/2014
K003033
K022771
ANAPHLAXIS - AERS
3M, ST PAUL, MN - EIR
FCN 1461
MANUFACTURER, IMPORTERS OF TOBACCO PRODUCTS - USER
FEES STARTING OCT 1, 2014 ETC
TOBACCO ESTABLISHMENT REGISTRATIONS & TOBACCO
PRODUCT LISTINGS AUGUST 2014 TO PRESENT
K010847
REVO TOBACCO PRODUCT - CORR, REPORTS, ETC
06/22/2009 - 12/12/2014
APOTEX, CANADA - 483 01/01/2014 - 12/12/2014
2014-9235
2014-8418
2014-9156
2014-8300
2014-8375
2014-9192
2014-9338 REQUEST LETTER ONLY
HEPTAVAX B - SBA
ANDA 204234 - APPROVAL LETTER
NDA 021526 S 004 ACTION PACKAGE
IPCA, SILVASSA, INDIA - 483 12/01/2014 - 12/15/2014
IPCA, SILVASSA, INDIA - 483 12/01/2014 - 12/31/2014

K122288 - SE LETTER
AGT-0010459-7 BL# UASUNGLOS001626 CONT#
UACU8308424
IPCA, INDORE, INDIA SILVASSA, INDIA - 483
01/01/2014 - 12/14/2014
AGT-0008500-2 BL# SAFM752756044 CONT# PONU0413020
SPECTRUM PLASTICS GROUP, MINNEAPOLIS, MN - EIR
08/18/2014 - 08/20/2014
CBP Entry Number 417-0282777-9 CBP Line Number 1
FDA Line Number 1 Refusal Date 7/12/2012 - LAB
RECS
K003909
K132429
AHRQ, CISNET COST EFFECTIVENESS STUDY 12/15/2012 -
12/15/2014
IPCA LABORATORIES, SILVASSA, INDIA - 483 12/07/2014
- 12/15/2014
IPCA LABORATORIES, SILVASSA, INDIA - 483 12/07/2014
- 12/15/2014
ZOFRAN - APPROVALS, STUDIES, AERS ETC
COMPLAINTS MADE ABOUT TREATMENT CENTERS PROMOTING
HYPERBARIC OXYGEN FOR CLINICAL USES NOT CLEARED BY
FDA 12/31/2010 - 12/15/2014
FOI DAILY LOG 121-6/14
GOLD BOND BODY POWDER REGULAR STRENGTH - AERS
GOLD BOND BODY POWDER EXTRA STRENGTH - AERS
EMED TECHNOLOGIES CORP - VERSARATE FLOW CONTROLLER
LTRS, EMAILS, CORR 1/14 TO PRESENT
EMED TECHNOLOGIES CORP - INFUSET FLOW CONTROLLER
EXTENSION SET LTRS, EMAILS, MEMOS, ETC 1/14 TO
PRESENT, EIRS, 483'S 1/12 TO PRESENT
MEDTRONIC - NEUROSTIMULATORS MODEL NUMBERS 37702,
37711, 37713, 510KS, PMAS, RPTS, ETC
ST JUDE MEDICAL - EON OR EON IMINI IMPLANTABLE
PULSE GENERATORS 510KS, PMAS, RPTS, ETC
K930511 - DECISION LTR
FORMS TO MAKE FOI REQUEST
ONIMIPOD - INVESTIGATION
SPECIALTY COMPOUNDING PHARMACY - RECS
ALL SHIPMENTS REGULATED BY US FDA 12/1-15/14
MIRA WINERY LLC - OCEAN-AGED WINES INVESTIGATION
AMARJIT JOWANDHA - RECS 4/1/13 TO 1/31/14
BIOMET 3I DENTAL IMPLANT RECALL Z-1458-2014
04/01/2014 - 12/01/2014
NEUTROGENA COSMETIC PRODUCTS 01/01/2013 -
12/15/2014
Retail Sample Testing and Results of Pampers Baby
Wipes - Sample Number 888892
New Drug Application and Attachments and
Supplementary Information for Synthroid
Chemistry review memoranda and any releasable data
relating to dietary exposure to silver in several
FCN
K842481
K001408
K911090
MAKENA - AERS
ATRIUM INNOVATIONS, PITTSBURGH, PA - EIR 09/01/2012
- 01/01/2013
K951721
K952638
BTG - SUBPOENA RE LC BEAD 01/01/2014 - 12/15/2014
DR STEPHEN OLSON, UINIV OF MINNESOTA - BIORESEARCH
MONITORING INQUIRY, SITE VISIT 10/14, 11/14
RAW CONE NATURAL UNREFINED ROLLING PAPERS -
INVESTIGATION RECS
HERITAGE ENVIRONMENTAL, HERITAGE INTERACTIVE, GA
WINTNER & SON CO, ETC - 483S
LIST OF FIRMS THAT RECEIVED NOTICES OF INSP
SPECIALTY COMPOUNDING LLC, CEDAR PARK, TX - RECS
STRYKER ORTHOPAEDICS - LFIT ANATOMIC V40 FEMORAL
HEAD 510K, CORR
STRYKER ORTHOPAEDICS - TRIDENT X3 0 DEGREE
POLYETHYLENE INSERT 510K, CORR
STRYKER ORTHOPAEDICS - TRIDENT PSL HA CLUSTER
ACETABULAR SHELL 510K, CORR
STRYKER ORTHOPAEDICS - ACCOLADE TMZF PLUS 127 NECK
ANGLE V40 HIP STEM 510K, CORR
NATURE HONEY ENTRY #9HX-5500134-8, ENTRY #CFS-
7500429-3
NATURE HONEY ENTRY #9HX-5500138-9, ENTRY #CFS-
7500417-8
ST JUDE - PM2210 GUIDANT - ATRIAL LEAD GUIDANT -
VENTRICULAR LEAD RPTS, INVESTIGATION RECS, RECALLS,
ETC
INDIVIDUAL RECS
LITHIUM CARBONATE - LBLG, AERS, MFR NAME, ETC
OMNI LIFE SCIENCE - APEX SURGICAL MODULAR FEMORAL
NECK WITH PLUG, APEX SURGICAL POROUS FEMORAL STEM,
APEX SURGICAL FEMORAL HEAD APRVL RECS
HETERO DRUGS LTD, MANDAL, VISAKHAPATNAM, INDIA -
EIRS 1/1/10 TO 9/28/14
SONNEBORN INC, PETROLIA, PA - 483, EIR 6/1/14-
8/1/14
ONE LAMBDA, INC - 483 12/15/2009 - 12/15/2014
NDA 202439 XARELTO INVESTIGATION, TESTING,
ANALYSIS ETC
EEMT - AERS
ALTECH ANIMAL FEED, LAKELAND ANIMAL NUTRITION -
INVESTIGATION RECS 10/01/2013 - 12/16/2014
K93490, K943739, K93004 MERIT MEDICAL SYSTEMS,
INC, GALWAY, IRELAND, SOUTH JORDAN, UT, MALVERN, PA
- EIR
IMBRUVICA - AERS
NDA 020698
K020288
HOSPIRA, INC, CLAYTON, NC - EIR JUNE 2013
K130921
POZEN, INC - COMMUNICATIONS REGARDING INSPECTION OF
A FOREIGN MANUFACTURING FACILITY 09/01/2014 -
12/17/2014
AYUSH HERBS, INC - EIR 01/01/2010 - 12/17/2014
HOSPIRA LISCATE SPA, ITALTY - EIR 05/05/2014 -
12/17/2014
Gastroenterology Regulatory Endpoints and the
Advancement of Therapeutics (GREAT II) Workshop
held in MD on October 21 - 22, 2013 - TRANSCRIPT
K133790
K141567, K140931, K141242 ETC
K140933
ANDA 076413, ANDA 077211 - COVER LETTER, APPROVAL
LETTER, RECALL LETTER ETC
NDA 205613
CONSUMER COMPLAINT 139502 - RECS
K123731
T-STAT OXIMETER - K04684
SYNTHES GMBH - STERNAL ZIPFIX WITH NEEDLE STERILE/5
PACK TESTING, MDRS
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
NANOSTRING TECHNOLOGIES, INC - CORR RE MARKETING,

ADVERTISING AND PROMOTION PRACTICES FOR THE
NANOSTRING TECHNOLOGIES NCOUNTER ELEMENTS GENERAL
PURPOSE REAGENTS BY OIR
DETERMINATION BY FDA THAT THE FIRST COMPANY TO

SUBMIT AN ANDA FOR ESOMEPRAZOLE MAGNESIUM DELAYED-
RELEASE CAPSULES, 20 MG AND 40 MG CONTAINING A
PARAGRAPH IV CERTIFICATION FOREITED OR LOST
ELIGIBILITY FOR 180 DAY EXCLUSIVITY ETC
JOHNSON AND JOHNSON APDC, MUMBAI, INDIA - EIR MAY
2014
HOSPIRA, AUSTIN, TX - EIR MAY 2014
JUSTIN A BOYD,CADLIA PHARMACEUTICALS LTD,
ANKIESHWAR,L GUJARAT STATE, INDIA , - 483S 3/24-
28/14
OLEKSANDRA V STASYSHYN MD PHD, LVIV, UKRAINE - 483S
1/21-25/13
DOREL SANDESC MD, TIMISOARA, ROMANIA - 483S
10/28/13-11/1/13
HIKMA PHARMACEUTICAL LTD, JORDAN, PORTUGAL - 483S
3/20-28/14
MTG WITH APPLE - MINS 12/12/13 TO PRESENT
PYRUS MALUS (APPLE) FRUIT METABOLISM EXTRACT, PYRUS

MALUS (APPLE) BARK EXTRACT, PYRUS MALUS (APPLE)
CARPEL POWDER, ETC - MEWTABOLISM/BIOAVL, DERMAL
PENETRATION, TOXICITY
TRIARRCO INDUSTRIES, PATTERSON, NJ, ARCHON VITAMIN

CORP, IRVINGTON, NJ, GARY NULL & ASSOC, NYC, NY -
RECALL, INVESTIGATION, WARNING COMPLIANCE, ETC
12/09 TO PRESENT
METHYLPHENIDATE - AERS
IMATINIB MESYLATE - TENTATIVE APPROVAL LETERS TO
SUN PHARMA INDUSTRIES 11/01/2009 - 11/01/2014
TOMOPHASE 510K SUBMISSION
FY 2014 483 UNDER 7348.001, 7348.808, 7348.808A ETC

FMC BUTNER - LINEAR ACCELERATOR LICENSING &
OPERATION OVER-RADIATION, MEAS OF REPAIRS, ETC
MEDICIS- PREDNISOLONE SODIUM PHOSPHATE ORAL SOL
ANDA 75-250 SUBMMISSION
AER
483 RELEASED 09/18/2014 - 12/22/2014
AVKARE, PULASKI, TN - REQUEST FOR INSPECTION JUNE
2014
K040977
P100046, K031247, K110117 ETC
SE0003298
K123633
ZYDELIG - AERS
DEN080011, K081406
ANDA 075753
SE0001698
SE0004001
K140366
SE0001697
K082491
K123128
K061248
IND 41653
NDA 22320
K071733
K071573
K140271
IMBRUVICA - AERS
SE0003297
METOCLOPRAMIDE - SBA
CREATIVE OCCASIONS, INC, NASHVILLE, TN -
INSPECTIONS, COMPLAINTS 01/01/2013 - 01/06/2015
KEYTRUDA - AERS
NDA 022535 ORPHAN DESIGNATION
SE0003299
5,129 Drugs Marketed Without an Approved NDA/ANDA
ASPIRE PHARMACEUTICALS, SOMERSET, NJ - EIR
02/01/2010 - 02/05/2015
BETASERON - PHASE III CLINICAL TRIAL DATA
NDA 205832 ORPHAN DESIGNATION
REFUSAL OF ADMINISSION ENTRY G33-0172430-5
DMF 23564 DMF 23596 - MANUFACTURING FACILITIES
ANDA 078936
2014-9430
LUPIN LIMITED - 483 01/01/2015 - 01/31/2015
K132028
DR SEGAL - FOLLOW UP LETTER 01/03/2013 - 02/05/2015

MERRELL RESEARCH CENTER, MERRELL NATIONAL
LABORATORIES, RICHARDSON MERRELL, CINCINNATI, OH
ETC - INSPECTION RECS
ATLANTIC SCALE, INC - RECALL RECS 08/01/2013 -
02/05/2015
CLOSED FOIA REQUESTS 12/29/14 TO1/3/15
K965134
CLOSED FOIA REQUESTS 12/9/14 TO 1/02/15
K955936
K090283
LBLG CLAIMS FOR PET CARE PRODS - COMPLNTS
BASF, GERMANY - 483
MONUROL - MEDICAL REVIEW
METROCREAM MEDICAL REVIEW

WLSEA1301 - COMPANY RESPONSE
CPT1400875 - NOTES, SUMM, COMM , ETC
DRUG EFFICACY LIST
ETHICON ENDO-SURGERY, INC - EIR, 483 01/01/2003 -
02/03/2015
SANOFI - MULTAQ (DRONEDARONE) AERS,, COMM, MEMO
UNREDACTED NIPOE, NOOH, WARNING LTR DTD AFTER 1/98
RECS RE MEETING BETWEEN TEVA AND FDA 08/26/10
NUTECK DISPOSABLE INC - SIMPLY RIGHT WIPES RECALL,
CORR, LAB STUDIES, ETC
ALTLANTA CENTER FOR NUTRIENT ANALYSIS (ACNA) -
VITAMIN A, B12,C, ETC TESTING PROTOCOLS
BAYER CORP, JANSSEN RESEARCH & DEVELOPMENT ENTITIES
- XARELTO APRVL APPL, PERMITS, PROCEDURE MANUALS,
ETC
BLA 103532/5175 SBA
FLYING FOOD GROUP, LOS ANGELES, CA HARBOR CITY, CA
BURLINGAME, CA ETC - INSPECTION RECS
DATA DICTIONARY FOR INSPECTIONS OF HUMAN CELL AND
TISSUE ESTABLISHMENTS 01/01/2010 - 02/01/2015
K033266
K123999
REVANCE THERAPEUTICS, MEDICIS PHARMACEUTICAL

CORPORATION - CORR RE RT001 01/01/2000 - 02/06/2015
2014-9541
CARDIOLITE - APPROVAL PACKAGE
FDA APPROVED METHOD TO ASSAY RACTOPAMINE IN TYPE B
AND C SWINE AND TURKEY FEEDS
2014-9792
APOTEX RESEARCH PRIVATE LIMITED, INDIA - 483
11/17/2014 - 02/06/2015
MEAD JOHNSON NUTRITION, EVANSVILLE, IN MEAD
JOHNSON NUTRITIONALS, ZEELAND, MI ETC - 483, EIR
09/01/2014 TO PRESENT
BREATHABLE FOODS - CORR RE WARNING LETTER
03/05/2012
K060463
NDA 020262 S 000 ETC
K110895
NDA 018669
DANNON, MINSTER, OH, PBM NUTRITIONALS, COVINGTON,
OH - EIR, 483 483 09/01/2014 TO PRESENT
K063458
K123444
ANDA 077263
ASEPTICO, WOODINVILLE, WA - EIR 09/01/2009 -
09/04/2009
BIOCOMPOSITE - EIR, CLOSEOUT LETTER 02/04/2013 -
02/04/2015
STRYKER, HOWMEDICA - GLOBAL MODULAR REPLACEMENT SYS
(GMRS), MODULAR ROTATING HINGE KNEE (MRHK) FEMORAL
COMPONENT MDRS, MEMOS, WARNING LTRS, ETC
POLYETHYLENE GLYCOL 3350 - AERS 1998 TO PRESENT,
CORR 6/13/84
CISPLATIN, PLATINOL, THIMEROSAL - AERS FLU VACCINE
- VACCINE INJURY TABLE 2013-2014, ETC
FCN 912
XARELTO (RIVAROXABAN) NDA 22-406, NDA 202-439 -
CORR, AERS, MOR, ETC
DAIICHI SANKYO INC, FOREST LABORATORIES INC, ETC -
BENICAR, AZOR, TRIBENZOR, ETC EIRS, CORR, AERS, ETC
ANDA 040745
GULF COAST COLD STORAGE A1, PASCAGOULA, MS - PHOTO,
VIDEO ETC RE FIRE AND CLEANUP EFFORTS 12/10/2013 -
12/10/2014
MEDWATCH RPTS CODED AS MEDICATION ERRORS 12/14 TO
1/15
KURT LESH, COLORADO SPRINGS FAMILY PRACTICE,
COLORADO SPRINGS, CO - 483S 5/09 TO PRESENT
SIPULEUCEL-T - NCT00065442 STUDY
ROCHE - TORADOL (KETOROLAC) IND SAFETY RPTS, AERS,
TOXICOLOGY RECS, ETC
HYDROXYCUT - CAERS 112830, 113122, 116215, ETC
EXPOSURE ESTIMATE FOR FD&C COLORS FOR THE US
POPULATION - PRODUCT IDENTITY
POWDERED CAFFEINE - SALE OR DISTRIBUTION PHONE
LOGS, LTRS, NOTES, ETC
INDIVIDUAL RECS
PRODUCT QUEST MANUFACTURING INC, DAYTONA BEACH, FL
- INSP RECS
REPUBLIC TOBACCO - CORR WITH FDA
LSG SKY CHEFS INC, SEATTLE, WA - 483 01/01/2014 -
01/06/2015
CORGARD (NADOLOL) NDA 18-063 APRVL LTR, LBLG, MOR,
ETC
SAMSCA - AERS
RECS RE COMPLAINT 139980
VANCOMYCIN - AERS
TRAVATAN DOSING AID - PATHWAY TO MARKET 01/01/2005
- 12/31/2011
NDA 201917
HERSHEY MEDICAL CENTER BLOOD BANK - EIR 12/10/2014
- 12/10/2014
NDA 022181 - SBA, ORPHAN DRUG DESIGNATION
INSYS THERAPEUTICS - INSPECTION RECS, AERS
01/02/2011 - 02/09/2015
K111393
SILVERFOILTUBES - CORR WITH FDA
WOUND BE GONE - IMPORT ALERT
DIETARY SUPPLEMENTS - INSPECTION DATA
DR JONATHAN SAMET - COMMUNICATIONS WITH FDA CTP
JUNE 20, 2014 TO PRESENT
HOUSE OF OLIVER TWIST A/S - CORR WITH FDA
NDA 205874
REPTILE INDUSTRIES - SALMONELLEA OUTBREAK,
INVESTIGATIVE REPORTS, MEDICAL REPORTS 05/01/2014 -
08/31/2014
ANTHROTRONIX INC DANA 510K
DR REDDY'S LABORATORIES, INDIA IPCA LABORATORIES,
INDIA - 483 01/01/2014 - 02/10/2015
ANDA 076373
ANDA 062531, ANDA 062307, ANDA 062427, ETC - SBA
BIOEQUIVALENCE REQUIREMENTS FOR INHALED NITRIC
OXIDE
K080966
HOUSE OF OLIVER TWIST A/S - CORR WITH FDA
XLEAR - 483 01/01/2000 - 02/09/2015
PAREXEL, BERLIN, GERMANY - EIR, 483
CLOZAPINE - DEATHS
S&M BRANDS - CORR WITH FDA
NDA 022472
ALBENZA (ALBENDAZOLE) NDA 20-666 APRVL LTR, LBLG,
MOR, ETC
NDA 19569
LOTENSIN HCT (BENAZEPRIL HCL, HYDROCHLOROTHIAZIDE)
NDA 20-033 APRVL LTR, LBLG, MOR, ETC
CHLORPROMAZINE HCL NDA 80-439 - APRVL LTR, LBLG,
MOR, ETC
GVK BIOSCIENCES, HYDERABAD - EIRS, 483S, COMM, ETC
9/14 TO PRESENT
CETERO RESEARCH - RESP TO UNTITLED LTR 7/26/11
GENERIC FIRMS THAT MARKETED 81 PRODUCTS AFFECTED BY
CETERO FRAUD - BIEQV STUDIES
K093642
GLAXOSMITHKLINE - LAMICTAL SAFETY UPDATE RPT, AERS
K141742
K132750
NDA 021446 S10
GRANDFATHERED TOBACCO PRODUCT STATUS DETERMINATION
FOR NATURAL AMERICAN SPIRIT PRODUCTS
2014-8655
2014-3330
NATUREX, SOUTH HACKENSACK, NJ - EIR, 483 RECALL
09/01/2013 - 02/10/2015
HARD CANDY CAT MAKEUP KIT - AERS 01/01/2010 -
02/01/2015
CORTEF - SUPPLEMENTAL NDA, CORR, SUPPLEMENTAL
APPROVAL 01/01/1973 - 01/01/1979
NDA 008697
2014-9433
2013-5597
2014-9359
2014-1940
SUN PHARMACEUTICALS - 483 UPDATE RECS 09/17/2014 -
01/07/2015
STERIS ISOMEDIX, STERIGENICS - LIST OF 483
01/01/2012 - 02/10/2015
K124006
NDA 021427
AUGMENT BONE GRAFT PREAPPROVAL INSPECTION - 483,
CORR
General and Plastic Surgery Devices Panel of the
Medical Devices Advisory Committee background
materials for 12/01/2011 meeting
ALL FOR CAUSE INSPECTION REQUESTS MADE TO FDA OSI
01/01/2010 - 02/01/2015
K093585
FAP 2B4297
WR MEDICAL, MAPLEWOOD, MN - EIR 04/01/2014 -
05/31/2014
K123955
510K RELEASED DECEMBER 2014
STANDARD PROCESS, PALMYRA, WI - EIR 01/01/2012 -
02/10/2015
SANOFI, ST LOUIS - EIR 02/04/2014 - 02/10/2015
NDA 103964
HEARTWARE INC - HVAD CLINICAL DATA
ADVISORY COMMITTEE MEETING MATERIALS - DNP REVIEW

OF NEURODEVELOPMENTAL DELAYS WITH PRENATAL VALPROIC
ACID EXPORSURE (CERTIFIED) 06/01/2009 - 06/30/2009
INDIVIDUAL RECS
CLOSSED FOIA REQUESTS 1/26-30/15
K083903
All registered drug and device manufacturers with
addresses, contact information, and the number of
annual anatomic pathology tests per year
ORALIEF OTC TOOTHPASTE FOR SENSITIVE TEETH -
K080228 ORALIEF THERAPY FOR SENSITWIVE TEETH -
K040858
EUGENE EMERGENCY PHYSCIANS PC, EUGENE, OR, ANN M

COOLEY MD, PEACEHEALTH SACRED HEART MEDICAL CENTER
AT RIVERBEND, SPRINGFIELD, OR, PEACEHEALTH SACRED
HEART MEDICAL CENTER HOSP UNIV DISTRICT, EUGENE, OR
- METOCOLPRAMID, REGLAN INJ, METOCLOPRAMIDE INJ BO
BAXTER HEALTHCARE CORP - METOCLOPRAMIDE, REGLAN

INJ, METOCLOPRAMIDE INJ RISK OF LONG-TERM OR HIGH-
DOSE BOXED WARING COMM, DEAR DOCTOR LTRS, ETC
(CERTIFIED)
MYLAN PHARMA - ESOMEPRAZOLE MAGNESIUM NDA 78-936
TENTATIVE APRVL LTR 2/14/15
LIST OF DRUG PRODS THAT ARE STILL ON THE MARKET W/O
ANDA OR NDA APRVL
MEDIMAGING INTEGRATED SOLUTION INC - EIR 08/18/2014
- 02/11/2015
PET FOOD SLAUGHTER RECS
AUROBINDO PHARMA UNIT IV, INDIA - 483 09/02/2014 -
09/30/2014
LASIX NDA 016273- APPROVAL PACKAGE
K132560, K102893, K041934 ETC
OREGON AESTHETIC TECNOLOGIES DBA ANSR - WARNING
LTR 9/14/12 REMAINDER OF CORR
INDIVIDUAL RECS
REMS DRUG ERROR REPORTS BY DRUG 01/01/2005 -
12/31/2013
Flex-Belt FDA clearance
B F MAZZEO FRUITE & PRODUCE INC, NORTHFIELD, NJ -
EIRS, ENFORCEMENT ACTIONS
DR REDDY'S LABORATORIES - 483 11/01/2014 -
02/11/2015
ENVIRO TECH CHEMICAL SERVICES INC - DKT 96F-0076
RELEASE OF GENETICALLY ENGINNEERED OR MODIFIED BEES
- RECS, RELATING TO INVESTIGATIONAL NEW ANIMAL
DRUG, SUPPORT, RDNA CONSTRUCT, ETC
SPL 756801, 756802 - RPT
BIDART BROTHERS APPLE PACKING, SHAFTER, CA, HAPPY

APPLE CO, OROSI, CA - RECALL LISTERIA PATHOGEN
SAFETY INSP, CMPLNT LTRS, CONSUMER INTERVIEWS, ETC
NDA 202439, NDA 022406
K051093
2014-9843
ANDA 076648
K810310
OHR PHARMACEUTICAL END-OF-PHASE II MEETING MINUTES
09/01/2014 - 10/15/2014
ANDA 077066
K870233
K973634
MINOCYCLINE HYDROCHLORIDE (LUPIN) ANDA 91-424 APRVL

K122474
Any and all complaints received by Intuitive

Surgical, Inc., or the FDA pertaining to electrical
arcing related to the use of the da Vinci Surgical
System
K954261
MINOCYCLINE HYDROCHLORIDE (AUROBINDO) ANDA 02-261
APRVL
K131153
K121478
MINOCYCLINE HYDROCHLORIDE (MYLAN) ANDA 01-467 APRVL

NDA 022496
MINOCYCLINE HYDROCHLORIDE (RANBAXY) ANDA 91-118
APRVL
CIVIL MONEY PENALTIES PURSUANT TO TOBACCO CONTROL
ACT
MINOCYCLINE HYDROCHLORIDE (SANDOZ) ANDA 90-422
APRVL

ACTAVIS, OWINGS, MILLS, MD - 483 01/01/2013 -
01/01/2015
MW5039853 - FACILITY NAME, CONTACT
ORANGE BOOK - APPROVALS, DELETIONS, CHANGES ETC
01/01/2014 - 02/12/2015

MINOCYCLINE HYDROCHLORIDE (BARR) ANDA 65-485 APRVL
MW5040174 - FACILITY, CONTACT
DR REDDY, INDIA - 483 11/01/2014 - 02/01/2015
VALEANT PHARMACEUTICALS INTERNATIONAL - WARNING
LETTER, RESPONSE 09/14/2014 - 02/11/2015
REVIEW DOCUMENTS FOR 12 CANCER DRUGS
2014-9889
2014-9886
FDA Form 3419 or electronic equivalent, and all

attachments thereto, of any user facility related
to a da Vinci Surgical System manufactured by
Intuitive Surgical, Inc
2014-3496
MINOCYCLINE HYDROCHLORIDE (IMPAX) ANDA 90-024 APRVL
FDA Form 3500A or electronic equivalent, and all

attachments thereto, of any user facility related
to a da Vinci Surgical System manufactured by
Intuitive Surgical, Inc
LIST OF REGULATED FOOD AND ANIMAL FEED FACILITES IN
IDAHO COUNTIES 01/01/2014 - 01/05/2015
NDA 50664, 50665
BIOLOGICS THERAPEUTICS, OCALA, FL 1/22/15 SCORPION
MEDICAL, OCALA, FL 1/22/15 EDGE BIOLOGICALS,
MEMPHIS, TN 1/29/15 - INSP
MINSA CORP, MULESHOE, TX - INSP 4/17/13,
CERTIFICATE OF FREE SALE & SANITATION APRVL
REGISTRATION LIST FOR FRAMEWORK FOR REGULATORY
OVERSITE OF LABORATORY DEVELOPED TESTS WORKSHOP
1/8-9/15
LISTERIA OUTBREAK OCTOBER - DECEMBER 2014
PROFESSIONAL COMPOUNDING CTRS OF AMERICA, HOUSTON,
TX OLAINFARM JSC, OLAINES NOVADS, LATVIA - EIR
ANTIHPERTENSIVE - CLNCL SUMMARY
HHSF223201000054I - CONTRACT, MODIFICATIONS, TASK
ORDERS
FDA-14-1131234, FDA-SOL-13-1118990 - SOLICITATION
RECS, CONTRACTS
ST LUCIE MEDICAL CTR - INVESTIGATION 2008 TO
PRESENT
K041934
INTERGRATED REGIONAL LABS LLP - INVESTIGATION 2008
TO PRESENT
INDIVIDUAL RECS
ABBOTT LABS, CASA GRANDE - POWERED FORMULA
NVESTIGATION 9/23/11 GAINT EAGLE WAREHOUSE -
SIMILAC INVESTIGATION 9/30/11
STRYER NEPTUNE - RECS PREVIOUSLY RELEASED UNDER
FOIA 05/01/2006 - 02/05/2015
PAR STERILE PRODUCTS LLC, ROCHESTER, MI - EIR
11/2014
LIST OF CURRENT REQUESTS
LASBORATORIES BOIRON, MESSIMY, FRANCE, KYOWA HAKKO
KOGYO CO LTD, SAKAI-CITY OSAKA, JAPAN, LUPIN LTD,
INDORE, INDIA - 483S 1/1-31/15
SEDATELEC, IRIGNY, FRANCE, ALCON LABORATORIES

IRELAND LTD, CORK, IRELAND, GUANGZHOU T K MEDICAL
INSTRUMENT CO LTD, GUANGXZZHOU CITY, CHINA, ETC -
483S 1/1-31/15
WOOD'S PHARMACY INC, BOONES MILL, VA - 483S 1/1-
31/15
GREAT LAKES NEUROTECHNOLOGIES INC, VALLEY VIEW, OH,

INTEGRATED MEDICAL SYSTEMS INTERNATIONAL INC, STOW,
OH, ELECTRO CAP INTERNATIONAL INC, EATON, OH, ETC -
483S 1/1-31/15
K102893
UNIVERSITY OF TEXAS MD ANDERSON CANCER CENTER,
HOUSTON, TX - EIRS 1/1-31/15
DYNATRONICS CORP, SALT LAKE CITY, UT - 483S 1/1-
31/15
WEXFORD LABS INC, KIRKWOOD, MO, MALLINCKRODT INC,
MARYLAND HEIGHTS, MO, TRIAD ISOTOPES INC, KANSAS
CITY, MO - 483S 1/1-31/15
BREWER COMPANY LLC, MENOMONEE FALLS, WI, LIFE

TECHNOLOGIES CORP, BROWN DEER, WI, BELL
INTERNATIONAL LABORATORIES INC, MINNEAPOLIS, MN -
483S 1/1-31/15
CAMBRIDGE ISOTOPE LABORATORIES INC, TEWKSBURY, MA -
483S 1/1-31/15
ARTEGRAFT INC, NORTH BRUNSWICK, NJ - 483S 1/1-31/15

BIG RIVER ENGINEERING & MANUFACTURING, MEMPHIS, TN,
MRP, LLC (AMUSA), NASHVILLE, TN, ISCREEN VISION
INC, CORDOVA, TN, ETC - 483S 1/1-31/15
ORTHO BIOLOGICS LLC, MANATI, PR, AMGEN MANFACTURING
LTD, JUNCOS, PR, EDWARDS LIFESCIENCES TECHNOLOGY
SARL, ANASCO, PR - 483S 1/1-31/15
COMFORT ACRYLICS INC, CAMAS, WA, OR SPECIFIC INC,
VANCOUVER, WA, VENTRIPOINT INC, BELLEVUE, WA, ETC -
483S 1/1-31/15
SMALL WORLD TRADING COMPANY INC, SAN RAFAEL, CA,
BENTEC MEDICAL INC, WOODLAND, CA - 483S 1/1-31/15
K050159
ABBEY COLOR INC, PHILADELPHIA, PA, PHARMACEUTICAL
MANFACTURING RESEARCH SERVICES INC (PMRS), HORSHAM,
PA - 483S 1/1-31/15
FISHER WALLACE LABS, NEW YORK, NY, SCIEGEN

PHARMACEUTICALS INC, HAUPPAUGE, NY, TIME-CAP
LABORATORIES INC, FARMINGDALE, NY, ETC - 4383S 1/1-
31/15
BARD PERIPHERAL VASCULAR INC, TEMPE, AZ,

PHARMACEUTICA NORTH AMERICA, GLENDALE, CA, PYRAMID
LABORATORIES INC, COSTA MESA, CA, ETC - 483S 1/1-
31/15
TARMAC PRODUCTS INC, MIAMI GARDENS, FL , SMITH &

NEPHEW INC, SAINT PETERSBURG, FL, SOFT COMPUTER
CONSULTANTS INC, CLEARWATER, FL, ETC - 483S 1/1-
31/15
FCN 256
STANDER INC (STANDER, STANDERS, STANDERS INC) - BED
RAILS OR MOBILLITY AIDS CMPLNTS, RECALLS,
INVESTIGATION, ETC
FABRAZYME SHORTAGE - INTERNAL DELIBERATIONS, CORR
REPLAGAL - BRIEFING MATERIALS, CORR
NDA 21-098/S022, NDA 21-676/S012, NDA 22-532/S004
ETC
21 CFR 1040.11(c) VARIANCES - LIST OF NAMES,
ADDRESSES, TERMINATIONS
NATCO PHARMA, STRIDES ARCOLAB - 483, EIR 01/01/2014
- 12/31/2014
DR REDDY, SRIKAKULAM, INDIA - 483 11/03/2014 -
11/28/2014
SAMPLE 888891
K081996, K102519, K112522, ETC
VACUUM ASSISTED DELIVERY - AERS
FCN 1353
K131982
K130077
IPCA LABS - EIR 10/01/2014 - 02/13/2015
ULTRADENT PRODUCTS INC, SOUTH JORDAN, UT - EIR
10/01/2014 - 02/12/2015
HOSPIRA, INC, INDIA - 483 01/01/2015 - 02/12/2015
DKT FDA-2013-P-0219
ERCROS SA, MADRID, SPAIN - 483 12/01/2014 -
01/07/2015
All documents related to the loss of A2LA
accreditation on September 19, 2014 of FDAs
Northeast Regional lab in Jamaica, New York.
K961837
Sitagliptin, Sitagliptin+Metformin - AERS
K033448
PRAXAIR - CORR RE BIOEQUIVALENCE REQUIREMENTS FOR
GENERIC INHALED NITRIC OXIDE
SHIPMENTS REGULATED BY THE US FDA 2/1-15/15
MENTHOL CIGARETTE STUDIES
BLA 103000
NDA 021588 S 042 - SBA
XANAX - SAFETY REVIEW, EVALUATION 3/24/89
NDA 020091
ALPRAZOLAM, TRIAZOLOBENZODIAZEPINES - TWO PAPERS
STEPHEN W LASTIG - WARNING LETTER RECS 01/01/2000 -
02/25/2005
ALPRAZOLAM - AERS
ANDA 074612
METHYPATCH - REVIEWS, LETTERS ETC RE REJECTED NDA
Alembic Pharmaceuticals, Ltd., MacLeods
Pharmaceuticals Ltd. - name and address of US Agent
AL CHI MI A SRL, PONTE S NICOLO, ITALY - 483S,

WARNING LTRS LAST 3 YRS
MEDICAL PRODUCTS LABORATORIES, INC. - WARNING
LETTER DOCUMENTATION
NDA 022068 S 020
Voriconazole - FAERS
K103113
FLUOROSIS - AERS
LITTLE TEA CUP CORP, SUNRISE, FL - EIR 12/03/2013 -
12/19/2013
STERI-PHARMA, SYRACUSE, NY - EIR 10/06/2014 -
10/10/2014
K133057
K121891
MITCHELL GHEN, INSTITUTE OF CELLULAR MEDICINE -
K833549, K923378
PUREGEN APPROVAL 2013
PUREGEN APPROVAL 2012
AXIS CLINICALS LIMITED - EIR 08/06/2013 -
08/08/2013
PURTOX - CLINICAL TRIAL PHASE 3 FINDINGS, RESULTS
SERTRALINE - AERS
NDA 000552
NDA 013132
NDA 014694
NDA 012674
NDA 012675
NDA 020430
ATRIUM, MAQUET - 483 01/01/2010 - 02/16/2015
ANAZAOHEALTH CORPORATION, LAS VEGAS, NV - EIR
01/20/2015 - 01/30/2015
INTUITIVE SURGICAL, INC DA VINCI SURGICAL SYSTEM -
FORM 3500A, INCDate Range: 01/01/2007 - 12/31/2014
FCN 519
K120816
K103008
BEECH-NUT NUTRITION COMPANY, TOWN OF FLORIDA, NY -
HINES NUT COMPANY SALMONELLA TESTING OF WALNUTS
02/01/2015 - 02/17/2015
NDA 013304
AMERICAN HYALURONIC ACID MANUFACTURERS, SUPPLIERS
02/17/2014 - 02/17/2015
GREEN VIBRANCE, VIBRANT CLEANSE, VIBRANT HEALTH ETC
- ADVERSE EVENTS
K092666
ATTACHMENTS TO EMAIL SENT FROM STATE OF MICHIGAN TO
FDA DETROIT DISTRICT 08/01/2014 - 02/17/2015
K030685, K112679
2014-8690
2014-9978
2014-10005
2015-389
EXPAREL, BUPIVACAINE - AERS
FCN 732
NDA 205122
EXPAREL - AERS
NDA 020038, NDA 019897
K052396
ETHOX INTERNATIONAL - EIR, 483 01/01/2010 -
03/31/2010
AZITHROMYCIN - AERS
EXPAREL - WRITTEN SUBMISSIONS TO FDA OFFICE OF

PRESCRIPTION DRUG PROMOTION 10/28/2011 - 02/17/2015
ANAZAOHEALTH CORPORATION, TAMPA, FL - EIR
02/19/2013 - 02/22/2013
PANORAMIC CORPORATION, FOR WAYNE, IN - 483
01/01/2009 - 12/31/2009
ANDA 078970
WOCKHARDT LTD, CHIKAHLTHANA - 483 01/01/2015 -
02/18/2015
K093642
LUPIN, INDIA - 483 01/12/2015 - 01/23/2015
PROZAC - APPROVAL RECS
SGS CANADA, INC - EIR 06/19/2014 - 06/20/2014
Clinical data for galantamine and/or galanthamine
submitted in conjunction with API submissions for
Nivalin, Razadyne, Razadyne ER, Reminyl, and
Lycoremine
K051007
XTANDI (ENZALUTAMIDE) - AER
PRAGMA PHARMACEUTICALS -DESYREL (TRAZODONE
HYDROCHLORIDE) NDA 18-207
ANCHEN PHARMS - CLONIDINE HYDROCHLORIDE SBA, MED
RVW, CHEM RVW, LBLG
ANCHEN PHARMS - CLONIDINE HYDROCHLORIDE ANDA 02-983
SBA, MEDICAL RVW, CHEMISTRY RVW, LBLG
ZETIA (EZITIMIBE) NDA 21-445 RX & OTC DRUG PRODUCT
PATENT & EXCLUSIVITY LIST MONTHLY SUPPLEMENTS 5/06
TO 10/06
KERYX BIOPHARMS - AURYXIA (FERRIC CITRATE) NDA 205-
874 SBA, RWV
FDA DRUG BULLETIN APR 1982 VOL 12 NO 1 -
(CERTIFIED)
PREMARKET BIOTECHNOLOGY NOTIFICATION FOR MON 87411
CORN W/DOUBLE STRANDED RNA
QUIMICA FARMACEUTICA BAYER SA, LA FERGUERA,
AUSTURIAS, SPAIN - 483 6/14 SHANDONG XINHUA
PHARMACEUTICAL CO LTD, ZIBO, CHINA - 483 4/14
Names and the locations of the dialysis centers in

Tennessee that received recalled lots of Fresensius
NaturaLyte Liquid Bicarbonate Concentrate.
MANUAL OF THE ASSOCIATION OF AMERICAN FEED CONTROL
OFFICIALS -INGREDIENT DEFINITION 36.15 - DOCS
LIST OF REQUESTERS WHO APPEALED DENIALS 2013
RESULT OF ALL FOIA REQUESTS 2013

ALCRESTA INC - FCN 001498 TOXICOLOGY
SUBSYS - AERS
GRATO HOLDINGS, WOODBINE, IA - EIR 03/01/2011 -
08/31/2013
SAREPTA - GUIDANCE, COMMUNICATIONS RE TIMELINE OF
NDA ETC 11/01/2013 - 02/18/2015
ZYDELIG - AERS
MEDISCA, PLATTSBURGH, NY LETCO MEDICAL, DECATUR,
AL PROFESSIONAL COMPOUNDING CENTERS OF AMERICA,
HOUSTON, TX - EIR, 483 02/18/2014 - 02/18/2015
5 HOUR ENERGY - PRODUCT COMPLAINTS, ADVERSE HEALTH
EVENTS 10/24/2012 - 02/18/2015
SAMPE 870515 - TESTING RESULTS
NADA 065-252
IBRUTINIB - CASE REPORTS
K032222
EUROFINS LANCASTER LABORATORIES - QAP 10/01/2012 -
02/18/2015
PEDIATRIC APPROVAL RECS
LOVALO - MEDICAL REVIEW
MERIAL LTD - NEXGARD (AFOXOLANER) CHEWABLE TABS FOR

DOGS NADA 141-406 AERS, LBLG, INVESTIGATIONS, ETC
EXTREME PRODUCTS GROUP - TRI-METHYL XTREME CAERS

STRYKER SUSTAINABILITY SOLUTIONS - REPROCESSED
HARMONIC ACB SHEARS WITHOUT ADAPTIVE TECHNOLOGY
K133672
BARBARA O SCHNEEMAN LTR 4/14/06 (CERTIFIED)
CLOMID AND CLOMIPHENE CITRATE NDA 16-131 - LBLG
2/1/67 TO PRESENT
CYCLOSPORINE - LETTERS, COMPLAINTS
K091292
GILENYA (FINGOLIMOD) - AERS 1/1/13 TO PRESENT
IMBRUVICA (IBRUTINIB) - FOI REQUESTS 1/1/10 TO
PRESENT
SUN PHARMACEUTICALS, HALOL - 483S 9/14 TO PRESENT
VAERS 554258-1
TABLO CONSOLE - K140866
TABLO CARTRIDGE- K140841
SEN PRAND PAUL - CORR 1/11 TO PRESENT
SANOFE - FLUZONE VAERS (CERTIFIED)
DARK CHOCOLATE PRODS CONTAINING MILK - FDA CONSUMER
UPDATE STUDY 2/15
FOIA LOG 01/01/2013 - 01/01/2015
ETEX CORP - EIRS 9/29/10, 2/15/13, 8/19/14
MONGIELLO ITALIAN CHEESE SPECIALTIES INC - WARNING
LTR NYK-2014-17 RESP, INSPS 7/22-24,26/13,
8/13/13, ANALYSIS, ETC
ANDA 201-173 - APRVL LTR
VELOXIS PHARMACEUTICALS INC - ENVARSUS XR

(TACROLIMUS ER TABS) NDA 206-406 ASTELLAS PHARMA
US INC - ASTAGRAF XL (TACROLIMUS EX CAPSULES) NDA
204-096 APRVL
LINZESS (ILINCLOTIDE) - AERS 1/13 TO PRESENT
TESTOPEL - FOLLOW UP RPTS
CLOMID, CLOMIPHENE CITRATE - NDA 16-131 LBLG 1/67
TO PRESENT
INSPECTION DATA
INSPECTION, APPLICATION, APPROVAL DATA
FOOD SHIPMENT CONSIGNEES
NATAIZUMAB - AERS
DATASET FOR POSTMARKET REQUIREMENTS NDA/BLA
01/01/1992 - 02/01/2015
DR SURESH GUPTA, DAYTON, OH - NIDPOE, CORR
01/01/2008 - 02/19/2015
DALBAVANCIN, TEDIZOLID, ORITAVANCIN - MEDWATCH
REPORTS 05/03/2014 - 02/19/2015
SILVER NITRATE CAUSTIC STICKS - AERS
K121609
CPT1400353
FOIA REQUESTS FROM FORSTA AP-FONDEN, DANSKE INVEST
MANAGEMENT A/S BLACKROCK ETC 01/01/2005 -
06/30/2013
FLUOROQUINOLONE DRUGS - AERS
ST JUDE MEDICAL - FOIA REQUESTS FOR 483
K070375
58 FR 2852 - COMMENTS 01/01/1991 - 01/12/1993
K083510
ANIKA THERAPEUTICS CINGAL TRIAL DATA
KEYTRUDA - AERS
K110693 PERFORMANCE TESTING DATA
K132437 PERFORMANCE TESTING DATA
KOVA LABORATORIES - COMPLAINTS
AMERX HEALTH CARE CORP - CONSUMER COMPLAINTS
01/01/2013 - 01/01/2014
K971918
FCN 823, 1239
K003940 PEROFRMANCE TESTING DATA
ASBESTOS REMEDIATION
FOIA LOG ST JUDE MEDICAL
INDIVIDUAL RECS
NDA 050450 SBA
ANDA 064144 SBA
NDA 020068 SBA
TERUMO CARDIOVASCULAR SYSTEMS CORPORATION, ANN
ARBOR, MI - EIR, 483, RESPONSE 01/01/2014 -
02/28/2014
LUPIN, GOA, INDIA - 483 01/05/2015 - 01/30/2015
HILL-ROM, INC, BATESVILLE, IN - EIR, 483, RESPONSE
01/01/2014 - 01/31/2014
MALLINKRODT, KUDCO - AERS CITED IN PRESS RELEASE
NDA 020430, NDA 012675, NDA 012674 ETC
DR REDDYS LABS, VIZAG SEZ PLANT, ANDHRA PRADESH,
INDIA - 483
NDA 016199, NDA 017351 SBA
RECS RE DATE AND TIME OF ST JUDE MEDICAL 483 POSTED

YEARLY STATISTICS FOR ADVERSE EVENTS BY PRODUCT
TYPE
Wazzoodles ProSoft PUL fabric COMPLIANCE WITH FDA
REGULATIONS
PREVAGEN - AERS
PREVAGEN - AERS
BK8200020
FDA CORR WITH MANUFACTURERS OF DUODENOSCOPES
01/01/2009 - 02/20/2015
EMAIL BETWEEN DANIEL FABRICANT AND KENNETH SPAETH
RE PURITY HEALTH FIRST 03/03/2013 - 07/31/2013
CORR BETWEEN FDA AND QUINCY BIOSCIENCE RE PREVAGEN
CADILA HEALTHCARE LTD MORAIYA - 483 08/25/2014 -
09/10/2014
ANDA 91422 BIOEQUIVALENCE REVIEWS
2015-27 (CERTIFIED)
K110661
FAP8A4598 / PMN000018
NDA 80472
STUDIES AND DATA RE SAFETY OF CORKS USED AS
CLOSURES FOR FOOD AND BEVERAGES CORR OPINIONS ETC
01/01/2013 - 02/20/2014
NDA 205613
MERCK, WEST POINT, PA - MUMPS VACCINE EFFICACY,
MUMPS OUTBREAK RECS 2005 TO PRESENT 483 8/6/01,
ETC
CAERS 181758
NYDRAZID NDA 08-392, NICONYL NDA 08-486, ISONIAZID
NDA 08-499, ETC
JANSSEN RESEARCH & DEVELOPMENT LLC LTR 2/6/13
CERTIFIED
ENTRY #RD8-0021189-1 - ANALYTICAL RECS
ENTRY #RD8-0021185-9 - ANALYTICAL RECS
AFINITOR (EVEROLIMUS) TABS 22-234 - SBA
BOTOX - AERS
TEMAZEPAM AERS
HDE HG130007
8A CONTRACTS FOR RELI GROUP DATA
GE HEALTHCARE JAPAN - EIR 11/26/2012 - 11/26/2012
LUPIN LTD, INDIA 01/01/2015 - 01/31/2015
NONCLINICAL SAFETY OF BUPHENYL
LONZA - 483, CO RESP, CLOSE OUT LTR
K113871
CHILDREN'S NATIONAL MEDICAL CENTER - CORR, AUDIT
01/01/2009 - 02/23/2015
LUPIN, INDIA - 483 01/01/2015 - 02/03/2015
DUODENOSCOPES - MDR, ENGINEERING ASSESSMENT
REFERENCED
WATSON/ACTAVIS, SALT LAKE CITY, UT - EIR, 483
01/01/2010 - 12/31/2012
CVM RECS RE OXITEC APPROVAL 01/01/2009 - 02/23/2015

JABIL CIRCUIT AUSTRIA GMBH - EIR 01/01/2011 -
02/23/2015
CORR BETWEEN FDA AND QUINCY BIOSCIENCE RE PREVAGEN
K130167
IDE G060182
K122167
PROTOTHECA MORIFORMIS - REGULATORY STATUS,
CONSUMPTION, SAFETY
IDE G090001
IDE G120137
IDE G120010
FREESURFER - RECS RE CLINICAL DRUG TRIALS
TIZANDINE, ZANAFLEX, CIPRO - AERS
KIVA - 510K
IDE G140145
LUPIN, INDIA - 483 01/01/2015 - 02/22/2015
LUPIN LTD - 483 01/01/2015 - 02/23/2015 IPCA -
STATUS UPDATE SCHEDUELD DATE OF INSPECTION IPCA
RATLAM API
FORTEO - AER
LUPIN, INDIA - 483 01/01/2015 - 02/23/2015
GDUFA ANNUAL REPORT
DAY-LEE FOODS, INC, SANTA FE SPRINGS, CA - REALL
RECS, COMPLIANCE 12/01/2010 - 02/22/2015
K942530, K131146
LUPIN, INDIA - 483 12/16/2014 - 01/23/2015
MAMMOGRAM DATA 01/01/2012 - 01/02/2014
GMP RELATED PRODUCT COMPLAINTS RE MONSTER ENERGY
DRINKS FOR LAST TEN YEARS, INSPECTIONS, CITATIONS
ETC
SANOFI US, BRIDGEWATER, NJ - 483, EIR, RESPONSE
07/01/2014 - 07/31/2014
PROVIDENCE HOSPITAL IRB, MOBILE, AL - 483, EIR,
RESPONSE 05/01/2014 - 06/30/2014
BIOGEN IDEC, INC, CAMBRIDGE, MA - 483, EIR,
RESPONSE 6/24/14-7/3/14
SANDOSTATIN (OCTREOTIDE) SOMATULINE (LANREOTIDE) -
AER
PFIZER PHARMACEUTICALS, VEGA BAJA, PR - 483, EIR,
RESPONSE 03/01/2014 - 03/31/2014
GILEAD SCIENCES, INC, SEATTLE, WA - 483, EIR,
RESPONSE 01/01/2014 - 03/31/2014
MEDTRONIC, INC, WEST DES MOINES, IA - 483, EIR,
RESPONSE 02/01/2012 - 02/29/2012
ALLERGAN, INC, IRVINE, CA - 483, EIR, RESPONSE
03/01/2014 - 03/31/2014
ABBOTT LABORATORIES, ABBOTT PARK, IL - 483, EIR,
RESPONSE 08/01/2013 - 08/31/2013
JOHN P BILEZIKIAN, MD, NEW YORK, NY - 483, EIR,
RESPONSE 03/01/2014 - 04/30/2014
BAXTER HEALTHCARE CORPORATION, LARGO, FL - 483,
EIR, RESPONSE 05/01/2014 - 05/31/2014
ZIMMER, INC, WARSAW, IN - 483, EIR, RESPONSE
02/01/2014 - 02/28/2014
BOSTON SCIENTIFIC CRM CORP, SAINT PAUL, MN - 483,
EIR, RESPONSE 08/01/2013 - 11/30/2013
COVIDIENT LP, NORTH HAVEN, CT - 483, EIR, RESPONSE
01/01/2012 - 02/29/2012
CHICKEN JERKY PET TREATS - INVESTIGATION, TESTING
FOR ANTI-VIRAL DRUGS 10/13 TO PRESENT
VERICHEM LABORATORIES INC, PROVIDENCE, RI - 483,
EIR, RESPONSE 10/01/2014 - 11/30/2014
MUSE, DEREK, MD - 483, EIR, RESPONSE 07/01/2014 -
07/31/2014
BEN VENUE LABORATORIES INC, BEDFORD, OH - 483, EIR,
RESPONSE 06/01/2014 - 06/30/2014
GUSTAV R ELES, DO, PITTSBURGH, PA - 483, EIR,
RESPONSE 02/01/2007 - 03/31/2007
THOMAS P DAVIS, MD - 483, EIR, DETROIT, MI -
11/01/2006 - 12/31/2006
WILSON T ASFORA, MD, SIOUX FALLS, SD - 483, EIR,
RESPONSE 11/01/2007 - 12/31/2007
STAAR SURGICAL COMPANY, MONROVIA, CA - 483, EIR,
RESPONSE 02/01/2007 - 03/31/2007
BRIDGES R MCINTYRE, MD, SHREVEPORT, LA - 483, EIR,
RESPONSE 03/01/2007 - 03/31/2007
AKORN, INC, DECATUR, IL - EIR, 483, RESPONSE
04/01/2013 - 05/31/2013
MYLAN TECHNOLOGIES - ESTRADIOL TRANSDERMAL SYS
(ANDA 01-675)
foi daily log 1/12-16/15
FOI DFAILY LOG 1/26-30/15
NDA 10-010 APPROVAL, LABELING DATA
FORREST LAB INC - CARAFATE NDA 09-183 SBA
MELHSEN, JESPER, DENMARK - EIR, 483, RESPONSE
01/01/2014 - 07/31/2014
LUPIN LTD, INDIA - 483 01/01/2015 - 01/31/2015
INDIVIDUAL RECS
LUPIN, INDIA - 483 11/01/2014 - 02/24/2015
LIST OF RECIPIENTS OF ALERT LTRS REGARDING BOTOX
2009 TO 2014
CAROLINA SURGICAL SOLUTIONS, LLC, FLORENCE, SC -
EIR, 483, RESPONSE 05/01/2014 - 05/31/2014
MERCK & CO, AMBLER, PA - EIR, 483, RESPONSE
09/01/2013 - 09/30/2013
SILIMED, INC, DALLAS, TX - EIR, 483, RESPONSE
01/01/2007 - 01/31/2007
WONTON FOODS INC - MUNG BEAN SPROUTS SALMONELLA
ENTERITIDIS OUTBREAK INVESTIGATION RECS, CORR,
RPTS, ETC
K881917
KRATOM - AERS
ZEMBRIN - AERS
PMA 030042
L PERRIGO CO, ALLEGAN, MI - 483 08/11/2014 -
09/04/2014
ELECTROMETER - INVESTIGATION
ANDA 078936 TENTATIVE APPROVAL LETTER
P980040/S041
IPCA LABORATORIES - 483, WARNING LETTER 01/01/2011
- 02/24/2015
SHUR-GREEN FARMS, ANSONIA, OH - 483 10/03/2014 -
11/19/2014
CAYMAN CHEMICAL COMPANY, ANN ARBOR, MI - 483
11/17/2014 - 11/19/2014
LUNDBECK, TEESSIDE, ENGLAND - 483
OTSUKA PHARMACEUTICAL CO LTD, TOKUSHIMA WAJIKI
FATORY, NAKA GUN, TOKUSHIMA PREFECTURE, JAPAN - EIR
6/9-17/14
OTSUKA PARMACEUTICAL CO LTD, SECOND TOKUSHIMA
FACTORY, EBISUNO HIRAISHI, KAWAUCHI-CHO TOKUSHIMA,
JAPAN - EIR 6/18-26/14
OTSUKA PHARMACEUTICAL CO LTD, ITANO FACTORY, ITANO-
JUN, TOKUSHIMA PREFECTURE, JAPAN - EIR 3/17-20/14
OTSUKA PHARMACEUTICAL CO LTD, TOKUSHIMA, WAJIKI
FACTORY, NAKA-GUN, TOKUSHIMA PREFECTURE, JAPAN -
EIR 7/11-19/12
ACTISITE (TETRACYCLINE HCL) NDA 50-653 SBA, RVWS
OTSUKA SAGA FACTORY, OTSUKA PHARMACEUTICAL CO LTD,
SAGA PREFECTURE, JAPAN - EIR 12/1-5/14
CASLTE CHEESE INC, SLIPPERY ROCK, PA - EIR CMPNT
11/14/12-12/11/12
PAR PHARMACEUTIAL - COLCHICINE ANDA 03-976 APRVL
CASTLE CHEESE INC, SLIPPERY ROCK, PA - CO RESP
11/14/12-12/11/12
ENTRY NO RDB-0021189-1
ENTRY NO RD8-0021185-9
LIST OF REQUESTS FROM NOVADAQ FOR 510K
FIBROIN, HYDROLYZED FIBROIN, HYDROLYZED SERICIN -
BIOEQUIV , TOXICITY
SUN PHARMACEUTICAL INDUSTIRES LTD - NIASPAN ANDA
200-484 APRVL
LUPIN LTD - NIASPAN ANDA 90-446 BIOEQUIV, CHEMISTY
RVW
2007P-0322
FINANCIAL RPTS FILED BY FDA FOR PARTICIPATION ON
ADVISORY COMMITTEES FOR DRUGS, VACCINES, DVCS 1/09
TO 12/1/14
SUN PHARMACEUTICAL INDUSTRIES LTD - NIASPAN ANDA
201-273 BIOEQUIV, CHEMISTRY RVW
LUPIN LTD - NIASPAN ANDA 90-892
SUN PHARMACEUTICAL INC - NIASPAN ANDA 200-484
BIOEQUIV, CHEMISTRY RVW
PIRAMAL HEALTHCARE UK LTD, NORTHUMBERLAND, ENGLAND
- EIR 10/14
PREMIUM LIPIL POWERED MILK - ENTRY NO 300-5257008-1

LUPIN LTD, INDIA - 483 01/12/2015 - 01/23/2015
K101882
MENTOR BREAST IMPLANT MEMORYSHAPE CORE STUDY TEN
YEAR DATA
BONINE - MEDWATCH REPORT
2014-2196
PML REPORT NOVARTIS
DRSP-CONTAINING COCs - STUDY REPORTS, ETC
HUMIRA - CLINICAL TRIAL PROTOCOL, INFORMED CONSENT
FORM
FLYING FOOD GROUP, STERLING, VA - AGREEMENTS,
INSPECTIONS, ETC 01/01/2014 - 02/24/2015
LABELING OF ORGANIC PRODUCTS
BELVIQ - CLINICAL TRIAL DATA SETS
ZOLL MANUFACTURING CORP, PITTSBURGH, PA - LIFEVEST
EIR, 483, WARNING LTR 2002 TO PRESENT
INSPECTIONS LIST 10/01/2011 - 09/30/2014
TOBACCO INSPECTION RECS
ARREST WARRANT
2014-3277
ARREST WARRANT
LIST OF 483S FOR DRUG FIRMS 1/1/15 TO PRESENT
DKT FDA-2013-P-0048
K043371
RECS RE ABC NEWS REQUEST FOR INFORMATION RE SHRIMP
IMPORTS 02/19/2015 - 02/25/2015
2014-5312
BLACK COHOSH - AERS

WOCKHARDT LIMITTED, INDIA - 483 11/01/2014 -
01/31/2015
2014-822
WOCKHARDT, INDIA - 483 01/01/2015 - 02/26/2015
WOCKHARDT, INDIA - 483 10/02/2014 - 02/26/2015
WOCKHARDT, INDIA - 483 01/01/2015 - 02/28/2015

WOCKHARDT, INDIA - 483 02/02/2015 - 02/26/2015
LUPIN,INDORE, INDIA - 483
SUGAR SWEETENED BEVERAGES - AER, MRKG, ETC
K001149 RECS PREVIOUSLY RELEASED
K052392, K092807, K094056 ETC
INITIATIVE FOODS, SANGER, CA - EIR, 483, CORR
01/01/2004 - 02/26/2015
K031012
NDA 021191
K130945
ZOFRAN (ONDANSTRERON) - AERS
DUODENOSCOPES - DISINFECTION DIFFICULTIES, SPREAD
OF INFECTIONS CORR 1/10 TO PRESENT
HONEST CO - ORGANIC PREMIUM FORMULA RECS
BIOLASE INC (BIOL) - WATERLASE IPLUS ER,CR,YSGG
CMPLNTS, MISBRANDING RECS
COOK INC - MIRAFLEX HIGH FLOW MICROCATHETER
K080737, MIRAFLEX MICROCATHETER K060224, CANTATA
MICROCATHETER K101450, ETC
GILEAD SCIENCES - 483 5/14/14
TARO PHARMACEUTICALS, HAWTHORNE, NY - 483 12/9-
19/14
PRESCRIPTION DRUG MAKRETING ACT (PDMA) LIST OF
INSPS 2010 TO PRESENT
AMBIT PUMP - MDRS 2013
K141450
MARCO RUBIO - CORR, CMPLNTS, RPTS, ETC 2000 TO
PRESENT
MEDTRONIC MINIMED - PREVIOUSLY RELEASED RECORDS
06/01/2009 - 02/18/2015
KAIYUAN HENGTAI CHEMICAL CO, LTD, CHINA - EIR
09/22/2014 - 02/24/2015
NDA 203441/S2
ZOFRAN - AERS
ANDA 074700 SBA
ANDA 074225 SBA
LIST OF DRUG APPROVED FOR EXPANDED USE

CADILA HEALTHCARE, INDIA - 483 01/01/2015 -
02/05/2015
ENGINEERING ASSESSMENT RE ERCP DUODENOSCOPES,
REVIEWS OF REPROCESSING DATA, CORR ETC
PPD DEVELOPMENT, LLC, RICHMOND, VA - EIR 05/21/2012
- 05/25/2012
DEXMEDETOMIDINE - AERS
NRDC - SETTLEMENT RECORDS
EXPAREL REPORTS
BIOMARIN PHARM VIMIZIM BLA 125460 MEDWATCH REPORT
PHARMACEUTICALS INNOVATIONS - REPORTS, WARNINGS,
LEGAL PROCEEDINGS ETC
NDA 203312
MYLAN, BANGALORE, INDIA - 483 02/01/2015 -
02/27/2015
MALLINCKRODT INC XARTEMIS XR NDA 204031 MEDWATCH
REPORTS
CUBIST PHARMS INC SIVEXTRO TEDIZOLID PHOSPHATE NDA
205435 MEDWATCH REPORTS
ANDA 076684
PPD DEVELOPMENT LLC, RICHMOND, CA - EIR 05/21/2012
- 05/25/2012
DURATA THERAPS INTL DALVANCE DALBAVANCIN
HYDROCHLORIDE NDA 021883 MEDWATCH REPORTS
ANDA 077857
ANDA 076726
DENDO PHARMS INC AVEED (TESTOSTERONE UNDECANOATE)
MEDWATCH REPORTS
UPSHER SMITH CYRAMZA (RAMUCIRUMAB) (BLA 125477)
MEDWATCH REPORTS
XIAFLEX - FAERS
NOVARTIS PHARMS CORP ZYKADIA (CERITINIB) (NDA
205755) MEDWATCH REPORTS
ELIQUIS, HARVONI, SOVALDI, ETC - AERS
ALPROLIX - MEDWATCH REPORTS
NDA 020340
K023905
BLA 125496 MEDWATCH REPORTS
Special Protocol Assessment for NewLink Genetics
Phase 3 trial of its HyperAcute therapy
(algenpantucel-L) for resected pancreatic cancer
NDA 019183
UPSHER SMITH NDA 204399 MEDWATCH REPORTS
NDA 018685 SBA
AMYLIN PHARMS LLC MYALEPT (METRELEPTIN) (BLA
125390) MEDWATCH REPORTS
YUNG SHIN PHARMACEUTICAL INDUSTRY CO, LTD, TAIWAN -
483
METHLYLPHENIDATE - ADVERSE EVENT ANALYSIS
K112802
K132312
K033256
Drug stability and Dissolution data for generic
methylphenidate hydrochloride ER
K122158
GENERIC METHYLPHENIDATE - AERS
K091158
K142940
NDA 22271
K072134
COR14000556
NDA 206088
WOCKHARDT - INSPECTIONS LAST SIX MONTHS
HUMIRA - AERS
K133237
FOCUS LABORATORIES INC, NORTH LITTLE ROCK, AR -
483, EIR SUMMARIES 08/01/2013 - 11/01/2013
K131559
GRN 000449 - FDA CORR WITH LONZA RE MEETINGS
HOSPIRA HEALTHCARE INDIA PRIVATE LIMITED - 483
02/15/2015 - 02/25/2015
SHENZHEN ORIENTAL PHARMACEUTICAL CO, CHINA - EIR
03/01/2014 - 03/30/2014
CODADOSE, INC - ORPHAN DRUG DESIGNATION REQUEST
FOCUS LABORATORIES, NORTH LITTLE ROCK, AR - EIR
08/01/2013 - 11/01/2013
K130126
K131129
CIPLA LIMITED FACILITIES - 483, IMPORT ALERTS,
WARNING LETTERS 02/01/2013 - 02/28/2015
K083704
ZYDYUS CADILA - 483 09/02/2014 - 02/28/2015
MW5038594 COMM WITH FDA
RECS DESCRIBING WHY FDA FUNDED 11 LABORATORIES TO
CONDUCT A MOUSE LD STUDY
ICLUSIG - AERS
ZYDUS CADILA - 483 10/01/2014 - 03/02/2015
HOSPIRA, INDIA - 483 07/01/2014 - 03/02/2015
TOBACCO MEDWATCH REPORTS
NDA 20599
PROMETHAZINE - AER
DCK 94P-0420 FDA 2008-P-0309-0001/CP - CITIZEN
PETITIONS
K081480
TSO3 STERIZONE VP4 STERILIZER K141163
OPTIM LLC, STURBRIDGE, MA - EIR 1/29/13 - 2/7/13
LYMPHOSEEK NDA 202-207 - AERS RESP LTR 4/1/14
LUPIN, INDORE MADHYA, PRADESH, INDIA - 483 1/12-
23/15
MEDTRONIC MINIMED INC, NORTHRIDGE, CA 12/16/13
VILLALBA, PR 5/15/14 HUMACAO, PR 5/13/11 ETC -
483, EIR, CO RESP
FOLIC ACID - AER
FENTANYL IV - AER
DOXYCYCLINE TETRACYCLINE - AER
HEPARIN INJ- AER
DESOGEN - AER
NDA 206627 EXCLUSIVITY SUMMARY
GLUCOPHAGE METFORMIN - AER
PRE NATAL VITAMINS - AER
BABY ASPIRIN - AER
OTSUKA - ABILIFY (ARIPIPRAZOLE) NDA 21-436 - FORM
3542
ARICEPT (DONEZIPIL HYDROCHLORIDE NDA 20-690 -
STATISICAL RVW
SANDOZ INC - LEVOLEUCOVORIN CALCIUM ANDA 203-563
TENTATIVE APRVL LTR
LTRS, EMAILS BY F EDWARD SCARBOROUGH CONCERNING
WHETHER A FOOD MFR CAN MAKE A STATEMENT ABOUT A
NUTRIENT ON A FOOD PACKAGE LABEL
OLYMPUS MEDICAL SYSTEM - Q180V ENDOSCOPE - 510K,
APRVL, CORR SINCE 2010
IMATINIB MESYLATE - ANDA
NDA 018205 SBA
K053434
ALL FOIA REQUESTS CLOSED FEB 2015
NDA 17455 SBA
ZOFRAN - CORR WITH SPONSOR RE BIRTH DEFECTS ETC
01/01/1985 - 03/02/2015
FOIA REQUESTS FILED BY SUSANNE RUST OR MEG
KISSINGER OF MILWAUKEE JOURNAL SENTINEL, RESPONSES
01/01/2008 - 01/01/2010
TOX PATH SPECIALISTS, LLC, FREDERICK, MD - EIR, 483
RESPONSE 07/14/2013 - 03/31/2015
NDA 017408
02/15/2015 - 02/26/2015
02/01/2015 - 02/28/2015
MANUFACTURERS AND IMPORTERS OF TOBACCO PRODUCTS FOR
WHICH A USER FEE WAS RECEIVED IN FIRST QUARTER OF
2015 ETC
P920023
REPORTS OF HEALTH OR SAFETY ISSUES WITH TOBACCO
PRODUCTS 10/9/14 TO PRESENT
BLA 103000
510K RELEASED FEB 2015
ANDA 074346
TRANSVASCULAR INC - CATHETER MODEL TA-XP-001
K031920
FRESCA FOODS INC, SUNLAND INC - PEANUT PRODS RECALL
RECS, CORR, NOTICES, ETC
DEPAKOTE NDA 18-723, NDA 19-680 - MEDICATION
GUIDES, LTRS, LBLG, ETC
SEN RAND PAUL - CORR LOGS 1/11 TO PRESENT
MEDTRONIC - DUET EXTERNAL DRAINAGE RECLASSIFICATION

ORDER, DECISION SUMMARY FOR DE NOVO DEN120017
K130651
SUN PHARMA GLOBAL - ZOLEDRONIC ACID ANDA 204-051
SUN PHARMA GLOBAL - ZOLEDRONIC ANDA 204-138
BIOMEDICAL FRONTIERS INC - 40SD02 ORPHAN PROD
DESIGNATION
K002154
ANDA 022396
NDA 203257
AQUAMID - SUBMISSION RE AGENT
CANNIBIDIOL - ORPHAN PRODUCT DESIGNATION RECS
DERMAZONE SOLUTIONS, ST PETERSBURG, FL - EIR, 483,
WARNING LETTER 01/01/2010 - 03/01/2015
ZOLOFT - HOMICIDE EVENTS
ANDA 201894
DMF 17922, 18348, 18387, ETC

ANDA 201578
AARTI DRUGS LIMITED, INDIA - 483 AUGUST 2014
UTMB Blood Donor Center - 483 MARCH 2014
AWARE PRODUCTS, CHATSWORTH, CA - EIR, 483, WARNING
LETTERS 01/01/2010 - 03/01/2015
ANDA 203005
MACRILEN - SPA, NDA, CORR ETC
NDA 076258
DRSP-CONTAINING COC - FINAL STUDY REPORT RECS
DISCOVERY - REDACTED EIRS 09/01/2007 - 06/01/2008
AMERICAN NATUROPATHIC RESEARCH INSTITUTE,

NATUROPATHIC ONCOLOGY RESEARCH INSTITUTE -
REGISTRATION, 482, 483 ETC 01/01/2005 - 03/03/2015
Consumer Complaint 137959
K103698
ANDA 203005
K141158
NOVARTIS PHARMACEUTICAL CORP - CLEEVEC (IMATINIB

MESYLATE) CAPS NDA 21-335 PHARMACOLOGY/ TOX RVW,
CLNCL & BIOPHARMACUTICS RVW, INTERNAL PROCEDURES
FOR PUBLISHING NDA
RESTLESS LEG SYSNDROME - PROD FDA APPRVD
PROZAC NDA 18-936 - CORR, COMM, DRAFTS, ETC
CS PLASMAL DANLIEL - INVESTIGATION 6/14
CPT1400619
NIZORAL - COMMUNICATIONS BETWEEN FDA AND
MANUFACTURERS 07/01/2013 - 02/01/2014
INTRAVENOUS CARBAMAZEPINE - ORPHAN DESIGNATION
RECS
IMBRUVICA - AERS
VEDOLUZIMAB, ENTYVIO, 125476 - APPROVAL RECS
K141560
CONTINENTAL DENTAL CERAMICS - CORR, INVESTIGATIONS,
MEMO ETC
ACCERA, INC - WARNING LETTER RECS 12/03/2013 -
03/04/2015
NDA 18033 S017, S018
2015-1068
K050016
K993678
5 HOUR ENERGY - CAERS 02/19/2014 - 03/04/2015
COUNCIL ON RADIONUCLIDES, RADIOPHARMACEUTICALS TO
CAROL BENNETT 04/29/2014 - 06/30/2014
PREMIUM PET HEALTH, DENVER, CO SIOUX CITY, IA
SMITHFIELD, VA, ETC - INVESTIGATIONS, EVALUATIONS,
VIOLATIONS, ETC
STEPHEN C OLSON, MD, UNIVERSITY OF MINNESOTA -
INVESTIGATION RESULTS
PACON MANUFACTURING, SOMERSET, NJ - 483, EIR
01/01/2012 - 03/01/2015
K142787
K0123338
K090001
THERANOS DEVICE APPROVALS
INTAS PHARMACEUTICALS, INDIA - INSPECTIONS
NEW DRAFT LABELING LANGUAGE SENT TO TESTOSTERONE
DRUG SPONSORS 02/01/2015 - 03/31/2015
OKANAGAN SPECIALTY FRUITS, CANADA - EMAILS, DATA,
ETC SENT TO CFSAN 01/01/2005 - 03/05/2015
ZYDELIG - AERS
RESER'S FINE FOODS INC, TOPEKA, KS - INSPS LAST 10
YRS, LISTERIA MONOCYTOGENES FINDINGS, VIOLATIONS,
ETC
PURINA, DENVER, CO - 483 01/01/2014 - 12/31/2014
KEYTRUDA - AERS
OCI 2014-NYN-701-0431 LAB REPORT
IBRUTINIB - AERS
K002465
SBA 019141
ALPHA CF, BOERICKE & TAFEL - REPORTS, COMM
K093565
NDA 019137 SBA
DEUTERTRABENAZINE - ORPHAN DESIGNATION LETTERS
RAYSEARCH LABS - RAYSTATION K140187
K023135
SODIUM THIOPENTAL, THIOPENTAL SODIUM POWDER AND
SOLUTION -IMPORT RECS 01/01/2014 - 03/06/2015
ANDA RE LEVOTHYROXINE SODIUM 01/01/2014 -
03/05/2015
CORR BETWEEN FDA, CENTER FOR FOOD SAFETY, AND
JUSTIN TEEGUARDEN, STEVE HENTGES, AMERICAN
CHEMISTRY COUNCIL 01/01/2010 - 03/01/2015
WHEELCHAIR ELEVATOR DEVICE, POWERED PATIENT
TRANSPORT DEVICE - EXEMPTION RECS
TOLOSA HUNT - HEPLISAV BLA 125-428 CAVERNOUS SINUS
SYNDROME CASE STUDY DV2-HBV-16 EVALUATION
COMPLAINT 131002
K132931
K022140.
K132121
CASTLE CHEESE INC, SLIPPERY ROCK, PA - CMPLNT
4/26/12, RESP TO 483, CORR, ETC
SUCCESSFUL CANDIDATES FOR POSITION OF CONSUMER
SAFETY OFFICER - ONE EXAMPLE OF CV FOR GS-07, GS-
09, GS-11, GS-12, GS-13 01/06/2013 - 03/03/2015
ADCENTRIS - AERS
K120552
K111250
K093642
K091718
K052396
ZOFRAN - AERS
SILVERFOILTURBES SE RECS
K123653
CASTLE CHEESE INC, SLIPPERY ROCK, PA - RESP TO
WARNING LTR 7/11/13
K14481
K143155
CTP EXPANDED CONFLICT OF INTEREST CRITERIA,
REVIEW/SCREENING OF TOBACCO PRODUCTS SCIENTIFIC
ADVISORY COMMITTEE MEMBERS SINCE JAN 2015
BLA 125160 S 213
K070598
K133520
MEDTRAD INC, INDIANOLA, PA - AVANTA FLUID
MANAGEMENT INJ SYS (CERTIFIED)
ALAMO MED RES, ERIC LAWITSZ, SAN ANTONIO, TX - 483S
5/10 TO PRESENT
ROBERT HERRING, NASHVILLE, TN - 483S 6/09 TO L
PRESENT
STANFORD UNIV, KRISTEN GANJOO, STANFORD, CA - 483S
4/08 TO PRESENT
FURADANTIN NDA 9-175 - APRVL LTR, LBLG, MEDICAL
RVW, ETC
CHU RANGUEIL/ SERV DE NEPHROLOGIE TRANSPLANTATION
D-ORGANE, TOULOUSE, FRANCE - 483S 12/09 TO PRESENT
NORTHWESTER UNIV, LEO GORDON, CHICAGO, IL - 483S
3/01 TO PRESENT
TFS MANUFACTURING PTY LTD, NORTH PLYMPTON, SOUTH
AUSTRALILA - TISSUE FIXATION SYS K0540418
FRESENIUS KABI - DIPRIVAN (PROPOFOL) INJ EMUISION
NDA 19-627 FORM 3542
CLASS ONE MEDICAL DVC - CMPNT
LIVECOR - LIVECOR HEART MONITOR K142743, LIVECOR
HEAT MONITOR OTC K130921
CIANNA MEDICAL - SGS TUSSUE MARKER & SYS DVC
K141318
DR GREGORY L BEATTY, PHILADELPHIA, PA 10/29-11/6/14

DR NOELLE V FREY, PHILADELPHIA 11/3-12/14 DR
MARCELA MAUS, 0PHILADELPHIA, PA 11/12-17/14, -
EIRS, 483S, CO RESP ETC
PHARMA PAC LLC, DEKALB, MS - EIRS 1118/13-12/06/13
HELSINN HEALTHCARE - PALONOSETRON HCL CAPS ORAL
(ALOXI) NDA 22-233 SBS
IODOPEN SODIUM IODIDE INJ - NONCLNCL ANIMAL
TOXICOLOGY DATA, HUMAN CLNCL TRIAL SAFETY DATA,
FORMULATION AND STABILITY
TEGRETOL, GEODON, DILANTIN, ETC - AERS
DOMPERIDONE - SBA
PROZAC (FLUOXTINE) NDA 18-936 - CORR, DRAFTS, RVWS,
ETC
PURINA - COMPLAINTS, TESTING, ETC 03/01/2011 -
03/03/2015
MIKE GAVINI, PETER BAKER - INSPECTIONS IN INDIA
01/01/1999 - 12/31/2014
SHILPA MEDICARE LTD, INDIA - 483 03/02/2015 -
03/07/2015
EXPRESS DIAGNOSTICS INTERNATIONAL, INC - EIR, COMM,
MEETING ETC 06/01/2014 - 03/06/2015
IPCA, INDIA - 483
PRAZAIR DISTRIBUTION INC, SOUTHEAST LLC - WARNING
LETTER, 483 03/06/2012 - 03/06/2015
K110134
DENDREON - PRE-APPROVAL EIR, 483 01/01/2007 -
12/31/2014
MEDICAL DEVICE COMPANIES REGISTERED IN MA, NJ, OH,
PA - NAME, ADDRESS, SPECIALTY
EUROGENTEC, BELGIUM - EIR, 483 12/19/2014 -
12/19/2014
MIRACULIN, MIRACLE FRUIT, SYNSEPALUM DULCIFICUM -
RECS RE FOOD ADDITIVE DENIAL, GRAS RECS 06/01/1974
- 12/31/1977
VINBLASTINE - CASE REPORTS

TOLBUTAMIDE, PROBENECID, SACCHARIN ETC -
APPLICATIONS, FORMULAS, APPROVALS ETC 01/01/1967 -
12/31/1982
FOOD SAFETY AND NUTRITIONAL ASSESSMENT OF
GENETICALLY ENGINEERED SUGAR BEET EVENT H7-1
CHANTIX - AERS
CPT 1400960
DIVI LABORATORIES, INDIA - EIR 05/01/2014 -
07/06/2014
KELLOGG'S - MINI--WHEATS RECALL DUE TO METAL MESH
CONTAMINATION
PROCESS THAT GOES THROUGH WHEN A COSMETIC PROD IS
BEING TESTED
NDA 20472
MARUCHAN NOODLES - CMPLNT
TURMERIC UKON CAPS ENTRY# U52-0788484-7 -
ANALYTICAL W/S,TESTING METHODS
HHSF2232010000081
FORIGIN & DOMESTIC DRUG COMPANIES, MEDICAL DVC
MFRS, BLOOD ESLABLISHMENTS, ETC - INSPS 1/1-31/15
CMPLNT
DR REDDY'S LABORATORIES, INDIA - 483 01/26/2015 -
02/20/2015
GILENYA - AERS
BLA 125553
2012 DIALYSATE CONCENTRATES, ALKALI DOSING ERRORS
WITH HEMODIALYSIS SAFETY COMMUNICATION
VYVANSE - BRIEFING RECS, MEDICAL REVIEWS 01/01/2013
- 03/07/2015
SUPREP - ISR
MEDICAL DEVICE RECALL DATA
DRUG RECALL DATA
INSPECTIONS DATA
MEDICAL DEVICE RECALL REPORT FY2003, FY2012 DATA
SPREADSHEET
MEDICAL DEVICE RECALLS BEFORE 2002
2000 WARNING LETTER TO CHESTER LABS, INC,
CINCINNATI, OH
BUPROPION PRODUCTS - AERS
VAAGE - FOIA REQUESTS
STAFF MANUAL GUIDE 4850.7

INFUSE - FOIA REQUESTS
REGISTERED FOREIGN FOOD FACILITIES BY COUNTRY -
NAME, NUMBER OF FOOD FACILITIES Date Range:
12/31/2014 - 12/31/2014
BAUSH & LOMB, TAMPLA, FL - 483 03/04/2015 -
03/06/2015
LIST OF FOIA REQUESTS SUBMITTED 01/01/2014 -
12/31/2014
K103277
FOOD ALLERGY ADVISORY LABEL COMPLAINTS 01/01/2012 -
03/09/2015
K133968
NDA 205552 S 2
NUTEK DISPOSABLES, ELHATTAN, PA - EIR 10/01/2014
GILENYA - AERS
INDIVIDUAL RECS
DR MARCELLO PIETRANTONI - CASE #2012-CIO-713-0124
Daily logs regarding Tysabri, Antegren, etc.
FRESENIUS KABI - DIPRIVAN (PROPOFOL) NDA 19-627
FORM 3542
NAMZARIC (MEMANTINE HCL ER) NDA 206-439 SBA
WOCKHARDT - FEXOFENADINE ANDA 79-112 CORR, MTG
MINS, APRVL LTRS, ETC
REGRANEX - STUDIES, TESTINGS, BLACK BOX WARNINGS,
ETC
INFANT FORMULA MFRS IN OR OUTSIDE THE US 1/1/13 TO
3/5/15
CHARLES RIVER LABORATORIES INC, WILMINGTON, MA -
EIR 5/29/14
GLAXOSMITHKLINE - ZOFRAN INVESTIGATIONS, RPTS,
STUDIES, ETC 1/87 TO 12/06
ONDANSETRON - PROCEDURE MANUALS, APRVL RECS, INSPS,
ETC 12/06 TO PRESENT
MICROQUART MEDICAL INC - QUADRALASE ADJUSTABLE
SIDE-FIRING LASER FIBER K952974
FOI DAILY LOG 6/13 TO PRESENT
FCN 1475
MICHAEL PENCE - RPTS, CMPLNTS, INVESTIGATIONS, ETC
1991 TO PRESENT
PIYUSH "BOBBY" JINDAL - CMPLNTS, RPTS,
INVESTIGATIONS, ETC 1996 TO PRESENT
JOHN KASICH - CMPLNTS, RPTS, INVESTIGATIONS, ETC
1983 TO PRESENT
RANDAL "RAND" PAUL - CMPLNTS, RPTS, INVESTIGATIONS,
ETC 1990 TO PRESENT
JAMES RICHARD "RICK" PERRY - CMPLNTS, RPTS,
INVESTIGATIONS, ETC 1972 TO 2015
JOHN ELLIS "JEB" BUSH - CMPLNTS, RPTS,
INVESTIGATIONS, ETC 1974 TO 2015
RAFAEL EDWARD "TED" CRUZ - CMPLNTS, RPTS,
CHRISTOPHER "CHRIS" J CHRISTIE - CMPLNTS, RPTS,
DKT 2014D-1891-001
1995G-GRAS-0009
DEFERASIROX - AERES
DKT 2012N-0378
42 FR 38608-38615
43 FR 146641-14644 49 FR 5608-5614 50 FR 49535-
49537
DKT 2014N-1051
DKT 2014D-1692
DKT 2014N-1051
OTC VOLS 070099, 070126, 070168
SYNGENTA SEEDS INC - MAIZE EVENT MIR162, BNF 113,
BNF 128, ETC RECS
DKT 2012P-0904
CAS MEDICAL SYSTEMS, INC FORE-SIGHT ELITE ABSOLUTE
TISSUE MONITOR 510K RECS
SOFT GEL TECHNOLOGIES, LOS ANGELES, CA - EIR
01/01/2011 - 01/09/2015
MIGRANAL NDA 20148 - CMC
FORE-SIGHT CEREBRAL OXIMETE MONITOR MC-2000 510K
RECS
WOCKHARDT LTD, INDIA - 483 02/01/2015 - 02/28/2015
NDA 050605 S 17 SBA
K871358
K902936
K922688
K942697
K955672
K011480
Letter dated September 28, 2012 from Martin Shimer,

Branch Chief, Regulatory Support Branch, Office of
Generic Drugs, concerning 180-Day Exclusivity for
Valsartan Tablets
NDA 12885
K122219
SUBMISSION TO THE FDA OFFICE OF PRESCRIPTION DRUG
PROMOTION RE EXPAREL 11/28/2011 - 03/10/2015
K141434
03/09/2015
ONCOLOGIC DRUGS ADVISORY COMMITTEE - 1/31/02
TRANSCRIPT (CERTIFIED)
ONCOLOGIC DRUGS ADVISORY COMMITTEE FINAL AGENDA
1/31/02
K091875
K112666
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
BLA 125527 S-000

K142915
K994074
ANDA 090874 SBA
SUN PHARMA, HALOL, INDIA CADILA HEALTHCARE,
ANKHALESHWAR, INDIA - WARNING LETTER, IMPORT ALERT
01/01/2014 - 12/26/2014
BIOMERIEUX VIDAS LYME - APPROVAL RECS SEPARATED BY
SEX OF SUBJECT 01/01/2000 - 01/01/2015
SUN PHARMA, HALOL, INDIA - EIR 09/08/2014 -
01/01/2015
IONIA PHARMACY - COMPLAINTS, LAB RESULTS 01/01/2015
- 03/10/2015
NDA 71961
SIGNAPHARM LABORATORIES, LLC, BENSALEM, PA - EIR
01/01/2014 - 03/10/2015
CAPPILLUS LLC - K143199
OCULAR SYSTEMS INC - ENDOSERTER K090626
INTAS - 483 2013
MEDWATCH RPTS CODED AS MEDICATION ERRORS 2/1-28/15
GILEAD SCIENCES - 483 5/16/14
FRANCK'S PHARMACY/FRANCK'S COMPOUNDING LAB -

BRILLIANT BLUE G (BBG) INJ, PRESERVATIVE-FEE
TRIAMCINOLONE INJ, PRESERVATIVE-FREE COMPOUNDED
RECS
ROBERT AMAETO, BAYLOR COLL MED/SEC GENITOURINARY
ONCOLOGY, HOUSTON TX \- 48I3S 8/25 TO PRESENT
K091515
MASIMO CORP - PULSE OXIMETER SUPPORT STUDY
INVESTIGATION RECS
TEEGUARDEN JG, TWADDLE N, CHURCHWELL MI, ETC -

BISHENOL A 24-HR HUMAN URINE & SERUM PROFILES
CHURCHWELL MI, CAMACHO L, VANLANDINGHAM, MM, ETC -
COMPARISON OF LIFE-STAGE DEPENDENT INTERNAL
DOSIMETRY FOR BISHENOL A, ETHINYL ESTRADIOL, ETC
DEHYDROPEIANDROSTENEDIONE (DHEA) - CAERS 1/10 TO
PRESENT
REQUESTS FOR DESIGNATION SUBMISSIONS AND DECISION

REGARDING DRUG-ELUTING EMBOLIZATION BEADS,
RADIATION-CONTAINING GLASS BEADS FOR CANCER
TREATMENT, DRUG/BIOLOGIC EMBOLIZATION AGENTS, ETC
CONAIR CORP, STAMFORD, CT - WARNING LTR RESPS,
CMPLNTS, 483 5/31/13, ETC
CISPLATIN (CISPLATINUM), MERCURY (THIMEROSAL) -

VAERS, FLU SHOTS VACCINE INFORMATION STATEMENT, ETC
BBMK ENTERPRISES LLC, OXYCARE INC, MIDDLESEX HOME
CARE & SUPPLIES INC, ETC - EIRS, 483S, WARNING LTRS
1/98 TO PRESENT
KLONOPIN (CLONAZEPAM) - RECS (CERTIFIED)
JOHNSON & JOHNSON, JANSSEN RESEARCH AND DEVELOPMENT
- RISPERDAL AERS
CELEXA (CITALOPRAM) - RECS
K132785
K123910
DR ROBERT LUPO, TAMPA, FL - COMPLAINT, TEST RESULTS
01/01/2015 - 03/09/2015
TRIMETHY XTREME - DEMOGRAPHICS, PAST MEDICAL
HISTORY, DATE OF ONSET OF SYMPTOMS, ETC
K123806
ISUPREL - APPROVAL RECS
K092886
WOCKHARDT LTD, INDIA - 483 02/01/2014 - 03/31/2015
PHARMACEUTICALS, BIOLOGICS, MEDICAL DVC MFG, CLNCL
TRIAL FACILITIES IN AND OUTSIDE THE US - 483S 2/1-
28/15
JUBILANT HOLLISTER, SPOKANE, WA - 483 11/01/2014 -
12/16/2014
NORDION INTERNATIONAL INC - THERASPHERE
ADMINISTATION SYS REQUEST FOR DESIGNATION,
HUMANITARION DVC EXEMPTION
GILEAD SCIENCES - CORR WITH DIVISION OF ANTI VIRAL
PRODUCTS 01/01/2001 - 02/10/2007
K092086
2015-1582
SUGAMMADEX - AERS
2015-295
2015-302
2015-303
2015-405
2015-506
K093642, K091718
STAR SCIENTIFIC, INC - REVIEW RECS FOR SE0000282,
SE0000283, SE0000284, ETC
K142310
ZOFRAN - AERS
JASH INTERNATIONAL, INC - REVIEW RECORDS RE
SE0003441, SE0003442, SE0003443, ETC
WEST HOPE DAIRY, LLC, SALTVILLE, VA - CORR WITH
FDA, RESPONSE TO WARNING LETTER 02/03/2015 -
03/11/2015
ANDA 091211 078355 077686 ETC APPROVAL LETTERS
LIST OF ALL PRODUCTS FOR WHICH CTP ISSUED
GRANDFATHER DETERMINATIONS 03/01/2011 - 03/31/2015
TESTOSTERONE UNDECANOATE - ORPHAN DRUG DESIGNATION
RECS
INSP PERFORMED AT ANY FACILITY PERFORMING GLP NON
CLNCL/BIOANALYTICAL TESTING 1/13 TO 12/131/13
MINDRAY DS USA INC - AS3700 ANESTHESIA DVC SYS -
CERTIFICATES TO FOREIGN GOVERNMENT
THERANOS DVC TESTING PROCESS - RECS
GUILIA BIANCHI, SC MEDICINA ONCOLOGICA, MILANO,
ITALY - 483 7/13 TO PRESENT
SABRIL - REMS
BAXTER HEALTHCARE - OSPA VACCINE CORP CLNCL TRIAL
BERLIN HEART INC - BERLIN HEART OUTFLOW ARTERIAL
FLOW CANNULA MDR 4216597
STRYKER SUSTAINABILITY SOLUTIONS - REPROCESSED
IIARMONIC ACE SHEARS W/O ADAPTIVE TISSUE TECHNOLOGY
K133672
ZARXIO SUMMARY AND REVIEW 01/01/2015 - 04/30/2015
K011471
BK130079
TETRABENAZINE - ORPHAN DRUG DESIGNATION
ZARXIO - SBA
NDA 20-449 PEDIATRIC STUDY RECS
MEDISCA INC, PLATTSBURGH, NY LETCO MEDICAL,

DECATUR, AL PROFESSIONAL COMPOUNDING CENTERS OF
AMERICA, HOUSTON, TX - EIR, 483 01/01/2012 -
03/12/2015
APOLLO ENSOSURGERY, AUSTIN, TX - 483, EIR,
COLLECTION REPORT 01/02/2014 - 01/01/2015
TUBERSOL - AERS
TETRABENAZINE - ORPHAN DESIGNATION FOR HUNTINTON'S
12/11/97
TETRABENAZINE - ORPHAN DESIGNATION FOR TOURETTE'S
YOUNG PHARMACEUTICALS, WETHERSFIELD, CT - EIR, 483
01/01/2010 - 03/12/2015
PATHEON PUERTO RICO, INC, MANATI, PR - EIR 2013,
2014 06/01/2013 - 09/30/2014
CENEXI LABORATORIES THISSEN, BELGIUM - EIR
03/27/2014 - 04/15/2014
AVEED - AERS
MEDECOR PHARMA LLC, BATON ROUGE, LA - EIRS, 483S
12/4/14
JAYMAC PHARMACEUTICALS LLC, SUNSET, LA - EIRS,
483S 4/21/14
BEEVERS MANUFACTURING & SUPPLY INC, BEEVERS MEDICAL

SOLUTIONS, MCMINNVILLE, OR - EIRS 6/24/14-7/7/14
K024291
INVOKANA - AERS
AJAY GOPAL, SEATTLE CA CARE ALLIANCE, SEATTLE, WA -
483S 4/11 TO PRESENT
FUSLLEV (LEVOLEUCOVORIN) - NDA 20-140/S002, FUSLLEV
(LEVOLEUCOVORIN CALCIUM) - NDA 20-140/S11 UNREDATED
RVWS
PERRIGO ISRAEL - FLUCINOLONE ACETONIDE ANDA 20-2847
SBA
DKT FDA-2014-P-1615
SANDOZ INC - LEVOLEUCOVORIN CALCIUM ANDA 20-563
RVWS
GRN 137
DKT FDA-2014-P-1649
METHODS FOR DETERMINING THE TOTAL LAMOUNT OF
VITAMIN C IN A DIETARY SUPPL
CAERS - 181758, 182431, 182803, ETC -
SCANTIBODIES, SANTEE, CA - 483
FY 2013 PDUFA PERFORMANCE RPTS
NDA 205677 MEDWATCH REPORTS
RAGWITEK - MEDWATCH REPORTS
2014 ANNUAL RPT USDA ARCHIVE INDEX, USDA DRUG
SAFETY RPT, ETC
INDIVIDUAL RECS
K800101
DKT 80N-0042
ETG-4000 Optical Topography System 510K
RECS RE POSTING OF ST JUDE MEDICAL OR PACESETTER,
SYLMAR, CA OR ARECIBO, PR 01/01/2009 - 06/30/2014
All records in connection with the TBB's

consultation with the FDA regarding arsenic levels
in wine discovered through the TTB's Alcohol
Beverage Sampling Program
BIOSYNTRX - 483, EIR 09/05/2014 - 03/13/2015
COR14000106
MANKO NATURAL FLAVOURS & EXTRACTS, BELOORBAYIR
BIOTECH LTD, BAYIR EXTRACTS PVT LTD ETC - 483 MOST
RECENT
EMIT-ST DRUG DETETION SYS - DRUG ABUSE PROFICIENCY
TESTING SURVEY 1972 TO 1981
BARTON PUBLISHING, SOUTH DAKOTA - CONSUMER
COMPLAINTS 01/01/2008 - 03/13/2015
K042259
QUETIAPINE - AERS
HIV TEST MEDIAN DATA
K092239
MEDISCA INC, PLATTSBURGH, NY - 483 01/01/2012 -
01/01/2014
K101791
TERUMO, BCT INC, LAKEWOOD, CO - EIR, 483, RESPONSE
04/01/2014 - 05/31/2014
SIEMENS HEALTHCARE, NEWARK, DE - 483, EIR, RESPONSE
12/01/2011 - 02/29/2012
Zimmer 483, EIR and correspondence May 2013
Mercredita, PR
COLESTIPOL HCL NDA 77-510 - APRVL, LBLG, CHEMISTRY
RVW, ETC
ZIMMER MANUFACTURING BV, PR - 483, EIR, RESPONSE
03/01/2013 - 05/31/2013
STRYKER INSTRUMENTS, PORTAGE, MI - 483, EIR,
RESPONSE 10/01/2012 - 11/30/2012
BRACCO DIAGNOSTIC INC, MONROE TOWNSHIP, NJ - 483,
EIR, RESPONSE 05/01/2013 - 06/30/2013
LINDE, LLC, KITTERY, ME - 483, EIR, RESPONSE
11/01/2013 - 11/30/2013
ABBVIE BIOTECHNOLOGY, LTD, BARCELONETA, PR - 483,
EIR, RESPONSE 07/01/2014 - 07/31/2014
GE HEALTHCARE LIFE SCIENCES, PRINCETON, NJ - 483,
EIR, RESPONSE 07/01/2014 - 07/31/2014
JAZZ PHARMACEUTICALS, INC, PALO ALTO, CA - 483,
EIR, RESPONSE 03/01/2014 - 04/30/2014
HODGSON, KIM, MD, SPRINGFIELD, IL - 483, EIR,
RESPONSE 06/01/2014 - 06/30/2014
ELWOOD, RICHARD K, MD, VANCOUVER, CANADA - 483,
EIR, RESPONSE 04/01/2014 - 04/30/2014
NOVACYL, LTD, THAILAND - 483, EIR, RESPONSE
04/01/2014 - 04/30/2014
NIMBEX NDA 20-551 - CHEMISTRY RVW
KONINKLIJKE KAASFABRIEK, NETHERLANDS - 483, EIR,
RESPONSE 08/01/2013 - 08/31/2013
NDA 205053
K133077
WOCKHARDT LIMITED, INDIA - 483 02/01/2015 -
03/16/2015
03/16/2015
SCANTIBODIES BIOLOGICS, INC - 483, AFFIDAVITS,
NOTES ETC 01/02/2013 - 12/31/2014
ONCO THERAPIES LIMITED, MYLAN LABORATORIES LIMITED,
INDIA - 483 12/01/2013 - 03/13/2015
NDA 050756, NDA 050703, ANDA 080198 ETC - SBA
ZOFRAN, KYTRIL, ANZEMET, ETC - APPROVAL PACKAGES,
REVIEWS, ADVERSE EVENTS ETC
TEA ASSIGNMENT COMMUNICATIONS, RESULTS 02/01/2015 -
03/13/2015
UNITED 1 INTERNATIONAL LABORATORIES LLC AKA GLOBAL
INTERNATIONAL, LLC - INVESTIGATION RECS, AUDITS
01/01/2010 - 01/09/2015
VICTOZA, TRULICITY, TANZEUM - AERS
AUROBINDO, INDIA - 483 03/09/2015 - 03/14/2015
LISTING OF INSPECTIONS 03/15/2014 - 03/15/2015
483 ISSUED AFTER 1/1/10 AND RELEASED UNDER FOIA
SINCE 12/22/14
PMA P010030 S034
ADVANCED BIONICS VENDOR B RELIABILITY OR FAILURE
01/01/2004 - 03/15/2015
COCHLEAR, MED-EL, ADVANCED BIONICS - WARNING
LETTERS, INSPECTION REPORTS, ADVERSE EVENTS ETC
03/01/2005 - 03/02/2015
XTC GET WET VISAGE PR USA, CARLSBAD, CA - 482, 483,
CO RESP, ETC LAST FIVE YEARS
PERRIGO ISRAEL- CLOBETASOL PROPIONATE SHAMPOO ANDA
-90-974 RVW, SBA
ACTAVIS MID ATLANTIC - CLOBETASOL PROPIONATE
SHAMPOO ANDA 78-854 SBA, RVW
ZYDUS BSV PHARMA PVT PTD, GUJARAT, INDIA - 483, EIR
SUMMARY 01/01/2014 - 01/31/2014
TB INFECTION, GREENWOOD COUNTY, SC 1/11 TO PRESENT

WARRANT OF AUTHORITY SHERRY SOLODKOVA (CONTRACTING
OFFICER)
RECS RELATED TO PATENT BARRIERS REGARDING THE
DEVELPOMENT OF NEW VACCINES & DRUGS
PATHEON PUERTO RICO, MANATI, PR TAPI PUERTO RICO
INC, HUMACAO, PR TAPI PUERTO RICO, GUAYAMA, PR -
483
BIOSCRIP INFUSION SERVICES OF NY, NEW HYDE PARK, NY

9/10-19/14 FRESENIUS KABI USA, GRAND ISLAND, NY
10/20-24/14 BRISTOL MYERS SQUIBB CO INC, EAST
SYRACUSE, NY 9/23-25/14 - 483
ACINO PRODUCTS LLC, HAMILTON, NJ 8/7-19/14 ACUPAC
PACKAGING INC, MAHWAH, NJ 10/16-27/14 AMARIN
PHARMA INC, BEDMINSTER, NJ 8/19 -9/9/14 - 483
OREXIGEN THERAPEUTICS, INC - CORR WITH FDA
02/23/2015 - 03/10/2015
ASANTE SOLUTIONS, SUNNYVALE, CA - EIR 01/01/2012 -
03/16/2015
EFAVIRENZ, LAMIVUDINE, TENOFOVIR COMBINATION ETC -
EXCLUSIVITY CLAIMS
K012480
TESTIM, TESTOPEL, ANDROGEL ETC - AERS
NDA 203312
K970748
AB LASER RESISTOR TRIMMING SYSTEM NEUMAN MICRO
TECHNOLOGIES - ACCESSION NUMBER 01/01/1996 -
03/16/2015
K082176
ULTRADENT PRODUCTS INC, SOUTH JORDAN, UT - EIR
11/01/2013 - 03/17/2014
MYLAN/STRIDES, INDIA - 483 03/01/2014 - 03/17/2015
K120454 - LABELING, IFU
FDA-1998-E-1268
ACETAMINOPHEN PREPARATIONS - ISRS 8681751, 898823,
919231, ETC
ADVANCED NEUROMODULATION SYSTEMS INC -TRIPOLE 16
LAMITODE PADDLE LEAD INSTRUCTION MANUALS,
DIRECTIOINS FOR USE, CLINICIANS' MANUALS, ETC
AERS - DATE PUBLISHED ON FDA WEBSITE 01/01/2004 -
01/09/2015
ATON - SYPRINE (TRIENTINE HCL) NDA 19-194 SBA
MW5040532 REPORTER CONTACT
ANDA 085982
CERAMIDE TRIHEXOSIDASE/ALPHA-GALACTOSIDASE A -
ORPHAN DESIGNATION RECS
VETOQUINOL - ANIMAL PRODS CMPLNTS
CYBERONICS VAGUS NERVE STIMULATOR - PREVIOUSLY
RELEASED RECS 01/01/1990 - 03/16/2015
K123421
2015-1273
K121214
K941407
EPIPEN - ISR 95007481, 95007781, 96969991
LIST OF SEAFOOD PACKING FACILITIES 03/17/2014 -
03/17/2015
DRUGS, DEVICES - 483S
MEDTRONIC LOGISTICS, MEMPHIS, TN - EIR 11/04/2013 -
03/17/2015
ETODOLAC - LABEL RECS
MEKINIST/TRAMETINIB - INVESTIGATOR BROCHURE
01/01/2012 - 05/31/2015
ZELBORAF/VENURAMFENIB - INVESTIGATOR BROCHURE
01/01/2010 - 03/30/2010
LIST OF FOREIGN FOOD FACILITIES RECEIVING 483 IN

CONNECTION WITH INSPECTIONS 11/01/2014 - 02/28/2015
MANNITOL NDA 013684 APPROVAL RECS
K121790
TAIHO ONCOLOGY - DATA FROM CLINICAL STUDIES AND
PRECLINICAL STUDIES IN SUPPORT OF ROLLING NDA
01/01/2008 - 03/17/2015
NUT BUTTER RECALL AUGUST 2014 08/19/2014 -
01/09/2015
FAERS DATA
RHOGAM - AERS
FCN 1458 - CHEMISTRY, TOXICOLOGY MEMOS
AMAG PHARMACEUTICALS - RECS RE MAKENA 01/01/2013 -
03/17/2015
2015-1641
2015-76
K072696
CLARITHROMYCIN - SBA
MMR II VACCINE - CLINICAL TRIALS, STUDIES
IMPORT REFUSAL DATA
DR REDDY LABORATORY, SRIKAKULAM, INDIA - 483
01/01/2014 - 12/31/2014
3M HEALTHCARE BUSINESS, SAINT PAUL, MN 12/9-15/14,

ALLIANCE PACKAGING GROUP INC, SAUKVILLE, WI 12/2-
4/14, COVANCE LABORATORIES INC, MADISON, WI,
10/21/14-11/3/14, ETC - 483S
QUALITEST PHARMS, HUNTSVILLE, AL 7/28/14-8/114.
VINTAGE PHARMACEUTICALS LLC, DBA QUALITEST,
HUNTSVILLE, AL 12/15-19/14 483S
B & G LABS INC, SAINT LOUIS, MO 10/29/14-11/7/14,

MERIDIAN MEDICAL TECHNOLOLGIES (PFIZER CO),
BRENTWOOD, MO 10/14/14-11/25/14, CATALENT CTS, LLC,
KANSAS CITY, MO 10/27/14-11/10/14, ETC - 483S
MERIT MEDICAL SYSTEMS INC, CHESTER, VA, 8/27/14-
9/16/14: MICROAIRE SURGICAL INSTRUMENTS LLC,
CHARLOTTESVILLE, VA 8/11/14-22/14 - 483S
NAVAJO MANUFACTURING CO, DENVER, CO 8/11-22/14,
CONMED ELECTROSURGERY, CENTENNIAL, CO 10/22/14-
11/18/14, BAXTER CORPORATION ENGLEWOOD, ENGLWOOD,
CO 12/12-19/14, ETC - 483S
ALLERGY LABORATORIES INC, OKLALHOMA CITY, OK

9/16/14-10/17/14, OXYSURE SYSTEMS INC, FRISCO, TX
9/3/14-10/3/14, CYBERONICS INC, HOUSTON, TX 8/11-
22/14, ETC - 483S
CELSUS LALBORATORIES INC, CINCINNATI, OH 11/5-

14/14, NORMAN NOBLE INC, HIGHLAND HEIGHTS, OH 9/15-
30/14, STERIS CORP, MENTOR, OH 7/14/14-9/19/14, ETC
- 483S
ABB VIE INC, NORTH CHICAGO 9/8-12/14, HYDROX LABS,
ELGIN, IL 6/30/14-9/4/14, SMITHS MEDICAL CO, VERNON
HILLS, IL 10/28/14-11/12/14, ETC - 483S
ENCOMPASS PHARMACEUTICAL SERVICES INC, NORCROSS, GA

11/10-13/14, REMINGTON MEDICAL INC, ALPHARETTA, GA
11/17-24/14, PATHEON MANUFACTURING SERVICES LLC,
GREENVILLE, NC 9/9-12/14, ETC - 483S
BELCHER PHARMACEUTICALS LLC, LARGO, FL 11/17-21/14,

KRAMER LABORATORIES INC, MIAMI, FL 9/29/14-
10/14/14, TARMAC PRODUCTS INC, MIAMI GARDENS, FL
11/4/14-1/8/15, ETC - 483S
HALOPERIDOL - REFERENCE LIST FOR SEVENTEEN PLACEBO-
CONTROLLED STUDIES IN BOX WARNING
K083344
ACRA PAC INC (KIK CUSTOM PRODS), ELKHART, IN 11/3-

21/14, KREMERS URBAN PHARMACEUTICALS INC, SEYMOUR,
IN 12/1-16/14, CAYMAN CHEMCAL COMPANY INC, ANN
ARBOR, MI 11/17-19/14, ETC - 483S
BARD PERIPHERAL VASCULALR INC, TEMPE, AZ 11/18/14-

1/5/14, INTERNATIONAL MEDICATIONS SYSTEMS LTD,
8/27/14-9/12/14, PRIMA PHARM INC, SAN DIEGO, CA
10/21-14-11/3/14, ETC - 483S
ABCO LABORATORIES INC, FAIRFIELD, CA 10/20/14-

11/4/14, CARLSBAD TECHNOLOGY INC, CARLSBAD, CA
10/21/14-11/21/14, PYRAMID LABORATORIES INC
CARLSBAD, CA, 1/5-15/15, ETC - 483S
ASTRA ZENECA PHARMACEUTICLS LP, NEWARK, DE 8/20-

27/14, KONSYL PHARMACEUTICALS INC, EASTON, MD
11/17-21/14, JANSSEN BIOTECH INC, MALVERN, PA 9/15-
24/14, ETC - 483S
PFIZER INC, GROTON LABS, GROTON, CT 9/16-30/14,
INNOTEQ INC, STRATFORD, CT 9/9-25/14, GENZYME CORP
9/8-25/14, FRAMING HAM, MA, ETC - 483S
BAXTER HEALTHCARE SA (TRAVENOL), CASTLEBAR, IRELAND
10/6-14/14, GE HEALTHCARE, CARRIGTOHILL, COUNTY
COR, IRELAND 9/8-15/14, ALCON LABORATORIES IRELAND
LTD, CORK, IRELAND, 1/12-15/2015, ETC - 483S
CADLILA HEALTHCARE LTD, AHEMEDABAD CITY, INDIA\

8/28/14-9/5/14, IPCA LABORATORIES, LTD, SILVASA (D
& NH), INDIA 12/11-19/14, SANDOZ PRIVATE LTD, NAVI
MUMBAI, INDIA, 8/12-28/14, ETC - 483S
HOSPIRA, MCPHERSON, KS - EIR, 483 MOST RECENT
MADISON POLYMERIC, BRANFORD, CT - EIR, 483 1/15
PAJUNK GMBH MEDIXZINTECHNOLOGIE, GEISINGER, GERMANY
- EIR, 483, 1/13
2014-P-0259 DRAFT 0003, 0004, 0005 ETC
HOSPIRA, ROCKY MOUNT, NC - EIR, 483, MOST RECENT
INDIVIDUAL RECS
AVASTIN - AERS
FOI DAILY LOG 2014
NATIONAL INSTITUTE OF HEALTH - HUMAN GENE TRANSFER

PROTOCOL #1404-1304 9/10/14 EXPENDITURE OF TIME &
MONEY IN RESEARCHING, DRAFTING & PROMULGATING THE
DISCUSSION, COMM, POWERPOINT PRESENTATION
OLYMPUS - ENDOSCOPES TJF-Q180V, TJFQI809 & TJF-
160VR DUODENOSCOPES - RECS
SIEMENS HEALTHCARE DIAGNOSTICS, INC, EAST WALPOLE,
MA - EIR, 483, RESPONSE 10/01/2011 - 01/31/2012
SMITH & NEPHEW, SAINT PETERSBURG, FL - EIR, 483,
RESPONSE 11/01/2013 - 11/30/2013
PHILIPS HEALTHCARE, SAN DIEGO, CA - EIR, 483,
RESPONSE 07/01/2013 - 07/31/2013
BAXTER HEALTHCARE CORP, ROUND LAKE, IL - EIR, 483,
RESPONSE 07/01/2013 - 07/31/2013
FDA 2014-N-1243-0001, FDA 2010-P-0559
LIST OF DRUG ESTABLISHMENTS THAT LIST REGISTRAR

CORP AS US AGENT OR REGISTRANT CONTACT IN THEIR
REGISTRATION, LABELER CODE, OR SELF-IDENTIFICATION
SPL SUBMISSIONS
GVK BIOSCIENCES, CLINOGENT - CORR, INSPECTIONS,
COMM 01/04/2007 - 03/17/2015
TERUMO CARDIOVASCULAR SYSTEMS CORPORATION, ANN
ARBOR, MI - EIR, 483, RESPONSE 09/01/2012 -
09/30/2012
03/18/2015
AUROBINDO PHARMA UNIT IV, UNIT VII, INDIA - 483,
CLASSIFICATION 03/18/2015 - 09/01/2014
NOTICES TO AMAZON RE LISTING, MARKETING, OR SELLING
PERSONAL LUBRICANTS WITHOUT APPROVAL 01/01/2015 -
03/15/2015
DAILY LOG 2014
LUITPOLD PHARMACEUTICALS, SHIRLEY, NY - EIR
04/01/2014 - 12/31/2014
MASTER FILE MAF-610
03/18/2015
SERTRALINE - 5 YEAR AERS SUMMARY
WOCKHARDT, INDIA - 483 10/21/2014 - 03/18/2015
QUANTA - WARNING LETTER RECS 10/01/2013 -
03/01/2015
ANDA A072041 SBA
K011880
K141167
ACTHAR GEL LETTER AND ATTACHMENTS
RX LIQUID SALICYLIC ACID - SBA 01/01/1980 -
01/01/1995
PRIMAL PET FOOD - CONSUMER COMPLAINT, ADVERSE
EVENTS 06/01/2014 - 03/16/2015
EMAIL BETWEEN FDA DETROIT DISTRICT AND VARIOUS
OTHERS 08/01/2014 - 03/18/2015
LIST OF FOOD WAREHOUSES AND DISTRIBUTION CENTERS
01/01/2010 - 04/30/2014
2014-N-1491, 2014-D-1167, 2014-D-0902
HHSF223201110005B
K040973
VALPROIC ACID - REVIEWS
SEEING MACHINES LTD - TRUE FIELD ANALYZER K063310
DESI DOCUMENTS
SCHIZPCHYTRIUM ILNANICUM - SAFETY INFO, USES IN
POULTRY ETC
TAKEDA PHARMACEUTIAL - COLCRYS APRVL
COSMETICS - AER 2005 TO PRESENT
MEDICAL DVCS ADVISORY COMMITTEE MTG 2/27/15
ANSWERS & QUESTIONS MADE TO GCP@OC.FDA.GOV IN 2012

FDA-1975-N-0012
SIMPLY THICK REQUESTS 1/5/15 TO PRESENT
K904422, K934261,0K942299
TEVA PHARMACEUTICALS - TERAZOSIN NDA 74-651 ABBOTT
LABS - PROPOFOL NDA 74-704 TEVA CANADA -
FAMOTIDINE NDA 74-687 ETC TENTATIVE APRVL
K133476 K140451 K140450
NUMBER OF EMPLOYEES IN EACH OFFICE IN CDER
TEMODAR, TEMODAL - COMPLETE RESPONSE LETTERS RE
ORPHAN DESIGNATIONS
ZOLINZA - COMPLETE RESPONSE LETTER RE ORPHAN
DESIGNATION
ANDA 085981
K081593
COMPLETE RESPONSE - COMPLETE RESPONSE RE ORPHAN
DESIGNATION
FDA-0009-N-0361
BLA 103780 S 5121 SBA
ANDA 040486 - EFFECTIVE APPROVAL LETTER NDA 205636
- TENTATIVE APPROVAL LETTER
NDA 20622 S089
K053451
K904421
GRAS 3G0026 GRAS 0G0363, GRAS 5G0415 ETC
FDA-15-223-SOL-1142466
VIINTAFOLIDE - COMPLETE RESPONSE RE ORPHAN
DESIGNATION
MERCK TOXICOLOGY REPORT
GR PRODUCE, MCALLEN, TX - EIR, SAMPLES, ETC
FDA-2014-N-1741-0001
K874656, K941870, K932199 ETC
KEYTRUDA - COMPLETE RESPONSE LETTER RE ORPHAN
DESIGNATION
FUJIAN FUKANG PHARMACEUTICAL CO, LTD - EIR
03/28/2014 - 03/28/2014
WOCKHARDT, INDIA - 483 01/01/2015 - 03/19/2015
NDA 019842 - SBA, MEDICAL REVIEW
HARVONI - AERS
COLOR DESIGN LABORATORY, NORTHRIGGE, CA - EIR, 483,
WARNING LETTER 0/01/2010 - 03/01/2015
WEST COAST COSMETICS, CHATSWORTH, CA - EIR, 483,
WARNING LETTER 01/01/2010 - 03/01/2015
ACETYLCYSTEINE 10% OPTH SOLN - AERS
ZULA - INVESTIGATION OF COMPLAINT, HACCP REGULATION
03/15/2014 - 03/15/2015
FDA-2014-N-1491-0001
DR GARY SCHILLER, UCLA MEDICAL CENTER, LOS ANGELES,

CA - 483, EIR, RESPONSES 09/01/2001 - 11/30/2011
COMPLETE RESPONSE POSACONAZOLE -COMPLETE RESPONSE
LETTER RE ORPHAN DESIGNATION
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
DINACICLIB - COMPLETE RESPONSE LETTER RE ORPHAN
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
JONES MEDICAL INSTRUMENT CO, OAK BROOK, IL SMITHS

MEDICAL CO, VERNON HILLS, IL EDWARD HINES VA
HOSPITAL PATHOLOGY & LABORATORY, HINES, IL, ETC -
483S 11/1-30/14
PREVENTIVE TECHNOLOGIES INC, INDIAN TRAIL, NC
PHARMA TECH INDUSTRIES, ROYSTON, GA REMINGTON
MEDICAL INC, ALPHARETTA, GA - 483S 11/1-30/14
NEWTON LABORATORIES INC, CONYERS, GA SUNNEX INC,
CHARLOTTE, NC - 483S 2/1-28/15
BLUE NATURALS LLC, CHARLOTTESVILLE, VA - 483 2/1-
28/15
THERAPEUTIC PROTEINS INTERNATIONAL LLC, CHICAGO, IL

SUNSTAR AMERICIAN INC, ELGIN, IL - 483S 2/1-28/15
SPOONAMORE DRUG CO INC, LOUISVILLE, KY NEUROWAVE

SYSTEMS INC, CLEVELAND HEIGHTS, OH CLEVELAND
MEDICAL DEVICES INC, CLEVELAND, OH - 483S 2/1-28/15
K141399
DENTAL REPUBLIC, DALLAS, TX TRILLLIANT SURGICAL
LTD, HOUSTON, TX CHEMOLEE LAB CORP, IRVING, TX,
ETC - 483S 2/1-28/15
FOREVERGREEN INTERNATIONAL LLC, PLEASANT GROVE, CO
CEA MEDICAL MANUFACTURING INC, COLORADO SPRINGS, CO
AMGEN INC, LONGMONT, ETC - 483S 2/1-28/15
BATTLE CREEK EQUIPEMNT, CO, FREMONT, IN APPLIED

LABORATORIES INC, COLUMUS, IN TRI-MED INC
(ADVANCED CARE INFUSION-SHELBY)L , SHELBY TOWNSHIP,
MI - 483S 2/1-28/15
RIVERSIDE WATER TECHNOLOGY INC (CULLIGAN OF

PERRYVILLE),. PERRYVILLE, MO MEDICAL SOLUTIONS
INTERNATIONAL INC, MERRIAM, KS LONG
PHARMACEUTICALS LLC, FENTON, MO - 483S 2/1-28/15
VERTEBRAL TECHNOLOGIES, INC, MINNETONKA, MN
WILSON-HURD MFG CO INC, BERLIN, WI QIG GROUP LLC,
BLAINE, MN, ETC - 483S 2/1-28/15
GARDNER DENVER THOMAS INC, MONROE, LA TEGRA
MEDICAL LLC, HERNANDOS, MS - 483S 2/1-28/15
IBA MOLECULAR NORTH AMERICA INC, COLONIE, NY C P

HEALTH PRODUCTS INC, HAUPPAUGE, NY - 483S 2/1-28/15
DEXTA CORP, NAPA, CA SOMERSAULT ORTHOPEDICS INC,
PLEASANTON, CA - 483S 2/1-28/15
BAXTER HEALTHCARE OF PUERTO RICO, GUAYAMA, PR - 483
2/1-28/15
SPEN TECH INC, REDMOND, WA GENESIS NORTHWEST INC,
PORTLAND, OR THORN FORD DENTAL LABORATORY LLC,
BOTHELL, WA, ETC - 483S 2/1-28/15
DIVI LABS - EIR, 483 01/01/2010 - 01/12/2015
EMCURE PHARMAEUTICAL LTD, HINJWADI, PUNE, INDIA

HOSPIRA HEALTHCARE INDIA PVT LTD, SRIPERUMBUDUR,
INDA, PRIME EUROPEAN THERAPEUTICAL S SPA
(EUTICALS SPA), ROZZANI, ITALY - 483S 2/1-28/15
DPT LAKEWOOD LLC, LAKEWOOD, NJ INOPAK LTD,
RINGWOOD, NJ CMIC CMO USA CORP, CRANBURY, NJ, ETC
- 483S 2/1-28/15
BREG INC, CARLSBA, CA STAAR SURGUICAL CO,
MONROVIA, CA SPEC ENGINEERING CO, VAN NUYS, CA,
ETC - 483S 2/1-28/15
INFUPHARMA LLC (PRESIDENT PHARMACY), HOLLYWOOD, FL

THE ANSPACH EFFORT INC, PALM BEACH GARDENS, FL
PRODUCT QUEST MANUFACTURING LLC, HOLLY HILL, FL,
ETC - 483S 2/1-28/15
APK TECHNOLOGY CO LTD, SHENZHEN CITY, CHINA APEX
MEDICAL (KUNSHAN) CORP, KUNSHAN, CHINA TECRES SPA,
SOMMACAMPAGNA, ITALY, ETC - 483S 2/1-28/15
HP ACTHAR
NDA 78992
NDA 71961 S1, S2, S3, S4
2014-6366
K840239
DEFICIENCY LETTER TO DR REDDY'S LABORATORIES, INDIA

RE: NEXIUM COMPLETE RESPONSE LETTER AND
BIOEQUIVALENCE DEFICIENCY ON NEXIUM ISSUED TO DR
REDDY'S LABORATORIES
K983436
YINLU FOOD GROUP CO LTD - IMPORT REFUSAL RECS
MIRALAX, POLYETHYLENE GLYCOL 3350 - AERS
PYRAMID, COSTA MESA, CA - INVESTIGATOR DIARIES
01/05-15/2015
PYRAMID LABORATORIES - RESPONSE TO 483 01/01/2015
- 03/12/2015
PYRAMID, COSTA MESA, CA - EIR, CORR 01/05-15/2015
ZOETIS LLC, LINCOLN, NE - 483 01/01/2015 -
01/31/2015
FREDA BIOPHARM CO LTD - 483, EIR SUMMARIES
01/01/2013 - 01/31/2015
SPREADSHEET LISTING COMPANIES THAT HAVE COMPLETED
THE DHHS/FDA MENU AND VENDING MACHINE LABELING
VOLUNTARY REGISTRATION
NDA, BLA APPROVAL TIMES 01/01/2009 - 02/28/2015
RYTARY - SBA
QUALITEST, CHARLOTTE, NC - 483, WARNING LETTER
07/01/2014 - PRESENT
QUALITEST, HUNTSVILLE, AL - 483, WARNING LETTER
NUTRITIONAL LABELING OF STANDARD MENU ITEMS IN
RESTAURANTS ETC - SPREADSHEET OF ENTITIES SUBJECT
TO RULE
K111066, K102909
MRSA, STAPH, ACNE, FUNGAL ET - EXPENSES FOR OTC
TOPICALS, RX 01/01/2011 - 03/15/2015
CDER FTE CEILING, FTE ONBOARD PLUS EOD CHART CDER
FTE CEILING SPLIT CHART
CHIMERIX - CORR RE EMERGENCY APPROVAL OF
BRINCIDOFOVIR IN EBOLA PATIENT
DAUNORUBICIN HYDROCHLORIDE INJECTION SOLUTION - RLD
LABELS
23ANDME 510K WITHDRAWAL, WARNING LETTER - OPINION,
INFORMATION LETTERS, EMAILS ETC Date Range
11/22/2013 - 03/20/2015
ANDA 202640 SBA
NDA 204300
K120972, K013061, K062818
ANDA 200294 SBA
PRACS, FARGO, ND - EIR 09/01/2011 - 12/31/2012
BRACCO DIAGNOSTICS INC, MONROE TOWNSHIP, NJ - 483
05/01/2014 - 06/30/2014
NDA 006488
NDA 018692
ANDA 083914
NUMBER OF EMPLOYEES AND STAFF IN CDER
KINCAID ENTERPRISES INC - ENTRY #EAQ00001631 CF 28,
CF29, CBP REDELIVER NOTICES,E TC
2003-6609, 2009-3077, 2012-5361, 2015-1737
BIDART BROS - 483 01/01/2005 - 01/15/2015
TPS - HDE SUBMISSION, APPROVAL ORDER, SAFETY
SUMMARY ETC
HOSPIRA INC, AUSTIN, TX - 483S 2009 TO 2015
SPRAY-ON SINSCREENS - AERS 2010 TO PRESENT
FLUOROQUINOLONES - PHARMACOVIGILANCE RVWS 4/17/13
TO PRESENT
2015-1122
PRODUCT SPECIFIC RECOMMNEDATIONS FOR GENERIC DRUG
DEVELOPMENT 01/01/2014 - 03/23/2015
ENFORCEMENT REPORTS - CORRECTED VERSIONS 01/01/2004
- 05/07/2012
ANDA 200294 SBA
K142006
NATURAL RESOURCES DEFENSE COUNCIL - PERFLUOROALKYL
ETHYL IN FOOD CONTACT APPLICATIONS
UNIVERSITY OF MINNESOTA - REQUESTS TO CDER
01/01/2008 - 01/01/2015
Any and all documents related to the FDA's March
18, 2014 request for review of the epidemiological
studies of pregnant women exposed to sertraline
PIRAMAL HEALTHCARE, UK - EIR 10/13/2014 -
10/17/2014
CANDELA LCS K926464 - SS&E, SE LTR
PARAGRAPH IV CERTIFICATIONS 1986 TO 2004
COMPLAINT RECORDS, COMMUNICATIONS
MONSANTO - WHOLESOMENESS STUDIES CITED IN BNF
000001
SHIPMENTS REGULATED BY FDA 3/1-15/15
FOIA REQUESTS TO CFSAN 02/25/2015 - 03/23/2015
OMSHEEL LLC - ENTRY #18500562535 CF28, CF29, NOTICE
OF ACTION, ETC
ZOETIS, KALAMAZOO, MI - 483 04/01/2014 - 04/30/2014

ORANGE BOOK DATA
NATIONAL THERAPY PRODUCTS, INC, ONTARIO, CANADA -
EIR, 483, RESPONSES 01/01/2007 - 12/31/2012
ASH STEVENS INC, RIVERVIEW, MI. BIOPRO INC, PORT
HURON, MI, OSSUR AMERICAS INC, ALBION, MI, ETC -
483S 11/1-30/14
LAC MAC LTD, LONDON, CANADA, STORZ MEDICAL AG,
TAGERWILEN, SWITZERLAND, DORO INC, OTTAWA, CANADA,
ETC - 483S 11/1-30/14
TRAVALERT - PATHWAY, DATE OF APPROVAL
LISINOPRIL, DIVALPROEX, REMERON, ETC - RECS
GOOGLE INC - CRIMINAL INVESTIGATION RECS TIMOTHY
ARMSTRONG, NIKESH ARORA, DENNIS WOODSIDE, ETC -
SETTLEMENT AGREEMENT 8/11
VIVONIC GMBH - AQUABPLUS, AQUABPLUS B2, AQUABPLUS
HF, ETC K133829
LAUER MEMBRAN WASSERTECHNIK GMBH - AQUABOSS ECORO
I, ECORO I HT, ECORO II, ETC K124059
SOLWAY - TORA (PHENTERMINE HCL) 8MG ANDA 84-035
CLNCL STUDIES, APRVL LTR
COOK LAWSON RETROGRADE NEPHROSTOMY KIT K833762
WELLMILL LLC DBA VITAMIX - 483 05/01/2014 -
05/31/2014
RISPERIDONE NDA 20-272 VOLS 127-135
CATALENT PHARMA SOLUTIONS LTD, SWINDON, WILTSHIRE,

UK 9/8-12/14 PATHEON UK LTD, SWINDON, UK 9/4-12/14
ROSEMONT PHARMACEUTICALS LTD, LEEDS, UK, 12/8-
12/14, ETC - 483S
SANOFI CHIMIE, SISTERON CEDEX, FRANCE 12/8-12/14
FERRING GMBH, KIEL, GERMANY 11/3-11/14 SANDOZ
GMBH, KUNDL, AUSTRIA 9/8-16/14, ETC - 483S
PARAMOUNT COSMETICS INC, CLIFTON, NJ MTI PRECISION
PRODUCTS LLC, LAKEWOOD, NJ SONAR PRODUCTS INC,
CARLSTADT, NJ, ETC - 483S 11/1-30/14
J STRICKLAND AND CO, OLIVE BRANCH, MS COASTAL MEDS
LLC, BILOXI, MS - 483S 11/1-30/14
NOVUM MEDICAL PRODUCTS CO, CLARENCE, NY - 483S
11/1-30/14
CUSTOM ULTRASONICS INC, IVYLAND, PA SIGMA PHARM
LABORATORIES LLC, BENSALEM, PA - 483S 11/1-30/14
ABCO LABORATORIES INC, FAIRFIELD, CA CONCENTRIC
MEDICAL INC, MOUNTAIN VIEW, CA UNITED BIO RESEARCH
INC, SAN JOSE, CA - 483S 11/1-30/14
TAPI PUERTO RICO INC, HUMACAO, PR - 483S 11/1-30/14

ELECTRODE STORE INC, BUCKLEY, WA CONTROLTEK INC,
VANCOUVER, WA GALENA BIOPHARMA INC, PORTLAND, OR -
483S 11/1-30/14
ALERE, SAN DIEGO, CA - 483 05/05/2014 - 06/09/2014
APOTEX PHARMACHEM INC, BRANTFORD, CANADA WYETH

LEDERLE SRL, CATANIA, ITALY DR REDDY'S
LABORATORIES LTD CTO VI, SRIKAKULAM DISTRICT, INDIA
- 483S 11/1-30/14
K123229
LIST OF CORR WITH CONGRESS 03/01/2010 - 03/01/2015

K120134 K120053
K031649
LEVAQUIN CIPRO AVELOX - AER
FOI REQUESTS 4/1/14 TO PRESENT
JOINT MGT OF THE ADVISORY COMMITTEE FOR

REPRODUCTIVE HEALTH DRUGS DRUG SAFETY & RISK MGMT
ADVISORY COMMITTEE - TRANSCRIPT, MINUTES 12/8/11
CERTIFIED
BUPRENORPHINE - AER
THERMACARE HEAT WRAP K953442 - CORR
K141389
LITTLE RIVER ICE CO LLC, CADIZ, KENTUCKY - EIR
ST JUDE MEDICAL INC - PENTA SPINAL STIMULATOR
PADDLE IMPLANT PMA, MDR
NALMA, SA - EIR, ATTACHMENTS MOST RECENT
ST JUDE MEDICAL, INC, PLANO, TX - 483, EIR,
RESPONSE 05/01/2014 - 05/31/2014
CALCAGNO, JOHN, GRESHAM, OR - 483, EIR, RESPONSE
10/01/2014 - 10/31/2014
MEDTRONIC PUERTO RICO OPERATIONS CO, VILLALBA, PR -
483, EIR, RESPONSE 05/01/2014 - 05/31/2014
MARTIN YUDOVICH, HOUSTON, TX - 483, EIR, RESPONSE
10/01/2014 - 10/31/2014
DENTSPLY ORTHOLAB INC, RACINE, WI - 483, EIR,
RESPONSE 04/01/2014 - 04/30/2014
2015-886
AMYLIN OHIO, LLC, WEST CHESTER, OH - 483, EIR,
RESPONSE 07/01/2014 - 07/31/2014
K141102
ALLERGAN, GOLETA, GA - 483, EIR, RESPONSE
08/01/2012 - 08/31/2012
BIOMARIN PHARMACUETICAL, INC, NOVATO, CA - 483,
EIR, RESPONSE 04/01/2014 - 04/30/2014
2015-1908
ONE BLOOD INC, LANTANA, FL - EIR, 483, RESPONSE
07/01/2013 - 07/31/2013
SUN PHARMACEUTICAL INDUSTRIES, DETROIT, MI - EIR,
483, RESPONSE 02/01/2013 - 05/31/2013
AGGLOMERATED STOPPERS - ANALYTICAL DATA, STUDIES
FOR ALCOHOLIC BEVERAGES CORR
BLA 125291 S 136 - SBA
CONVATEC INC - FLEXI SEAL CONTROL FECAL MGMT SYS
RECALL, CMPLNTS, MDRS
BIO-RAD LABORATORIES, REDMOND, WA - EIR, 483,
RESPONSE 04/01/2014 - 04/30/2014
DATA RE INSPECTIONS FOR FOOD, DRUGS, COSMETICS
01/01/2000 - 01/02/2014
2015-1477 - REQUEST LETTERS ONLY
SOLVALDI (SOFOSBUVIR) REQUEST LOG 1/1/10 TO PRESENT

NDA 205060
INSYS THERAP ANDA 78-501 001, 78-501 002, 78-501
003 SBA
2015-1342, 1344, 1345, 1346, 1347, 1355 - REQUEST
LETTERS ONLY
EGG, PRODUCE, DAIRY PRODUCERS - TESTING DATA,

COMPLIANCE INFO, ENFORCEMENT INFO, RECALL 1990-2014
OREXIGEN THERAPEUTICS INC - CONTRAVE (NALTREXONE
HCI, BUPROPION HCI) CORR
FOIA REQUESTS CLOSED 2014
TEVA PHARMACEUTICALS - TERZOSIN HYDROCHLORIDE
ABBOTT LABORATORIES - PROPOFOL TEVA CANADA -
FAMOTIDINE ETC - APRVL
SUBMISSIONS MADE BY DEVICE MANUFACTURERS OF POWER

MORCELLATOR DEVICES REGARDING FDA REVIEW OF
CANCEROUS TUMOR RISK FOR UTERINE FIBROID PROCEDURES
03/01/2013 - 12/31/2013
IMPORT DATA 01/01/2013 - 03/31/2015
SCANTIBODIES BIOLOGICS INC - 483
LUIS SANCHEZ-RAMOS, UF HEALTH SCIENCE CENTER
UNIVERSITY, JACKSONVILLE, FL - 483 02/09/1998 -
02/09/1998
REQUESTS REGARDING REGULATORY STATUS OF GENOME-
EDITED ANIMAL RECS RE REGULATORY STATUS OF GENOME-
EDITED ANIMAL INCLUDING RESPONSE TO REQUESTS
INADA FOR PORCINE ZONA PELLUCIDA
TEVA PHARMACEUTICALS, KFAR SABA, ISRAEL - EIR
12/01/2013 - 12/31/2013
BENEFUL - ADVERSE EVENTS, CONSUMER COMPLAINTS
03/18/2014 - 03/24/2015
NDA 202880
K021606
TEVA PHARMACEUTICALS, BEER SHEVA, ISRAEL - EIR
07/01/2014 - 07/31/2014
VIOXX - APPROVAL, APPLICATION, CORR 01/01/1999 -
12/31/2002
LLOYD, INC - FOIA REQUESTS 01/01/2012 - 03/25/2015
GARDASIL - APPROVAL LETTER, EMAILS, APPLICATION
01/03/2005 - 12/27/2010
LEVAQUIN, CIPRO, AVELOX - AERS 03/25/2010 -
03/25/2015
2013-2250
NDA 206627
CONFAB LABORATORIES INC - PROFILE CLASS CODES
DPT LAKEWOOD - PROFILE CLASS CODES 12/01/2001 -
03/01/2015
ORANGE BOOK DATA FILES FOR EXPIRED PATENTS
2014-2945
DORIPENEM, DORIBAX - AERS
K950897, K950898, K001337
HARBOR HOUSE SEAFOOD, SEAFORD, DE - EIRS, 483S
7/1/10
LIPITOR COUNTERFEIT DRUG CASE RECS
VIAGRA COUNTERFEIT DRUG RECS
SHIRE DEVELOPLMENT LLC CLINICAL HOLD LETTER SPD602,
SSP-004184
PULMONETICS SYSTEMS, CAREFUSION LTV 1150 VENTILATOR

- INVESTIGATION RECS 01/27/2014 - 04/30/2014
INSYS THERAPEUTICS - LAZANDA, ABSTRAL & FENTORA
SUMMARY STATISTICS
ADVANCE PHARMACEUTICAL, INC - RECALL RECS LOT
13A026
SEROQUEL - AERS
2014-3378
THOMAS ELLIOTT, DIABETES CLINIC & RESEARCH,
VANCOUVER, CANADA - 483S 11/13 TO PRESENT
ANDA 085635 DEPO-TESTOSTERONE (TESTOSTERONE
CYPIONATE)
FDA-CDRH-15-MP-1255935LK SELECTED APPLICANTS
NAVIDEA BIOPHARMACEUTICALS - LYMPHOSEEK NDA 20-
2207 SAFETY RPT 7/1/14-9/30/14
NADA 030-438, SUPPLEMENTS NADA 030-525,
SUPPLEMENTS
ALLERGAN INC, SMITH-KETTLEWELL EYE RESEARCH
INSTITUTE - OCLINUM 1987 TO 1997
MECHANICALLY SEPARATED CHICKEN - RECS
CMPLNT
BELCHER PHARMACEUTICALS LLC - RIMADYL CHEWABLE TABS
NADA 141-111 QUALITATIVE FORMULA, SCIENTIFIC
DISCUSSION
VACANCY ANNOUNCEMENT FDA-CDER-14-DE-1164921DM
RESEARCH TOXICOLOGIST GS-0415-13 - APPL PKG
2014-3259
FCN 415
P&L DEVELOPMENT, LLC, LYNWOOD, CA - EIR 01/01/2014
- 12/31/2014
ZHEJIANG TIANTAI AURISCO PHARMACEUTICAL CO - 483,
EIR, RESPONSE 11/12/2013 - 11/15/2013
ANDA 90999
NDA, ANDA SPREADSHEETS
LIST OF PARAGRAPH I, II, AND III CERTIFICATIONS
DPT LABORATORIES, SAN ANTONIO, TX - PROFILE CLASS
CODES
INACTIVE INGREDIENT DATA
EXPANSIA, DIVI'S LABORATORIES LTD, INDIA - EIR
SUMMARY 01/01/2009 - 03/25/2015
ANDA, NDA APPLICATION DATES
2014-8643
TIZANIDINE CASE REPORTS
TEVA PHARMACEUTICALS, KFAR SABA, ISRAEL - EIR
(CERTIFIED) 12/01/2013 - 12/31/2013
ZYCLARA - AERS
APTUIT, OXFORD, ENGLAND VERONA, ITALY - 483, EIR,
RESPONSE ETC 01/22/2005 - 03/25/2015
FRESCA FOODS - RECALL RECS
DOW CHEMICAL CO - FCN 1357
BABY FORMULA ENTRY #AV3-0041796-9
OPANA ER, ACETAMINOPHEN, VENLAFAXINE HCL, ETC - ISR
6545759 DMEROL, FENTORA, CYMBALTA, ETC - ISR
5321794
EZ-ALIGN DENTAL APPLIANCE K121396
COMPASSIONATE USE PROTOCOL PN104 (TRIACETYLURIDINE)

2014-3361
K940973
INDIVIDUAL RECS
ALLIED HEALTHCARE, STUYVESANT FALLS, NY - 483 NY
12/09-11/2013
2014-9081
VIRBAC CORPORATION, ST LOUIS, MO - 483 09/01/2014
- 03/20/2015
OBAMACARE - RECS
LIST OF NEW DIETARY INGREDIENT NOTICE OF GYNOSTEMMA
PENTAPHYLLUM AND POLLEN PINI
FICTIONAL CIGARETTE, TILXA CIGARETTES, MERCHER
CIGARETTES ETC
NESTLE, MODESTO, CA - 483 04/01/2013 - 04/01/2015
FCN 45
2014-3361
FCN 415
INDIVIDUAL RECS 02/01/2014 - 03/26/2015
FORM 483 FOIA REQUESTS LAST TWO YEARS
INDIVIDUAL RECS
DIETARY SUPPLEMENTS FOR SEXUAL ENHANCEMENT, BODY
BUILDING, AND WEIGHT LOSS - ADVERSE EVENTS
510K CLEARANCE LETTER FOR IVA SEALS
CALDWELL TRACE, BIRMINGHAM, AL - EIR 04/28/2014 -
05/02/2014
DEPUY PFC SIGMA KNEE PROSTHESIS, FEMORAL STEM
ADAPTERS - 510K, AERS, RECS RE DESIGN, SAFETY ETC
01/01/1995 - 03/31/2015
2014-5838
DOTERRA INTERNATIONAL LLC, PLEASANT GROVE, UT -
INSPECTION RECS
2014-3361
K070173
AEGERION PHARMACEUTICALS, INC, CAMBRIDGE, MA - EIR
08/21/2012 - 12/31/2012
GERBER, FORT SMITH. AR - MICROBIOLOGICAL RESULTS
12/03/2014 - 12/04/2014
SIMPLOT PLANT SCIENCES, BIOTECHNOLOGY CONSULTATION

AGENCY RESPONSE LETTER GENETICALLY ENGINEERED
POTATOES - RECORDS RE CONSULTATION 01/01/2012 -
03/27/2015
CATALENT PHARMA SOLUTIONS, MORRISVILLE, NC
03/16/2015 - 03/20/2015
LUSSIER DAIRY, HAWTHORNE, FL - INSPECTIONS,
ACTIONS, RESPONSE ETC 12/01/2014 - 03/26/2015
DPT LAKEWOOD, INC, LAKEWOOD, NJ - EIR, 483
01/01/2014 - 03/27/2015
K150121, K143394, K 143025 ETC
ENDOCRINOLOGIC AND METABOLIC DRUGS ADVISORY
COMMITEE MEETING - TRANSCRIPT, MINUTES, BACKGROUND
DOCS ETC 02/04/1987 - 09/14/1987
ENDOCRINOLOGIC AND METABOLIC DRUGS ADVISORY
COMMITTEE MEETING - TRANSCRIPT, MINUTES, BACKGROUND
ETC 03/06/1994 - 01/14/1995
HUMAN BIOSCIENCES INC, OAK GROVE, MN - SKINWTEMP II

K122325 BIOCORE INC, TOPEKA, KS - SKINTEMP
MODIFICATION K925545 BIOCORE INC, TOPEKA, KS -
SKINTEMP K913023, ETC
K945835
K981013, K013971, K023075
CONGRESSMAN VERNON BUCHANAN - CORR 1/1/14 TO
3/25/15
CYMBALTA - AER
FDA TO ASSESS ROSK OF SALMONELLOSIS ASSOCIATED
W/EATING TREE NUTS - STUDY RECS 2013
SMITH & NEPHEW - GENESIS II KNEE SYS MODEL 71420182
MDRS
MERCK & CO INC - ZOSTAVAX APRVL, STATISTICAL RVW,
CLNCL RVW
VYNVANSE NDA 21-977/S-036/S-037 SUPPLEMENTARY APRVL
RECS
BOSTON SCIENTIFIC - ZERO TIP NITINOL STONE
RETRIEVAL BASKET 510K, PMA, RECALLS, MDRS
NATURE'S EATS NATURAL MACADAMIA NUTS - TEST RESULTS

DR MULLAI, HEMATOLOGY & ONCOLOGY CENTER, SOMERSET,
KY - UNAPPROVED & IMPROPERLY LABELED CHEMOTHERAPY
DRUGS INVESTIGATION RECS LAST 5 YRS
INTUITIVE SURGICAL - ADVERSE EVENTS

P000025 S079, P000025 S063
GARDASIL - PURCHASE BY GOVERNMENT 05/01/2006 -
03/29/2015
FDA-CDRH-15-MP-1255935LK - CV, SF-50
Appendix A Certified Color Additive Assignment FPB
92-5
COPERNICUS GROUP IRB - EIR 09/16/2014 - 03/30/2015
Import Alert 54-15
K133147
FDA MEMO FROM JOHN PETERS REGARDING TRACKED SAFETY

ISSUE 1349 METHYLPHANIDATE ER SUMMARY & CONCLUSIONS
SMITH & NEPHEW INC - SPATIALFRAME VERSION 4.1
K110069
DR ROBERT SCHLOSSMAN, BOSTON MA 6/16-23/14 DR
KEITH ROBINSON, OAKLAND PARK, FL 6/23/14-7/3/14 -
EIRS, 483S, 482S, ETC
SMITH & NEPHEW INC - TYLOR SPATIAL FRAME K970748
SMITH & NEPHEW INC - CIRCULAR FIXATION K093047
FTSI-FOOD TECHNOLOGY SERVICES INC - EIRS 3/4-16/13
ACTAVIS LABORATORIES INC - ANDA 07-7302 TEVA
PHARMACEUTICAL INDUSTRIES LTD - ANDA 07-7488 APRVL
PRAZIQUANTEL (BILTRICADE) TABS 600 MG - NDA 18-
714 CHEMISTRY RVW, BIOEQV RVW, CORR
AB SCIENCE SA, PARIS, FRANCE - INSPECTIONS OF
CLINICAL TRIALS 01/01/2010 - 03/26/2015
Date Range: 01/01/2013 - 01/31/2015 I request the
following: Any and all 483 Inspectional
Observation(s) and Establishment Inspection Report
SUMMARIES related to any FDA inspection(s) of
Virupaksha Organics Pvt. Ltd., F-10, I.D.A., Gandhi
Nagar, Balan
VIRUPAKSHA ORGANICS, INDIA - 483, EIR SUMMARY
01/01/2013 - 01/31/2015
VIRUPAKSHA ORGANICS, INDIA - EIR 01/03/2013 -
01/31/2015
ENBREL - AERS
Number of REMS Drug Error Reports (by drug) - from
2005 through 2013
PRAGAMA PHARMS - DESYREL(TRAZODONE HCL) TABS 50 MG,
100 MG, 150 MG, 300 MG NDA 18-207 APRVD APPL
CONCEPTUS INC, BAYER CORP - 483, CAPA, VIOLATIONS,
ETC RE ESSURE 01/03/2002 - 03/26/2015
2014-1247, 2014-1316, 2014-1332, ETC
L-CARNITINE - STRUCTURE/FUNCTION CLAIMS 03/26/2005
- 03/26/2015
PROPOFOL - AERS 2013, 2014, 2015
NANISILVA - ALL RECS, COMMUNICATIONS, CONSULTATIONS
01/01/2013 - 03/27/2015
2014-7403
2014-7056
2014-7058
ZIMMER - ZIMMER PERSONA PERSONALIZED KNEE SYSTEM
MDRS, 510KS, PMAS, ETC
2014-7060
WELLBUTRON, VISCRILL - AERS
2014-5778
2014-5860
2013-7269
2013-7130
2014-5553
NDA 17871
NDA 206289
COUMADIN - AERS 03/26/2014 - 03/26/2015
ELTOPRAZINE - IND
SIXDOG INVESTMENT, LLC, DBA SIXDOGS FARMS,
WELLINGTON, CO - WARNING LETTER RECS 04/28/2014 -
03/27/2015
JAMIESON - RECS (INCLUDING FDA 3500, 3500A, 3500B)
9/3/14-12/31/14
OCTOBER 2014 FDA MEMO FROM JOHN PETERS MD RE
TRACKED SAFETY ISSUE 1349 METHYLPHENIDATE ER
SUMMARY AND CONCLUSIONS
NDA 018723 LABEL RECS
HEPATITIS C DRUGS - NINE CASE REPORTS
NDA 18680 S60
EMCURE PHARMACEUTICALS, INDIA - 483 01/01/2014 -
03/27/2015
2014-5179
OPDIVO - AERS
2012-2336
2014-3401
2014-4784
K141520
2012-8873
TOLBUTAMIDE, PROBENECID, SACCHARIN ETC -
APPLICATIONS, PROCESSES, APPROVALS ETC
EXPAREL - AERS
REGULATION OF PHASE IV CLINICAL STUDIES AND
PHARMACOGENOMICS
NDA 20430
ELASE-CHLOROMYCETIN SBA
ADM ALLIANCE NUTRITION, CORDELE, GA - 483 2/31/2014
- 01/13/2015
AFREZZA - REVIEW AND APPROVAL RECS 01/01/2014 -
03/30/2015
K001962
K002099
K142554
NDA 205613 - SBA
K142697
K130545
K141399
K142432
CLOZARIL (CLOZAPINE) - AERS
FOI DAILY LOG 9/1/14 TO 3/31/15
EYLEA (AFILIBERCEPT) INJ BLA 125387/48 - SBA
PARAGON VISION SCIENCES - CMPLNT CPT1200119
CIRPOFLOXIN, LEVAQUIN - CMPLNTS 2012-2014
XYTEX CORP, ATLANTA, GA - EIR 2/28/11
CARL ZEISS INC - HUMPHREY FIELD ANALYZER K954167

CARL SEISS MEDITEC INC - GUIDED PROGRESSION
ANALYSIS ON THE HUMPHREY FIELD ANALYZER II AND II-I
SERIES K093213
MEDTRONIC XOMED INC - TONO-PEN AVIA TONOMETER AND
OCU-SHIELD TIP COVER K053430 MENTOR OPHTHALMICS
INC - MENTOR TONO-PEN 3 K964312
INDIVIDUAL RECS - VAERS
DKT 77N-0094, C1, VOLUME 4, DKT 77N-0094, LET17,
VOLUME 60 ETC CERTIFIED
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
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
ANALYSIS OR REANALYSIS BY OFFICE OF

PHARMACOVIGILANCE AND EPIPEMIOLOGY OR OFFICE OF
SURVEILLANCE AND EPIDEMIOLOGY OR OFFICE OF DRUG
SAFETY
Laboratory Information Bulletin (LIB) #4424
Deltex Pharmceuticals Recall Termination Letter -
RES 58065
K822068 APPROVAL LETTER
K770002
K051681
COMPLAINT RECS
2014-7023
C-PULSE HEART ASSIST DEVICE - CLINICAL TRIAL RECS
SHARP CORPORATION, CONSHONOCKEN, PA - EIR
05/01/2012 - 08/31/2012
A list of all FOIA requests closed 3/1-31/2015
DRUG MASTER FILE 14760

SPARHAWK LABORATORIES, CHEMDEX - EIR 02/02/2015 -
02/12/2015
MIRACLE MINERAL SUPPLEMENT, MASTER MINERAL
SUPPLEMENT, MMS ETC - CONSUMER COMPLAINTS, MEDWATCH
ETC 01/01/2005 - 04/02/2015
GMP ADVISORY COMMITTEE - TRANSCRIPT, AGENDA, DATA
ETC 08/22/1995 - 09/15/1995
INDIGO CARMINE - AERS
WIL RESEARCH COMPANY, ASHLAND, OH - EIR, 483, 482
03/27/2011 - 03/31/2015
UNIQUE BIOTECH LTD - BACILLUS COAGULANS UNIQUE 1S2
GRN 526 COMMENTS
OMEGA TECH LABS, LLC, GDMI, INC - WARNING LETTER
RESPONSES, CORR, ETC
KETAMINE - APPROVED DOSING
PACIRA PHARMACEUTICALS, SAN DIEGO, CA - EIR
02/03/2014 - 02/10/2014
KURT LESH - EIR 06/01/2009 - 06/30/2009
K132182
HETERO LABS, INDIA - EIR 09/01/2014 - 10/01/2014
FCN 1434
HERERO LABS, INDIA - 483, EIR SUMMARIES 09/01/2014
- 10/01/2014
INTERFASHION COSMETICS, TETERBORO, NJ - EIR
02/05/2009 - 02/25/2009
SIMPLY THICK, SIMPLY THICK LLC - FOIA REQUESTS
10/30/14 TO PRESENT
NDA 017643, NDA 020248 - SBA
RIVASTIGMINE - DRAFT GUIDANCE 02/05/2010 -
11/29/2010
PURINA BENEFUL DOG FOOD COMPLAINTS 01/01/2011 -
04/02/2015
CYTOMEL NDA 010379 APPROVAL RECS

HUMAN CELL AND TISSUE ESTABLISHMENT REGISTRATIONS
ACCELLERATED BIOLOGICS, CR BARD, BIOMET ETC
BOTOX - APPROVAL RECS RE HYPERHIDROSIS
DOG FOOD COMPLAINTS 01/01/2011 - 04/02/2015
SOLGAR INC ABC DOPHILUS MOLK OUTBREAK - CFSAN CORE
INVESTIGATIONS RECS 07/03/2014 - 04/03/2015
CASE REPORT 10800144
ODYSSA PHARMA, BELGIUM - EIR 09/01/2014 -
09/30/2014
K140439
MIRENA - DETAILED ADVERSE EVENT REPORT 01/03/2001 -
04/03/2015
ZOLOFT 7299275, 7415583, 7419942, ETC
K000580
INDIVIDUAL RECS
NUEDEXTA - AERS
K131287
COPAXONE - AERS
K093937, K112704, K133127 ETC
CUSTOM ULTRASONICS - INSPECTIONS, RESPONSES
01/01/2007 - 01/01/2015
K132167
ASHCRAFT & GEREL - FOIA REQUESTS 2007-2014
POHOXILLUM RENAL REPLACEMENT SOL NDA 207-026 - SBA

6.5X45 POLYAXIAL SCREW - LOT #501259 7.2X40
POLYADXIAL SCREW - L9OT #101 266 65MM SPONAL ROD,
ETC - LOT 500972, 103126 RECS
LUITPOLD PHARMACEUTICALS INC - INJECTAFER FERRIC
CARBOXYLMALTOSE INJ NDA 203-565 VAERS 7/25/13
AMAG PHARMACEUTICALS INC - FERAHEME FERUMOXYTOL INJ
NDA 22-180 VAERS 4/1/14
INDIVIDUAL RECS
MERCK - SHINGLES VACCINE VAER, MEMO, CONGRESSIONAL
TESTIMONIES, ETC
DKT 2011P-0671
DANISCO A/S -FCN #750, 812, 1126
AN ASSESSMENT OF RISK ASOCIATED WITH THE HUMAN
CONSUMPTION OF SOME SPECIES OF FISH CONTAMINATED
WITH POLYCHLORINATED BIPHENEYLS (PCB'S) 1979
K113202, K062525, K032347 ETC
MALLINCKRODT - GABLOFEN (BACLOFEN) INJ NDA 22-462
APRRVL PKG UNREDACTED
DKT 2011N-0921
ARSENIC IN RICE - ANALYSES, RISK ASSESSMENTS 9/13
SHIPMENTS REGUALTED BY THE FDA 2/16-28/15
SHIPMENTS REGULATED BY THE FDA 3/16-31/15
CATTLEMEN'S BEEF BOARD, NATIONAL PORK BOARD, DAIRY

MANAGEMENT INC, ETC - RPTS, MEMOS, OBJECTIVES, ETC
ACTAVIS - FENTANYL AERS
LIST OF INDIVIDUALS ASSOCIATED WITH RESEARCH
INSTITUTIONS, PHARMACEUTICAL, BIOTECHNOLOGY AND DVC
COMPANIES, ETC
DRUGS - AERS
LUCENTIS (RANIBIZUMAB INJ) - SBA
K133951, K140638, K121609, ETC
ACELRX PHARMACEUTICAL INC - EIR, 483 6/14
US FLUE CURED TOBACCO GROWERS, TIMBERLAKE, NC
LORILLARD TOBACCO, GREENSBORO, NC SANTA FE NATURAL
TOBACCO, OXFORD, NC - INVESTIGATOR DIARIES
KENTUCKY CUT RAG, LEXINGTON, KY TANTUS TOBACCO,
RUSSELL SPRINGS, KY GF VAUGHAN TOBACCO, LEXINGTON,
KY - 483, WARNING LETTERS, ASSIGNMENTS ETC
DOMESTIC TOBACCO, LANCASTER, PA, ROCKTENN,
CONVERTING COMPANY, MARLTON, NJ SOUTHERN CROSS
TOBACCO, MOUNTAIN TOP, PA - INVESTIGATOR DIARIES
2014-3357
2014-3358
2014-3353
2014-3362
2014-3375
2014-3351
ABIOMED IMPELLA - 510K, PMA, DATA ETC 01/01/2008 -
12/31/2014
2014-3345
2014-3364
2014-3321
2014-3366
2014-2213
2014-3367
2014-2211
2014-3374
2014-3368
2014-3373
ESSENTIAL PHARMACY COMPOUNDING - CLOSEOUT LETTER
01/01/2005 - 01/01/2015
ROCKTENN, DES MOINES, IA SWISHER INTERNATIONAL
WHEELING, WV STARION, CHASE CITY, VA - EIR, 483,
WARNING LETTER ETC
CONCEPTS/PREMIERE PACKAGING, MEMPHIS, TN DOSAL
TOBACCO, OPA LOCKA, FL VIRGINIA CAROLINA COMPANY
ETC - INVESTIGATOR DIARIES
NADA 139075
NORTH CAROLINA FILTER, WILSON, NC ALLIANCE ONCE
SPECIALTY PRODUCTS, WILSON, NC TOBACCO RAG,
PROCESSORS, WILSON, NC - INVESTIGATOR DIARIES
NORTH CAROLINA FILTER, WILSON, NC ALLIANCE ONE

SPECIALTY PRODUCTS, WILSON, NC TOBACCO RAG
PROCESSORS, WILSON, NC - EIR, 483, WARNING LETTER
ETC
DOMESTIC TOBACCO, LANCASTER, PA ROCKTENN

CONVERTING COMPANY, MARLTON, NJ SOUTHERN CROSS
TOBACCO,MOUNTAIN TOP, PA ETC - EIR, 483, WARNING
LETTER, ETC
KENTUCKY CUT RAGE, LEXINGTON, KY TANTUS TOBACCO,
RUSSELL SPRINGS, KY GF VAUGHAN TOBACCO, LEXINGTON,
KY - EIR, 483, WARNING LETTER ETC
ROCKTENN, DES MOINES, IA SWISHER INTERNATIONAL,
WHEELING, WV STARION, CHASE CITY, VA ETC - EIR,
483, WARNING LETTER ETC
CHETOVIS, PSICOSTERONE, DIANDRONE - NDA,, AERS
CRESCENT CONCEPTS/PREMIERE PACKAGING, MEMPHIS, TN
DOSAL TOBACCO, OPA LOCKA, FL VIRGINIA CAROLINA
COMPANY - EIR, 483, WARNING LETTERS ETC
FDA FOOD CODE MANUAL 2014
FANTIS FOODS INC - INSPECTIONS, VIOLATIONS, FINES
01/01/2009 - 01/13/2015
US FLUE CURED TOBACCO GROWERS, TIMBERLAKE, NC

LORILLARD TOBACCO, GREENSBORO, NC SANTA FE NATURAL
TOBACCO, OXFORD, NC - EIR, 483, WARNING LETTER ETC
ODYSSEA PHARMA - EIR AUGUST 22, 2014
HOSPIRA, LAKE FOREST, IL - EIR 01/01/2014 -
04/06/2015
K880683
NDA 206229 SBA
NADA 096298
2014-5592
SIMILAC - SUPPLEMENTATION EARLY SHIELD FORMULATION,

MFG PROCESS & QUALITY FACTORS OF NORMAL PHYSICAL
GROWTH & SUFFICIENT BIOLOGICAL QUALITY O\F PROTEIN
COMPONENT 10/1/12 TO 10/1/13
SIMILAC EARLY SHIELD - FORMULATION, MFG PROCESSES &

QUALITY FACTORS OF NORMAL PHYSICAL GROWTH &
SUFFICIENT BIOLOGICAL QUALITY OF PROTEIN COMPONENTS
12/1/07 TO 7/1/08
SIMILAC ADVANCE OPTIGRO STAGE 1 - FORMULATION, MFG

PROCESSES & QUALITY FACTORS OF NORMAL PHYSICAL
GROWTH & SUFFICENT BIOLOGICAL QUALITY OF PROTEIN
6/1/13 TO 1/1/14
PHARMACEUTICALS INNOVATIONS, INC - 483, AMENDMENTS,

HRA ETC (CERTIFIED) 04/01/2011 - 05/01/2013
CASES WITH PROGRESSIVE MULTIFOCAL
LEUKOENCEPHALOPATHY
AGENCY RECORDS THAT LIST ANY AND ALL CHEMICALS
ADDED TO TOBACCO PRODUCTS THAT ARE CURRENTLY IN USE
BY ANY AND ALL TOBACCO COMPANIES
AGRO HIDRO E.I.R.L., PERU SU ZHOU HOUSSY DRINKS
CO, LTD, CHINA SHAKTI APIFOODS PVT LTD, INDIA ETC
- 483
SPREADSHEET OF FIRMS THAT ISSUED A RECALL, MARKET
WITHDRAWAL OR SAFETY ALERT 10/01/2011 - 03/31/2015
CVM RECS THAT SUPPORT THE 2014 OFFICIAL PUBLICATION
DEFINITION OF REED-SAGE PEAT AS ANIMAL FEED
INGEDIENT
PL DEVELOPMENTS, WESTBURY, NY - 483, EIR 01/01/2011
- 01/01/2015
FORM 2481 MOST RECENT VERSION
10083238 10213779 10227236 ETC
10052145 10057916 10058020 ETC
10065250 10067727 10102273
BIRTH CONTROL DRUGS - ADVERSE EVENTS
DARK CHOCOLATE TEST DATA
VACCINES GIVEN TO CHILDREN - INGREDIENTS 09/01/1994
- 09/01/2005
IRBUTINIB - AERS
WALLCUR, LLC - LAB RESULTS 12/01/2014 - 04/01/2015
K920025
ESSENTRA POROUS TECHNOLOGIES, COLONIAL HEIGHTS, VA
- 483, EIR, RECALLS 03/01/2013 - 04/06/2015
WARNING LETTER SPREADSHEET
NADA: 140-915 LABELING
FCN 24
ENTRY AV3-0041771-2
K132167
ENTRY AV0040929-7
RYANODEX - ORPHAN DESIGNATION RECS
ENTRY FY6-2008519-8
ENTRY AV3-0040984-2
IZBA - SBA
K082981
INDIVIDUAL RECS
UNO FOODS INC, BROCKTON, MA - RPTS, NOTES, MEMOS,
INSPS, ETC
PHARMAVITE LLC, NATURE MADE - HERBAL SUPPLEMENTS
TRANS, NOTES, INVESTIGATIONS, ETC
GANITUMAB IND 120449
FDARFP1130645 - WINNING PROPOSALS
PERCHLORATE - WHITE PAPERS, FACT SHEETS, RPTS, ETC

2014-6191 - ITEM #8 RECS
KV PHARMACEUTICAL CO - PREVENTION OF PRETERM BIRTH
IN SINGLETON PREGNANCIES ORPHAN DRUG DESIGNATION
1/25/07
EDOXABAN NDA 206-316 - MOR
ENBREL - AERS
TEVA PHARMACEUTICALS USA - COPAXONE NDA 02-
0622/S088,S089,S090 APRVL RECS
SPECTRA MEDICAL DEVICES, WILMINGTON, MA - EIR, 483
MOST RECENT
SUN PHARMA GLOBAL - LIPODOX ANDA 203-263 RVWS,
ANALYSIS, MEMOS, ETC
SUN PHARMA - LIPOSOMAL DOXORUBICIN ANDA 203-263 SBA

SUN PHARMA GLOBAL - LIPODOX IMPORTATION RVWS,
MEMOS, ANALYSIS, ETC
DELPHARM LILLE SAS, FRANCE PIRAMAL HEALTHCARE -
PHARMA SOLUTIONS, ENGLAND - 483
HARVONI - AERS
BABY ASPIRIN - AERS
JAMIESON - FORM FDA 3500, 3500A, 3500B
DOTERRA - FORMA FDA 463A (ATTACHMENT 6 TO EIR)
IDEAL IMPLANT INC, DALLAS, TX - EIRS, 483S 2/25/13-
3/1/13
VYVANSE NDA 21-977/S036.S037 - AERS
CYMBALTA - AERS
FORA CARE - K110044 OMRON - K042506 A&D
ENGINEERING INC - K012472
PHARMACEUTICAL, BIOLOGICS, MEDICAL DVC MFG AND
CLNCL TRIAL FACILITIES IN AND OUTSIDE THE US - 483S
3/1-31/15
2015-2528, 2015-2463, 2015-2261, ETC
VARIZIG - ISRS 10458399, 10446763
2015-1068
2015-886
ANDA 91-422 - ROUTING SHEETS, APRVL LTRS
ICLUSIG - AERS
INDOMETHACIN RECS
INDOMETHACIN - APPROVAL RECS
ALPRAZOLAM APPROVAL RECS
SHIPMENTS REGULATED BY THE FDA 1/1-15/15
MICROSORT - CLASSIFICATION RECS
INDIVIDUAL RECS
OREXIGEN - COMM, AGREEMENTS WITH FDA RE CONTRAVENE
06/01/2014 - 04/06/2015
HYDROXYCUT SX-7 - REPORTS, MEMOS, CORR ETC
01/01/2011 - 04/07/2015
RO4917523 STUDY RECS
K130802
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
ADENOSCAN AERS
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
TEXAS APPLIED BIOMEDICAL SERVICES, HOUSTON, TX -
EIR, 483, CO RESP 4/16-25/12
APPLIED LABORATORIES INC, CLOUMBUS, IN - EIR, 483,
CO RESP 2/11-18/14
CENTURY PHARMACEUTICALS INC, INDIANAPOLIS, IN -
EIR, 483, CO RESP 1/13-14/14
DIETARY SUPPLEMENT FIRMS - CGMP INSP RPTS 1/10 TO

3/15 JINHER INC, CHINO, CA 3/26/14, KABCO
PHARMACEUTICALS INC, AMITYVILLE, NY 11/26/13,
ROBINSON PHARMA INC, SANTA ANA, CA 11/1813, ETC -
483S
CMPLNT 139589
ZOOM 100DC K082886 NEUROFAST MONITORING SYS MODEL
NS 201 K092477 SWAY BALANCE K121590, ETC
LABORATORY SERCICE, CARTERET, NJ - EIR, 483, CO
RESP 2/27/14-3/5/14
ANDA 203-136, ANDA 091-422 APRVL
DURAMORPH (MORPHINE SULFATE) NDA 18-565
DURAMORPH (MORPHINE SULFATE) NDA 18-565
MAUDE CMPLNT MW5017940

PROLIA - AER
MEDWATCH MEDICATION ERRORS 3/2015
SAFEHEART - LBLG
MAXWELL ENERGY PRODUCTS DVISION (SIERRA) -

BROADBAND EMI FILTER DESIGNS FOR HUMAN IMPLANTABLE
PACEMAKERS & DEFIBRILLATORS THAT PROVIDE IMMUNITY
TO CELLULAR PHONES & OTHER EMITTERS PRESENTATION
RECS 9/10/96
PROVIDER PLUS INC, MI OR KS - 483, EIR, WARNING
LTRS 1/98 TO PRESENT
QMES, LLC, CT, MA, NH, NY, RI - 483, EIR, WARNING
LABORATORY SERCICE, CARTERET, NJ - EIR, 483, CO
RESP 2/27/14-3/5/14
NATURE'S WAY - INSPECTION REPORTS, WARNING LETTERS
HANGZOU MINSHENG PHARMACEUTICAL GROUP, CHINA
HANGZOU MINSHENG PHARMACEUTICAL CO LT, CHINA - EIR
06/01/2002 - 12/31/2004
NAZ, AFTAB, MADERA, CA - EIR, 483, RESPONSE
10/01/2014 - 10/30/2014
INTERNATIONAL DIVERSIFIED PRODUCTS, INC, LAWRENCE
R. KOH, INMOTIONSPINEBOARD - 510K, REGISTRATION
RECS, APPROVAL DATE ETC
DOMPERIDONE IND
MEDIMMUNE VACCINES, INC, SANTA CLARA, CA - EIR,
483, RESPONSE 01/01/2014 - 01/31/2014
SUNOVION PHARMACEUTICALS, MARLBOROUGH, MA - EIR,
483, RESPONSE 05/01/2013 - 05/30/2013
EXXON MOBIL CHEMICAL COMPANY, BATON ROUGE, LA -
EIR, 483, RESPONSE 04/01/2013 - 04/30/2013
ABBVIE, LTD, BARCELONETA, PR - EIR, 483, RESPONSE
05/01/2014 - 05/30/2014
GENERITECH CORPORATION, FRESNO, CA - EIR, 483,
RESPONSE 04/01/2013 - 04/30/2013
ISAAC TAWII MD, ALBUQUERQUE, NM - EIR, 483, CO RESP
11/19/13-12/5/13
HISAMITSU PHARMACEUTICAL, TOSU, JAPAN - EIR, 483,
RESPONSE 04/01/2014 - 04/30/2014
WUXI APPTEC INC, PHILADELPHIA, PA - EIR, 483,
RESPONSE 12/17/2002 - 04/10/2015
ARROW GENERICS LTD, STEVENAGE, UK ARROW PHARMA
LTD, MALTA COBALT PHARMACEUTICALS, CANADA ETC -
483
HI-TECH PHARMACEUTICAL, JARED WHEAT - CORR WITH FDA
01/01/2000 - 04/10/2015
TOLMAR, INC, FORT COLLINS, CO - EIR, 483, RESPONSE
01/01/2014 - 01/31/2014
THERMO-RX ETC - AERS 01/01/2010 - 04/10/2015
ATTENTION LINK, BETA-STIM, GREEN COFFEE BEAN
EXTRACT ETC - AERS
PHARMACEUTICS INTERNATIONAL, INC BUPRENORPHINE
HYDROCHLORIDE - NDA 018401 TERMINALLY STERILIZED
PRODUCT
ETHICON ENDO-SURGERY, ETHICON SURGICAL STAPLERS,
RELOADS - COMPLAINTS 01/01/2008 - 12/31/2014
DV1-0155421-5 - SEIZURE RECS, CORR, ETC
ANDA 203286 COMPLETE RESPONSE

DOXYLAMINE-PYRODOXINE, BENDECTIN - PEER REVIEW
GROUP RECS 01/12/1956 - 04/12/2015
BEBIDA BEVERAGE COMPANY - WARNING LETTER RESPONSE,
CORR 01/01/2015 - 04/10/2015
K102776
XARELTO, PRADAXA, HARVONI ETC - AERS
LAMPRENE - APPROVAL RECS 01/01/1985 - 04/13/2015
K132520, K053625, K120894
APIXABAN - AERS
E COLI OUTBREAK, MA - INVESTIGATION RECS 5/13 TO
6/13
ESTAR TECHNOLOGIES LTD -TROPOCELLS AUTOLOGOUS
PLATELET PREPARATION KIT BK110035
SOMEDIC SALES AB (SOMEDIC AB) - FDA ESTABLISHMENT
REGISTRATION NUMBER 8030907
FRESENIUS KABI USA LLC, MELROSE PARK, IL - EIR,
483, CO RESP 9/25/13-12/11/13
L HIP TOTAL ARTHROPLASTY - CMPLNTS, RECALLS
THIOLA (TIOPRONIN) - ORPHAN DRUG APRVL
VACANCY ANOUNCEMENT - INTERDISCIPLINARY SCIENTIST
FDA-ORA-14-MP-1120616-DY APPLICATION PACKAGE
ZOLOFT, PROZAC, PAXIL - CERTIFIED RECS
BOROSILICATE GLASS VIALS - DATA, REPORT RE RECALLS
BOROSILICATE GLASS - MEMOS, MEETING MINUTES,
REPORTS ETC 01/01/2008 TO PRESENT RE RISKS
BOROSILICATE GLASS - AERS
TRADER JOE'S - RAW WALNUT RECALL LAB RESULTS
03/01/2015 - 03/31/2015
NAPOLI LLC - INSPECTION REPORT, EXHIBIT, WARNING
LETTER ETC 01/21/2011 - 04/13/2015
NVE PHARMACEUTICALS, INC, ANDOVER, NJ - 483,
WARNING LETTER 01/01/2011 - 12/31/2014
DELIZ PHARMACEUTICAL CORP, CAROLINA, PR - EIR, 483,
CO RESP 3/3-6/14
THOMAS O BARR, MD, MARIETTA, GA - INSPECTION
REPORT, LETTER, EXHIBITS RE WARNING LETTER
01/01/2010 - 04/13/2015
K920873, K935403
K133164
ORENITRAM - AERS
List of FOIA Requests made by Baum Hedlund
NUSCIENCE CORPORATION, LANCASTER, CA - RECS SINCE
OCT 2013 12/01/2014 - 04/13/2015
LAMOTRIGINE - AERS
POST FOODS - EIR, 483, RESPONSES 2014
INDEPENDENT REVIEW CONSULTING - INSPECTION REPORTS,

EXHIBITS, RESPONSE ETC 04/01/2010 - 04/13/2015
GP PHARM PLANT - 483 01/01/2015 - 04/30/2015
GARDASIL 9 - STATISTICAL RVW AND EVALUATION, CLNCL
RVW
SHELLY D SENDERS MD, SOUTH EUCLID, OH - EIR, 483,
CO RESP 1/16-23/14
RECS RE FDA ADVISORY RE FORMATION OF GLASS LAMELLAE
IN CERTAIN INJECTABLE DRUGS
TENEO IRB, TULSA, OK - INSPECTION REPORT, WARNING
LETTER, RESPONSE ETC 11/01/2009 - 04/13/2015
CANDESARTAN CILEXTIL ANDA 078702

DEXCOM SUBMISSION DOCUMENT FOR DEXCOM SHARE DIRECT
SECONDARY DISPLAYS 12/01/2014 - 02/01/2015
CORPAK MEDSYSTEMS - EIR 2014
K112774
LIST OF INSPECTIONS FOR FOOD, DRUG COMPANIES IN
COSTA RICA, DOMINIC REPUBLIC, CHILE, ARGENTINA, AND
BRAZIL
HUNTER HOLMES MCGUIRE VETERANS AFFAIRS MEDICAL
CENTER, NORTH CHESTERFIELD, VA - INSPECTION RECS
02/03/2015 - 04/14/2015
SUN PHARMACEUTICALS INDUSTRIES LIMITED - 483
12/31/2012 - 04/15/2015
K141399
NOSTRUM LABORATORIES INC, KANSAS CITY, MO - EIR,
483, CO RESP 2/10-19/14
HEALTH MANAGEMENT ASSOCIATES - REPORT INTO TAINTED
BLOOD 01/01/1983 - 01/01/1986
PFIZER, PHARMACIA AND UPJOHN - COMM WITH FDA RE
ADDING THE RISK OF BLOOD CLOTS TO LABEL FOR DEPO-
TESTOSTERONE 01/01/2014 - 02/01/2016
YOUNG LIVING, LEHI, UT DOTERRA INTERNATIONAL,
PLEASANT GROVE, UT - WARNING LETTER RECS
09/01/2014 - 04/14/2015
ACTIENT PHARMACEUTICALS, AUXILIUM PHARMACEUTICALS,

ENDO PHARMACEUTICALS - CORR WITH FDA RE RISK OF
BLOOD CLOTS TO LABEL FOR TESTOPEL 01/01/2014 -
02/01/2016
KAN HERBS, SANTA CRUZ, CA - EIR 01/01/2011 -
12/31/2014
BLA 125319/62
ELI LILLY - CORR WITH FDA RE ADDING RISK OF BLOOD
CLOTS IN THE VEINS TO LABELING FOR AXIRON
PROPECTIN, VITAPRO - COMPLAINTS 03/11/2011 -
04/14/2015
ENDOPHARMACEUTICALS - CORR WITH FDA RE ADDING RISK
OF BLOOD CLOTS IN THE VEINS TO LABELING FOR
FORTESTA
ACTAVIS - CORR WITH FDA RE ADDING RISK OF BLOOD
CLOTS IN THE VEINS TO LABELING FOR ANDRODERM
IVF PHOENIX, SCOTTSDALE, AZ - EIR, 483, CO RESP
2/1-5/10
K130978
ENDO PHARMACEUTICALS - CORR WITH FDA RE ADDING RISK
OF BLOOD CLOTS IN THE VEINS TO LABELING FOR
DELATESTRYL
AUXILLIUM, ENDO PHARMACEUTICALS - CORR RE LABELING
CHANGES FOR TESTIM
ABBOTT, ABBVIE - CORR WITH FDA RE ADDING RISK OF
BLOOD CLOTS IN THE VEINS TO LABELING FOR ANDROGEL
ETC
AUXILIUM PHARMACEUTICALS,. ENDO PHARMACEUTICALS -
CORR WITH FDA RE ADDING RISK OF BLOOD CLOTS IN THE
VEINS TO LABELING FOR STRIANT ETC
2015-2128
GRN 526
NDA 018677 SBA
PROPECIA - AERS
ANDA 079135 BIOPHARMACEUTICAL REVIEW
EMANUEL CALENOFF MD, DALLAS, TX - EIR, 483, CO RESP
5/19-22/14
2014-6187
NADA 055-099 - CLINICAL DATA, SUMMARY,
COMMUNICATIONS, NAME CHANGE RECS
K112458
2015-1946
2015-1867
2015-1742
2015-1654
SCANTIBODIES LABORATORIES INC - 483 05/24/2013 -
05/24/2013
NUTRIFORCE NUTRITION, MIAMI, FL - EIR 01/01/2015 -
04/15/2015
PHILIP MORRIS USA INC, RJ REYNOLDS TOBACCO CO,
LORILLARD TOBACCO CO, AND/OR LIGGETT GROUP LLC -
TOBACCO CONTROL ACT VIOLATION RECS
KEITH AQUA, BOYNTON BEACH, FL - EIR, 483, CO RESP
2/3/14-3/17/14
EUGENE LU MD, LITTLE ROCK, AR 5/12-21/09 MATTHEW J

GUY MD, ROCKAWAY PARK, NY 8/2/04-12/8/04 PATRICK J
DALEY, TULSA, OK 7/19/02-9/6/02, ETC - INPS
TEVA PHARMACEUTICALS USA - COPAXONE NDA 02-
0622/S089,S090 APRVL RECS
CLINTON RIVER MEDICAL PRODUCTS LLC - TAILWIND
WHEELCHAIR RPTS
K984413
OCULINUM - APPLICATIONS 01/01/1977 - 12/31/1989
NDA103234 RAW DATA, DATA DICTIONARY
DR HO - COMPLIANCE FOLLOW UP RECS 03/05/2015 -
04/14/2015
DEFERASIROX - CLINICAL, PRECLINICAL DEVELOPMENT
DOMPERIDONE - NUMBER OF EXPANDED ACCESS IND
APPLICATIONS 01/01/2005 - 12/31/2014
CHAGA MUSHROOM - NDA, GRAS 04/01/1990 - 04/15/2015

BAXTER HEALTHCARE CORP, MARION, NC - EIR, 483, CO
RESP 1/15-24/14
GENITRIX - PRE-IND RECS 04/01/2004 - 04/15/2015
LEGACY AERS DATA 01/01/1990 - 12/31/2003
FIRST PRIORITY, ELGIN, IL - EIR, 483 01/01/2009 -
04/15/2015
MTC, ONTARIO, CANADA - EIR, 483 01/01/2009 -
04/15/2015
2015-1947
2015-1926
2015-2040
INDOCO REMEDIES LTD, PARALGANGA, INDAI - 483
03/01/2015 - 04/15/2015
NDA 020629, NDA 021478
PATHEON, WHITBY, ONTARIO - 483, EIR 01/19/2009 -
04/15/2015
NORMAN KALMIN MD, SAN ANTONIO, TX - EIR, 483, CO
RESP 11/7-9/11
AJANTA PHARMA - EIR, 483 LAST FIVE YEARS
DOW PHARMACEUTICAL SCIENCES - JUBLIA
(EFINACONAZOLE) TOPICAL SOL NDA 203-567 MEDICAL,
CLNCL PHARMACOLOGY BIOPHARMACEUTICS RVWS
ELLIQUENCE LLC - GRASPING FORCEPS CMPLNTS, ACCIDENT
RPTS
RECALL F-1884-2013 - RECS
FDA ENTRY DOCUMENTATION REQUEST: ALL DOCUMENTATION
APR 01, 2015 - APR 15, 2015
MINUTES OF MEETINGS WITH FDA RE HP ACTHAR GEL
AMERICAN CLINICAL LABORATORY ASSOCIATION (ACLA),

QUEST DIAGNOSTICS, LABORATORY CORPORATION OF
AMERICA (LABCORP) - LABORATORY-DEVELOPED TESTS
CONGRESSIONAL CORR, EMAILS, CMPLNTS, ETC
K102478
AMERICAN LABORATORIES INC, OMAHA, NE - EIRS, 483S
3/29/10, 5/2/11, 11/19/12
FOREIGN AND DOMESTIC DRUG INSPS 10/14 TO 3/15
IMPAX LABORATORIES (TAIWAN) INC, JHUNAN, MIAO-LI
COUNTY, TAIWAN - 483 7/21-26/14
SDVALDI, RIBAVIRIN - AERS
2015-2341
WICHITA FUSION NAIL - AERS, INVESTIGATIONS
01/01/1990 - 04/15/2015
CASE 10330990
CALCIUM GLUCONATE IV - AERS
2015-1723
2015-1291
K092086
MERZ - REPORTS, SUMMARIES RE RECALL OF RADIESSE
01/01/2010 - 04/16/2015
IAMS DOG FOOD - SPECIE OF SALMONELLA AUGUST 2013
DKT 1994P-0036
899704, 899705 LAB RECS
VAERS RECS
EEO COMPLAINTS CDRH AND CDER OFFICE OF COMPLIANCE
04/16/2005 - 04/16/2015
TRADE COMPLAINT RESULTS 04/12/2013 - 04/16/2015
MORTARA INSTRUMENT, INC, MILWAUKEE, WI - EIR
08/01/2013 - 10/01/2013
ANDA 091149, ANDA 203136, ANDA 203326
TORRENT PHARMA INDRAD, INDIA - 483 03/01/2015 -
04/16/2015
PROPOSED REGULATION OF ELECTRONIC CIGARETTES
EMPLOYEES HIRED SINCE 01/01/10 FOR POSITIONS THAT

REQUIRE A LAW DEGREE AND WHOSE DUTIES INCLUDE
INVESTIGATING OR PROSECUTING AGENCY ENFORCEMENT
ACTIONS
2014-9888
INDIANA BOTANIC GARDENS, INC., HOBART, IN - EIR
08/01/2009 - 08/31/2009
NDA 018651 SBA
LEO PHARM A/S, MUSTAFA NEVZAT ILAC SANAYII AS,
NOBILUS ENT ETC - 483
BLUE BELL CREAMERIES, , TX, AR, OK - EIRS 1/113 TO
4/13/15
WAWONA PACKING CO - LISTERIA MONOCYTOGENES RECALL
IN PEACHES, NECTARINES, PLUMS, PLUOTS TEST RESULTS,
STUDIES, RPTS, ETC 7/19/14
TERAZOSIN - AERS
LABORATORI DERIVATI ORGANICI, MILANO, ITALY,

VERCELLI, ITALY - HEPARAN SULFATE DECISION TO
REFUSE ENTRIES BSS-0000370-9, BSS-0000369-1 & ADD
TO IMPORT ALERT 66-66 CORR UNREDACTED
IND 071384
AUROBINDO PHARMA CEFIXIME - SBA
FLUOROQUINOLONE ANTIBACTERIAL DRUGS - AERS
JOERNS HEALTHCARE - HOSPITAL ELECTRIC BED MDR
3041143
K091034
ALTRIA CLIENT SERVICES, PHILIP MORRIS USA INC, US

SMOKELESS TOBACCO BRANDS INC - FILINGS RE INTENT TO
ADVERTISE OR LABEL CIGARETTES OR SMOKELESS TOBACCO
INDA REWERITE - FEDERAL REGISTER ANNOUNCEMENT WITH
PREAMBLE 01/01/1985 - 12/31/1987
K014063
ROCA LABS, INC, ROCA LABS NUTRACUETICALS, ROCA LABS
USA - COMPLAINTS, APPLICATIONS, IMPORT REFUSALS ETC
01/01/2010 - 04/16/2015
K003015
THERAPEUTIC PROTEINS INTERNATIONAL, LLC - 483
12/01/2014 - 03/31/2015
K036726
DR STEPHEN OLSON - INSPECTION REPORT 10/01/2014 -
04/17/2015
WRITE UPS REFERENCED IN LETTER FROM FELICIA
BILLINGSLEA, CFSAN
COMMUNICATIONS BETWEEN CTP PRESS OFFICERS AND
SABRINA TAVERNISE, MATT RICHTEL, MICHAEL FELDERBAUM
04/01/2014 - 04/17/2015
K133443
IND ANNUAL REPORTS ON OCULINUM 01/01/1977 -
12/31/1989
DALIRESP - POST MARKET REPORT 01/01/2012 -
06/30/2014
2014-76
MONOSOL RX LLC, PORTAGE, IN - EIR 3/30 - 4/3/15
RIVAROXABAN (XARELTO) NDA, APRVL
HYDROXYCUT HARDCORE CAPSULES 160492 HYDROXYCUT
REGUALR RAPID RELEASE CAPLETS 160495 HYDROXYCUT
(EPHEDRA FREE) REGULAR RELEASE CAPLETS 160498
CMPLNT 209951007
CMPLNT CC139385
DCK FDA-2015-H-0950
MERCK & CO - ZOSTAVAX SBA, CLNCL RVW, STATISTICAL
RVW
2013-5283
INDIVIDUAL RECS
INDIVIDUAL RECS
ECLIPSE AESTHETICS LLC - ECLIPSE PRP REGISTRATION
3009032449
ASBESTOS IN TALC - RPTS
ORPHAN DESIGNATION TREATMENT OF PEDIATRIC CROHNS
DISEASE 10-19-2006
AMERICAN MEDICAL SYSTEMS (INNOVAQUATZ) - SUREFLEX
FIBER K994010
LIST OF FOOD MANUFACTURING COMPANIES, FOOD
PROCESSING COMPANIES, FOOD DISTRIBUTION COMPANIES
IN USA ETC 01/01/2014 - 04/17/2015
SILDENAFIL - AERS
AIRLINE SUPPORT, INC, LSG SKYCHEF, ANCHORAGE, AK -
483 01/01/2010 - 04/15/2015
ABBOTT PHARMACEUTICALS, ABBVIE, ACTAVIS ETC - JUNE

2014 LABELING CHANGE ADDING RISK OF BLOOD CLOTS IN
THE VEINS TO THE LABELING FOR ANDRODERM, ANDROGEL,
AXIRON ETC
2012-4524
K944656
METHADONE - AERS
CSL BEHRING, BRADLEY, IL - EIR 07/01/2014 -
04/20/2015
K983017
DMF 015490
NDA 21330 S013
8 ANDA APPROVAL LETTERS
ORIENT BIO INC, REPUBLIC OF KOREA - CYCLOSPORINE
FOR FORMS 1571, 1572 COVER SHEETS
WYETH - EFFEXOR ER, PSYCHOPAHRMACOLOGICAL DRUGS A/C
9/20/91 -WHY DISCONTINUATION OF THIS FORMULATION,
MINS
ENTRY NUMBER 413-9018678-6
THIOLA (TIOPRONIN) - ORPHAN DSRUGS APRVL LTR
LORAD M-IV MAMMOGRAPHY SYS CLASS 11 RECALL #Z-0148-
04, #Z0149-04 - MFG REQUIREMENTS
CODEINE - AERS
K031964
FAP 3B4373
K073630
PIRACETAM - IND, CLINICAL TRIAL DATA, ETC
ELITE MEDICAL SUPPLY, WEST SENECA, NEW YORK - 483
08/01/2014 - 08/31/2014
2015-1409
2015-2740
2014-1008
MEFLOQUINE (LARIAM) - SAFETY LABELING CHANGES, SBA,
ADVISORY COMMITTEE MEETING MINUTES ETC
FERUMOXITOL - AERS
APTUIT, UK APTUIT LTD, ITALY - EIR 01/22/2005 -
03/25/2015
PHARMACEUTICS INTERNATIONAL, INC, COCKEYSVILLE, MD
- EIR 08/27/2013 - 09/13/2013
K093438
BOTOX - AERS
PROLIA - AERS LINE LISTING
DR ASHOK KADAMBI, MD FORT WAYNE ENDOCRINOLOGY
BELLE SANTE MEDICAL SPA - CORR, COMPLAINTS,
INVESTIGATIONS ETC 04/01/2005 - 04/21/2015
REQUESTS FOR 483, EIR SINCE 7/1/2014
K070180
The initial ANDA submissions (letters) by Dr
Reddy's Laboratories between 01 Jan 2014 to 31 Dec
2014
2013-999, 2013-6827, 2013-6949, ETC
3M PHARMS - QVAR (BECLOMETHASONE DIPROPIONATE)
INHALATION AEROSOL NDA 20-911 MEDICAL RVWS
ACTAVIS - FENTANYL AERS
HAGOP KANTARJIAN, UNIV OF TEXAS MD ANDERSON CANCER
CTR, HOUSTON, TX - 483S 9/11 TO PRESENT
DMF 6371
PURDUE PHARMA, CANADA - 483, EIR, RESPONSE
09/01/2013 - 09/30/2013
TERUMO CORP, JAPAN - 483, EIR, RESPONSE 04/01/2014
- 04/30/2014
K102915, K111862
CMPLNT #140551
All product literature and product specifications
regarding the ConforMIS Total Knee Replacement
implant
FUNGI-NAIL BRAND, FUNGI-NAIL BRAND ANTI-FUNGAL
TREATMENT SYSTEM - WARNING LETTER RECS
ROBERT READ, MD, UK - EIR, 483, RESPONSE08/01/2014
- 08/31/2014
CAREFUSION 2200, INC, MANNFORD, OK - EIR, 483,
RESPONSE 06/01/2014 - 06/30/2014
TECFIDERA - AERS
K922789
BLUE BELL - INSPECTION REPORTS 01/01/2010 -
04/22/2015
MIRACLE MINERAL SUPPLMENT - AERS 04/01/2009 -
04/22/2015
IMAGING3, BURBANK, CA - 510K DENIAL RECS 10/20/2010
- 04/22/2015
BLUE BELL CREAMERIES, BRENHAM, TX, BROKEN ARROW, OK
ALABAMA - 483 01/01/2015 - 04/20/2015
LEXAPRO - UNREDACTED MEMO, REVIEW
The Manufacturing Site indicated by Dr Reddy's for
its DMF filing for ESOMEPRAZOLE MAGNESIUM
TRIHYDRATE. The DMF number is 25858.
BLUE BELL CREAMERIES, BROKEN ARROW, OK - INSPECTION
RECS 01/01/2009 - 01/01/2013
COMPLAINT 137032
K131973
K100066
K092910
K110212
P960009 Annual Report 002 Amendment 004
NDA 205060 - SBA
21 CFR PART 20 - CORR, CO RESP, 483, EIR 2010 TO
2015
LASALOCID CONTANIMATION - ANIMAL FEED RTP 8/2014
TO 9/2014
MAUDE REPORT
PACIRA PHARMACEUTICALS INC - WARNING LTR, CORR,
CRECS RELATED TO WARNING LTR, ETC
FILE 2010-AST-713-0290
MICRO SURGICAL INC - EG-383OUT W/HITACHI SCANNER

EUB-525 K031789 EG-383OUT W/HITACHI SCANNER EUB-
5500/8500 EG-387OUTK W/HITACHI SCANNER HV-900
K090197
2014-7819, 2014-8195, 2014-8723, 2015-1282
2002-4427, 2006-11050, 2007-4393
TRADER JOES SALMONELLA CONTAMINATION OF WALNUTS
LOT NO GU4345, GU4346, GU4349 ETC
INNOVATIVE PRODUCTS UNLIMITED INC - IPU SHOWER
TRANSPORT GURNEY MODEL TSG500 RECALL, MAUDE PRT
CERTIFIED
DELALUTIN (HYDROXYPROGESTERONE CAPROATE) APRVD LBLG

STUDY REGARDING TASTE PERCEPTIONS IN TOBACCO USE,
EFFECTS OF MENTHOL
PFGE PATTERN JF6X01.0045, JF6X01.0258, JF6X01.0326
ETC 1996 TO PRESENT
LIST OF FDA INVESTIGATORS WHO ARE NATIONAL EXPERTS
ROSSMAX INTERNATIONAL, TAIWAN, CHINA - EIR, 483
OBIM FRESH CUT FRUIT CO LLC, FORT WORTH, TX - DOCS
6/1/05 - 5/1/12 CERTIFIED COPIES
RESUMES OF PEOPLE WHO HAVE INVOLVEMENT IN
BIOCOMPATIBILITY TOXICOLOGY OR RISK ASSESSMENT
AEROBIKA OSCILLATING POSITIVE EXPIRATORY PRESSURE
DVC K123400
GENERVON BIOPHARMACEUTICALS LLC - DRUG TRIALS
GODS GARDEN PHARMACY - CLOSE OUT LTR
NDA 020430
FDA-CTP-15-RG-1367576JCH, FDA-CTP-14-RG-1139104KL,
FDA-CTP-15-DE-1318963JJ
K023579
K143182, K023254
LIST OF CFSAN FOIA REQUESTS 03/24/2015 - 04/23/2015

MEDTRONIC MINIMED PARADIGM INSULIN INFUSION SETS -
MAUDE RECS
YUNHSHIN PHARMACEUTICAL, TAIWANN - EIR, 483
GENERVON BIOPHARMACEUTICALS LLC - GM604 STATISTICAL
RPTS, RAW DATA, SUPPORTING RECS
BAYER HEALTH CARE - ESSURE CONTRACEPTIVE MDRS
SANOFI, TORONTO, CANADA - RESPONSE TO 2012 WARNING
LETTER
SSED CLINICAL TRIAL META FROM OFFICE OF COMPLIANCE
01/01/1980 - 04/22/2015
ANALYSES OF CANNABIDIOL AVAILABLE FOR PURCHASE
ONLINE 02/22/2015 - 04/22/2015
ELITE MESSAGERS - MDR RECS 12/31/2014 - 03/12/2015
5212969, 5216751, 5217088 ETC
NDA 008693
POLYSCIENCES, INC, WARRINGTON, PA - EIR 06/01/2010
- 06/30/2010
FOREIGN FOOD FACILITIES REGISTERED AS OF 1/12/15
ZHEJIANG HISUN PHARMACEUTICAL, CHINA - EIR, 483
01/01/2009 - 04/23/2015
K091168
MAPP 6020.7 OFFICE OF NEW DRUGS FOREIGN LANGUAGE
LABELING
GLATOPA ANDA 090218 BIOEQUIVALENCE REVIEW
5285150, 5285150, 5395627, ETC
GALENA BIOPHARMA, INC. DISCOVERY BAY, CA - EIR,
483, RESPONSE 11/01/2014 - 11/30/2014
7109375 7248251 7278230 ETC
22083 NDA SUPP 16
DMF 14760 AERS
VYVANSE, ADDERALL XR, CONCERTA ETC - AERS
NDA 203629 SBA
SEROQUEL - AERS
5741038, 5830129, 5903311 ETC
ISR - INTIAL AND FOLLOW-UP SERIOUS AERS
MW5017940
INDIVIDUAL RECS
SUPER TREN V, TREN V - CAERS

FLU SHOTS, TETANUS/WHOOPING COUGH VACCINE INJURY
TABLE
DELALUTIN (HYDROXYPROGESTERONE CAPROATE) DNA 10-
347, NDA 16-911 - LBLG IN EFFECT WHEN FDA WITHDREW
APRVL
FDA 79-2115 FDA CONSUMER MAGAZINE
OUTCOME SOLUTIONS LLC MOCKSVILLE, NC 7 OAKS

PHARMACEUTICAL CORP, EASLEY SC ATLANTA HEALTHCARE
SERVICES, ATLANTA, GA, ETC - 483S 3/1-31/15
PROLIA, FOXAMAX - AERS
HOME ACCESS HEALTH CORP (HAHC), HOFFMAN ESTATES, IL
ASTRON DENTAL CORP, LAKE ZURICH, IL - 483S 3/1-
31/15
DR PHARMACY INC, MIDLAND, TX THE APOTHECARY SHOPPE
LLC, TULSA, OK WEXLER SURGICAL INC, HOUSTON, TX -
483S 3/1-31/15
VENTLAB LLC, GRAND RAPIDS, MI INDUSTRIAL
WOODWORKING CORP, ZEELAND, MI COOK INC,
BLOOMINGTON, IN, ETC - 483S 3/1-31/15
GLOBAL SURGICAL, SAINT LOUIS, MO MERIDIAN MEDICAL

TECHNOLOGIES (PIFZER CO), BRENTWOOD, MO CARE-TECH
LABORATORIES INC, SAINT LOUIS, MO, ETC - 483S 3/1-
31/15
WARNER CHILCOTT COMPANY LLC, FAJARDO, PR FENWAL
INTERNATIONAL INC, MARICAO, PR - 483S 3/1-31/15
THE SEABERG COMPANY INC (SAM MEDICAL PRODS),

WILSONVILLE, OR OCULAR INSTRUMENTS INC, BELLLEVUE,
WA GENZYME (SANOFI CO), LYNNWOOD, WA, ETC - 483S
3/1-31/15
OCTAPHAMA PHARMAZEUTIKI PRODUKTIONS GMBH, VIENNA,
AUSTRIA - 483S 3/1-31/15
AUROBINDO PHARMA LTD - UNIT 9, HATINOORA, MEDAK,

HYDERABAD, INDIA DR REDDY'S LABORATORIES LTD,
VISAKHAPATNAM, INDIA DANIPHARM A/S, NIBE, DENMAR -
483S 3/1-31/15
LGO MEDICAL LLC, FRANKLIN, WI CPR RSQ ASIST INC,
FRANKLIN, WI - 483S 3/1-31/15
KEYSTONE LABORATORIES INC, MEMPHIS, TN DEROYAL
INDUSTRIES INC, POWELL, TN - 483S 3/1-31/15
MEDIMERGENT LLC - RESEARCH COLLABORATION AGREEMENT
(RCA) RECS
STRYKER HOWMEDICA OSTEONICS CORP, MAHWAH, NJ KOBO
PRODUCTS INC, S PLAINFIELD, NJ BURPEE MATERIALS
TECHNOLOGY LLC, EATONTOWN, NJ - 483S 3/1-31/15
B BRAUN MEDICAL, IRVINE, CA AFFINITY MEDICAL
TECHNOLOGIES LLC, COSTA MESA, CA IONIA PHARMACY,
TUSTIN, CA, ETC - 483S 3/1-31/15
BURKLOW PHARMACY, MILTON, FL BAUSCH & LOMB INC,
TAMPA, FL POWERS MEDICAL DEVICES LLC, DELRAY
BEACH, FL, ETC - 483S 3/1-31/15
SOPHONO INC, BOULDER, CO MESA LABORATORIES, INC,
LAKEWOOD, CO INTERNATIONAL MEDICAL DEVELOPMENT
CORP, HUNTSVILLE, UT, ETC - 483S 3/1-31/15
RADIOMETER AMERICA INC, WESTLAKE, OH SMITHS

MEDICAL ASD INC, DUBLIN, OH QUALITY
ELECTRODYNAMICS LLC, MAYFIELD VILLAGE, OH, ETC -
483S 3/1-31/15
HUNTER HOLMES MCGUIRE VETERNAS ADMIN MEDICAL

CENTER, RICHMOND, VA C B FLEET CO INC, LYNCHBURG,
VA THE WELLNESS PHARMACY LLC, WINCHESTER, VA, ETC
- 483S 3/1-31/15
CORIN LTD, CIRENCESTER, UK BREAS MEDICAL AB,
MOLNLYCKE, SWEDEN CONTEC MEDICAL SYSTEMS CO LTD,
QINHUAGDAO, CHINA, ETC - 483S 3/1-31/15
OCULAR THERAPEUTICX INC, BEDFORD, MA THERAPUTIX

MEVION MEDICAL SYSTEMS INC, LITTLETON, MA FAIRA
LTD (SHEFFIELD PHARMS), NEW LONDON, CT, ETC - 483S
3/1-31/15
FRESENIUS KABI USA LLC, GRAND ISLAND, NY FALLON
WELLNESS PHARMACY LLC, LATHAM, NY NORTECH LABS,
FARMINGDALE, NY, ETC - 483 3/1-31/15
AESCULAP IMPLANT SYSTEMS LLC, BREINGSVILLE, PA
BIOSPECTRA INC, ROSETO, PA ZOLL MANUFACTURING
CORP, PITTSBURGH, PA, ETC -483S 3/1-31/15
GETINGE 633HC STREAM STERILIZER AIR GLIDE SYS -
K120532
RAPID DIAGNOSTICS (MP BIOMEDICALS LLC),

BURLINGAME,CA BECKMAN COULTER INC, WEST
SACRAMENTO, CA DREAM SYSTEMS LLC, ROSEVILLE, CA,
ETC - 483S 3/1-31/15
MASIMO SET RAD-5 PULSE OXIMETER - K033296 NBM
200MP PULSE OXDIMETRY DVC - K091564
DIPEXIUM PHARMACEUTICALS INC - EIRS, 483S, WARNING
LTRS, ETC
AGENUS INC - EIRS, 483S, WARNING LTRS, ETC
DIETARY SUPPLEMENTS - CARES, EIRS 4/1/10 TO 4/1
FOUGERA - BESTAMETHASONE DIPROPIONATE OINTMENT NDA
19-141 SBA
ACETAMINOPHEN - ISR 4208507, 657U1460, 7U507205,
ETC
NYMOX PHARMACEUTICAL CORP - NX02-0017, NX02-0018
DELAY IN RESULTS, CERTIFICATIONS
EMORY UNIV, GILEAD SCIENCES INC - EMTRIVA
(EMTRICITABINE) CLNCL TRIALS, EXPERIMENTAL STUDIES,
APRVL, ETC
HISUN PHARMACEUTICALS, PRC - 483 03/01/2015 -
03/30/2015
WESTINGHOUSE ELECTRIC CORP - FAP 5M1592
K102961 TESTING DATA
TOBACCO INSPECTIONS JAN TO MAR 2015 - EIR
ZIMMER - CORR WITH FDA RE Z-1266-2015
K071063
K133033
MASIMO CORP - RECS PREVIOUSLY RELEASED UNDER FOIA,
REQUEST LETTERS
DEPOCYT - APPROVAL RECS
K101979
OPANA ER - AERS, EMAILS
SANDOZ INC METHOTREXATE PRODUCTS - QUALITY DEFECT
REPORTS
DENVER PLEURAL - PERITONEAL SHUNT K842139
SIMENENS HEALTHCARE, NORWOOD, MA - INSPECTION RECS
SIEMENS ADIOLOGISCHE TECHNIK, GERMANY - INSPECTION
RECS
LIST OF ALL DRUG-DEVICE AND BIOLOGIC-DEVICE
COMBINATION PRODUCTS APPROVED 01/01/2003 -
04/24/2015
5285150, 5395627, 5429211, ETC
IBRUTINIB - AERS
CELECOXIB - AERS
HHSF 22320110350M PAYMENT RECS
K101314
K101786
K133534
OLYMPUS CORP OF THE AMERICAS, OLYMPUS MEDICAL
SYSTEMS CORP - NARROW BAND IMAGING 510K
DEMECLOCYCLINE HYDROCHLORIDE ANDA 065425 SBA
AMITRIPTYLINE HYDROCHLORIDE FDA ANDA 085966 SBA
NDA 006035 SBA
SOFOSBUVIR, SPIRONOLACTONE - AERS
ZOLL MANUFACTURING, LIFEVEST, PITTSBURGH, PA - 483
02/01/2015 - 04/30/2015
K102350
SUZHOU FLEXTRONICS TECHNOLOGY, CHINA - INSPECTION
RECS
ABBOTT, GERMANY - EIR
JENI'S SPLENDID ICE CREAMS, COLUMBUS, OH - 483
VENDOR SUBMITTALS AND PAYMENTS TO FRANKLIN REGIONAL

COUNCIL OF GOVERNMENTS FOR PARTICIPATING IN FDA
FOOD PROGRAM STANDARDS ETC 04/01/2010 - 12/31/2014
IND SUBMISSIONS TO CDER IN 2014 BREAKDOWN OF
ACTIVE IND WORKLOADS BY DIVISION ETC
SUN SPROUTS - PRDUCT SPLS 878359, 878360, 878361,
878362 12/22/14
GUDID DATA SET
DEPO-MEDTROL - PAGE 4 OF SAFETY SECTION OF THE FDA
INFORMATION
NDA 205636 SBA
ACTHAR GEL - AERS
MEDICORP LTD - OTC BLOOD GLUCOSE TEST - ENTRY NO
MH9-0087497-4
2015-1714 - COMPLETE RESPONSE
BRIDGEPORT HOSPITAL, BRIDGEPORT, CT - MDRS 1/08 TO
PRESENT
INDIVIDUAL RECS
HHSF 2230110350M
FRESHPET - CONSUMER COMPLAINT RECS, INSPECTION RECS
01/01/2011 - 04/24/2015
GALENA BIOPHARMA, INC, PORTLAND, OR - 483, EIR,
RESPONSE ETC 11/01/2014 - 12/31/2014
INSYS THERAPEUTICS - SUBSYS AERS
ELIQUIS - AERS
BLUE BELL, JENI'S ICE CREAM - INSPECTION RECS
04/29/2005 - 04/27/2015
AMERICAN SNUFF, CLARKSVILLE, TN - INSPECTION RECS
HOSPIRA, VICTORIA, AUSTRALIA - EIR, 483
FENTORA - AERS
DRUG ESTABLISHMENTS CURRENT REGISTRATION SITE
01/01/2000 - 01/01/2009
INDIVIDUAL RECS
INDIVIDUAL RECS
MUTCHLER INC PHARMACEUTICAL INGREDIENTS, HARRINGTON
PARK, NJ 01/01/2012 - 04/27/2015
NDA 206538
APTIMA HRHPV CLEAR TRIAL DATA
K122982
EMCURE - GMP INSPECTION REPORTS 01/02/2014 -
04/27/2015
IND 109278
NDA N022472
FDA MEMO RE DISPOSITION OF 180-DAY EXCLUSIVITY FOR
LAMOTRIGINE ORALLY DISINTEGRATING TABLETS ANDA
200828
LIST OF BIMO INSPECTIONS 10/01/2013 - 09/30/2014

BRENTUXIMAB VEDOTIN (ADCENTRIS) - AERS
ACTIQ - AERS
DELALUTIN (HYDROXYPROGESTERONE CAPROATE) INJ NDA
10-347, NDA 16-911 - LBLG
INDIVIDUAL RECS - VAERS
EFFERDENT DENTURE CLEANSING TABS, PERCARDIA -
ALERTS, WARNINGS, NOTIFICATIONS, ETC
COLLOIDAL SILVER - AERS
K070112
K133355
BRACCO SUISSE, SWITZERLAND - EIR
INTAS PHARAMCEUTICALS - 483 04/01/2015 - 04/20/2015

K133578
CMPLNT #140748
2014-690 - DELETED RECS
ADVANCE PHARMACEUTICAL INC - RUGBY IRON SUPPLEMENT
FERROUS SULFATE, ENTERIC ASPIRIN RECALL RECS
OCATA THERAPEUTICS INC - EIRS, 483S, WARNING LTRS,
ETC
ADVANCED CELL TECHNOLOGY INC - EIRS, 483S, WARNING
LTRS, ETC
TG THERAPEUTICS INC - EIRS, 483S, WARNING LTRS, ETC

K072008, K081444
K134044
SINCLAIR RESEARCH CENTER, AUXVASSE, MO - 483, EIR,
ETC
MEETINGS BETWEWEN OFVN OR CFSAN AND FOOD INDUSTRY
AND TRADE GROUPS RE: PARTIALLY HYDROGENATED OILS,
ARSENIC 01/05/2015 - 04/27/2015
KRISTEN COMELLA, SHARON MCQUILLAN, AGELESS
REGENERATIVE, STEMLOGIX - 482, 483, CORR ETC
01/03/2012 - 01/14/2015
INDIVIDUAL RECS
CREATIVE TESTING SOLUTIONS, ST PETERSBURG, FL - EIR
08/01/2014 - 08/31/2014
K122550
AMMONIUM HYDROXIDE IN FOOD
K964325
KNEX WORLDWIDE, CHARLOTTE, NC TENOWO, LINCOLNTON,
NC RJ REYNOLDS, WINSTON-SALEM, NC ETC - EIR, 483,
ETC
K133948
LIST OF PERSONAL LUBRICANT MANUFACTURERS IN NUC
CATEGORY CONTACTED BY FDA 01/01/2014 - 04/27/2015
BURZYNSKI RESEARCH INSTITUTE, STAFFORD, TX -
INSPECTION RECS 01/01/2015 - 04/03/2015
2015-2732
PNC NOS 1317, 1398
2015-2732
2013-2804
2015-2488
2015-1517
2015-1521
PURCHASE CARD, CREDIT CARD HOLDERS
K133997
K131681
PERNIX, HOUSTON, TX - 483
K142282
SF-1019 WAS LABELED UNABLE TO CONTINUE - RECS
MPI RESEARCH, INC, MATTAWAN, MI - EIR REDACTED
08/01/2012 - 04/29/2015
FCN 360
CORR BETWEEN BETWEEN CFSAN, OVFM AND PUBLIC RE KIND

LLC, KIND BRAND PRODUCTS 01/01/2012 - 04/30/2015
RECS RE CBER-02-010
ALI R REZAI, MD, CLEVELAND, OH - WARNING LETTER
RECS 07/01/2008 - 12/01/2009
DR THOMAS ORTEL, DURHAM, NC - CLOSE OUT LETTER

SYNOVIS MICRO COMPANIES ALLIANCE INC - GEM
MICROVASCULAR ANASTOMOTIC COUPLER CMPLNTS
HARBOR HOUSE SEAFOOD - EIR, EXHIBITS,
ATTACHEMMENTS
INDIVIDUAL RECS
KAZ INC - VICKS VAPORIZER MODEL V150 AER, RECALLS
1/1970
HEALTH & LIFE, JIANGSU, CHINA - EIR, 483
WOCKHARD'S CHIKALTHANA PLANT - 483'S
2012-2656, 2012-2510, 2012-927, ETC
XARELTO -FOIA REQUESTS
MORPHINE SULFATE - ISR 8762180, 9015676, 9995001,
ETC
SURAMORPH (MORPHINE SULFATE) - NDA 18-565 SBA
CYANOCOBOLAMIN INJ - ANDA 80-737 APRVL LTR, LBLG,
CHEMISTRY RVW, ETC
VIBISONE - CYANOCOBOLAMIN INJ - ANDA 80-557 APRVL
LTR, LBLG, CHEMISTRY RVW, ETC
CYANOCOBOLAMIN INJ - ANDA 87-967 APRVL LTR, LBLG,
CHMISTRY RVW, ETC
TURNCO TOOL & INSTRUMENT INC, GEORGETOWN, TX - 483
3/28/14
23ANDME PERSONAL GENOME SERVICE - CARRIER SCREENING
TEST FOR BLOOM SYNDROME ORIGINAL REQUEST,
ATTACHMENTS, SUBMISSIONS, ETC
BASF CORP - FCN 1285
NOEL MCELVANEY, DUBLIN, IRELAND - 483 04/13/2014 -
05/08/2014
MAERSK MEDICAL LTD - K004028
ANGIOMAX (BIVALIRUDIN) - AERS
AMBIEN (ZOLPIDEM) - AERS
PAR PHARMACEUTICAL INC, SPRING VALLEY, NY -
CHOLESTYRAMINE POWDER PACT CMPLNTS
SLEEP SCIENCE PARTNERS INC (THE PURE SLEEP CO) -
CMPLNT 139586
PAR PHARMACUTICAL INC - DEXLANSOPRAZOLE ANDA 202-
294 ROUTING SUMMARY, APRVL LTR
PERRIGO - SCOPOLAMINE TRANSDERMAL THERAPEUTIC SYS
ANDA 78-883 ACTAVIS - LIDOCAINE PATCH ANDA 200-675
APRVL PKG
DR GRAY SMALL, DR JORGE BARRIO - INVESTIGATION
CMPNT, CORR 2/15
2015-2207
2015-2007
2014-7048
2015-1753
NOVARTIS PHARMACEUTICALS CORP - GLEEVEC (IMATINIB

MESYLATE) CAPS NDA 21-335 WEB POSTINGS REQUEST
FORMS PERTAINING TO APRVL PKG, COMM WITH APPLICANT,
STANDARD OPERATING PROCEDURES, ETC
2015-1710
2015-1524
2015-1647
2015-886
2015-2522
2015-2533
2015-883
NUTRA BALANCE, INDIANAPOLIS, IN - EIRS, RESULTS,
ENFORCEMENT RPTS 6/13 TO 6/14
2014-7059
2015-2491
NDA 202971 S 3
NDA 050600 SBA
BLA 125057/062
NDA 18276
ANDA 076131 S 000
BOROSILICATE VIALS - DELAMINATION, LAMELLAE, DATA,
REPORTS ETC
DIET COKE - CMPLNT 140139
ANDA 090218 SBA
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
AUVI-Q, EPIPEN, EPIPEN JR - ADRENACLICK STABILITY
ASHWIN PATKAR, DURHAM, NC - CLOSE OUT LETTER

2014-7734
BIOTEST - WARNING LETTER, CLOSE OUT LETTERS
01/01/2005 - 04/01/2015
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
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
CATARACTS, ALTERNATIVE AND CONVENTIONALTREATMENTS

FOR CATARACTS AND CATARACT LENS REPLACEMENT SURGERY
FRESENIUS KABI USA - XYLOCAINE (LIDOCAINE HCL) NDA
06-488 APRVL RECS
NEXPLANON IMPLANON - AERS
BIOLOGENE LLC - IND 108281 MTG MINS, CORR, RPTS,
ETC
DIOMED INC - EVLT KIT D15 PLUS & D30 PLUS DLODE
LASERS K023543
PROHEART 6 - CMPLNTS, RECALL RECS, APRVL, ETC
INDIVIDUAL RECS
MELATONIN, WARFARIN - DDI RECS
RESERPINE TABS NDA 98-859, CHLORPROMAZINE HCI TABS
NDA 85-331 - RECS
HOFFMANN-LA ROCHE - ACCUTANE RECS
2012-2656, 2012-2510, 2012-927, ETC
PARENTERAL IRON AND ANAPHYLACTOID - MINI-SENTINEL
ASSESMENT PROTOCOL FINAL RPT
WARNING LETTER CLOSEOUT DATES
PATHEON, MONZA, ITALY - 483, WARNING LETTERS
01/01/2013 - 04/30/2015
K021176
K093223
K081151
2014-10001, 2014-10005, 2014-10022, ETC
2014-7044
CANGENE, WINNIPEG, CANADA - 483, EIR 01/26/2015 -
02/03/2015
DEMETRIUS LOPES, MD - EIR 01/01/2003 - 01/01/2004
CUSTOM ULTRASONICS - CEASE AND DESIST ORDER 9/12
483S 5/26/10, 1/26/12/ 11/8/12
ORANGE BOOK DATA 01/01/2000 - 05/01/2015
COMMUNICATIONS AND DATA SHARED BETWEEN FDA AND EPA
UNDER MOU RE PESTICIDES AND TOXIC SUBSTANCES
03/03/2015 - 05/01/2015
CLOSED FOI REQUEST 4/13-17/15
CLOSED ROI REQUESTS 4/13-17/15
NALCO - FCN 1277
RADIANT RESEARCH, CINCINNATI, OH - EIR 12/01/2013 -
07/31/2014
CLOSED FOI REQUESTS 3/30/15-4/3/15
TRADE COMPLAINT RECS 14F00017 7/9/2014, 14G00004
7/9/2014 14G00005 7/9/2014, ETC
K112595
K122226, K111479, K103072
LYNN PEAVEY COMPANY - WARNING LETTER RECS
ORANGE BOOK ANNUAL 34TH EDITION
NDA 206229
FERTILITY DRUGS AERS
KADCYLA - AERS
ISR 5500699, 6115627, 6121983, ETC
K955841
K000068
K003175
DREAMPAK, LCC, NEW BERLIN, WI - EIR 03/09/2015 -
03/10/2015
ROBOTIC ASSISTED SURGERIES AT ADVOCATE SOUTH SURBAN
HOSPITAL, HAZEL CREST, IL - INCIDENT REPORTS
01/01/2014 - 05/04/2015
NDA DATA 01/04/1990 - 01/15/2015
K072201
K140929
CATALENT PHARMA SOLUTIONS, LLC, MORRISVILLE, NC -
483, EIR 03/16/2015 - 03/20/2015
K033052
K051085
K040194
ANDA 074132, ANDA 074234, ANDA 073553 SBA
K143280
DROSPIRENONE-BASED BIRTH CONTROL PILLS, PROGESTIN-
BASED BIRTH CONTROL PILLS - AERS
K142203
GUDID DATABASE FOR INFUSION PUMPS
K031482
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
ASSOCIATES OF CAPE COD, EAST FALMOUTH, MA - EIR, 43

CIRO REYES, MD, MIAMI LAKES, FL - 483 03/24/2015 -
05/05/2015
KRATOM, MITRAGYNA, VIVAZEN - AERS
GEMSA ENTERPRISES LLC, ITALCAL TRADING CO, EMILIO

VISCOMI, ETC - INVESTIGATION RECS 1/1/10 TO PRESENT
CLOSE OUT LETTER DATA 01/01/2004 - 09/01/2009
BELGIAN CONDIMENT SAUCES
FLUORIDE RECS
INDIVIDUAL RECS
PACIRA PHARMACEUTICALS - RESPONSE LETTER,

ACKNOWLEDGEMENT OF RESPONSE 09/23/2014 - 05/06/2015
MEDIONICS INTERNATIONAL, CANADA - EIR 06/22/2009 -
06/25/2009
API MANUFACTURER EIR 07/01/2012 - 05/06/2015
FDA ACTION RELATED TO PRODUCTS DETERMINED TO BE
MEDICAL DEVICES THAT ARE BEING MARKETED WITHOUT
510K 01/01/2010 - 05/07/2015
DR JESSE ANDREW STOFF - 483 01/01/1980 - 12/31/2000

EARGO, INC - APPROVAL RECS 01/01/2013 - 05/06/2015
MARATHON PHARMACEUTICALS, LLC, DEERFIELD, IL - EIR
1/30/13
LISTING OF 483'S NOTICES FOR PHARMACEUTICAL,
BIOLOGICS & MEDICAL DEVICE MFG, CLNCL TRIAL
FACILITIES IN US & OUTSIDE US 12/1-31/14
TIMITE AND SONS, TIMITE AND SONS BEAUTY SUPPLY,
WORLD BEAUTY SUPPLY ETC - FDA IMPORT NOTICES ETC
01/01/2008 - 05/06/2015
ANDA 077623
AGILUX LABORATORIES, WORCESTER, MA - EIR, 483,
RESPONSE 07/01/2013 - 07/31/2013
INTERTEK USA, INC, SAN DIEGO, CA - EIR, 483,
RESPONSE 09/01/2012 - 09/30/2012
CHANTEST CORPORATION, CLEVELAND, OH - EIR, 483,
RESPONSE 06/01/2013 - 06/30/2013
K111303, K111851
NDA 20-333/S-013 FDA ASSESSMENT OF 2 YEAR RAT STUDY

TEXAS BIOMEDICAL RESEARCH INSTITUTE, SAN ANTONIO,
TX - EIR, 483, RESPONSE 09/01/2012 - 09/30/2012
TOXIKON CORP, BEDFORD, MA - EIR, 483, RESPONSE
09/01/2013 - 09/30/2013
PRESENTATIONS BY THE FOUNDATION FOR BIOMEDICAL
RESEARCH OR THE NATIONAL ASSOC FOR BIOMEDICAL
RESEARCH - 1/1/10 TO PRESENT
IPB300 BATH LIFT - CMPLNT
ALLERGAN, INC, IRVINE, CA - EIR, 483, RESPONSE
03/01/2013 - 03/31/2013
BATTELLE MEMORIAL INSTITUTE, COLUMBUS, OH - EIR,
483, RESPONSE 10/01/2012 - 10/31/2012
RIKEN VITAMIN CO LTD - ETHOXYLATED ALCOHOLS FCN
1313 CHEMISTRY AND TOXICOLOGY RVW MEMO, CORR, FORM
3480, ETC
COVANCE LABORATORIES, GREENFIELD, IN - EIR, 483,
RESPONSE 06/01/2014 - 06/30/2014
HOFFMAN LA ROCHE, NUTLEY, NJ - EIR, 483, RESPONSE
05/01/2013 - 05/31/2013
PITISUTTIHUM PUNNEE MD, BANGKOK, THAILAND - EIR,
483, RESPONSE 05/01/2014 - 05/31/2014
DYAX CORP, BURLINGTON, MA - EIR, 483, RESPONSE
08/01/2014 - 08/31/2014
CANGENE CORPORATION, CANADA - EIR, 483, RESPONSE
07/09/2014 - 07/18/2014
VALEANT PHARMACEUTICALS INTERNATIONAL, CANADA -
EIR, 483, RESPONSE 09/01/2013 - 09/30/2013
EMERGENT BIODEFENSE, LANSING, MI - EIR, 483,
RESPONSE 11/01/2013 - 11/30/2013
Any documents that list the compounding pharmacies

in the United States that compounded large
quantities (ten (10) or more vials per week) of
hydroxyprogesterone caproate (17P) for the past six
(6) months from the date of the search for
responsive records
CSL BEHRING, BRADLEY, IL - EIR, 483, RESPONSE
07/01/2014 - 07/31/2014
K910007
FCN 0277
CORDEN PHARMA COLORADO, BOULDER, CO - EIR, 483,
RESPONSE 06/01/2013 - 06/30/2013
BRISTOL MYERS SQUIBB, DEVENS, MA - EIR, 483,
RESPONSE 06/01/2013 - 06/30/2013
CARDINAL HEALTH LLC, LAS VEGAS, NV - EIR, 483,
RESPONSE 11/01/2013 - 11/30/2013
GILEAD SCIENCES, INC, FOSTER CITY, CA - EIR, 483,
RESPONSE 09/23/2013 - 10/10/2013
PREMIER RESEARCH INTERNATIONAL, PHILADELPHIA, PA -
EIR, 483, RESPONSE 02/01/2012 - 02/29/2012
CANGENE BIOPHARMA, INC DBA EMERGENT BIOSOLUTIONS,
BALTIMORE, MD - EIR, 483, RESPONSE 03/31/2014 -
04/09/2014
IND 45228
DIMETHYLDIALKYLAMMONIUM IN SUGAR MILLS FOR
PRODUCTION OF WHITE SUGAR
CILASTATIN - FORMULATION, PRECLINICAL INFORMATION,
BIOAVAILABILITY ETC
TUZISTRA XR APPROVAL RECS
ADVETRIS, KYNAMRO, HETLIOZ, ETC - AERS
TEVA PARENTERAL MEDICINES, IRVINE, CA - EIR,
EXHIBITS, ATTACHMENTS, ETC 01/07/2009 - 01/01/2010
LONZA BIOLOGICS - IMMOBILIZED MONOCLONAL ANTIBODY
DMF 18596
NYMOX PHARMACEUTICAL CORP - NX02-0017 NX02-0018
FUJIFILM CORP - DUODENOSCOPES 483'S, WARNING LTRS,
FOREIGN & DOMESTIC SINCE 1/1/15
PENTAX MEDICAL, HOYA CORP - DUODENSCOPES MEDWATCH,
CMPLNTS SINCE 7/96
SYN TECH PHARM, TAINAN COUNTY, TAIWAN - EIR 1/26-
29/15
CORDIS CORP - OPTEASE VENA CAVA FILTER RETRIEVAL
CATHETER PERMANENT VENA CAVA FILTER & INTRODUCTION
KIT
SILVER ACETATE STUDY RECS
TRADER JOES - RAW WALNUTS SALMONELLA RECALL
OLYMPUS MEDICAL SYS CORP - DUODENOSCOPES WARNING
LTRS, 483'S FOREIGN & DOMESTIC SINCE 1/1/15
DKT MER-L-1112-13
SPINAL SOLUTUONS, LONG BEACH, CA - COSIGNEES
JENIS SPLENDID ICE CREAMS - SPL 2673
K090318
ANDA 200630 TENTATIVE APPROVAL LETTER, LABELING
K140828
ANDA 203976 LABELING, PACKAGE INSERT
K150615 SUMMARY
DRUGS FILED UNDER NDA GRANTED PRIORITY REVIEW
STATUS 01/01/1992 - 12/31/2014
OFEV - PHARMACOLOGY REVIEW
PERPHENAZINE - AERS
K093547
COUNTERFEIT BOTOX - AERS, TOXICOLOGY
PATANASE - AERS
DERMA PEN WARNING LETTER RECS 03/16/2015 -
03/31/2015
STRATTERA - AERS
IBUPROFEN, ACETAMINOPHEN, PROZOSIN, ETC -
MEDICATION GUIDE, PRESCRIPTION PROTOCOLS, DURATION
LIMITS
PRODUCT QUANTITY CHANGE SUBSTANTIAL EQUIVALENCE
RPTS, DKT 2011D-0147
CAERS 183160
ALTEPLASE - AERS
4-METHYLIMIDAZOLE IN SODA - RPTS 2014 TO PRESENT
INDIVIDUAL RECS
COLLOIDAL SILVER - RPT
OTTOBOCK C-LEG 4 MICROPROCESSOR CONTROLLED
PROSTHETIC KNEE - IP TESTING, LIQUID INGRESS
PROTECTION TESTING, IMMERSION TESTING, ETC
GLAXOSMITHKLINE PLC, NOVARTIS AG, NOVARTIS
PHARMACEUTICAL COR - ZOFRAN (ONDANSETRON) RVWS,
AERS, COMM, ETC 1991 TO 2015
FOREST PHARMS, FOREST LABS - CELEXA (CITALOPRAM),
LEXAPRO (ESCITALOPRAM) RVWS, AERS, COMM, ETC 2009
TO 2015
CYANOCOBOLAMIN INJ ANDA 87-969 - CHEMISTRY RVW
VIBISONE (CYANOCOBOLAMIN) INJ ANDA 80-557 -
CHEMISTRY RVW
CYANOCOBOLAMIN INJ ANDA 80-737 - CHEMISTRY RVW
OTSUKA PHARMACEUTICAL CO LTD, SAGA PREFECTURE,
JAPAN - EIR 12/1-5/14
TABLES OF FINAL CONCLUSIONS PLASMA DONOR FATALITIES
FY 2013, 2014
OTSUKA PHARMACEUTICAL CO LTD, NAKA-GUN, TOKUSHIMA
PREFECTURE, JAPAN - EIR 6/9-17/14
OTSUKA PHARMACEUTICAL CO LTD, EBISUNO HIRAISHI,
KAWAUCHI-CHO, TOKUSHIMA, JAPAN - EIR 6/18-26/14
OTSUKA PHARMACEUTICAL CO LTD, ITANO-GUN, TOKUSHIMA
PREFECTURE, JAPAN - EIR 3/17-20/14
LUNDBECK, TEESSIDE, ENGLAND, UK - EIR MOST RECENT
ALUMINOSILICARE GLASS IN PARENTERAL APPLICATIONS -
CORR, MINS, REGULATORY OPINIONS 1/10 TO PRESENT
STEVANTO GROUP - ALUMINOSILICATE GLASS CORR, MINS,
REGULATORY OPINIONS, ETC
OMPI PHARMA - ALUMINOSILICARE GLASS CORR, MINS,
REGULATORY OPINIONS, ETC
CORNING - ALUMINOSILICATE GLASS CORR, MINS,
REGULAOTRY OPINIONS, ETC
DRAFT GUIDANCE HEART VALVES - INVESTIGATIONAL
DEVICE EXEMPTIONS AND PREMARKET APPROVAL
APPLICATIONS 02/20/2010 - 04/27/2015
ALOE MAN INTERNATIONAL CORP, ALOE MAN INC -
INSPECTION REPORTS, WARNING LETTER RESPONSE
01/16/2009 - 01/16/2015
DRUG SHORTAGE DATA 01/01/2008 - 12/31/2013

PROMETHAZINE - OUTCOME OF THE DRUG EFFICACY SAFETY
IMPLEMENTATION (DESI) RVWS
BLUE BELL CREAMERIES
BLUE BELL CREAMERIES
DKT 1998P-0547
DKT 2013N-0500
DKT 2015P-0091
DKT 1975-0184
DKT 2013N-0500
1975N-0183
NDA 20782, 21168 S004 - APPROVAL LETTER (CERTIFIED)
DKT 2011N-0920, 2011N-0921

DKT 2007N-0363-0040
DKT 2015P-0569
DKT 2011N-0830, 2007N-0363, 2013N-0500
DKT 2003N-0196, 2005N-0453, 20060-0314, ETC
FEDERAL REGISTER VOL 50 N062 PG 12821-12825
DKT 75N-0184
DKT 2007N-0363-0040
DKT 2014N-1168-0029
DKT 2014N-1051
SUN PHARMACEUTICAL, INDIA - 483 09/01/2014 -
09/30/2014
NDA 21168 S012 - APPROVAL LETTER (CERTIFIED)
COUGH & COLD PREPARATIONS - ISRS 91691343,
94455812, 96810154, ETC
IMPAX LABS, HAYWARD, CA, MIAOLI COUNTY 350, TAIWAN
- EIRS
JENI'S SPLENDID ICE CREAMS - EIRS 1/1/10 TO 5/8/15
LIST OF 483S FOR PHARMACEUTICAL, BIOLOGICS &
MEDICAL DVC MFG & CLNCL TRIAL FACILITIES IN THE US
& OUTSIDE THE US 4/1-30/15
SENATOR RICHARD DURBIN OR SENATOR DIANE FEINSTEIN -
RESP LTR 3/11/15
NDA 016954
BIO-MEDICAL INC, OVERLAND PARK, KS - EIR,
INVESTIGATOR NOTES, 483 03/01/1994 - 10/31/2012
NDA 017031
PHARMA MEDICA RESEARCH INC, CANADA - EIR 03/16/2015
- 03/27/2015
K091935
9797153, 9805305, 9921411 ETC
LIST OF FOIA REQUESTS LAST 12 MONTHS
CANGENE CORPORATION, CANADA - EIR 02/03/2015 -
02/03/2015
GUIDANCE RECS FOR PHARMACEUTICAL COMPANIES RE
TESTING NEW DRUGS FOR TREATMENT OF SCHIZOPHRENIA OR
PSYCHOSIS IN CHILDREN AND ADULTS 01/01/2000 -
01/01/2015
ADR DATA 01/01/2012 - 12/31/2014
K110825
K003332, MEDITHERM RESPONSE TO WARNING LETTER
NDA 017422
K09056
K123546
CTP GRANDFATHER DETERMINATIONS LIST 03/01/2011 -
03/31/2015
9922370, 10024182 - MEDWATCH, SOURCE DOCUMENTS,
DIRECT REPORTS
CLASS I MEDICAL DEVICE RECALLS 11/1/2002
NDA 17469
NDA 12107
K122538
CORR BETWEEN FDA AND MY CHAI RE WARNING LETTER
VIOLATIONS 11/07/2014 - 05/08/2015
DOCETAXEL, TAXOTERE - AERS
NDA 021336, NDA 021708
DIETARY SUPPLEMENT AERS 07/01/2013 - 12/31/2014
COUNTERFEIT BOTOX - AERS, TOXICOLOGICAL EFFECTS
BLUE BELL CREAMERIES - LAB RESULTS, ENVIRONMENTAL
ASSESSMENTS, ETC 02/01/2015 - 05/08/2015
9959011, 9796988, 9880454 ETC - DIRECT REPORTS,
MEDWATCH REPORTS, ANY SOURCE DOCUMENTS
ESSURE - APPROVAL RECS
ZIOPTAN - SBA
DORNIER MEDICAL SYSTEMS INC - LITHOTRIPTERS SS&E
SODIUM PERBORATE MONOHYDRATE, POTASSIUM

MONOPERSULFATE WARNINGS, RPTS, CONSUMER ALERTS, ETC
EUROFINS MEDINET, BREDA, THE NETHERLANDS - EIR
11/3-7/08 (REDACTED)
NOVARTIS - SANOREX (MAZINDOL) NDA 17-247 PI
METHODS FOR CONDUCTING RECALL EFFECTIVENESS CHECKS
BAYER HEALTHCARE PHARMACEUTICALS INC - ESSURE
INVESTIGATION RESULTS 3/26/15
FORTEO - AERS
SHEATHING TECHNOLOGIES INC - SHEATHES STERILE
ULTRASOUND GEL K130041
TEVA BRANDED PHARMACEUTICAL PRODUCTS R & D, MIAMI,
FL - 483 01/01/2005 - 01/16/2015
RANTIDINE - RECS, RISK FACTORS
K132031
POST MARKET REQUIREMENTS AND COMMITTMENT DATA SINCE
1970
BB-IND 7471
AMERICAN PHARAMCEUTICAL INGREDIENTS, LLC,
WATERFORD, MI - 483, EIR 01/01/2015 - 05/05/2015
SMITHKLINE BEECHAM, CORK, IRELAND HOSPIRA
HEALTHCARE INDIA WYETH LEDERLE, ITALY ETC - 483
LIST OF FOOD SAFETY INSPECTIONS IN TEXAS, LISTERIA
RECS, BLUE BELL CORR 01/01/2012 - 05/10/2015
INDIVIDUAL RECS
FCN 1505
K944692
K142120, K133017
2013-5575, 2013-7111, 2014-8117
EMKINETICS, INC - RECS SUBMITTED BY OR PERTAINING
TO CE MARK AND 510K CLEARANCE 07/01/2011 -
06/30/2013
DEN060002/K051338, K150174
K140306, K130943
K991864
PROAIR RESPCLICK 205636 AERS
SYNRIBO AERS
QUARTETTE - AERS
NDA 021008 S030
QNASL - AERS
NDA 021008 S030
ADASUVE - AERS
TBO-FILGRASTIM - AERS
AMGEN, JUNCOS, PUERTO RICO - INSPECTION RECS,
WARNING LETTERS 10/01/2013 - 05/01/2015
SENZA SYSTEM PMA
CORR RE APLIGRAP, DERMAGRAF, EPIFIX, ETC
BLUE BELL CREAMERIES - INSPECTION RECS 01/01/2012 -
05/12/2015
ARGATROBAN - AERS
DMF SPREADSHEET
NEOMEDIX CORP - WARNING LTR, CO RESP 2/2/14
BLU BELL CREAMERIES - LYSTERIA OUTBREAK
NATUS MANUFATURING LTD - EIR 1/20-23/14
INDIVIDUAL RECS
DRUG, BIOLOGIC, MEDICAL DVC, DIETARY SUPPLEMENTS -
ADDRESS DATABASE
ROXANE LABORATORIES INC - REMS FOR ALOSETRON
PRODUCTS
INDIVIDUAL RECS
CELERION, INC, TEMPE, AZ - EIR 08/13/2013 -
08/22/2013
INTRA LOCK INTL BK110053
CASE NOS 4184938, 5671663, 6034579
DELALUTIN - AERS, STUDIES, CMPLNTS, ETC
GUIDANT ANCURE ENDOGRAFT SYS - RECALL, CORR,
INVESTIGATION RECS, ETC
K080650
ANDA 088042, ANDA 74514 APPROVAL LETTERS
K123985
HUMIRA, ENBREL - AERS
ADVANCED COSMETIC RESEARCH LABORATORIES,
CHATTSWORTH, CA - EIR, 483, WARNING LETTER
01/01/2011 - 05/12/2015
2015-3223
ISR 3760332
TRICLOSAN NOTICE OF ARRIVALS
DERMAMEDICS LLC - RECALL RECS ETC
LIST OF FIRMS APPROVED FOR COLLECTION OF PMSG
CORTEX MANUFACTURING INC, LAKE STEVENS, WA DENTAL
ALLIANCE HOLDINGS LLC, ALBANY, OR SPIRATION INC,
REDMOND, WA, ETC - 483S 4/1-30/15
COASTAL CONTACTS INC, VANCOUVER, CANADA ORTHOGEM
LTD, NOTTINGHAM, UK WU'S TECH CO LTD, HSIN-CHU,
TAIWAN, ETC - 483S 4/1-30/15
ROCKWELL MEDICAL INC, WIXOM, MI MONOSOL RX LLC,
PORTAGE, IN PROGRESSIVE DYNAMICS INC, MARSHALL,
MI, ETC - 483S 4/1-30/15
ARSTASIS INC, FREMONT, CA SILK ROAD MEDICAL INC,
SUNNYVALE, CA OCUMETRICS INC, MOUNTAIN VIEW, CA,
ETC - 483S 4/1-30/15
TRIAD ISOTOPES, MACON, GA ETHICON INC, CORNELIA,
GA - 483S 4/1-30/15
MAXIM BIOMEDICAL INC, ROCKVILLE, MD LC

TECHNOLOGIES INC, FAIRFAX, VA HAWKNAD
MANUFACTURING INDUSTRIES INC. ALEXANDRIA, VA - 483S
4/1-30/15
ORGAN RECOVERY SYSTEMS INC, ITASCA, IL - 483S 4/1-
30/15
B & P INDUSTRIAL INC, TULSA, OK GRESCO PRODUCTS
INC, STAFFORD, TX ELITE MASSAGERS LLC, RICHARDSON,
TX, ETC - 483S 4/1-30/15
K090421
TRONOX, GREEN RIVER, WY OTTO BOCK HEALTHCARE, SALT
LAKE CITY, UT BROWN'S COMPUNDING CENTER INC,
ENGLEWOOD, CO - 483S 4/1-30/15
CFS DENTAL INC, HIALEAH, FL ULTROID TECHNOLOGIES
INC, TAMPA, FL GENICO INC, WINTER PARK, FL, ETC -
4/1-30/15
PETNET SOLUTIONS INC, OVERLAND PARK, KS HOSPIRA
INC, MCPHERSON, KS WEEKS & LEO CO INC, ETC - 483S
4/1-30/15
PRECISION COMPOUNDING CENTERS LLC, BREA, CA TMJ

SOLUTIONS INC, VENTURA, CA AVRIO
BIOPHARMACEUTICALS LLC, IRVINE, CA, ETC - 483S 4/1-
30/15
ALLESEE ORTHODONTIC INC, STURTEVANT, WI FAGRON
INC, ST PAUL, MN - 483S 4/1-30/15
HOLLYWOG LLC, CHATTANOOGA, TN SANMINA INC,
HUNTSVILLE, AL MAX MOBILITY LLC, ANTIOCH, TN -
483S 4/1-30/15
BROOKFIELD MEDICAL/SURGICAL SUPPLY INC, BROOKFIELD,

CT INFRAREDX INC, BURLINGTON, MA POLYCARBON
INDUSTRIES INC, NEWBURYPORT, MA - 483S 4/1-30/15
ALTAIRE PHARMACEUTICALS INC, AQUEBOGUE, NY RTF
MANUFACTURING CO LLC, HUDSON, NY PURINEPHARMA LLC,
MASSENA, NY - 483S 4/1-30/15
CUSTOM ULTRASONICS INC, IVYLAND, PA POLYSCIENCES
INC, WARRINGTON, PA - 483S 4/1-30/15
AMGEN TECHNOLOGY IRELAND, DON LAOGHAIRE, IRELAND

LUPIN LTD, AURANGBAD, INDIA PFIZER PHARMACEUTICALS
LTD, DALIAN, CHINA - 483S 4/1-30/15
BOSTON IVF, SOUTH PORTLAND, ME - EIR 01/01/2013 -
01/01/2015
SONAR PRODUCTS INC, CARLSTADT, NJ DERMACEUTICAL
LABORATORIES LLC, TETERBORO, NJ THERAKOS INC,
BRIDGEWATER, NJ, ETC - 483S 4/1-30/15
POST FOODS WARNING LETTER RESPONSE 03/10/2015
NDA 21484 PROTOCOLS
BABY FORMULA - LIST OF PRODUCERS 05/12/2000 -
05/12/2015
LIST OF EXPORTERS WHO DELIVER PMSG TO US
SURVEY TOOL USED TO COLLECT DATA FOR FDA HEALTH AND
DIET SURVEY
CPT1400711
GILLETTE COMPANY, ANDOVER, MA - EIR 01/23/2014 -
06/30/2014
ESSURE - ADVERSE EVENTS
NDA 018716
HI TECH PHARMACEUTICALS, NORCROSS, GA - WARNINGS,
EVIDENCE, NOTIFICATION
AMERICAN RED CROSS GEORGIA LOCATIONS - EIR
06/02/2010 - 03/19/2015
NAPP TECHNOLOGIES INC - EIR, 483, WARNING LETTER
01/01/2011 - 05/13/2015
FDA CONTRACTS WITH DUNS & BRADSTREET 01/01/2005 to
05/30/2015
JAGSONPAL PHARMACEUTICALS LIMITED, INDIA - 483,
EIR, WARNING LETTER 01/01/2011 - 05/31/2015
SIMPONI - AERS
VOLCANO CORPORATION, RANCHO CORDOVA, CA - EIR
10/01/2012 - 06/28/2013
K063722
K864690
OXTELLAR XR - AERS
BLUE BELL CREAMERIES INSPECTION RECS
K043299
K122462
K926104
K102452
K072932, K082870, K032315
INDIVIDUAL RECS
MEDWATCH REPORT
ANDA 075113
PREGABALIN - MEDWATCH REPORTS OR OTHER PRE OR POST
MARKET REPORTS AERS
ESSURE - PMA
TELEFLEX MEDICAL, NORRISVILLE, NC - NEEDESCOPIC

RESPOSABLE DVC SYS K132232 MINI-LAP BIPOLAR
ELECTROCAUTERY DVC K113597 ARVIKI LAPAROSCOPIC
ASPIRATION STRUMENT K102274, ETC
K003431
SITAGLPTIN, SAXAGLIPTIN, LINAGLIPTIN, ETC - AERS

10/06, 7/06, 7/09, 2011 TO PRESENT, 2013 TO PRESENT
LIST OF ALL BULK INGREDIENT DRUG PRODS SUBMITTED BY

DOMESTIC & FOREIGN ESTABLISHMENTS 1/11 TO PRESENT
DELALUTIN (17-HYDROXY PROGESTERONE CAPROATE INJ) -
AERS
BENICAR - AERS, LIST OF DRUGS BEING RECALLED
ROXANE LABORATORIES INC - ALOSETRON MEMO TO SUPPORT
DECISON TO APRVD & WAIVE REQUIREMENTS
ORANGE BOOK WEB LINK
NADA 141-042 FOIA SUMMARY
SOLIRIS - AERS
STAFF MANUAL GUIDE 8/31/76
NDA 18723 S020, NDA 19680 S008 - APPROVAL LETTER
CANNABIDIOL TRIAL SUBMISSION RECS 01/01/2013 -
01/01/2015
DMAA CAERS
GOOGLE INC - COMMUNICATIONS WITH RE DEVELOPMENT OF
CONTACT LENSES WITH INTEGRATED ELECTRONIC ELEMENTS
01/01/2013 - 05/13/2015
AVELOX (MOXIFLOXACIN) - AERS
ANDA 075074 PHARMACOKINETIC REVIEW
MEDROXYPROGESTERONE ACETATE - AERS
KCAS LLC BIOANALYTICAL FACILITY, SHAWNEE, KS - EIRS
8/25/14, 9/2/14
NU VASIVE INC, SAN DIEGO, CA - EIR 2/14
US FLUE CURED TOBACCO GROWER - KENTUCKY RED,
SILVER, GOLD, BLUE, GREEN TOBACCO SUSTASNIAL
EQUIVALENCE RPTS
SYNACTHEN (SYNACTHEN DEPOT) - ACTH EIRS, 483S,
WARNING LTRS, ETC
K141668
DR REUBEN MATALON - RESP OF P HENYLKETONURIA TO
TETRAHYDROB IOTERN (BH4) PROJECT GRANT APPL
5R01FD002006-1 THROUGH 5401FD002006-03-2005
SILICON DIOXIDE - GRN 298 ACACIA OR GUM ARABIC -
GRN 48 LACTOBACILLUS - GRN 463, 409,324, ETC
MARLOW FOODS LTD - QUORN-BRAND MEAT SUBSTITUTE
CMPLNTS 5/1-8/15
PETITIONS FOR EXEMPTION FOR PREEMPTION
ASBESTOS - SOURCING OF TALC, TESTING SURVEY, CUMM
2000 TO PRESENT, 2009 TO 2010
2014-344, 2009-10122, 2014- 8613, ETC
90 MEATS DEPOT & LATINO FOOD DISTRIBUTORS,
SPRINGFILED, MA - HEALTH, SAFETY & SANITARY INSPS,
VIOLATIONS, CMPLNTS LAST 15-20 YRS
ALLERGAN - RESTASIS (CYCLOSPORINE) RPT
ORANGE BOOK 1986, 2001-2003
MERCK & CO INC - GARDASIL HPV VACCINE NUMBER OF
CMPLNTS UNTL 3/15
CELERION, LINCOLN, NE - EIR 06/20/2011 -
06/24/2011
ESTABLISHMENTS, ETC - FOREIGN AND DOMESTIC INSPS
2/15 TO 3/15
MYLAN, INDIA - 483 12/01/2014 - 03/01/2015
FOOD ADVISORY COMMITTEE MEETING TRANSCRIPT 2/24/03
MONSTER ENERGY ADVERSE EVENTS
K091780
REAL SCIENTIFIC HEMP OIL - LAB RESULTS
K120301
BLUE BELL CREAMERIES - OCI INVESTIGATION RECS
01/01/2010 - 05/15/2015
FDA ENTRY RECS 5/1/15 TO 5/15/15
BLA 103795 - SBA S-1004
CELERION, LINCOLN, NE - EIR 06/29/2010 - 07/02/2010

K133853
INDIVIDUAL RECS
BLUE BELL CREAMERIES - ENVIRONMENTAL TESTING
01/01/2010 - 05/15/2015
K120298
K091781
FAP3B3696
ECLIPSE AESTHETICS - 483, RESPONSE, CLOSE OUT ETC
02/01/2014 - 01/31/2015
XARELTO - APPLICATION, INVESTIGATION, TESTING ETC
QUALITY ASSURANCE LABORATORIES FOR FOOD ANALYSIS
10175042, 10175158, 10355704, ETC
K050808
INDIVIDUAL RECS
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
FRESENIUS KABI USA - AZITHROMYCIN INJ NDA 65-179

12/13/05 PILVA HERVATSKA DOLO- AZITHROMYCIN INJ
NDA 65-265 1/18/07 HOSPIRA - AZITHROMYCIN INJ NDA
65-500 6/26/09, ETC APRVL LTRS
QUALITAS HEALTH - ALMEGA PL OMEGA-3 OIL NEW DIETARY
INGREDIENT NOTIFICATION (NDIN)
BIS (2,2,6,6-TETRAMETHYI-4-PIPERIDINYL SEBACATE
TINUVIN.770) - TOXICOLOGY RVWS
K140313
INTEGRATED RESOURCES INC OR BIOGEN IDEC - MR LEI
YIIN'S COMM 1/1/11-12/31/11
IAMS DOG FOOD - SALMONELLA OUTBREAK RECS 8/13
SHUR GREEN FARMS - WARNING LETTER RESPONSE TO APRIL
2015 WARNING LETTER
K003289, K022287, K063442 ETC
FRESH MEDICAL LABORATORIES - REVIEW LETTERS
02/01/2015 - 02/28/2015
BLUE BELL CREAMERIES - COMMUNICATIONS WITH FDA
01/01/2015 - 05/18/2015
K133895
LYMPHOSEEK - ORPHAN DRUG DESIGNATION RECS
K041771, K060963, K070201 ETC
K061515
NDA 019188 SBA
NATCO PHARMA LTD, HYDERABAD, INDIA - 483 07/01/2014
- 12/31/2014
NDA 018687 SBA
TELESTA TEHRAPEUTICS INC - MEETING MINUTES RE BLA
MCNA 01/19/2014 - 05/18/2015
DMF 9543
COMM BETWEEN FDA AND MALLINCKRODT RE
METHYLPHENIDATE EXTENDED RELEASE AND CONCERTA
APPROVAL RECS PREVIOUSLY RELEASED
COMPASSIONATE USE, INVESTIGATOR-SPONSORED OR

PHYSICIAN-SPONSORED SINGLE PATIENT IND REQUESTS FOR
USE OF BANKED TCELL THERAPIES FROM MEMORIAL SLOAN
KETTERING
HERAEUS PRECIOUS METALS GMBH & CO HG, IDT BIOLOGIKA
- EIR, 483, COVER LETTER
PRA HEALTH SCIENCES, CRI LIFETREE - EIR 11/15/2004
- 09/04/2014
K122886
ESSENTIAL OILS
MAXALT - AERS
HERBALIFE - AERS
2015-3551
FRESHPET - CONSUMER COMPLAINTS 01/01/2015 -
05/19/2015
BECTON DICKINSON GRAY TOP VACUTAINER 367001
APPROVAL RECS 05/01/1960 - 05/19/2015
MASIMO - CLEARANCE OF THEIR PRODS 2000 TO PRESENT
K060702 K102458 K101818 ETC
SAMPLE RESULTS
OTSUKA PHARMACEUTICAL & DEVELOPMENT &
COMMERCIALIZATION INC - EIRS, 483S, COMM, ETC
3/6,7,10,11,13,14 ,18/14
CADILA HEALTHCARE - 483 07/02/2014 - 10/31/2014

BEAT BIO THERAPUTICS - BB-412 THERAPY TREATMENT
IND APPL, RVW, APRVL, ETC
USE OR EVALUATION OF THE LABEL DECAFFEINATD ON
COFFEE OR TEA PRODS POLICY, COMM, RPTS, ETC
ASPARTAME - HIPAA STATE OF MAINE RULES &
REGULATIONS
CUTISPHARMA - EIR 01/01/2014 - 05/20/2015
CROSS DISCIPLINE TEAM LEADER AND DIVISION OF
PHARMACOVIGILANCE - MEMOS RE LABELING CHANGE FOR
OLYSIO 01/01/2014 - 05/20/2015
INDIVIDUAL RECS
PROCEDURES FOR THE ISSUANCE OF A PUBLIC HEALTH
ADVISORY
MAXIMUM AMOUNT OF PERMETHRIN ALLOWED IN FDA-APRVD
ANTI-FELA/TICK MEDICATION FOR CATS
BLUE BELL CREAMERIES, BROKEN ARROW, OK BLUE BELL
CREAMERIES BRENHEM, TX - INSPECTION RECS 01/01/2010
- 05/19/2015
HUVEPHARMA INC, ST LOUIS, MO - EIR 02/14/2013 -
07/02/2014
WIL RESEARCH, ASHLAND, OH - EIR 05/05/1986 -
05/23/1986
FAERS SEROQUEL CASES
ANDA 073403
10647564, 10736427, 10741259 ETC
ANDA 062653
VITA KEY PACKAGING, INC, RIVERSIDE, CA - 482, 483
01/01/2014 - 05/20/2015
PETNET REPORTS RE PURINA BENEFUL 01/01/2011 -
05/20/2015
K111862
10175042, 10175158, 10355704, ETC
K133921, K103595, K082188
CLARIS INJECTABLES LIMITED, INDIA - 483 03/01/2015
- 05/15/2015
K143189
KEVIN BLACK, ROBERT BONWETSCH, PHILIP BOURGEOIS,
ETC - 483, EIR, RESPONSE ETC
XTANDI AERS
ADVERSE EVENT
DMF 4181
K142098
GUIDANT/BOSTON SCIENTIFIC DEFECTIVE IMPLANTABLE
CARDIAC DEFIBRILLATORS - OCI INVESTIGATION RECS
05/02/2005 - 12/30/2011
10069989, 10283699, 10353121, ETC
NDA 204516
STRATTERA - AERS
DROXIDOPA - ORPHAN DESIGNATION RECS
CAMPTOSAR NDA 20-571
CHIMERIX - BRINCIDOFOVIR CORR
PREDNISONE - CMPLNT
FAIRFAX CRYOBANK, CRYOGENIC LABORATORIES INC,
GENETICS & IVF INSTITUTE INC - INSPS,
INVESTIGATIONS, WARNINGS, ETC
RAISIN PERSONAL MONITOR K093976 PROTEUS PATCH
INCLUDING INGESTIBLE SENSOR K133263, K131524,
K131009
EPANOVA NDA 205-060 - APRVL RECS
INDIVIDUAL RECS - CMPLNTS TO CDER
LEVAQUIN NDA 21-721, NDA 20-635, NDA 20-634
QUIXIN, LEVOFLOXACIN - AERS 6/5/12 TO PRESENT
LEVOFLOXACIN, QUIXIN, LEVAQUIN NDA 21-721, NDA 20-
635, NDA 20-634 - AERS 11/1/97 TO 6/14/12
GEMSITABINE - NDA, IND
DENVER METRO AREA E COLI OUTBREAK - INVESTIGATION
RECS
ETHACRYNIC ACID NDA 16-092 LBLG, APRVL LTR, MOR,
ETC
PET FOOD LBLG - ENFORCEMENT ACTIONS, VIOLATIONS,
CORR, ETC 6/14 TO PRESENT
DKTS 1994P-0420, FDA-2008-0309-0001/CP
DR DENNIS MARCUS, MEDICAL COLLEGE OF GEORGIA,
ATLANTA, GA - EIRS, 483S, CORR 2005 TO 2011
TITLE, PROFESSIONAL INSTITUTIONAL AFFILIATIONS OF
TEMPORARY AND PERMANENT A/C MEMBERS 1997 TO 2014
COCA COLA CO - SAFETY OF CAFFEINE CORR, CO RESP
8/1/13
PEPSICO - SAFETY OF CAFFEINE CORR, CO RESP 8/1/13
MONSTER BEVERAGE CO - SAFETY OF CAFFEINE CORR, CO
RESP 6/24/13
KRAFT FOODS GROUP INC - SAFETY OF CAFFEINE CORR, CO
RESP 8/5/13
INDIVIDUAL RECS
INDIVIDUAL RECS
TAXOL (PACLITAXEL) LBLG
MYSLEE, FLUOXETINE, VYVANSE ETC - AERS
RISPERDAL, ZOLPIDEM TARTRATE, CYAMEMAZINE ETC -
AERS
EBI-005 IND RECS
CHELSEA FOOD SERVICES, DENVER, CO - 483 01/03/2013
- 01/15/2015
NEW ORAL ANTICOAGULANTS - TESTING, INVESTIGATION,
ANALYSIS ETC
LIST OF CFSAN FOIA REQUESTS SINCE 4/24/15
BLUE BELL - CORRECTIVE ACTION, AFFIDAVIT, RESPONSE
TO 483 07/23/2009 - 05/21/2015
NADA 139-877 TOTALON, NADA 140-844 TRAMISOL
K143531, K992911
BLA/STN 101246
HUMAN DRUGS - AERS
ZOMETA NDA 21-386 ALL VERSIONS
BK140141 SUMMARY
MASIMO CORP, IRVINE - EIR, 483, RESPONSE 01/01/2013
- 05/21/2015
Transcript of Gastroenterology and Urology Devices
Panel Meeting May 14-15, 2015
K101801
NDA 21299
MONSTER ENERGY DRINK REPORTS
REPORT RE CHEMICAL CONTAMINANTS IN DOMESTICALLY
PRODUCED ANIMAL DERIVED FOOD
HHSF223201210027I
MEDTRONIC - INFUSE BONE GRAFT EXEMPTION RPT COMM,
MEMOS, CORR
UNION SQUARE MEDICAL IMAGING & MANNOGRAPHY -
INVESTIGASTION, INSP RECS
MIRENA POST MARKETING SURVEILLANCE STUDY IN JAPAN
IDENTIFIER NCT01414140 - CORR, ATTACHMENTS,
ENCLOSURES, ETC
WALGREENS, COUNCIL BLUFFS, IA - USED SYRINGE IN A
BOTTLE OF WAL-MUCIL INVESTIGATION, COMM
SANDOZ - GLATOPA (GLATIRAMER ACETATE INJ) ANDA 090-
218 RECS
CARDIOPULMONARY BYPASS OXYGENATOR - REG AUTHORSHIP,
GUIDANCE AUTHORSHIP, 6 HOUR LIMIT
DONNATAL - LIST OF DRUGS, COMPANIES THAT REQUESTED
HEARINGS, LIST OF COHORT DRUGS REMOVED FROM MARKET,
LIST OF DRUGS THAT HAVE HAD A HEARING ETC
K011291
OCI IT POSITION DESCRIPTIONS GS-14
BISPHENOL A - RECORD LAYOUTS, DICTIONARTIES,
LOOKUP TABLES, ETC
DKA, SGLT2 - AERS
ROCKSTAR INC - SAFETY OF CAFFEINE LTR, CO RESP
6/24/13
MASTERS PHARMACEUTICALS, FAIRFIELD, OH WAYNE
CORONA - FINES, AGREEMENTS, INVESTIGATIONS
01/11/2007 - 05/22/2015
INDIVIDUAL RECS
JELLY BELLY CANDY CO - SAFETY OFO CAFFEINE LTR, CO
RESP 6/24/13
CXL-USA, LLC, ROCKVILLE, MD - EIR, 483, RESPONSE
8/18/14
WIL RESEARCH, HILLSBOROUGH, NC - EIR, 483, RESPONSE
02/01/2013 - 03/07/2013
JANSSEN RESEARCH & DEVELOPMENT, RADNOR, PA - EIR,
483, RESPONSE 08/05/2013 - 08/09/2013
AMERICAN NATIONAL RED CROSS, TOLEDO, OH - EIR, 483,
RESPONSE 08/01/2014 - 08/29/2014
PACIFIC NORTHWEST NATIONAL LABORATORY - JUSTIN

TEEGUARDEN, RUDY GUNAWAN, SESHS HANSON-DRURY, ETC
LTRS, EMAILS, ATTACHMNENTS 1/10 TO PRESENT NCTR,
NIEHS STAFF, LITTLE ROCK, AR - CLARITY PROGRAM WITH
PRINCIPAL INVESTIGATORS RECORDINGS, TRANS, AGENDAS
2/
OCI INTELLIGENCE RESEARCH SPECIALIST, INVESTIGATIVE
ANALYST GS-14 POSITION DESCRIPTIONS 05/01/2014 -
05/22/2015
JOSEPH A KWNETUS, MD, FLOWOOD, MS - EIR, 483,
RESPONSE 03/01/2013 - 03/18/2013
PMSG - LIST OF APPROVED COMPANIES TO IMPORT
AKORN, ALZA, BAXTER ETC - 483
ALL SHIPMENTS REGUALTED BY FDA 1/1-15/15
K992762
K111680, K120371, K120372 ETC
IND 64125, 64126 FORM 1572

ANNA KLUKOWSKA, WARSAW, POLAND - EIR, 483, RESPONSE
09/01/2014 - 09/30/2014
BLUE BELL CREAMERIES - COMPLAINTS THAT PROMPTED
INPSECTIONS 01/01/2005 - 05/22/2015
SHUR-GREEN FARMS, ANSONIA, OH - RESPONSE TO WARNING
LETTER 04/24/2015 - 05/24/2015
NOVACYL, THAILAND - EIR, 483, RESPONSE 04/01/2014 -
04/30/2014
CIPA LIMITED, INDIA - EIR, 483, RESPONSE 6/23/15
ALEXION PHARMACEUTICALS - EIR, 483, RESPONSE
09/01/2014 - 09/30/2014
NEPHRON PHARMACEUTICALS CORP, ORLANDO, FL - EIR,
483, RESPONSE 02/01/2014 - 02/28/2014
ENTRY NO UPS-1716242-3
TOX PATH SPECIALISTS, FREDERICK, MD - EIR, 483,
RESPONSE 07/01/2013 - 07/31/2013
PRODUCT SAFETY LABS, DAYTON, NJ - EIR, 483,
RESPONSE 08/26/2013 - 09/11/2013
CMPNT 140447
NDA 019258
TANDEM LABS, SALT LAKE CITY, UT - EIR, 483,
RESPONSE 05/13/2013 - 05/17/2013
STEPHEN W. WELDEN, MD, LUTZ, FL - EIR, 483,
RESPONSE 12/01/2014 - 01/08/2015
HUNTINGDON LIFE SCIENCES, EAST MILLSTONE, NJ - EIR,
483, RESPONSE 08/22/2014 - 09/12/2014
BAXTER HEALTHCARE CORPORATION, JAYUYA, PR - EIR,
483, RESPONSE 01/15/2014 - 02/11/2014
UNIVERSITY OF MARYLAND SCHOOL OF MEDICINE,
12/31/2012
TERUMO CARDIOVASCULAR SYSTEMS, ANN ARBOR, MI - EIR
01/01/2014 - 05/22/2015
ISRS 6892196, 6983996, 6984134 ETC
SHUR-GREEN FARMS, LLC - RESPONSE TO 483 12/15/2014
- 12/16/2014
MEDTRONIC - LETTERS REFERENCING MEDICAL DEVICES OR
SPINAL IMPLANTS FOR INTENDED USE OF VERTEBRAL BODY
REPLACEMENT DETERMINED NSE 01/01/2000 - 05/23/2015
FCN 54
Electronic Drug Product Reporting for Human Drug
Compounding Outsourcing Facilities Under Section
503B of the Federal Food, Drug, and Cosmetic Act
BLUE BELL ICECREAM - LISTERIA INVESTIGATION
SHUR-GREEN - 483, LETTERS, RESPONSES 11/19/2014 -
05/25/2015
K011693, K061317, K091246
NATIONAL DRUG CODE PRODUCT LIST 12/31/1996 -
12/31/2014
2013-4738
ANDA 200652
FAERS 78721474, 90524889, 93634437
MASTERS PHARMACEUTICALS, INC, WAYNE CORONA -
INVESTIGATION RECS ETC
RISPERDONE - NDA, ANDA APPROVAL, NONAPPROVABLE
LETTERS
OBIZUR, KITABIS PAK, BLINCYTO, ETC - AERS
K033437
DISHMAN PHARMACEUTICALS AND CHEMICALS LTD - EIR,
483 04/26/2013 - 09/09/2013
NDA 21321 UNREDACTED CHEMISTRY REVIEWS
05/27/2015
K132698
K093845
CASE REPORTS 3427653 3595565 3634908 ETC

FAERS 7872147, 8444988, 8784430 ETC
K933652
FLOURIDE DENTIFRICE DRUG PRODUCTS - TESTING
PROCEDURES
AMERICAN HOME PATIENT INC - 483, EIR, WARNING LTR
1/12 TO PRESENT
CELEXA - APRVL, EFFICACY RVWS, AER, CMPLNTS,
SIMPLY THICK - FOI REQUESTS 3/12/15 TO PRESENT
NEBRASKALAND, BRONX, NY - CMPLNTS SINCE 2000
LATINO FOOD DISTRIBUTORS, WEST SPRINGFIELD, MA -
CMPLNTS SINCE 2000
INDIVIDUAL RECS
DUCHESNAY INC - DICLECTIN APRVL, RVWS, AER
K110268
LABORATORIO MAGNACHEM INTL - RESP TO 483'S
K133987
K150155
CONSUMER COMPLAINT 137532 RECS
K061201
K133333
VINCULOS AGRICOLAS E.I.R.L. IMPORT ALERT RECS
04/01/2015 - 05/24/2015
PYRAMID LABORATORIES - 483 04/29/2015 - 05/31/2015
K133125
jJLM PHARMACTECH, LLC - EIR 11/13/2012 - 12/31/2012

K131700
YOSEMITE HANTAVIRUS OUTBREAK 2012 CDC RECS
NAVILYST MEDICAL - NAMIC FLUID DELIVERY SET MEDRAD
- MARK V PROVIS POWER INJ MDRS
CLR ROASTERS LLC, MIAMI, FL - INSP RECS 5/19/15
ROCKSTAR INC - SAFETY OF CAFFEINE CORR, CO RESP
6/13
ZIMMER INC - TOTAL HIP PROSTHESIS INAPPROPRIATE
PROMOTIONAL CLAIM CMPLNTS 11/14/14
ESTABLISHMENTS, ETC - DOMESTIC AND FOREIGN INSPS
4/1-30/15
BISPHENOL A, PHTHALATES, FLAME RETARDANTS, ETC -
FOI REQUESTS 2008 TO PRESENT
CANAGLIFOZIN - RPTS 1/1/13 TO 1/2/14
ALLERGAN - 410 COHESIVE GEL BREAST IMPLANTS LIST OF
PLASTIC SURGEONS CHOSEN FOR FDA STUDIES
RESPONSE TO CONSUMER COMPLAINT
NAVIDEA BIOPHARMACEUTICALS, INC - ORPHAN PRODUCTS
RECS RE LYMPHOSEEK 05/01/2014 - 10/31/2014
MICROSOFT BAND - APPROVAL RECS 01/02/2014 -
01/03/2015
SEVENTH WAVE LABORATORIES, CHESTERFIELD, MO - EIR
09/27/2013 - 01/16/2015
K080377, K120949
ETHICO ENDO-SURGERY SUTUE ASSISTANT - APPROVAL RECS
12/12/1987 - 05/26/2015
NAVILYS MEDICAL NAMIC FLUID DELIVERY SET, MEDRAD
MARK V PROVIS POWER INJECTOR - INVESTIGATION,
RECALL, MALFUNCTION RECS 3/11/2010 - 05/26/2015
TPSAC CONFLICT OF INTEREST RECS
INTUITIVE SURGICAL - 510K RECS
ZHEJIANG HISUN PHARMA CO, CHINA - 483 03/01/2015 -
03/30/2015
ANDA 202298
XIAFLEX - AERS
PFIZER -LYRICA (PREGABALIN) RESP LTR 12/09 : NON
APPROVABLE LTR 8/04 : RESP LTR OR NON-APPROVABLE
BAUSCH & LOMB - LUMINESSE BRIMONIDINE TARTARATE
OPHTHALMIC SOL NDA 208-144 ISR 369082, 3445488,
3778011, ETC
Clinical Investigator Inspection Reports (CLIIL)
and FDA Form 483s
SCANTIBODIES LABORATORY INC, SCANTIBODIES CLINICAL
LABORATORY INC, SCANTIBODIES BIOLOGICS INC -
INSP/AUDITS, EIRS, 483S, ETC 1/1/13 TO 12/31/14
K820622, K790738
BIAXIN (CLARITEHROMYCIN) - LONG TERM TOXICITY
STUDIES
K080769
CMP PHARMA GMBH & CO KG, GERMANY - EIR 09/01/2013 -
09/30/2014
IND 64125, 64126 FORM 1572
APPENDIX M, CLINICAL PROTOCOL FOR #0712-886, #1010-
1071, #1207-1176, #1312-1281
K142564
DRUG ACCESS - RECS RE CEASE AND DESIST, EAP ETC
01/01/2010 - 07/31/2015
DR DEMETRIUS LOPES - 483 01/01/2001 - 01/01/2011
LETTER FROM FDA TO PURDUE PHARMA RE OXYCONTIN OCT
1994
LIST OF QIDP-DESIGNATED DRUG APPLICATIONS
7241182 7250072 6642518 ETC
MEETINGS BETWEEN FDA AND COCA-COLA, CORR 01/01/2005
- 04/30/2015
PENN PHARMACEUTICAL SERVICES LTD, UK - EIR
11/01/2014 - 05/28/2015
HILLANDALE FARMS, PENNSYLVANIA, OHIO, IOWA - 483
07/01/2010 - 05/25/2015
LIST OF DRUGS ON DO NOT COMPOUND LIST
WOCKHARDT - 483 ISSUED MAY 2015
SAMPLE RESULTS
MUCUNA PRURIENS - AERS
FORM FDA 3542 FOR NDA 20571
JETREA - AERS
FARXIGA - AERS
CLARIS LIFE SCIENCES, INDIA - 483 05/01/2015 -
05/15/2015
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 LOG 5/18-23/15
CLOSD FOIA REQUESTS 5/11-15/15
K033333
FOI DAILY LOG 4/27/15-5/2/15
FOI DAILY LOG 4/27/15-5/1/15
FOI DAILY LOG 4/27/15-5/1/115
FOI DAILY LOG 4/27/15-5./1/15
FAP 9A3441
FOI DAILY LOG 4/27/15-5/1/15
FOI REQUESTS 4/20-24/15
YOUNG VETERINARY RESEARCH SERVICES, TURLOCK, CA -
483 02/19/2013 - 03/18/2013
FOI DAILY LOG R5/18-23/15
FOI DAILY LOG 4/27/15-5/2/15
FAP 6A4763
FOI DAILY LOG 4/27/15-5/1/15
K874106
FOI DAILY LOIG 5/18-22/15
FOI DAILY LOG 4/27/15-5/1/15
FOI DAILY LOG 5//4-8/15
FOI DAILY LOG R5/11-15/15
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
FEDERAL TRADE COMMISSION (FTC), DEPT OF

AGRRICULTURE (USDA), COSMETIC MFRS, ETC - USE OF
GREEN MARKETING TERMS TO DESCRIBE COSMETICS
CMPLNTS, RECS LAST 5 YRS
ASBESTOS CONTAMINATION OF COSMETICS, FOOD, AND
DRUGS THAT CONTAIN TALC - RECS, CORR 2000 TO
PRESENT
ORANGE BOOK 1985 ORANGE BOOK SUPPLEMENTS 1985-2013
GRAHAM CHEMICAL - LIDOCAINE 5% OINTMENT ANDA 80-210

DASABUVIR IND 101-636 - CORR, RECS
VIEKIRA PAK NDA 206-619 - CLNCL TRIALS SIMULATIONS,
CORR, APRVL RECS, ETC
OMBITASVIR IND 108-434, NDA 206-619 - EXPOSURE-
EFFICACY MODELING, EXPOSURE-RESPONSE ANALYSES,
CORR, ETC
K945594, K951085, K940208 ETC
PARITAPREVIR INDA 103-526 - CLNCL TRIAL
SIMULATIONS, EXPOSIURE-RESPONSE ANALYSES, EXPOSURE-
EFFICACT MODELING CORR, ETC
INDIVIDUAL RECS
FDA CORR WITH INDIA MINISTRY OF HEALTH AND FAMILY
WELFARE 01/02/2014 - 06/02/2015
K093477
NALMEFENE, NALTREXONE, BACLOFEN, ETC - CLNCL TRIAL
RECS
DRUG MASTER FILE SPREADSHEET
ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY
ENDOSCOPES REFERENCED IN EXECUTIVE SUMMARY - MDR
HARVONI - MEDWATCH REPORTS
2015-324 CERTIFIED
IMPORT DATA
FCN 56, 345
LIST OF TOBACCO RETAILERS IN MINNESOTA
ICLUSIG - AERS
TECFIDERA - 5 YEAR NEW CHEMICAL ENTITY EXCLUSIVITY
RECS
JACOBS TOBACCO COMPANY - SE REPORTS
CORR FROM WEINBERG GROUP RE PHTHALATES OR BPA CORR

FROM JOHN KYTE, BURSON MARSTELLAR RE PHTHALATES OR
BPA CORR FROM SOCIETY OF PLASTICS INDUSTRY MEMBERS
RE PHTHALATES OR BPA
DR VESOLE, HACKENSACK, NJ - 483, EIR
ATLANTA, GA - EIRS, 483S, CORR 2005 TO 2011
GMP, GLP, GCP INSPS 1/16/15-5/1/15
HEPARIN - AERS 2014
JOHN GOFF, GASTROENTEROLOGY ASSOC PC, DENVER, CO -
K140580
KURT LESH, COLORADO SPRINGS FAMILY PRACTICE,
COLORADO SPRINGS, CO - 483S 5/09 TO PRESENT
LAWRENCE WRUBLE, MEMPHIS GASTROENTEROLOGY GROUP,
MEMPHIS, TN - 483S 2/06 TO PRESENT
ROBERT PROVENZANO, ST JOHN HOSPITAL & MEDICAL
CENTER, DETROIT, MI - 483S 4/08 TO PRESENT
MARK RINGOLD, NEW RIVER VALLEY RESEARCH INSTITUTE,
CHRISTIANSBURG, VA - 483S 1/12 TO PRESENT
SUZANNE GAZDA, INTEGRA CLINICAL RESEARCH, SAN
ANTONIO, TX - 483S 10/05 TO PRESENT
MARIO JUAREZ, PANACEA CLINICAL RESEARCH, SAN
ANTONIO, TX - 483S 6/14 TO PRESENT
JOHN LOWE, ADVANCED RESEARCH INSTITUTE, OGDEN, UT -
DOUGLAS YOUNG, NORTHERN CALIFORNIA RES CORP,
SACRAMENTO, CA - 483S 7/06 TO PRESENT
GERALD PIERONE, TREASURE COAST INFECT DISEASE
CONSULTS, VERO BEACH, FL - 483S 6/01 TO PRESENT
SUNIL DHAWAN, EAST BAY DERM MED GRP, FREMONT, CA -
APOTEX PHARMACHEM INC, ONTARIO, CANADA - 483
10/01/2014 - 01/20/2015
ANDREW SCHREIBER, NG, IRVINE, CA - 483S 6/12 TO
PRESENT
MOUSTAFA MOUSTAFA, SOUTH CAROLINA NEPHROLOGY &
HYPERTENSION CENTER, ORANGEBURG, SC - 483S 8/10 TO
PRESENT
MAHENDRA SANAPATI, ADVANCED PAIN CARE CLINIC,
EVANSVILLE, IN - 483S 1/14 TO PRESENT
BETH SAFIRSTEIN, MD CLINICAL, HALLANDALE BEACH, FL
- 483S 5/09 TO PRESENT
GIGI LEFEBVRE, MERIDIEN RESEARCH, ST PETERSBURG,
FL - 483S 6/11 TO PRESENT
ROY FREEMAN, DEACONESS HOSPITAL, BOSTON, MA - 483S
8/95 TO PRESENT
RESPONSE TO 483 - RECS PREVIOUSLY RELEASED UNDER
FOIA 01/01/2014 - 06/01/2015
VIVITROL, NALTREXONE - AERS
NDA 21-196/S-005 MEDICAL REVIEW
SHANDONG XINHUA PHARMACEUTICAL CO LTD, SHANDONG,
CHINA - EIR 03/24/2014 - 04/04/2014
NDA 021196 - SBA
COPAXONE - SBA
K143536
NORCO - APPROVED LABELING (CERTIFIED) 01/01/2008 -
03/01/2010
K131158
ANDA 200652, 91149, 91422 - REMS NOTIFICATION
LETTERS
NDH MEDICAL INC, SAINT PETERSBURG, FL - EIR MOST
RECENT
NOVA BIOMEDICAL CORP, BILLERICA, MA - EIR 7/6-17/13

AFLURIA PLATINOL - AERS
LIST OF GRANTS OF NCE SINCE ENACTMENT OF HATCH
WAXMAN
FCN 0561
K102082
RECALL F-2314-2015
BIOTEST PHARMACEUTICALS - WARNING LETTER 01/01/2013
- 05/26/2015
FLORIDA BOTTLING INC LAKEWOOD ORGANIC LAKEWOOD
JUICES - INVESTIGATIONS, INSP, CMPLNTS SINCE 2012
FOSAMAX - FEMUR FRACTURES
DKT 3:13-CV-01094
FDA INTRAMURAL FUNDING
DKT 00D-1392
SIROB IMPORTS, INC, LINDENHURST, NY - INSP, EIR,
FOOD EXPORT CERT
PALMER NATURAL PRODUCTS - 483
ARSENIC IN RICE & RICE PRODUCTS RISK ASSESSMENT -
DRAFT RPT CORR, STUDIES, RESEARCH, ETC
NATIONAL BIOCHEMICALS CORP - INSPS 6/24-26/96,
7/8/96 2/22-24,28,29/00, 3/2/00 RECS
NEOSTIGMINE METHYLSULFATE - APPROVAL POSTING DATE
CVS HEALTH CORP AER, MEDWATCH
ACCERA INC - WARNING LTR 1/14
YS HEALTH - WARNING LTRS, INSP, 483, SINCE 2010
K933652
CASE 3740975, 3877826, 3925288, ETC
SARAPIN (SARRACENIA PURPUREA) LBLG
FOX RIVER FIBER - NOL SUBMISSION, CORR
DKT 019-0343
SMITH & NEPHEW ORTHOPAEDICS - BIRMINGHAM HIP
RESURFACING (BHR) SYS P040033/S001,S002,S003 ETC
APRVL RECS
CORIN USA - CORMET HIP RESURFACING SYS
P050016/S001,S002,S003, ETC APRVL RECS
K024148
MICROPORT ORTHOPEDICS INC - CONSERVE PLUS TOTAL

RESURFACING HIP SYS APRVL, P030042/S002, S003, S004
LYRICA (PREGABALIN) - AER SINCE 1996
FCN 0728
DRUG SHORTAGE RECS 01/01/1965 - 05/28/2015

PENTAX MEDICAL, PENTAX PRECISION INSTRUMENTS
ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY -
510K 01/01/2010 - 05/31/2015
MEDIVATORS REPROCESSING SYSTEMS AUTOMATIC ENDOSCOPE

REPROCESSOR - 510K 01/01/2010 - 05/31/2015
FUJIFILM, FUJI MEDICAL SYSTEM USA INC, FUJINON, INC
- ENDOSCOPE MDR 01/01/2010 - 05/31/2015
DUODENOSCOPE 510K REFERENCED IN FDA EXECUTIVE
SUMMARY 01/01/2009 - 05/31/2015
CUSTOM ULTRASONICS - AUTOMATIC ENDOSCOPE
REPROCESSOR 510K 01/01/2010 - 05/31/2015
AUTOMATED ENDOSCOPE REPROCESSORS REFERENCED IN FDA
EXECUTIVE SUMMARY - MDR
K091495
FUJIFILM, FUJI MEDICAL SYSTEMS USA USA, FUJINON
ENDOSCOPE - 510K
PENTAX MEDICAL, PENTAX PRECISION INSTRUMENTS - MDR
SUMMARIES 01/01/2010 - 05/31/2015
MEDIVATORS REPROCESSING SYSTEMS AUTOMATIC ENDOSCOPE

REPROCESSOR - MDR 01/01/2010 - 05/31/2015
CUSTOM ULTRASONICS - AUTOMATIC ENDOSCOPE
REPROCESSOR MDR 01/01/2010 - 05/31/2015
IND 47776
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
VIEKIRA PAK - NDA 206-619, PARITAPREVIR 103-526,

OMBITASIVIR 108-434 CLNCL TRIAL SIMULATIONS, APRVL,
CORR RELATED TO EXPOSURE-EFFICACY MODELING
EXPOSURE-RESP AFTER 1/08 & PRIOR TO 12/21/14
SPECTRUM PHARMACEUTICALS INC, IRVINE, CA - EIRS
3/13-18/14
PRADAXA JANSSEN- RIVAROXABAN 20 MG DABIGATRAN,
ISR 10271037, ETC
FDA ENTRY DOCUMENTATION REQUEST ALL DOCUMENTATION
MAY 16, 2015 - MAY 31, 2015
K123300
K140516
ABBOTT LABS, ABBOTT PARK, IL - SYNTHROID VARIATION
IN STRENGHT FROME ON TAB TO ANOTHER
K140497
K113811
prescription drug list published in the annual
version of orange book from 2000 to 2013
K141785
MYLAN PHARMACEUTICALS INC, CANONSBURG, PA -
LEVOTHYROXINE (LEVOTHYROXINE SODIUM) VARIATION IN
STRENGTH FROM ONE TAB TO ANOTHER
LIST OF PHARMACEUTICAL AND FOOD PRODUCTS WITH
SILICA APPROVED BY FDA FOR HUMAN USE, CLINICAL
TRIALS 06/04/2015 - 06/18/2015
CAROLINA BIOLOGICAL SUPPLY COMPANY, BURLINGTON, NC
- ANIMAL PURCHASES 09/01/2014 - 05/30/2015
MEMO RE WAIVER OF REQUIREMENT FOR SINGLE, SHARED
REMS PROGRAM
DESIGNER ANABOLIC STERIOID CONTROL ACT OF 2014 -
COMM, EMAILS
UNSATURATED KETONE IMPURITIES IN OPIODS
STILLMEADOW, INC, DALLAS, TX - EIR 04/23/2013 -
06/05/2013
WENNG DRUCK GMBH - EIR, 483, RECALL 06/01/2012 -
06/03/2015
L'OREAL USA MELA-D PIGMENT CONTROL - COMM WITH
EMPLOYEES, AGENTS, REPRESENTATIVES, WARNING LTR
2/12/15
K040129
NEW WAVE SEAFOOD INC, STAMFORD, CT - EIR
GMP INSPECTION LIST RE COMPLIANCE WITH 21 CFR 111
01/01/2014 - 12/31/2014
DELAWARE INLAND BAYS - SHELLFISH SANITARY AND
SHORELINE SURVEYS, CORR 01/01/2011 - 06/01/2015
EXPAREL - IND RECS
NDA 016750
G&W LABORATORIES, SOUTH PLAINFIELD, NJ - 483, EIR
TWO MOST RECENT 06/01/2010 - 06/03/2015
ANDA 203005
K100786
PACIRA PHARMS - EXPAREL APRVL MTG MINS 3/15, 4/15
CHELSEA THERAPEUTICS INTERNATIONAL LTD - NORTHERA

(DROXIDROPS) NDA 203-202 FOI REQUESTS MADE BY ROMAN
ZAK OR FARUQI & FARUQI LLP 3/29/12 TO 3/29/15
CLOVERHILL PASTRY-VEND, CHICAGO, IL - 483
04/22/2014 - 04/22/2014
CERTIFIED RECS
APPLIED MEDICAL RESOURCES - VOYANT OPEN SEALER-
DIVIDER DVC K143517
DOONESBBURY CARTOON STRIP PARODY OF GOVERNEMNT
EMMPLOYEES OR POLICIES 10/70 TO PRESENT
TEH FONG MIN - OPTICAL BRIGHTENERS IN FOOD CONTACT
PAPER NO OBJECTION LTRS
EXPERIMENTAL STUDY ON CONSUMER RESPONSES TO

NUTRITION FACTS LABELS WITH VARIOUS FOOTNOTE
FORMATS AND DECALRATION OF ADDED SUGARS -
QUESTIONNAIRE, SURVEYS, FOCUS GROUPS ETC 4/13 TO
PRESENT
PARTIALLY HYDROGENATED OIL (PHO) - FOOD ADDITIVE
PETITIONS 1/15 TO PRESENT
LEVONORGESTREL/ETHINYL ESTRADIOL TABS ANDA 201-088
- APRVL LTR
AZITHROMYCIN ORAL SOL ANDA 65-488 - APRVL LTR
AZITHROMYCIN TABS ANDA 65-400 - APRVL LTR
ESCITALOPRAM OXALATE SOL ANDA 203-967 - APRVL LTR
STAAR SURGICAL - INSPECTION REPORTS 1/1/2013 -
1/20/2015
BUPROPION HCL ER TABS ANDA 202-304 - APRVL LTR
RISENDRONATE SODIUM DELAYED-RELEASE TABS ANDA 203-
217 - APRVL LTR
ACITRETIN CAPS ANDA 204-633 - APRVL LTR
LEVITIRACITAM ER TABS ANDA 203-468 - APRVL LTR
METHOTREXATE SODIUM TABS ANDA 201-749 - APRVL LTR
BICALUTAMIDE TABS ANDA 200-274 - APRVL LTR
DESOGESTREL/ETHINYL ESTRADIOL TABS ANDA 202-085 -
APRVL LTR
GLIPIZIDE ER TABS ANDA 202-298 - APRVL LTR
AFLURIA - VAERS 2012-2013
PHARMACEUTCAL COMPANIES, CROs - PHARMACOVIGILANCE
AND GCP INSP RPTS 1/14 TO 5/15
K063677
AURORA PRODUCTS - INSPECTION REPORTS 01/01/2015 -
06/02/2015
FAERS REPORTS
INSPECTION LIST 01/01/2008 - 06/01/2015
PURTOX IND 012042, BOTULINUM TOXIN, MENTOR
CORPORATION, MENTOR WORLDWIDE, ETC
NCI - CIRB, EMMES CORP - EIR 01/01/2015 -
06/06/2015
SYNERGY HEALTH CONCEPTS 05/01/2012 - 06/03/2013
CORR FROM HILLARY CLINTON 01/03/2001 - 01/21/2009
SCINOPHARM TAIWAN, LTD - 483
SCINOPHARM TAIWAN, LTD - EIR
HOSPIRA LIDOCAINE 2% - AERS
NDA 202880
LONZA AG, SWITZERLAND - EIR, 483 03/31/2015 -
03/31/2015
PYRAMID LABORATORIES - INSPECTION RECS PREVIOUSLY
RELEASED 01/01/2000 - 06/03/2015
INDIVIDUAL RECS
IXAZOMIB - AERS
K122295
NDA 8578
K132560, K102893, K041934 ETC
K970052
METHIMAZOLE ISCR AND LIVER INJURY
HOSPIRA, INC, MCPHERSON, KS - 483, EIR 04/03/2015 -
04/03/2015
PHENYLEPHRINE - RECS RE CONCENTRATION 01/01/2011 -
06/05/2015
ANDA 202937
K983068, K950566, K953645
PATHEON MANUFACTURING SERVICES LLC, ETC -
INPSECTION RECS PREVIOUSLY RELEASED 05/30/2010 -
05/30/2015
K041606
ANDA 202610
CANNABIS, CANNABIDIOL - DIETARY SUPPLEMENT ADVERSE
EVENTS
NDA 203929 APPROVAL LETTER
AUREX LABORATORIES, EAST WINDSOR, NJ -
GREYHOUNDS ARE OUR BUSINESS - EIR 10/01/2013 -
12/01/2013
K112205
INVENTURE FOODS, JEFFERSON, GA - EIR, 483, RESPONSE

SOLARA, INC - INVESTIGATION RECS 01/01/2012 -
12/31/2014
K090367, K141946, K142105
PMA 040033, K5002996, K061243 ETC

BLUE BELL CREAMERIES - CORR WITH FDA, LAB RESULTS
01/01/2015 - 06/08/2015
LIST OF TOBACCO RETAILERS IN VIRGINIA 01/01/2012 -
01/31/2015
MASTERPHARM PHARMACY - RECS RE APPROVAL TO COMPOUND
MEDICATION FOR CLINICAL TRIALS 03/06/2011 -
06/04/2015
NANNOCHLOROPSIS - INVESTIGATIONAL FOOD ADDITIVE,
FOOD USE AUTHORIZATIONS, FOOD ADDITIVE PETITION,
ETC
BRUCE SALZBERG, ALTANTA GASTROENTEROLOGY
ASSOCIATES, A TLANTA, GA - 483'S 11/08 TO PRESENT
ZIAD YOUNES, GASTRORENTEROL CTR MIDSOUTH, MEMPHIS,
TN - 483'S 12/06 TO PRESENT
DOUGLAS WOLF, ATLANTA GASTROENTEROLOGY ASSOCIATES
LLC, ATLANTA, GA - 483'S 10/07 TO PRESENT
KENNETH BROWN, DIGESTIVE HLTH ASSOC TEXAS, PLANO,
TX - 483'S 9/10 TO PRESENT
2013-323, 2014-1612, 2014-4237
LIST OF 483'S FOR PHARMACEUTICAL, BIOLOGICS &
MEDICAL DVC MFG & CLNCL TRTIAL FACILITIES BOTH IN
THE US & OUTSIDE THE US 5/1-31/15
IRS 182803, 183304, 182912 - CAERS
QUELL - K130919
ENTRY 231-8131584-1
EXPLANATION OF FIELDS ADDED TO THE CLASSIFICATION

DATABASE FILE, NAMELY PHYSICALSTATE,
TECHNICALMETHOD, TARGETAREA, IMPLANT FLAG & LIFE
SUSTAIN SUPPORT FLAG
DR KEITH ROBINSON, OAKLAND PARK, FL - EIR, 482,
4836/23/14-7/3/14
NUTECK DISPOSABLES INC - SIMPLY RIGHT WIPES
RECALL, CORR, LAB STUDIES, ETC
BAILY INTERNATIONAL (SPICE KING), ST LOUIS, MO -

RECALL OF AFOREMENTIONED SPICE KING PRODS
INVESTIGSATION NOTES, RECORDED STATEMENTS,
PHOTOGRAPHS, ETC 4/26/11
ISR 3794682, 6099237, 6355270, ETC
BRIMONIDINE TARTATE - ISR 4157759, 6750362,
8023104, ETC
ABB VIE INC, NORTH CHICAGO, IL - DUODOPA (LEVODOPA
& CARBIDOPA NDA 203-952 CORR,ORPHAN DRUGS
DESIGNATION & APRVL
WESTRIDGE LABS, SANTA ANA, CA -I-D GLIDE EIR, 483,
482, ETC
IN VIVO BIOEQIVALENCE 7348.001 GLP (NONCLINICAL
LABS) 7348.808 GLP (NONCLINICAL LABS) EPA DATA
AUDIT INSP 7348.808A, ETC 483S 2013
JOLT, ROCKSTAR, 5 HOUR ENERGY DRINKS, ETC - CAERS,
MEDICAL RPTS, MEMOS, ETC 1/13 TO PRESENT
MARGARET HAMBURG, ELIZABETH DICKINSON, MARTINA
VAMADO, ETC - CV
TECFIDERA (DIMETHYL FUMARATE) 240 MG - IS THERE ANY

DATA ON PATIENTS THAT DISCONTUNUE TECFIDERAL UNTIL
LYMPHOPENIA IS RESOLVED & RESTARTED AGAIN? DO THEY
HAVE THE SAME AERS EFFECT OF LOW LYMPHOCYTES? HAVE
THERE BEEN MALIGNANCIES RPORTED ON OTHER PATI
SODIUM SULFACETAMIDE - AERS
CANNABIS, CANNABIDIOL IN IND, MARKETED DRUGS - AERS
AIRGAS, TACOMA, WA - EIR 01/05/2015 - 01/17/2015
CMC BIOLOGICS, BOTHELL, WA - EIR, 483
PREMPRO - LABEL, PACKAGE INSERT, CHANGES ETC
01/01/2005 - 12/31/2013
ESTRADIOL/NORETHINDRONE - SBA, LABELS, PACKAGE
INSERTS ETC 04/01/2008 - 05/15/2013
K143531
FDA-ORA-15-DE-1345224-KBH - APPLICATION, CV OF
SUCCESSFUL CANDIDATE
THE ANGELES CLINIC, SANTA MONICA, CA - 483, EIR,
CORR 01/01/2010 - 05/26/2015
FISHER DIAGNOSTICS, MIDDLETOWN, VA - 483S 12/1-
31/14
BENEFUL - PRODUCT TESTING RESULTS 01/01/2011 -
06/05/2015
LIST OF DRUGS APPROVED FOR EXPANDED ACCESS USES

K062817
GALENA BIOPHARMA INC, PORTLAND, OR - 483 11/17/2014
- 11/21/2014
ANDA 091620
DEPO MEDROL - AERS
K072374
bb2121 BCMA CAR-T IND RECS
ANDA 062349, 062512, 062517, ETC - LABELING
PREVICOX - AERS
JM HUBER CORP, QUINCY, IL - 483S 12/1-31/14
PRILOCAINE - AERS
P080027
K081042
NDA 021537/S-008
JUBILANT HOLLISTERSTIER, SPOKANE, WA - 483, WARNING
LETTER 01/08/2012 - 06/08/2015
DOOR COUNTY, WISCONSIN - PARAMEDICS INVESTIGATION
01/01/2014 - 06/05/2015
AKORN, INDIA - 483 01/01/2014 - 06/09/2015
COMM BETWEEN FDA, SOUTH CAROLINA, AND CDC RE
POSITIVE LISTERIA TESTS ON BLUE BELL ICE CREAM
01/01/2015 - 06/05/2015
RODAN AND FIELDS - UNTITLED LETTERS, WARNING
LETTERS, ENFORCEMENT ACTIONS 06/01/2011 -
06/01/2015
SYNAPSE BIOMEDICAL INC, OBERLIN, OH THERMEDX LLC,
SOLON, OH RAM PRECISION INDUSTRIES, CENTERVILLE,
OH, ETC - 483S 12/1-31/14
MEDWATCH REPORTS
REFRIG-IT WAREHOUSE, KEARNY, NJ - PINE NUT RECS
03/01/2015 - 06/08/2015
BEUTHANASIA D - SAFETY STUDIES
118-1108244-2-001-004 LAB REPORT
INDIVIDUAL RECS
CBER SOP 000333 POTENCY DETERMINATION OF

INACTIVATED INFLUENZA VIRUS VACCINE BY THE SINGLE
RADIAL IMMUNODIFFUSION TEMPLATE SRID TRIVALENT
CALCULATIONS
THIOPENTAL SODIUM, PANCURONIUM, POTASSIUM CHLORIDE
- IMPORTATION RECS
CMPLNT REGARDING CONTAMINATION AND POOR QUALITY
CONTROL AT THE NIH PHARMACEUTICAL DEVELOPMENT
SERVICE
DRUG LIST - FOI REQUESTS 2014-493, 2014-1703
FDA RECORD RETENTION SCHEDULE
CARDIOVASCULAR SYSTEMS INC, HOUSTON, TX RIGHT

VALUE DRUG STORES INC, HURST, TX AMERICAN
SPECIALTY PHARMACY, PLANO, TX, ETC - 483S 12/1-
31/14
BAUSCH & LOMB, TAMPA, FL - 483 03/04/2015 -
03/06/2015
MEDICAL DEVICE RECALL DATA 10/01/2012 - 06/01/2015
DATA INTEGRITY REQUIREMENT FOR CHINESE
PHARMACEUTICAL FIRMS
P120032
ADVANCEPIERRE FOODS, ENID, OK, ETC - 483
MD-715
DOTERRA - COMPLAINTS, RESPONSE TO 483 01/01/2015 -
06/08/2015
FDA ENTRY DOCUMENTATION REQUEST AM1-0196057-4
SRI KRISHNA PHARMACEUTICALS, HYDERABAD, INDIA - 483
08/01/2014 - 12/20/2014
ZYTO TECHNOLOGIES INC, LINDON, UT CYCLOTRON

RADIOCHEMISTRY LAB (HUNTSMAN CANCER INSTITUTE),
SALT LAKE CITY, UT BAXTER CORPORATION ENGLEWOOD,
ENGLEWOOD, CO - 483S 12/1-31/14
ANDA 077863 SBA
10280030, 10335010, 10343763, ETC
ADVANCEPIERRE FOODS - LETTERS, COMMUNICATIONS
01/01/2010 - 06/01/2015
CAPTEK SOFTGEL INTERNATIONAL, CERRITOS, CA - EIR
01/01/2008 - 06/09/2015
RECS RE USE OF PLANT DNA MADE BY APPLIED DNA
SCIENCES, ETC 06/01/2014 - 06/09/2015
GLENMARK PHARMACEUTICALS LIMITED, INDIA - 483
01/01/2015 - 05/27/2015
FREEMAN MANUFACTURING CO, STURGIS, MI KREMERS
URBAN PHARMACEUTICALS INC, SEYMOUR, IN MEDICAL
MINDS LLC, ALLENDALE, MI, ETC - 483S 12/1-31/14
J&D LABORATORIES, VISTA, CA - EIR 01/01/2010 -
06/09/2015
HIKMA, PORTUGAL - 483 2003 TO PRESENT
ENTRY 916-2702957-1 TEST RESULTS
EMAIL SENT BY JEFF VENTURA TO ASSOCIATED PRESS RE
NEBREASKA ATEMPTS TO IMPORT LETHAL INJECTION DRUGS
TO US, OTHER CORR 05/29/2015 - 06/09/2015
FDA SCORES FOR EMPLOYEE VIEWPOINT SURVEY, FEDERAL

EQUAL OPPORTUNITY RECRUITMENT PROGRAM, DISABLED
VETERANS AFFIRMATIVE ACTION PROGRAM PLANS SUBMITTED
TO OPM ETC
DEERLAND ENZYMES, KENNESAW, GA - EIR 01/01/2010 -
06/09/2015
FLORIDA SUPPLEMENTS, HOLLYWOOD, FL - EIR
A-PLUS SECURE PACKAGING, LAVERGNE, TN - EIR
01/01/2010 - 06/09/2015
ZYTIGA - AERS
VOLTAREN GEL - AERS
EUSA GLOBAL LLC (DBA ECLERIS USA), MEDLEY, FL FEN
DENTAL MANUFACTURING INC - 483S 12/1-31/14
ANDA 205256
REPORTS FOR 10356808 DIFICID
REPORTS FOR 10284699, 10289533, 10290402,
10301457, ETC DULERA
NADA's 141-276 141-280 141-278 ETC TYPE C BLUEBIRD
LABELING
ERFOSAFE PRODUCTS LLC (DBA PRISM MEDICAL), MARYLAND
HEIGHTS, MO ORTHOTIC & PROSTHETICS ONE INC,
WATERLOO, IA - 483S 12/1-31/14
SANDOZ INC - RESC SUBMITTED FOR GLATIRAMER ACETATE
INJECTION 20 MG/ML
AMGEN MANUFACTURING LIMITED, JUNCOS, PR - EIR, 483,
RESPONSE 01/01/2015 - 01/23/2015
SANTA CLARA VALLEY MEDICAL CENTER IRB, SAN JOSE, CA
- EIR, 483, RESPONSE 08/01/2014 - 09/19/2014
DR NICOLAS SHONKA, OMAHA, NE - EIR, 483, RESPONSE
06/01/2014 - 06/20/2014
OCTAPHARMA PLASMA, INC, OMAHAM, NE - EIR, 483,
RESPONSE 12/01/2014 - 01/08/2015
MERCK SHARP & DOHME, RAHWAY, NJ - EIR, 483,
RESPONSE 05/01/2014 - 05/19/2014
ST JOHN HEALTH SYSTEM IRB, TULSA, OK - EIR, 483,
RESPONSE 12/01/2014 - 01/09/2015
BIOTEST PHARMACEUTICALS, CORP, BOCA RATON, FL -
EIR, 483, RESPONSE 07/01/2014 - 08/14/2014
LONZA BIOLOGICS, PORTSMOUTH, NH - EIR, 483,
RESPONSE 01/01/2015 - 02/10/2015
VERTEX PHARMACEUTICALS, BOSTON, MA - EIR, 483,
RESPONSE 10/01/2014 - 10/16/2014
MAST BIOSURGERY USA INC, SAN DIEGO, CA NEW WORLD

MEDICAL INC, RANCHO CUCAMONGA, CA WATSON
LABORATORIES INC, CORONA, CA, ETC - 483S 12/1-31/14
COMPLAINT 141514
ORANGE BOOK ELECTRONIC ZIPPED FILES
TOMASZ SZCZPANSKI, POLAND - EIR, 483, RESPONSE
09/08/2014 - 09/11/2014
FOIA LOG 01/01/2014 - 05/31/2015
PATHEON INC, CANADA - EIR, 483, RESPONSE
01/01/2015 - 01/31/2015
BATTELLE MEMORIAL INSTITUTE, COLUMBUS, OH - EIR,
483, RESPONSE 03/01/2014 - 04/04/2014
CHARLES RIVER, NV - EIR, 483, RESPONSE 07/01/2012
- 07/25/2012
ALVARO OCAMPO, MIAMI, FL - EIR, 483, RESPONSE
06/01/2014 - 07/07/2014
BOEHRINGER INGELHEIM ROXANE, COLUMBUS, OH - EIR,
483, RESPONSE 06/01/2014 - 06/26/2014
CEUTICAL LABORATORIES, INC, FARMERS BRANCH, TX -
EIR, 483, RESPONSE 02/01/2014 - 06/24/2014
ALLIANCE PACKAGING GROUP INC, SAUKVILLE, WI HOOF
HEALTH LLC (DBA HOOF EFFECTS), HELENVILLE, WI EPIC
SYSTEMS CORP, VERONA, WI - 483S 12/1-31/14
GILEAD SCIENCES, SAN DIMAS, CA - EIR, 483, RESPONSE
05/07/2014 - 05/16/2014
HERON BOTANICALS, INC, KINGSTON, WA - EIR, 483,
RESPONSE 09/01/2014 - 09/30/2014
K041478
K142672
ANDA 202179
SUBCUTANEOUS DIPHENHYDRAMINE - AERS, LABELING
CHANGE RECS PRESERVATIVES, CARRIER INGREDIENTS
JS DENTAL MANUFACTURING INC, RIDGEFIELD, CT
COOPERSURGICAL INC, TRUMBULL, CT - 483S 12/1-31/14
DAILY LOG SINCE 2006
BLA 125582
MDR 2031966-2015-00022
CORR BETWEEN FDA & OMPI PHARMA REGARDING GLASS
TUBING 1/10 TO PRESENT
CORR BETWEEN FDA & STEVANATO GROUP REGARDING GLASS
TUBING 1/10 TO PRESENT
CORR BETWEEN FDA & CORNING REGARDING GLASS TUBING
1/10 TO PRESENT
GLAXO SMITH KLINE - ZOFRAN (ONDANSETRON) NDA 20-
0007
REPRODUCTIVE DRUG TRANSCRIPTS
CMPLNT 137847
DR. MICHAEL CAROME RECS
BASF CORP, WASHINGTON, NJ SOMA LABS INC,
MIDDLESEX, NJ ACCRIVA DIAGNOSTICS, EDISON, NJ, ETC
- 483S 12/1-31/14
NATIONAL FORMULARY
ABILIFY (ARIPIPRAZOLE) - AERS 3/14, LBLG THAT
MENTIONS GAMBLING AS A WARNING
VINTAGE PHARMACEUTICALS LLC (DBA QUALITEST PHARMS),
HUNTSVILLE, AL - 483S 12/1-31/14
CORR CONFIRMING WHETHER OR NOT THE APRVL OF PARASAL

(AMINOSALICYLIC ACID), PARSAL SODIUM
(AMINSALICYLATE SODIUM) NDA 6-811 HAS BEEN
WITHDRAWN
SOUTHERN ILLINOIS MEDICAL SERVICES (LOGAN PRIMARY

CARE), HERRIN, IL - METHYLPREDNISONE ACETATE (MPA)
AERS 2011 TO PRESENT MAIN STREET FAMILY PHARMACY,
NEWBERN, TN - METHYLPREDNISONE ACETATE (MPA) INJ
INVESTIGATIONS 2011 TO PRESENT
K133578
K073262
CPT1400952
INSULET CORPORATION - 483, RESPONSE, WARNING
LETTERS 01/05/2012 - 06/11/2015
FDA ENTRY DOCUMENTATION REQUEST (REFUSAL) AM1-
0192966-0
BLUE OCEAN MEDICAL PRODUCTS LLC, ROCHESTER, NY -
483S 12/1-31/14
FDA ENTRY DOCUMENTATION REQUEST (REFUSAL) AM1-
0196649-8
FDA ENTRY DOCUMENTATION REQUEST (REFUSAL)AM1-
0191769-9
INVOKANA - AERS
K090725
K123601
INSULET CORPORATION, BILLERICA, MA - 483, RESPONSE,
WARNING LETTERS 01/01/2012 - 06/11/2015
K142973
K132809
ICLUSIG - AERS, NARRATIVES
KVK-TECH INC, NEWTOWN, PA - 483S 12/1-31/14
NDA 022272 S14
NDA 203510 SUPPLEMENTS
BLUE BELL CREAMERIES ICE CREAM RECS
K000748
CYKLOKAPRON NDA 019281 APPROVAL REVIEWS
K020659
COMPLAINT FOLLOW UP RECORDS
INDIVIDUAL RECS
CROWN LABS - SUBMISSION FOR USE OF POTASSIUM IODIDE
AS API FOR RADIATION TREATMENT 01/01/2015 -
06/12/2015
IMPAX LABS, HAYWARD, CA TAIWAN - 483 01/01/2015 -
12/31/2015
IRIDEX CORP, MOUNTAIN VIEW, CA PACIFIC IMPLANT
INC, RIO DELL, CA BIOCHECK INC, FOSTER CITY, CA,
ETC - 483S 12/1-31/14
SARTORIUS MINISART K844504, K851816, K851817, ETC
CORR BTWN FDA AND WAL-MART PHARMACIES TO PROVIDE
MEDICATION GUIDES TO ITS PHARMACY PATIENTS,
INVESTIGATIONS, RPTS, INSPS, ETC
POTASSIUM MONO PERSSULFATE COMPUND, TETRA SODIUM
EDTA HYDRATE, SODIUM SULFATE ANHYDROUS, ETC - RECS
OLYMPUS MEDICAL SYSTEMS CORP - EIRS, 483S, WARNING
LTRS, ETC 1/15 TO PRESENT
HOYA CORP, PENTAX LIFE CARE DIVISION - EIRS, 483S,
WARNING LTRS, ETC 1/15 TO PRESENT
ACTAVIS MID ATLANTIC - CLOBETASOL PROPIONATE
SHAMPOO ANDA 78-854 SBA, PHARMACOLOGY AND
BIOPHARMACEUTICS RVWS
GLAXOSMITHKLINE - CEFTIN (CEFUROXIME AXETIL) FOR
ORAL SUSPENSION NDA 50-672 SBA, RVWS
PERRIGO ISRAEL - CLOBETASOL PROPRIONATE SHAMPOO
ANDA 90-974 PHARMACOLOGY AND BIOPHARMACEUTICS RVWS,
SBA
GLAXOSMITHKLINE - CEFTIN (CEFUROXIME AXETIL NDA 50-
605 SBA, RVWS
ESSILOR INDUSTRIES, PONCE, PR - 483S 12/1-31/14
2009-4213
LIFEPORT INC, WOODLAND, WA PEDIGO PRODUCTS INC,
VANCOUVER, WA MEDIANA USA INC, REDMOND, WA, ETC -
483S 12/1-31/14
ZIMMER INC - PERSONA KEE SYS, PERSONA TRABECULAR
METAL TIBIAL PLATE CLNCL TRIALS, RECALL NOTICES,
CORR, ETC
CADILA HEALTHCARE LTD INDIA, AHMEDABAD, INDIA F

HOFFMAN-LA ROCHE LTD, KAISERAUGST, SWITZERLAND IDT
BIOLOGIKA GMBH, DESSAU-ROSSLAU, GERMANY - 483S
12/1-31/14
PREDNISONE - AERS
VRL LABORATORIES, CENTENNIAL, CO - WARNING LETTERS,
483 06/11/2012 - 06/11/2015
ANDA 070730, NDA 020541, N016131 ETC
RAW DATA USED IN REGULATORY IMPACT ANALYSIS FOR
2003 FINAL RULE 01/01/1998 - 01/01/2004
EMAILS TO/FROM Jeb@jeb.org, Jeb@myflorida.com,
fl.governor@eog.state.fl.us ETC AND FDA OC -
PYRAMID LABS - AUGMENT (PDFG-BB+BETA TCP) 483, CO
RESP 6/15
BMC MEDICAL CO LTD, BEIJING, CHINA SCICAN LTD,
TORONTO, CANADA PEROUSE MEDICAL, IRGNY, FRANCE,
ETC - 483S 12/1-31/14
PUMA BIOTECHNOLOGY - COMMUNICATIONS WITH FDA RE NDA
FOR PB272 01/01/2014 - 05/13/2015
7241182 7250072 6642518 ETC
NDA 020165 SUPP 011 TO 019 SBA
10/23/2009 LETTER FROM FDA TO AXXIN, VETROP &
HARKRIDER RE 5 YEAR NCE EXCLUSIVITY FOR VYVANSE
VASCEPA - EXCLUSIVITY RECS
PAYMENT MADE BY FDA TO GPO 06/01/2007 - 05/31/2012
2015-4081
RECS RE MW5041780
K140415
K050273
K003028, K072076
TOBACCO INSPECTION RECS SEPT TO DEC 2014
FARXIGA AERS
GLYXAMBI AERS
JARDIANCE AERS
INVOKANAMET AERS
XIGDUO XR AERS
TOBACCO 483
FOIA DAILY LOG 02/28/2014 - 06/15/2015
AMO MANUFACTURING, SPAIN - EIR 6/09-12/14
ALTEPLASE PACKAGE INSERT WORDING CHANGE 01/01/2012
- 04/01/2015
H & T SEAFOOD - WARNING LETTERS, INVESTIGATIONS,
ETC 06/11/2010 - 06/12/2015
POST MARKET STUDIES
DIN/Unit # W0876 14 013911
TEVA PHARMACEUTICALS, BEER SHEVA, ISRAEL - EIR
07/01/2014 - 07/31/2014
SOLGAR ABC DOPHILUS POWDER - TESTING RESULTS
09/01/2014 - 06/15/2015
EDWARDS LIFE SCIENCES INC AROTIC CATHETER EL1001 -
CORRECTIVE ACTIONS, ADVERSE LIFE SCIENCES INC
01/01/2009 - 06/15/2015
WOCKHARDT - 483 10/02/2014 - 06/15/2015
ANDA 200222 FDA MEMO DETERMINATION THAT 180 DAY
EXCLUSIVITY WAS NOT FORFEITED
DKT FDA-2012-P-0895, DKT FDA-2012-P-0895-0001, ETC
PYRAMID LABORATORIES - 483, RESPONSE 03/12/2015 -
06/12/2015
CHEEN HOUNG ENTERPRISE CO, LTD - EIR 08/10/2015 -
11/01/2014
COMM REGARDING POTENTIAL ABC NEWS COVERAGE OF FOOD
SAFETY MATTERS 04/01/2015 - 06/15/2015
2014-5904
ZHEJIANG HISUN PHARMACEUTICALS CO, LTD, CHINA - 483
02/01/2015 - 04/30/2015
BLUMAR USA LLC, CHILE - IMPORT ALERT RECS
07/21/2014 - 07/21/2014
SCANADU SCOUT DEVICE - 510K, PRESALE CAMPAIGN OF
INVESTIGATIONAL USE
K131345
MEDICAL OPTICS, SANTA ANA, CA - EIR 07/29/2013 -
08/01/2013
RELIANCE VITAMINS, EDISON, NJ - EIR 01/01/2010 -
06/15/2015
FOIA LOGS ALL AVAILABLE
K112568
SINCLAIR - K024367
EXPERIMENTAL PATHOLOGY LABORATORY, STERLING, VA -
482, 483, EIR 12/22/2011 - 12/31/2014
2014-5918
TEVA PHARMACEUTICALS USA INC, MEXICO, MO - EIRS,
483S, CORRECTIVE PLANS OF ACTION, ETC 3/5/15
ROXANE - ALOSETRON HCL TABS ANDA 200-652 DECISION

TO WAIVE THE REQUIREMENTS FOR A SINGLE SHARD SYS
REMS PROGRAM MEMO 4/30/15: BUPREONPRPHINE-
CONTAINING TRANSMUCOSAL PRODS ANDA EXTENSION OF
SINGLE SHARED SYS REMS WAIVER MEMO 2/19/15
VIAGRA - APRVL 3/27/98
2015-3919
FORTESTA NDA 021463 SBA
K983314
K851818
K851817
K851816
K844504
2014-5749
CPT1400894, CPT1400892 RECS
K955015
RECS RE FDA DECISION TO EXCLUDE CANNABIDIOL FROM
DIETARY SUPPLEMENT CATEGORIZATION
K100117
K140920
ZOLPIDEM - AERS REPORT
JUNE 01, 2015 TO JUNE 15, 2015
K110686
K133868
2014-7824
K052217
INTERCEPT BLOOD SYSTEM RECS
483 RELEASED SINCE 3/15/15
FERUMOXYTOL - DEATH REPORTS
FCN 685 ETC
K093138
INTELENCE - AERS
SHENZHEN DONGDIXIN TECHNOLOGY - INSPECTION RECS
06/01/2010 - 06/16/2015
PATIENTS LIKE ME - CONTRACT WITH FDA RE DATA AND
ANALYSIS EVALUATION 04/13/2015 - 06/01/2015
LEVAQUIN, LEVOFLOXACIN - AERS 01/01/2010 -
06/10/2015
2014-7827
LANNETT COMPANY, PHILADELPHIA, PA - 483, WARNING
LETTERS, RESPONSE LETTERS 01/02/2014 - 06/16/2015
LEVAQUIN/LEVOFLOXACIN - DEATHS
VESTA, INC, FRANKLIN, WI - 483 05/01/2014 -
08/01/2015
K041414
MERCK & CO, INC, WEST POINT, PA - 8/6/01 INSPECTION

RECS, SUPPLEMENTAL BIOLOGICS LICENSE APPLICATION
SUBMITTED 1/29/04 STN 101069, APPROVAL RECS RE
PROTOCOL 007 ETC
K140284
K042674
K083423
K012313
K030982
2014-7828
SUNQUEST PRO 26SX WOLFF BED OPERATING MANUAL
INSULET CORPORATION AERS
K101530, K062750
K000781
WOCKHARDT WALUJ, INDIA - 483 05/01/2015 -
06/16/2015
MURACA SRL, ITALY DELLEPIANE SAN LUIS SA,
ARGENTINA SHANGHAI PASSIONO INTERNATIONAL CO, LT,
CHINA ETC - 483
PRESCRIPTION DRUG MARKETING ACT - 483, WARNING
LETTER 01/03/2013 - 06/16/2015
2015-2802
2015-2879
2015-2882
K924436
2015-2906
2015-2914
2015-2915
2015-2918
2015-2922
2015-2930
2015-2951
2015-2953
2015-3056
2015-3423
NESTLE PURINA PETCARE, ALLENTOWN, PA - INSPECTION
RECS
2015-3710
2015-3713
2015-3723
2015-2770
FLURALANER, AFOXOLANER - AERS
SMITH & NEPHEW, ST PETERSBURG, FL - EIR, 483
12/14/14 TO 1/13 /15
DESRYEL (TRAZODONE HYDROCHLORIDE) NDA 18-207
ANALYSES OF CANNABIDIOL PRODUCTS
INDIVIDUAL RECS
INVENTURE FOODS INC - LISTERIA MONOCYTOGENES RECALL
6/14 TO PRESENT
FCN 140
FCN 1458
GRANDFATHER DETERMINATION LETTER OF PORDUCT SOLD
2/15/07
ACS DOBFAR, SWITZERLAND - 483
K050404
K110823, K072983
ELISA METHODOLOGY USED IN THE STUDY OF ADVERSE
REACTIONS
FERAHEME - AERS
ACS DOBFAR, ITALY - 483
K122132
FCN 880
DRUG MANUFACTURING PLANT DATA 01/01/2000 -
12/31/2014
NORVELL SKIN SOLUTIONS, ALEXANDRIA, TN - 483,
RECALLS, WARNING LETTERS 05/05/2015 - 06/17/2015
K002136
NELSON LABORATORIES, SALT LAKE CITY, UT - WARNING
LETTER, 483, EIR 01/20/2012 - 05/18/2015
K090993
ACS DOBFAR, ITALY - 483
TEVA API PUERTO RICO - 483
WG CRITICAL CARE, HAMILTON, NY - 483
K902075
SCINOPHARM, TAIWAN - 2012 483
2014-7051
AVENT TUSCON, AZ - EIR 11/01/2014 - 12/01/2014
ORGANIC SPROUTED CHIA SEEDS POWDER - INVESTIGATION,

REPORTS, LAB ANALYSIS ETC 04/02/2014 - 09/30/2014
MITEK, RAYNHAM, MA - EIR 01/01/2013 - 12/31/2013
K040237
FOOD ADDITIVE PETITIONS RE PARTIALLY HYDROGENATED
OILS OR TRANS FATS SUBMITTED BY GROCERY
MANUFACTURERS ASSOCIATION 01/01/2015 - 06/17/2015
AMRI, NY, MA - 483
FCN 1471
BIOCON, INDIA - 483
HISUN, CHINA - 483
NDA 205060 SBA
ACTIONS TAKEN AGAINST ANY US COMPANY, CORPORATION,

OR BUSINESS FOR VIOLATIONS OF ANY SECTION OF THE
COSMETIC LABELING ACT 1/1/14-12/20/14, CMPLNTS, ETC
2014-7055
CLOPIDOL - TARGET ANIMAL AND HUMAN FOOD SAFETY
INFORMATION
XELLIA, HUNGARY, DENMARK - 483
MALLADI DRUGS & PHARMACEUTICALS, INDIA - EIR
09/10/2012 - 09/14/2012
DR SUNIL VERNA, SUNNYBROOK HEALTH SCIENCES CENTER,
ODETTE CANCER CENTRE, CANADA - 483 01/01/2012 -
12/31/2012
02/16/2015 - 02/27/2015
05/18/2015 - 05/29/2015
K041111
K082331
K043030
K041111 MAGNETON C SYS
2014-7063
K992135 EXCITE MR SYS
K043112 SIGNA PROFILE EXCITE MR SYS
K033168 GE O.2T SIGNA PROFILE MAGNETIC RESONANCE
SYS
FUJIFILM - DUODENOSCOPES WARNING LTRS, 483S, EIR,
CO RESP SINCE 1/15
THIOPENTAL, PANCURONIUM - RECS 1/14 TO 1/1/16
FINAL CLARIFICATION 6/17
PHARMACOVIGILENCE - 483S
ORGANIC SPROUTED CHIA SEEDS POWDER - SALMONELLA
OUTBREAK
ACRYLATES COPOLYMER - APRVL
DIGOXIN SBA ANDA 78-556, 76-363, 77-002
TRANSCRIPTS FROM CLASSIFICATION PANEL MEETINGS -
GFD DERMATONE
GLAXO SMITH KLEIN NDA 21-077/S-51, CO RESP
CASE 3:13-MJ-00750-BK
AMLOPIPINE, ASCEND, CARLSBAD T, ZYGENERICS,
DOXAZOSIN MESYLATE - AER
ASAP WOUND DRESSING GEL K082333 ELTA SILVER
ANTIMICROBIAL WOUND GEL K071703 ACRYDERM SILVER
ANTIMICROBIAL WOUND GEL K011994
K864696, K853607, K875066 ETC
APPLIED LABS INC - EIR 2/20/15
K150137
MEVACOR, LIPITOR, CRESTOR ETC - AERS
AIRGAS USA, LLC, CHESHIRE, CT - EIR, 483, RESPONSE
ALKERMES, INC, WILMINGTON, OH - EIR, 483, RESPONSE
K140719
MERCK SHARP & DOHME CORP, ELKTON, VA - EIR, 483,
RESPONSE
LINCARE, BREMERTON, WA - EIR, 483, RESPONSE
DR ANANT DESI, GRANADA HILLS, CA - 483 02/01/2015 -
05/31/2015
DR STEVEN ZEIG, PEMBROKE PINES, FL - EIR, 483,
RESPONSE 02/01/2015 - 05/31/2015
NDA 21107
DR MOHAMED EL-SHAHAWY, LOS ANGELES, CA - 483
02/01/2015 - 05/31/2015
DR PAUL CRAWFORD, EVERGREEN PARK, IL - 483
02/01/2015 - 05/31/2015
MDR RECS
ENTRY WBO-0028489-7
CATALENT MORRISVILLE, NC - EIR, 483 03/02/2015 -
06/18/2015
K120093
CENTRAL BIOMEDIA, IRWIN, MO LENEXA, KA - 483
01/01/2013 - 06/18/2015
EMAILS RE SINGLE SHARED REMS FOR ALOSETRON HCI
DR WARREN SHAPIRO, BROOKLYN, NY - 483 02/01/2015 -
05/31/2015
DR KAMAL V. GANDHI, GRANADA HILLS, CA - 483
02/01/2014 - 05/31/2015
DR SATYA P. AHUJA, EVERGREEN, IL - 483 06/01/2014 -
09/30/2014
DR MARIA ELENA SANTOLAYA DE PABLO, CHILA - 483
08/11/2014 - 08/22/2014
JOINN LABORATORIES, CHINA - 483
AMERICAN NATIONAL RED CROSS, EAU CLAIRE, WI - EIR,
483, RESPONSE
LLOYD INC OF IOWA, SHENANDOAH, IA - EIR, 483,
RESPONSE 03/18/2013 - 04/16/2013
MCNEIL CONSUMER HEALTHCARE, INC (DIV OF MCNEIL-PPC,

FORT WASHINGTON, PA AIR LIQUIDE HEALTHCARE AMERICA
CORP, PLUMSTEADVILLE, PA GURADIAN ANGEL PRODUCTS
INC, HUNTINGDON VALLEY, PA - 483S 5/1-31/15
CPT 1400805
MEDIMMUNE UK LTD, LIVERPOOL, UK - 483S 5/1-31/15
SMITHKLINE BEECHAM (CORK) LTD, CORK, IRELAND NOSCH

LABS PRIVATE LTD, VELIMINEDU, INDIA DIPHARMA
FRANCIS SRI, BARNZATE, ITALY - 483S 5/1-31/15
MONTANA COMPOUNDING PHARMACY, MISSOULA, MT
INDEPENDENT NUTRITION CENTERS INC, EUGENE, OR -
483S 5/1-31/15
BAXTER HEALTHCARE CORP, JAYUYA, PR - 483S 5/1-31/15
MS SURGICAL INC, MEMPHIS, TN THE COMPOUNDING

PHARMACY OF AMERICA, KNOXVILLE, TN THE WELLNESS
CENTER PHARMACY INC (DESIGNER DRUGS), CHATTANOOGA,
TN, ETC - 483S 5/1-31/15
MIRROR PHARMACEUTICALS LLC, FAIRFIELD, NJ ZIMMER

TRABECULAR METAL TECHNOLOGY INC, PARSIPPANY, NJ
IBA MOLECULAR NORTH AMERICA, TOTOWA, NJ, ETC - 483S
5/1-31/15
NEUROMETRIX INC, WOBURN, MA CARDINAL HEALTH, EAST
HARTFORD, CT AUTUMN HARP, ESSEX JUNCTION, VT -
483S 5/1-31/15
ALPHA SOURCE INC, MILWAUKEE, WI MEDIVATORS INC,
PLYMOUTH, MN MODERN PRODUCTS INC, MEQUON, WI, ETC
- 483S 5/1-31/15
NESHER PHARMACESUTICALS (USA), LLC, BRIDGETON, MO
SAINT LOUIS, MO GRAIN PROCESSING CORP, MUSCATINE,
IA ESSENTIAL PHARMACY COMPOUDING, OMAHA, NE, ETC -
483S 5/1-31/15
MATERIALISE USA, LLC, PLYMOUTH, MI CARDINAL

HEALTH, MSU PET SITE, EAST LANSING, MI INNOVATIVE
SURGICAL SOLUTIONS LLC (SENTIO LLC), WIXOM, MI -
483S 5/1-31/15
NIBEC CO LTD, KOREA - INSPECTION REPORTS 01/01/2010
- 01/01/2015
SYNTHES (USA), LLC, MONUMENT, CO ABL MEDICAL, LLC,
AMERICAN FORK, UT EMERGE MEDICAL INC, DENVER, CO -
483S 5/1-31/15
APNEICARE LLC, WORTHINGTON, OH 3D AND COMPANY,
CINCINNATI, OH KILTEX CORP, AKRON, OH, ETC - 483S
5/1-31/15
CAREFUSION 2200 INC, VERMON HILLS, IL HOSPIRA INC,

LAKE FOREST, IL CENTRAL ILLIONIS COMPOUNDING INC
(PRECKSHOT PROFESSIONA), PEORIA HEIGHTS, IL, ETC -
483S 5/1-31/15
AFTON SCIENTIFIC LLC, CHARLOTTESVILLE, VA AG
ESSENCE INC, RICHMOND, VA - 483S 5/1-31/15
OUTCOME SOLUTIONS LLC, MOCKSVILLE, NC 7 OAKS

PHARMACEUTICAL CORP, EASLEY, SC ATLANTA HEALTHCARE
SERVICES, ATLANTA, GA, ETC - 483S 5/1-31/15
DECIMAL INC, SANDFORD, FL LD TECHNOLOGY LLC,
MIAMII, FL UNILENS CORP, USA, SEMINOLE, FL, ETC -
483S 5/1-31/15
SPECIALITY COMPOUNDING LLC, CEDAR PARK, TX HOME

INTENSIVE CARE PHARMACY LLC, SAN ANTONIO, TX
NEUROLUMEN LLC, OKLAHOMA CITY, OK, ETC, 483S 5/1-
31/15
VISTA BIOLOGICALS CORP, CARLSBAD, CA AMERICAN
IMEX, IRVINE, CA AJINOMOTO ALTHEA INC, SAN DIEGO,
CA, ETC - 483S 5/1-31/15
MEDICAL TECHNOLOGY PRODUCTS INC, RONKONKOMA, NY

CHARTWELL PHARMS, CONGERS, NY NEW PRODUCT
DEVELOPMENT INC, EAST SYRACUSE, NY, ETC - 483S 5/1-
31/15
HELIO USA INC, SAN JOSE, CA THE QUEEN'S MEDICAL
CENTER, HONOLULU, HI ALEXZA PHARMACEUTICALS INC,
MOUNTAIN VIEW, CA, ETC - 483S 5/1-31/15
LOW ACID CANNED FOOD DATA 2014
STERILIN LTD, NEWPORT, UK FUJIFILM, ASHIGARAKAMI
GUN, JAPAN MED-EL ELEKTROMEDIZINISCHE GEREATE
GMMBH, INNSBRUCK, AUSTRIA, ETC - 483S 5/1-31/15
CT ELNISTE - FOLLOW UP
VENAXIS INC - APPY1 DIAGNOSTIC TEST APPL FOR APRVL,
PMA APRVL, 510K CLEARANCE, ETC
USP LABS LLC, SK LABORATORIES INC - EIRS, 483S
INTEGRITY NUTRACEUTICALS, SPRING HILL, TN - EIR,
483 10/01/2012 - 06/18/2015
RICONPHARMA, LLC, DENVILLE, NJ - EIR, 483, RESPONSE
01/20/2015 - 01/21/2015
TGA SCIENCES, MEDFORD, MA - EIR, 483, RESPONSE
STEVEN ROHRBECK, HIGH POINT, NC - EIR, 483,
RESPONSE 04/15/2013 - 05/06/2013
LOVELACE RESPIRATORY RESEARCH INSTITUTE,
ALBUQUERQUE, NM - EIR, 483, RESPONSE 02/25/2013 -
03/13/2013
ZOETIS P & U, LLC,, KALAMAZOO, MI - EIR, 483,
RESPONSE 04/07/2014 - 04/17/2014
MERCK SHARP & DHOME, RAHWAY, NJ - EIR, 483,
RESPONSE
WYETH BIOPHARMA DIVISION OF WYETH PHARMACEUTICALS,
ANDOVER, MA - EIR, 483, RESPONSE 02/01/2014 -
02/28/2014
BLOOD BANK OF ALASKA - LIST OF CITATIONS 01/01/1994
- 06/17/2015
NDA 014901 SBA
ANDA 200652 SINGLE SHARED REMS
DR RAFFI R MINASIAN, GLENDALE, CA - 483 02/01/2015
- 05/31/2015
K992893, K992868
CSL PLASMA INC, MESQUITE, TX - EIR, 483, RESPONSE
01/07/2015 - 01/09/2015
LAURENCE H BELKOFF, BALA CYNWYD, PA - EIR, 483,
RESPONSE 02/05/2015 - 02/12/2015
BRACCO DIAGNOSTICS, MONROE TOWNSHIP, NJ - EIR, 483,
RESPONSE 05/01/2014 - 05/30/2014
DR BRIAN PEARLMAN, ATLANTA MEDICAL CENTER -
INSPECTION RECS 07/01/2012 - 02/23/2013
ACTAVIS LABORATORIES, FL, INC, DAVIE, FL - EIR,
483, RESPONSE 12/01/2013 - 12/20/2013
NDA 020459 SBA
B. BRAUN MEDICAL, INC, IRVINE, CA - EIR, 483,
RESPONSE 01/23/2014 - 02/13/2014
NADA 128-967, NADA 100-809 FOIA SUMMARY
HOSPIRA, LAKE FOREST, IL - 483 02/01/2015 -
05/31/2015
RESTAURANT RECYCLING SERVICES, LLC, FREMONT, MI -
483 08/01/2014 - 06/18/2015
CIPLA, INDIA, ZYDUS, INDIA - EIR, 483 04/08/2015 -
04/17/2015
HERBRUCK POULTRY RANCH, SARANAC, MI - 483
08/01/2014 - 06/18/2015
K943272
SIETSMA FARM FEED, LCC, HOWARD CITY, MI - 483
08/11/2014 - 06/18/2015
K053106
VICTUS FEMTOSECOND LASER PLATFORM K140615
K041242
NDA 206406 FINAL THREE YEAR EXCLUSIVITY
PFIZER, INC, ROCHESTER, MI - 483 08/01/2014 -
08/30/2014
INSULET CORPORATION, BILLERICA, MA - EIR 03/10/2015
- 03/28/2015
POPCORN INDIANA - INSPECTION REPORT 12/23/2013 -
05/30/2015
INFUSE BONE GRAFT - LABELING RECS 01/01/2000 -
06/18/2015
MEMOS TO ANDA HOLDERS OF BUPRENORPHINE-CONTAINING
TRANSMUCOSAL PRODUCTS REGARDING SINGLE-SHARED REMS
K812442
ANDA 078340, NDA 079179
K844401
K090802, K060187
LASALOCID IN GREASE - SAMPLE ANALYSIS, REPORTS
07/01/2014 - 01/21/2015
SB-73 - APRVL RECS
DIGOXIN, URSODIOL, ACETAZOLAMMIDE, ETC - RECS
COMMUNICATIONS BETWEEN FDA MEDICAL REVIEWERS AND
AERIE PHARMACEUTICALS RE RHOPRESSA 07/01/2014 -
06/19/2015
GUIDANT ACS HI-TORQUE HEAVYWEIGHT GUIDE WIRE WITH
HYDROCOAT - RECS RE DESIGN AND MANUFACTURE
(K982083) 01/01/1998 - 06/19/2015
K142480
GRAS AFFIRMATION PETITION 2G0280
NDA 018933
DCI DONOR SERVICES REFICIO PUTTY - 510K 01/01/2000
- 06/19/2015
K990284
ANALYSIS OF LASALOCID RESIDUES IN GREASE AND FAT
USING LIQUID CHROMATOGRAPHY MASS SPECTOMETRY -
SAMPLE DATA
SKELAXIN - SIDE EFFECT STUDIES 01/01/1968 -
01/21/2015
K051670
SOLUMEDROL, METHYLPREDNISOLONE - AERS, RECALLS
01/01/2004 - 06/19/2015
INDIVIDUAL RECS
THENTIX - RECS RE BAN FROM SALE IN US
NDA 022496 SBA
K111377
K142432
THRIVE - AERS
ETHICON - PROXIMATE PPH HEMORRHOIDAL CIRCULAR
STAPLER K030411, K030925, K051301, ETC RECALL RECS
K073326 REVIEW NOTES
2015-4464
AMPAC FINE CHEMICALS LLC, RANCHO CORDOVA, CA - 483
JAN 2015
SHIRE, CAMBRIDGE, MA - EIR 06/03/2013 - 11/29/2013
OFLOXACIN 0.3% - AERS, TONICITY, PH 01/01/2006 -
12/31/2011
PFIZER, HANNIBAL, MISSOURI - EIR 2012
SHIRE HGT, LEXINGTON, MA - EIR 05/06/2013 -
11/29/2013
ANDA 090218
K010265
K102859
MEGA FINE PHARMA PRIVATE LTD, INDIA - 483
04/01/2015 - 06/13/2015
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
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
MIRENA REPORT 68420195
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
RECS RE PACE AND SCOPE OF IMPLEMENTATION OF FACTS

UP FRONT NUTRITION KEYS, COMPLIANCE WITH FACTS UP
FRONT PROGRAM RULES, EVALUATION OF FACTS UP FRONT
SYSTEM ETC
P140025
K141399
CBER STATISTICAL PLAN FOR POTENCY TESTING OF
INFLUENZA VACCINES BY SRID METHOD
K960728 K883780 K860158 ETC
K813324
K022241
SUBOXONE, RITALIN, SUDAFED, ETC - MFG PROCESS
K011702
K061166
K061892
K120479
K122048
K140300
K131143
K133169
K101587
K091499
ORANGE BOOK
ANDA 091695
CAP 8C0253
ANDA 091695
DMF 6371
2012 REMOVAL OF KOREAN CERTIFIED SHIPPERS OF
MOLLUSCAN SHELLFISH FROM THE INTERSTATE CERTIFIED
SHELLFISH SHIPPERS LIST
ANDA APPROVED SINCE 2002 FILING DATE

MOGEN, MOGEN-TYPE CIRCUMCISION CLAMPS - MAUDE
REPORTS MISDOM-FRANK CIRCUMCISION CLAMPS - ALL
RECS
SVC MANUFACTURING, INC, PROPEL ZERO POWDER -
INGREDIENTS, COMPLAINTS, ETC 08/06/2002 -
06/23/2015
METHOTREXATE - AERS
METHOTREXATE - PROBLEM REPORTS

DEXAMETHASONE SODIUM PHOSPHATE INJ, SODIUM
BICARBONATE INJ - RECALL RECS
K050471 K060702 K082453 ETC
GP PHARM, SPAIN - EIR 01/01/2015 - 01/31/2015
PINNACLE COMPLETE ACETABULAR HIP SYSTEM - IDE
G050078
CAP 3C0176
MICROBIOLOGICAL CONSULTANTS, INC, HUNTINGTON, WV -
EIR, 483, RECALL 06/01/2014 - 06/23/2015
PFIZER PHARMACEUTICALS LTD, CHINA ZHEJIANG HISUN
PHARMACEUTICAL CO, LTD, CHINA - 483
FDA - C-31034-SB "CVM Database and Web Support"
ANDA 091602
AVANTOR PERFORMANCE MATERIALS, PHILLIPSBURG, NH -
EIR, 483, RECALL RECS 06/01/2011 - 06/23/2015
K003154
NAGASAKI FALLOUT - RECS
VOLUNTARY COSMETIC REGISTRATION PROGRAM (VCRP)
SPREADSHEET
FOIA DAILY LOG JAN THROUGH APRIL 2015
K070423, K092503, K111837 ETC
PYRAMID LABORATORIES - RESPONSE TO 483
WELLBUTRIN - AER
AMBIEN - AER
PROPANOL - AER
AMBIEN CR AER
WELLBUTRIN XL - AER
ST JOHNS WORT - AER
ZOLPIDEM, PROPINOL, WELLBUTRIN XL - CLNCL TRIALS
STREM CHEMICALS INC, NEWBURYPORT, MA RHODES
TECHNOLOGIES, COVENTRY, RI MASS BIOLOGICS, BOSTON,
MA, ETC - 483 RESPS
NDA 19322, NDA 19323
ANDA 074248
K072404
DUPUY - SB CHARITE III INTERVERTEBAL DISC SPACER
FDA INVESTIGATION
LIST OF RECALLED DRUGS
GLAXO SMITH KLEIN NDA 21-077/S-51 COMPLETE RESPONSE

CMPLNT 133479
ACRYLATES COPOLYMER AS AN INGREDIENT
SANTA BARBARA SMOKEHOUSE - RPTS, TEST RESULTS,
CORR 2003 TO PRESENT
2015-3579 CERTIFIED
INVOKANA - AERS
FAP 2267
INDIVIDUAL RECS
SINGULAIR - AER
SGLT2 INHIBITORS CANAGLIFLOZIN, DAPAGLIFLOZIN &
EMPAGLIFLOZIN - MEDWATCH SINCE 2013
BIFORTUNA LTD, MERSEYSIDE, UK - SSPGO HLA TYPING
KIT BK130028
KING OF POPS INC, ATLANTA, GA - REGISTRATION
NUMBER, BIOTERRORISM NUMBER
BUBBA BURGERS - INJURY RECS, GMP COMPLAINTS,
INSPECTIONS ETC LAST TEN YEARS
NDA 18081 APPROVAL LETTER CERTIFIED
P090002
K132649
INDOCO REMEDIES LIMITED - 483 05/10/2013 -
01/08/2015
HORSEPRERACE.COM - RESPONSES RE 10/29/14 LETTER
10/29/2015 - 06/24/2015
LETTER FROM NEVIN SCRIMSHAW TO COMMISSIONER
MCCLELLAN 6/30/03 RE MYCOPROTEIN
ANDA 074220
DAPTOMYCIN - AERS
NIKKISO CO PTD, JAPAN - EIR
ANDA 090854
PMA BP 140143
K842754
06/24/2015
EMCURE PHARMACEUTICALS, INDIA - 483 01/01/2015 -
06/01/2015
CUMIN RECALL - MANUFACTURER, SUPPLIER 12/01/2014 -
01/21/2015
CLNCL TRIAL INFO
SANOFI AVENTIS US LLC - AMBIEN NDA 19-908/SE5,
AER, ALRVL
MEDTRONIC - SYNCHRO MED II INFUSION SYS EIR,
WARNING LTRS, 483, CORR
MEDTRONIC - SYNCHRO MED II MODEL 8637-20 PREMARKET
APRVL, RECALL
IMPAX LABS - DIGOXIN ANDA 78-556 BIOEQUIV RVW
HAMPTON CREEK FOODS INC - JUST MAYO LBLG CORR
HETLIOZ (TASIMELTEON) - APRVL
VANTNIN (CEFPODOXIME PROXETIL) NDA 50-674 ANDA, SBA

MOGEN & MOGEN TYPE CIRCUMCISION CLAMPS MISDOM-
FRANK CIRCUMCISION CLAMP - MDRS RTP
BEVACIZUMAB - AERS 1/09 TO PRESENT

AMBULATORY DIAGNOSTIC CENTER INC - MAMMOGRAPHY
QUALITY STANDARDS ACT RECS
STANDARD FORM LLL FILED BETWEEN 2/1/15 TO 3/31/15
K900295
K900295
NADA 111-798, NADA 141-261
K883239
CERVICAL CORPECTOMY CAGE DEVICES - ONGOING
CYBERONICS, INC, HOUSTON, TX - 483 12/07/2012 -
03/01/2013
BRADSTREET WELLNESS CENTER, BUFORD, GA - FORM 482
04/01/2015 - 06/25/2015
CVM REVIEW OF YEAST OR MODIFIED YEAST FOR USE IN

ANIMAL FEED REGARDING THE USE IN ETHANOL AND FOR
PRODUCT OF DISTILLERS COPRODUCT ETC - CORR,
SUBMISSIONS ETC 01/01/2011 - 06/01/2015
GRAS NOTICE RE INACTIVE MODIFIED YEAST,

SACCHAROMYCES CEREVISIAE AS A COMPONENT OF ANIMAL
FEED WHEN USED IN THE FERMENTATION OF CORN TO
PRODUCE ETHANOL
K140022 - CORR, MINS, ATTACHMENTS, ETC
K990565
K030611
2011-6972
2012-6994
2014-3999
INDIVIDUAL RECS
LIST OF COMPANIES WITH APPROVED PRE-LAUNCH
ACTIVITIES IMPORTATION REQUEST FOR RIFAMIXIN, LIST
OF COMPANIES THAT HAVE FILED PLAIR WITH CDER
PRECONSULTATION OR SUBMITTED MATERIALS RE FAP RE
ARTIFICIAL TRANS FAT (PHO)
RECS RE RESEARCH PAPER RE CIGAR SMOKING
CHOSKI LABORATORIES LTD, INDIA - EIR, 483
01/07/2014 - 01/12/2014
K141119
K883239, K900295
2014-5032
2014-3995
2014-5910
2014-5916
2014-5911
2014-6252
2014-4994
2014-5159
2014-6261
2014-6251
2014-6258
2014-6514
2011-5055
2013-7690
2014- 5239
2013- 4979
2013-8180
2013- 4978
DROXOLAN TABS NDA 03-044 - ACTIVE AND INACTIVE
INGEDIENTS, SAFTEY DATA, LBLG, ETC
MEDTRONIC, COVIDIEN - IRVINE, CA 3/23-26/15
BOULDER, CO 2/12-26/15 ARGYLE, NY 12/12-16/13, ETC
EIRS
SOY INFANT FORMULAS - CAERS
HOFFMAN LAROCHE INC - INJECTABLE VITAMINS A, D, E
CORR 1975 TO 1982
WELLBUTRIN, ZYBAN - AERS
JEFFREY A SOSMAN MC, VANDERBILT UNV SCHOOL OF
MEDICINE, NASHVILLE, TN - INSP 8/22/14-10-9/14
K103366
BLUE PEARL VETERINARY PARTNERS - EIR 11/11/2014 -
06/25/2015
SWEET SEASONS, MARABELLA PRODUCE - ENTRY RECS
05/20/2015 - 06/25/2015
BRADSTREET WELLNESS CENTER, BUFORD, GA BRADSTREET
IRB - INSPECTION RECS 01/01/2010 - 06/25/2015
DEPAKOTE - BLACK BOX WARNINGS, AERS
IMMUNEX LEUKINE - SBA
QSYMIA - 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
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
ACTHAR GEL-SYNTHETIC NDA 17-861 - SBA
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)
LENOX MACLAREN SURGICAL CORPORATION FACILITY - EIRS

11/13-16/06 BONE FRAGMENTOR - DVC LISTING
PAPERWORK 7/17/00 MEDTRONIC SOFAMAR DANEK - BONE
FAFMENTOR RECALL LTR 4/4/07 (CERTIFIED)
INGREDIENTS GENERALLY RECONIZED AS SAFE -

ACQUISTITION, A/C IN GRAS DETERMINATIONS AUDITS &
REQUESTS REGARDING NOTIFICATIONS OR DETERMINATION
OF G\RAS STATUS, ETC
NEPHRON PHARMACEUTICALS CORPORATION, WEST COLUMBIA,
SC - 483 01/01/2015 - 06/01/2015
K141770
RADIOGEL - DE NOVO APPLICATION REJECTION LETTER
06/10/2015 - 06/30/2015
WITHDRAWN K86-3 GUIDANCE

GILDEAD SCIENCES - HARVONI (SOFOSBUVIR, LEDIPASVIR)
AERS, MEDICATION ERRORS
HDE H990008
BLA 103792/5275
ANDA 207488
ANDA 207488 SBA
BLA 103792
ANDA 200900 SBA
MERREM I.V. SBA
BOEHRINGER GRASSE, AUSTRIA - EIR, EIR SUMMARY
11/11/2014 - 11/11/2014
K141122
DMF 4181
GILEAD SCIENCES - SOVALDI (SOFOSBUVIR) AERS,
MEDICATION ERRORS
EUROGENTEC, BELGIUM - EIR 12/19/2014 - 12/19/2014
K101990
IBUPROFEN - AERS
K142282
K946165
SUN PHARMACEUTICAL INDUSTRIES LIMITED, INDIA - 483
06/01/2015 - 06/30/2015
FAERS REPORT NARRATIVES
FERAHEME - CASE REPORTS
THIOPENTAL, THIOPENTAL SODIUM POWER AND SOLUTION -
IMPORT RECS 03/01/2015 - 06/29/2015
PENTOBARBITAL SODIUM POWDER AND SOLUTION - IMPORT
RECS 03/01/2015 - 06/29/2015
ABBVIE - PAK (DASABUVIR SODIUM, OMBITASVIR,
PARITPREVIR, RITONAVIR) AERS, MEDICATION ERRORS
NDA 200063
HARRISPHARMA - CORR WITH NEBRASKA RE IMPORTATION OF
EXECUTION DRUGS, ETC 01/01/2015 - 06/29/2015
FAERS REPORT NARRATIVES
HERCEPTIN - SUPPLEMENTS, SITES, SHELF LIFE
CLARIS INJECTABLES INC, INDIA - EIR 06/21/2015 -
07/06/2015
AARTI INDUSTRIES, INDIA - EIR, 483
LINCARE - LAB RESULTS 06/01/2015 - 06/30/2015
NOVARTIS, PHILADELPHIA, PA - EIR 10/29 - 11/6/14,
11/3-12/14, 11/12-17/14
RPT MW5041917 REDACTED
K133823, K103472, K072260
HEMISPHERX BIOPHARMA INC, NEW BRUNSWICK, NJ - INSP
11/19/14 MEMO
K011935
K071573
LIST OF INGREDIENTS IN ALL FOODS
HEPATITIS INFECTIONS - AER
CMPLNT 141610
RANFAC CORP - MARROW CELLUTION BONE MARROW
ASPIRATION NEEDLE K150563
STUART PRODUCTS INC - VITAL E A D REPORT
DKT 80N-0042
AUGUSTA, GA - EIRS, 483S, CORR, ETC 2005 TO 2011
PROTEUS PERSONAL MONITOR - K113070
RITEDOSE CORP, COLUMBIA, SC - EIR 9/8-30/10
DR DAVID KINGMAN MURRAY, SAMARITAN CLINIC, MOSES
LAKE, UT - CIVIL CLAIMS
ABRAXANE SUPPLEMENT NDA
UNIMED MEDICAL SUPPLIES INC K142832
ARTIFICIAL TRANS FAT - FAP 1/15 TO PRESENT
MOTOR CITY CASINO, DETROIT, MI - INSP 6/4/15
FI DAILY LOG 6/15-19/15
2011-1940
FOFI DAILY LOG 6/15-19/15
JPMS MANUFACTURING LLC, READING, PA - DANGEROUS
WORK CONDITIONS, WORKPLACE CONTAMINATION, MOLD, ETC
9/12 TO 3/14
PHOTO MEDEX INC, CARLSBAD, CA - 483 6/16/15
ACIST MEDICAL SYSTEMS INC, CINCINNATI, OH - ACIST
ANGIOGRAPHIC INJECTOR & SYRINGE MDRS , UNINTEDED
AIR INJ RPTS, ETC 12/8/14
MEDTRONIC INSERTER 510K, MAUDE RECS, TESTING, ETC

PEG 3550 - AERS, RECS
NAMES OF HUMAN GROWTH HORMONE MFRS, LIST OF DRUGS
THAT CONTAIN ANTI-ANDROGENIC PROPERIES, CBER LIST,
CDER LIST, ETC
APOTHECON - KENALOG-40 14-901, 12-041 LUITPOLD -

BETAMETHASONE ACETATE & BETAMETHASONE SODIUM
PHOSPHATE 90-747 LUITPOLD - CYANOCOBALAMIN 80-737,
ETC APRVL LTRS
FIBROUS DYSPLASIA RECS
2006-999
K932438
FDA INSPECTION OF PHARMACEUTICAL AND API
MANUFACTURING FACILITIES IN INDIA 06/01/2014 -
06/01/2015
KEITH J PIERCE, MD - INVESTIGATION RECS 01/01/2000
- 07/01/2015
CLINOGENT, GVK BIOSCIENCES - INSPECTION REPORTS
07/01/2012 - 07/01/2015
MAUDE RPT 8010047-2012-00088
APPROVAL LETTERS FOR PRODUCE LICENSURE SUBMISSIONS
01/01/1991 - 12/31/2012
FOREIGN AND DOMESTIC DRUG INSPS 3/14 TO 12/14
ACS DOBFAR, ITALY - INSPECTION RECS
HISUN, FUYANG CITY, CHINA - INSPECTION RECS
LIST OF TOBACCO RETAILERS IN IOWA 01/01/2015 -
07/01/2015
LIST OF TOBACCO RETAILERS IN INDIANA 01/01/2015 -
07/01/2015
K031327
REGISTERED FOOD FACILITIES 01/01/2014 - 07/01/2015
ICLUSIG - AERS
J & J FISH TRADING COMPANY, BROOKLYN, NY -
INSPECTIONS, COMPLIANCE RECS 07/01/2010 -
07/02/2015
MEVACOR - LABEL RECS
K791963
FARXIGA - AERS
COTY BODY WAX KITS - AERS 01/02/2015 - 07/01/2015
SALLY HANSEN EXTRA STRENGTH ALL-OVER BODY WAX KIT,
LAVENDER BODY WAX KIT - AERS
TOBACCO INSPECTIONS APRIL 2015 TO JUNE 2015
K964518
MELATONIN - AERS 01/01/2005 - 01/01/2015
K090348
PHARMACEUTIC LABS, ALBANY, NY - 483 11/13/2014 -
07/02/2015
JUNE 16, 2015 TO JUNE 30, 2015
3969811, 4151372, 5784699, ETC
K083019
K140151
NDA 050514 SBA
OCULUS SURGICAL INC PORT ST LUCIE, FL - EIR,
WARNING LETTER, ETC
NDA 206321
FRESENIUS KABI USA, LLC, GRAND ISLAND, NY - 483,
EIR
10005945, 9278196, 10048500, ETC
K100789
SERATONIN FORMULA - AERS
ANDA 202027
ANADA 200-139
TECFIDERA - AERS
MEDTRONIC INSULIN PUMPS - AERS 01/01/2005 -
01/22/2015
NDA 206940 SBA
GRENZACH PRODUKTIONS GMBH, GERMANY - 483
06/01/2014 - 02/01/2015
DRUG SAFETY AND RISK MANAGEMENT ADVISORY COMMITTEE,

ANESTHETIC AND ANALGESIC DRUG PRODUCTS ADVISORY
COMMITTEE - BACKGROUND MATERIALS FOR CANCELED
MEETING 07/01/2015 - 07/10/2015
2013 HEPATITIS A OUTBREAK - TOWNSEND FARMS, PURELY
POMEGRANATE, ETC
METFORMIN, ALBUTEROL, ZOLPIDERM ETC - ENVIRONMENTAL
ASSESSMENTS, ENVIRONMENTAL IMPACT STATEMENTS,
FONSIS, ETC
OSIRIS THERAPEUTICS, INC - CORR WITH FDA
01/01/2012 - 07/02/2015
DEL LABS SALLY HANSEN EXTRA STRENGTH ALL-OVER BODY
WAX KIT AND LAVENDER BODY WAX KIT - AERS 01/01/2000
- 12/31/2007
SANDOZ GMBH, AUSTRIA - 483 10/01/2012 - 02/01/2015
SE0009409, SE0009410, SE0009411 ETC
IMPORT EXAMINATIONS 10/13 TO 6/15
NDA 019892
ANNUALIZED PHARMACEUTICAL PURCHASES BY NDC NUMBER
2014
CASE RPTS
CONSUMER CMPLNTS REGARDING PRODS SOLD ON AMAZON.COM
1/10 TO PRESENT
THERANOS - RECS
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
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
SKIN AUTHORITY LLC, MOY-FINCHER MEDICAL GROUP,

STRICTVECTIN OPERATING COMPANY ETC - WARNING LETTER
RECS, RESPONSES, CORR 05/01/2014 - 06/30/2015
INDIVIDUAL RECS
PEREGRINE PHARMACEUTICALS BREAKTHROUGH THERAPY
DESIGNATIONS 07/03/2012 - 07/03/2015
BRADSTREET WELLNESS CENTER, BUFORD, GA - SEARCH
WARRANT, AFFIDAVIT, INVENTORY ETC 01/01/2002 -
07/03/2015
doTERRA INTERNATIONAL, LLC - WARNING LETTER
RESPONSE, INSPECTION RECS 01/01/2014 - 12/30/2014
IMBRUVICA - 10621827,10622185, 10622410, ETC
GRQ CONSULTING DBA TRIFECTA, RENO, NV - 483
QUEST LIFE SCIENCES, CHENNAI, INDIA - 483
01/01/2014 - 07/06/2015
P130030 SSED
AMGEN NEULASTA BLA 125031 S 175 SBA
SE0009409-SE0009411 SE0009413 SE0009415 ETC

FOIA REQUESTS CLOSED JUNE 2015
K962807
LINZESS - AERS
SOFOSBUVIR - IND, NDA
ZYDELIG - AERS
NDA 206321
K072045, K142377
ONDANSETRON - AERS
PMA P850007
K083759 PREDICATE DEVICE 510K
K914145
NASHA Y GABRAIL, MD, CANTON, OH - EIR, 483,
RESPONSE
SUDHIRKUMAR PATEL, MD, GREENVILLE, SC - EIR, 483,
RESPONSE 04/30/2012 - 05/17/2012
BIOMARIN, SAN RAFAEL, CA - EIR, 483, RESPONSE
02/08/2014 - 02/17/2014
MEGLUMINE (N-METHYLGLUCAMINE) - TECHNICAL, SAFETY,
AND TOXICOLOGICAL RECS
KEYTRUDA - AERS
BIOLIFE PLASMA SERVICES LP, FINDLAY, OH - EIR, 483,
RESPONSE
THE INTEGRA GROUP, MINNEAPOLIS, MN - EIR, 483,
RESPONSE 06/05/2012 - 06/11/2012
CARDINAL HEALTH 418, AURORA, CO - EIR, 483,
RESPONSE 06/16/2014 - 06/17/2014
AMPAC FINE CHEMICALS, RANCHO CORDOVA, CA - EIR,
483, RESPONSE
sNDAs 020583/S-027, 020583/S-028 SBA
K102217
AZAZUDDIN AHMED, CHICAGO, IL - EIR, 483, RESPONSE
01/03/2014 - 01/23/2014
UNIVERSITY OF MARYLAND SCHOOL OF MEDICINE,
12/12/2012
MIHN MACH, VALENCIA, CA - EIR, 483, RESPONSE
BIHN BUI NGUYEN, MD, BORDEAUX, FRANCE - 483
09/17/2014 - 09/19/2014
K120922
ALZA CORPORATION, BEDFORD, OH - EIR, 483, RESPONSE
MICHAEL W KONSTAN, MD, CLEVELAND, OH - EIR, 483,
RESPONSE 02/02/2015 - 02/13/2015
ATTIX PHARMACEUTICALS, TORONTO, CANADA - 483
11/10/2014 - 11/14/2014
ALEXIAN BROTHERS HOSPITAL NETWORK IRB, ARLINGTON
HEIGHTS, IL - EIR, 483, RESPONSE 11/22/2013 -
12/12/2013
DAVETVELOCITY PHARMA, FARMINGDALE, NY - EIR, 483,
RESPONSE
KLONOPIN - AERS
UNOMEDICAL SRO, SLOVAKIA - EIR 01/26/2015 -
01/29/2015
FOX RIVER FIBER - NO OBJECTION LETTER,
DOCUMENTATION 05/01/2013 - 07/06/2015
LIST OF ESTABLISHMENTS 06/01/2015 - 07/01/2015
PINE PHARMACEUTICALS, TONAWANDA, NY - EIR OCT 2014
FCN 1356
PERSONAL SOUND AMPLIFICATION PRODUCTS, HEARING AIDS

- UNTITLED LETTERS OR OTHER LETTERS TO
MANUFACTURERS OBJECTING TO LABELING, ADVERTISING,
OR OTHER PROMOTIONAL MATERIAL AFFECTING
CLASSIFICATION
CPT1500352, CPT 1500251
INSPIRE PHARMACEUTICALS, INC - LETTERS TO DOCTORS
RE FINDINGS 04/01/2011 - 07/07/2015
ALOSETRON - AERS
INSULET CORPORATION, BILLERICA, MA - EIR, 483,
RESPONSE TO WARNING LETTER 01/01/2010 - 07/07/2015
PCC IN NEONATES AND INFANTS - AERS
REGISTERED FOOD FACILITIES 01/01/2012 - 07/07/2015
MEETING AMONG FDA, CUSTOMED, AGG - MINUTES, NOTES

3258437 3434840 3494140 ETC
NOVARTIS - SECUKINUMAB FAERS
K141220
BRODALUMAB LXEKINUMAB - FAERS
RAKESH AGGARWAL, LUDHIANA PUNJAB, INDIA - EIR, 483,
CO RESP, ETC 4/6,9/15
CASE NOS 8838684, 9058742, 8964216 ETC
ALOXI NDA 21-372 - APRVL, MEDICAL RVW, CLNCL RVW
ETC
CYMBALTA - AER
WRIGHT MEDICAL TECH INC - PROFEMUR TITANIUM NECK OR
HIP SYS 510K
GABAPENTIN (NEURONTIN) AERS
ZYBAN - AER
BUPROPION - R
ZOLPIDEM - AER
MONSTER - ADVERSE EVENTS 01/01/1997 - 12/31/2014
CORR RE MARCO RUBIO
ADVANCED NEUROMODULATION SYS INC, PLANO, TX - PMA
P010032/S011
ANULEX TECHNOLOGIES INC - CTS EC100567/E001
2012-3746
SIETSEMA FARMS, WEST MI - TURKEY MORTALITIES
8/11/14
THERANOS - APRVL
2015-5141
IXEKINUMAB - AERS
FOIA LOG FY 2014, 2015
K140199
5HOUR, 5 HOUR, FIVE HOUR, ETC - ADVERSE EVENTS
01/01/1997 - 12/31/2014
ANDA 089560
K143014
K102293, K072970
VACANCY ANNOUNCEMENT FOR DEPUTY DIRECTOR, OFFICE OF
EQUAL EMPLOYMENT OPPORTUNITY, FDA
PEGINTRON - SBA BLA 103949
JCB LABS, WICHITA, KS - EIR FEB 2013
DEN140044 DEN NOVO SUMMARY REVIEW
ALL FOREIGN & DOMESTIC INSP 1/15 TO 7/1/15
AMLOPIPINE ASCEND, CARLSBAD T, ZYGENERICS,
DOXAZOSIN MESYLATE - AER
OSIRIS THERAPEUTICS INC, COLUMBIA, MD - EIR 5/23-
6/4/13
NOS - ADVERSE EVENTS 01/01/1997 - 12/31/2014
SURGICAL BIOLOGICS, KENNESAW, GA - INSP 7/30-8/1/12

BLUE BELL CREMERIES, BROKEN ARROW, OK BRENHAM, TX
- INSP RPTS
JOINT MTG OF ADVISORY COMMITTEE 12/8/11 - RED
RIBBON CERTIFIED
CASE NOS 8838684 9058742 8964216 ETC
NOTICE OF ACCEPTANCE OF TRANSFER OF SUBMISSIONS
FROM LORILLARD INC
COMPOUNDING PHARMACIES IN GEORGIA SINCE 5/1/13 -
EIRS
ZEO HEALTH LTD, VALLEY COTTAGE, NY - 483, WARNING
LTR, INSP SINCE 1/15
MTGS BETWEEN FDA & EPIZYME 1/14 TO 12/31/15
CELMARK INTERNATIONAL INC (CEMI INTERNATIONAL),
ORLANDO, FL - EIRS, 483S, RESP TO 483 5/1-8/13
GARDEN STATE NUTITIONALS (GSN) VITAQUEST, WEST
CALDWELL, NJ - EIR, 483, RESP TO 483 11/13, 4/15
AMP - ADVERSE EVENTS 01/01/1997 - 12/31/2014
NOVO NORDISK INC - SAXENDA (LIRAGLUTIDE
RECOMBINANT) APRVL RVW RECS 12/23/14
MERCK SHARP & DOHME CORP (MERCK) - SYSTEMIC
FLUOROQUINOLONE ANTIBACTERIAL CLASS LTR 6/27/13
MERCK - NOROXIN (NORFLOXACIN) TABS 400 MG NDA
NOVARTIS CONSUMER HEALTH INC OR GLAXOSMITHKLINE -
BENEFIBER PRODS COMM, 483S, CONSENT ORDERS, ETC
2008 TO PRESENT
JUXTAPID (LOMITAPIDE) - APRVL, STUDIES, RPTS, ETC
DKT: FDA-20115--DRAFT-2970
WRIGHT MEDICAL GROUP INC, WRIGHT MEDICAL TECHNOLOGY

INC - METAL ON METAL HIP IMPLANTS ACETABLUAR:,
SUPERP FINISH SPIKED PMA APRVL, K990007, K001523,
ETC
SPINAL SOLUTIONS, ORTHOPEDIC ALLIANCE - INSPECTION
RECS, CRIMINAL INVESTIGATIONS, ETC 06/01/2011 -
01/18/2013
INSPECTORS BY STATE
CROSSFIT TRADITION, PORT SAINT LUCIE, FL -
COMPLIANCE RECS 03/01/2015 - 08/30/3015
AMERICAN RED CROSS, ALBANY, GA ATHENS, GA
GAINESVILLE, GA - EIR
FULL THROTTLE, FULLTHROTTLE - ADVERSE EVENTS
01/01/1997 - 12/31/2014
ARIAD PHARMACEUTICALS ZYKADIA ORPHAN DESIGNATION
REVIEW
UNIQUE PHARMACEUTICALS, TEMPLE, TX - EIR JAN 2015
SCA PHARMACEUTICALS, LITTLE ROCK, AR - EIR
MARCH/APRIL 2014
MS DRUGS - AERS
HHSF223201010074G STATEMENT OF WORK
PHARMAKON PHARMACEUTICALS, NOBLESVILLE, IN - EIR
MARCH/APRIL 2014
PACLITAXEL - DESIGNATION REVIEW
CANTRELL DRUG COMPANY, LITTLE ROCK, AR - EIR
OCT/NOV 2013
CAERS 139742, 141559, 176303 - MEDWATCH REPORTS,
MEDICAL RECORDS, LAB RESULTS ETC
ALLEN MEDICAL SYSTEMS YELLOFINS STIRRUPS, ALLEN
MEDICAL SYSTEMS YELLOFIN STIRRUPS - MEDWATCH RECS
ETC
K141771
ANDA 77863
AMD-VERDE, EGYPT TRINITY VIETNAM CO, LTD, VIETNAM
OROUBA AGRIFOODS PROCESSING, EGYPT ETC - 483
K011536
K141877
K133879
SE0009409
SE0009473
K86130727, K861316, K822735
MEDWATCH RECS
K090989
2014-9023
K130010
K101680
BRODALUMAB - AERS
KRATOM - CORR, EMAIL, MEETING NOTES
DEN130045
NATALIZUMAB - AERS
Potential Tobacco Violation Report ID 15D00013
IDT BIOLOGIKA GMBH, GERMANY - 483 12/01/2014 -
12/12/2014
MCNEIL CONSUMER HEALTHCARE, LANCASTER, PA - EIR
08/19/2013 - 08/30/2013
NARMS RETAIL TESTING RESULTS FROM OREGON 1/1/10 TO
PRESENT
LANTUS CMC ETC
CELLTEX THERAPEUTICS CORPORATION, HOUSTON, TX -
INSPECTION REPORTS, RESPONSES
MONSTER BEVERAGE CORP RESPONSE TO JULY 2013 LETTER
FROM MICHAEL LANDA
5660246 5678148 5678634 ETC
DIMETHYL FUMARATE - AERS
PYRAMID LABORATORIES, INC, COSTA MESA, CA - 483,
RESPONSE ETC 04/30/2015 - 07/10/2015
REPRODUCTIVE TISSUE BANKS - RECORDS RE VIOLATIONS
01/01/2010 - 07/13/2015
KREMERS URBAN PHARMACEUTICALS, SEYMOUR, IN - EIR,
483, RESPONSE 08/06/2013 - 08/15/2013
STAAR SURGICAL, MONROVIA, CA - 483, COMPANY
RESPONSE
CYTOVENE - TOXICOLOGY DATA NDA 19-661
FDA ANNUAL REPORT
K122474
K130349
LIST OF 483'S FOR PHARMACEUTICAL, BIOLOGICS &
MEDICAL DVC MFG, CLNCL TRIAL FACILITIES BOTH IN THE
US & OUTSIDE THE US 6/1-30/15
SANDOZ, MOMENTA - GLATOPA (GLATIRAMER ACEATE) AERS

XENAZINE (TEBRABENAZINE), NDA 21-894 ADRE VIEW
(LOBENUANE) NDA-22-290 NUCYNTA (TAPENTADOL HCL)
NDA 22-304, ETC - IND FILLING
AFFIRMATION OF COMPLIANCE FOR SHIPMENTS
3258437 3434840 3494140 ETC
GILADEL - ORPHAN DRUG DESIGNATION
ANDA 091071 SBA
ANDA 078912 - SBA
DRUG MASTER FILE 10500
SUN PHARMA - EIR, 483 01/01/2015 - 07/13/2015
MEKINIST, TAFINLAR - ORPHAN DRUG DESIGNATION RECS
BEXXAR - ORPHAN DRUG DESIGNATION RECS
TORAY INDUSTRIES INC, LENEXA, KS - IND FURAFINE HCL
NDA 101-322 SUBMISSIONS 0001 THRU 0014
COLONOSCOPY - ISRS 5660246, 5678148, 5678634, ETC
FDA'S CALANDAR RELATED TO YPE A,B, & C MTGS BTWN
FDA & A SPONSOR FROM 1/1/14 TO 12/31/15
JANSSEN RESEARCH & DEVELOPMENT LLC - SYSTEMIC

FLUOROQUINOLONE ANIBACTERIAL CLASS LTR 6/27/13
LEVAQUIN (LEVOFLOXACIN) TABS NDA 20-634/065
LEVAQUIN (LEVOFLAXACIN) INJ NDA 20-635/071, ETC
SUPPLEMENTAL NDA
THIOLA (TIOPRONIN) - MEDICAL RECS, COMMENTS
GYLCINE SCOGS REVIEW
LIST OF INSPECTED FOOD FACILITIES 01/01/2010 -
07/10/2015
ZYDUS BSV PHARMA PVT LTD, INDIA - EIR 01/01/2014 -
01/31/2014
WIL RESEARCH LABS, ASHLAND, OH - INSPECTION RECS
EXELON, RAZADYNE, ARICEPT ETC - AERS
REMS WEBPAGE DATA
DERMA PEN WARNING LETTER RECS, MEETING CORR
2012 DRAFT GUIDANCE ON CIPROFLOXACIN, DEXAMETHASONE

NDA N007936 APPROVAL LETTER
NEW YORK NEW YORK CIGARETTES - ORDER APPROVING
PREDICATE PRODUCT, SE PRODUCT APPLICATION
883771 883772 883773 ETC SAMPLE RECS
PROPOSALS FOR WRITTEN REQUESTS SUBMITTED TO FDA
UNDER FDAMA, BPCA, PREA WRITTEN REQUESTS ISSUED BY
FDA FOR PEDIATRIC EXCLUSIVITY
787625 855170 855171 ETC SAMPLE RECS
IND VX-770
787625 855170 855171 ETC - SAMPLE RECS
RECS RE MACROBIOTIC DIET 01/01/1950 - 01/01/1980
ARGININE, L-ARGININE - AERS

K132105
PRODUCT CODE HOT, RETINAL IMAGING LASER EYEWEAR -
510(G), DE NOVO SUBMISSION 07/01/2012 - 07/13/2015
CATALENT PHARMA SOLUTIONS, LLC - FOIA REQUESTS FOR
483 02/02/2015 - 07/13/2015
CHIA OIL - AERS

K070425
K113375
K930622
ALEDA E LUTZ VA MEDICAL CENTER, SAGINAW, MI -
INSPECTION REPORT FOR BLOOD BANK LABORATORY
08/15/2013 - 08/16/2013
IMPAX LABS, HAYWARD, CA - EIR 04/01/2015 -
07/13/2015
KYBELLA - AERS
MCNEIL CONSUMER HEALTHCARE, LANCASTER, PA - EIR
03/17/2015 - 03/27/2015
SUNMOON TRADING INC - ENTRY #EVH-00142337 NOTICES
FOR REQUEST OF INFOMRATION, FDA NOTICE OF ACTION,
CBP REDELIVER NOTICES, ETC
FOOD ALLERGEN LABELING AND CONSUMER PROTECTION ACT,

INFORMATION FOR CONSUMERS WEBPAGE QUESTION 27 -
HOW WILL FALCPA APPLY TO FOODS PURCHASED AT
BAKERIES, FOOD KIOSKS AT THE MALL, AND CARRY0UT
RESTAURANTS
KETOROLAC - AERS
CATECHINS FROM GREEN TEA EXTRACT GRAS 259
FDA NATIONAL ENVIRONMENTAL POLICY ACT (NEPA)

ANALYSES OF FOOD ADDITIVE PETITIONS 1/70 TO PRESENT
GENETICALLY MODIFIED ORGANISMS (GMO) IN FOOD PRODS
- RECS
ALCON LENSX INC, ALISO VIEJO, CA - EIR 6/7/12-
8/2/12
Any and all transcripts of Psychopharmacologic

Drugs Advisory Committee and Drug Safety and Risk
Management Advisory meetings related to NDA 11-522
and SLI-381 (Adderall and Adderall XR)
PRODS SOLD UNDER THE BRAND NAME JAMIESON - FORM FDA

3500, FORM FDA 3500A, FORM FDA 3500B 4/1/15-6/30/15
CMPLNT 121322 (CERTIFIED) BLUE BELL CREAMERIES,
SYLACAUGA, AL - ERIS 7/17/11, 3/14/12
DKT 2011N-076 - NAMES OF INDIVIDUALS RESPONSIBLE
FOR THE PREPARATION AND APRVL OF THE CONTENT OF THE
CITED FEDERAL NOTICE
SIGMA-ALDRICH, ST LOUIS, MO - EIR, 483, RECALL RECS
07/01/2011 - 07/13/2015
STERIS/ISOMEDIX, SOUTH PLAINFIELD, NJ - EIR, 483,
RECALL RECS 05/22/2013 - 07/13/2015
SPECTRUM CHEMICALS AND LABORATORY PRODUCTS, INC,
NEW BRUNSWICK, NJ - EIR, 483, RECALL RECS
07/01/2011 - 07/13/2015
UNION CARBIDE, PISCATAWAY, NJ - EIR, 483, RECALL
RECS 07/01/2011 - 07/13/2015
FRUTAROM, UK - EIR, 483, RECALL RECS 07/01/2012 -
07/13/2015
CLARIS LIFESCIENCES, CLARIS INJECTIBLES, INDIA -
483 05/01/2015 - 05/30/2015
K082535, K111564, K092508
K131153
RICCA CHEMICAL COMPANY, ARLINGTON, TX - EIR, 483,
RECALL RECS 07/01/2011 - 07/13/2015
CIPLA, LUPIN, WOCKHARDT ETC - EIR, 483 2015
US STUDY FOR P040033 SMITH & NEPHEW BHR HIPS
OXITEC FLORIDA KEYS MOSQUITO CONTROL DISTRICT -
INSPECTION REPORT 12/01/2014 - 06/01/2104
K112822
LETER FROM DR NEIL SCRIMSHAW TO DR MARK MCCLELLAN
RE MYCOPROTEIN, QUORN LETTER FROM CSPI TO FDA
01/01/2003 - 12/30/2012
LETTER FROM DR NEIL SCRIMSHAW TO DR MARK MCLELLAN
RE MYCOPROTEIN, QUORN LETTER FROM CPSI TO FDA RE
MYCOPROTEIN, QUORN 01/01/2003 - 12/30/2012
MMR RECS NON RESPONSIVE
ANDA 076758, ANDA 076636
CAS-SPECIFIC CUM DC, CUMULATIVE ESTIMATED DAILY
INTAKE - CALCULATIONS, DATA
TSO3 - STERIZONE STERILIZER K141163
K142168
METHODS PHARMACEUTICALS, LLC, MATTHEW S TUCKER,
SCOTT TUCKER, ARLINGTON, TX - WARNING LETTER, EIR,
483 ETC 01/01/2013 - 07/13/2015
MCNEIL CONSUMER HEALTHCARE, FORT WASHINGTON, PA -
EIR 04/20/2015 - 05/06/2015
NEVRO CORP, MENLO PARK, CA - EIR, MEMO, CORR RE
INSPECTION 01/29/2015 - 07/13/2015
HARMONY FOODS CORPORATION, SBA SANTA CRUZ
NUTRITIONALS - 483, EIR 01/01/2015 - 07/13/2015
SUN PHARMACEUTICALS INDUSTRIES, LTD, INDIA - 483
05/01/2015
COBAMAMIDE, DIBENCOZIDE, ADENOSYLCOBALAMIN - AERS
SODIUM FERROUS CITRATE - 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
MISLABELING OF SEAFOOD IN NY - ENFORCEMENT ACTIONS,

WARNING LETTERS ETC 01/01/2010 - 07/14/2015
ORTHOFIX, LEWISVILLE, TX - EIR 01/17/2012 -
12/31/2012
NDA 205747, NDA 206538
EMCURE PHARMACEUTICALS, INDIA - INSPECTION RECS RE
IMPORT ALERT 11/01/2014 - 07/14/2015
K090034
K862935
BIOCON LIMITED, INDIA - 483, WARNING LETTER
01/01/2012 - 07/14/2015
MEDILUX LABORATORIES PVT, INDIA - 483, WARNING
LETTER 01/01/2012 - 07/14/2015
WANBURY LIMITED, INDIA - 483, WARNING LETTER
01/01/2012 - 07/14/2015
HARMAN FINOCHEM LIMITED, INDIA - 483, WARNING
LETTER 01/01/2012 - 07/14/2015
LORILLARD TOBACCO COMPANY NEWPORT NON-MENTHOL GOLD
BOX 100S SE0003730 NEWPORT NON-MENTHOL GOLD BOX
SE0003731 UNREDACTED
SWATI SPENTOSE PRIVATE LIMITED, INDIA - 483,
WARNING LETTER 01/01/2012 - 07/14/2015
RED BULL, REDBULL - ADVERSE EVENTS 01/01/1997 -
12/31/2014
FOI DAILY LOG 6/29/15-7/3/15
FOI DAILY LOG 6/29/15-7/3/15
FOI DAILY LOG 6/29/15-7/3/15
FOI DAILY LOG 6/29/15-7/3/15
DEN140020
MARTIN SCHULER, MD, GERMANY - 483, CORR, EIR
03/18/13
ISR 11152854
SUN PHARMACEUTICAL INDUSTRIES LIMITED - 483,
WARNING LETTER 01/01/2012 - 07/14/2015
K142476
K132882
FOI DAILY LOG 6/29/15-7/3/15
FOI DAILY LOG 6/29/15-7/3/15
FOI DAILY LOG 6/29/15-7/3/15
2015-5141
CLOSED FIIA REQUESTS 7/6-11/15
CLOSED FIIA REQUESTS 7/6-10/15
NDA 017426
OPEN & CLOSED FOI DAILY LOGS 1/1/13 TO PRESENT
YORK HOSPIAL, YORK ME - METHYLENE BLUE AERS
ELIQUIS - AERS
K132413
ELOCTATE - AERS
LAM IPM WOULD GEL & 1PM GERM GEL- K130781: IPM
WOUND GEL BIO/IPM DERM GEL BIO - K143527
NORTH AMERICAN MEDICAL CORP (NAM), MARIETTA, GA

NORTH AMERICAN RESCUE LLC, GREER, SC ST JUDE
MEDICAL (CARDI-OMEMS), ATLANTA, GA - 483S 6/1-30/15
IZI MEDICAL PRODUCTS LLC, OWINGS MILLS, MD
EPIPHANY HEALTHCARE DATA MANAGEMENT LLC,
MIDLOTHIAN, VA GE HEALTHCARE, LAUREL, MD, ETC -
483S 6/1-30/15
NOVARTIS VACCINES & DIAGNOSTICS LTD, LIVERPOOL, UK
- 483S 6/1-30/15
QILU TIANHE PHARMACEUTICAL CO LTD, ITAIA CHINA

PATHEON ITALIS SPA, MONZA, ITALY LOTUS
PHARMACEUTICAL COMPANY LTD, NANTOU, TAIWAN - 483S
6/1-30/15
HUBEI WEIKANG PROTECTIVE PRODUCTS CO LTD, XIANTAO

CITY HUBEI, CHINA NITINOL DEVICES & COMPONENTS
COSTA RICA SRL, EL COYOL, COSTA, RICA HANDICARE
AB, LULEA, SWEDEN, ETC - 483S 6/1-30/15
RONDEX PRODUCTS INC, ROCKFORD, IL GEMA INC

(BALLERT ORTHOPEDIC), CHICAGO, IL FORTE AUTOMATION
SYSTEMS INC, MACHESNEY PARK, IL, ETC - 483S 6/1-
30/15
MDI MEDICAL LLC, BEACHWOOD, OH TROY INNOVATIVE
INSTRUMENTS INC, MIDDLEFIELD, OH TRANSDERMAL CAP
INC, CLEVELAND, OH - 483S 6/1-30/15
NEOS THERAPEUTICS INC, GRAND PRAIRIE, TX LINCARE
INC, LITTLE ROCK, AR CAREfUSION 213, LLC, EL PASO,
ETC - 483S 6/1-30/15
OSO BIOPHARMACEUTICALS MANUFACTURING LLC,

ALBUQUERQUE, NM CERAPEDICS INC, WESTIMINSTER, CO /
WALKMED INFUSION LLC, CENTENNIAL, CO, ETC - 483S
6/1-30/15
ZONTIVITY - AERS
MILLER TECHNICAL SERVICES INC, PLYMOUTH, MI
GOODMAN ROGER DDS, OKEMOS, MI CONTAINMED INC,
INDIANAPOLIS, IN, ETC - 483S 6/1-30/15
DMX-WORKS IMAGING INC, PALM HARBOR, FL PRIME
ENTERPRISES: INC, HIALEAH CARDINAL HEALTH 414, LLC,
FT LAUDERDALE, ETC - 483S 6/1-30/15
BIOMERIEUX INC, HAZXELWOOD, MO RAINING ROSE INC,
CEDAR RAPIDS, IA - 483S 6/1-30/15
TRIGG LABORATORIES INC, SANTA CLARITA, CA CURA
MEDICAL TECHNOLOGIES LLC, LAKE FOREST, CA ALERE
SAN DIEGO INC, SAN DIEGO, CA, ETC - 483S 6/1-30/15
DATEX-OHMEDA INC (GE HEALTHCARE), MADISON, WI

GALIL MEDICAL INC, ARDEN HILLS, MN SYNOVIS LIFE
TECHNOLOGIES INC (BAXTER INT'L INC), SAINT PAUL, MN
- 483S 6/1-30/15
TEI BIOSCIENCES, BOSTON, MA INTRINSIC

THERAPEUTICS, WOBURM, MA PHILIPS ELECTRONICS NORTH
AMERICA CORP, ANDOVER, MA, ETC - 483S 6/1-30/15
AKORN INC, SOMERSET, NJ GENESIS BPS, LLC, RAMSEY,
NJ 86 HARRIET AVE CORP (GENERAL DVCS), RIDGEFIELD,
NJ, ETC - 483S 6/1-30/15
MAIN STREET CASUAL LIVING LLC, MABEN, MS ANGIO
SYSTEMS INC, DUCKTOWN, TN - 483S 6/1-30/15
EPIC PHARMA LLC, LAURELTON, NY PAR PHARMACEUTICAL
INC, SPRING VALLEY, NY PHARBEST PHARMACEUTICALS
INC, FARMINGDALE, NY ETC - 483S 6/1-30/15
WRIGHT THERAPY PRODUCTS INC, OAKDALE, PA PEREGRINE
SURGICAL LTD, NEW BRITAIN, PA SYERGETICS INC,
PRUSSIA, PA, ETC - 483S 6/1-30/15
K101006
NIDEK INC, FREMONT, CA CEPHEID, SUNNYVALE, CA
BECTON, DICKINSON & CO (BD BIOSCIENCES), SAN JOSE,
CA, ETC - 483S 6/1-30/15
GALEPHAR PHARMACEUTICAL RESEARCH INC, HUMACAO, PR
NEOLPHARMA, INC, CAGUAS, PR - 483S 6/1-30/15
SAGEMAXX BIOCERAMICS INC, FEDERAL WAY, WA SEATTLE
GENETICS INC, BOTHELL, WA INOVISE MEDICAL LINC,
BEAVERTON, OR, ETC - 483S 6/1-30/15
K130350
SMS PHARMACUETICALS LITMITED, INDIA - 483, WARNING
LETTER 01/01/2012 - 07/14/2015
NIFTY LABS PRIVATE LIMITED INDIA - 483, WARNING
LETTER 01/01/2012 - 07/14/2015
CHK NUTRITION - EIR 09/01/2013 - 07/01/2015
ULTRATECH INDIA LIMITED, INDIA - 483, WARNING
LETTER 01/01/2012 - 07/14/2015
ENBREL - APPROVAL RECS
3M - 483, EIR, UNTITLED LETTER ETC RE MICROCHANNEL
SKIN SYSTEM 07/01/2011 - 07/01/2015
NUMBER OF PMA SUBMISSIONS, NUMBER OF PMA
SUBMISSIONS RECEIVING APPROVABLE LETTER, ETC
01/01/2011 - 06/30/2014
DR MOHAN IYER - AVASTIN LAB RESULTS
CENTURY PHARMACEUTICALS LIMITED, INDIA - 483,
WARNING LETTER 01/01/2012 - 07/14/2015
K150137
BIDART BROTHERS, SHAFTER, CA - EXHIBITS,
ATTACHMENTS TO EIR 12/01/2014 - 07/16/2015
ANDA 089560, NDA 005963
P010030
PYRAMID LABORATORIES RESPONSE TO 483 06/05/2015 -
07/14/2015
CHARLRES RIVER, HORSHAM, PA - INSPECTION RECS
07/11/2011 - 07/14/2015
EMCURE PHARMACEUTICALS LIMITED, INDIA - 483
01/15/2014 - 07/15/2015
GENZYME/SANOFI - SEPRAFILM BIORESORBABLE MEMBRANE
P950034 MEMO 11/2/05, 6/20/05 EMAIL 6/15/05
ROBERTO BOTELHO, UBERLIINDIA, BRAZIL 4/27/15-5/8/15

WEIMIN LI, HARBIN, CHINA 5/11-20/15 ANGELINA
STANEVA, SOFIA, BULGARIA 5/4-8/15 - EIRS, 48S,
CORR, ETC
COMPLAINT RECS
SAGENT PHARMS - LIDOCAINE HCL NDA 201-094 APRVL LTR

LEVAQUIN, LEVOFLOXACIN - AERS 11/97 TO PRESENT
IMPAX LABS, HAYWARD, CA - EIR 5/15
NIKKEN, INC, IRVINE, CA - COMPLAINTS RE KENKO
NATUREST MATTRESS TOPPER, KENKO POWERCHIP ETC
07/01/2010 - 07/15/2015
GE HEALTHCARE, LAUREL MD, - HEEIR EXHIBITS,
ATTACHMENTS 06/01/2015 - 06/19/2015
TRI-METHYL XTREME - ISR
UNITED STATES BLOOD BANK, MIAMI, FL - EIR, 483,
RESPONSE 04/29/2015 - 06/16/2015
LIST OF INSPECTIONS
REGISTERED DRUG AND BIOLOGICS FIRMS - CONTACT
INFORMATION
PHARMACEUTICS iNTERNATIONAL INCORPORATED, HUNT
VALLEY, MD - EIR 04/01/2015 - 07/01/2015
FCN 1502
Guidance for Industry, Designing Clinical Programs

for Developing Human Drugs, Medical Devices, or
Biological Products Intended for the Treatment of
Rheumatoid Arthritis Availability of Draft
Guidance Notice of Public Workshop" ETC
SANDOZ GMBH -EIR SUMMARIES, AUSTRIA 01/05/2015 -
07/15/2015
DMF CONTACT INFORMATION 01/01/2013 - 12/31/2013
ANDA 090816 SBA
K052292
HARRIS PHARMA LLP - DRUG REGISTRATION RECS
BAUSCH AND LOMB, TAMPA, FL - RESPONSE TO 483
03/02/2015 - 07/16/2015
ANDA 090811
CAP 6C-4403
AV3-0043236-4 REFUSAL RECS
CARE RESEARCH LLC, FORT COLLINS, CO - COMPLIANCE
WITH GOOD LABORATORY PRACTICES EIRS, COMM ,
PHOTOGRAPHS, ETC 1/10 TO PRESENT
2004-15917, 2009-951, 2009-1298 ETC
EASTMAN KODAK CO FAP 2197 ENVIRONMENTAL ASSESSMENT
01/01/1984 - 06/30/1992
EASTMAN KODAK CO - RECS FILED IN SUPPORT OF
ENVIRONMENTAL ASSESSMENT FOR FAP 2197 01/01/1984 -
06/30/1992
PMA number P020014
MEDTRONIC INFUSE BONE GRAFT - PREVIOUSLY RELEASED
RECS 01/01/1999 - 07/16/2015
NDA 020184
2015-3289
NDA 050740
GENERIC 6-ALPHA-ETHYLENODEOXYCHOLIC ORPHAN
DESIGNATION RECS
CLEAR EYES CONTACT LENS MULTI-ACTION RELIEF EYE
DROPS - 510K
A/C ANESTHETIC & LIFE SUPPORT COMMITTEE MEETING
12/1-2/86
K002063, K140249
K111601, K081473, k021230 ETC
MUCINEX, MUCINEX DM - AERS 06/30/2009 - 07/01/2015
CATALENT PHARMA SOLUTIONS, MORRISVILLE, NC - EIR
03/16/2015 - 07/16/2015
MEDTRONIC INFUSE BONE GRAFT - ADVERSE EVENTS
FCN 949
ARANESP - AMGEN APPROVAL STUDIES 01/01/2000 -
12/31/2005
REMS OVERSIGHT COMMITTEE MEETING RECS
BLUE BELL CREAMERIES - RECS RE RETURN TO PRODUCTION
04/01/2015 - 07/17/2015
CANAGLIFLOZIN - AERS
AGGRASTAT (TIROFIBAN HCL) - AERS
K150042
2015-3542
K830561
OSIRIS - LETTER FROM CBER 09/26/2013
ATTIX PHARMACEUTICALS, CANADA - 483 11/04/2014 -
11/30/2014
STERIS CORP, ST LOUIS, MO - EIR, 483
MENTAL HEALTH MEDICTION - RECALLS
CROHNS DISEASE - SYMPTOMS, TREATMENT
FOOD INGREDIENTS WHICH COME FROM ANIMAL HORN, HUMAN

HAIR. INSECTS, PORK, PETROLEUM SYNTHETIC MATERIALS
FCN 685 FCN 837
BAYER - ALEVE PM (DIPHENHYDRAMINE HCL NAPROXEN
SODIUM) NDA 205-352 RVWS
PHARMACEUTICAL PRODCUT DEVELOPMENT, MORRISVILLE, NC
- 483 1/12 TO 7/15
METAGENICS INC - INVESTIGATIONS, CO RESP, FINDINGS,
ETC.
CORR FROM THE FDA COMMISSIONER REGARDING BOTULINUM
STRAIN IBCA10-7060 5/1/12 TO 6/30/15
SURGICAL MESH - DEFECTIVE
EFFERDENT DENTURE CLEANSER - AER
MICRO QUALITY LABS, BURBANK, CA - EIRS, 482S, 483S,
ETC
SHIPMENTS REGULATED BY THE US FDA 1/15-31/15
PROLIA, XGEVA (DENOS UMAB AMG 162 HUMAN MONOCLONAL
ANTIBODY TO RAK LIGAND) BLA 125320/5,6 - APRVL LTR,
RVWS
OBINUTUZUMAB - AERS
TOCILIZUMAB - AERS
FILGRASTIM - AERS
JOINT INSTITUTE FOR FOOD SAFETY AND APPLIED
NUTRITION MEETING RECS 06/16/2015 - 06/18/2015
IDELALISIB - AERS
BELIMUMAB - AERS
ECULIZUMAB - AERS
DENOSUMAB - AERS
K040971
FRANKLIN PHARMACY, RUSSELLVILLE, AL - AFFIDAVIT
8/8/12
ALEMTUZUMAB - AERS
PONATINIB - AERS
10647564, 10736427, 10741259 MEDWATCH REPORTS
15WA001638 WARNING LETTER RECS
GOLIMUMAB - AERS
PAZOPANIB - AERS
PROTON PUMP INHIBITORS - POTENTIAL SIGNALS OF
SERIOUS RISKS/NEW SAFETY INFORMATION
CHIQUITA BRANDS INTERNATIONAL, FRESH EXPRESS,
INCORPORATED - WARNING LETTER STATUS RECS
10/06/2010 - 07/19/2015
VAERS RECS
MEDICAL DEVICES CERTIFIED RUNNING WINDOWS
08/24/2001 - 07/18/2015
DELETED RECS
BELMONT CONFECTIONS, INC, YOUNGSTOWN, OH TRUFOOD
MANUFACTURING INC, PITTSBURGH, PA - VIOLATION RECS
01/01/2008 - 07/17/2015
FOIA LOG
INVENTORY OF DRUGS SEIZED DURING EXECUTION OF
SEARCH WARRANTS IN USA V. MARTIN THUNA ET AL
LUPIN LIMITED, INDIA - 483 07/13/2015 - 07/20/2015

NDA 50-706 SBA
FOOD COMPLIANCE PROGRAM 7303.037
PARTIALLY HYDROGENATED OILS/TRANS FAT FOOD ADDITIVE
PETITIONS 05/01/2015 - 12/31/2015
NDA APPROVAL RECS

JADENU - APPROVAL RECS
CEFTRIAXONE - AERS
MEDS IV LLC - TOTAL PARENTERAL NUTRITION SOL
MARCESCENS BACTERIA RECS, INVESTIGATION,
REGISTRATION, ETC
COUNCIL TO IMPROVE FOODBORNE OUTBREAK RESPONSE RECS

BLUE BELL OUTBREAK RECS 01/01/2012 - 07/20/2015
RESPONSE TO SEN CLAIRE MCCASKILL, SEN SUSAN COLLINS

TEXAS STATE HEALTH RECS REVIEWED BY FDA FOLLOWING
BLUE BELL ICE CREAM LISTERIA OUTBREAK 01/01/2013 -
07/20/2015
DOOR COUNTY WISCONSIN INVESTIGATION RECS 01/01/2014
- 06/05/2015
LIST OF BOTTLED WATER PLANTS IN THE US
SURGICAL OCULAR GRAFT K053622 KERASYS LAMELLAR
PATCH GRAFT K090078
STERIS CORP, QUEBEC, CANADA - EIR
VELOXIS PHARMACEUTICALS INC - ENVARSUS XR
(TACROLIMUS) NDA 206-406 APRVL
MEXATE (METHOTREXATE SODIUM) ANDA 86-358/S027 -
LAST APRVD LBLG MEXATE-AQ ANDA 88-760/S000.S023 -
FIRST AND LAST APRVD LBLG, ETC
ZIONS RX FORMULATIONS LLC - CONTAMINATED CALCIUM
GLUCONATE INVESTIGATION
LOPRESSOR HCT (METOPROLOL TARTRATE,
HYDROCHLOROTHIZIDE) TABS NDA 18-303 - RECALLS,
SAFETY ALERTS, MARKET WITHDRAWALS 1/07 TO PRESENT
LEVAQUIN 20-634/065 20-635/S071 21-721/S032
GEODON RESPIDOL, PROZAC, ETC - AER
NUMBER OF ANDAS APRVD WITHIN ONE CYCLE OF RVW -
LTR, MEMO, PRESENTATION , ETC 1/10 TO PRESENT
ALLTR LREFUSE TO RECIEVE LTRS ISSUED FOR ANDA WHICH

CITE MISSING OR IMCOMPLETE STABILITY RECS AS THE
SOLE BASIS FOR AGENCY'S REFUSAL TO RECIEVE THE
APPLICATION, ETC 1/10 TO PRESENT
APPEALS OF REFUSE TO RECIEVE LTRS FOR ANDATHAT

CITE MISSING OR INCOMPLETE STABILITY RECS AS SOLE
BASIS FOR AGENCY'S REFUSAL TO RECIEVE APPLICATION,
CORR FROM APPLICANT, ETC 1/10 TO PRESENT
ARROW-HOWES - LARGE BORE MULTI-LUMEN CENTRAL

VENOUS CATHETERIZATION KIT AK-15123-H - MFG RECS,
PRE-MARKET NOTIFICATIONS, PRE-MARKET SUBMISSIONS BY
MFR REGARDING PROD, ETC
GE OEC MEDICAL SYSTEMS INC - INSTA TRAK 3500 PLUS
IT3500 PLUS -URGENT MEDICAL DVC CORRECTION LTRS
RYTARY (CARBIDOPA & LEVODOPA) ER CAPS NDA 203-312 -
APRVL PKG
COZAR (LOSARTAN) - AERS
NON-STEROIDAL ANTI-INFLAMATORY DRUGS (NSAIDS) - NEW

SAFETY RECS USED TO STRENGTHEN EXISTING LAB
WARNINGS THAT INCREASE THE CHANCE OF A HEART ATTACK
OR STROKE
CHILDREN'S FEXOFENADINE HCL ALLERGY, CHILDREN'S
FEXOFENADINE HCL HIVES ANDA 203-330 - APRVL LTR
11/18/14
JOHN LLEIGHTON - PROFESSIONAL OUTLOOK, GOOGLE
CALANDAR, AGENDA, APTS
MERCK SHARP & DOHME CORP - MK-3641 RAGWEED

SUBLINGUAL IMMUNOTHERAPY TBS IND 12-970 SCHERING-
PLOUGH RESEARCH INSITUTE - LONG-TERM FOLLOWP0UP
SUBJECTS IN PHASE I, II, III CLNCL TRIALS IN
BOCEPREVIR OR NARLAPREVIR FOR TREATMENT OF CHRONIC
HEPATITS C IN 6
OTC MEDICAL SUBSTANCE - WARNING LABEL OR DRUG FACTS
INSERT CONTAINS THE TERM DEPRESSED, SUICIDE OR
THEIR VARIANTS TRADE MAME & MFR OF EACH REGULATED
PRESCRIPTION MEDICAL SUBSTANCE, ETC
ERLOTINB HC TABS ANDA 91-002 APRVL PKG
CMPLNT 136134
WESTERN INSTITUTIONAL REVIEW BOARD, WIRB-COPERNICUS
GROUP, COPERNICUS GROUP INSTITUTIONAL REVIEW BOARD,
ETC - EIRS 1/10 TO PRESENT
BIDART BROS APPLE PROCESSING FACILITY, SHAFTER, CA
- INSP RECS 1/05 TO PRESENT.
SYNTHES INC, WEST CHESTER, PA - EIR, 483, WARNING
LTR RESP, ETC 6/18/04
2014-6711, 2014-7335, 2015-1835, ETC
DRAFT GENOME SEQUENCE OF BIVALENT CLOSTRIDIUM
BOTULINUM STRAIN IBCA10-7060 - EMAILS, MEMOLS,
RPTS, ETC 5/1/12 TO 6/30/15
ZHEJIANG LUDAO, TAIZHOU LUDAO - IMPORT ENTRY 1/13
TO PRESENT
SIMPLY THICK, SIMPLY THICK LLC - FOIA REQUEST LTRS
5/18/15 TO PRESENT
NY CITY DEPT OF CORRECTION FACILITIES - FOOD

HAZARDS TEST LEVELS , RESULTS GEORGE B VIERNO
CENTER - TEST LEVELS, RESULTS DANGER OF H-PYLOR
1982 TO 2014
SCOTT WALKER CORR LOGS WITH FDA 01/01/2011 -
07/17/2015
COLISTINE METHANE SULFATE - AERS
TOLMAR, INC, FORT COLLINS, CO - EIR, 483, RESPONSE
FEB 2014
WYETH PHARMACEUTICAL COMPANY DBA PFIZER CONSUMER
HEALTHCARE, GUAYAMA, PR - EIR, 483, RESPONSE NOV
2014
LLOYDS, INC OF IOWA, SHENANDOAH, IA - EIR, 483,
RESPONSE FEB 2015
PRAXAIR DISTRIBUTION MID-ATLANTIC, RICHMOND, VA -
EIR, 483, RESPONSE FEB 2015
DAIICHI SANKYO PROPHARMA CO, AKITA-SHI, JAPAN - 483
JUNE 2014
BIOMARIN PHARMACEUTICALS, NOVATA, CA - EIR, 483,
RESPONSE SEPT 2013
ENTRY # 9ES-0019509-7 - LAB TEST RESULTS AND
ANALYSIS
GRIFOLS-CHIRON CORPORATION, EMERYVILLE, CA - EIR,
483, RESPONSE MAY 2012
ALLERGAN SALES, WACO, TX - EIR, 483, RESPONSE
07/22/2013 - 08/02/2013
DAVID CHRISTOPHER BLACK, MD, BIRMINGHAM, AL - EIR,
483, RESPONSE 04/01/2014 - 06/18/2014
BIO-RAD LABORATORIES, REDMOND, VA - EIR, 483,
RESPONSE 01/24/2012 - 01/31/2012
BANNER PHARMACAPS, HIGH POINT, NC - EIR, 483,
RESPONSE JULY 2012
MOBILE INFIRMARY MED CTR IRB, MOBILE, AL - EIR,
483, RESPONSE AUGUST 2013
SATYAPRAKASH N MAKAM, MD, MUNSTER, IN - EIR, 483,
RESPONSE AUGUST 2012
SCANTIBODIES LABORATORY, INC, SANTEE, CA - EIR,
483, RESPONSE MAY 2014
SHIRE HUMAN GENETIC THERAPIES, CAMBRIDGE, MA - EIR,
483, RESPONSE 06/03/2013 - 08/05/2013
SINGING RIVER HEALTH SYSTEM IRB, PASCAGOULA, MS -
EIR, 483, RESPONSE MAY 2014
PFIZER - ZOLOFT (SERTALINE) CORR, MTG MINS
REGARDING DRUG LBLG SECTION 8.1
STASON PHARMACEUTICALS, IRVINE, CA - EIR, 483,
RESPONSE JAN 2015
TAKEDA PHARMACEUTICAL COMPANY LIMITED, OSAKA, JAPAN
- 483 SEPT 2013
HOWARD M GROSS, MD, DAYTON, OH - EIR, 483, RESPONSE
11/19/2014 - 01/14/2015
AUROBINDO PHARMA LIMITED, INDIA - 483 06/01/2015 -
07/21/2015
CINRYZE, BERINERT, ROCONEST - 12 YEAR EXCLUSIVITY
DATES
CTFA REPORTS RE CHRONIC TOXICITY OF SODIUM LAURYL
SULFATE
2014-9883
K131508
CORR BETWEEN FDA AND ATLAS PACIFIC MANUFACTURING RE
SE0011354, SE0011608
NAME, ADDRESS OF US FDA AGENT FOR FOREIGN
MANUFACURER OF API THAT EXPORTS TO THE US
01/01/2013 - 07/20/2015
EASTSIDE COMPREHENSIVE MEDICAL SERVICES, NEW YORK,
NY - AUDIT RPT 9/86
HIKMA FARMACEUTICA, PORTUGAL - 483
07/21/2015
TECFIDERA - AERS
ARTICAINE - AERS
2014-9108
LUPIN LABS, INDIA - 483 05/01/2015 - 07/22/2015

GARDASIL BLA 125126 SBA
BAXTER HEALTHCARE CORPORATION, MARION, NC - 483,
EIR, STATUS RECS 01/02/2014 - 07/21/2015
K091900
LUPIN LIMITED, INDIA - 483 07/01/2015 - 07/21/2015
XENICAL - AERS
LEVAQUIN LEVOFLOXACIN CIPRO CIPROFLOXACIN
AVELOX - AERS 11/1997 TO PRESENT
GREEN CABBAGE - E COLI INCIDENT RPT, FINAL RPT,
CLOSING LTR
REMRUM - RECALL
DA VINCI ROBOT - PANEL MEETING MINUTES 01/04/2001 -
12/27/2001
INDOMETHACIN ( INDOCIN) AER
PECTINASE ENZYME FROM ASPERGILLUS NIGER GROUP FOR
USE IN WINE MAKING - FDA ADVISORY LETTER 08/01/1983
- 08/30/1983
BARRY S GEORGE, MD, MIDWEST CARDIOLOGY RESEARCH
FOUNDATION, COLUMBUS, OH - INVESTIGATION,
INSPECTION RECS 01/01/2000 - 12/31/2003
CPT1400452
CIPRO - LINE LISTING
K090609
K040975
IPCA LABORATORIES LTD, RATLAM (MADYA PRADESH),
INDIA - IMPORT ALERT
NDA 19430 SBA
SOCIETY OF THE PLASTICS INDUSTRY - COMM RE FOOD
CONTACT MATERIALS
07/21/2015
HI TECH PHARMACEUTICALS, NORCROSS, GA - INSPECTION
RECS 01/01/2006 - 12/31/2007
PRE-CONSULTATION, SUBMITTED MATERIALS RE FAP RE
TRANS FATS AKA PHO 06/03/2015 - 06/21/2015
SE0009414, SE0009420, SE0009434
K002138
2014-9433
QTEST LABS, COLUMBUS, OH - 483, 482, EIR
Gigante Verde S de RL de CV EIR, 483 03/01/2015 -
04/30/2015
APOTEX HOLDINGS, INC - EXHIBITS

GENERAL MILLS, WEST CHICAGO, IL - EIR, 483
05/01/2015 - 07/21/2015
PLEXUS WORLDWIDE INC - WARNING LETTER RESPONSE
07/30/2014 - 07/14/2015
MIDWEST VETERINARY SERVICES, OAKLAND, NE - 483,
482, EIR 06/20/2012 - 07/21/2015
K122744
JULY 01, 2015 TO JULY 15, 2015
CPT1500570
CUSTOM ULTRASONICS - CORR WITH FDA 01/01/2015 -
07/01/2015
PORTSMOUTH REGIONAL HOSPITAL MAMMOGRAPHY DEPT -
INSPECTION RECS 01/02/2010 - 06/30/2015
FDC LIMITED, INDIA ETC - 483 01/01/2012 -
07/22/2015
K103233
FAP 2259
K130943
CORDIS - OPT EASE PERMANENT VENA CAVA FILTER
K023116 510K, SS&E OPTEASE RETRIEVAL CATHETER
K140286 510K (CERTIFIED)
NDA 205060
2011-7663
2012-6621
2012-6617
2015-3764
2014-5284
FORT WORTH EYE BANK - WARNING LETTER, 483
01/23/2012 - 01/23/2015
2015-5393
DKTS RECS CERTIFIED
2014-5968
2013-5005
2015-4753
K151115
K984167
K061855
K120315
K904950 SUMMARY
P050027 TABLE OF CONTENTS
K881767
MEXATE (METHOTREXATE SODIUM) ANDA 86-358/S027

7/12/89 MEXATE AQ ANDA 88-760/S000, 023 2/14/85,
6/30/89 MEXATE AQ PRESERVED ANDA 89-887/S000, 001
4/14/89, 7/30/90 - LBLG
K021362
SPINAL SOLUTIONS LLC - INVESTIGATION RECS 2011,
PROD RECAL 20013, ETC
NESTLE PURINA - BENEFUL CORR, INVESTIGATION 1/05 TO
PRESENT
CONTRACT HHS2722010000401
LUPIN, GOA, INDIA - 483 05/01/2015 - 07/22/2015
LUPIN, GOA, INDIA - 483 07/01/2015 - 07/23/2015
LUPIN, GOA, INDIA - 483 06/01/2015 - 07/23/2015
LUPIN, GOA, INDIA - 483 07/01/2015 - 07/23/2015
HEALTHTRONICS, AUSTIN, TX - EIR (CERTIFIED)
10/01/2011 - 10/31/2011
THERMOLIFE INTERNATIONAL - CREATINE NITRATE NDI
RECS, CORR
LUPIN, GOA, INDIA - 483 01/01/2015 - 07/23/2015
LUPIN, GOA, INDIA - 483 06/01/2015 - 07/23/2015
LUPIN, GOA, INDIA - 483 07/08/2015 - 07/20/2015
LUPIN, GOA, INDIA - 483 07/01/2015 - 07/23/2015
CAPRI SUN DRINKS - CONSUMER COMPLAINTS 01/01/2013 -
07/22/2015
AUROBINDO, INDIA - 483 07/01/2015 - 07/22/2015
BASI INC, MOUNT VERNON, IN - EIR 04/10/2012 -
04/17/2012
ISRS 3005075853-2010-00739 3005075853-2011-00219
K964518
K113207
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
"A Randomized, Multicenter, Double-Blind, Placebo-

Controlled, Dose-Comparison Study to Determine the
Efficacy and Safety of BG00012 in Subjects With
Relapsing-Remitting Multiple Sclerosis"
EPANOVA NDA 05-060 APRVL
DEEP BRAIN STIMULATION TO TREAT SKIN PICKING
DISORDER - ADVERSE EVENTS 01/01/1995 - 01/01/2015
K040974
VIVITROL ADVERSE EVENTS 100284791 99977791 99255091
ETC
CORDRAN TAPE NDA 16-455 DORYX NDA 50-582
NAPROXEN - SAFETY RVW
IRS 95007481 96969991 96970022
K061640
K101133
K050702
NDA 20449/S45 FOIA REQUESTS, RESPONSES
K133951
AMBROXOL - CASE REPORTS
PHENYLEPHRINE - CASE REPORTS
K970596
K141119
K092746
K033880
K102722
K143531
NDA 018024
GENUINE BAYER ASPIRIN 325 MG TABLETS - LABELING,
PRODUCT PACKAGING
CASE REPORT 11175314
IND 40061 NDA 021677 FAX TO FDA
NDA 022535 SBA UNREDACTED
UNIVERSITY OF MIAMI TISSUE BANK - 483 11/20/2012 -
01/01/2015
EMAILS, LETTERS BETWEEN FDA AND CDC RE REGULATION
OF OPIOID PAINKILLERS 01/01/2011 - 07/28/2015
K141685
PHENYLEPHRINE - AERS
DEFINITY VIAL FOR INJECTABLE SUSPENSION - AERS
K131482
DELTEX MEDICAL, UK - EIR JULY 2015
VERTELLUS HEALTH AND SPECIALTY PRODUCTS, LLC,
ZEELAND, MI - EIR, 483 06/01/2012 - 08/01/2014
IRBUTINIB - MEDWATCH REPORTS 07/01/2000 -
07/24/2015
LETTERS FROM FDA RE PRODUCTS IDENTIFIED ON THEIR
LABELS AS MANYONAISE OR MAYO ETC 10/01/2014 -
07/24/2015
47 FR 18623, 53 FR 12764
SAMPLE 720483 - COLLECTION, LAB REPORT
WARNING LETTERS SENT TO TMJ J IMPLANT DEVICE
COMPANIES JAN 2011 TO PRESENT
SUBSTANTIAL EQUIVALENCE REPORTS WITHDRAWN BY SMALL
TOBACCO PRODUCT MANUFACTURERS
VITALITY WORKS INC, ALBUQUERQUE, NM - EIR
01/24/2012 - 07/24/2015
THE BLOOD CENTER, HAMMOND, LA - WARNING LETTERS,
483 07/24/2012 - 07/24/2015
FAERS CASE REPORTS
NDA, SNDA - RECS RE ENVIRONMENTAL IMPACTS

DKT FDA-1976-N-052C LET071, ANS002
LETTER FROM ELI LILLY & CO TO FDA RE IND IND 40,061

MEDWATCH REPORTS 9601471, 10300803, 10687109, ETC
FCN 1195
NEVADA DONOR NETWORK - WARNING LETTER, 483
01/23/2012 - 01/23/2015
GLYCERIN TRADERS, LAPORTE, IN - 483 08/01/2014 -
07/28/2015
BARRETTS MINERALS INCORPORATED, SOUTH OF DILLON, MT
- EIR DEC 2012, FEB 2015
SHANGHAI DESANO - 483 ZHEJIANG HISUN
PHARMACEUTICAL - EIR 02/01/2015 - 07/21/2015
CHONGQING DAXIN PHARMACEUTIAL CO, CHONGQING, CHINA

1/26-29/15 CHONGQING KANGLE PHARMACEUTICAL CO LTD,
CHONGQING, CHINA 1/26-30/15 CHONGQING TAIHAO
PHARMACEUTICAL CO LTD, JIULONGPOQU, CHINA 3/9-13/15
- 483
OFATUMUMAB - MEDWATCH REPORTS
K070686
K063359
K091633
NDA 20629
BLINATUMOMAB - MEDWATCH REPORTS
EKOSONIC MACH 4 ENDOVASCULAR DVC, EKOSONIC CONTROL
UNIT K140151
TESAMORELIN - AERS
CORTEX MANUFACTURING INC, LAKE STEVENS, WA 3/25/15-

4/1/15 GENZYME, LYNNWOOD, WA 2/18/15-3/18/15
PERSONAL MEDICAL CORP, REDMOND, WA 1/14-22/15
PHILIPS ELECTRONICS NORTH AMERICA CORP, BOTHELL,
WA 2/18/15-4/21/15 - 483
OCILIZUMAB - MEDWATCH REPORTS
CARTILZOMIB - AERS
TBO-FILGRASTIM - MEDWATCH REPORTS
GLOBAL MEDICAL PRODUCTION CO LTD, JIAXING CITY,
CHINA 4/27-30/15 HISUN PFIZER PHARMACEUTICALS CO,
FUYANG CITY, CHINA 4/20-25/15
RAXIBACUMAB - MEDWATCH REPORTS
DINUTUXIMAB - MEDWATCH REPORTS
NIVOLUMAB - MEDWATCH REPORTS
PALBOCICLIB - MEDWATCH REPORTS
DR DAVID I WIRTA, EYE RESEARCH FOUNDATION, NEWPORT

BEACH, CA - INSPECTION RECS 01/01/2011 - 01/23/2015
PEMBROLIZUMAB - MEDWATCH REPORTS
HACCP CERTIFICATION CERTIFIED TO EXPORT SEAFOOD TO
THE USA - VENEZUELA, MEXICO, INDONESIA
PANOBINOSTAT - MEDWATCH REPORTS
TOFACITINIB - MEDWATCH REPORTS
FOOD REGULATORY PROGRAM STANDARDS REPORTS FOR NORTH

CAROLINA DEPARTMENT OF AGRICULTURE MOST RECENT
DIOP SPREADSHEET OF IMPORTED DRUGS SINCE 1/1/10 -
PENTOBARBITAL, SODIUM THIOPENTAL, MIDAZOLAM
DEPUY SPECIALIST 2 INTRAMEDULLARY ROD - COMPLAINTS,
ADVERSE EVENTS 07/19/2002 - 07/08/2015
FDA SAN JUAN PUERTO RICO OFFICE CONFERENCE CALL
6/23/15
INVENTURE FOODS, INC - RECALL RECS, REPORTS RE
FACILITY, COMM WITH GA DEPARTMENT OF AGRICULTURE
08/01/2014 - 07/01/2015
RECS RE SUMMARY REPORT REFERENCED IN MAUDE REPORT
1030489-2014-00628
DR HOWARD I SCHENKER, ROCHESTER OPHTHALMOLOGICAL
GROUP PC, ROCHESTER, NY - INSPECTION REC 08/18/2014
- 08/22/2014
WARNING LETTER RE NASAL SPRAY PRODUCTS
DENTAL AMALGAM - MDRS 1993 TO 2003
PFIZER MANUFACTURING BELGIUM NV, PUURS, BELGIUM -
483 6/30/15
CORK FEI 1000170338 PARMA FEI 3002807114
ULVERSTON FEI 3003722404
SYNCARDIA SYSTEMS INC, TUCSON, AZ 4/13-17/15

AFFINITY MEDICAL TECHNOLOGIES LLC, COSTA MESA, CA
2/24/15-3/3/15 AJINOMOTO ALTHEA INC, SAN DIEGO, CA
5/6-18/15 - 483
ADVANCED ORTHOGONAL EQUIPMENT INC, SAINT

PETERSBURG, FL 2/18 - 3/19/15 BAUSCH & LOMB,
TAMPA, FL 3/2 - 6/15 ECI PHARMACEUTICALS LLC, FT
LAUDERDALE, FL 2/23-27/15 - 483
AMGEN INC, BOULDER, CO 2/3 - 11/15 AMGEN INC,
LONGMONT, CO 2/3 - 11/15 COVIDIEN LP, BOULDER, CO
2/12 - 26/15 - 483
KING SYSTEMS CORP, NOBLESVILLE, IN 3/25/15-4/24/15

SIGMA TAU PHARMASOURCE INC, INDIANAPOLIS, IN
3/23/15-4/10/15 AMERICAN PHARMACEUTICAL
INGREDIENTS, WATERFORD, MI 1/28/15-2/1015 - 483
FUJIFILM MEDICAL SYSTEMS USA INC, STAMFORD, CT 2/5-

19/15 PFIZER INC, GROTON, CT 1/20-23/15 SHEFFIELD
PHARMACEUTICALS LLC, NEW LONDON, CT 3/6-19/15 - 483
BELL MORE LABORATORIES, HAMPSTEAD, MD 3/3-13/15 US

ARMY MEDICAL RESEARCH INSTITUTE OF INFECTIOUS
DISEASES, FORT DETRICK, MD 1/12-21/15 AG ESSENCE
INC, RICHMOND, VA 3/30/15- 5/14/15 - 483
PPI DRUGS, ACID BLOCKING DRUGS - AERS
ALEXZA PHARMACEUTICALS INC, MOUNTAIN VIEW, CA 5/18-

21/15 AMERICAN MEDICAL SYSTEMS INNOVATION CENTER,
SAN JOSE, CA 3/30/15- 4/3/15 AMPAC FINE CHEMICALS
LLC, RANCHO CORDOVA, CA 1/20- 23/15 - 483
WEEKS & LEO CO INC, CLIVE, IA 4/6-10/15 HOSPIRA
INC, McPHERSON, KS 3/23/15-4/3/15 AG INDUSTRIES
LLC, ST LOUIS, MO 3/26/15-4/13/15 - 483
FOCUS LABORATORIES INC, NORTH LITTLE ROCK, AR

1/26/15- 2/6/15 CARDINAL HEALTH 200 INC, ELPASO,
TX 3/23-26/15 CHEMOLEE LAB CORP, IRVING, TX
1/12/15-2/13/15 - 483
DSM NUTRITIONAL PRODUCTS - ALGAL OIL GRAS NO 553
QUESTCOR PHARMACEUTICALS - HP ACTHAR GEL NDA 08-372
APRVL UN REDACTED
EARTHDOG DENVER LLC, DENVER, CO - CMPLNTS, CORR 8/1
- 12/13/13
CELECOXIB, IBUPROFEN, MELOXICAM ETC - AER

CRAVE MARKET LP, SAN ANTONIO, TX - HACCP PLAN
ALL REFUSE TO RECEIVE LTRS FOR ABBREVIATED NDAS
FROM 1/10 TO PRESENT
PFEIFFER P HARMACEUTICALS INC, ATLANTA, GA
CRYOLIFE INC, KENNESAW, GA RESEARCH TECHNOLOGIES
INC, GREENVILLE, SC - 483S 3/1-31/14
GREAT PLAINS LION EYE BANK - WARNING LETTER, 483
01/23/2012 - 01/23/2015
MYLAN PHARMACEUTICALS INC, MORGANTOWN, WV FAREVA
RICHMOND INC, HENRICO, VA C-CARE LLC, LINTHICUM
HEUIGHTS, MD, ETC - 483S 3/1-31/14
GOOD-LITE COMPANY INC, ELGIN, IL STEREO OPTICAL CO
INC, CHICAGO, IL CORPAK MEDSYSTEMS INC, BUFFALO
GROVE, IL, ETC - 483S 3/1-31/14
MORRISON MEDICAL PRODUCTS, COLUMBUS, OH THE UTOPIA
GROUP LLC, LOVELAND, OH NOVOSOURCE INC, DAYTON, OH
- 483S 3/1-31/14
VICTOR TECHNOLOGIES INC, DENTON, TX IMMUNO-
MYCOLOLGICS INC, NORMAN, OK PERNIX MANUFACTURING
INC, HOUSTON, TX, ETC - 483S 3/1-31/14
E C MOORE CO, DEARBORN, MI ELBA INC (ELBA LABS),
TROY, MI INTEGRATED BIOMEDICAL TECHNOLLOGY INC,
ELKHART, IN, ETC - 483S 3/1-31/14
SEPARATION TECHNOLOGY INC, SANFORD, FL SWISS CAPS
USA INC, MIAMI, FL MICRUS ENDOVASCULAR CORP,
MIRAMAR, FL, ETC - 483S 3/1-31/14
3M UNITEK CORP, MONROVIA, CA STAAR SURGICAL CO,

MNROVIA, CA MEDTRONIC CARDIOVASCULAR SURGERY (THE
HEART VALVE DIVISION), SANTA ANA, CA, ETC - 483S
3/1-31/14
TAPEMARK CO, SAINT PAUL, MN UPSHER SMITH
LABORATORIES, INC, MAPLE GROVE, MN NEV'S INK INC,
WAUKESHA, WI, ETC - 483S 3/1-31/14
THE DODGE CO INC, BILLERICA, MA HUESTIS MACHINE
CORP, BRISTOL, RI ACME MONACO CORP, LNEW BRITAIN,
CT, ETC - 483S 3/1-31/14
MCNEIL-PPC INC, SKILLMAN, NJ COSMETIC ESSENCE INC,
RIDGEFIELD, NJ OHM LABORATORIES INC, NORTH
BRUNSWICK, NJ, ETC - 483S 3/1-31/14
K040973
510K for BIOELECTRICAL IMPEDANCE ANALYZER - SE
LETTER
JOHN W HOLLIS INC, NASHVILLE, TN MAX MOBILITY LLC,
ANTOCH, TN MOTION VIEW SOFTWARE LLC, HIXSON, TN -
483S 3/1-31/14
TEVA WOMEN'S HEALTH INC, NORTH TONAWANDA, NY
GERITREX CORP, MOUNT VERNON, NY - 483S 3/1-31/14
PACKAGING COORDINATORS INC, PHILADELPHIA, PA
CONDUCTIVE TECHNOLOGIES INC, YORK, PA CHILDRENS
MEDICAL VENTURES, MONROEVILLE, PA - 483S 3/1-31/14
DEXTA CORP, NAPA, CA ALZA CORP, VACAVILLE, CA
INTUITIVE SURGICAL INC, SUNNYVALE, CA, ETC - 483S
3/1-31/14
AMO PUERTO RICO MANUFACTURING INC, ANASCO, PR EX-
LAX INC, HUMACAO, PR AMGEN MANFACTURING LTD,
JUNCOS, PR, ETC - 483S 3/1-31/14
DRAVON MEDICAL INC, CLACKAMAS, OR BIOJECT MEDICAL
TECHNOLOGIES INC, TIGARD, OR ADVANCED RENAL
TECHNOLOGIES, INC, ETC 483S 3/1-31/14
HARMAC MEDICAL PRODUCTS LTD, ROSCOMMON, IRELAND

LAKE REGION MEDICAL LTD, NEW ROSS, IRELAND HOME
CARE TECHNOLOLGY CO LTD, TAINAN CITY, TAIWAN, ETC -
483S 3/1-31/14
K003016, K002149, K0P21346, ETC
GE OEC MEDICAL SYSTEMS INC - INSTA TRAK 3500

PLUS/IT3500 PLUS URGENT MEDICAL DVC CORRECTION
LTRS, URGENT MEDICAL DVC CORRECTION LTR SENT TO ALL
AFFECTED CUSTOMERS 11/26/13 RECALL RECS
SCHNUCKS ENTERPRISE, ST LOUIS, MO - CMPLNT 141652
EAST TENNESSEE LIONS EYE BANK, INC - WARNING
LETTER, 483 01/23/2012 - 01/23/2015
BMPEA, ACACIA RIGIDULA, YELLOW NEUPHORIA GEN2, ETC
- COMM, LTRS, E-MAILS, ETC
GERBER GOOD START INFANT FORMULA, NESTLE USA,
NESTLE NUTRITION, ETC - DKT 2009Q-0298, DKT 2009Q-
0301, WARNING LTRS, CORR, ETC
PES - ALPHA T2 VPX - BLACK ON BLUE SERIES REDLIN
V.2, NRG-X LABS - BLACK STINGER, ETC - CAERS
LIST OF DEPT OF HEALTH & HUMAN SERVICES EMPLOYEES -
NAME, EMAIL, MAILING ADDRESS, ETC
POINCIANA MILLING COMPLEX, KISSIMMEE, FL -
INSPECTION RECS 07/28/2005 - 07/28/2015
CHARLES LESTER, ZARBEE VITAMIN DROPS -
INVESTIGATION RECS, NOTES, TESTS ETC
EGG PRODUCTION FACILITIES IN CALIFORNIA - WARNING
LETTERS, EIR, ENVIRONMENTAL TESTING ETC 07/28/2012
- 07/28/2015
OHL-0406025-1 LAB RESULTS
BIOENERGY, INC, ACUITY MEDICAL, INC ETC - REPORTS,
RECS, CORR ETC RE IDE 12/01/1998 - 07/28/2015
HISTORY AND ENCYCLOPEDIA ON DRUGS, LAGAURDIA
PAPERS, VICTOR LICATA HISTORY, ETC
DAILY LOG 7/13-17/2015
PLANTAIN PRODUCTS COMPANY, TAMPA, FL -
INVESTIGATIONS, FINES 07/01/2000 - 07/28/2015
VILLA VALENTI SAUCE CO, WYNANTSKILL, NY -
INSPECTION RECS, ATTACHMENTS, REPORTS ETC
01/01/2001 - 01/01/2010
RECS RE PARTICIPATION OF FDA STAFF WITH DGAC RE
ROLE OF ADDED SUGAR IN AMERICAN DIET DEVELOPMENT
OF STATEMENT ON P 27, CHAPTER 6 OF DGAC REPORT
SASH AND BASSINETTE - DEVICE DETERMINATION RECS
EMAIL, LETTERS BETWEEN FDA AND CDC RE EVALUATION OF
RISK OF ELECTRONIC CIGARETTES 01/01/2011 -
07/28/2015
K030419
ENCO PHARMACEUTICAL DEVELOPMENT, CARY, NC - EIR
01/01/2009 - 07/01/2015
WJW MEDICAL PRODUCTS INC, WALTER MEDICAL PRODUCTS,
INC, WALTER J WOLANSKE - REGISTRATION RECS ETC
01/01/2006 - 07/29/2015
INMODE DEVICE - APPROVAL RECS, ADVERSE EVENTS
01/01/2010 - 07/25/2015
K123435
PROVIA LABORATORIES, LITTLETON, MA - EIR 01/01/2014
- 12/31/2014
LIONS EYE BANK OF TEXAS - WARNING LETTER, 483
01/23/2012 - 01/23/2015
K150365
K032350
K113259
K141049
CORR BETWEEN FDA AND KEYVIEW LABS, INC RE DIETARY
SUPPLEMENT PROCERA AVH
VETERINARY MEDICAL OFFICER GS-701-13 FDA-DH-14-
1070239-GP
K032519, K060980, K140933 ETC
PROCERA AVH - AERS
SE0003730. SE0003731
K042623 K103083 K110450 ETC
BIODLOGICS, CORDOVA, TN - INSPECTION RECS
VETERINARY MEDICAL OFFICER GS-701-13 FDA-DH-14-
1228253-GP
ORPHAN DRUG DESIGNATION REQUEST FOR AMIKACIN
SULFATE
LONICERA JAPONICA, JAPANESE HONEYSUCKLE MEDWATCH
RECS
K090507, K082262, K080572
K113285, K110327
CERTIFIED INSPECTION REC 07/03/2013 - 07/20/2015
ADVERSE EVENT REPORT RE XPAND CORPECTOMY SPACER,
GLOBUC EXPAND TITUANIUM CAGE WTIH GLOBUS ANTERIOR
CERVICAL PLATING
STN SE0004388,STN SE0003525
LIST OF CANADIAN FOOD COMPANIES THAT HAVE BEEN

INSPECTED 1/1/10 TO PRESENT 483 ISSUED TO CANADIAN
FOOD COMAPANIES THAT HAVE BEEN PREVIOUSLY RELEASED
UNDER FOIA SINCE 11/1/14
PURE POWDERED CAFFEINE - NUMBER OF DEATHS, ADVERSE
EVENTS IN US 01/01/2014 - 01/23/2015
ZARBEE'S NATURALS - VITAMIN D SUPPLEMENT 400 IU FOR
INFANTS LAB TESTING, RPTS, ANALYTICAL W/S
GENZYME/SANOFI - SEPRAFILM BIOABSORBABLE MEMBRANE
P950034 CORR 3/23/05
2015-5325, 2015-5200, 2015-4590, ETC
BELIMUMAB - AERS
ALEMTUZUMAB - AERS
DENOSUMAB - AERS
RECALL RECS 2009 AND EARLIER
ZYPREXA - RECS
AUVI-Q, ADRENACLICK - AERS
GOLIMUMAB - AERS
K072370
COMPLAINT SUBMITTED TO OFFICE OF PRESCRIPTION DRUG
PROMOTION BAD AD PROGRAM IN WARNING LETTER ISSUED
TO PACIRA PHARMACEUTICALS 11/28/2011 - 07/29/2015
ECULIZUMAB - AERS
IV DILUADID - SBA
TRIFEXIS - CMPLNTS, AERS, MARKETING DATE, ETC 2011
TO PRESENT
DIFICID - APPROVAL PACKAGE
OBINUTUZUMAB - AERS
FILGRASTIM - AERS
DMSO - AERS
INDIVIDUAL RECS
NDA, sNDA data
CVS SpectraVite Multivitamin Adult 50+ - AERS
IDELALISIB - AERS
MAK-SYSTEM SAS INTERNATIONAL GROUP - EIR 01/01/2010
- 07/29/2015
PONATINIB - AERS
2015-4027
FENTANYL GEL PATCH - TESTING RECS 7/1/15-9/30/15
STRABISMUS KETAMINE HCL CASE REPORTS
WRITTEN SUBMISSIONS TO OPDP CONTAINING ANY

ALLEGATION THAT ANY ADVERTISEMENT OR PROMOTIONAL
DOCUMENT FOR EXPAREL IS FALSE OR MISLEADING
11/28/2011 - 07/29/2015
API LABS IN CHINA, INDIA - INSPECTION REPORTS
7/1/13 TO 6/30/15
Pasteur Mrieux Connaught Meningococcal

Polysaccharide Vaccine Groups A, C, Y and W-135
Combined Menomune A/ C/Y/W-135 package insert,
June 1998, Copy serial 2494
GAMMA-AMINOBUTYRIC ACID - AERS

K040972
GVK BioSciences Private Ltd., - EIR, 483
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
WILLOW BARK, SALIX - AERS

LUPIN LABORATORIES LIMITED - 483 06/01/2015 -
07/29/2015
A copy of any decisions or memoranda issued by the
CDER Exclusivity Board in calendar year 2014
BioPlex HIV Ag Ab Assay product/package insert
K102651, K010315
2015-4106
Post-marketing pharmacovigilance data for Viadur
ALZA Corporation Application No.: 21-088. Approval
Date: 3/3/2000
K143236
ANDA 71644
K022002
K143378
K133237
K954167
K091935
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
FERRING PHARMACEUTICALS (CHINA) CO LTD, ZHONGSHAN,

CHINA - 4/13-17/15 GUILLIN PHARMACEUTICAL CO LTD,
GUILIN, CHINA -3/9-13/15 GE MEDICAL SYSTEMS CHINA
CO LTD, WUXI, CHINA, ETC - 483S 2/2-5/15
APEX INTERNATIONAL MFG INC 5/5-13/15 WILSON-HURD
MFG CO INC, BERLIN, WI, ETC - 483S 1/27/15-2/18/15
APOTHECA SUPPLY INC, DECATUR, AL- 2/10-12/15

SANIMINA INC, HUNTSVILLE, AL - 4/6-23/15 HEALTH
SCIENCE PRODUCTS INC, HUEYTOWN, AL, ETC - 483S
12/17-27/15
APNEICARE LLC, WORTHINGTON, OH - 4/28/15-5/5/15

ELECTRO CAP INTERNATIONAL INC. EATON, OH - 1/13-
23/15 KILTEXC CORP, AKRON, OH, ETC - 483S 5/13-
198/15
CAREFUSION 2200 INC, VERNON HILLS, IL - 4/27/15-

5/7/15 HOSPIRA INC, LAKE FOREST, IL - 4/20/15-
5/11/15 THERAPEUTIC PROTEINS INTERNATIONAL LLC,
CHICAGO, IL, ETC - 483S 1/13/15-2/9/15
ETHICON INC, CORNELIA, GA - 4/13-24/15 CATALENT
PHARMA SOLUTIONS INC, MORRISVILLE, NC - 3/16-20/15
SUNNEX INC, CHARLOTTE, NC, ETC - 483S 1/28/15-
2/18/15
ADVANCED BACK TENCHOLOGIES INC, HAUPPAUGE, NY-4 /9-

21/15 ALTAIRE PHARMACEUTICALS INC, P O BOC 849,
AQUEBOGUE, NY - 3/31/15-4/13/15 BIODEX MEDICAL
SYSTEMS INC, SHIRLEY, NY, ETC - 483S 3/12-17/15
CMIC CMO USA CORP, CRANBURY, NJ - 2/9-13/15

FUJIFILM MEDICAL SYSTEMS USA INC, WAYNE, NJ -
3/24/15-4/9/15 HERITAGE PHARMA LABS INC, EAST
BRUNSWICK, NJ, ETC - 483S 3/19/15-4/16/15
AMGEN MANUFACTURING LTD, JUNCOS, PR - 1/12-23/15

BAXTER HEALTHCARE OF PUERTO RICO, GUAYAMA, PR -
1/20/15-2/6/15 FENWAL INTERNATIONAL INC, MARICAO,
PR, ETC - 483S 3/28-25/15
ISRS 3612157, 3794682, 3918348, ETC
CINCINNATI EYE BANK - WARNING LETTER, 483
01/23/2012 - 01/23/2015
ISRS 8709906, 8759142, 9613594, ETC
ACETIAMINOPHEN - STEVEN JOHNSON SYNDROME (SJS),

TOXIC EPIDERMANAL NECROZYSIS (TEN), ACUTE GENERIZED
EXANTHEMATOUS PUSTLOSIS (AGEP) AERS 1969 TO 2012
TOLIVER & GAINER - TYLENOL PG 1 2010-6478, PG 2
2011-5919, PG 3 2015-5443
2015-5969
ODWALLA SUPER FOOD SMOOTHIE - CMPLNT 140551
ANTI-INFECTIVE DRUGS A/C - GLAXOSMITHKLINE CEFIN
NDA 50-605 SLIDES, MTG, AGENDAS, ETC 7/22-23/93
INITIATIVE FOODS LLC, SANGER, CA - FAP, RVWS
10/1/08, 6/10/09, FOOD COMPOSITION STANDARDS, LBLG,
ECONOMICS RPT 6/22/11, ETC
GLAXOSMITHKLINE - CEFTIN NDA 50-605/017 APRVL,
ADMINISTRATIVE RECS, SBA
FDA ALERT 8/7/08, INFORMATION FOR HEALTHCARE
PROFESSIONS - SIMVASTAIN USED WITH AMIODARONE
(CERTIFIED)
MERCK -BELSOMRA (SUVOREXTANT) AERS
ADUSAVE - AERS
DMF 3356 - UNPURGED COPY
LUPIN PHARMA, GOA, INDIA - 483 7/15
BAUSCH & LOMB - LUMINESSE BRIMONIDINE TARTRATE
OPHTHALMIC SOL NDA 208-144 AERS
UNITED DYNACARE LABORATORIES, MILWAUKEE, WI - EIR,
483, RESPONSE 1/29/15
CARLSBAD TECHNOLOGY, INC, CARLSBAD, CA - EIR, 483,
RESPONSE 0/21/2014 - 11/21/2014
B. BRAUN MEDICAL, INC, IRVINE, CA - EIR, 483,
RESPONSE 04/23/2013 - 05/17/2013
HOBERMAN ALEJANRO, PITTSBURGH, PA - EIR, 483,
RESPONSE 01/21/2015 - 02/04/2015
WYETH BIOPHARMA, ANDOVER, MA - EIR, 483, RESPONSE
6/20/12
BRISTOL-MYERS SQUIBB COMPANY, INC., MOUNT VERNON,
IN - EIR, 483, RESPONSE 10/21/2013 - 10/25/2013
KAYALEH OMAR, ORLANDO, FL - EIR, 483, RESPONSE
02/19/2015 - 04/02/2015
NDA 019890 SBA
CARDINAL HEALTH, JACKSON, MS - EIR, 483, RESPONSE
8/2/12
CARDINAL HEALTH, JACKSON, MS - EIR, 483, RESPONSE
8/2/12
BOERINGER INGELHEIM, FREMONT, CA - EIR, 483,
RESPONSE 8/7/12
AMGEN MANUFACTURING LIMITED, JUNCOS, PR - EIR,
483, RESPONSE 07/24/2013 - 08/15/2013
MAHENDRA CHEMICALS, INDIA - 483 05/19/2014 -
05/24/2014
LEHIGH VALLEY TECHNOLOGIES, INC, ALLENTOWN, PA -
EIR, 483, RESPONSE 10/17/14
MONTO ARNLOD, ANN ARBOR, MI - EIR, 483, RESPONSE
12/02/2014 - 12/11/2014
NOVO NORDISK A/S, DENMARK - 483 3/14/14
CONSTANCE M WESTHOFF, LONG ISLAND, NY - EIR, 483,
RESPONSE 08/21/2013 - 09/12/2013
MATHESON TRI-CAS, INC, TUALATIN, OR - EIR, 483,
RESPONSE 3/4/15
TBO-FILGRASTIM - AERS
SIETSEMA FARM FEEDS, HOWARD CITY, MI - 483, EIR,
COMMUNICATIONS 08/01/2014 - 07/31/2015
HERBRUCK POULTRY RANCH, SARANAC, MI - 483, EIR,
COMMUNICATIONS 08/01/2014 - 07/31/2015
CLOSED FOIA REQUESTS JULY 2015
FCN 1225
FCN 968
GA WINTZER & SO CO, WAPAKONETA, OH - 483, EIR,
COMMUNICATIONS
SUCRALFATE - REPORTS OF HYPERGLYCEMIA
PEGINTERFERON BETA-IA - AERS
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
5 HOUR ENERGY, MONSTER ENERGY, ROCKSTAR ETC - CAERS

NDA 22360/S8
K142596
NDA 21330 SUPP 2, 4, 7, 13, 14
GLATOPA, GLATIRAMER ACETATE, COPAXONE - FAERS
EMKINETICS CE MARK - RECS RE APPROVAL FOR TRANSTIM
TRANSDERMAL NEUROMODULATION SYSTEM 07/01/2011 -
06/30/2013
BIG SKY DIAGNOSTIC IMAGING - MQSA ACCREDITATION,
REVOCATION 01/01/2012 - 01/23/2015
3847251, 3824145,9441625 ETC
9621562, 10503061, 10459655 ETC
CORR WARNING LETTER 15-NWJ-01 WINDMILL HEALTH
PRODUCTS
CORR RE WARNING LETTER 12-13 LIQUID HEALTH INC
01/31/2013 - 08/03/2015
SPARC - COMPLETE RESPONSE LETTER RE XELPROS
NDA 018509 SBA
SUNESIS PHARMACEUTICALS INC - QINPREZO (VOSAROXIN)
NDA, CORR 10/1/14 - 7/28/15
AZTREONAM - ORPHAN DRUG DESIGNATION REQUEST
AZTREONAM - ORPHAN DRUG DESIGNATION REQUEST
DELFLEX, PHOSLOS, PHOSLYRA - ICSR LINE LISTING
LIONS EYE BANK OF NEBRASKA - WARNING LETTER, 483
01/23/2012 - 01/23/2015
FDA ENTRY DOCUMENTATION 07/16/2015 - 07/31/2015
BLA 125477
CERTIFICATE OF FACILITY REGISTRATION
NDA 18081 - APPROVAL LETTER, REGULATIONS
(CERTIFIED)
ICLUSIG - AERS
TOBRAMYCIN - ORPHAN DRUG DESIGNATION APPLICATION
NUTRI PHARMACEUTICALS RESEARCH, LAS VEGAS, NV - 483
9/16/13
SPINOSAD, MILBEMYCIN - AERS 01/04/2007 - 08/03/2015

K141371
K130744
ORTHO EVRA, NUVARING, IMPLANON, ETC - NUMBER OF
PERSCRIPTIONS FILLED 5/01 TO 11/14
CIPRO - REVIEWS, RECS RE PERIPHERAL NEUROPATHY
FDA RESPONSE TO PYRAMID LABORATORIES REPLY TO FORM
483 06/08/2015 - 08/04/2015
INDIVIDUAL RECS
K141288
K143654
DENDREON, GILEAD SCIENCES - FOIA REQUESTS
01/01/2014 - 06/30/2015
K151340
QILU PHARAMACEUTICAL LTD, CHINA - EIR, 483
NDA 205777
K150641
LIST OF ALL DIETARY SUPPLEMENTS OR DIETARY

INGREDIENTS ON THE MARKET BEFORE 10/15/94 AND HAVE
BEEN DEEMED ADULATERATED ENFORCEMENT ACTIONS
WARNING LETTERS ETC
QNASL - AERS
K141153
AMRI, BURLINGTON, MA - EIR 2013
DR. RANDALL V. EHRLICH, M.D. - WARNING LETTER RECS
(CERTIFIED) 01/01/2004 - 08/04/2015
AMRI, BURLINGTON, MA - EIR 2014
K132522
K983483
K955293
K993455
K901337
NDA 205777
ASTELLAS, XTANDI, ZYTIGA ETC - AERS
K940189
K913128
CELEXA - AER
K122797
K123212
K123141
K150912
YARDLEY DENISE, SARAH CANNON RESEARCH INSTITUTE,
NASHVILLE, TN - EIR, 483 03/27/2012 - 03/29/2012
K100597
MUSTAFA OZGUROGLU, ISTANBUL, TURKEY - 483
05/10/2010 - 05/14/2010
UPSTATE NEW YORK TRANSPLANT SERVICES - WARNING
LETTER, 483 01/23/2012 - 01/23/2015
DYNA FLEX - EZ ALIGN K121396
CHU, FRANKLIN, SAN BERNADINO, CA - 483 10/04/2001 -
10/11/2001
K131435
JAMES L BAILEN, MD, JEFFERSONVILLE, IN - 483
04/20/2009 - 04/24/2009
ALMAC PHARMA SERVICES, LLC, AUDUBON, PA - EIR
01/01/2013 - 02/01/2013
SERIOUS ADVERSE EVENTS REPORTED IN RELATION TO
DIETARY SUPPLEMENTS, SUMMARY OF ENFORCEMENT
ACTIONS, ETC 12/22/2007 - 08/04/2015
GENERAL MILLS, LODI, CA - EIR, 483 08/01/2009 -
09/30/2009
COMPLAINT 141671
SOY INFANT FORMULA - APRVL PROCESS, WHEN MARKETED
IN THE US, SAFETY STUDIES
EXCEDE - AERS
HORMONAL CONTRACEPTIVES - AERS
AMBROXOL - CASE NARRATIVES
ZOETIS - EIR, 483, WARNING LETTER ETC 08/01/2014 -
08/04/2015
HERITAGE INTERACTIVE, HERITAGE ENVIRONMENTAL - 483,

EIR, WARNING LETTER, ETC 08/01/2014 - 08/04/2015
CLINOGENT, INDIA GVK BIOSCIENCES PVT LTD, INDIA -
483
SUPERIOR FEED INGREDIENTS, WACONIA, MN - 483, EIR,
WARNING LETTER, ETC 08/01/2014 - 08/04/2015
NDA 020415
ABH NATURE'S PRODUCTS, INC - WARNING LETTER
(CERTIFIED)
SOMBRA COSMETICS, ALBURQUERQUE, NM - EIR, 483
01/01/2013 - 01/01/2015
COOPER FARMS, MERCER COUNTY, OHIO - 483, EIR,
WARNING LETTER ETC 08/01/2014 - 08/04/2015
THERANOS - APRVL
QUARTETTE - AERS
K113546 K110619 K110586
AGRYLIN - SUMMARY OF CLINICAL EVIDENCE SUBMITTED
FOR ORIGINAL APPROVAL
CALDERA MEDICAL INC - T SLING INVESTIGATION
JK BIOSCIENCE INC URIMUL CO LTD, JANGSEONG GUN,
KOREA - REGISTRATION NUMBER & STATUS
INSYS THERAPEUTICS - SUBSYS CORR AERS
HARD LIQUOR DISTILLERIES IN KY - INSPECTION MOST
RECENT 01/01/2013 - 08/04/2015
K112174
NDA 90218
HYDROXYCUT, SMARTBURN, RAPID SLIM, ETC - CAERS
DANA E RATHKOPF, MD, NEW YORK, NY - EIR, 483
05/19/2014 - 05/30/2014
AMIODARONE - AERS
CHATTA GURKAMEL, PITTSBURGH, PA - 483 05/16/2007 -
05/30/2007
MITSUI CHEMICALS - PRIME POLYMER FCN 978 TOXICOLOGY
STUDIES
K123929, K040179, K030632, ETC
K131516
RECORDS RELEASED TO JESSE MCCLEAN, DAVID BRUSER,

TORONTO STAR RECORDS PREVIOUSLY RELEASED RE TRITON
PHARMA INC, ASPRI PHARMA, ASPEN PHARA INSPECTIONS
09/01/2014 - 08/05/2015
INDIVIDUAL RECS
INDIVIDUAL RECS
DIADEXUS INC, SOUTH SAN FRANCISCO, CA - EIR
5/18,19,21/15
INDIVIDUAL RECS
POLICY, GUIDANCE, MEMOS, RPTS PERTAINING TO THE USE

OF THE LABEL DECAFFEINATED ON COFFEE OR TEA PRODS
SYNRIBO - AERS
ANDA 080737 SBA
PATRICK FLYNN, ST LOUIS PARK, MN - EIR 08/25/2014 -
09/05/2014
ROSS, MERRICK, HOUSTON, TX - EIR, 483, RESPONSE
11/18/2014 - 01/27/2015
K150776
TAIL AND HAIR IN BREAD - CMPLNT
ROXANE - LIDOCAINE HCL ANDA 88-803 APRVL LTR
ESTABLISHMENTS, ETC - DOMESTIC AND FOREIGN INSPS
5/15 TO 6/15
SEMLER RESEARCH CENTRE PVT LTD, VINAYAGAMPATTI,
SELAM - EIR 8/17-14/13
BIODEFENSE INC - RESP TO WARNING LTR 6/30/15
RFDD DENNIS BAKER - CY 2014 PMAP, CALENDAR DEPUTY
RFDD KREUZER - CALENDAR
THRESHOLD OF REGULATION EXEMPTION 2014-001
PERIPHERAL IV - AERS, MEDWATCH 09/26/2002 -
09/26/2012
PREVIOUSLY RELEASED 483 01/01/2015 - 07/31/2015
DR MARIA GREEWALD MD, PALM DESERT, CA - 483
01/01/2000 - 08/05/2015
K080949
OXYELITE PRO DIETARY SUPPLEMENTS - LETTERS FROM
FDA, HEALTH HAZARD EVALUATION, RECALL RECS
09/01/2013 - 01/31/2014
CAP 5C0193, CAP 8C0200, CAP 8C0213 ETC
GELMON KAREN, VANCOUVER, CANANDA - 483 11/28/1993
NDA 019012 SBA
K023566
RECS RE FDA DECISION TO EXERCISE ENFORCEMENT
DISCRETION RE REMOTE PATIENT INTELLIGENCE PRODUCT -
01/01/2010 - 07/31/2015
LONE STAR LIONS EYE BANK - WARNING LETTER, 483
01/23/2012 - 01/23/2015
LIST OF GRANTS OF NCE SINCE ENACTMENT OF HATCH
WAXMAN
DROXOLAN TABS NDA 3-044 - ACTIVE & INACTIVE
INGREDIENTS SAFETY DATA, LBLG, ETC
STERIS ISOMEDIX SERVICES, LIBERTYVILLE, IL - EIR
1/8/14
ZEO HEALTH LTD, VALLEY COTTAGE, NY - EIRS, 483S
WARNING LTRS, ETC 1/1/15
INVENTIV HEALTH CLINIQUE, QUEBEC CITY, QUEBEC,
CANADA - ANDA 205-159, ANDA 204-844 STUDIES, EIRS
2/18-27/15
DIANA SCHENDEL, WILLIAM THOMPSON, FRANK DESSTEFANO,
MERCURY, THIMERSOL, MERTHIOLATE, ETC, RECS, EMAILS
1999 TO PRESENT
NAVILYST MEDICAL - NAMIC FLUID DELIVERY ST 72'' &
135'' MEDRAD MARK V PROVIS POWER INJECTOR CORR,
RECALL LTR, WARNING LTR, ETC
INVENTIV HEALTH CLINQUE, QUEBEC CITY, QUEBEC,
CANADA - ANDA 203-5143, ANDA 204-056, ANDA 305-159,
EIR, ETC
MDSAP Quality Management System Manual
CELANESE LTD - BINYL ACETATE POLYMERS MODIFIED BY
GLYCIDL METHACRYLATE OR ETHYLENE FCN 1352
POZEN INC - PA8140, PA32540 LTRS, EMAILS, COMM
3/27/13 TO 11/16/14
MISSISSIPPI LIONS EYE BANK - WARNING LETTER, 483
01/23/2012 - 01/23/2015
NECHER PHARMACEUTICALS - EIR 04/22/2015 -
05/07/2015
K141789
PFIZER GLOBAL MANUFACTURING, KALAMAZOO, MI - EIR
2014 483 2015
COMPLIANCE PLANS, CORR IN RESPONSE TO NON

SUBSTANTIAL EQUIVALENCE DETERMINATIONS OF
PROVISIONAL TOBACCO PRODUCT MARKETING ORDERS
TECFIDERA 9455159, 9461106, 9725102 ETC
PEDIATRIC ADVISORY COMMITTEE MEETING RE ADDERALL
03/01/2006 - 04/30/2006
RESULTS OF DRUG EFFICACY STUDY OF THE NATIONAL
RESEARCH COUNCIL DIVISION OF MEDICAL SCIENCES
08/01/1930 - 12/31/1963
FOLLOW UP COMMUNICATIONS BETWEEN INNOVATIVE
BIODEFENSE RE 6/30/2015 WARNING LETTER 06/30/2015 -
08/05/2015
A copy of the agendas of any meeting of the CDER
Exclusivity Board held in January 2015
Exclusivity Board held in February 2015
ARGATROBAN - AERS
Exclusivity Board held in March 2015
Exclusivity Board held in May 2015
Exclusivity Board held in April 2015
Exclusivity Board held in June 2015
DKT FDA-2014-D-1747 COMMENTS
Exclusivity Board held in July 2015
GENERAL MILLS, BELVIDERE, IL - EIR, 483 06/01/2009
- 07/31/2009
GF1200548
CTP FOIA REQUESTS LOG 06/22/2009 - 08/06/2015
K053256
MENVEO VACCINE - ALLERGIC REACTIONS
MERCK, DURHAM, NC - 483, EIR 8/31/12
K090802
NDA 009838 SBA
ANNUAL LIST OF REGISTERED DRUG ESTABLISHMENTS 1995-
2014
FENTORA - COMPLAINTS, STUDIES, REPORTS
CYMBALTA - AERS
ARCHER DANIELS MIDLAND, LAND OF LAKES, NUTRABLEND,
RIDLEY FEED, PROVIMI CARGILL - EIR PREVIOUSLY
RELEASED UNDER FOIA 01/01/2013 - 07/01/2015
PRELIMINARY DATA FROM NARMS 2014
SAI LIFE SCIENCES LTD, INDIA - EIR 01/01/2013 -
05/01/2015
ANTIBIOTIC SALES DATA SUBMITTED TO FDA UNDER
PROVISIONS OF ADUFA SECTION 105 FOR VIRGINIAMYCIN,
OXYTETRACYCLINE, ETC 01/01/2013 - 08/06/2015
MEACTRA VACCINE - ALLERGIC REACTIONS
SAI LIFE SCIENCES LDT, INDIA - EIR SUMMARY, 483
01/01/2013 - 05/01/2015
INFERIOR VENA CAVA, RECOVERY CONE REMOVAL SYSTEM -
CORR WITH FDA ETC
DECORATION DESIGN SOLUTIONS, INC, VINELAND, NJ -
EIR, 483, RECALL RECS 07/01/2012 - 08/07/2015
WUXI APPTEC, PHILADELPHIA, PA - 483 04/10/2015 -
04/24/2015
K042994
ANDA 202580
NDA 202731
K011364, K011366, K003559, ETC
ANDA 04687, ANDA 04698, ANDA 04692 APPROVAL
LETTERS
ISENTRESS - AERS
ANDA 040556, ANDA 040658 APPROVAL LETTER
ANDA 071611
K062868
KEYVIEW LABS - NEW DIETARY INGREDIENT APPLICATION
FOR PROCERA
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
8/17/89 ANTI INFECTIVE DRUGS ADVISORY COMMITTEE MTG

9/12-13/94 ANTIVIRAL DRUGS ADVISORY COMMITTEE MTG
FDA-2015-N-0303
82 N 0116 C8 V9 82N 0166 SUP 3 V 13& 14
2015 P 2482
FDA-1987-P-0002
FDA-1987-P-0002
12/12/95 ADVISORY COMMITTEE MTG
2011-N-0830
2003-D-0522
96N-0299
ANDA A201172
1975N-0184 - SUP043, SUP034, SUP027 1975N-0223 -
SUP03, SUP05 1975N -0184, 1975N-0223
2011-5-0933-0184 2012-5-1178-0011 2012-5-1178-
0021
FDA-2007-N-0363
2007-N-0363-0040
FDA-2013-D-1600
96P-0511 CITIZENS PETITION
OFATUMUMAB - 8960319, 8650985, 9270120 ETC
OCRIPLASMIN - AERS
AFLIBERCEPT - AERS
DULAGLUTIDE - AERS
ANDA 202489
ELOSULFASE ALFA - AERS
TRASTUZUMAB EMTANSINE - AERS
ASPARAGINASE - AERS
INCOBOTULINUMTOXINA - AERS
ZIV-AFLIBERCEPT - AERS
ALGLUCOSIDASE ALFA2 - AERS
BELATACEPT
BRENTUXIMAB VEDOTIN AERS
METRELEPTIN - AERS
GLUCARPIDASE - AERS
DR REDDY - RESPONSE TO 483

APREMILAST - TEST RESULTS
DINITROPHENOL, DINETROPHENOL, 2,4 DNP, ETC - AERS,
PATIENT INFORMATION, DATE OF EVENT, ETC
FDA ALERT - INFORMATION FOR HEALTHCARE PROFESSIONS
SIMVASTATIN USED WITH AMIODARONE 8/8/08
PHARMACEUTICAL, BIOLOGICS, MEDICAL DVC MFG AND
CLNCL TRIAL FACILITIES IN AND OUTSIDE THE US - 483S
7/1-31/15
OXFORD MENISCAL UNICOMPARTMENTAL KNEE SYS P010014 -
PREMARKET APRVL
UNIVERSAL HOLDINGS LLC (DBA SMITH BROTHERS CO),
CHICAGO, IL - EIR 5/8-23/14
PURACON GMBH, GERMANY - 483 08/02/2014 - 10/31/201
BLOOD BPD CODE BC-41-02 RECS FINAL CONCLUSION OF

BIOLOGICAL PRODUCT DEVIATION REPORT 10140120 RECS
SUBMITTED BY VIRGINIA BLOOD SERVICES RE BIOLOGICAL
PRODUCT DEVIATION REPORT 10140120 ETC
BACTINE - ACTIVE INGREDIENTS BEFORE 1972
SURVEY ABOUT ANTISEPTICS ON THE MARKET USED TO
WRITE THE GUIDELINES FOR TFM FOR ANTISEPTICS
01/01/1950 - 12/31/1972
LANNETT CO - FEDERAL INVESTIGATION INTO POSSIBLE
VIOLATIONS OF THE SHERMAN ACT
ADDERAL - AERS
DKT 76N-052C COMMENT NUMBER LET077
BELCORP - FORM FDA 3742 PAGE 5
RESMED ASIA OPERATIONS PTY LTD - DATE REGISTERED AS
CONTRACT MANUFACTURER
P020014, SUPPLEMENTS, APPROVAL ORDERS, LABELING ETC
MIMEDX, MARIETTA, GA - INSPECTION RECS 08/20/2014
PROMETHAZINE - AERS
K972217, K972219
ALLOGRAFT INNOVATIONS, LLC, GAINSVILLE, FL - EIR
07/01/2011 - 10/31/2012
MIMEDX, MARIETTA, GA - INSPECTION RECS 04/01/2015 -
08/01/2015
DOLLAR GENERAL STORE, FONDA, NY - CTP INVESTIGATION
RECS 04/22/2015 - 04/22/2015
CLOSTRIDIAL COLLAGENASE - AERS
2015 Investigations Operations Manual for CDRH
PINE PHARMACEUTICAL LLC, TONAWANDA, NY - EIR, 483.
482, ETC 10/14
AVELLA SPECIALTY PHARMACY, DEER VALLEY, AZ -
EIRS,483S, 482S, ETC 7/12, 2/13
ARTICAINE (SEPTOCAINE) - AERS
STANISLAW R BURZYNSKI - ANTINEOPLASTON A IN CANCER
THERAPY 1977
ALPRAZOLAM & ALCOHOL, ETC - AERS
RECS REC'D IN RESP TO ANNOUNCEMENT OF THE INTENT
TO ESTABILISH THE DIETARY GUIDELINES A/C (DGAC) &
TO INVITE NOMINATIONS FOR THE COMMITTEE 2015
CMPLNT - INDIVIDUAL RECS
BLUE BELL CREAMERIES (BLUE BELL CREAMERIES LP),
BRENHAM TX - LISTERIA OUTBREAK RECS, EIRS, LAB
RESULTS, RESEARCH STUDIES, ETC 1/10 TO PRESENT
BAXTER PHARMACEUTICAL SOLUTIONS, LLC, BLOOMINGTON,
IN - 483, EIR 10/20/2014 - 10/24/2014
MOUNTAIN BEVERAGE SUPPLY, FOUNTAIN, CO - SEARCH
WARRANT, EIRS, NOTES, ETC 7/20/15-8/1/15
2015-3702
2015-3703
2015-3707
2015-3708
2015-3633
2015-3061
2015-2723
2015-4122
2015-4635
CANGENE CORPORATION, WINNIPEG, CANADA - EIR, 483
07/09/2014 - 07/18/2014
2015-4563
2015-5095
2015-4548
2014-9193
2015-4146
2015-4980
2015-3720
2015-3726
2015-4140
CALDERA MEDICAL INC - T SLING, FRANCOIS BLAUDEAU
RECS
BOEHRINGER INGELHEIM RCV, GMBH, AUSTRIA - EIR, 483
11/03/2014 - 11/11/2014
2015-3711
2015-4139
2015-4049
2015-3724
2015-4138
2015-4144
2015-4141
2015-5001
2015-3714
2015-4123
LIFESHARE BLOOD CENTERS, BEAUMONT, TEX LIFESHARE
BLOOD CENTERS, TEXARKANA, TX - EIR 05/31/2015 -
11/02/2015
MALLADI DRUGS & PHARMACEUTICALS, INDIA - EIR
12/15/2014 - 08/11/2015
LINE LIST OF ALL CONFIRMED CASES OF ILLNESS IN

CONNECTION WITH THE ASPEN FOODS SALMONELLA
OUTBREAK, COMMUNICATIONS, FOIA REQUESTS 05/01/2015
- 06/30/2015
FDA RESPONSE TO ATTORNEY GENERAL ERIC SCHNEIDERMAN
AND GREG ZOELLER RE DIETARY SUPPLEMENTS 08/01/2015
- 08/19/2015
MAF 1521
CHANGZHOU WUJIN FEIDA CHEMICAL COMPANY, CHINA -
EIR, 483, RECALL RECS
NDA 019906
ANDA 074947, ANDA 074364, ANDA 074694 ETC
CDER INTEGRITY PROJECT BY DELOITTE 08/11/2015 -
08/17/2015
ALTHEA AKA AJINIMOTO, SAN DIEGO, CA - EIR
01/01/2012 - 08/01/2015
NDA 18509, NDA 18509
CHEEN HOUNG ENTERPRISE, TAIWAN - EIR 08/05-08/2013
UNAPPROVED PACKAGING RECS
SUTHERLAND PACKAGING, ANDOVER, NJ - EIR, 483,
RECALL RECS 08/01/2012 - 08/11/2015
FAP MF-3655
BECTON DICKINSON AND COMPANY, FRANKLIN LAKES, NJ -
EIR, 483, RECALL RECS 08/01/2011 - 08/11/2015
EMAILS RE CELEBRITY ENDORSEMENT OF PRESCRIPTION
DRUG 07/31/2015 - 08/12/2015
PEMBROLIZUMAB AERS
FDA CORR WITH SENTREHEART RE LARIAT SUTURE DELIVERY
SERVICE 01/01/2012 - 08/11/2015
ANDA 086457
ATL, MEMOMONEE FALLS, WI - EIR, 483, RECALL RECS
METHYLPREDNISOLONE ACETATE 80 MG/ML INJECTION
SUSPENSION - AERS
STALLERGENES ORALAIR - AERS
PERRIGO, ISRAEL - 483 JAN 2015
NECROPSIES RECS RE COMFORTIS, TRIFEXIS 01/01/2012 -
08/12/2015
INSPECTIONS CLASSIFICATIONS DATA 10/1/2011 TO
3/31/2015
TERUMO BCT LTD, UK - 483 3/28/14
PLEXUS MEGAX PROPERTIES 08/01/2013 - 08/12/2015
Metoprolol succinate extended release tablets 25mg,
50mg, 100mg and 200mg
K142794, K130065, K131251 ETC
K132733
K112437
K052776
HARVONI, SOVALDI, XIGDUO XR - AERS
Bendamstine Submission Clinical Trial Documents
GRACE MEDICAL CENTER, LUBBOCK, TX - 483, 482, EIR
1/31/13
LIST OF GRANDFATHERED SUBMISSIONS TO CTP 03/31/2015
- 08/31/2015
K100556
DKT FDA1988N0004
870301 SAMPLE RECS
870300 SAMPLE RECS
870303 SAMPLE RECS
UQUIFA MEXICO, SA DE CV, MEXICO - EIR MOST RECENT
01/01/2013 - 08/13/2015
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 -
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
PROCEDURES, POLICIES, MEMOS, ETC REGARDING THE

REGULATION OF COLLECTION, DISTRIBUTION, SHARING OF
DNA DATA COLLECTED BY ORGANIZATIONS CONDUCTING
DIAGNOSTIC TESTS
HAMAMATSU - K143219
HITACHI - K042501
COMMUNICATIONS RE PERCENT DAILY LIMIT OF ADDED
SUGARS
483
PAULA CRAWFORD, MD, EVERGREEN PARK, IL - 483
07/29/2014 - 08/18/2014
GALLANT PHARMA INTERNATIONAL, INC - HOSPITALS,
MEDICAL FACILITIES, DOCTORS SOLD DRUGS, DEVICES
ADVERSE EVENTS 01/01/2010 - 12/31/2015
K110179
DRUG ESTABLISHMENT DATA SINCE 1991
REGISTERED REPRODUCTIVE TISSUE BANKS DATA
01/01/2012 - 08/12/2015
FOREVER ALOE VERA GEL SAFETY RECS FOR HUMAN
CONSUMPTION
CYMBALTA, DULOXETINE - AERS
K151236, K141929, K150910 ETC
DAAVLIN, BRYAN, OH - LATEST EIR 07/01/2012 -
08/13/2015
ADVAIR - AERS
HYDRODOT, INC, WESTFORD, MA 7/7/15 - 483S 7/1-31/15

MEDTRONIC LOGISTICS FACILITY, MEMPHIS, TN - EIR
05/11/2015 - 08/14/2015
BIPORE MEDICAL DEVICES INC, NORWOOD, NJ GRANT

INDUSTRIES INC, ELMWOOD PARIK, NJ VALEANT
PHARMACEUTICALS INTENATIONAL, BRIDGEWATER, NJ -
483S 7/1-31/15
ANDA 064134 SBA
COMPOUNDING PHARMACIES - INSPECTION RECS, DRUG
SHORTAGE INDEXES, OTHER DRUG SHORTAGE LISTS
01/01/2006 - 08/13/2015
CNMC COMPANY, INC, NASHVILLE, TN 7/8/15 - 483S 7/1-
31/15
ANALYTICAL BIOCHEMISTRY LABORATORIES, INC - EIR
03/01/2015 - 08/13/2015
K122288
ROXANOL AERS
K151363
Copies of all Not Substantially Equivalent (NSE)

orders and refuse-to-file (RTF) letters for
substantial equivalence (SE) reports issued by the
Center for Tobacco Products 07/01/2015 - 08/31/2015
MANA PRODUCTS INC, LONG ISLAND CITY, NY 7/1/15

DESIGNS FOR VISION, RONKONKOMA, NY 7/17/15 NOMIR
MEDICAL TECHNOLOGIES, WOODMERE, NY 7/17/15, ETC -
483S 7/1-31/15
MUTUAL PHARMACEUTICAL COMPANY, INC, PHILADELPHIA,
PA 7/17/15 MEDICAL PRODUCTS LABATORIES, INC,
PHILADELPHIA, PA 7/21/15 - 483S 7/1-31/15
AGILENT TECHNOLOGIES INC , SANTA CLARA, CA 7/6/15
CLAREBLEND, INC, RENO, NV 7/17/15 AFFYMETRIX INC,
SANTA CLARA, CA 7/29'/ 15 - 483S 7/1-31/15
17-alpha HYDROXYPROGESTERONE CAPROATE COMPOUNDED IN
US
PFIZER PHARMACEUTICALS LLC, BARCELONETA, PR 7/2/15
- 483S 7/1-31/15
K082626, PAM3000
TARGINIQ - RECS RE IND MEETING DEVELOPMENT PLAN
GREENLAND INC, SEATTLE, WA 7/6/15 KIRKMAN

LABORATORIES INC, LAKE OSWEGO, OR 7/15/15 JD & SN
INC (MOSES LAKE PROFESSIONAL PHARMACY) , MOSES
LAKE, WA 7/23/15, ETC - 483S 7/1-31/15
RAPID RELEASE TECHNOLOGIES, SANTA ANA, CA 7/6/15

HARTLEY MEDICAL CENTER PHARMACY INC, LONG BEACH, CA
7/8/15 EMERGENT RESPIRATORY LLC, CARLSBAD, CA
7/16/15, ETC - 483S 7/1-31/15
STEUART LABS, MABEL, MN NEMSCHOFF CHAIRS INC,
SHEBOYGAN, WI MERGE HEALTHCARE INC, HARLAND, WI,
ETC - 483S 7/1-31/15
CLEARWATER COLON HYDROTHEARAPY INC, OCALA, FL
NOVEN PHARMACEUTICALS INC, MIAMI, FL GROMAN INC,
MARGATE, FL, ETC - 483S 7/1-31/15
ALLIED HEALTHCARE PRODUCTS INC, SAINT LOUIS, MO
CORELINK LLC, SAINT LOUIS, MO CENTRAL SOLUTIONS
INC, KANSAS CITY, KS, ETC - 483S 7/1-31/15
MED-MIZER INC, BATESVILLE, IN PHARMACIA & UPJOHN
COMPANY LLC, KALAMAZOO, MI FRONTIER MEDICAL
DEVICES INC, GWINN, MI - 483S 7/1-31/15
MOST RECENT DIVISION OF RISK MANAGEMENT REVIEW
MEMORANDUM AND MOST RECENT OFFICE OF COMPLIANCE
REVIEW MEMORANDUM ASSOCIATED WITH REMS ASSESSMENT
FOR REVLIMID, TRANMUCOSAL IMMEDIATE RELEASE
FENTANYL ETC
NDA 050592 SBA
PARAXEL, BERLIN, GERMANY - 483, EIR,
DRUG APPROVALS, WITHDRAWALS 01/01/1938 -
12/31/1971
INISIBLE HAND ENTERPRISSES LLC (TOUGHWARE
PROSTHETICS) WESTMINSTER, CO 7/2/15 DNTL WORKS
EQUPMENT CORP, CENTENNIAL, CO 7/20/15 - 483S
CARDIAC DESIGNS INC, ROUND ROCK, TX 7/2/15

HYPERION MEDICAL TECHNOLOGIES, INC 7/9/15, ADDISON,
TX ISO-TEX DIAGNOSTICS INC, ALVIN, TX, 7/10/15 ETC
- 483S 7/1-31/15
TECHNI-MED INC (THE COMPOUNDER), AURORA, IL 7/9/15

CSL BEHRING LLC, BRADLEY, IL Y.17.15 KALMAN HEALTH
& WELLENSS (ESSENTIAL WELL NESS PHARMACY 2),
PEORIA, IL 7/21/15 - 483S 7/1-31/15
BIOLYTICAL LABORATORIES, INC, RICHMOND, CANADA 483S
7/9/15
GLAXOSMITHKLINE CONSUMER HEALTHCARE
(GLAXOSMITHKLINE), AIKEN, SC 7/10 /15 OPTEC USA
INC, LAWRENCEVILLE, GA 7/13/15 - 483S 7/1-31/15
BIOELECTRONICS CORP, FREDERICK, MD 7/14/15 ARETECH
LLC, ASHBUM, VA 7/17/15 TRYCO INC, MCLEAN, VA
7/23/15, ETC - 483S 7/1-31/15
ARAB PHARMECEUTICAL MANFACTURING CO PSC LTD, SAHAB,

JORDAN 7/2/15 KLINGE CHEMICALS LTD, GLASGOW, UK
7/3/15 ALLERGAN PHARMACEUTICALS IRELAND, WESTPORT,
IRELAND 7/3/15, ETC - 483S 6/15 TO 7/15
AUGUST RECHLEN GMBH, TUTTINGEN, GERMANY 7/2/25

PRODIMED, NEUILLY EN THELLE NEUTHAUSEN OB, FRANCE
7/2/15 TREU INSTRUMENT GMBH, ECK, GERMANY 7/2/15,
ETC
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
AVENTS PHARMACUTICALS INC - ELAINE DECEMBRINO

TAXOTERE INTERVIEW, RPTS, PROMOTION, ETC 1996, 2004
ANDA 201000, ANDA 090824
2015-5256 & 2015-5262 - REQUEST LETTER(S) ONLY
ALCON LENSX INC, ALISO VIEJO, CA - EIR 1/27/14-
2/10/14
GANCICLOVIR, VALGANCICLOVIR, FOSCARNET ETC - ADV
COMM NOTES, TRANSCRIPTS 01/01/1985 - 01/01/2002
2015-5802- REQUEST LETTER ONLY
AUCTUS PHARMA, GRANULE INDIA FACILITIES - 483,
WARNING LETTER, IMPORT ALERT ETC : 01/01/2008 -
01/01/2015
BRISTOL-MYERS SQUIBB - ERBITUX (CETUXIMAB) AERS
K030684
P900032 S001
CELLTEX THERAPEUTICS OF TEXAS - LIST OF PREVIOUS
REQUESTS
K132403
INFIXIMAB - AERS
NDA 18276 CLINICAL TRIAL DATA
2015-6229 & 2015-6230 - REQUEST LETTER(S) ONLY
ANDA 090962, ANDA 091314, ANDA 200298
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
CORBION CARAVAN, LENEXA, KS - EIR, 483, RESPONSES
ETC 01/01/2010 - 01/27/2015
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
COMPLAINT FOR FORENSIC USE ONLY - PREMIER BIOTECH
01/01/2014 - 01/11/2015
PHARMACYCLICS, INC, SUNNYVALE, CA - CORR 07/01/2014
- 01/27/2015
STAR OF THE WEST MILING CO, VASSAR, MI - 483, EIR,
CARGILL INCORPORATED, HERSEY, MI - 483, EIR,
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,
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
LIST OF CFSAN FOIA REQUESTS 01/01/2015 - 01/27/2015
STRYKER INSTRUMENTS WOUNDCARE REPLACEMENT KIT - HHE

STRYKER INSTRUMENTS NEPTUNE 2 DIVERTER VALVE
ASSEMBLY - HHE
STRYKER INSTRUMENTS ELITECORE - HHE
STRYKER INSTRUMENTS SELECTCORE VARIABLE THROW
BIOPSY DEVICE - HHE
STRYKER INSTRUMENTS CBCII WOUND DRAINS AND
AMBULATING BULB - HHE
STRYKER INSTRUMENTS NAVIGATION SYSTEM II CART
ARTICULATED ARM CAMERA - HHE 06/01/2014 -
08/11/2015
STRYKER INSTRUMENTS SMARTLIFE ASEPTIC HOUSINGS -
HHE
STRYKER INSTRUMENTS SURGICOUNTER CHARGING CRADLE -
HHE
STRYKER INSTRUMENTS NEPTUNE 2 DOCKING STATION - HHE

ADELINE NEW YORK HENNA TATTOOS - INVESTIGATION RECS
07/08/2014 - 08/14/2015
RANBAXY - NEXIUM ANDA 77-830 TEVA - NEXIUM ANDA
78-003 DR REDDY'S - NEXIUM ANDA 78-279 FDA
DECISION TO REVOKE APRVL
K133538
BELVIQ/LORCASERIN - CASE REPORTS 10423763 9914853
10872100 ETC
COMPLAINTS RE HUMAN DRUGS AND VACCINES
ADVERTISEMENTS MADE ON INSTAGRAM, TWITTER, FACEBOOK
ETC 01/01/2014 - 08/17/2015
NADA 095-183, NADA 009-782, NADA 116-089
TORNALATE NDA 018770
ALEXION PHARMACEUTICALS, SMITHFIELD, RI - 483,
WARNING LETTER, RESPONSE LETTERS 01/02/2014 -
08/17/2015
INTAS PHARMACEUTICALS LTD, INDIA - 483 06/01/2015 -
08/01/2015
MEDICAL DEVICE REPORT
NEW FASHION PORK, WORTHINGTON, MN - EIR, 483,
WARNING LETTER 08/01/2014 - 08/17/2015
WEN HAIR CARE - CONSUMER COMPLAINTS,
COMMUNICATIONS, TESTING 01/01/2009 - 08/17/2014
LIST OF FACILITIES, COMPANIES MAKING DRUGS, API,
DIETARY SUPPLEMENTS INSPECTED IN CHINA 08/01/2013 -
08/18/2015
K863721
RFI INGREDIENTS, BLAUVELT, NY - EIR 08/03/2013 -
08/18/2015
TRICOR MANUFACTURING, IL - WARNING LETTERS,
UNTITLED LETTERS, 483 01/01/2005 - 08/19/2015
BOTULINUM TOXIN PRODUCTS - MEDWATCH REPORTS
AZIDUS LABORATORIES LTD, INDIA - 483 01/01/2014 -
12/31/2014
ELOCTATE - MEDWATCH RECS 07/01/2014 - 09/30/2014
TERUMO NEEDLES INVESTIGATION REPORT 07/01/2015 -
08/18/2015
STERILE WATER FOR INJECTION USP LOT 50-074-JT LAB
RESULTS
GRAPHIC ARMOR, GRAPHIC ARMOR INC, ETC - 510K
SUMMARIES, ESTABLISHMENT REGISTRATION AND DEVICE
LISTING, GUIDANCE DOCUMENT 01/01/2009 - 12/31/2013
ANILYTICS, GAITHERSBURG, MD - EIR AUGUST 2013
GERBER & SONS, INC, BALTIC, OH - EIR, 483, WARNING
LETTER 08/01/2014 - 08/18/2015
3427653 3595565 3634908 ETC

K031566, K111386
K862022 - APPROVAL LETTER
PMA P900032 S016
K141837
Potential Tobacco Violation Report ID 15D00013
LAB ANALYSIS FOR COLLECTION REPORT 909125, 909126
LUPIN, GOA, INDIA - 483 07/01/2015 - 07/31/2015
FDA ENTRY DOCUMENTATION AUG 01, 2015 AUG 15, 2015
K063047
K010710
PURCHASE CARD HOLDER LIST
K033967
ANDA 062752 SBA
KALYDECO, ORKAMBI, JAKAFI ETC - AERS
BICULTIMIDE, CASODEX - AERS 1/95 TO 7/15
FLUZONE HIGH DOSE VACCINE - TOXICITY, ADVERSE
EVENTS 01/01/2000 - 08/18/2015
CELLTRION, SOUTH KOREA - 483 03/01/2015 -
06/30/2015
TALLEY MEDICAL - VENTURI NEGATIVE PRESSURE WOUND

THERAPY SYS K080897 MOLNLYCKE HEALTH CARE - AVANCE
FOAM KITS K141847 MEDELA AG - MADELA INVIA WOUND
THERAPY K080357, ETC
EVZIO - RISK MANAGEMENT ANALYSIS 01/01/2013 -
08/17/2015
CUSTOMED - MEETING MINUTES, NOTES FROM 8/19/15 CALL
WITH FDA RE CORRECTIVE ACTIONS
NDA21-035 (S-040), NDA21-505 (S-007) PHARMACOLOGY,
TOXICOLOGY REVIEW
K091207
EDWARD KAPLAN, MD, RUSH PRESBYTERIAN ST LUKES
MEDICAL CENTER, CHICAGO, IL - 483 02/06/1991 -
10/27/2005
NDA 018333, NDA 019183
ONDANSETRON HCL 4 MG TABLETS RECS
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
DR KARL E LEWIS, AURORA, CO 2/9-12/15 DR GEOFFREY

GIBNEY, TAMPA, FL 1/5/15-2/12/15 CANFIELD
SCIENTIFIC, FAIRFIELD, NJ 1/20-28/15, ETC - 482S,
483S, EIRS, ETC
K090288
GARDEN STATE NUTRIONALS, WEST CALDWELL 2012, 8/13
VITAQUEST INTERNATIONAL, FAIRFIELD, NJ 2011, 11/13
- EIRS, 483S
GREGORY PACKAGING INC, PHOENIX, AZ - EIR MOST
RECENT
FCN 301
GREGORY PACKAGING INC, NEWMAN, GA - EIR MOST RECENT
GREGORY PACKAGING INC, NEWARK, NJ - EIR MOST RECENT

K112121
NDA 020428 SBA
NDA 014215
CFSAN FOIA REQUESTS SINCE 7/23/15
OLYMPUS QUICKCLIP PRO 510K
NDA 13025 CHEMISTRY SECTION
NDA 018692
MEETING BETWEEN ACTING FDA COMMISSIONER DR STEPHEN

OSTROFF AND ADVANCED MEDICAL TECHNOLOGY
ASSOCIATION - MEETING SUMMARY, MATERIALS SHARED
08/07/2015 - 08/07/2015
MAKO SURGICAL CORPORATION, PLANTATION, FL - EIR
08/12/2014 - 08/20/2015
PATHEON HOLDINGS, GREENVILLE, NC - 483 02/01/2014 -
08/20/2015
PATHEON HOLDINGS, FERENTINO, ITALY - 483 02/01/2014
- 08/20/2015
PATHEON HOLDINGS, MONZA, ITALTY - 483 02/01/2014 -
08/20/2015
DPT LABORATORIES, SAN ANTONIO, TX - EIR 07/28/2014
- 09/30/2014
REMINDERS FROM FDA REGARDING RUPTURES VASCULAR
ACCESS DEVICES FROM POWER INJECTION - OLDER VERSION
07/07/2004 - 07/07/2004
SAMPLE 855170
BIOGEN IDEC, CAMBRIDGE, MA - 483 6/22/2015 PAR

PHARMACEUTICAL INC, SPRING, VALLEY, NY 5/11/2015
SCHERING PLOUGH LABO NV, BELGIUM - 483 6/15/2015
ETC
ALMAC PHARMA SERVICES, CB - EIR 04/01/2013 -
05/31/2013
SABRA HUMMUS RECALL RECS 01/01/2010 - 08/20/2015
INSPECTION REPORTS
DIRECT REPORTS, MEDWATCH REPORTS and ANY SOURCE
DOCUMENTS for THE FOLLOWING FOUR (4) CASE NUMBERS:
10562990 10572949 10576391 10682304 for DULERA
DOCUMENTS for THE FOLLOWING ONE (1) CASE NUMBER:
10622309, for KEYTRUDA
DOCUMENTS for THE FOLLOWING TWO (2) CASE NUMBERS:
10562520 10562525, for VICTRELIS aka BOCEPREVIR

DOCUMENTS for THE FOLLOWING TWENTY-ONE (21) CASE
NUMBERS 10488787 10494142 10501391 ETC JANUVIA,
JANUMET
K130873
K990803
MITABAN FOIA SUMMARIES
EVANGER'S DOG & CAT FOOD CO - AERS FOR LOT 1814 E
20 BB 12 06/01/2014 - 08/21/2015
DOCUMENTS for THE FOLLOWING ONE (1) CASE NUMBER:
10501140, for DIFICID
AARON INDUSTRIES, LYNWOOD, CA WESTBURY, NY - 483,
EIR 03/01/2012 - 01/27/2015
HYPERBRANCH MEDICAL TECHNOLOGY, INC - EIR
01/19/2015 - 08/20/2015
2015-2014
CORR BETWEEN FDA AND GIB, LLC DBA BRAZILIAN BLOWOUT
FOLLOWING AGENCY WARNING LETTER
PRA HEALTH SCIENCES - EIR, 483, 482 ETC 05/09/2005
- 09/04/2014
2015-2147
2015-2216
2015-2217
2015-2219
2015-4028
2015-2449
IND RECS
2015-2447
2015-2222
2015-653
2015-2889
2015-1953
2015-107
2015-2882
GENENTECH, VACAVILLE, CA - 483 MARCH 2012
BRASSELER USA DENTAL, LLC, SAVANNAH, GA - EIR
09/22/2014 - 09/29/2014
2015-2906
RANBAXY - FDA DECISION TO REVOKE GENERIC NEXIUM
Investigational new drug applications for
participants in the NIH Biomedical test materials
program
THERMO FISHER SCIENTIFIC MICROBIOLOGY, LENEXA, KS -
EIR 06/01/2014 - 06/30/2014
KYBELLA - AERS
CDER Exclusivity Board Memoranda
NDA 19523 MOST RECENT LABELING
FLAVOR AND EXTRACT MANUFACTURERS ASSOCIATION -
SUBMISSIONS TO FDA RE FLAVOR ADDITIVES
LOTRONEX - AERS
MEDROXYPROFESTERONE ACETATE - WARNING LABELS, AERS,
PROVERA ETC 01/01/1995 - 08/20/2015
K141704, K141816
ABBOTT LABORATIES, ROSS PRODUCTS - SUBMISSIONS TO
FDA RE CHANGE OR MODIFICATION TO
MANUFACTURING/PAKCAGING FACILITIES FOR SIMILAC
INFANT FORMULA, ASEPTIC PACKAING/BOTTLING FOR
SIMILAC 32 OZ LIQUID READY TO FEED INFANT FORMULA
K150089
NITARSONE - DRUG EXPERIENCE REPORTS, COMMUNICATIONS
WITH SPONSORS, ETC
NEPHRON PHARMACEUTICALS CORPORATION, ORLANDO, FL -
483 01/01/2011 - 08/22/2015
CLOSED FOIA REQUESTS 8/10-14-15
FOI DAILY LOIG 8/10-14/15
CLOSED FOIA REQUESTS 8/10/15
BIOCON LIMITED, INDIA - 483 06/01/2015 - 06/30/2015

2014-9827 - REQUEST LETTER
CORE RX - 483S 1/14-14/14
DOMINION COLOUR CORP - BENZENESULFONIC ACID (4-
METHYLPHENYL AMINO)-2 OXOPROPYL(JAZO) 3-NITRO
CALCIUM SALT FCN 607
FDA SAFETY COMM: ONGOING SAFETY RVW OF HIGH-DOSE
ZOCOR (SIMVASTATIN) & INCREASED RISK OF MUSCLE
INJURY 3/19/10 (CERTIFIED
FORM 2579 - SECTION 4
CYMBOLTA - AERS
ZOLOFT - AERS
PFIZER US DEPO-MEDROL ACETATE 80 MG INJ
(METHYLPRENSOLONDE) AERS 8/11/14 TO 8/11/15
SODIUM-GLUCOSE CO-TRANSORTER- KETOACIDOTIC EPISODES
SAE RPTS
DUCHESNAY INC, DUCHESNAY USA - WARNING LETTER
RESPONSE
Memoranda regarding 180-Day ANDA Exclusivity
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
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
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
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
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
BLUE BELL CREAMERIES - UPDATED INFORMATION PROVIDED

TO FDA RE RESPONSES TO 483 05/23/2015 - 08/25/2015
SEROQUEL, RISPERDAL, CLOZARIL ETC - AERS
CVM MEETING MINUTES RE KINDREDBIO ANTI-TNF
MONOCLONAL ANTIBODY 08/04/2014 - 05/15/2015
INDIVIDUAL RECS
884178 SAMPLE RECS
LIDOCAINE PATCH 5% 08/07/2015
CORR BETWEEN FDA AND RESMED 1/1/15 TO 8/25/15 RE
CARDIOVASCULAR RISK
INSULET CORP, BILLERICA, MA - OMNIPOD INSULIN
MANAGEMENT SYS MANUFACTURE, DESIGN, DISTRIBUTION
CORR 2000 TO PRESENT INSP RECS 3/11-27/15, ETC
THE EYE MACHINE LLC - PRE-SUBMISSION MTG, MINS,
RISK ASSESSMENT, ETC
SODIUM-GLUCOSE CO-TRANSPORTER 2 (SGT2) INHIBITOR-
KETOUCIDOTIC EPISODESS SAE RPTS
DR PAUL GOLDENHEIM PRUDE PHARMA LP - OXYCODONE &
NALOXONE MTGS BEFORE 4/5/2, CR OXYCODONE WITH
NALOXONE DEVELOPMENT PLANS 5/29/01, ETC
RECS RE WARNING LETTER TO OMEGA TECH LABS, LLC
01/01/2007 - 12/31/2009
ERLOTINIB HCL TABS ANDA 91-002 - APRVL PKG
MANUFACTURER ID CODES FOR ALL FOREIGN & DOSESTIC
10/5/05
COMMUNICATIONS BETWEEN 6/1/14 AND 08/25/2015 RE

EFFICACY OF RHOPRESSA, COMMUNICATIONS BETWEEN FDA
AND AERIE PHARMACEUTICALS CHIEF MEDICAL OFFICER
BRIAN LEVY, CHIEF EXECUTIVE OFFICER VICENTE ANIDO
JR ETC
RECS RE COMMUNICATIONS WITH GOJO INDUSTRIES
01/01/2002 - 08/26/2015
MEDTRONIC MINIMED PARADIGM RESERVOIRS MMT-326A,
MMT-332A - RECALL RECS ETC 07/01/2012 - 07/01/2015
JONATHAN KANTOR MD,FLORIDA CTR FOR DERMATOLOGY, PA
- ID #526467 2/4/13, 4/17/13 NORTH DERM ASSOC - ID
3540153 8/21/12 FL CTR FOR DERMA, PA - ID 3233277,
ETC 4/23/13, 6/25/13, 10/21/14
K001828 K991936 K032005
RECS RE WARNING LETTER TO OH SO CLEAN, INC DBA
CLEANWELL 01/01/2009 - 12/31/2011
RECS RE WARNING LETTER TO GDMI, INC 01/01/2008 -
12/31/2009
NDA 20-254/S-016 SBA
RECS RE WARNING LETTER TO JD NELSON AND ASSOCIATES
01/01/2009 - 12/31/2011
CONFORMIS ITOTAL CR, ITOTAL PS, IUNI G2, IDUO G2 -
AERS
2014-7882 UNREDACTED
GENERIC NEXIUM - ANTITRUST LAWSUITS COMM
NDC NUMBERS ISSUED TO US FOREIGN DRUG COMPANIES
DRUG SHORTAGES - MONTHLY DATA
AMAZON FOREST INC, LEDGEWOOD, NJ - EIRS, 483S SINCE
1/10, DIETARY SUPPLEMENT
2015-4649
2015-4650
2015-4709
2015-4800
2015-4830
2015-4930
2015-4949
2015-4951
YICHANG SANXIA PHARMACEUTICAL CO LTD, HUBEI
PROVINCE PR CHINA - EIR 1/1/14 TO 12/31/14
2015-4975
2015-4981
2015-4990
2015-5381
2015-5513
2015-3728
2015-3907
UNIVERSITY OF TEXAS MEDICAL BRANCH GALVESTON -
QUALITY AUDIT RPT 1/15, EIR SIX ADDITIONAL PAGES
2006
2015-4166
2015-4637
IMBRUVICA (IBRUTINIB) NDA 02-552 - RVWS
2015-4639
2015-4646
2015-5021
2014-9760
2014-7222
BLUE BELL CREAMERIES LP BRENHAM, TX 5/1/15 BLUE
BELL CREAMERIES INC, SYLACAUGA, AL 4/30/15 BLUE
BELL CREAMERIES LP, BROKEN ARROW, OK 4/23/15 483S,
EXHIBITS
LAWRENCE A BORAWSKI, NAPLES , FL - WARNING LTR
12/2104
510K, 522K TISSUE FIXATION SYSTEM
TECFIDERA 10526694,10969585,11078171 ETC
GP PHARM, SPAIN EIR 01/01/2015 - 01/31/2015
PETITION TO REMOVE VIVIDA SA CC FROM IMPORT ALERT
89-08 - CORR (UNREDACTED)
2011-5324 CERTIFIED
DRUG SAFETY AND RISK MANAGEMENT ADVISORY COMMITTEE,

ANESTHETIC DRUG PRODUCTS ADVISORY COMMITTEE -
PRESENTATIONS, BRIEFING DOCUMENTS, MATERIALS
08/02/2014 - 08/26/2015
CENTRAL NERVOUS SYSTEM DRUGS ADVISORY COMMITTEE
MATERIALS 2/22/80
DYNAMIC PET PRODUCTS, WASHINGTON, MO - INSPECTION
REPORTS, INVESTIGATION RE REAL HAM BONE 11/01/2010
- 08/26/2015
THE MID YORK PRESS, INC, SHERBURNE, NY - EIR, 483,
RECALLS 08/01/2013 - 08/26/2015
ENTRY U47-06200167
DAVID CRAIG LOUCKS, MD - CONSENT DECREE WITH FDA
04/01/2008 - 01/01/2011
ZIJA INTERNATIONAL INC, KENNETH BRAILSFORD -
INVESTIGATIONS, VIOLATIONS, COMPLAINTS ETC
07/01/2014 - 08/26/2015
ANDA 65-488
RUBELLA VACCINE - WI-38 CELL LINE SET ASIDE
MW5039125
SUNRISE PHARMACEUTICAL, RAHWAY, NJ - 483,
RESPONSES, WARNING LETTER, ETC
SUBSYS - FAERS CASE NUMBERS 8978134 9413216
10064211 ETC
MEMORANDA ISSUED IN 2014 AND 2015 FROM CDER
EXCLUSIVITY BOARD RE EXCLUSIVITY RECOMMENDATIONS
FOR NDA PRODUTS FOR NDA 19-523
MEMORANDA ISSUED 2014, 2015 FROM OFFICE OF GENERIC
DRUGS RE 180-DAY EXCLUSIVITY FOR ANDA PRODUCTS FOR
ANDA 78-621
INDIVIDUAL RECS
UNDOCUMENTED IMMIGRANTS - CDC EMERGENCY OPERATIONS
CENTER (EOC), DEPT OF HOMELAND SECURITY (DHS) RECS,
COMM, RPTS, ETC 6/14 TO PRESENT
INNOVATIVE BIODEFENSE INC - ZYLAST LBLG,
ADVERTISING CLAIMS, CMPLNTS, CONGRESSIONAL CORR,
ETC
RAW COCOA BEANS - CARGO DETAINMENT AND REFUSAL
5/11/15
ACETOMINOPHEN - CASE RPTS
ENERGY & COMMERCE COMMITTEE - AGENCY POLICIES
RELATED TO UNTITLED LTRS
MERCK SHARPE & DOHME CORP, WEST POINT, PA - 483,
EIR 09/12/2014 - 09/12/2014
CORERX, INC, CLEARWATER, FL - EIR 06/18/2015 -
08/11/2015
K021551
K141081
K131629
ARTICAINE (SEPTOCIANE) - AERS 2000 TO 12/31/12
LIDOCAINE - AERS 2000 TO 2015
REGARDS INCIDENT AT A MCDONALDS - CAERS
CIPRO - AERS
VETAC INC SUPERFUND SITE, JACKSONVILLE, AR - DIOXIN
CAERS
KRAFT- COUNTRY TIME LEMONADE CMPLNT
CENTRIX PHARMACEUTICALS, BIRMINGHAM, AL -
INSPECTION RECS, APPROVAL RECS 01/03/1995 -
01/27/2015
GENECARE MORCELLEX TUSSUE MORCELLOR MODELS MX0100 &

MX1004 - K061050, K100280 GYNECARE X-TRACT
MORCELLATOR SYS K993801 & K963872 - CORR BTWN FDA
& SPONSOR, WARNING LTRS, MDRS, ETC
DEFLUX PASS RPT SUBMISSION P000029/R021

ALWAYS - UNSCENTED MENSTRUAL PADS K071827
UNITED CONSORTIUM INC, VALENCIA, CA - JO H20
FLAVORED LUBRICANT 100/% CONDOM COMPATIBLE EIRS,
483S, 482S, ETC
GLAXOSMITHKLINE, WORTHING WEST SUSSEX, UK - RESP TO
483 MOST RESENT
ALLERGEN OR ACTivis - BYOstolic- LEC OR( MEBIVOLOL
HCL TABS )CMPLNTS
PHARMANET MONTREAL, CANADA - AMIODARONE ANDA 22-325
MINOCYCLINE ANDA 50-808 EIR 8-25-08-9-4-08
STEVIA STEVIOSIDE CAS 57817-89-7 STEVIOL CAS 471-
80-7 REBAUDIOSIDE A CAS 58543-16-1, ETC -
REGULATORY STAUS, SAFETY RECS 2007-2015
DRIED BIOMAS OF EUGLENA GRACLIS BETA 1,3 GLUCAN
GRAS 00513 -MTG, MEMOS, CORR
YELLOW NEUPHORIA GEN2- TEST RESULTS, TESTING
PROTOCOLS, CMPLNTS,ETC (CERTIFIED)
SYNTHO PHARMACEUTICALS, FARMINGDALE, NY -
01/27/2015
ALEXION PHARMS - EIRS, 483S 8/19/15
2015-6569
2013-6545
FCN 334 EFFECT OF DBDMH AS A BROILER CHICKEN CHILL
FOOD TANK ADDITIVE ON CHILL TANK WATER BACTERIA
POPULATIONS
JUST MAYO OR HAMPTON CREEK - CMPLNTS, LTRS, EMAILS,
ETC AFTER 8/26/12
METHOTREXATE SODIUM (ANDA) 081235
STRUCTURED PRODUCT LABELING FOR BULK INGREDIENTS
FOR HUMAN PRESCRIPTION COMPOUNDING
ATTACHED LETTER
NATURERIPE, MUNGER BROS, MONARCH NUT COMPANY ETC -
INSPECTION RECS 1/1/12 TO 8/26/15
COMPLAINT 139835 INSPECTION RECS, FOLLOW UP
CREEKWOOD PHARMACEUTICALS, BIRMINGHAM, AL -
01/27/2015
FIRST CHOICE INGREDIENTS, GERMANTOWN, WI - 483,
EIR, RESPONSE 01/01/2015 - 08/27/2015
IND FOR CHEMICALLY-MODIFIED TETRACYCLINE
NDA 18-206
CORR BETWEEN HYLTON JOFFE, MD, SHELLEY SLAUGHTER,
MD, RHONDA HEARNS-STOKES, MD ETC AND DUCHESNAY
01/01/2005 - 08/27/2015
TESTS, ANALYSIS RE RHIZOPUS ORYZAE IN UNOPENED
CONTAINERS OF SOLGAR ABC DOPHILUS POWDER
EFFICACY SUPPLEMENT OR SUPPLEMENTAL NEW DRUG
APPLICATION SUBMITTED BY DUCHESNAY FOR DICGLEGIS
K912472
ACRYMED, BEAVERTON, OR - EIR 01/01/2010 -
08/01/2015
METHOTREXATE SODIUM ANDA 040054 - BIOEQUIVALENCE
REVIEW
SUBSYS - AERS CASE NUMBERS 9413216 9676389
10064231
AMNEAL PHARMACEUTICALS, PATERSON, NJ - INSPECTION
RECS, APPROVAL RECS 01/03/1995 - 01/27/2015
DUCHESNAY - FORM 3454 DICLEGIS
510K CLEARSHEILD
CVM DIVISION OF COMPLIANCE, CANNA-COMPANION LLC -
CORR 01/01/2014 - 08/27/2015
2015-6646
METHOTREXATE SODIUM ANDA 201749 BIOEQUIVALENCE
REVIEW
PEDICAL SCREW PANEL RECS
MICHIGAN NATURAL STORAGE, COMSTOCK, MI - 483, EIR,
WARNING LETTERS 08/01/2014 - 08/28/2015
MOXIFLOXACIN, CIPROFLOXACIN, LEVOFLOXACIN ETC -
AERS, SAFETY, WARNINGS ETC
NDA 19-847/S10, NDA 19-857/S11, NDA 19-858/S9, NDA
19-537/S22
K830332
NALMEFENE - CLNCL TRIAL RECS

BRECKENRIDGE PHARMACEUTICALS, BOCA RATON, FL
BERLIN, CT - INSPECTION RECS, APPROVAL RECS
01/03/1995 - 01/27/15
VAN ELDEREN INC, MARTIN, MI - 483, EIR, WARNING
LETTER 08/01/2014 - 08/28/2015
K121743
2014-689, 2014-1094, 2014-2422, 2015-4643
K140951
BRENNTAG GREAT LAKES LLC, KENTWOOD, MI - 483, EIR,
WARNING LETTER 08/01/2014 - 08/28/2015
08/27/2015
K093624
NATCO PHARMA LIMITED, INDIA TORRENT
PHARMACEUTICALS, INDIA - 483 05/01/2014 -
08/28/2015
K120033
K120499
SYNTHO PHARMACEUTICALS - EIR AUGUST 2013
K133276
NEPHRON PHARMACEUTICALS, ORLANDO, FL - 483, EIR
01/01/2015 - 09/01/2015
CLOSED FOIA REQUESTS AUGUST 2015
UFP TECHNOLOGIES, GRAND RAPIDS, MI - 483, EIR,
RECALL RECS
FDA ENTRY DOCUMENTATION REQUEST (REFUSAL) FY6-
2008482-9
K760936
FDA ENTRY DOCUMENTATION REQUEST (REFUSAL) FY6-
2008464-7
VISTAPHARM, INC, LARGO, FL - EIR 05/28/2015 -
08/22/2015
NDA 10-598
DEPUY - LCS DUOFIX FEMORAL INSERT KNEE REPLACEMENT
COMPONENT CORR, PRTS, MEMOS, ETC
K010809
NDA 20-971 - ANNUAL REPORTS, FDA Forms 2252 AND
2253
POLYETHYLENE GLYCOL, ELECTROLYTES - AERS
R&D BATTERIES, BURNSVILLE, MN - 483 08/01/2015 -
09/01/2015
K130313
AGILA SPECIALTIES PRIVATE LTD, INDIA - EIR, 483
01/01/2011 - 09/01/2015
VERAPAMIL 9882521 CASE REPORT
GLATOPA, GLATIRAMER, ACETATE, COPAXONE - AERS
GLENMARK GENERICS, INDIA GLENMARK PHARMACEUTICALS,

INDIA GLENMARK GENERICS, ARGENTINA - 483
AGILA SPECIALTIES PRIVATE LTD, INDIA - EIR, 483
01/01/2011 - 09/01/2015
RAW BUTTER - BAN ON INTERSTATE SHIPMENT RECS
PARAXEL, SOUTH AFRICA - 483, EIR
K101386
PARAXEL, BALTIMORE, MD - EIR, 483
MYLAN LABORATORIES LIMITED OTL, INDIA - EIR, 483
01/01/2011 - 09/01/2015
MYLAN LLC, PUERTO RICO - EIR, 483 01/01/2011 -
09/01/2015
KRATOM - AERS RECS
SANTA FE NATURAL TOBACCO COMPANY - WARNING LETTER
RECS
PURIXAN - ORPHAN DESIGNATION RECS
RJ REYNOLDS TOBACCO COMPANY, AMERICAN SNUFF, SANTA

FE NATURAL TOBACCO CO - RECS RE COMMUNICATIONS
BETWEEN FDA AND THIRD PARTIES NOT RELATING TO
WARNING LETTER
K150776
ASTHMA INC CLINICAL RSEARCH CENTER, SEATLLE, WA -
EIR 11/17/14-12/17/14
BD SYRINGE WARNING ISSUED ON 8/18/15
POST APPROVAL REPORTS, STUDIES FILED BY MEDTRONIC
RE P000058
MAUDE 1030489-2014-00628 RECS

INSPECTION RECS FOR CONTAINER
EMCU5283723/EMCBQK1573
CPT1500077
BRENTUXIMAB VEDOTIN - AERS
BAXTER ONCOLOGY GMBH, GERMANY - 483 OR EIR
05/29/2014 - 08/29/2015
BNC COMMERCE INTERNATIONAL - INSPECTIONS RECS
05/01/2015 - 09/01/2015
ASPARAGINASE - AERS
CORERX, CLEARWATER, FL - EIR 05/01/2013 -
08/29/2013
SANTA BARBARA SMOKEHOUSE, SANTA BARBARA, CA - EIR
8/14 TO 9.14
WARNING LETTERS, NIDPOES CLINICAL INVESTIGATORS
10/01/2009 - 09/30/2014
VENLAFAXINE, SSRI, SNRI ANTIDEPRESSANTS - AERS
NEPHRON PHARMACEUTICALS, ORLANDO, FL - 483
07/20/2015 - 08/14/2015
MYLAN PHARMACEUTICALS, MORGANTOWN, WV - INSPECTION
RECS 01/01/2011 - 09/01/2015
BRINAVESS - AERS
FERUMOXYTOL - AERS
1998 Advisory Committee for Reproductive Health
Drugs on April 20-21, 1998 concerning Antocin
(atosiban) for preterm labor - SLIDES
Minutes & Briefing Materials for Drug Safety
Oversight Board Meetings
ANDA 65-488 EXCLUSIVITY MEMO
OLYMPUS CORP, FUJIFILM MEDICAL SYSTEMS, HOYA CORP -
WARNING LETTER RESPONSE RESPONSES TO 510K STATUS
LETTERS 08/12/2015 - 09/30/2015
PERUSA INC - ENTRY #MH900947259 NOTICES FOR REQUEST
OF INFORMATION (CF28), NOTICE OF ACTION, CBP
REDELIVER NOTICES, ETC
NDA 021978 SBA
ADDYI - PHASE I, II, and III clinical trial
K013705, K113088
NDA 201050
DYSAL SA DE CV - EIR, 483 APRIL 2015
rVIII-Single Chain BLA STN 125591 LIST OF REVIEWERS

K013559
ENTRY 316-1931823-6 ANALYTICAL REPORT
PRIVIGEN - MEDWATCH RECS
POWERPOINT PRESENTATION, MATERIALS AT 31ST ICPE
CONFERENCE 01/01/2015 - 08/31/2015
DOCTOR'S DATA INC, ST CHARLES, IL - CORR, CMPLNTS,
INVESTIGATIONS, ETC
TRAMADOL, ELAVIL - AERS
Acceptance Letter Request for ANDA 204299
ROANOKE, IL - 483, EIR, WARNING LETTER 08/01/2014 -
09/02/2015
LIST OF PRODUCT APPLICATIONS FROM GVK CLINICAL
STUDY DATA
JEUNESSE GLOBAL - AERS
NICORETTE - INFORMATION SUBMITTED BY MANUFACTURER
01/01/1990 - 01/01/2015
LETTER TO GMA RE PARTIALLY HYDROGENATED OILS TRANS
FATS 08/04/2015 - 09/02/2015
ALEXION PHARMACEUTICALS, SMITHFIELD, RI - 483, EIR,
RESPONSE 08/18/2014 - 08/22/2014
ALEXION PHARMACEUTICALS, SMITHFIELD, RI - 483, EIR,
RESPONSE 08/04/2015 - 08/12/2015
FDA ENTRY DOCUMENTATION REQUEST (REFUSAL) Entry
Number: AV3-0039650-2
INIDIVIDUAL RECS
Number: 109-0924698-4
Number: FY6-2008409-2
Number: FY6-2008412-6
Number: FY6-2008428-2
Number: FY6-2008452-2
Number: FY6-2008460-5
Number: AV3-0039713-8
Number: AV3-0039775-7
Number: AV3-0040074-2
Number: FY6-2008650-1
INDIVIDUAL RECS
Number: FY6-2008689-9
Number: FY6-2008767-3
Number: FY6-2008767-3
Number: FY6-2008519-8
Number: FY6-2008517-2
Number: FY6-2008503-2
Number: FY6-2008500-8
Number: AV3-0039700-5
Number: AV3-0041931-2
Number: FY6-2008485-2
K874867
DERMA=FLEX QS HIGH VISCOSITY TISSUE ADHESIVE
K101276
Number: FY6-2008484-5
Number: FY6-2008490-2
Number: FY6-2008489-4
Number: FY6-2008488-6
Number: AV3-0041223-4
Number: AV3-0041030-3
Number: AV3-0040929-7
Number: FY6-2008540-4
Number: FY6-2008605-5
Number: AV3-0041574-0
GMP, GLP, GCP INSPS 8/1/14 TO 1/15/15
Number: AV3-0041030-3
MYLAN LABORATORIES, INDIA - 483 02/06/2015 -
02/13/2015
AGILA SPECIALTIES, INDIA - 483 08/01/2014 -
08/08/2014
Copy of the disclosable portions of materials from
the January 2013 meeting of FDA's DSB
BERNARD A MICHLIN, SAN DIEGO, CA - EIR, 483,
RESPONSE 01/08/2015 - 01/23/2015
FARID MARQUEZ, HIALEAH, FL - EIR, 483, RESPONSE
09/08/2014 - 10/06/2014
AGILA SPECIALTIES PRIVATE, INDIA - 483 09/23/2014 -
10/03/2014
MICHAEL MILKEN, MILKEN INSTITUTE, FASTER CURES ETC
- CORR WITH FDA 01/01/2011 - 09/02/2015
ALBUTEROL, SYMBICORT - AERS
CMPLNT 140409
BD VACUTAINER PLUS PLASTIC URINE C &S TUBES AND
KITS K102420
AVANTOR PERFORMANCE MATERIALS, PHILIPSBURG, NJ -
EIR 11/15/13
FCN 537, 935
FAERS - 1Q2015
CMPLNT 121235
BRAINREADER APS - NEUROREADER MEDICAL IMAGE
PROCESSING SOFTWARE K140828
2015-4464
RITUXIN (RITUXIMAB) AER
FCN 15, FCN 180
IND 74346
K093665, K971125
BD VACUTAINER RAPID SERUM TUBE PLUE BLOD COLLECTION
TUBE K091292
K140838
ANDA 084903
STRATTERA - AERS
K142934
GERBER BABY FOOD - INDIVIDUAL RECS
ABC DOPHILUS POWDER - INVESTIGATION, TESTS, RPTS,
ETC INDIVIDUAL RECS
PHARMACEUTICALS - AERS
ERBITUX - ISR 9788044
INDIVIDUAL RECS
CHANTIX (VERENICLINE) - AERS
MOMETAMAX - DEAFNESS IN DOGS
TEVA PHARMACEUTICAL INDUSTRIES LTD - ANDA 07-707,
ANDA 77-873 RVWS, BIOEQV, CORR
NUTRITIONAL CONTENTS, REGULATIONS OF ANY MEAT
PRODUCED BY THE ILLINOIS DEPT OF CORRECTIONS
FDA EMPLOYEES EMPLOYED AT CONOPCO INC FDA

EMPLOYEES DISCUSSING HAMPTON CREEK FOOD RECS RE
ENFORCEMENT ACTION RE MAYONAISE 08/01/2015 -
08/31/2015
WEST-WARD PHARMACEUTICALS CORP, EATONTOWN, NJ - 483
06/01/2012 - 09/02/2015
HAMPTON CREEK - COMMUNICATIONS WITH FDA 08/01/2015
- 09/07/2015
FOIA REQUEST LOG 08/01/2014 - 09/02/2015
ANDA 203263 DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)
METHYLENE BLUE SOLUTION FOR INJECTION - AERS
01/01/1999 - 09/02/2015
CIPLA LIMITED, INDIA - 483 04/01/2015 - 09/03/2015
NUMBER OF OCI CASES RE SALE OF UNTAXED, COUNTERFEIT
CIGARETTES IN NY SEIZURE STATISTICS
AMANTADINE HYDROCHLORIDE ORPHAN DESIGNATION RECS
FCN 1225
SPREADSHEET OF ENTRIES KL INTERFOOD
K131234
K140186
DAPSONE ORAL TABLETS, DAPSONE TOPICAL GEL - AERS
DRAINAGE TUBE RESTRAINT/WOUD COVER K905766
ORA SOUTHEAST REGIONAL FIELD OFFICE - ELECTRIC OR
GAS BILLS
NUVASIVE - XL SPINAL IMPLANT COROENT SYS TRAINING
MATERIALS, BROCHURES, COMM, ETC
DKT FDA-2015P-1977
K120080
FEG TEXTILTECHNIK, GERMANY - EIR 08/17/2015 -
08/20/2015
EIR 4/17/2015
EIR 6/26/2015
BENZOCAINE - AERS
GENECARE MORCELLEX TISSUE MORCELLATOR MODELS MX0100

& MX1004 - K061050, K100280 GYENCARE X--TRACT
MORCELLATOR SYS K993801 & K963872 - CORR, WARNING
LTRS, MDRS, ETC
GLATOPA - TECHNICAL RECS 01/01/2010 - 09/02/2015
JUBILANT HOLLISTERSTIER, LLC, SPOKANE, WA - EIR,
483 7/31/2015
CALHOUN VISION INTRAOCULAR LENS - AERS 01/01/2012 -
06/01/2015
NASHVILLE FERTILITY CENTER PC, REPRODUCTIVE
SPECIALTY LAB OF MIDDLE TENNESSEE - EIR 01/01/2015
- 09/02/2015
AMYL NITRATE - AERS
K131870
All SF-50s for all GDUFA-related hires in FDA's
Office of the Commissioner as well as FDA's Office
of Operations.
NDA 206321
2015-5238
NDA 009925
ENTRY 906-0006077-9, ENTRY 906-0013549-8, ENTRY
906-0014527-3
NDA 20049, S27
K143350, K133482
K091135
NOTES, MINUTES, MEMO OF ANY MEETINGS OR

CONVERSATIONS BETWEEN OR AMONG OFVM and/or CFSAN-
OCD and/or CFSAN-OFS and/or CFSAN-OAO and/or CFSAN-
OC, ETC 01/17/2013 - 09/03/2015
CTP MEMO BY CRISTI STARTK RE OFFICE OF SCIENCE

CRITERIA FOR DEFINING NONRESPONDER AND OFFICE OF
SCIENCE PROCESS FOR HANDLING PROVISIONAL SE REPORTS
FROM APPLICANTS WHO ARE NON RESPONDERS 06/22/2009 -
09/04/2015
ALCON LABORATORIES, INC, FORT WORTH, TX - EIR
07/14/2014 - 07/24/2014
CORR RECEIVED BY FDA FROM JOSHUA TETRICK OR HAMPTON
CREEK FOODS, INC RE 8/12/15 WARNING LETTER
08/12/2015 - 09/30/2015
HUMAN CELL AND TISSUE ESTABLISHMENT REGISTRATION
DATA
PMC/PMR STUDIES SET NUMBER 07/01/2009 - 07/31/2015
FORM FDA 3356 HCT/P
POLYETHYLENE GLYCOL - ISRS 598629, 5987573,
6004839, ETC
SPECIAL AGENT KNOX'S INTERVIEW WITH ELAINE
DECEMBRINO REGARING THE PROMOTION OF TAXOTERE 1994
TO 2004 RHONE-POLENC RORER DDMAC LTR 6/18/96
ACETAMINOPHEN PREPARATIONS - ISRS 8043547, 8130667,
9709400, ETC
TORAY INDUSTRIES - NALFURAFINE HCL IND 101,322
POSITION EMISSION TOMOGRAPHY (PET)
RADIOPHARMACEUTICAL PRODUCTION CENTERS - 483S 2013
TO PRESENT
DEPT OF HEALTH AND HUMAN SERVICES' ROLE IN

REVERSING THE FDA'S RECOMMENDATION TO ADVISE
DENTISTS AGAINST USING MERCURY AMALGAM FILLINGS IN
CERTAIN PATIENTS
SUNQUEST INFORMATION SYSTEMS, ARIZONA & UK - 483'S
SINCE 2009
DS SERVICES OF AMERICA INC - NO OBJECTION LTR #184,
PRENOTIFICATION CONSULTATION (PNC) 1631
INVAGEN PHARMACEUTICALS, HAUPPAUGE, NY - 483
02/16/2015 - 03/20/2015
INVAGEN PHARMACEUTICALS, INC, HAUPPAUGE, NY - 483
05/01/2015 - 05/31/2015
INVAGEN - 483 SINCE 2011 01/01/2011 - 09/07/2015
870299 sample records
RECS RE COMPLAINT 07/16/2015 - 09/06/2015
CHRISTOPHER J LOGOTHETIS, MD, HOUSTON, TX - 483
08/02/2005 - 08/05/2005
EXPIRED BLOOD RECS
CC 137532
MERGE HEALTHCARE INC, WI - 483'S SINCE 2009
NDA 17692
K091411, K090474, K093998 ETC
K143001
DR LYDIE HAZAN, IMPACT CLINICAL TRIALS, LOS
ANGELES, CA - 483, EIR 01/22/2015 - 01/22/2015
K080779
DR JOE SULLIVAN, BELFAST, UK - 483 03/04/2013 -
03/08/2013
SCC SOFT COMPUTER, FL - 483'S SINCE 2009
K150256
GREGORY L BEATTY, MD, PHILADELPHIA, PA - EIR, 483
10/29/2014 - 11/05/2014
JOHN D HAINSWORTH, NASHVILLE, TN - 483, EIR,
RESPONSE 02/23/2011 - 03/29/2011
GOMELLA, LEONARD, PHILADELPHIA, PA - 483 01/23/2006
- 01/26/2006
WELLABLE MARINE BIOTECH HOLDING LIMITED - EIR, 483
01/01/2015 - 09/04/2015
K150012
K070876
SPROUT PHARMACEUTICALS - CORR BY FDA EMPLOYEES RE
FLIBANSERIN 09/02/2013 - 09/04/2015
ZHEUGIANG HISUN PHARMACEUTICALS - EIR, 483
01/01/2015 - 09/04/2015
INTRAVENOUS IMMUNOGLBULIN, SUBCUTANEOUS
IMMUNOGLOBULINS SUCH AS HIZENTRA, AND ICATIBANT,
RUCONEST ETC - AERS
DATA INNOVATIONS INC - BK120051
AUDIO RECORDING OF 6/16/15 FDA MEDIA BRIEFING
483 ASSOCIATED WITH INSPECTIONS OF DIETARY
SUPPLEMENT FACILITIES 01/01/2014 - 12/31/2014
FDA LETTER TO SEN CLAIRE MCCASKILL AND SUSAN
COLLINS 08/01/2015 - 08/31/2015
MONSTER ENERGY DRINKS, RED BULL, ROCKSTAR ETC -
AERS, CORR ETC
HAMPTON CREEK, JUST MAYO - COMPLAINTS 01/01/2014 -
09/04/2015
K080788
NDA 020073 SBA
MEDTRONIC INFUSE BONE GRAFT - ANNUAL REPORTS
07/02/2002 - 08/31/2015
KCAS LLC, KCAS - 483, WARNING LETTERS 01/01/2012 -
09/04/2015
ICLUSIG - AERS
SANGUIN INTL INC - BK090061
FDA LETTER TO COVINGTON & BURLING FROM FELICIA
BILLINGSLEA IN CFSAN 01/29/2010 - 09/07/2015
K001217
IRIS DIAGNOSTICS - IQ 200 SYS K022774 10/21/02
AXIS SHIELD - AFINION LIPID PANEL & AFINION LIPID
PANEL CONTROL K132031 CLEARANCE
NUVASIVE - COROENT XL MARKETING BROCHURE 2008
EXTERME LATERAL IMPLANTS MARKETING BROCHURE 2009
TRAINING MATERALS SHOWING THE OFF LABEL MARKETING
OLYMPUS CORPOIRATION OF AMERICAS - EIR EXHIBITS
SANOFI PASTEUR, SWIFTWATER, PA - DELAMINATION
PROBLEMS 1/13 TO PRESENT
PROZAC - INTERNAL MEMOS, DECLASSIFIED RECS
FCN 1056, FCN 1473 - MIGRATION EVALUASTION,
TOXICOLGY RVWS, MEMOS
COMPLETE ANATOMY OF THE BRAIN - BEHAVIORS,
ACTIVITIES, THOUGHTS, ETC
COSMETIC TALC & TALC-CONTAINING COSMETIC PRODS -
SURVEY, SAMPLING & TESTING PROGRAM 2008, 2014
SYSMEX CORP, JAPAN, MUNDELEIN, IL, LINCOLNSHIRE, IL
- 483'S SINCE 2009
FCN 350,FCN 650, FCN, 679, ETC - MIGRATION
EVALUATION, TOXICOLOGY RVW MEMO
RFA-FD-15-039 - SF 424, RESEARCH STRATEGY
CERTAIN RECS RE ASBESTOS - CERTIFIED 01/01/1967 -
12/31/1977
SCHERING-PLOUGH CORP, LAFAYETTE, NJ - EIR, 483
5/5/1997
PHILIPS MEDICAL SYSTEMS, CLEVELAND, OH - WARNING
LETTERS 01/01/2014 - 09/09/2015
CIPLA PHARMA LTD, INDIA - EIR 04/08/2015 -
04/16/2015
ANDA 091002, ANDA 091059
2014-5843
SURGICAL MESH ADVERSE EVENTS
ANDA 076737
ROCHE DIAGNOSTICS, GRAZ STEIERMARK, AUSTRIA
MANNHEIM BADEN - WURTTEMBERG, GERMANY ROTKREUZ
ZUG, SWITZERLAND - 483'S SINCE 2009
2014-6519, 2014-9207, 2014-9248, 2014-9250, 2015-
3930
SIETSEMA FARM FEEDS, LLC - EIR EXHIBITS,
ATTACHMENTS 08/01/2014 - 09/09/2015
INVAGEN PHARMACEUTICALS, INC, HAUPPAGUE, NY - 483
02/01/2015 - 09/09/2015
NDA 204592 S2, S4
RECS RE DR JEFF SHUREN MEETINGS WITH ADVANCED
MEDICAL TECHNOLOGY ASSOCIATION - 1/15 TO 9/15
BELLEVUE MEDICAL IMAGING, BELLEVUE, WA - MQSA
INSPECTION REPORT 01/01/2015 - 09/08/2015
Reminders from FDA Regarding Ruptured Vascular
Access Devices from Power Injection - ORIGINAL
ISSUE DATE
PRA HEALTH SCIENCES - EIR, 483, 482 12/01/2004 -
07/17/2014
K123279, K103110, K130391
TIMOPIC - AERS
SIEMENS HEALTHCARE DIAGNOSTICS INC, MALVERN, PA
TARRYTOWN NY NEWARK, DE NORWOOD, MA - 483'S
SINCE 2009
FAP 3A1019, FAP 3A 3699
FAERS 10418060 FAERS 11394743 FAERS 11394722 etc
K142779
FCN 1430
MEGA ALIMENTOS SA DE CV - ENTRY #918-4779702-3
REFUSAL CORR, RECS
TIMOPTIC .5% AERS
K923946
XIAFLEX - AERS
FDA-1997-N-0398
CELLFOOD - INVESTIGATION RECS RE SULFURIC ACID
01/01/2015 - 09/01/2015
MISYS HEALTHCARE SYS - BK040065
GENETICALLY ENGINEERED ANIMALS - FOI REQUESTS 1/96
TO PRESENT
TOLVAPTAN, CONIVAPTAN - AERS
INDUSTRIAL BIOLOGY RESEARCH AND TESTING
LABORATORIES 1993 ETC
APHIS REGULATED LTRS OF INQUIRY
STRYKER ORTHOPEDICS - SPINAL RODS AND HARDWARE
CORR, RPTS, NOTICES, ETC 2012 TO PRESENT
NATIONAL VACCINE INJURY COMPENSATION PROGRAM -
INDIVIDUAL RECS (CERTIFICATION)
NATIONAL VACCINE INJURY COMPENSATION PROGRAM
(NVICP) - INDIVIDUAL RECS (CERTIFIED)
ANITA NARULA, ROBERT TOLLEFSEN - EIR 09/01/2012 -
09/04/2015
AMERICAN NATIONAL RED CROSS BIOMEDICAL
HEADQUARTERS, WASHINGTON DC - 483, CORR 05/01/2014
- 09/08/2015
GROCERY MANUFACTURERS ASSOCIATION FAP RE PARTIALLY
HYDROGENATED OIL, CORR 06/01/2015 - 09/09/2015
MEDICAL INFORMATION TECHNOLOGY, MA GA MI - 483'S
SINCE 2009
EMAILS BETWEEN OES, OC AND REDCROSS.ORG -
02/01/2014 - 03/31/2015, 2015.
NATIONAL VACCINE INJURY COMPENSATION PROGRAM
(NVICP) - INDIVIDUAL RECS (CERTIFIED)
PHARMACEUTICAL, BIOLOGICS, MEDICAL DVC MFG, CLNCL
TRIAL FACILITIES IN AND OUTSIDE THE US - 483S 8/1-
31/15
K112484, K112533, K112664, ETC
K143752
K141952
K082512
ANDA 74-726 S1, S5, S13, S16
NDA 205552/S-001
NDA 009170
GE MEDICAL SYS INFORMATION TECHNOLOGIES, EL PASO,
TX MILWAUKEE, WI - 483'S SINCE 2009
K143752
K131553
ENTRY G33-0175243-9 Lab Analysis Report for
pesticides for Line 002/001 Dried Shiitake
Mushrooms
K071371
K063059
K143151
K100591
K140553
List of FDA-registered device firms
K132931
K930530, K930530C
EIGHT MEDICAL, BLOOMINGTON, IN - EIR MOST RECENT
K950491
MACKNIGHT FOOD GROUP, INC, MIAMI, FL MACKNIGHT
SMOKE HOUSE, MIAMI, FL HICKORY SMOKE HOUSE, INC -
INSPECTION RECS 01/01/2004 - 12/31/2014
DRUG TESTING LABORATORY, FORT COLLINS, CO - EIR
08/01/2014 - 08/31/2014
MIRCERA - AERS
BIOPHARMASOLUTIONS BAXTER HEALTHCARE CORPORATION,
BLOOMINGTON, IN - 483 10/01/2014 - 09/05/2015
List of FDA-registered tobacco firms
Orphan drug applications for Cresemba
BENDECTIN, DICLEGIS - AERS
PRALUENT, SUBSYS, FENTORA ETC AERS
BENCHMARK MEDICAL, INC, SALT LAKE CITY, UT - EIR.
483, RESPONSE 12/10/2012 - 12/13/2012
MAIL FROM LAW ENFORCEMENT 2001 TO 2012
KRAFT FOODS - COMPLAINTS 01/01/2015 - 09/01/2015
SALUTARIS MEDICAL DEVICES 510K
WILLIAM W LEWIS, MD, DALLAS, TX - EIR. 483,
RESPONSE 01/27/2014 - 01/30/2014
WETHOFF CONSTANCE, MD, LONG ISLAND, NY - EIR. 483,
RESPONSE 08/21/2013 - 09/12/2013
ANDA 200271
GRIFOLS THERAPEUTICS, INC, CLAYTON, NC - EIR. 483,
RESPONSE 03/01/2014 - 04/01/2014
O2 NAKED AIR LLC, CITRUS HEIGHTS, CA - EIR. 483,
RESPONSE 03/12/2014 - 03/31/2014
CONSTANCE MAO, MD, SEATTLE, WA - EIR. 483, RESPONSE
03/26/2014 - 04/14/2014
MEDIVATION, INC, SAN FRANCISCO, CA - EIR. 483,
RESPONSE 06/08/2012 - 06/27/2012
ABBVIE, INC, NORTH CHICAGO, IL - EIR. 483, RESPONSE
12/03/2013 - 12/13/2013
2010-63
ACTAVIS, SALT LAKE CITY, UT - EIR. 483, RESPONSE
12/03/2012 - 12/14/2012
AMERICAN RED CROSS DONOR MANAGEMENT CENTER, TULSA,
OK - EIR. 483, RESPONSE 02/04/2013 - 03/01/2013
BAYER CORPORATION, BERKELEY, CA - EIR, 483,
RESPONSE 09/01/2013 - 09/19/2013
LINDE, INC, INDIANAPOLIS, IN - EIR, 483, RESPONSE
12/16/2013 - 12/17/2013
POWER MORCELLATOR DVC - PREVIOUSLY RELEASED RECS
KINEVAC (SINCALLDE) TREANDA (BENDAMUSLINE) MFG
CHANGE OR ADDITION
MEDICAL IMAGING & TECHNOLOGY ALLIANCE MTG - CORR,
MEMOS, EMAILS, ETC 8/5/15
TEVA ANDA - 79-246 APRVL
CONTRACT HHSF223201400036G
LIST OF CONFIRMED CASES OF ILLNESS REGARDING ANY
AND ALL BLUE BELL ICE CREAM LISTERIOSIS OUTBREAKS
LONZA AG, SWITZERLAND - EIR 08/29/2014 - 08/29/2014

OPTOS PLC - OPTOS LIMITED PANORAMIC 200CAF K100644
INSPECTIONS OF PHARMACEUTICAL CHEMISTRY AND
MICROBIOLOGY LABS, TRAINING FOR FIELD AND CENTERS
ON DATA INTEGRITY ETC 01/02/2014 - 01/28/2015
873686 SAMPLE RECS
NATURE'S VALUE, INC, CORAM, NY - 483 07/01/2015 -
09/14/2015
XTANDI - AERS
COUGH & COLD PREPARATIONS - ISRS 7233393, 9564763,
9603009, ETC
873687 SAMPLE RECS
K002931
K133769
K131707
CIBA VISION ASIAN MANUFACTURING AND LOGISTICS PTE
LTD, SINGAPORE - EIR 06/23/2014 - 06/26/2014
CARDINAL HEALTH 414 LLC, BIRMINGHAM, AL - EIR, 483,
RESPONSE 04/22/2013 - 04/25/2013
873689 SAMPLE RECS
K110629
FEI 2523928 - EIR
ANDA 090043 APPROVAL ROUTING SUMMARY
K073697
2015-5807
ANDA 205442
ARKANSAS CHIDREN'S CENTER - INFANT SOY FORMULA
1/1/00 TO 1/31/05
RECYCLED PLASTICS - NO OBJECTION LTR 1/11/10
PUREGEN, ALPHATEC SPINE - PARCELL LABORATORIES -
REPORTS, RECALLS, WARNINGS ETC (CERTIFIED)
01/01/2005 - 01/29/2015
AMRICAN ALTERNATIVE INSURANCE CORP - ENTRY AGT-
00116500, AGT-00117193 FDA NOTICE OF ACTION, CBP
REDELIVER NOTICES
ABBOT IRLAND DIABETES CAREDONEGAL TOWN CO-
PICTURES, OASIS COMPUTER SCREEN SHOTS, EMAILS, ETC
INDIVIDUAL RECS (CERTIFIED)
PREVIOUSLY RELEASED EIRS
LIST OF MANUFACTURERS WHO HAVE SUBMITTED ACCIDENTAL

RADIATION OCCURRENCE REPORTS FOR PRODUCTS
IDENTIFIED AS DENTAL DIAGNOSTIC XRAY EQUIPMENT
09/01/2013 - 09/11/2015
NUPLAZIDTM - APPROVAL RECS, INSPECTION RECS RE
MANUFACTURING
SUBMISSIONS FOR APPROVAL/CLEARANCE FOR CONDOM FOR
ORAL SEX 01/01/1976 - 09/11/2015
K031838
BIONDILLO'S BAKERY LLC, CHICAGO, IL - CLOSEOUT
LETTER 11/01/2013 - 01/31/2015
CALDEROL CLINICAL DATA
DR ELLEN MARMUR, NEW YORK, NY - 483, EIR 12/29/2014
- 01/08/2015
K973704
PERIPHERAL AND CENTRAL NERVOUS SYSTEM DRUGS
ADVISORY COMMITTEE - TRANSCRIPTS, BRIEFING FOR
BETASERON 03/18/1993 - 09/19/1996
K141770
K130349
LUPIN, INDIA - 483 07/01/2015 - 07/30/2015
SMITH & NEPHEW INC, ANDOVER, MA - EIR 03/02/2015 -
04/30/2015
LUPIN, INDIA - 483 05/01/2015 - 09/11/2015

TEVA PARENTERAL MEDICINES, INC, IRVINE, CA - EIR
04/01/2006 - 08/01/2010
LIFESOUTH COMMUNITY BLOOD CENTERS - 483, RESPONSES,
WL CORR 10/17/2011 - 09/11/2015
K051926
NDA 017630
LUPIN, INDIA - 483 07/08/2015 - 07/19/2015
FLUTICASONE SALMETEROL - PLAIR RECS
STN1003000/5000 TOXICITY STUDIES
LUPIN, INDIA - 483 06/01/2015 - 09/11/2015
ANDA 078830
873688 SAMPLE RECS
RACC FOR DRIED SEAWEED
SHUR-GREEN FARMS, ANSONIA, OH - EIR EXHIBITS,
ATTACHMENTS 02/01/2014 - 09/13/2015
CHS INC, HOLLAND, MI - 483, EIR, WARNING LETTERS
ETC 03/01/2014 - 06/01/2014
CHS INC, FAIRMONT, MN ETC - 483, EIR, WARNING
LETTERS ETC 06/01/2014 - 02/01/2015
K910081, K910081/A
K120150
MCGUFF DELALUTIN - LABEL 08/24/2015 - 09/12/2015
SUPERIOR FEED INGREDIENTS, WACONIA, MN - EIR
EXHIBITS, ATTACHMENTS 02/01/2014 - 09/13/2015
DIANNA C SONNENBURG MEMO TO STEVE SKAAR RE SUPERIOR
FEED INGREDIENTS 10/01/2014 - 10/31/2014
RESTAURANT RECYCLING LLC, FREMONT, MI - EIR
EXHIBITS, ATTACHMENTS 02/01/2014 - 09/13/2015
NINE ANDA APPROVAL LETTERS

2013-9072
2015-6171
K142881
FCN 599, FCN 1451, FCN 1522
DINETHYL SULFOXIDE (RIMSO 50) AER
K974020
FCN 315
MEDELA AG - INVIA ENDURE NEGATIVE PRESSURE WOUND
THERAPY SYS K141926
PHUSION PROJECTS LLC (DBA DRINK FOUR BREWING CO)
CORR, RECS THROUGH 11/20/10
RISPERDAL - AER
LUPIN LTD, GOA, INDIA - 483
McGUFF - HYDROXYPROGESTERONE CAPROATE ANDA 20-271
APRVL LTR, PI
DR REDDYS LABORATORIES INC - SUMATRIPTAN SUCCINATE
NDA 90-495 RVWS
AMERICAN RED CROSS - FORT WAYNE, IN 7/12/10
LOGANSPORT, IN 5/15/12 GOSHEN, IN 5/15/12 EIR
APRVL LTR, LBLG
APRVL LTR, LBLG
K790238
HILL ROM, BATESVILLE, IN - EIR
3082915, 84738122, 107690081 ISRS ETC
ANY DVC IMPLANTED INTO A PATIENT AT VA MEDICAL CTR
DURHAM, NC BY BRUCE KILSTROM MD 2/27/15
SUBOXONE - RECS
Form 483, EIR, and company response, Clinical
Investigator Inspection.
CC 141110, FOLLOW UP EIR NESTLE USA, SOLON, OH
INSULET CORPORATION OMNIPOD INSULIN MANAGEMENT
SYSTEM RECALL RECS 07/01/2015 - 09/14/2015
ZHEJIANG HISUN PHARMACEUTICAL CO, LTD, CHINA - 483,
EIR 01/02/2014 - 09/14/2015
2015-501
K141865
NDA 19698
ANDA 78193
BLA 125522 SBA
2011-4212
K111450
K131198, K060526
2015-581
K141338
2012-3163
2012-2566
K143663
Blood Establishment Registration Database
K140751
K123428
ANDA 90842
K123864
2015-5444
K134005
DEN050003
Not substantially equivalent (NSE) order issued on

August 6, 2015, by the Center for Tobacco Products
(CTP) to California Clinical Supply Company for CCS
Papers
NEMOTO KYORINDO CO LTD - DUAL SHOT ALPHA 7 K133189
ALVOGEN - ANDA 204-403 SBA
NEOPHARM LABS INC, CANADA - EIR 01/01/2012 -
01/01/2015
ARMOUR PHARMACEUTICALS INC - ACTHAR GEL SYNTHETIC
(SERACTIDE ACETATE) NDA 17-861 CITIZEN PETITION
LIPARI FOODS, JB GLOBAL, PK SUNFLOWER CORP -
SUNFLOWER SEEDS LISTERIA OUTBREAK 6/13,
INVESTIGATION RECS, TESTING, RPTS, ETC
AMANDA STURGILL-JONES - INVESTIGATION RECS
BEVACIZUMAB - ISRS 4724369, 4746889, 4902722, ETC
RISPERDAL - AERS
MEDICAL ACTIONS INDUSTRIES INC, ARDEN, NC - INSP
RECS 9/25/07-10/9/07
VIOPTIX - K04657
BIMAGRUMAB - FORM FDA 3926, FDA1571
VIOPTIX - K133983
SPECTROS - K081233
SGS LIFE SCIENCE SERVICES, CANADA - EIR 01/01/2012
- 01/01/2015
PMA FOR T:SLIM G4 INSULIN PUMP FROM TANDEM DIABETES
CARE
ZHEJIANG HISUN PHARMACEUTICAL CO LTD - 483, WARNING
LETTER 1/01/2015 - 09/14/2015
HISTORICAL DRUG SHORTAGE DATA 01/01/2009 -
09/01/2015
ACT ADVANCED COOLING THERAPY - CLINICAL,
PRECLINICAL TRIALS ETC 01/01/2014 - 09/30/2015
ER/LA REMS FIRST ASSESSMENT REPORT, SECOND
ASSESSMENT REPORT, THIRD ASSESSMENT REPORT
RECS RE CYBER SECURITY VULNERABILITIES IN MEDICAL
DEVICES 01/01/2001 - 09/01/2015
SPREADSHEET OF FIRMS THAT RECEIVED WARNING LETTERS
ABBOTT MEDICAL OPTICS, UPPSALA, SWEDEN - EIR
08/29/2013 - 09/06/2013
08/16/2015 - 08/31/2015
07/01/2015 - 07/31/2015
IPCA - IMPORT ALERT RATLAM API FACILITY
BIOCON LIMITED, INDIA - 483 06/01/2015 - 06/30/2015

COMMUNICATION BETWEEN FDA AND GOJO INDUSTRIES RE
REGULATORY STATUS OF BENZETHONIUM CHLORIDE AND/OR
BENZALKONIUM CHLORIDE 08/26/2003 - 12/31/2008
CRYOTHERAPY DEVICES INVESTIGATION RECS 07/01/2014 -
09/15/2015
ANDA 200271
All communications since April 9, 2013 between
Cytokinetics, Inc. and the Food and Drug
Administration regarding the number of patients in
the clinical trial of Tirasemtiv (formerly known as
CK-2017357) including, but not limited to,
correspondence abo
IRANIAN SAUCE, WHEY SAUCE DEHKADE NASR CO, IRAN -
VETERINARY REVIEW 01/01/2014 - 09/14/2015
DATABASE OF FIELD EXAMS/PHYSICAL EXAMINATIONS FOR

ALL IMPORTED FISHERY AND SEAFOOD PRODUCTS, TOTAL
NUMBER OF LABORATORY TESTS ETC 01/01/2013 -
12/31/2014
LIST OF INSPECTIONS 3/15/14 TO 9/15/15
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
SE000276, SE000277, SE000278 ETC

ORIGINAL DRAFT MANUSCRIPT FDA APPROVAL OF
DOXYLAMINE-PYROXIDINE THERAPY FOR USE IN PREGNANCY
01/01/2010 - 03/20/2014
K140464
METHEMOGLOBINEMIA - AERS
GULF FIBEROPTICS, FLORIDA - 483 04/01/2013 -
07/30/2013
FOIA LOG 1/1/08 TO PRESENT
NDA 012157
K150852
K112478
UNIVERSITY OF NEBRASKA MEDICAL CENTER, OMAHA, NE -
EIR 06/01/2014 - 12/31/2014
CHONDRITIN, GLUCOSAMINE - AERS
ANDA 079011
NDA 20357
K991139
2015-4585
LIST OF FEI NUMBERS
LA MEXICANA, VERNON, CA - EIR 06/22/2015 -
06/22/2015
HAMPTON CREEK RESPONSE TO FDA WARNING LETTER
DEVICE EVENT BD DIAGNOSTIC SYSTEMS BD VERITOR
PHYSICIAN KIT
AV-TEMECULA-CT EMBOSHIELD NAV6 EMBOLIC PROTECTION
SYSTEM ETC - AERS
COMPLAINT FOLLOW UP RECS
KIWI COMPLETE VACUUM DELIVERY SYSTEM BY CLINICAL
INNOVATIONS - PMA, 510K ETC
SANOFI PASTEUR LIMITED, CANADA - 483, EIR
K150095
NDA 002918
INVESTIGATION RECS
WAVEGUIDES RECS
MOUNTAIN VALLEY SPRING WATER RECS
DKT 80N-0042
VTECH COMMUNICATIONS LTD, CHINA - INSPECTION RECS
01/01/2014 - 09/17/2015
NDA 020505 S-052, S-022
RECS RE NEW DRUG APPLICATIONS, ABBREVIATED NEW DRUG
APPLICATIONS WITH ACTIVE MOIETY HYDROXYPROGESTERONE
CAPROATE
METHIMAZOLE ISR
483 SINCE 2010 RELEASED SINCE JUNE 2015
INSULET, BILLERICA, MA - 483 07/01/2015 -
09/14/2015
K781444
COOPER FARMS, FORT RECOVERY, OH - EIR, 483, CORR
10/01/2014 - 09/17/2015
COOPER FARMS, FORT RECOVERY, OH - EIR, CORR, 483
10/01/2014 - 09/17/2015
DAILY LOG 8/31-9/15/15
DAILY LOG 8/31-9/4/15
DAILY LOG 8/31-9/4/15
DAILY LOG 8/31-9/4/15
DAILY LOG 8/31-9/4/15
DAILY LOG 8/31-9/4/15
DAILY LOG 8/31-9/4/15
K791009
DAILY LOG 8/31-9/4/15
DAILY LOG 8/31-9/4/15
DAILY LOG 8/31-9/4/15
DAILY LOG 8/31-9/4/15
CONSUMER PRODUCT SAFETY COMMISSION - UNIT DOSE
PACKAGING FOR BUPRENORPHINE PRODS COMM 2/13
RECS SUBMITTED BY MFRS, DISTRIBUTORS, OR RETAILERS
INTENDING TO DISSEMIATE ADVERTISING OR LBLG FOR
CIGARETTES OR SMOKELESS TOBACCO
STELLA AND CHEWY'S - CMPLNTS, TESTS, INSPS, ETC ON
OR BEFORE 7/1/16 INDIVIDUAL RECS
AMERICAN ALTERNATIVE INSURANCE CORP - ENTRY

#60520761473 NOTICES FOR REQUEST OF INFORMATION
(CF28), FDA NOTICE OF ACTION, CBP REDELIVER NOTICES
(CF4647), ETC
NAMES, POSITIONS, GRADE, BARGAINING STATUS, ETC OF
EMPLOYEES IN CDER (OFFICE OF PRESCRIPTION DRUG
PROMOTION)
DAVID O CARPENTER MD, NEW YORK UNIV OF ALBANY -
CLNCL TRIAL TREATMENT PROTOCOL CORR 9/11
NDA 22574 S 001
PRAZOSIN, BUSPAR - LBLG
SUREFURE INFUSION CATHETER SYS K110459
CHARLES LOPEZ, OREGON HEALTH AND SCIENCE UNIV,
PORTLAND, OR - EIR, 483, CO RESP 8/14 TO PRESENT
ZYTO TECHNOLOGIES INC - ZYTO HAND CRADLE CMPLNTS
SUZUKEN CO LTD, AICHI, JAPAN - EIR 1/27-30/14
STRYKER - ABG 2 STEM HIP IMPLANT CORR 5/11 TO 6/12
UNITED STATES BLOOD BANK INC - INVESTIGATION RECS,
RPTS, MEMOS, ETC 7/02
POLYETHYLENE GLYCOL - AERS 1/83 TO PRESENT
GLAXOSMITHKLINE BIOLOGICALS, DRESDEN, GERMANY - 483
2015
ID BIOMEDICAL CORP, QUEBEC, CANADA - 483 2015
FOIA LOG 2013, 2014
K142794
NDA 008975, NDA 009854
GLXOSMITHKLINE BIOLOGICALS, RIXENSART, BELGIUM -
483 2014, 2015
NDA 009854
NDA 009854, NDA 008975
NOVARTIS VACCINES AND DIAGNOSTICS, HOLLY SPRINGS,
NC - 483 2014, 2015
NOVARTIS VACCINES AND DIAGNOSTICS LTD, LIVERPOOL,
UK - 483 2015
K002630
MERCK & CO INC, WEST POINT, PA - 483 2015
FOIA LOG 01/01/1999 - 12/31/2013
K053452
PROTEIN SCIENCES CORP, MERIDEN, CT - 483 2014, 2015

NDA 20785
K940852
MEDIMMUNE, LIVERPOOL, UK - 483 2015
ANDA A200271
ANDA 077488
MARCELA V MAUS, MD, PHILADELPHIA, PA - EIR, 483,
RESPONSE 11/12/2014 - 11/17/2014
SUZUKEN CO LTD, KENZ PRODUCT DEPT,AICHI, JAPAN -
EIR 6/15-17/15
TOBACCO MEDWATCH RECS 3/1/15 TO 9/30/15
INDIVIDUAL RECS
REVIEW OF LIDEGAARD REANALYSIS
RECS RE AFFECTS OF CALORIE COUNTS ON HUMAN

PSYCHOLOGICAL RESPONSE TO EATING, FACT CHECKING ETC
AGIOPH001 AERS
K112535 K073168 K792558 ETC
K971758
K132839
K142327
NDA 009854 LABELING MOST RECENT
NDA 203312
ANDA 076536
K150850
NDA 21-098/S022 NDA 21-676/S012 NDA 22-532/S004
ETC
NDA 019599 S 007, NDA 019599 S 006 ETC
K003412
FLU VACCINE - VAERS RPT 7/8/15
CTR FOR GLOBAL HEALTH DIVISION OF PARASITIC
DISEASES & MALARIA 7/29/13 TO 8/9/13 - DOCS
RJRT CAMAL CRUSH BOLD SUBSTANTIAL EQUIVALENCE RPT

SE0000276 VANTAGE TECH 13 RPT SE0000277 PALL MALL
DEEP SET RECESSED FILTER MENTHOL SE RPT ETC - RVWS
METHYELENE BLUE, CHLOROQUINE, PRIMAQUINE, ETC IN
METHEMAGLOBINEMIA
Correspondence/emails between FDA employees acting

individually or collectively to communicate with
any of the companies listed below regarding the
research and findings in Pharmacovigilance Review:
Disabling Peripheral Neuropathy Associated with
Syste
NORATLANTIC 21, LLC - INVESTIGATION RECS ETC
02/01/2010 - 09/18/2015
COSAMO LOVE YOUR COLOR - INGREDIENT RECS
WEN CLEANSING CONDITIONER HAIR CARE PRODUCT -
COMPLAINTS 10/01/2004 - 09/18/2015
MILLENNIUM PRODUCTS DBA KOMBUCHA, SYNERGY -
INVESTIGATIONS, PRODEEDINGS 01/01/2013 - 01/30/2015
09/01/2015 - 09/15/2015
SEABAND DEVICE - 510K
CDER MEMO RE MOXDUO
DIOP SPREADSHEET OF IMPORTED DRUGS FOR SODIUM
THIOPENTAL 01/01/2015 - 09/18/2015
SURGIQUEST AIRSEAL SYSTEM MAUDE REPORTS
LIST OF WARNING LETTERS
MAGNESIUM STEARATE, SOY AND HOT PEPPERS
EXPERT REPORT RE PROZAC, ETC
FRANCES COLLICHIO, MD, CHAPEL HILL, NC - EIR, 483,
RESPONSE 01/13/2015 - 01/30/2015
JAYCHEM INDUSTRIES, LTD, AUCKLAND, NEW ZEALAND -
483 07/07/2014 - 07/10/2014
INAD 83491, NADA 141-217 - PIVOTAL STUDY DATA
COMM BETWEEN FDA AND SAN ANTONIO COMMUNITY
HOSPITAL, UPLAND, CA RE ACTINOMYCS, BACTERIA
02/26/2014 - 01/29/2015
MAGNESIUM STEARATE RECS RE USES
GARY BUEHLER, REGULATORY REQUIREMENTS FOR STABILITY

TESTING OF GENERICS 09/01/2007 - 09/30/2007
AP PHARMA/HERON THERAPEUTICS COMPLETE RESPONSE
LETTERS FOR GRANISETRON CONTROLLED RELEASE IN
CHEMOTHERAPY INDUCED NAUSEA AND VOMITING
EFFICACY DATA USED TO APPROVE BUSPAR
ANDA 040440
ANDA 040439
HARVONI - AERS
N203214/S4
2015-7407
2015-7118
K021494
2015-7090
FARYDAK - AERS
OXALIPLATIN - AERS
INNOPHARMA LICENSING - LEVOLEUCOVORIN CALCIUM ANDA
203-576 TENTATIVE APRVL LTR 4/13/15
ATOPICLAIR WOUND AND SKIN EMULSION K024367
LEVOTHYROXINE - ISRS 5804546, 7096589, 7277250, ETC

AMPHETAMINE/DEXTROAMPHETAMINE - ISRS 7759445,
7820687, 7834307, ETC TAMSULOSIN - ISRS 7412020,
7418312, 7620755, ETC
SC INFORMED FLUIDS SRL - EIRS
CONFIDENTIAL MEFLOQUINE RPT
MEFLOQUINE - DOSE RESPONSE, PK, PHARMACOLOGY, ETC
GOJO INDUSTRIES - PREVIOUSLY RELEASED RECS
01/01/2000 - 09/11/2015
NDA 22-532 S1
BACTOLAC PHARMACEUTICAL, INC, HAUPPAUGE, NY - EIR
01/01/2014 - 09/21/2015
MEDWATCH REPORT
AHMED Glaucoma Valve model FP7 COMPLAINTS ETC
E-CIGARETTE DEEMING RULE, ANPRN RE NICOTINE
EXPOSURE WARNINGS AND CHILDPROOF PACKAGING
LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM - RECS
RE SAFETY, USE, DESIGN 01/01/2001 - 09/21/2015
WARNING LETTER TOBACCO RETAILER 15WA006995
GENERAL MILLS, SUPERIOR, WI - EIR, 483 APRIL 2015
WILLOW CURVE - AERS
SPREADSHEET OF 463A FORMS 01/01/2014 - 09/21/2015
SAFETY COMMUNICATION RE FLEXIBLE BRONCHOSCOPES
01/01/2013 - 09/21/2015
XELLIA PHARMACEUTICALS LTD, HUNGARY - EIR
01/01/2014 - 01/01/2015
SYNTHES, INC, WEST CHESTER, PA - 483, EIR MAY 2004
LIST OF 483, EIR FOR PHARMACEUTICAL MANUFACTURING
FIRMS 09/30/2014 - 09/22/2015
TECFIDERA 10526694,10969585,11078171, ETC
QRX PHARMA LTD - COMPLETE RESPONSE, ETC
NADA 141-440
K983210
CBER BLOOD PRODUCTS ADVISORY COMMITTEE, TRANSCRIPT
04/06/1989 - 04/06/1989
COSENTYX - AERS
XELLIA PHARMACEUTICALS LTD, HUNGARY - EIR SUMMARY,
483 01/01/2014 - 01/01/2015
FOI DAILY LOGS 9/7-11/15
FDA/CBER PROTOCOL FOR SINGLE RADIAL IMMUNODIFFUSION

MINDRAY BC-3600 AUTO HEMATOLOGY ANALYZER - K143348
K123910
STRYKER - NEPTUNE WASTE MANAGEMENT K122665
HORMONE PREGNACY TESTS - STUDIES, COMM 1960S, 197S,
1980S
THERANOS HERPES SIMPLEX BIRUS-1 (HSV-1) IGG ASSAY -
K143236
INNOPHRMA LICENSING - LEVOLTEUCOVORI CALCIUM ANDA
203-576 APRVL LTR
LIDOCAINE ANDA 080-210 - RECS
OCEAN STATE PAIN MANAGEMENT PC, WOONSOCKET, RI -
INVESTIGATIONS, CORR, RPTS, ETC 2011 TO PRESENT
SODIUM THIOPENTAL - CORR, COMM, LOGS, ETC 8/1/2014
TO PRESENT IMPORT RECS
COMMUNICATIONS BETWEEN FDA AND VENAXIS, INC RE 510K
01/01/2015 - 01/29/2015
2015-581
NDA 008975
SANTA FE NATURAL TOBACCO CO, NEW YORK CITY, NY -
RESP TO WARNING LTR 8/27/15
FDA-DH-14-1070239-GP
FDA-DH-14-1228253-GP
VERATHON INC, BOTHELLE, WA GALENA BIOPHARMA INC,
PORTLAND, OR - 483S 8/1-31/15
PENUMBRA INC, ALAMEDA, CA MIRAMAR LABS INC, SANTA
CLARA, CA SCITON INC, PALO ALTO, CA, ETC - 483S
8/1-31/15
MAJOPA INDUSTRIES CORP, GUAYAMA, PR BLU CARIBE
INC, DORADO, PR AIAC INTERNATIONAL PHARMA LLC,
ARECIBO, PR - 483S 8/1-31/15
PANTHERA LEO - INSPECTION RECS 01/01/2004 -
01/28/2015
GENTELL, BRISTOL, PA ORASURE TECHNOLOGIES,
BETHLEHEM, PA JOHNSON MATTHEY INC, CONSHOHOCKEN,
PA - 483S 8/1-31/15
TRIS PHARMA INC, MONMOUTH JUNCTION, NJ - 483S 8/1-
31/15
TOBACCO INSPECTIONS RECS
PATHEON, FERENTINO, ITALY - 483, EIR SUMMARIES
06/09/2009 - 09/22/2015
BRENTUXIMAB - AERS
SE0000276, SE0000277, SE0000278 ETC
PROTON PUMP INHIBITORS - AERS
EMAILS BETWEEN RICHARD J DAVEY AND REDCROSS.ORG
01/01/2013 - 09/22/2015
HISOAR PHARMACEUTICAL CO, CHINA - 483, EIR
01/01/2015 - 09/22/2015
RJ REYNOLDS NSE RECS
KEYTRUDA - AERS 12/01/2014 - 12/31/2014
CORR WITH CONGRESS RE SODA, SODA POP, SWEETENED
BEVERAGES ETC - 1/1/12 TO PRESENT
HIKMA FARMACEUTICA, PORTUGAL - 483 JUNE/JULY 2015
510K CHIRON DIAGNOSTICS AUTOMATED CHEMILUMINESCENCE
SYSTEM (ASC) CENTAUR ANALYZER
K050102
UPM PHARMACEUTICALS, BRISTOL, TN MICROPORT

ORTHOPEDICS INC, ARLINGTON, TN DIABETES
CORPORATION OF AMERICA (DBA DCA PHARMCY) - 483S
8/1-31/15
ITG BRANDS, SANTA FE NATURAL TOBACCO, SHERMANS -
WARNING LETTER RECS
ZHEGIANG HISUN PHARMACEUTICALS, CHINA - 483 TWO
MOST RECENT
NDA 008975 MOST RECENT LABELING
ESTEE LAUDER INC (LEN RON MFG), MELVILLE, NY SMK
IMAGINNG LLC, ELMSFORD, NY PARKELL INC, EDGEWOOD,
ETC - 483S 8/1-31/15
INTAS BIOPHARMACEUTICALS - 483 06/15/2015 -
07/15/2015
NDA 012380, ANDA 200892, 040686, 040430 ETC
CORR WITH CONGRESS RE GROCERY MANUFACTURERS
ASSOCIATION, SNACK FOOD ASSOCIATION, CALORIE
CONTROL COUNCIL ETC - 1/1/12 TO PRESENT
N-MOLECULAR INC, HAVERHILL, MA RI CONSULTANTS LLC,
NASHUA, NH MAREL CORP, WEST HAVEN, CT, ETC - 483S
8/1-31/14
ALKEM BADDI - 483 09/02/2014 - 09/24/2015
FINGOLIMOD, DACLIZUMAB, RITUXAN ETC - AERS
QUARTETTE - AERS
ADASUVE - AERS
ZECUITY - AERS
QNASAL - AERS
Granix TBO AERS
MAYO CLINIC PET RADIOCHEMISTRY FACILITY, ROCHESTER,
MN R&D BATTERIES INC, BURNSVILLE, MN TREYMED INC,
SUSSEX, WI, ETC - 483S 8/1-31/15
R2 DIAGNOSTICS INC, SOUTH BEND, IN SURESTEP LLC,
SOUTH BEND, IN INNOVATIVE SURGICAL DESIGNS,
BLOOMINGTON, IN, ETC - 483S 8/1-31/15
CORR WITH CONGRESS RE MONSANTO, SYNGENTA, BAYER
CROPSCIENCE ETC - 1/1/12 TO PRESENT
WALGREENS INFUSION SERVICES, SAN ANTONIO, TX
CARROLL CO, GARLAND, TX US COMPOUNDING INC,
CONWAY, AR, ETC - 483S 8/1-31/15
PHILIPS BURTON, FRANKLIN PARK, IL ABBOTT LABS,
ABBOTT PARK, IL - 483S 8/1-31/15
STERLING MEDICAL INC, FORT MILL, SC UNITED

THERAPEUTICS CORP, RESEARCH TRIANGLE PARK, NC
GULBRANDSEN TECHNOLOGIES, ORANGEBURG, SC - 483S
8/1-31/15
PHIPPS & BIRD INC, RICHMOND, VA - 483S 8/1-31/15
ALFA WASSERMANN SPA, ALAMO, ITALY INTAS
BIOPHARMCEUTICALS LTD, AHMEDABAD, INDIA SEQUEST
SCIENTIFIC LTD, MANGALORE, INDIA - 483S 8/1-31/15
SUMMIT MEDICAL LTD, GLOUCESTERSHIRE, UK IMMEDICO
A/S, AAHUS N, DENMARK ARDO MEDICAL AG,
UNTERAEGERI, SWITZERLAND, ETC - 483S 8/1-31/15
DOUBLEDAY ACQUISTIONS LLC, MORAINE, OH GENPAK
SOLUTIONS LLC, HILLIARD, OH DIAPHARMA GROUP INC,
WEST CHESTER, OH, ETC - 483S 8/1-31/15
GULF FIBEROPTICS INC, OLDSMAR, FL INVIVO CORP,
ORLANDO, FL DEMETECH CORP, MIAMI LAKES, FL, ETC -
483S 8/1-31/15
ADVANCED VISION SCIENCE INC, GOLETA, CA BIT GROUP,
SAN DIEGO, CA HOSPIRA INC, SAN DIEGO, CA, ETC -
483S 8/1-31/15
INNOPHARMA LICENSING - LEVOLEUCOVORIN CALCIUM ANDA
203-576 RVWS
CORR WITH CONGRESS RE AGRICULTURAL PESTICIDE OR
HERBICIDE ETC - 1/1/12 TO PRESENT
DR VAN VELDHUIZEN, UNIV OF KANSAS CANCER CTR,
FAIRWAY, KS - 483 6/24/15-7/2/15
PARADIGM HEALTH & WELLNESS INC - FITNESS GEAR
INVERSION TABLE MDRS, CMPLNTS, HEALTH CLAIMS, ETC
DR PRABHIT S PUREWAL MD - INVESTIGATION RECS
CHANG CHUN PETROCHEMICAL CO - FCN 1282
PHOTONIC WAVEGUIDES - FUNCTIONS, PHYSICAL
COMPOSTITIONS, RESEARCH RECS, ETC
INDIVIDUAL RECS
WEINBERG GROUP, HILL AND KNOWLTON, EDELMAN, ETC -
VACCINE PROGRAMS
DAILY MULTIPLE FOR MEN - CMPLNT #139910
SCHERING-PLOUGH - ESTRUMATE (CLOPROSTENOL SODIUM)
NADA 113-645 FOI SUMMARY
ALLIED BIOMEDICAL RESEARCH INSTITUTE INC, GENECELL
INTERNATIONAL LLC, MIAMI CHILDREN'S HOSPITAL, ETC -
CMPLNTS, EIRS, POLICIES, ETC
CORR WITH CONGRESS RE ARTIFICIAL SWEETENERS,
ADVANTAME, ASPARTAME ETC - 1/1/12 TO PRESENT
DKT 2000P-0586
DKT 1999P-5198
INDIVIDUAL RECS
K043050
TECHWORLD INC, WILMINGTON, DE - 483
2013-8866
K083620
CORR WITH CONGRESS RE ADDED SUGAR, HIGH FRUCTOSE
CORN SYRUP, HFCS - 1/1/12 TO PRESENT
CORR WITH CONGRESS RE GMO ETC - 1/1/12 TO PRESENT
2014-7414
2014-7050
2014-6806
IMBRUVICA - AERS
2012-8218
2012-7000
2013-7000
2014-8272
2014-5129
2014-3480
2013-657
GLYSOPHATE IN FOOD, ADVERSE HEALTH EFFECTS, TESTING

GMOS IN FOOD, ADVERSE HEALTH EFFECTS, SAFETY
TESTING
K891688
ABC DOPHILUS FROM SOLGAR - SAMPLE PHOTOGRAPHS YALE
UNIVERSITY
ZYDELIG - AERS 12/01/2014 - 12/31/2014
K001083
CPT 1300573
INFLAMMATORY CYTOKINES IN BEEF - RECS
E COLI OUTBREAK IN DENVER - RPT 4/16/14
GE HEALTHCARE, BARRINGTON, IL - 483S 2009 TO
PRESENT
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES INC -
CENTRICITY ULTRA LABORATORY MEDICINE BK050018
IVAX, TEVA - NEXIUM (ESOMEPRAZOLE MAGNESIUM) APRVL
RECS
MK-9 PEPPER MACE FOGGER - SAFETY RECS
VENLAFAXINE - AERS
K123369
GRALISE - ORPHAN DRUG DESIGNATION CORR 11/01/2010 -
11/30/2010
ACTOS (PIOGLIAZONE) - REPRODUCTIVE CANCER RECS
CADILA HEALTHCARE LIMITED - 483 12/01/2014 -
12/12/2014
COMPLAINT 137942
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
2014-7821
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
GHANDI SAADEH MD, NORFOLK, VA - EIRS, 483S, CO RESP

PRAXAIR DISTRIBUTION INC, HILLSIDE, IL - EIRS,
483S, CO RESP 12/03-04/13
JUNE JACOBS LABS LLC, MOONACHIE, NJ - EIRS, 483S,
CO RESP 1/08-14/14
DR REDDY LABS, INDIA - 483 01/05/2012 - 01/05/2015

OCTAPHAMA PLASMA, YPSILANTI, MI - EIRS, 483S, CO
RESP 2/03-06/14
BELCHER PHARMACEUTICALS LLC, LARGO, FL - EIRS,
483S, CO RESP 1/15/14-2/3/14
DR MAHENDRA SANAPATI, EVANSVILLE, IN - EIRS, 483S,
CO RESP 1/22/14-2/6/14
LYNE LABORATORIES INC, BROCKTON, MA - EIRS, 483S,
CO RESP 1/27/14-2/13/14
PAXAIR INC, RIVER ROUGE, MI - EIRS, 483S, CO RESP
9/25/13
BROWER ENTERPRISES, CANTON, SD - EIRS, 483S, CO
RESP 12/04-07/12
GENZYME (SANOFI CO), CAMBRIDGE, MA - EIRS, 483S, CO
RESP 9/20-30/13
PACIFIC COAST TISSUE BANK, LOS ANGELES, CA - EIRS,
483S, CO RESP 4/24-66/19/12
SYNERGY ORTHOPAEDIC SYSTEMS INC, SACRAMENTO, CA -
EIRS, 483S, CO RESP 8/08-13/12
FENWAL INTERNATIONAL INC, MARICAO, PR - EIRS, 483S,
CO RESP 4/25/13
INDUSTRIAS QUIMICAS FALCON, MEXICO - 483 01/05/2012
- 01/05/2015
PRIME ENTERPRISES INC, HIALEAH, FL - EIRS, 483S, CO
RESP 11/27/12 TO 1/03/13
FRANCIS W PRICE JR MD, INDIANAPIOLIS, IN - EIRS,
483S, CO RESP 1/08-17/14
MEFLOQUINE MTG 11/11/13 - OFFICE OF THE
COMISSIONER AGENDAS, PRESENTIATIONS, INTERNAL MO,
ETC, 7/12 TO 7/13
MEFLOQUINE MTG 1/11/13 - GENERIC DRUGS AGENDAS,
PRESENTATIONS, INTERNAL MO, ETC 7/12 TO 7/13
MEFLOQUINE MTG 1/11/13 - SURVEILLANCE &
EPIDEMIOLOGY AGENDAS, PRESENTATIONS, INTERNAL MO,
ETC 7/12 TO 7/13
MEFLOQUINE MTG 1/11/13 - ANTIMICROBIAL PRODS
AGENDAS, PRESENTATIONS, INTERNAL MO, ETC 7/12 TO
7/13
ENTYVIO - AERS
pHARMECEUTICAL, BIOLOGICS, MEDICAL DVC MFG, CLNCL
TRIAL FACILITIES IN & OUTSIDE THE US - 483'S 1/1-
31/15
ELECTONIC CIGARETTES - BACKUP DETAILS, TEST
RESULTS, SPREADSHEETS, ETC 4/22/14
CARE RESEARCH LLC, FORT COLLINS, CO - EIRS, COMM,
PHOTOGRAPHS, ETC 1/10 TO PRESENT
K071202
K941911 SUMMARY
ACI INC - GFX NERVE ABLATION SYS K063753 BIO FORM
MEDICAL INC - MODIFICATION TO GFX NERVE ABATION SYS
K081729
ACTEMRA (TOCILIZUMAB) - AERS
CASTLEBERRY FOOD CO - 483S, LAB RPORTS, EXHIBIT 6A-
B AFFIDAVITS, ETC 7/17/07-8/10/07
INTUITIVE SURGICAL - PREVIOUSLY RELEASED RECS
01/01/2009 - 01/29/2015
ANTRIA - APPROVAL RECS
METHYLERGONOVINE - AERS
TDCS - MEDICAL DEVICE ANALYSIS SENT TO CAL

DEPARTMENT OF PUBLIC HEALTH 10/01/2012 - 06/08/2013
ICLUSIG - AERS
NDA 202344
ANASTROZOLE - AERS
K891773 SUMMARY
NDA 009866
MIRENA, SKYLA, JADELLE ETC - AERS
SOLGAR ABC DOPHILUS POWDER - TESTS, ANALYSES,
INTEPRETATIONS 09/01/2014 - 02/03/2015
DKT 00N-1396 - INDEX TO COMMENTS
LUPIN LTD, INDIA - 483 12/01/2014 - 02/03/2015

VIRBAC CORP, BRIDGETON, MO - 483 01/03/2013 -
02/03/2015
ANDA A078668
P950037, P950037/S28, P840068 - SSED
TECFIDERA, SOVALDI, HARVONI ETC - AERS
SUN PAC MANUFACTURING, TAMPA, FL - EIR 01/01/2010 -
02/03/2015
K001515
BIOMIMETICS/WRIGHT MEDICAL - 483 01/25/2015 -
01/28/2015
BIOMIMETICS/WRIGHT MEDICAL - 483 01/01/2015 -
02/03/2015
ALASKA SPRING PHARMACEUTICALS INC, WESTBURY, NY -
EIR 01/01/2011 - 02/03/2015
BIOMIMETIC/WRIGHT MEDICAL - 483 10/24/2014 -
02/02/2015 APPROVABLE LETTER
Q-MED AB, SWEDEN - EIR 07/13/2006 - 09/26/2006
APPLIED LABORATORIES, INC. - EIR 01/01/2014 -
12/31/2014
DEVICE EVENT KEY 4124583 ETC
SANDOZ GMBH BIOPHARMACEUTICALS, AUSTRIA - 483, EIR
01/02/2014 - 12/31/2014
K113276
CSB NUTRITION CORPORATION, SPANISH FORK, UT -
01/01/2010 - 02/03/2015
K960496 SUMMARY
PHARMACYCLICS INC - IMBRUVICA (IBRUTINIB) AERS
EASTERN RESEARCH INC, HIALEAH, FL 1/8/14 OHIO

STATE UNIV/NISONGER CTR , COLUMUS, OH 4/25/14 UNIV
OF FLORIDA HEALTH SCIENCE CENTER SHANDS
JACKSONVILLE, JACKSONVILLE, FL 1/13/14, ETC EIRS,
483S
OVASCIENCE - UNTITLED LTR 9/6/13
CARE RESEARCH LLC OF FORT COLLINS, CO - EIRS,
EXHIBITS, ATTACHMENTS 8/22/12
FCN 1472 - RVW MEMO
PRODUCT QUEST MANUFACTURING INC, DAYTONA BEACH, FL
- INSPS, VIOLATIONS
MARGARET HAMBURG, ELIZABETH DICKINSON, MICHAEL R
TAYLOR, ETC - CV
BOTOX, BOTOX COSMETIC - AERS
PRAXAIR INC, TONAWANDA, NY - EIR, 483, CO RESP
7/2914-8/8/14
TREYMED INC, SUSSEX, WI - EIR, 483, CO RESP 10/7-
21/14
PENTOBARBITAL SODIUM POWDER, SOLUTION - IMPORT DATA
01/05/2014 - 01/05/2015
WEST-WARD PHARMACEUTICAL CORP, EATONTOWN, NJ - EIR,
483, CO RESP 2/4-26/14
HODI FRANCK, DANA-FARBER CANCER INSTITUTE, BOSTON,
MA - EIR, 483, CO RESP 8/30/10
LOUISE A TABER MD, PHOENIX, AZ - EIR, 483, CO RESP
7/7-18/14
MIDWEST MEDICAL HOLDINGS LLC (DBA MIDWEST MEDICAL
SERVICE), MOUNDS VIEW, MN - EIR, 483, CO RESP 1/22-
23/14
JHP PHARMACEUTICALS LLC, ROCHESTER, MI - EIR, 483,
CO RESP 2/3-10/14
MEDICAL DEVICE COMPANIES - 483 01/01/2015 -
01/31/2015
ADVANCED RESEARCH INSTITUTE, OGDEN,UT- 483 4/08 TO
1/15
NEW RIVER VALLEY RESEARCH INSTITUTE,
CHRISTIANSBURG, VA - 483 1/12 TO 1/15
EAST BAY BERM MED GROUP, FREMONT CA - 483 7/10 TO
1/15
YICHANG SANXIA PHARMACEUTICAL CO, YICHANG CITY,
HUBEI PROVINCE, PR CHINA - EIR 1/11 TO 1/31/11
VERDENAFIL, LEVITRA - AERS Date Range: 08/01/2003
- 01/01/2015
REMICADE - AERS 01/01/2010 - 01/01/2015
YICHANG SANXIA PHARMACEUTICAL CO LTD, YICHANG CITY,

HUBEI PROVINCE, PR CHINA - 483 1/11 TO 12/31/11
YICHANG SANXIA PHARMACEUTICAL CO LTD, YICHANG CITY,

HUBEI PROVINCE, PR CHINA - 483 1/14 TO 1/31/14
SYNEPHRINE - REPORTS, MEMO, CORR ETC 01/01/2011 -
02/03/2015
K140845
SMITHS MEDICAL ASD INC - EIR 08/01/2013 -
02/02/2015
ELUXADOLINE - APPROVAL STATUS
SANDOZ - OXACILLIN ANDA 61-490 APRVD ARTWORK FOR
THE SECONDARY PACKAGING
Shinnecock Cigarette Products
K141420
ANDA 203286
EMPIRE KOSHER POULRTY, HARRISBURG, PA - 10/18/13
INVESTIGATON
SPL 731693
SPORICIDIN STERILIZING AND DISINFECTING SOLUTION -
AERS
NDA 010515 SBA
HEMELN PHARMACEUTICLAS GMBH, GERMANY - 483
07/01/2014 - 07/31/2014
MEDTRONIC SYNCHROMED II - PMA, POST APPROVAL
STUDIES, 510K ETC
CORR SUBMITTED BY SEN DURBIN, BLUMENTHAL REQUESTING
NATIONWIDE INVESTIGATION INTO DIETARY SUPPLEMENTS
02/02/2015 - PRESENT
BIOMIMETICS (WRIGHT CO) 483
BIOFILM - ASTROGLIDE SENSUAL STRAWBERRY K140590
TRIGG LABORATORIES INC - WET PLATINUM PERSONAL
LUBRICANT K30012
TOTAL SWEETENERS INC, PLAINES, IL - RECS
AVANAFIL, STENDRA - AERS 04/01/2012 - 01/01/2015
ADM EQUINE FEED INVESTIGATION - EMAILS, SAMPLES,
ETC 08/01/2014 - 02/28/2015
ORTHO MCNEIL PHARMA INC RISPERDAL - AER
TOZAL SAMPLE 728891
MW5014928
TENTATIVE APPROVAL LETTERS - ANDA 090961, ANDA
203499
VICTOZA, MINASTRIN 24 FE, EPOGEN/PROCRIT ETC - AERS

ORGANON - SUSTANON 250 CHEMICAL STRUCTURE,
SYNTHESIS, PHARMACOLOGY, ETC
LINDANE - AERS
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
IOVATE - HYDROXYCUT SMARTBURN RAPIDSLIM ETC CAERS
SERIOUS COMPILCATIONS ASSOCIATED WITH TRANSVAGINAL

PLACEMENT OF SURGICAL MESH IN REPAIR OF PELVIC
ORGAN PROLAPSE & STRESS URINARY INCONTINENCE
CONSIDERATIONS ABOUT SURGICAL MESH FOR SUI
(CERTIFIED)
K040976
DAILY LOG 12/22-26/14
DAILY LOG 12/29/14-1/2/15
DAILY LOG 12/22-26/14
DAILY LOG 12/29/14-1/2/15
DAILY LOG 12/22-27/14
DAILY LOG 12/29/14 -1/3/15
DAILY LOG 12/19/14-1/2/15
DAILY LOG 12/29/14-1/2/15
DAILY LOG 12/29/14-1/2/15
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2014-10006 12/24/2014 Nivagen Pharmaceuticals, Inc.

2014-10007 12/24/2014 Newtyn Management

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2014-10033 12/29/2014 Kotak Securities

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2014-10039 12/29/2014 Medtronic, Inc.

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2014-8005 10/01/2014 ARMAS, MIVHSRL A

2014-8006 10/01/2014 MASSACHUSETTS GENERAL HOSPITAL

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2014-8040 10/03/2014 Bennett, Michael F

2014-8045 10/03/2014 PROCTER & GAMBLE

2014-8046 10/03/2014 Kane Kessler, P.C.

2014-8053 10/03/2014 FOI Services, Inc.

2014-8054 10/03/2014 Law Office of Matthew Strugar

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