disclosure foi request log date range from 01/28/2013 … · thursday february 7 2013 11:43 am ......

Thursday February 7 2013 11:43 AM

Disclosure FOI Request Log Date range from 01/28/2013 to 02/01/2013 Report

Total Records: 212

of 22

Control # Recd Date /Due Date

Action Office Signature/ Requester Subject

NURSERY WATER, WELL WATER - TESTING RECS; COMPLAINT; ETC

NORLESTRIN 21 2.5/50 - MEDICAL OFFICER REVIEW AND OTHER REVIEWS

NDA 21366 S10

CONTAMINATED DRIED FRUITS - ADVERSE EVENTS (01/01/2000 - 01/25/2013)

CONSUMER COMPLAINT 129691

RADIATION EMITTING MACHINES IN HOSPITALS - NUMBER,INSTALATION

GATE GOURMET - CONSUMER COMPLAINT RECS

NORLESTRIN 21 1/50 - MEDICAL OFFICER REVIEW

MOLYBDENUM, NICKEL, COBALT, VANADIUM, AND STRONTIUM IN TOTAL DIET

PLACEBO-CONTROLLED CLINICAL TRIALS DATABASE FOR SUICIDALITY AND PREPARING DATA SETS FOR ANALYSIS BY FDA - DRAFT GUIDANCE

MANUKA HONEY, WEDDERSPOON ORGANIC - REPORTS,

Melissa Hirst

Chris Cano

michele hong

Chris Lahiff

Janice M. Rizzi

Curtis Obert

Brian Roemer

Chris Cano

Zoi Pappayiannis

Jennifer Brown

Travis J. Jacobs, Esq.

JONES DAY

Agile Therapeutics

michele hong

McDermott Will & Emery LLP

Radagast Pet Food, Inc.

CASE WESTERN RESERVE UNIVERSITY

Gate Gourmet

Agile Therapeutics

N/A (CONSUMER)

INFOTRIEVE

01/28/2013

01/28/2013

01/28/2013

01/28/2013

01/28/2013

01/28/2013

01/28/2013

01/28/2013

01/28/2013

01/28/2013

01/28/2013

02/26/2013

02/26/2013

02/26/2013

02/26/2013

02/26/2013

02/26/2013

02/26/2013

02/26/2013

02/26/2013

02/26/2013

2013-628

2013-629

2013-630

2013-631

2013-632

2013-633

2013-634

2013-635

2013-636

2013-637

2013-638

FDA/OF/CFSAN/OCD/EOS/

FDA/OGROP/ORA/CE-FO/DET-DO/DET-CB/

FDA/OGROP/ORA/SE-FO/ATL-DO/ATL-CB/

FDA/OMPT/CDER/ORP/DIDP/









ORA/

ORA/

FDA/OMPT/CDRH/OCER/DFOI/











OM/OMP/DODM/




Total Records: 212

of 22



TEST RESULTS, APPLICATION, ETC (01/01/2005 - 01/25/2013)

SCOTTS MIRACLE GRO - CORR WITH FDA RE RECALLS; TELEPHONE CALLS

POST DONATION FATALITY REPORTS

VERIDEX - CELL TRACKS AUTO PREP SYS K122821; K110406; K100684; IMMUNICON - CELL TRACKS AUTO PREPSYS K040077

ARIAD PHARMACEUTICALS - RIDAFOROLIMUS SPA

FOOD LBLG POLICY REGARDING HUMAN FOOD 9/11 TO PRESENT

SHAKER DAKHIL, CA CTR KANSAS, WICHITA, KS - 483 3/12 TO PRESENT

SALMONELLA, E COLI, LISTERIA AT FOOD FACILITIES - 483S

APEX ENERGETICS INC, IRVINE, CA - RECS

ARMEN SIMONIAN, ORANGE COUNTY, CA - RECS

BLOOD NUTRITION INSTITUTE INC, SANTA ANA, CA - RECS

PRINCIPAL LAB INC, SANTA ANA, CA - RECS

HEALTH SCIENCES INVESTMENT GROUP, PHOENIX, AZ - RECS

ARMOND SIMONIAN, ORANGE COUNTY, CA - RECS

Jason A. Forge

Mary Gustafson

ERAN BEN-TAL

ELLIOTT FAVUS, M.D.

PATRICIA L. REGENYE

MARY CLARE JALONICK

The Jacobs Law, LLC

Robbins, Geller, Rudman & Dowd

PLASMA PROTEIN THERAPEUTICS ASSOCIATION

BIOCEP LTD

FAVUS INSTITUTIONAL RESEARCH LLC

GREENBERG, BEATRICE .

Celgene Corporation

ASSOCIATED PRESS

ZIMMERER, CHARLES

ZIMMERER, CHARLES

ZIMMERER, CHARLES

ZIMMERER, CHARLES

ZIMMERER, CHARLES

ZIMMERER, CHARLES

01/28/2013

01/28/2013

01/28/2013

01/28/2013

01/28/2013

01/28/2013

01/28/2013

01/28/2013

01/28/2013

01/28/2013

01/28/2013

01/28/2013

01/28/2013

02/26/2013

02/26/2013

02/26/2013

02/26/2013

02/26/2013

02/26/2013

02/26/2013

02/26/2013

02/26/2013

02/26/2013

02/26/2013

02/26/2013

02/26/2013

02/26/2013

2013-639

2013-640

2013-641

2013-642

2013-643

2013-644

2013-645

2013-646

2013-647

2013-648

2013-649

2013-650

2013-651

ORA/

ORA/

FDA/OGROP/ORA/CE-FO/PHI-DO/PHI-CB/

CVM/OCD/

FDA/OGROP/ORA/CE-FO/CIN-DO/CIN-CB/

FDA/OMPT/CBER/OCOD/DDOM/ALFB/







FDA/OGROP/ORA/SW-FO/KAN-DO/KAN-CB/

ORA/OE/

ORA/OE/

FDA/OGROP/ORA/PA-FO/LOS-DO/LOS-CB/








Total Records: 212

of 22



CYREX LABORATORIES LLC, PHOENIX, AZ - RECS

BLOOD NUTRITION SOFTWARE INC - RECS

AMBIEN (ZOLPIDEM) - AERS

AMOUNT OF 14 HYDROXYCODEINONE PERMITTED IN OXYCODONE HCL ACTIVE PHARMACEUTICAL INGREDIENT (API) - RECS

HEMOCCULT TEST FOR RECAL OCCULT BLOOD

CORR BETWEEN FDA COMMISSIONER, THE DEPUTY COMMISSIONER FOR FOODS AND VETERINARY MEDICINE, IVACARE CORP

FELINE HAIRBALLS; FELINE UNIARY TRACT HEALTH - LBLG, NO OBJECTION LTRS

ENTRY NO AV300383518

PFIZER INC - ZOLOFT WARNING LTR 8/1/96

LAURA HOBBS

NANETTE CANEPA

ABRAHAM PAYTON

DAN ASHE

DOUGLAS N. BLUE

COLEEN KLASMEIER

ZIMMERER, CHARLES

ZIMMERER, CHARLES

HOBBS 134225, BRIAN

LEXIS NEXIS COURTLINK INC

BECKMAN COULTER INC

AMERICAN BRIDGE 21ST CENTURY

PATTERSON BELKNAP WEBB & TYLER

PATTERSON BELKNAP WEBB & TYLER

SIDLEY AUSTIN LLP

01/28/2013

01/28/2013

01/28/2013

01/28/2013

01/28/2013

01/28/2013

01/28/2013

01/28/2013

01/28/2013

02/26/2013

02/26/2013

02/26/2013

02/26/2013

02/26/2013

02/26/2013

02/26/2013

02/26/2013

02/26/2013

2013-652

2013-653

2013-654

2013-655

2013-656

2013-657

2013-658

2013-659

2013-660


















OC/COS/OL/

OC/OCC/

ORA/

ORA/

CVM/OCD/

FDA/OGROP/ORA/SE-FO/FLA-DO/FLA-CB/






Total Records: 212

of 22



ABBOTT LAB V797P-5057B; ELI LILLY V797P-2237D; GENENTECH V797P-5067B

AZO GESIC; AZO SEPTIC; AZO STANDARD - AER 2005 TO PRESENT

VENOFER AER

SIMPLY THICK - NECROITIZING ENTEROCOLITIS INSP, RPTS, CORR 1/10 TO PRESENT

WYETH LABORATORIES INC, PFIZER INC - 483S, WARNING LTRS; EFFEXOR XR LBLG CHANGES, FINES, ETC

JK SUCRALOSE INC, EDISON, NJ - EIR, 483, WARNING LTR, CORR SINCE 2005

JM HUBER CORP - EIR, 483, WARNING LTR, CORR SINCE 2005

RE-LY (NCT 0262600), RELY-ABLE (NCT 00808060), TRIALS - EIRS, 483S, FDA FORM 1572

ERIN E. SEDER

PETER S. REICHERTZ

TRISH McGRADE

J SCOTT NABERS

SHERI O. COVINGTON

SHERI O. COVINGTON

JOHN CREWDSON

FOI SERVICES INC

VENABLE LLP

SHEPPARD MULLIN ET AL

PRITZKER OLSEN

BLIZZARD MCCARTHY & NABERS LLP

K&L GATES

K&L GATES

PROJECT ON GOVERNMENT OVERSIGHT

01/28/2013

01/28/2013

01/28/2013

01/28/2013

01/28/2013

01/28/2013

01/28/2013

01/29/2013

02/26/2013

02/26/2013

02/26/2013

02/26/2013

02/26/2013

02/26/2013

02/26/2013

02/27/2013

2013-661

2013-662

2013-663

2013-664

2013-665

2013-666

2013-667

2013-668


FDA/OO/OFBA/OAGS/

OM/OSS/OPILS/DFI/

OM/OSS/OPILS/DFI/





OM/OSS/OPILS/DFI/

OM/OSS/OPILS/DFI/






OM/OSS/OPILS/DFI/

OM/OSS/OPILS/DFI/

ORA/

ORA/

ORA/OE/

ORA/OE/

FDA/OGROP/ORA/CE-FO/NWJ-DO/NWJ-CB/

FDA/OGROP/ORA/CE-FO/CHI-DO/CHI-CB/






FDA/OGROP/ORA/NE-FO/NWE-



Total Records: 212

of 22



PRADAXA (DABIGATRAN) - APRVL PKG, A/C, AGENDAS, ETC

BOEHRINGER INGELHEIM PHARMACEUTICALS - RELY-ABLE TRIAL RESULTS, RPTS 12/12

BOEHRINGER INGELHEIM PHARMACEUTICALS - RE-LY & RELY-ABLE TRIALS USER FEES; MERCK & CO INC - SHINGLES PREVENTION STUDY RVWS, USER FEES

HERPES ZOSTER VACCINE - VAERS 283902, 316387, 277377, ETC

AKRIMAX - TIROSINT 50 MG CMPLNT

VIGOR-25 - MFR NAMES, CONTACT RECS, DISTRIBUTORS NAMES, ETC

JOHN CREWDSON

JOHN CREWDSON

JOHN CREWDSON

JOHN CREWDSON

FRANCISCO JAVIER DAVALOS





DAVIS, DAWN

FARRIMOND CASTILLO & BRESNAHAN PC

01/29/2013

01/29/2013

01/29/2013

01/29/2013

01/29/2013

01/29/2013

02/27/2013

02/27/2013

02/27/2013

02/27/2013

02/27/2013

02/27/2013

2013-669

2013-670

2013-671

2013-672

2013-673

2013-674

DO/NWE-CB/

FDA/OGROP/ORA/NE-FO/NYK-DO/NYK-DCB/




























Total Records: 212

of 22



2011-7792, 2011-7791, 2011-7790, ETC

FOI DAILY LOG 1/03 TO PRESENT

PFIZER INC, (ZOETIS), KALAMAZOO, MI - 483S, WARNINGS 1/1-25/13

GATE GOURMET, BOSTON, MA, NEW YORK, NY, ELIZABETH, NJ, ETC - AIRPORT KITCHEN EIRS, VIOLATIONS, CMPLNTS RPTS, ETC

MARLENE LANTZ, MCHENRY COUNTY, IL, FDA CHICAGO FIELD OFFICE - MEMOS, MTG MINS, SUMMARIES, ETC 2005

CHRIS WEAVER

MOLLY SHEARER

DAVID B SUDZUS

WALL STREET JOURNAL

CAROLLO, RUSSELL

SCHONHOFT, BRAD

UNITEHERE!

01/29/2013

01/29/2013

01/29/2013

01/29/2013

01/29/2013

02/27/2013

02/27/2013

02/27/2013

02/27/2013

2013-675

2013-676

2013-677

2013-678

2013-679



OM/OSS/OPILS/DFI/

OM/OSS/OPILS/DFI/

OM/OSS/OPILS/DFI/

OM/OSS/OPILS/DFI/

OM/OSS/OPILS/DFI/

OM/OSS/OPILS/DFI/

FDA/OGROP/ORA/CE-FO/BLT-DO/BLT-CB/







FDA/OGROP/ORA/PA-FO/SAN-DO/SAN-CB/

FDA/OGROP/ORA/PA-FO/SEA-DO/SEA-CB/



FDA/OGROP/ORA/SE-FO/NOL-DO/NOL-CB/

FDA/OGROP/ORA/SW-FO/DAL-DO/DAL-CB/





Total Records: 212

of 22



7345315, 7389965, 7419534 ETC - FAERS DETAILED RPTS

MILO'S KITCHEN CHICKEN JERKY RECALL - INSPECTIONS, TESTING, RECALL RECS, ETC

INTERNAL CORR RE CLINICAL TRIAL COMPLAINT

FACTS ASSIGNMENT 808885 - TRAVEL VOUCHERS, RECEIPTS, EXPENSES, ETC

PROTOCOL, BACKGROUND INFORMATION SENT TO DISTRICT OFFICE FOR FACTS ASSIGNNMENT 808885

CFSAN FOIA REQUESTS (01/04/2013 - 01/28/2013)

INDIVIDUAL RECS

INDIVIDUAL RECS

CORR RE CSO AND SUPERVISOR FOR FACTS ASSIGNMENT 808885

Gary Wolff

Ryan T. Kearney

B Burges

b. Burges

b burges

Megan Pickel

b. burgess

DRINKER BIDDLE REATH LLP

SHIRE PHARMACEUTICALS INC

COZEN O'CONNOR

BURGESS, BERNIE

BURGESS, BERNIE

BURGESS, BERNIE

Beveridge & Diamond, PC

Doe J

Doe J

BURGESS, BERNIE

01/30/2013

01/30/2013

01/30/2013

01/30/2013

01/30/2013

01/30/2013

01/30/2013

01/30/2013

01/30/2013

02/27/2013

02/28/2013

02/28/2013

02/28/2013

02/28/2013

02/28/2013

02/28/2013

02/28/2013

02/28/2013

02/28/2013

2013-680

2013-681

2013-682

2013-683

2013-684

2013-685

2013-686

2013-687

2013-688





CVM/OCD/






OC/COS/OES/

OC/COS/OES/











OM/OSS/OPILS/DFI/

OM/OSS/OPILS/DFI/

ORA/OCI/

ORA/OCI/

FDA/OO/OHR/





Total Records: 212

of 22



HILL-ROM, INC, BATESVILLE, IN - INSPECTION RECS (03/01/2011 - 1/28/13)

RANBAXY ATORVASTATIN - AERS (11/01/2012 - 01/28/2013)

FOIA REQUEST LOG (01/21/2013 - 01/25/2013)

NUVARING, YAZ, YASMIN - AERS (01/01/2009 - 01/28/2013)

NUTRO PET FOOD - LAB RESULTS SINCE JAN 2012

SCULTPRA - PACKAGE AND PRODUCT INSERTS (01/01/2009 - 01/28/2013)

AETERNA ZENTARIS INC, KERYX BIOPHARMACEUTICALS - PHASE 2 AND PHASE 3 TRIALS TESTING PERIFOSINE FOR TREATMENT OF COLORECTAL CANCER

VACCINE LOT NUMBERS R05172, 471804, 469395

K112946

OSTEOCEL, TRINITY - AERS

Alexander Barney

Jeff Overley

Johnathan Rickman

Lynn Walsh

David Hanson

Courtney Burgess

Richard Gonnello

Anne-Solenne Rolland

Bob Bowers

Jim Petricek

The Karmel Law Firm

Law360

FDANEWS

WPTV 5

N/A

Sugarman & Sugarman, P.C.

Faruqi & Faruqi, LLP

Sutton Law Group, P.A.

OBT

01/30/2013

01/30/2013

01/30/2013

01/30/2013

01/30/2013

01/30/2013

01/30/2013

01/30/2013

01/30/2013

01/30/2013

02/28/2013

02/28/2013

02/28/2013

02/28/2013

02/28/2013

02/28/2013

02/28/2013

02/28/2013

02/28/2013

2013-689

2013-690

2013-691

2013-692

2013-693

2013-694

2013-695

2013-696

2013-697

2013-698









OM/OSS/OPILS/DFI/

OM/OSS/OPILS/DFI/





ORA/

ORA/
















Total Records: 212

of 22



INDIVIDUAL RECS

GUIDE TO INFORMED CONSENT - INFORMATION SHEET 2004

PREDNISONE - AERS (01/01/2012 - 01/28/2013)

FCN 725

IND 104117 - CORR

K113188

K090995

K112994

IND 104861 - CORR

K854334

ANDA 74531 S1

Kathryn del Real

Christopher Lotito

Rachel Johnson

Kevin Sill

Rachel Johnson

Rachel Johnson

Laura Boll

Kevin Sill

Rachel Johnson

Rachel Johnson

Harpeth Advisors

Doe J

The Cavanagh Law Firm

Biotechnology Dashboard

FOI SERVICES INC

Intezyne

FOI SERVICES INC

FOI SERVICES INC

Medovations Inc.

Intezyne

FOI SERVICES INC

FOI SERVICES INC

01/30/2013

01/30/2013

01/30/2013

01/30/2013

01/30/2013

01/30/2013

01/30/2013

01/30/2013

01/30/2013

01/30/2013

01/30/2013

02/28/2013

02/28/2013

02/28/2013

02/28/2013

02/28/2013

02/28/2013

02/28/2013

02/28/2013

02/28/2013

02/28/2013

02/28/2013

02/28/2013

2013-699

2013-700

2013-701

2013-702

2013-703

2013-704

2013-705

2013-706

2013-707

2013-708

2013-709





FDA/OO/OHR/

OM/OMP/DODM/























Total Records: 212

of 22



ANDA 091328

K922187

QUETIAPINE - AERS

IMS TRADING CORP - INSPECTIONS, INVESTIGATIONS, RECALLS ETC

WAGGIN TRAIN, CANYON CREEK - INSPECTIONS, INVESTIGATIONS, RECALLS ETC

CADET CHICKEN JERKY PET TREATS - INSPECTION, INVESTIGATION, TESTING ETC

VASCEPA (ICOSAPENT ETHYL) - PHARMACODYNAMIC & PHARMACOKINETIC DATA, PHASE 1 & PHASE 2 TESTING, ETC

ALLEGIANCE HEALTHCARE CORP - EXCHANGE TRANSFUSION TRAY PROCEDURE TRAY FDA FORM 3500A, RPTS, MEMOS, ETC

ALOE VERA - REGULATORY STATUS, CONSUMPTION, SAFETY RECS, ETC

Rachel Johnson

Jeff Wurtsbaugh

Krista Brown (Pharmacist)

Ryan T. Kearney

Ryan T. Kearney

Ryan T. Kearney

ROSS D PLONT

CLAUDIA NUNN

FOI SERVICES INC

PromoLogics, Inc.

Krista Brown (pharmacist, BRHA)

COZEN O'CONNOR

COZEN O'CONNOR

COZEN O'CONNOR

BORON, MELANIE

GRUEL MILLS NIMS & PYLMAN LLP

BURDOCK GROUP

01/30/2013

01/30/2013

01/30/2013

01/30/2013

01/30/2013

01/30/2013

01/30/2013

01/30/2013

01/30/2013

02/28/2013

02/28/2013

02/28/2013

02/28/2013

02/28/2013

02/28/2013

02/28/2013

02/28/2013

02/28/2013

2013-710

2013-711

2013-712

2013-713

2013-714

2013-715

2013-716

2013-717

2013-718












CVM/OCD/

CVM/OCD/


FDA/OGROP/ORA/SW-FO/DEN-DO/DEN-CB/



CVM/OCD/






OM/OSS/OPILS/DFI/

OM/OSS/OPILS/DFI/




Total Records: 212

of 22



HILL-ROMM, BATESVILLE, IN - 483S 10/12, 11/12

DENOSUMAB BLA 125320 - APRVL RECS

AKORN INC, DECATUR, IL 5/14-25/12; ABBOTT MOLECULAR, DES PLAINES, IL 7/2-11/12; BIOSYNERGY INC, ELK GROVE VILLAGE, IL 2/27/12-3/2/12, ETC - 483S

PAIN MANAGEMENT TECHNOLOGIES INC, AKRON, OH 6/4-8/12; CASCO MANUFACTURING SOLUTIONS INC, CINCINNATI, OH 5/7-10/12; REESE PHARMACEUTICAL CO, CLEVELAND, OH 12/14/11-1/11/12, ETC - 483S

KIMBERLY CLARK CORP, CONWAY, AR 4/23-27/12; ENCOMPASS GROUP LLC, ADDISON, TX 1/18-20/12; MISSION PHARMACAL CO, BOERNE, TX 5/9-25/12. ETC - 483S

ACELLA PHARMACEUTICALS LLC, ALPHARETTA, GA 3/19-22/12; REMINGTON MEDICAL INC, ALPHARETTA, GA 5/21/12-6/6/12; BANNER PHARMACAPS INC, HIGH POINT, NC 6/25/12-7/2/12, ETC - 483S

PETNET SOLUTIONS INC - EIRS, 483S, CO RESP 2/12

BECTON DICKINSON MEDICAL SYSTEMS, CANAAN, CT 3/14-16/12; PFIZER INC, GROTON, CT 2/21-24/12; Z-MEDICA CORP, WALLINGFORD, CT 3/29/12-4/11/12, ETC - 483S

ALTAIRE PHARMACEUTICALS INC, AQUEBOGUE, NY 3/15-19/12; AMNEAL PAHRMACEUTICALS OF NEW YORK LLC, HAUPPAUGE, NY 5/8-15/12; FOREST LABORATORIES INC, COMMACK, NY 2/15-22/12, ETC - 483S

CIANNA MEDICAL INC, ALISO VIEJO, CA 12/14/11-1/9/12; REVITOL CORP, BURBANK, CA 4/24/12-6/1/12; PURQUALITY LLC, TEMPE, AZ 1/10-30/12, ETC - 483S

PHARMATEC LLC, DAVIE, FL 1/12-24/12; BECKMAN COULTER INC, HIALEAH, FL 7/16-20/12; PACE TECH INC, CLEARWATER, FL 3/15-19/12, ETC - 483S

2012-7518

TRAVIS SCHAFTENAAR

JOSEPH M LANE MD

WALTER E CHALKLEY

WALTER E CHALKLEY

UBS GLOBAL ASSET MANAGEMENT

HOSPITAL FOR SPECIAL SURGERY

THOMPSON, RAY

THOMPSON, RAY

THOMPSON, RAY

THOMPSON, RAY

THOMSON REUTERS

THOMPSON, RAY

THOMPSON, RAY

THOMPSON, RAY

THOMPSON, RAY

THOMSON REUTERS

01/30/2013

01/30/2013

01/30/2013

01/30/2013

01/30/2013

01/30/2013

01/30/2013

01/30/2013

01/30/2013

01/30/2013

01/30/2013

01/30/2013

02/28/2013

02/28/2013

02/28/2013

02/28/2013

02/28/2013

02/28/2013

02/28/2013

02/28/2013

02/28/2013

02/28/2013

02/28/2013

02/28/2013

2013-719

2013-720

2013-721

2013-722

2013-723

2013-724

2013-725

2013-726

2013-727

2013-728

2013-729

2013-730











FDA/OGROP/ORA/NE-FO/NWE-DO/NWE-CB/




OM/OSS/OPILS/DFI/

OM/OSS/OPILS/DFI/



Total Records: 212

of 22



ST MARY'S HOSPITAL & MEDICAL CENTER INC, GRAND JUNCTION, CO - EIRS, 483S, CO RESP 6/4-15/12

TAIWAN THREE MAST PHARMACEUTICAL CO LTD, TAINAN CITY, TAIWAN - EIRS, 483S, CO RESP 4/23-27/12

APHENA PHARMA SOLUTIONS-MARYLAND LLC, EASTON, MD 1/9-13/12; MYLAN PHARMACEUTICALS INC, MORGANTOWN, WV 1/23/12-2/2/12; BOEHRINGER INGELHEIM CHEMICALS INC, PETERSBURG, VA 3/22/12-4/4/12 - 483S

RUGER CHEMICAL, LINDEN, NJ - EIRS, 483S, CO RESP 9/22/11-10/11/11

AMGEN INC, BOULDER, CO 12/14/11-1/6/12; ADAPTA MEDICAL INC, COLORADO SPRINGS, CO 1/23-26/12; NELSON LABORATORIES INC, SALT LAKE CITY, UT 3/5-9/12, ETC - 483S

GLOBUS MEDICAL INC, AUDUBON, PA 4/18/12-5/1/12; AUXILIUM PHARMACEUTICALS INC, HORSHAM, PA 6/25/12-7/6/12; MUTUAL PHARMACEUTICAL CO INC 1/9-27/12, ETC - 483S

SAGE PHARMACEUTICALS INC, SHREVEPORT, LA 2/14-17/12; HAWTHORN PHARMACEUTICALS INC, MADISON, MS 1/30/12-2/15/12; ONYX MEDICAL CORP, LMEMPHIS, TN 2/1-13/12, ETC - 483S

MIRGEN PHARMACEUTICAL, BOISE, ID 1/9-30/12; GENETECH INC, HILLSBORO, OR 6/19-27/12; GYNEX CORP, REDMOND, WA 7/16-20/12, ETC - 483S

HUMAN DRUG, MEDICAL DVC FIRMS - GMP, GLP, GCP INSPS 8/1/12-12/31/12

HERBRAND PHARMACHEMICALS GMBH, GENGENBACH, GERMANY 6/11-15/12; SCICAN BHT, GERSTHOFEN, GERMANY 7/16-19/12; BASF PHARMACHEMIKALIEN GMBH &CO KG, MINDEN GERMANY 2/6-10/12,ETC - 483S

JHP PHARMACEUTICALS LLC, ROCHESTER, MI - EIR, 483, CO RESP 3/12

GUARDIAN DRUG CO, DAYTON, NJ - EIR, 483, CO RESP 3/12

WALTER E CHALKLEY

WALTER E CHALKLEY

WALTER E CHALKLEY

WALTER E CHALKLEY

WALTER E CHALKLEY

THOMSON REUTERS

THOMSON REUTERS

THOMPSON, RAY

THOMSON REUTERS

THOMPSON, RAY

THOMPSON, RAY

THOMPSON, RAY

THOMPSON, RAY

THOMPSON, RAY

THOMPSON, RAY

THOMSON REUTERS

THOMSON REUTERS

01/30/2013

01/30/2013

01/30/2013

01/30/2013

01/30/2013

01/30/2013

01/30/2013

01/30/2013

01/30/2013

01/30/2013

01/30/2013

01/30/2013

02/28/2013

02/28/2013

02/28/2013

02/28/2013

02/28/2013

02/28/2013

02/28/2013

02/28/2013

02/28/2013

02/28/2013

02/28/2013

02/28/2013

2013-731

2013-732

2013-733

2013-734

2013-735

2013-736

2013-737

2013-738

2013-739

2013-740

2013-741

2013-742












ORA/ORM/

ORA/ORM/









Total Records: 212

of 22



NOVO NORDISK A/S, GENTOFTE, DENMARK 6/28-26/12; NOVO NORDISK A/S, HILLEROED, DENMARK 3/21/12; NOVO NORDISK A/S, KALUNDBORG, DENMARK 3/5-9/12 - 483S

RTI BIOLOGICS, ALACHUA, FL - EIR, CORR 6.25/12-7/11/12

GENZYME FLANDERS NV, GEEL, BELIGIUM 1/16/24/12; HOSPIRA COSTA RICA LTD, LA AURORA DE HEREDIA, COSTA RICA 4/16-19/12; BRISTOL-MYERS SQUIBB, ANAGNI,ITALY 3/5-8/12, ETC - 483S

BECTON DICKINSON DE MEXICO, CUAUTITLAN IZCALLI, MEXICO 1/16-19/12; AKZO NOBEL CHEMICALS SA DE CV, LOS REYES LA PAZ EDO, MEXICO 3/26-30/12 - 483S

SHIONGI & CO LTD, AMAGASAKI-SHI, JAPAN 2/10-15/12; TAKEDA PHARMACEUTICAL CO LTD, HIKARI, JAPAN 7/17-20/12 - 483S

DEPUY (IRELAND) LOUGHBEG, RINGASKIDDY, IRELAND 1/23-26/12; JANSSEN BIOLOGICS (IRELAND) BARNAHELY, RINGASKIDDY, IRELAND 6/12-18/12 - 483S

DR MALCOLM PAUL, NEWPORT BEACH, CA 6/14/12-7/17/12; DR RICHARD D'AMICO, ENGLEWOOD, NJ 10/11/12-11/12/12, ETC - EIR, 483, CO RESP

ASTRAZENCA, MACCLESFIELD, CHESHIRE, UK 3/12-16/12; DEPUY INTERNATIONAL LTD, LEEDS, UK 2/13-16/12 - 483S

WALTER E CHALKLEY

WALTER E CHALKLEY

THOMPSON, RAY

THOMSON REUTERS

THOMPSON, RAY

THOMPSON, RAY

THOMPSON, RAY

THOMPSON, RAY

THOMSON REUTERS

THOMPSON, RAY

01/30/2013

01/30/2013

01/30/2013

01/30/2013

01/30/2013

01/30/2013

01/30/2013

01/30/2013

02/28/2013

02/28/2013

02/28/2013

02/28/2013

02/28/2013

02/28/2013

02/28/2013

02/28/2013

2013-743

2013-744

2013-745

2013-746

2013-747

2013-748

2013-749

2013-750


OM/OSS/OPILS/DFI/

OM/OSS/OPILS/DFI/














OM/OSS/OPILS/DFI/

OM/OSS/OPILS/DFI/













Total Records: 212

of 22



HAMELN PHARMACEUTICALS GMBH, HAMELN, GERMANY -EIR, 483, CO RESP 6/4-14/12

NOVARTIS PHARMA BPO, HUNINGUE, FRANCE 1/23-31/12; SANOFI CHIMIE, PLOERMEL, FRANCE 3/26-30/12 - 483S

APP PHARMS, GRAND ISLAND, NY - EIR, 483, CORR 10/2-19/12

BOEHRINGER INGELHEIM RCV GMBH, VIENNA, AUSTRIA 3/15/23/12; DSM FINE CHEMICALS AUSTRIA GMBH NFG GMBH & CO KG, LLINZ, AUSTRIA 5/29-12-6/1/12 - 483S

POLYMED THERAPEUTICALS INC, ERLANG, CHINA 5/21-23/12; CHONGQING KANGLE PHARMACEUTICAL CO LTD, CHONGQING, CHINA 4/23-26/12 - 483S

ABBOTT BIOTECHNOLOGY LTD, BARCELONETA, PR 6/26/12-7/12/12; BIO LAB-ST JOSEPH CORP, BAYAMON, PR 4/17/12-5/9/12; ABBOTT DIAGNOSTICS INTERNATIONAL LTD, BARCELONETA, PR 1/18-12-3/12/12, ETC - 483S

IMPLANT RESCOURCE INC, BURNSVILLE, MN 5/16-12-6/17/12; MEDTRONIC NEUROMODULATION, MINNEAPOLIS, MN 3/14/12-5/9/12; BOSTON SCIENTIFIC CRM CORP, SAINT PAUL, MN 3/19/12-4/16/12, ETC

GLAXOSMITHKLINE CONSUMER HEALTHCARE LP, CLIFTON, NJ 12/20/11 TO 1/9/12; AUSTARPHARMA LLC, EDISON, NJ 5/30/12-6/5/12; ACTAVIS ELIZABETH LLC, ELIZABETH, NJ 12/13/11 TO 1/13/12, ETC - 483S

NOVARTIS VACCINE & DIAGNOSTICS INC, EMERYVILLE, CA 3/20-30/12; IMMUNETECH INC, FOSTER CITY, CA 3/12-23/12; BIOGENEX LABORATORIES INC, FREMONT, CA 12/20/11 TO 1/6/12, ETC - 483S

SANDOZ PRIVATE LTD (NOVARTIS), NAVI MUMBIA, INDIA

WALTER E CHALKLEY

WALTER E CHALKLEY

THOMSON REUTERS

THOMPSON, RAY

THOMSON REUTERS

THOMPSON, RAY

THOMPSON, RAY

THOMPSON, RAY

THOMPSON, RAY

THOMPSON, RAY

THOMPSON, RAY

01/30/2013

01/30/2013

01/30/2013

01/30/2013

01/30/2013

01/30/2013

01/30/2013

01/30/2013

01/30/2013

01/30/2013

02/28/2013

02/28/2013

02/28/2013

02/28/2013

02/28/2013

02/28/2013

02/28/2013

02/28/2013

02/28/2013

2013-751

2013-752

2013-753

2013-754

2013-755

2013-756

2013-757

2013-758

2013-759

2013-760



















FDA/OGROP/ORA/SE-FO/SJN-DO/SJN-CB/

FDA/OGROP/ORA/CE-FO/MIN-DO/MIN-CB/






Total Records: 212

of 22



1/2-9/12; CADILA HEALTHCARE LTD, AHEMEDABAD CITY, INDIA 2/13-23/12; CIPLALTD, BANGALORE, KARNATAKA, INDIA 6/21-28/12, ETC - 483S

NOVARTIS PHARMA AG, BASEL, SWITZERLAND 7/19-26/12; CILAG AG, SCHAFFHAUSEN, SWITZERLAND 4/20-27/12; NOVARTIS PHARMA STEIN AG, STEIN, SWITZERLAND 6/11-22/12, ETC - 483S

APOTEX FERMENTATION INC, WINNIPEG, CANADA 6/4-7/12;CONTRACT PHARMACEUTICALS LTD (CPL), MARKHAM, CANADA 1/31/12 TO 2/2/12; CARDIOMED SUPPLIES INC, LINDSAY, CANADA 2/20-23/12 - 483S

FCN 1206

PETNET SOLUTIONS, KENT, WA - EIR 2/12

BACHEM INC, TORRANCE, CA - EIR 1/20/12

PETNET SOLUTIONS, ST LOUIS, MO - EIR 2/11

2008-1744, 2011-7185, 2012-3210, ETC

2008-3812, 2012-3360, 2012-3741

RECS RE: FOI REQUEST

ADVANCED ORTHOPRO INC, INDIANAPOLIS, IN 4/6-26/12; L PERRIGO CO, ALLEGAN, MI 4/17/12-5/8/12; ACUMEDIA MANUFACTURERS INC, LANSING, MI 12/19/11-1/9/12, ETC - 483S

K062604

OSCAR GOODMAN, NEVADA CANCER CENTER, LAS VEGAS, NV - EIR (6/25/2012 - 07/03/2012)

CYNTHIA B LIEBERMAN

BRENDA M GARTZ

BRENDA M GARTZ

BRENDA M GARTZ

CHRISTOPHER WEAVER

CHRISTOPHER WEAVER

BERNIE BURGESS

Richard Superfine

Rachel Johnson

THOMPSON, RAY

THOMPSON, RAY

THOMPSON, RAY

Keller and Heckman LLP

ELI LILLY & CO

ELI LILLY & CO

ELI LILLY & CO

WALL STREET JOURNAL

WALL STREET JOURNAL

BURGESS, BERNIE

THOMPSON, RAY

Rheomics, Inc.

FOI SERVICES INC

01/30/2013

01/30/2013

01/30/2013

01/30/2013

01/30/2013

01/30/2013

01/30/2013

01/30/2013

01/30/2013

01/30/2013

01/31/2013

01/31/2013

02/28/2013

02/28/2013

02/28/2013

02/28/2013

02/28/2013

02/28/2013

02/28/2013

02/28/2013

02/28/2013

02/28/2013

02/28/2013

03/01/2013

03/01/2013

2013-761

2013-762

2013-763

2013-764

2013-765

2013-766

2013-767

2013-768

2013-769

2013-770

2013-771

2013-772

















OM/OSS/OPILS/DFI/

OM/OSS/OPILS/DFI/

OM/OSS/OPILS/DFI/

OM/OSS/OPILS/DFI/

OM/OSS/OPILS/DFI/

OM/OSS/OPILS/DFI/






Total Records: 212

of 22



MEDIVATION, SAN FRANCISCO, CA - EIR 06/08/12

INVACARE - INSPECTION RECS, CORR, UNTITLED LETTER ETC

GENENTECH, HILLSBORO, OR; GENENTECH, SAN FRANCISCO; GENENTECH, VACAVILLE, CA ETC - 483

AIDI BIOMEDICAL - MDR SINCE 01/01/2013

SYNOVIS DURA-GUARD - SAMPLE RESULTS

ANDREW ARMSTRONG, DUKE UNIVERSITY MEDICAL CENTER, DURHAM, NC - EIR (6/13/12)

ETHICON, ETHICON ENDO-SURGERY GASTRIC BYPASS SURGERY STAPLERS - COMPLAINTS, INVESTIGATIONS, REPORTS ETC

NDA 203491

HSH-QEC-12-D-00002

RILUZOLE - SUMMARIES OF IN VITRO AND ANIMAL SAFETYPHARMACOLOGY AND TOXICOLOGY STUDIES

FAP 2269

AGA MEDICAL CORP - MATERIALS SUBMITTED FOR OCCLUDER OR OCCLUSION DEVICE (01/02/1996 - 01/02/2001)

Rachel Johnson

Michael Feiler

Linda Bowen

Juan Herrera

Joshua A. Leach

Rachel Johnson

Laura Hass

Mahidhar Chinta

Shadonna Messiah

Jay Wrobel, Ph.D.

Scott Krygier

Tomas Friend

FOI SERVICES INC

Qulling Selander Lownds Winslett &Moser

SANOFI

AIDI Biomedical

Baxter Healthcare Corp.

FOI SERVICES INC

Hass, Laura

MICRO LABS USA INC

United Union Of Security Guards

Fox Chase Chemical Diversity Center

BASF - The Chemical Company

KIPA AB

01/31/2013

01/31/2013

01/31/2013

01/31/2013

01/31/2013

01/31/2013

01/31/2013

01/31/2013

01/31/2013

01/31/2013

01/31/2013

01/31/2013

03/01/2013

03/01/2013

03/01/2013

03/01/2013

03/01/2013

03/01/2013

03/01/2013

03/01/2013

03/01/2013

03/01/2013

03/01/2013

03/01/2013

2013-773

2013-774

2013-775

2013-776

2013-777

2013-778

2013-779

2013-780

2013-781

2013-782

2013-783

2013-784







ORA/

ORA/









FDA/OO/OFBA/OAGS/









Total Records: 212

of 22



HILL-ROM, BATESVILLE, IN - 483 (09/01/2012 - 01/01/2013)

US PHARMA LAB INC, NORTH BRUNSWICK, NJ - EIR (01/01/2012 - 01/01/2013)

PMA P000039

K014018

RSA CORP, DANBURY, CT; ALLERQUEST LLC, PLAINVILLE, CT; PCI SYNTHESIS, NEWBURYPORT, MA, ETC - 483S 12/1-31/12

GUY & O'NEILL INC, FREDONIA, WI; BRUNO INDEPENDENT LIVING AIDS INC, OCONOMOWOC, WI - 483S 12/1-31/12

CUSTOM COMPOUNDING CENTERS, LOS ALAMITOS, CA; SCIENTIFIC PHARMACEUTICALS INC, POMONA, CA; BIOSEAL CORP. PLACENTIA, CA, ETC - 483S 12/1-31/12

NESHER PHARMACEUTICALS (USA) LLC, BRIDGETON, MO; NESHER PHARMACEUTICALS (USA), LLC, SAINT LOUIS, MO;WEXFORD LABS INC, KIRKWOOD, MO - 483S 12/1-31/12

ORION CORP, ESPOO, FINLAND - 483S 12/1-31/12

AMERICAN ORTHO-TECH (P) LTD, CHENNAI, TAMBRAM, INDIA; UNOMEDICAL LSDN BHD, SUNGAI PETANI, KEDAH, MALAYSIA; GARAVENTA (CANADA) LTD, ST SURREY, CANADA, ETC - 483S 12/1-31/12

BSP PHARMACEUTICALS SRL, LATINA SCALO, ITALY; FARMHISPANIA SA, MONTMELO, SPAIN; SICOR SRL, SANTHIA (VC), ITALY, ETC - 483S 12/1-31/12

PETNET SOLUTIONS INC, FORT LAUDERDALE, FL; CFS DENTAL INC, HIALEAH, FL; VYCOR MEDICAL INC, BOCA RATON, FL, ETC - 483S 12/1-31/12

Xiang Liu

LIFE EXTENSION - Alexandra Ajmo

Tomas Friend

Cathy Shachaf

JOHNATHAN RICKMAN

JOHNATHAN RICKMAN

JOHNATHAN RICKMAN

JOHNATHAN RICKMAN

JOHNATHAN RICKMAN

JOHNATHAN RICKMAN

JOHNATHAN RICKMAN

JOHNATHAN RICKMAN

Blackrock

Ajmo, Alexandra

KIPA AB

Orlucent

FDA NEWS

FDA NEWS

FDA NEWS

FDA NEWS

FDA NEWS

FDA NEWS

FDA NEWS

FDA NEWS

01/31/2013

01/31/2013

01/31/2013

01/31/2013

01/31/2013

01/31/2013

01/31/2013

01/31/2013

01/31/2013

01/31/2013

01/31/2013

01/31/2013

03/01/2013

03/01/2013

03/01/2013

03/01/2013

03/01/2013

03/01/2013

03/01/2013

03/01/2013

03/01/2013

03/01/2013

03/01/2013

03/01/2013

2013-785

2013-786

2013-787

2013-788

2013-789

2013-790

2013-791

2013-792

2013-793

2013-794

2013-795

2013-796





FDA/OGROP/ORA/NE-FO/NWE-DO/NWE-CB/




ORA/

ORA/













Total Records: 212

of 22



PFIZER INC, ROCHESTER, MI; EXCEL MEDICAL PRODUCTS INC, FENTON, MI - 483S 12/1-31/12

BENCHMARK MEDICAL INC, SALT LAKE CITY, UT; WATSON LABORATORIES INC, SALT LKE CITY, UT; FRESENIUS MEDICAL CARE NORTH AMERICA, OGDEN, UT, ETC

AMERICAN PHARMACEUTICALS & COSMETICS INC, FORT WORTH, TX; CYBERONICS INC, HOUSTON, TX; MEDRO SYSTEMS INC, MCKINNEY, TX, ETC - 483S 12/1-31/12

PEMCO INC, INDEPENDENCE, OH; NORMAN NOBLE INC, HIGHLAND HEIGHTS, OH; HAVELS INC, CINCINATI, OH, ETC - 483S 12/1-31/12

MEDFIL INC, GLENDALE HEIGHTS, IL; LATTICE INC, WHEATION, IL; DEL MEDICAL INC, ROSELE, IL - 483S 12/1-31/12

RX SOUTH LLC (DBA RX3 PHARMACY), CHESTER, VA; HEMAGEN DIAGNOSTICICS INC, COLUMBIA, MD; ACELL INC, COLUMBIA, MD - 483S 12/1-31/12 - 483S 12/1-31/12

SUMMIT INDUSTRIES, MARRIETA, GA; HEAVENLY HARVESTINC, MOULTRIE, GA - 483S 12/1-31/12

BLOOD BANK COMPUTER SYSTEMS INC, AUBURN, WA; CARDINAL LHEAL 414 INC, SEATTLE, WA; MALONEY'S CUSTOM OCULAR PROSTHETICS, LAKE OSWEGO, OR, ETC- 483S 12/1-31/12

SALIX PHARMACEUTICALS - RELISTOR (METHYLNALTREXONE BROMIDE) CO RESP

INDIVIDUAL RECS

LTR TO KAREN TANNERT, RPH TX DEPT OF STATE HEALTHSERVICES 5/4/05

NU WORLD CORP, CARTERET, NJ; OHM LABORATORIES INC, NEW BRUNSWICK, NJ; CATALENT PHARMA SOLUTIONS LLC, SOMERSET, NJ - 483 12/12

BD CARIBE LTD, CAYEY, PR; KNOLL LLC, JAYUYA, PR - 483 12/12

JOHNATHAN RICKMAN

JOHNATHAN RICKMAN

JOHNATHAN RICKMAN

JOHNATHAN RICKMAN

JOHNATHAN RICKMAN

JOHANTHAN RICKMAN

JOHNATHAN RICKMAN

JOHNATHAN RICKMAN

LEO STERNLICHT

JOHNATHAN RICKMAN

JOHNATHAN RICKMAN

FDA NEWS

FDA NEWS

FDA NEWS

FDA NEWS

FDA NEWS

FDA NEWS

FDA NEWS

FDA NEWS

RIDGEBACK CAPITAL MANAGEMENT LLC

MASSEY, GEORGE

KYRIAKIDIS, JOANNA

FDA NEWS

FDA NEWS

01/31/2013

01/31/2013

01/31/2013

01/31/2013

01/31/2013

01/31/2013

01/31/2013

01/31/2013

01/31/2013

01/31/2013

01/31/2013

01/31/2013

01/31/2013

03/01/2013

03/01/2013

03/01/2013

03/01/2013

03/01/2013

03/01/2013

03/01/2013

03/01/2013

03/01/2013

03/01/2013

03/01/2013

03/01/2013

03/01/2013

2013-797

2013-798

2013-799

2013-800

2013-801

2013-802

2013-803

2013-804

2013-805

2013-806

2013-807

2013-808

2013-809



















FDA/OGROP/ORA/SE-FO/SJN-DO/SJN-CB/



Total Records: 212

of 22



INTERSECT ENT INC, PALO ALTO, CA; AMPAC FINE CHEMICALS LLC, RANCHO CORDOVA, CA; NATUREX INC, SHINGLE SPRINGS, CA - 483 12/12

B BRAUN MEDICAL INC, ALLENTOWN, PA - 483 12/12

ASCENT PHARMACEUTICALS INC, CENTRAL ISLIP, NY; HI TECH PHARMACAL CO INC, AMITYVILLE, NY; NOVARTIS PHARMACEUTICALS CORP, SUFFERN, NY - 483 12/12

CRYOSURGERY INC, NASHVILLE, TN; AXIS HEALTH CARE LLC, MONTGOMERY, AL - 483 12/12

CANNULATED BONE SCREW K061620; BONE FIXATION DEVICE K071035; PROFILE PLATES SCREWS & WASHERS K110086

AN DERINGER INC - LTR SHOWING CO AS AN AGENT OF THE US

ACIST ANGIOGRAPHIC CONTRAST MGMT INJECTORSYS MODEL CMS2000 k991103; ACIST ANGOGRAPHIC INJECTION SYS, MODEL R2000 CMS (K010390); ACIST ANGIOGRAPHIC CONTRAST MGMT SYS (K984231)

CARDINAL HEALTH EXCHANGE TRANSFUSION TRAY 6/13/07

ALLEGIANCE HEALTHCARE PHARMASEAL EXCHANGE TRANSFUSION TRAY 2/20/02

RESPONSE LTR FROM FDA TO CETERO RESEARCH 7/26/11

INDIVIDUAL RECS

HARTZ CHICKEN CHEWS, HARTZ OINKIE PIG SKIN WRAPPED WITH CHICKEN - INVESTIGATION, INSPECTIONS, TESTING, ETC

JOHNATHAN RICKMAN

JOHNATHAN RICKMAN

JOHNATHAN RICKMAN

JOHNATHAN RICKMAN

CHRISTOPHER B. SPUCHES, Esq.

ROBERT A. DeCAMP

SARA BEARDSLEY

ROSS D. PLONT

ROSS D. PLONT

MARK SCHOOFS

Ryan T. Kearney

FDA NEWS

FDA NEWS

FDA NEWS

FDA NEWS

EHRENSTEIN CHARBONNEAU ET AL

DERINGER LOGISTICS CONSULTING GROUP

SIDLEY AUSTIN LLP



PRO PUBLICA

COLOSI, JOSEPH A

COZEN O'CONNOR

01/31/2013

01/31/2013

01/31/2013

01/31/2013

01/31/2013

01/31/2013

01/31/2013

01/31/2013

01/31/2013

01/31/2013

01/31/2013

02/01/2013

03/01/2013

03/01/2013

03/01/2013

03/01/2013

03/01/2013

03/01/2013

03/01/2013

03/01/2013

03/01/2013

03/01/2013

03/01/2013

03/04/2013

2013-810

2013-811

2013-812

2013-813

2013-814

2013-815

2013-816

2013-817

2013-818

2013-819

2013-820

2013-821








OM/OSS/OPILS/DFI/

OM/OSS/OPILS/DFI/

OM/OSS/OPILS/DFI/

OM/OSS/OPILS/DFI/






ORA/OCI/

ORA/OCI/

CVM/OCD/

FDA/OGROP/ORA/CE-FO/NWJ-



Total Records: 212

of 22



FORTEO - NUMBER OF MEDWATCH RPTS FOR OSTEOSARCOMA, BONE CANCER

KARIM FIZAZI, INSTITUTE GUSTAVE-ROUSSY, VILLEJUIF, FRANCE - EIR (07/30/2012 - 08/03/2012)

WOLFGANG LOIDL, LINZ UROLOGIE ABTEILUNG, LINS, AUSTRIA - EIR (08/2012)

SAMPLE 661933 - ALL RECS

SUREPATH FLUID COLLECTION VIAL - FOI REQUESTS

DKT 2008P-0347

PHARMEDIUM SERVICES LLC - WARNING LTRS, APRVL RECS, INSPS, ETC 1/07 TO PRESENT

CENTRAL ADMIXTURE PHARMACY SERVICES INC, B BRAUN MEDICAL INC - WARNING LTRS, APRVL RECS, INSPS, ETC 1/07 TO PRESENT

Bobbie Sanderson

Rachel Johnson

Rachel Johnson

Becky Cooseman

CHARLOTTE VALLAEYS

REBECCA FIELD EMERSON

REBECCA FIELD EMERSON

Sanderson, Bobbie

FOI SERVICES INC

FOI SERVICES INC

Brown & Crouppen, PC

MINTZ GROUP

CORNUCOPIA INSTITUTE

MITTS LAW LLC

MITTS LAW LLC

02/01/2013

02/01/2013

02/01/2013

02/01/2013

02/01/2013

02/01/2013

02/01/2013

02/01/2013

03/04/2013

03/04/2013

03/04/2013

03/04/2013

03/04/2013

03/04/2013

03/04/2013

03/04/2013

2013-822

2013-823

2013-824

2013-825

2013-826

2013-827

2013-828

2013-829

DO/NWJ-CB/













ORA/

ORA/

OM/OSS/OPILS/DFI/

OM/OSS/OPILS/DFI/


OC/COS/OES/

OC/COS/OES/

OM/OMP/DODM/





ORA/

ORA/





ORA/

ORA/



Total Records: 212

of 22



JANSSEN PHARMA - TERAZOL 3 (TERCONAZOLE) VAGINALSUPPOSITORY NDA 19-641; PERRIGO NEW YORK - TERCONAZOLE VAGINAL SUPPOSITORY ANDA 77-149 SBA

NAMES OF ESTABLISHMENTS ENGAGED IN THE MANUFACTURE, PREPARATION, COMPOUNDING OF TOBACCO PRODS

HAIR STRAIGHTENER COSMETICS - CAERS 2000 TO PRESENT

OCTAPHARMA AB, STOCKHOLM, SWEDEN - 483 1/11

DKT 2012P-0566

CONKLIN COMPANY INC - EIR, 483, CO RESP 10/12

INDIVIDUAL RECS

AAI PHARMA SERVICES, EDISON, NJ - EIR 3/15/12; IRVINE PHARM SERVICES, IRVINE, CA - EIR 11/24/09, 4/2/12; NORTH AMERICAN SCIENCE ASSOC INC, IRVINE, CA - EIR 10/14/11; NORTH AMERICAN SCIENCE ASSOC, NORTHWOOD, OH - EIR 12/9/11

DKT FDA-1975-N-0355

RAVI DESHPANDE

DAVID C STEINBERG

WALTER E CHALKLEY

Lorraine Shelton

GLORIA GASKINS

ACINO PRODUCTS LLC

FOI SERVICES INC

STEINBERG & ASSOCIATES INC

CURTIN, DENNIS D

Empire State Consumer Project, Inc

THOMSON REUTERS

Doe J

Exova Inc.

KLEINFELD, KAPLAN & BECKER

02/01/2013

02/01/2013

02/01/2013

02/01/2013

02/01/2013

02/01/2013

02/01/2013

02/01/2013

02/01/2013

03/04/2013

03/04/2013

03/04/2013

03/04/2013

03/04/2013

03/04/2013

03/04/2013

03/04/2013

03/04/2013

2013-830

2013-831

2013-832

2013-833

2013-834

2013-835

2013-836

2013-837

2013-838





FDA/OMPT/CTP/OD/











OM/OMP/DODM/








OC/OM/OMP/DDM/



Total Records: 212

of 22



OTC VOLS. 160414, 160397ANGELIA SLAYTON

INC RESEARCH

02/01/2013

03/04/2013

2013-839 OC/OM/OMP/DDM/

disclosure foi request log date range from 01/28/2013 … · thursday february 7 2013 11:43 am ......

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