FDA FOIA Team Has Been Busy

The FDA processed roughly 12,000 FOIA requests in the last 12 months. That’s right, 12,000. 1,000 every month. About one every ten minutes that the office is open. So, it’s not surprising that there are 16 FDA employees with “government information” or “freedom of information” in their titles. And of course, so many FOI requests go beyond FOI staff. All the time spent tracking down documents, redacting confidential information, and doing database queries. For many of our requests related to 483s and EIRs, it is up to the district office staff to process the information – all of this on top of the day jobs.

Screen Shot 2015-06-24 at 12.07.46 PMIf you look through the list, there is an interesting array of requests and requestors. There are the usual suspects who do a lot of requesting (e.g. FDA news, FOI Services). And there’s also what you’d expect: reporters, law firms (watch out there!), and of course, industry.  Even though the table below is just 20 days of data, you can learn a lot about where a company is on their regulatory intelligence!

See this chart on the left – here’s the top 10 requesters of FDA FOI, by number of requests made in the last 12 months.

 

And here’s some of the most recent data. If you’d like to download the list, here’s the data we have: FDA FOIA REQUESTS May 2014 through May 2015 (it’s a big file…).

Recd Date Action Offices Requester Subject
05/01/2015 FDA/OC/OES/DFOI/ FDA NEWS WOCKHARD’S CHIKALTHANA PLANT – 483’S
05/01/2015 FDA/OC/OES/DFOI/ CAROLLO, RUSSELL 2012-2656, 2012-2510, 2012-927, ETC
05/01/2015 FDA/OMPT/CDER/ORP/DIDP/ FDA/OC/OES/DFOI/ PETER ANGELOS LAW OFC XARELTO -FOIA REQUESTS
05/01/2015 FDA/OMPT/CDER/ORP/DIDP/ LAW OFFICES   GREGORY J GREBE MORPHINE SULFATE – ISR 8762180, 9015676, 9995001, ETC
05/01/2015 FDA/OMPT/CDER/ORP/DIDP/ LAW OFFICES   GREGORY J GREBE SURAMORPH (MORPHINE SULFATE) – NDA 18-565 SBA
05/01/2015 FDA/OMPT/CDER/ORP/DIDP/ EAS CONSULTING GROUP LLC CYANOCOBOLAMIN INJ – ANDA 80-737 APRVL LTR, LBLG, CHEMISTRY RVW, ETC
05/01/2015 FDA/OMPT/CDER/ORP/DIDP/ EAS CONSULTING GROUP LLC VIBISONE – CYANOCOBOLAMIN INJ – ANDA 80-557 APRVL LTR, LBLG, CHEMISTRY RVW, ETC
05/01/2015 FDA/OMPT/CDER/ORP/DIDP/ EAS CONSULTING GROUP LLC CYANOCOBOLAMIN INJ – ANDA 87-967 APRVL LTR, LBLG, CHMISTRY RVW, ETC
05/01/2015 FDA/OGROP/ORA/SW-FO/DAL-DO/DAL-CB/ FDA NEWS TURNCO TOOL & INSTRUMENT INC, GEORGETOWN, TX – 483 3/28/14
05/01/2015 FDA/OMPT/CDRH/OCER/DFOI/ Keller and Heckman LLP 23ANDME PERSONAL GENOME SERVICE – CARRIER SCREENING TEST FOR BLOOM SYNDROME ORIGINAL REQUEST, ATTACHMENTS, SUBMISSIONS, ETC
01/05/2015 FDA/OFVM/CFSAN/OCD/EOS/ ERIC F GREENBERG PC BASF CORP – FCN 1285
01/16/2015 FDA/OMPT/CDRH/OCER/DFOI/ Grifols Inc, NOEL MCELVANEY, DUBLIN, IRELAND – 483 04/13/2014 – 05/08/2014
05/01/2015 FDA/OMPT/CDRH/OCER/DFOI/ FDA/OC/OES/DFOI/ HILL-ROM MAERSK MEDICAL LTD – K004028
05/01/2015 FDA/OMPT/CDER/ORP/DIDP/ APCER Pharma Solutions, Inc ANGIOMAX (BIVALIRUDIN) – AERS
05/01/2015 FDA/OMPT/CDER/ORP/DIDP/ Gary J McGarity, PharmD AMBIEN (ZOLPIDEM) – AERS
05/01/2015 FDA/OMPT/CDER/ORP/DIDP/ Doe J PAR PHARMACEUTICAL INC, SPRING VALLEY, NY – CHOLESTYRAMINE POWDER PACT CMPLNTS
05/01/2015 OC/ORA/ FDA/OGROP/ORA/PA-FO/SAN-DO/SAN-CB/ LAW OFC KEVIN R SCUDDER SLEEP SCIENCE PARTNERS INC (THE PURE SLEEP CO) – CMPLNT 139586
05/01/2015 FDA/OMPT/CDER/ORP/DIDP/ RADICE LAW FIRM PAR PHARMACUTICAL INC – DEXLANSOPRAZOLE ANDA 202-294 ROUTING SUMMARY, APRVL LTR
05/01/2015 FDA/OMPT/CDER/ORP/DIDP/ Wilson Sonsini Goodrich & Rosati PERRIGO – SCOPOLAMINE TRANSDERMAL THERAPEUTIC SYS ANDA 78-883 ACTAVIS – LIDOCAINE PATCH ANDA 200-675 APRVL PKG
05/01/2015 FDA/OMPT/CDER/ORP/DIDP/ SPORTS BUSINESS JOURNAL DR GRAY SMALL, DR JORGE BARRIO – INVESTIGATION CMPNT, CORR 2/15
05/01/2015 FDA/OC/OES/DFOI/ MERCK & CO., INC. 2015-2207
05/01/2015 FDA/OC/OES/DFOI/ MERCK & CO., INC. 2015-2007
01/16/2015 FDA/OC/OES/DFOI/ FOI Services, Inc. 2014-7048
05/01/2015 FDA/OC/OES/DFOI/ MERCK & CO., INC. 2015-1753
05/01/2015 FDA/OMPT/CDER/ORP/DIDP/ GOODWIN PROCTER LLP 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
05/01/2015 FDA/OC/OES/DFOI/ MERCK & CO., INC. 2015-1710
05/01/2015 FDA/OC/OES/DFOI/ MERCK & CO., INC. 2015-1524
05/01/2015 FDA/OC/OES/DFOI/ MERCK & CO., INC. 2015-1647
05/01/2015 FDA/OC/OES/DFOI/ MERCK & CO., INC. 2015-886
05/01/2015 FDA/OC/OES/DFOI/ MERCK & CO., INC. 2015-2522
05/01/2015 FDA/OC/OES/DFOI/ MERCK & CO., INC. 2015-2533
05/01/2015 FDA/OC/OES/DFOI/ MERCK & CO., INC. 2015-883
05/01/2015 FDA/OGROP/ORA/SW-FO/DEN-DO/DEN-CB/ FDA/OGROP/ORA/CE-FO/DET-DO/DET-CB/ LEITNER WILLIAMS ET AL NUTRA BALANCE, INDIANAPOLIS, IN – EIRS, RESULTS, ENFORCEMENT RPTS 6/13 TO 6/14
01/16/2015 FDA/OC/OES/DFOI/ FOI Services, Inc. 2014-7059
05/01/2015 FDA/OC/OES/DFOI/ MERCK & CO., INC. 2015-2491
05/01/2015 FDA/OMPT/CDER/ORP/DIDP/ FOI Services, Inc. NDA 202971 S 3
05/01/2015 FDA/OMPT/CDER/ORP/DIDP/ G&W Laboratories, Inc. NDA 050600 SBA
05/01/2015 FDA/OMPT/CDER/ORP/DIDP/ THOMSON REUTERS (SCIENTIFIC) SAS BLA 125057/062
05/01/2015 FDA/OMPT/CDER/ORP/DIDP/ UNIVERSITY OF KENTUCKY NDA 18276
05/01/2015 FDA/OMPT/CDER/ORP/DIDP/ Kinex Pharmaceuticals Inc. ANDA 076131 S 000
05/01/2015 FDA/OMPT/CDER/ORP/DIDP/ FOI Services, Inc. BOROSILICATE VIALS – DELAMINATION, LAMELLAE, DATA, REPORTS ETC
05/01/2015 OC/ORA/ FDA/OGROP/ORA/CE-FO/BLT-DO/BLT-CB/ Doe J DIET COKE – CMPLNT 140139
05/01/2015 FDA/OMPT/CDER/ORP/DIDP/ Dr. Reddy’s Laboratories Inc. ANDA 090218 SBA
05/01/2015 FDA/OMPT/CDER/ORP/DIDP/ Eli Lilly and Company – Global Patient Safety NDA 206538
01/16/2015 FDA/OC/OES/DFOI/ FOI Services, Inc. 2014-7062
05/01/2015 FDA/OMPT/CDER/ORP/DIDP/ Hyman, Phelps & McNamara P.C. ARROW PHARMACEUTICALS LTD, AUSTRALIA – INSPECTION RECS JUNE 2008
05/01/2015 FDA/OMPT/CDER/ORP/DIDP/ WebMD OSE reviews related to oxymorphone (Opana ER) and the medical complication thrombotic microangiopathy (TMA)
05/01/2015 FDA/OMPT/CDER/ORP/DIDP/ Samip Patel – Inox Consulting Services WOCKHARDT LIMITED, INDIA – EIR, 483 09/02/2014 – 04/28/2015
05/01/2015 FDA/OGROP/ORA/CE-FO/CIN-DO/CIN-CB/ YSI Incorporated YSI INCORPORATED,   YELLOW SPRINGS, OH – EIR 03/01/2014 – 12/31/2014
05/01/2015 FDA/OMPT/CDER/ORP/DIDP/ INC RESEARCH SBA 202608
05/01/2015 FDA/OFVM/CFSAN/OCD/EOS/ Steve Heim Process Validation study submitted to FDA for HPP- High Hydrostatic Pressure Processing for packaged as Pouched or Cup Applesauce
05/01/2015 FDA/OMPT/CDER/ORP/DIDP/ Aerie Pharmaceuticals Inc. NDA 21214 S 6, S 7 – SBA
05/01/2015 FDA/OMPT/CDER/ORP/DIDP/ Synthon Pharmaceuticals ANDA 90218
05/01/2015 FDA/OMPT/CDER/ORP/DIDP/ Seattle Children’s Hospital Research Foundation AUVI-Q, EPIPEN, EPIPEN JR – ADRENACLICK STABILITY
05/01/2015 FDA/OGROP/ORA/SE-FO/ATL-DO/ATL-CB/ Duke University Ethics and Compliance Office ASHWIN PATKAR, DURHAM, NC – CLOSE OUT LETTER
01/16/2015 FDA/OC/OES/DFOI/ FOI Services, Inc. 2014-7734
05/01/2015 FDA/OMPT/CBER/OCOD/DDOM/ALFB/ OC/ORA/ FDA/OGROP/ORA/SE-FO/FLA-DO/FLA-CB/ Global Biotech Experts, LLC BIOTEST – WARNING LETTER, CLOSE OUT LETTERS 01/01/2005 – 04/01/2015
05/01/2015 FDA/OMPT/CDER/ORP/DIDP/ Keck Graduate Institute of Applied Life Sciences ANDA 062349
05/01/2015 FDA/OMPT/CDER/ORP/DIDP/ Ag Conexus, Inc. ONDANSETRON – AERS
05/01/2015 OC/ORA/ INTERNATIONAL BOTTLED WATER ASSOCIATION DELEGATION AGREEMENT BETWEEN FDA AND COMMONWEALTH OF PENNSYLVANIA FOR ENFORCEMENT OF FSMA 01/01/2011 – 04/30/2015
05/01/2015 FDA/OMPT/CDER/ORP/DIDP/ LACHMAN CONSULTANT SERVICES, INC. NDA 20430, NDA 000552, NDA 013304 ETC – CMC SUPPLEMENT UNREDACTED
05/01/2015 FDA/OFVM/CFSAN/OCD/EOS/ Faces By Design FACT SHEET RE TATTOOS 01/01/1995 – 01/01/1996
05/01/2015 FDA/OMPT/CDRH/OCER/DFOI/ CytoVale DEN140019
05/01/2015 FDA/OC/OES/DFOI/ MERCK & CO., INC. FOI DAILY LOG   4/1-30/2015
05/01/2015 FDA/OC/OES/DFOI/ MERCK & CO., INC. CLOSED FOIA REQUESTS 4/1-30/2015
05/01/2015 FDA/OMPT/CBER/OCOD/DDOM/ALFB/ Doe J VAERS RECS
01/16/2015 FDA/OMPT/CDER/ORP/DIDP/ Dr. Reddy’s Laboratories Inc. NDA 203159 GENERIC BE GUIDANCE
05/01/2015 FDA/OMPT/CDRH/OCER/DFOI/ Anngela Beaudoin ESSURE FIVE YEAR REVIEW
05/01/2015 FDA/OMPT/CDER/ORP/DIDP/ DeMarco, Jacqueline ZOFRAN – AERS
05/01/2015 FDA/OMPT/CDER/ORP/DIDP/ UPPC HALOPERIDOL NON INJECTABLE – MONOGRAPH
05/01/2015 FDA/OMPT/CDRH/OCER/DFOI/ ICON CLINICAL RESEARCH K090224
05/01/2015 OC/ORA/ FDA/OGROP/ORA/CE-FO/CIN-DO/CIN-CB/ Zetetic, Inc. AEK-0186764-4
05/01/2015 FDA/OFVM/CFSAN/OCD/EOS/ AkzoNobel Packaging Coatings DOW CHEMICAL CO – FCN 1095 MALEIC ANHYDRIDE GRAFED POLYROYLENE
05/01/2015 FDA/OC/OPP/OP/ FDA/OMPT/CBER/OCOD/DDOM/ALFB/ FOI Services, Inc. MTG BETWEEN FDA AND ORGANOGENESIS – EMAIL, MINUTES, PRESENTATIONS
05/01/2015 FDA/OMPT/CTP/OD/ FOI Services, Inc. THIRD TRILATERAL MEETING ON TOBACCO AND REGULATION – AGENDA, ROSTER, NOTES ETC
05/04/2015 FDA/OMPT/CDRH/OCER/DFOI/ SI-TECHNOLOGY, LLC K150017, K150714
05/04/2015 FDA/OMPT/CDRH/OCER/DFOI/ BioSig Technologies K110878
01/16/2015 FDA/OMPT/CDER/ORP/DIDP/ PFIZER XALATAN – SBA
05/04/2015 FDA/OMPT/CDRH/OCER/DFOI/ RESMED CORP K143646
05/04/2015 FDA/OMPT/CDRH/OCER/DFOI/ RESMED CORP K140575
05/04/2015 FDA/OMPT/CDRH/OCER/DFOI/ FOI Services, Inc. K960777
05/04/2015 FDA/OMPT/CDRH/OCER/DFOI/ FOI Services, Inc. K100049
05/04/2015 OC/ORA/ FDA/OGROP/ORA/SW-FO/DAL-DO/DAL-CB/ HOUSTON CHRONICLE BLUE BELL CREAMERIES – 483 01/01/2005 – 05/01/2015
05/04/2015 FDA/OMPT/CDER/ORP/DIDP/ United BioSource Corporation FDA AERS 8967754 9186133 9314001 9513408 9513490
05/04/2015 FDA/OMPT/CDRH/OCER/DFOI/ RESMED CORP K140980
05/04/2015 FDA/OMPT/CDRH/OCER/DFOI/ RESMED CORP K142988
05/04/2015 FDA/OMPT/CDER/ORP/DIDP/ ADVERSEEVENTS INC ALIMTA, AVASTIN, GILOTRIF ETC – AERS 10/01/2014 – 05/01/2015
05/04/2015 FDA/OMPT/CDER/ORP/DIDP/ Intarcia Therapeutics, Inc NDA 21919, NDA: 22200 GENOTOXICITY STUDIES
01/16/2015 FDA/OGROP/ORA/SE-FO/FLA-DO/FLA-CB/ FDA/OC/OES/DFOI/ Smart, Ben NATURE’S PRODUCT INC, SUNRISE, FL – EIR, 483, CORR ETC 06/01/2007 – 12/21/2014
05/04/2015 FDA/OMPT/CDRH/OCER/DFOI/ MEDTRONIC MAGUET CARDIOPULMONARY SET – JOSTRA HLM TUBING SET K053025
05/04/2015 FDA/OMPT/CDER/ORP/DIDP/ Celgene Corporation IVAN BUNGANIC, GASTROENTEROLO AMBULANCIA MUCO, PRESOV, SVK – 483 9/12 TO 4/15
05/04/2015 FDA/OMPT/CDER/ORP/DIDP/ UNIVERSITY OF CALIFORNIA DAVIS NICLOSAMIDE – PHARMACOLOGY, TOXICOLOGY STUDY
05/04/2015 FDA/OC/OES/DFOI/ Zuniga, P CATARACTS, ALTERNATIVE AND CONVENTIONALTREATMENTS FOR CATARACTS AND CATARACT LENS REPLACEMENT SURGERY
05/04/2015 FDA/OMPT/CDER/ORP/DIDP/ FOLEY & LARDNER LLP FRESENIUS KABI USA – XYLOCAINE (LIDOCAINE HCL) NDA 06-488 APRVL RECS
05/04/2015 FDA/OMPT/CDER/ORP/DIDP/ BAHRIJCZUK, TAYLOR NEXPLANON   IMPLANON – AERS
05/04/2015 FDA/OMPT/CDER/ORP/DIDP/ MORRISON MAHONEY LLP BIOLOGENE LLC – IND 108281 MTG MINS, CORR, RPTS, ETC
05/04/2015 FDA/OMPT/CDRH/OCER/DFOI/ ANGIODYNAMICS INC DIOMED INC – EVLT KIT D15 PLUS & D30 PLUS DLODE LASERS K023543
05/04/2015 OC/CVM/OCD/ JENNIFER C PRATT PLLC PROHEART 6 – CMPLNTS, RECALL RECS, APRVL, ETC
05/05/2015 FDA/OO/OHR/ WRITTEN DEPOSITION SERVICE LLC INDIVIDUAL RECS
01/16/2015 FDA/OMPT/CDER/ORP/DIDP/ PFIZER MELATONIN, WARFARIN – DDI RECS
05/05/2015 FDA/OMPT/CDER/ORP/DIDP/ MAPI USA INC RESERPINE TABS NDA 98-859, CHLORPROMAZINE HCI TABS NDA 85-331 – RECS
05/05/2015 FDA/OGROP/OIP/ HARRISON PENSA LLP HOFFMANN-LA ROCHE – ACCUTANE RECS
05/05/2015 FDA/OC/OES/DFOI/ CAROLLO, RUSSELL 2012-2656, 2012-2510, 2012-927, ETC
05/05/2015 FDA/OMPT/CDER/ORP/DIDP/ SHEPPARD MULLIN RICHTER & HAMPTON, LLP PARENTERAL IRON AND ANAPHYLACTOID – MINI-SENTINEL ASSESMENT PROTOCOL FINAL RPT
05/05/2015 OC/ORA/ OC/ORA/ORM/ University of Passau, Bavaria, Germany WARNING LETTER CLOSEOUT DATES
05/05/2015 FDA/OMPT/CDER/ORP/DIDP/ Willow Run Advisors, LLC PATHEON, MONZA, ITALY – 483, WARNING LETTERS 01/01/2013 – 04/30/2015
05/05/2015 FDA/OMPT/CDRH/OCER/DFOI/ BioTex, Inc. K021176
05/05/2015 FDA/OMPT/CDRH/OCER/DFOI/ BioTex, Inc. K093223
05/05/2015 FDA/OMPT/CDRH/OCER/DFOI/ BioTex, Inc. K081151
05/05/2015 FDA/OC/OES/DFOI/ FDA/OGROP/ORA/PA-FO/SEA-DO/SEA-CB/ WASHINGTON INFORMATION SOURCE 2014-10001, 2014-10005, 2014-10022, ETC
01/16/2015 FDA/OC/OES/DFOI/ FOI Services, Inc. 2014-7044
05/05/2015 FDA/OMPT/CDER/ORP/DIDP/ Govzilla, Inc. CANGENE, WINNIPEG, CANADA – 483, EIR 01/26/2015 – 02/03/2015
05/05/2015 FDA/OGROP/ORA/CE-FO/CHI-DO/CHI-CB/ Rush University Medical Center DEMETRIUS LOPES, MD – EIR 01/01/2003 – 01/01/2004
05/05/2015 FDA/OC/OES/DFOI/ FDA/OGROP/ORA/CE-FO/PHI-DO/PHI-CB/ USA TODAY CUSTOM ULTRASONICS – CEASE AND DESIST ORDER 9/12 483S 5/26/10, 1/26/12/ 11/8/12
05/05/2015 FDA/OMPT/CDER/ORP/DIDP/ Precision Health Economics ORANGE BOOK DATA 01/01/2000 – 05/01/2015
05/05/2015 FDA/OC/OES/DFOI/ WOLTERS KLUWER LAW & BUSINESS CLOSED FOI REQUESTS 4/13-17/15
05/05/2015 FDA/OC/OES/ FDA/OFVM/CFSAN/OCD/EOS/ OC/CVM/OCD/ Buzzfeed News COMMUNICATIONS AND DATA SHARED BETWEEN FDA AND EPA UNDER MOU RE PESTICIDES AND TOXIC SUBSTANCES 03/03/2015 – 05/01/2015
05/05/2015 FDA/OC/OES/DFOI/ FDA REVIEW/FDA WEBVIEW CLOSED FOI REQUEST 4/13-17/15
05/05/2015 FDA/OC/OES/DFOI/ JH BARR & ASSOCIATES LLC CLOSED ROI REQUESTS 4/13-17/15
05/05/2015 FDA/OC/OES/DFOI/ WOLTERS KLUWER LAW & BUSINESS CLOSED FOI REQUESTS 4/6-10/15
05/05/2015 FDA/OC/OES/DFOI/ FDA REVIEW/FDA WEBVIEW CLOSED FOI REQUESTS 4/6-10/15
01/05/2015 FDA/OFVM/CFSAN/OCD/EOS/ ERIC F GREENBERG PC NALCO – FCN 1277
01/16/2015 FDA/OGROP/ORA/CE-FO/CIN-DO/CIN-CB/ RADIANT RESEARCH RADIANT RESEARCH, CINCINNATI, OH – EIR 12/01/2013 – 07/31/2014
05/05/2015 FDA/OC/OES/DFOI/ JH BARR & ASSOCIATES LLC CLOSED FOI REQUESTS 4/6-10/15
05/05/2015 FDA/OC/OES/DFOI/ WOLTERS KLUWER LAW & BUSINESS CLOSED FOI REQUESTS 3/30/15-4/3/15
05/05/2015 FDA/OC/OES/DFOI/ FDA REVIEW/FDA WEBVIEW CLOSED FOI REQUESTS 3/30/15-4/3/15
05/05/2015 FDA/OC/OES/DFOI/ JH BARR & ASSOCIATES LLC CLOSED FOI REQUESTS 3/30/15-4/3/15
05/05/2015 FDA/OC/OES/DFOI/ FOI Services, Inc. CLOSED FOI REQUESTS 3/30/15-4/3/15
05/05/2015 FDA/OC/OES/DFOI/ FOI Services, Inc. CLOSED FOI REQUESTS 4/6-10/15
05/05/2015 FDA/OC/OES/DFOI/ FOI Services, Inc. CLOSED FOI REQUESTS 4/13-17/15
05/05/2015 FDA/OMPT/CTP/OD/ King & Spalding LLP TRADE COMPLAINT RECS 14F00017 7/9/2014, 14G00004 7/9/2014 14G00005 7/9/2014, ETC
05/05/2015 FDA/OMPT/CDRH/OCER/DFOI/ SI-TECHNOLOGY, LLC K112595
05/05/2015 FDA/OMPT/CDRH/OCER/DFOI/ SI-TECHNOLOGY, LLC K122226, K111479, K103072
01/16/2015 FDA/OGROP/ORA/SW-FO/KAN-DO/KAN-CB/ Donald C. Barrett, P.A. LYNN PEAVEY COMPANY – WARNING LETTER RECS
05/05/2015 FDA/OMPT/CDER/ORP/DIDP/ Riconpharma LLC ORANGE BOOK ANNUAL 34TH EDITION
05/05/2015 FDA/OMPT/CDER/ORP/DIDP/ PharmaCompany, Inc NDA 206229
05/05/2015 FDA/OMPT/CDER/ORP/DIDP/ PROPUBLICA FERTILITY DRUGS AERS
05/05/2015 FDA/OMPT/CDER/ORP/DIDP/ UNIVERSITY OF WASHINGTON MEDICAL CENTER KADCYLA – AERS
05/05/2015 FDA/OMPT/CDER/ORP/DIDP/ PROPUBLICA ISR 5500699, 6115627, 6121983, ETC
05/05/2015 FDA/OMPT/CDRH/OCER/DFOI/ BioTex, Inc. K955841
05/05/2015 FDA/OMPT/CDRH/OCER/DFOI/ BioTex, Inc. K000068
05/05/2015 FDA/OMPT/CDRH/OCER/DFOI/ BioTex, Inc. K003175
05/05/2015 FDA/OGROP/ORA/CE-FO/MIN-DO/MIN-CB/ DreamPak, LLC DREAMPAK, LCC, NEW BERLIN, WI – EIR 03/09/2015 – 03/10/2015
05/05/2015 FDA/OGROP/ORA/CE-FO/CHI-DO/CHI-CB/ FDA/OMPT/CDRH/OCER/DFOI/ Schmittgens Jr, Eugene   P ROBOTIC ASSISTED SURGERIES AT ADVOCATE SOUTH SURBAN HOSPITAL, HAZEL CREST, IL – INCIDENT REPORTS 01/01/2014 – 05/04/2015
01/16/2015 FDA/OMPT/CDER/ORP/DIDP/ THE OHIO STATE UNIVERSITY NDA DATA 01/04/1990 – 01/15/2015
05/05/2015 FDA/OMPT/CDRH/OCER/DFOI/ BioTex, Inc. K072201
05/05/2015 FDA/OMPT/CDRH/OCER/DFOI/ UNIVERSITY OF CINCINNATI K140929
05/05/2015 FDA/OGROP/ORA/SE-FO/ATL-DO/ATL-CB/ Govzilla, Inc. CATALENT PHARMA SOLUTIONS, LLC, MORRISVILLE, NC – 483, EIR 03/16/2015 – 03/20/2015
05/05/2015 FDA/OMPT/CDRH/OCER/DFOI/ BioTex, Inc. K033052
05/05/2015 FDA/OMPT/CDRH/OCER/DFOI/ BioTex, Inc. K051085
05/05/2015 FDA/OMPT/CDRH/OCER/DFOI/ BioTex, Inc. K040194
05/05/2015 FDA/OMPT/CDER/ORP/DIDP/ Zydus Pharmaceuticals USA Inc. ANDA 074132, ANDA 074234, ANDA 073553 SBA
05/06/2015 FDA/OMPT/CDRH/OCER/DFOI/ EyeReg Consulting Inc. K143280
05/06/2015 FDA/OMPT/CDER/ORP/DIDP/ CBS NEWS DROSPIRENONE-BASED BIRTH CONTROL PILLS, PROGESTIN-BASED BIRTH CONTROL PILLS – AERS
05/06/2015 FDA/OMPT/CDRH/OCER/DFOI/ MEDTRONIC SOFAMOR DANEK K142203
01/16/2015 FDA/OMPT/CDRH/OCER/DFOI/ Avalere Health GUDID DATABASE FOR INFUSION PUMPS
05/06/2015 FDA/OMPT/CDRH/OCER/DFOI/ FDA/OC/OES/DFOI/ MEDTRONIC SOFAMOR DANEK K031482
05/06/2015 FDA/OMPT/CDER/ORP/DIDP/ BOEHRINGER INGELHEIM PHARMACEUTICALS, INC. BLA 125477/S-007
05/06/2015 FDA/OGROP/ORA/PA-FO/SEA-DO/SEA-CB/ Oregon Nurses Assoication PUGET SOUND BLOOD CENTER – 483, CORR 01/01/2014 – 05/05/2015
05/06/2015 FDA/OGROP/ORA/CE-FO/CHI-DO/CHI-CB/ DEPOMED INC MORTON GROVE PHARMACEUTICALS, MORTON GROVE, IL – EIR 03/26/2014 – 05/05/2015
05/06/2015 FDA/OMPT/CDER/ORP/DIDP/ ARIAD Pharmaceuticals, Inc. ICLUSIG – AERS
05/06/2015 FDA/OGROP/ORA/SE-FO/SJN-DO/SJN-CB/ Arnall Golden Gregory LLP (on behalf of Customed, Inc.) CUSTOMED – MEETING MINUTES, NOTES 03/12/2015 – 04/17/2015
05/06/2015 FDA/OMPT/CDER/ORP/DIDP/ TUDUJ M05570, TOM FORFIVO XL – AERS
05/06/2015 FDA/OMPT/CDER/ORP/DIDP/ TUDUJ M05570, TOM ADVAIR – AERS
05/06/2015 FDA/OMPT/CDER/ORP/DIDP/ TUDUJ M05570, TOM AVANDIA – AERS
05/06/2015 FDA/OMPT/CDER/ORP/DIDP/ TUDUJ M05570, TOM PAXIL CR – AERS
01/16/2015 FDA/OGROP/ORA/PA-FO/LOS-DO/LOS-CB/ OASIS Medical Inc. OASIS MEDICAL INC – EIR 04/11/2014 – 09/30/2014
05/06/2015 FDA/OMPT/CDER/ORP/DIDP/ TUDUJ M05570, TOM PAXIL – AERS
05/06/2015 FDA/OMPT/CDER/ORP/DIDP/ TUDUJ M05570, TOM ZOLPIDEM – AERS
05/06/2015 FDA/OMPT/CDER/ORP/DIDP/ TUDUJ M05570, TOM PROPRANOLOL – AERS
05/06/2015 FDA/OMPT/CDER/ORP/DIDP/ TUDUJ M05570, TOM AMBIEN – AERS
05/06/2015 FDA/OMPT/CDER/ORP/DIDP/ TUDUJ M05570, TOM AMBIEN CR – AERS
05/06/2015 FDA/OMPT/CDER/ORP/DIDP/ TUDUJ M05570, TOM BUPROPION – AERS
05/06/2015 FDA/OMPT/CDER/ORP/DIDP/ TUDUJ M05570, TOM WELLBUTRIN – AERS
05/06/2015 FDA/OMPT/CDER/ORP/DIDP/ TUDUJ M05570, TOM WELLBUTRIN SR – AERS
05/06/2015 FDA/OMPT/CDER/ORP/DIDP/ TUDUJ M05570, TOM WELLBUTRIN XL
05/06/2015 FDA/OMPT/CDER/ORP/DIDP/ TUDUJ M05570, TOM ST JOHN’S WORT – AERS
01/16/2015 FDA/OMPT/CDER/ORP/DIDP/ Jeanie Ward POLYETHYLENE GLYCOL – ADVERSE EVENTS
05/06/2015 FDA/OMPT/CDRH/OCER/DFOI/ Fresenius Medical Care North America DEKA RESEARCH & DEVELOPMENT CORP, MANCHESTER NH – AMIA AUTOMATED PD SYS K124018
05/06/2015 FDA/OMPT/CDER/ORP/DIDP/ SUPERNUS PHARMACEUTICALS INC TOPAMAX (TOPIRAMATE) – ISRS 4502937-1, 6120398-6, 7161594-9, ETC
05/06/2015 FDA/OMPT/CBER/OCOD/DDOM/ALFB/ FDA/OMPT/CDER/ORP/DIDP/ SOPER E-94630, STEPHEN AFLURIA, ERBITUX – PROD MOLNOGRAPH, AERS 2/12/13 TO 2/13/15
05/06/2015 FDA/OGROP/ORA/CE-FO/CIN-DO/CIN-CB/ STEVENSON, JEFFREY E UNCLE JESTER’S FINE FOODS LLC – EIRS 3/15 TO 4/15
05/06/2015 FDA/OGROP/ORA/CE-FO/NWJ-DO/NWJ-CB/ LAW OFC PATRICIA R CARLEY LLC CORE PHARMA LLC, MIDDLESEX, NJ – MSDS SHEETS, ACCIDENTS, INVESTIGATIONS, ETC 2014, 2015
05/06/2015 FDA/OFVM/CFSAN/OCD/EOS/ IOVATE HEALTH SCIENCES INTERNATIONAL INC IOVATE, HYDROXYCUT, SMARTBURN, ETC – CAERS 2/\3/15 TO PRESENT
05/06/2015 OC/CVM/OCD/ PULLMAN, CRAIG MOLNSANTO’S SEPTEMBER 2 SUBMISSION PAGE 49
05/06/2015 FDA/OFVM/CFSAN/OCD/EOS/ INTERTEK REGULATORY SERVICES FRAUNHOFER INSTITUT VERFAHRENSTECHNIK UND VERPACKUNG (LUIGI BANDERA SPA) – POLYETHYLENE TEREPHTHALATE (PET) FCN 119
05/06/2015 FDA/OMPT/CDRH/OCER/DFOI/ TaiDoc Technology Corp. CPT1400457, GEN1400371, CPT1400361
05/06/2015 FDA/OGROP/ORA/SE-FO/NOL-DO/NOL-CB/ FDA/OGROP/ORA/SW-FO/KAN-DO/KAN-CB/ General Mills- QRO GENERAL MILLS, CARLISLE, IA MURFREESBORO, TN – EIR, 483, ETC
01/16/2015 FDA/OGROP/ORA/CE-FO/CIN-DO/CIN-CB/ RADIANT RESEARCH RADIANT RESEARCH, CINCINNATI, ON – EIR 02/01/2014 – 12/31/2014
05/06/2015 OC/ORA/ FDA/OGROP/ORA/ORO/DIOP/ Zetetic, Inc. IMPORT DATA 4/16/15 – 4/30/15
05/06/2015 FDA/OMPT/CDRH/OCER/DFOI/ Talariant K063304
05/06/2015 FDA/OMPT/CDER/ORP/DIDP/ Blau, Jenny E CANAGLIFLOZIN, DAPAGLIFLOZIN, EMPAGLIFLOZIN – AERS
05/06/2015 FDA/OC/OES/DFOI/ FOI Services, Inc. 2014-9550
05/07/2015 FDA/OC/OES/DFOI/ FOI Services, Inc. 2015-312
05/07/2015 FDA/OC/OES/DFOI/ FOI Services, Inc. 2015-1455
05/07/2015 FDA/OC/OES/DFOI/ FOI Services, Inc. 2014-5840
05/07/2015 FDA/OC/OES/DFOI/ FOI Services, Inc. 2014-7820
05/07/2015 FDA/OC/OES/DFOI/ FOI Services, Inc. 2014-9024
05/07/2015 FDA/OC/OES/DFOI/ FOI Services, Inc. 2012-4168
01/16/2015 FDA/OMPT/CDER/ORP/DIDP/ Susquehanna Financial Group ANDA AWAITING OGD ACTION
05/07/2015 FDA/OC/OES/DFOI/ FOI Services, Inc. 2012-4230
05/07/2015 FDA/OC/OES/DFOI/ FOI Services, Inc. 2013-10022
05/07/2015 FDA/OC/OES/DFOI/ FOI Services, Inc. 2014-2190
05/07/2015 FDA/OC/OES/DFOI/ FOI Services, Inc. 2014-5803
05/07/2015 FDA/OC/OES/DFOI/ FOI Services, Inc. 2014-4624
05/07/2015 FDA/OC/OES/DFOI/ FOI Services, Inc. 2014-8639
05/07/2015 FDA/OC/OES/DFOI/ FOI Services, Inc. 2014-8640
05/07/2015 FDA/OC/OES/DFOI/ FOI Services, Inc. 2014-8475
05/07/2015 FDA/OC/OES/DFOI/ FOI Services, Inc. 2014-5549
05/07/2015 FDA/OC/OES/DFOI/ FOI Services, Inc. 2012-2028
01/16/2015 FDA/OMPT/CDER/ORP/DIDP/ LUPIN PHARMACEUTICALS INC KERYX BIOPHARMS – AURYXIA (FERRIC CITRATE) TABS 210 MG NDA 205-874 SBA
05/07/2015 FDA/OC/OES/DFOI/ FOI Services, Inc. 2014-8210
05/07/2015 FDA/OC/OES/DFOI/ FOI Services, Inc. 2015-877
05/07/2015 FDA/OC/OES/DFOI/ FOI Services, Inc. 2015-984
05/07/2015 FDA/OC/OES/DFOI/ FOI Services, Inc. 2014-9023
05/07/2015 OC/ORA/ Endevr Inc ENTRY 277-0143296-8
05/07/2015 FDA/OMPT/CDRH/OCER/DFOI/ Memphis Regulatory Consulting, LLC K864492
05/07/2015 FDA/OMPT/CDER/ORP/DIDP/ ADVERSEEVENTS INC LANOXIN – AERS
05/07/2015 FDA/OGROP/ORA/NE-FO/NWE-DO/NWE-CB/ FOI Services, Inc. ASSOCIATES OF CAPE COD, EAST FALMOUTH, MA – EIR, 43
05/07/2015 FDA/OGROP/ORA/SE-FO/FLA-DO/FLA-CB/ Precision Research Organization LLC CIRO REYES, MD, MIAMI LAKES, FL – 483 03/24/2015 – 05/05/2015
05/07/2015 FDA/OMPT/CDER/ORP/DIDP/ FDA/OFVM/CFSAN/OCD/EOS/ FOI Services, Inc. KRATOM, MITRAGYNA, VIVAZEN – AERS
01/16/2015 FDA/OGROP/ORA/PA-FO/LOS-DO/LOS-CB/ FDA/OGROP/ORA/SE-FO/FLA-DO/FLA-CB/ FDA/OGROP/ORA/SE-FO/NOL-DO/NOL-CB/ PAYNE & FEARS GEMSA ENTERPRISES LLC, ITALCAL TRADING CO, EMILIO VISCOMI, ETC – INVESTIGATION RECS 1/1/10 TO PRESENT
05/07/2015 OC/ORA/ OC/ORA/ORM/ University of Passau, Bavaria, Germany CLOSE OUT LETTER DATA 01/01/2004 – 09/01/2009
05/07/2015 FDA/OC/OES/DFOI/ EATALIA Fine Foods LLC BELGIAN CONDIMENT SAUCES
05/07/2015 FDA/OC/OES/DFOI/ FDA/OMPT/CDER/ORP/DIDP/ Allen FLUORIDE RECS
05/07/2015 OC/ORA/ FDA/OGROP/ORA/CE-FO/CIN-DO/CIN-CB/ Doe J INDIVIDUAL RECS
05/07/2015 FDA/OMPT/CDER/ORP/DIDP/ Greenville Health System PACIRA PHARMACEUTICALS – RESPONSE LETTER, ACKNOWLEDGEMENT OF RESPONSE 09/23/2014 – 05/06/2015
05/07/2015 FDA/OMPT/CDRH/OCER/DFOI/ Medionics International Inc. MEDIONICS INTERNATIONAL, CANADA – EIR 06/22/2009 – 06/25/2009
05/07/2015 FDA/OC/OES/DFOI/ FDA/OMPT/CDER/ORP/DIDP/ Accucaps Industries Limited API MANUFACTURER EIR 07/01/2012 – 05/06/2015
05/07/2015 FDA/OMPT/CDRH/OCER/DFOI/ Bloomberg Businessweek FDA ACTION RELATED TO PRODUCTS DETERMINED TO BE MEDICAL DEVICES THAT ARE BEING MARKETED WITHOUT 510K 01/01/2010 – 05/07/2015
05/07/2015 FDA/OGROP/ORA/PA-FO/LOS-DO/LOS-CB/ Neil Wallace DR JESSE ANDREW STOFF – 483 01/01/1980 – 12/31/2000
05/07/2015 FDA/OMPT/CDRH/OCER/DFOI/ Varun Bhardwaj EARGO, INC – APPROVAL RECS 01/01/2013 – 05/06/2015
01/05/2015 FDA/OGROP/ORA/CE-FO/CHI-DO/CHI-CB/ Marathon Pharmaceuticals, LLC MARATHON PHARMACEUTICALS, LLC, DEERFIELD, IL – EIR 1/30/13
01/16/2015 OC/ORA/ORM/ FDA NEWS LISTING OF 483’S NOTICES FOR PHARMACEUTICAL, BIOLOGICS & MEDICAL DEVICE MFG, CLNCL TRIAL FACILITIES IN US & OUTSIDE US 12/1-31/14
05/07/2015 OC/ORA/ FDA/OGROP/ORA/ORO/DIOP/ FDA/OGROP/ORA/CE-FO/NWJ-DO/NWJ-CB/ FDA/OGROP/ORA/NE-FO/NYK-DO/NYK-DCB/ FDA/OGROP/ORA/SE-FO/FLA-DO/FLA-CB/ Diserio Martin O’Connor & Castiglioni, LLP TIMITE AND SONS, TIMITE AND SONS BEAUTY SUPPLY, WORLD BEAUTY SUPPLY ETC – FDA IMPORT NOTICES ETC 01/01/2008 – 05/06/2015
05/07/2015 FDA/OMPT/CDER/ORP/DIDP/ POLICHEM SA ANDA 077623
05/07/2015 FDA/OGROP/ORA/NE-FO/NWE-DO/NWE-CB/ THOMSON REUTERS (SCIENTIFIC) SAS AGILUX LABORATORIES, WORCESTER, MA – EIR, 483, RESPONSE 07/01/2013 – 07/31/2013
05/07/2015 FDA/OGROP/ORA/PA-FO/LOS-DO/LOS-CB/ THOMSON REUTERS (SCIENTIFIC) SAS INTERTEK USA, INC, SAN DIEGO, CA – EIR, 483, RESPONSE 09/01/2012 – 09/30/2012
05/07/2015 FDA/OGROP/ORA/CE-FO/CIN-DO/CIN-CB/ THOMSON REUTERS (SCIENTIFIC) SAS CHANTEST CORPORATION, CLEVELAND, OH – EIR, 483, RESPONSE 06/01/2013 – 06/30/2013
05/07/2015 FDA/OMPT/CDRH/OCER/DFOI/ quanta system spa K111303, K111851
05/07/2015 FDA/OMPT/CDER/ORP/DIDP/ AOP ORPHAN PHARMACEUTICALS AG NDA 20-333/S-013 FDA ASSESSMENT OF 2 YEAR RAT STUDY
05/07/2015 FDA/OGROP/ORA/SW-FO/DAL-DO/DAL-CB/ THOMSON REUTERS (SCIENTIFIC) SAS TEXAS BIOMEDICAL RESEARCH INSTITUTE, SAN ANTONIO, TX – EIR, 483, RESPONSE 09/01/2012 – 09/30/2012
05/07/2015 FDA/OGROP/ORA/NE-FO/NWE-DO/NWE-CB/ THOMSON REUTERS (SCIENTIFIC) SAS TOXIKON CORP, BEDFORD, MA – EIR, 483, RESPONSE 09/01/2013 – 09/30/2013
05/07/2015 FDA/OC/OES/ PEOPLE FOR THE ETHICAL TREATMENT OF ANIMALS PRESENTATIONS BY THE FOUNDATION FOR BIOMEDICAL RESEARCH OR THE NATIONAL ASSOC FOR BIOMEDICAL RESEARCH – 1/1/10 TO PRESENT
01/16/2015 OC/ORA/ FDA/OGROP/ORA/CE-FO/BLT-DO/BLT-CB/ Doe J IPB300 BATH LIFT – CMPLNT
05/07/2015 FDA/OMPT/CDER/ORP/DIDP/ FDA/OGROP/ORA/PA-FO/SAN-DO/SAN-CB/ FDA/OGROP/ORA/PA-FO/LOS-DO/LOS-CB/ THOMSON REUTERS (SCIENTIFIC) SAS ALLERGAN, INC, IRVINE, CA – EIR, 483, RESPONSE 03/01/2013 – 03/31/2013
05/07/2015 FDA/OGROP/ORA/CE-FO/CIN-DO/CIN-CB/ THOMSON REUTERS (SCIENTIFIC) SAS BATTELLE MEMORIAL INSTITUTE, COLUMBUS, OH – EIR, 483, RESPONSE 10/01/2012 – 10/31/2012
05/07/2015 FDA/OFVM/CFSAN/OCD/EOS/ INTERTEK RIKEN VITAMIN CO LTD – ETHOXYLATED ALCOHOLS FCN 1313 CHEMISTRY AND TOXICOLOGY RVW MEMO, CORR, FORM 3480, ETC
05/07/2015 FDA/OGROP/ORA/CE-FO/DET-DO/DET-CB/ THOMSON REUTERS (SCIENTIFIC) SAS COVANCE LABORATORIES, GREENFIELD, IN – EIR, 483, RESPONSE 06/01/2014 – 06/30/2014
05/07/2015 FDA/OGROP/ORA/CE-FO/NWJ-DO/NWJ-CB/ THOMSON REUTERS (SCIENTIFIC) SAS HOFFMAN LA ROCHE, NUTLEY, NJ – EIR, 483, RESPONSE 05/01/2013 – 05/31/2013
05/07/2015 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CBER/OCOD/DDOM/ALFB/ THOMSON REUTERS (SCIENTIFIC) SAS PITISUTTIHUM PUNNEE MD, BANGKOK, THAILAND – EIR, 483, RESPONSE 05/01/2014 – 05/31/2014
05/07/2015 FDA/OGROP/ORA/NE-FO/NWE-DO/NWE-CB/ THOMSON REUTERS (SCIENTIFIC) SAS DYAX CORP, BURLINGTON, MA – EIR, 483, RESPONSE 08/01/2014 – 08/31/2014
05/07/2015 FDA/OMPT/CDER/ORP/DIDP/ Govzilla, Inc. CANGENE CORPORATION, CANADA – EIR, 483, RESPONSE 07/09/2014 – 07/18/2014
05/07/2015 FDA/OMPT/CDER/ORP/DIDP/ THOMSON REUTERS (SCIENTIFIC) SAS VALEANT PHARMACEUTICALS INTERNATIONAL, CANADA – EIR, 483, RESPONSE 09/01/2013 – 09/30/2013
05/07/2015 FDA/OGROP/ORA/CE-FO/DET-DO/DET-CB/ THOMSON REUTERS (SCIENTIFIC) SAS EMERGENT BIODEFENSE, LANSING, MI – EIR, 483, RESPONSE 11/01/2013 – 11/30/2013
01/20/2015 FDA/OMPT/CDER/ORP/DIDP/ Scott Hodes, Attorney at Law 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
05/07/2015 FDA/OGROP/ORA/CE-FO/CHI-DO/CHI-CB/ THOMSON REUTERS (SCIENTIFIC) SAS CSL BEHRING, BRADLEY, IL – EIR, 483, RESPONSE 07/01/2014 – 07/31/2014
05/07/2015 FDA/OMPT/CDRH/OCER/DFOI/ Epic International (Thailand) Co., Ltd. K910007
05/07/2015 FDA/OFVM/CFSAN/OCD/EOS/ TECHNOLOGY SERVICES GROUP INC FCN 0277
05/07/2015 FDA/OGROP/ORA/SW-FO/DEN-DO/DEN-CB/ THOMSON REUTERS (SCIENTIFIC) SAS CORDEN PHARMA COLORADO, BOULDER, CO – EIR, 483, RESPONSE 06/01/2013 – 06/30/2013
05/07/2015 FDA/OGROP/ORA/NE-FO/NWE-DO/NWE-CB/ THOMSON REUTERS (SCIENTIFIC) SAS BRISTOL MYERS SQUIBB, DEVENS, MA – EIR, 483, RESPONSE 06/01/2013 – 06/30/2013
05/07/2015 FDA/OGROP/ORA/PA-FO/SAN-DO/SAN-CB/ THOMSON REUTERS (SCIENTIFIC) SAS CARDINAL HEALTH LLC, LAS VEGAS, NV – EIR, 483, RESPONSE 11/01/2013 – 11/30/2013
05/07/2015 FDA/OGROP/ORA/PA-FO/LOS-DO/LOS-CB/ FDA/OGROP/ORA/PA-FO/SAN-DO/SAN-CB/ THOMSON REUTERS (SCIENTIFIC) SAS GILEAD SCIENCES, INC, FOSTER CITY, CA – EIR, 483, RESPONSE 09/23/2013 – 10/10/2013
05/07/2015 FDA/OGROP/ORA/CE-FO/PHI-DO/PHI-CB/ THOMSON REUTERS (SCIENTIFIC) SAS PREMIER RESEARCH INTERNATIONAL, PHILADELPHIA, PA – EIR, 483, RESPONSE 02/01/2012 – 02/29/2012
05/07/2015 FDA/OGROP/ORA/CE-FO/BLT-DO/BLT-CB/ THOMSON REUTERS (SCIENTIFIC) SAS CANGENE BIOPHARMA, INC DBA EMERGENT BIOSOLUTIONS, BALTIMORE, MD – EIR, 483, RESPONSE 03/31/2014 – 04/09/2014
05/07/2015 FDA/OMPT/CDER/ORP/DIDP/ University of Maryland, Baltimore School of Medicine Clinical Neurobehavioral Center IND 45228
01/20/2015 FDA/OFVM/CFSAN/OCD/EOS/ CarboUA DIMETHYLDIALKYLAMMONIUM IN SUGAR MILLS FOR PRODUCTION OF WHITE SUGAR
05/07/2015 FDA/OMPT/CDER/ORP/DIDP/ SPHERIUM BIOMED CILASTATIN – FORMULATION, PRECLINICAL INFORMATION, BIOAVAILABILITY ETC
05/07/2015 FDA/OMPT/CDER/ORP/DIDP/ The Weinberg Group TUZISTRA XR APPROVAL RECS
05/07/2015 FDA/OMPT/CDER/ORP/DIDP/ BRIDGER CAPITAL LLC ADVETRIS, KYNAMRO, HETLIOZ, ETC – AERS
05/07/2015 FDA/OGROP/ORA/PA-FO/LOS-DO/LOS-CB/ Searcy Denney Scarola Barnhart & Shipley, P.A. TEVA PARENTERAL MEDICINES, IRVINE, CA – EIR, EXHIBITS, ATTACHMENTS, ETC 01/07/2009 – 01/01/2010
05/07/2015 FDA/OMPT/CDER/ORP/DIDP/ HEMISPHEREX BIOPHARMA INC LONZA BIOLOGICS – IMMOBILIZED MONOCLONAL ANTIBODY DMF 18596
05/07/2015 FDA/OMPT/CDER/ORP/DIDP/ BERNARD M GROSS LAW OFCS NYMOX PHARMACEUTICAL CORP – NX02-0017 NX02-0018
05/07/2015 FDA/OGROP/ORA/CE-FO/NWJ-DO/NWJ-CB/ FDA/OMPT/CDRH/OCER/DFOI/ SIDLEY AUSTIN LLP FUJIFILM CORP – DUODENOSCOPES 483’S, WARNING LTRS, FOREIGN & DOMESTIC SINCE 1/1/15
05/07/2015 FDA/OMPT/CDRH/OCER/DFOI/ SIDLEY AUSTIN LLP PENTAX MEDICAL, HOYA CORP – DUODENSCOPES MEDWATCH, CMPLNTS SINCE 7/96
05/07/2015 FDA/OMPT/CDER/ORP/DIDP/ BOSCOGEN INC SYN TECH PHARM, TAINAN COUNTY, TAIWAN – EIR 1/26-29/15
05/07/2015 FDA/OGROP/ORA/CE-FO/NWJ-DO/NWJ-CB/ FDA/OGROP/ORA/SE-FO/FLA-DO/FLA-CB/ FDA/OMPT/CDRH/OCER/DFOI/ MAZIE SLATER KATZ ET AL CORDIS CORP – OPTEASE VENA CAVA FILTER RETRIEVAL CATHETER PERMANENT VENA CAVA FILTER & INTRODUCTION KIT
01/20/2015 FDA/OFVM/CFSAN/OCD/EOS/ TECHNOLOGY SCIENCES GROUP INC SILVER ACETATE STUDY RECS
05/07/2015 FDA/OGROP/ORA/PA-FO/LOS-DO/LOS-CB/ LAW OFFICES OF PATRICK D RIDDLE PC TRADER JOES – RAW WALNUTS SALMONELLA RECALL
05/07/2015 FDA/OMPT/CDRH/OCER/DFOI/ K and L Gates LLP OLYMPUS MEDICAL SYS CORP – DUODENOSCOPES WARNING LTRS, 483’S FOREIGN & DOMESTIC SINCE 1/1/15
05/07/2015 FDA/OGROP/ORA/CE-FO/NWJ-DO/NWJ-CB/ Gregory Gogo, Esq. DKT MER-L-1112-13
05/07/2015 FDA/OGROP/ORA/PA-FO/LOS-DO/LOS-CB/ Doe J SPINAL SOLUTUONS, LONG BEACH, CA – COSIGNEES
05/07/2015 OC/ORA/ FDA/OGROP/ORA/CE-FO/CIN-DO/CIN-CB/ FDA/OGROP/ORA/SW-FO/DEN-DO/DEN-CB/ JONES DAY JENIS SPLENDID ICE CREAMS – SPL 2673
05/08/2015 FDA/OMPT/CDRH/OCER/DFOI/ Siemens Medical Solutions USA, Inc. K090318
05/08/2015 FDA/OMPT/CDER/ORP/DIDP/ FOI Services, Inc. ANDA 200630 TENTATIVE APPROVAL LETTER, LABELING
05/08/2015 FDA/OMPT/CDRH/OCER/DFOI/ icometrix K140828
05/08/2015 FDA/OMPT/CDER/ORP/DIDP/ FOI Services, Inc. ANDA 203976 LABELING, PACKAGE INSERT
05/08/2015 FDA/OMPT/CDRH/OCER/DFOI/ Reckitt Benckiser Group K150615 SUMMARY
01/20/2015 FDA/OMPT/CDER/ORP/DIDP/ Macquarie CAF LLC DRUGS FILED UNDER NDA GRANTED PRIORITY REVIEW STATUS 01/01/1992 – 12/31/2014
05/08/2015 FDA/OMPT/CDER/ORP/DIDP/ ELI LILLY & CO OFEV – PHARMACOLOGY REVIEW
05/08/2015 FDA/OMPT/CDER/ORP/DIDP/ Center for the Study of Empathic Therapy PERPHENAZINE – AERS
05/08/2015 FDA/OMPT/CDRH/OCER/DFOI/ FDA/OC/OES/DFOI/ Multi Radiance Medical K093547
05/08/2015 FDA/OMPT/CDER/ORP/DIDP/ Pike Photocopy, Inc. COUNTERFEIT BOTOX – AERS, TOXICOLOGY
05/08/2015 FDA/OMPT/CDER/ORP/DIDP/ Steve J. Polich PATANASE – AERS
05/08/2015 FDA/OGROP/ORA/SW-FO/DEN-DO/DEN-CB/ Contract In-House Counsel Consl. LLC DERMA PEN WARNING LETTER RECS 03/16/2015 – 03/31/2015
05/08/2015 FDA/OMPT/CDER/ORP/DIDP/ BAKER, DAVID STRATTERA – AERS
05/08/2015 FDA/OMPT/CDER/ORP/DIDP/ COCHRAN V-04815, BILLY IBUPROFEN, ACETAMINOPHEN, PROZOSIN, ETC – MEDICATION GUIDE, PRESCRIPTION PROTOCOLS, DURATION LIMITS
05/08/2015 FDA/OC/OES/DDM/ FDA/OMPT/CTP/OD/ CAMPAIGN FOR TOBACCO-FREE KIDS PRODUCT QUANTITY CHANGE SUBSTANTIAL EQUIVALENCE RPTS, DKT 2011D-0147
05/08/2015 FDA/OFVM/CFSAN/OCD/EOS/ Jamieson Laboratories CAERS 183160
01/20/2015 FDA/OMPT/CDER/ORP/DIDP/ JOHNS HOPKINS HOSPITAL ALTEPLASE – AERS
05/08/2015 FDA/OFVM/CFSAN/OCD/EOS/ MUCKROCK NEWS 4-METHYLIMIDAZOLE IN SODA – RPTS 2014 TO PRESENT
05/08/2015 FDA/OMPT/CDER/ORP/DIDP/ Doe J INDIVIDUAL RECS
05/08/2015 FDA/OMPT/CDER/ORP/DIDP/ VACCA, JEAN COLLOIDAL SILVER – RPT
05/08/2015 FDA/OMPT/CDRH/OCER/DFOI/ A STEP AHEAD PROSTHETICS OTTOBOCK C-LEG 4 MICROPROCESSOR CONTROLLED PROSTHETIC KNEE – IP TESTING, LIQUID INGRESS PROTECTION TESTING, IMMERSION TESTING, ETC
05/08/2015 FDA/OMPT/CDER/ORP/DIDP/ Blizzard & Nabers, LLP GLAXOSMITHKLINE PLC, NOVARTIS AG, NOVARTIS PHARMACEUTICAL COR – ZOFRAN (ONDANSETRON) RVWS, AERS, COMM, ETC 1991 TO 2015
05/08/2015 FDA/OMPT/CDER/ORP/DIDP/ Blizzard & Nabers, LLP FOREST PHARMS, FOREST LABS – CELEXA (CITALOPRAM), LEXAPRO (ESCITALOPRAM) RVWS, AERS, COMM, ETC 2009 TO 2015
05/08/2015 FDA/OMPT/CDER/ORP/DIDP/ EAS CONSULTING GROUP LLC CYANOCOBOLAMIN INJ ANDA 87-969 – CHEMISTRY RVW
05/08/2015 FDA/OMPT/CDER/ORP/DIDP/ EAS CONSULTING GROUP LLC VIBISONE (CYANOCOBOLAMIN) INJ ANDA 80-557 – CHEMISTRY RVW
05/08/2015 FDA/OMPT/CDER/ORP/DIDP/ EAS CONSULTING GROUP LLC CYANOCOBOLAMIN INJ ANDA 80-737 – CHEMISTRY RVW
05/08/2015 FDA/OMPT/CDER/ORP/DIDP/ EAS CONSULTING GROUP LLC OTSUKA PHARMACEUTICAL CO LTD, SAGA PREFECTURE, JAPAN – EIR 12/1-5/14
01/20/2015 FDA/OMPT/CBER/OCOD/DDOM/ALFB/ PPTA TABLES OF FINAL CONCLUSIONS PLASMA DONOR FATALITIES FY 2013, 2014
05/08/2015 FDA/OMPT/CDER/ORP/DIDP/ EAS CONSULTING GROUP LLC OTSUKA PHARMACEUTICAL CO LTD, NAKA-GUN, TOKUSHIMA PREFECTURE, JAPAN – EIR 6/9-17/14
05/08/2015 FDA/OMPT/CDER/ORP/DIDP/ EAS CONSULTING GROUP LLC OTSUKA PHARMACEUTICAL CO LTD, EBISUNO HIRAISHI, KAWAUCHI-CHO, TOKUSHIMA, JAPAN – EIR 6/18-26/14
05/08/2015 FDA/OMPT/CDER/ORP/DIDP/ EAS CONSULTING GROUP LLC OTSUKA PHARMACEUTICAL CO LTD, ITANO-GUN, TOKUSHIMA PREFECTURE, JAPAN – EIR 3/17-20/14
05/08/2015 FDA/OMPT/CDER/ORP/DIDP/ EAS CONSULTING GROUP LLC LUNDBECK, TEESSIDE, ENGLAND, UK – EIR MOST RECENT
05/08/2015 FDA/OMPT/CDER/ORP/DIDP/ EAS CONSULTING GROUP LLC ALUMINOSILICARE GLASS IN PARENTERAL APPLICATIONS – CORR, MINS, REGULATORY OPINIONS 1/10 TO PRESENT
05/08/2015 FDA/OMPT/CDER/ORP/DIDP/ EAS CONSULTING GROUP LLC STEVANTO GROUP – ALUMINOSILICATE GLASS CORR, MINS, REGULATORY OPINIONS, ETC
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05/14/2015 FDA/OMPT/CDRH/OCER/DFOI/ FDA NEWS COASTAL CONTACTS INC, VANCOUVER, CANADA ORTHOGEM LTD, NOTTINGHAM, UK WU’S TECH CO LTD, HSIN-CHU, TAIWAN, ETC – 483S 4/1-30/15
05/14/2015 FDA/OGROP/ORA/CE-FO/DET-DO/DET-CB/ FDA NEWS ROCKWELL MEDICAL INC, WIXOM, MI MONOSOL RX LLC, PORTAGE, IN PROGRESSIVE DYNAMICS INC, MARSHALL, MI, ETC – 483S 4/1-30/15
05/14/2015 FDA/OGROP/ORA/PA-FO/SAN-DO/SAN-CB/ FDA NEWS ARSTASIS INC, FREMONT, CA SILK ROAD MEDICAL INC, SUNNYVALE, CA OCUMETRICS INC, MOUNTAIN VIEW, CA, ETC – 483S 4/1-30/15
05/14/2015 FDA/OGROP/ORA/SE-FO/ATL-DO/ATL-CB/ FDA NEWS TRIAD ISOTOPES, MACON, GA ETHICON INC, CORNELIA, GA – 483S 4/1-30/15
05/14/2015 FDA/OGROP/ORA/CE-FO/BLT-DO/BLT-CB/ FDA NEWS MAXIM BIOMEDICAL INC, ROCKVILLE, MD LC TECHNOLOGIES INC, FAIRFAX, VA HAWKNAD MANUFACTURING INDUSTRIES INC. ALEXANDRIA, VA – 483S 4/1-30/15
05/14/2015 FDA/OGROP/ORA/CE-FO/CHI-DO/CHI-CB/ FDA NEWS ORGAN RECOVERY SYSTEMS INC, ITASCA, IL – 483S 4/1-30/15
05/14/2015 FDA/OGROP/ORA/SW-FO/DAL-DO/DAL-CB/ FDA NEWS B & P INDUSTRIAL INC, TULSA, OK GRESCO PRODUCTS INC, STAFFORD, TX ELITE MASSAGERS LLC, RICHARDSON, TX, ETC – 483S 4/1-30/15
01/20/2015 FDA/OMPT/CDRH/OCER/DFOI/ DT Ward PC K090421
05/14/2015 FDA/OGROP/ORA/SW-FO/DEN-DO/DEN-CB/ FDA NEWS TRONOX, GREEN RIVER, WY   OTTO BOCK HEALTHCARE, SALT LAKE CITY, UT BROWN’S COMPUNDING CENTER INC, ENGLEWOOD, CO – 483S 4/1-30/15
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05/14/2015 FDA/OGROP/ORA/PA-FO/LOS-DO/LOS-CB/ FDA NEWS PRECISION COMPOUNDING CENTERS LLC, BREA, CA TMJ SOLUTIONS INC, VENTURA, CA AVRIO BIOPHARMACEUTICALS LLC, IRVINE, CA, ETC – 483S 4/1-30/15
05/14/2015 FDA/OGROP/ORA/CE-FO/MIN-DO/MIN-CB/ FDA NEWS ALLESEE ORTHODONTIC INC, STURTEVANT, WI FAGRON INC, ST PAUL, MN – 483S 4/1-30/15
05/14/2015 FDA/OGROP/ORA/SE-FO/NOL-DO/NOL-CB/ FDA NEWS HOLLYWOG LLC, CHATTANOOGA, TN SANMINA INC, HUNTSVILLE, AL MAX MOBILITY LLC, ANTIOCH, TN – 483S 4/1-30/15
05/14/2015 FDA/OGROP/ORA/NE-FO/NWE-DO/NWE-CB/ FDA NEWS BROOKFIELD MEDICAL/SURGICAL SUPPLY INC, BROOKFIELD, CT INFRAREDX INC, BURLINGTON, MA POLYCARBON INDUSTRIES INC, NEWBURYPORT, MA – 483S 4/1-30/15
05/14/2015 FDA/OGROP/ORA/NE-FO/NYK-DO/NYK-DCB/ FDA NEWS ALTAIRE PHARMACEUTICALS INC, AQUEBOGUE, NY RTF MANUFACTURING CO LLC, HUDSON, NY PURINEPHARMA LLC, MASSENA, NY – 483S 4/1-30/15
05/14/2015 FDA/OGROP/ORA/CE-FO/PHI-DO/PHI-CB/ FDA NEWS CUSTOM ULTRASONICS INC, IVYLAND, PA POLYSCIENCES INC, WARRINGTON, PA – 483S 4/1-30/15
05/14/2015 FDA/OMPT/CDER/ORP/DIDP/ FDA NEWS AMGEN TECHNOLOGY IRELAND, DON LAOGHAIRE, IRELAND LUPIN LTD, AURANGBAD, INDIA PFIZER PHARMACEUTICALS LTD, DALIAN, CHINA – 483S 4/1-30/15
01/20/2015 FDA/OGROP/ORA/NE-FO/NWE-DO/NWE-CB/ Boston Ivf BOSTON IVF, SOUTH PORTLAND, ME – EIR 01/01/2013 – 01/01/2015
05/14/2015 FDA/OGROP/ORA/CE-FO/NWJ-DO/NWJ-CB/ FDA NEWS SONAR PRODUCTS INC, CARLSTADT, NJ DERMACEUTICAL LABORATORIES LLC, TETERBORO, NJ THERAKOS INC, BRIDGEWATER, NJ, ETC – 483S 4/1-30/15
05/15/2015 FDA/OFVM/CFSAN/OCD/EOS/ FOI Services, Inc. POST FOODS WARNING LETTER RESPONSE 03/10/2015
05/15/2015 FDA/OMPT/CDER/ORP/DIDP/ Covance Labs NDA 21484 PROTOCOLS
05/15/2015 FDA/OFVM/CFSAN/OCD/EOS/ Nathan Mayer BABY FORMULA – LIST OF PRODUCERS 05/12/2000 – 05/12/2015
05/15/2015 OC/ORA/ Wendy Kowal LIST OF EXPORTERS WHO DELIVER PMSG TO US
05/15/2015 FDA/OFVM/CFSAN/OCD/EOS/ SAINT LOUIS UNIVERSITY HEALTH SCIENCES CENTER SURVEY TOOL USED TO COLLECT DATA FOR FDA HEALTH AND DIET SURVEY
05/15/2015 FDA/OMPT/CDRH/OCER/DFOI/ Doe J CPT1400711
05/15/2015 FDA/OGROP/ORA/NE-FO/NWE-DO/NWE-CB/ The Gillette Company GILLETTE COMPANY, ANDOVER, MA – EIR 01/23/2014 – 06/30/2014
05/15/2015 FDA/OMPT/CDRH/OCER/DFOI/ Salim-Beasley, LLC ESSURE – ADVERSE EVENTS
05/15/2015 FDA/OMPT/CDER/ORP/DIDP/ Zydus Pharmaceuticals USA Inc. NDA 018716
01/20/2015 FDA/OFVM/CFSAN/OCD/EOS/ FDA/OGROP/ORA/SE-FO/ATL-DO/ATL-CB/ FDA/OC/OES/DFOI/ Gary Black HI TECH PHARMACEUTICALS, NORCROSS, GA – WARNINGS, EVIDENCE, NOTIFICATION
05/15/2015 FDA/OGROP/ORA/SE-FO/ATL-DO/ATL-CB/ AMERICAN RED CROSS AMERICAN RED CROSS GEORGIA LOCATIONS – EIR 06/02/2010 – 03/19/2015
05/15/2015 FDA/OGROP/ORA/CE-FO/NWJ-DO/NWJ-CB/ Drug Quality Assurance, LLC NAPP TECHNOLOGIES INC – EIR, 483, WARNING LETTER 01/01/2011 – 05/13/2015
05/15/2015 FDA/OO/OFBA/OAGS/ FOI Services, Inc. FDA CONTRACTS WITH DUNS & BRADSTREET 01/01/2005 to 05/30/2015
05/15/2015 FDA/OMPT/CDER/ORP/DIDP/ Drug Quality Assurance, LLC JAGSONPAL PHARMACEUTICALS LIMITED, INDIA – 483, EIR, WARNING LETTER 01/01/2011 – 05/31/2015
05/15/2015 FDA/OMPT/CDER/ORP/DIDP/ Doe J SIMPONI – AERS
05/15/2015 FDA/OGROP/ORA/PA-FO/LOS-DO/LOS-CB/ FDA/OGROP/ORA/PA-FO/SAN-DO/SAN-CB/ Volcano Corporation VOLCANO CORPORATION, RANCHO CORDOVA, CA – EIR 10/01/2012 – 06/28/2013
05/15/2015 FDA/OMPT/CDRH/OCER/DFOI/ Stericycle, Inc. K063722
05/15/2015 FDA/OMPT/CDRH/OCER/DFOI/ Brain Sentinel K864690
05/15/2015 FDA/OMPT/CDER/ORP/DIDP/ Sibet Freides OXTELLAR XR – AERS
05/15/2015 OC/ORA/ FDA/OGROP/ORA/SW-FO/DAL-DO/DAL-CB/ FOI Services, Inc. BLUE BELL CREAMERIES INSPECTION RECS
01/20/2015 FDA/OMPT/CDRH/OCER/DFOI/ FDA/OC/OES/DFOI/ Society for Technology in Anesthesia K043299
05/15/2015 FDA/OMPT/CDRH/OCER/DFOI/ ConMed Corporation K122462
05/15/2015 FDA/OMPT/CDRH/OCER/DFOI/ ConMed Corporation K926104
05/15/2015 FDA/OMPT/CDRH/OCER/DFOI/ FDA/OC/OES/DFOI/ FOI Services, Inc. K102452
05/15/2015 FDA/OMPT/CDRH/OCER/DFOI/ Briteseed, LLC K072932, K082870, K032315
05/15/2015 FDA/OMPT/CDRH/OCER/DFOI/ Tormoen, Madeline INDIVIDUAL RECS
05/15/2015 FDA/OMPT/CDRH/OCER/DFOI/ Butler, Vines and Babb, PLLC MEDWATCH REPORT
05/15/2015 FDA/OMPT/CDER/ORP/DIDP/ Zydus Pharmaceuticals USA Inc. ANDA 075113
05/15/2015 FDA/OMPT/CDER/ORP/DIDP/ The Patient Advocate PREGABALIN – MEDWATCH REPORTS OR OTHER PRE OR POST MARKET REPORTS AERS
05/15/2015 FDA/OMPT/CDRH/OCER/DFOI/ HENNIS & HENNIS ESSURE – PMA
05/15/2015 FDA/OMPT/CDRH/OCER/DFOI/ TELEFLEX MEDICAL TELEFLEX MEDICAL, NORRISVILLE, NC – NEEDESCOPIC RESPOSABLE DVC SYS K132232 MINI-LAP BIPOLAR ELECTROCAUTERY DVC K113597   ARVIKI LAPAROSCOPIC ASPIRATION STRUMENT K102274, ETC
01/20/2015 FDA/OMPT/CDRH/OCER/DFOI/ Ethicon K003431
05/15/2015 FDA/OMPT/CDER/ORP/DIDP/ NATIONAL INSTITUTES OF HEALTH DEPT OF HEALTH HUMAN SERVICES SITAGLPTIN, SAXAGLIPTIN, LINAGLIPTIN, ETC – AERS 10/06, 7/06, 7/09, 2011 TO PRESENT, 2013 TO PRESENT
05/15/2015 FDA/OMPT/CDER/ORP/DIDP/ BENJAMIN L ENGLAND & ASSOCIATES LLC LIST OF ALL BULK INGREDIENT DRUG PRODS SUBMITTED BY DOMESTIC & FOREIGN ESTABLISHMENTS 1/11 TO PRESENT
05/15/2015 FDA/OMPT/CDER/ORP/DIDP/ NAIR & LEVIN PC DELALUTIN (17-HYDROXY PROGESTERONE CAPROATE INJ) – AERS
05/15/2015 FDA/OMPT/CDER/ORP/DIDP/ CROSBY, COURTNEY BENICAR – AERS, LIST OF DRUGS BEING RECALLED
05/15/2015 FDA/OMPT/CDER/ORP/DIDP/ HOGAN   LOVELLS LLP ROXANE LABORATORIES INC – ALOSETRON MEMO TO SUPPORT DECISON TO APRVD & WAIVE REQUIREMENTS
05/15/2015 FDA/OMPT/CDER/ORP/DIDP/ University of St. Gallen, Switzerland ORANGE BOOK WEB LINK
05/15/2015 FDA/OMPT/CDER/ORP/DIDP/ University of Helsinki (FINLAND) ANDA APPROVAL LETTERS
05/15/2015 OC/CVM/OCD/ Zoetis NADA 141-042 FOIA SUMMARY
05/15/2015 FDA/OMPT/CDER/ORP/DIDP/ Symogen Ltd SOLIRIS – AERS
05/15/2015 FDA/OMPT/CDER/ORP/DIDP/ RESEARCH INVESTIMENT INC STAFF MANUAL GUIDE 8/31/76
01/20/2015 FDA/OMPT/CDER/ORP/DIDP/ Venable, LLP NDA 18723 S020, NDA 19680 S008 – APPROVAL LETTER
05/15/2015 FDA/OMPT/CDER/ORP/DIDP/ Partisan Pictures CANNABIDIOL TRIAL SUBMISSION RECS 01/01/2013 – 01/01/2015
05/15/2015 FDA/OFVM/CFSAN/OCD/EOS/ Epstein Becker Green DMAA CAERS
05/15/2015 FDA/OMPT/CDRH/OCER/DFOI/ IEEE Spectrum GOOGLE INC – COMMUNICATIONS WITH RE DEVELOPMENT OF CONTACT LENSES WITH INTEGRATED ELECTRONIC ELEMENTS 01/01/2013 – 05/13/2015
05/15/2015 FDA/OMPT/CDER/ORP/DIDP/ LILIAM RODRGUEZ IVARZ LAW OFC AVELOX (MOXIFLOXACIN) – AERS
05/15/2015 FDA/OMPT/CDER/ORP/DIDP/ QUALITY RESEARCH SERVICES ANDA 075074 PHARMACOKINETIC REVIEW
05/15/2015 FDA/OMPT/CDER/ORP/DIDP/ The Reardon Law Firm MEDROXYPROGESTERONE ACETATE – AERS
05/15/2015 FDA/OGROP/ORA/SW-FO/KAN-DO/KAN-CB/ KCAS LLC KCAS LLC BIOANALYTICAL FACILITY, SHAWNEE, KS – EIRS 8/25/14, 9/2/14
05/15/2015 FDA/OGROP/ORA/PA-FO/LOS-DO/LOS-CB/ NUVASIVE INC NU VASIVE INC, SAN DIEGO, CA – EIR 2/14
05/15/2015 FDA/OMPT/CTP/OD/ SILVER MCGOWAN & SILVER PC US FLUE CURED TOBACCO GROWER – KENTUCKY RED, SILVER, GOLD, BLUE, GREEN TOBACCO SUSTASNIAL EQUIVALENCE RPTS
05/15/2015 FDA/OMPT/CDER/ORP/DIDP/ OC/ORA/OCI/ CAROLLO, RUSSELL SYNACTHEN (SYNACTHEN DEPOT) – ACTH EIRS, 483S, WARNING LTRS, ETC
01/20/2015 FDA/OMPT/CDRH/OCER/DFOI/ STRYKER CORPORATION K141668
05/15/2015 FDA/OO/OFBA/OAGS/ FDA/OO/OFBA/OAGS/ ARENT FOX LLP DR REUBEN MATALON – RESP OF P HENYLKETONURIA TO TETRAHYDROB IOTERN (BH4) PROJECT GRANT APPL 5R01FD002006-1 THROUGH 5401FD002006-03-2005
05/15/2015 FDA/OFVM/CFSAN/OCD/EOS/ CENTER FOR SCIENCE IN PUBLIC INTEREST SILICON DIOXIDE – GRN 298 ACACIA OR GUM ARABIC – GRN 48 LACTOBACILLUS – GRN 463, 409,324, ETC
05/15/2015 FDA/OFVM/CFSAN/OCD/EOS/ CENTER FOR SCIENCE IN PUBLIC INTEREST MARLOW FOODS LTD – QUORN-BRAND MEAT SUBSTITUTE CMPLNTS 5/1-8/15
05/15/2015 FDA/OFVM/CFSAN/OCD/EOS/ CENTER FOR SCIENCE IN PUBLIC INTEREST PETITIONS FOR EXEMPTION FOR PREEMPTION
05/15/2015 FDA/OC/OES/DFOI/ ENVIROMENTAL WORKING GROUP ASBESTOS – SOURCING OF TALC, TESTING SURVEY, CUMM 2000 TO PRESENT, 2009 TO 2010
05/18/2015 FDA/OC/OES/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ WEITZ & LUXEMBERG PC 2014-344, 2009-10122, 2014- 8613, ETC
05/18/2015 FDA/OGROP/ORA/NE-FO/NWE-DO/NWE-CB/ RONAYNE, LISA 90 MEATS DEPOT & LATINO FOOD DISTRIBUTORS, SPRINGFILED, MA – HEALTH, SAFETY & SANITARY INSPS, VIOLATIONS, CMPLNTS LAST 15-20 YRS
05/18/2015 FDA/OMPT/CDER/ORP/DIDP/ OC/ORA/ FUENTES, SUSAN ALLERGAN – RESTASIS (CYCLOSPORINE) RPT
05/18/2015 FDA/OMPT/CDER/ORP/DIDP/ UNIV OF MISSOURI SCHOOL OFLAW LIBRARY ORANGE BOOK 1986, 2001-2003
05/18/2015 FDA/OMPT/CBER/OCOD/DDOM/ALFB/ NEW YORK UNIVERSITY MERCK & CO INC – GARDASIL HPV VACCINE NUMBER OF CMPLNTS UNTL 3/15
01/20/2015 FDA/OGROP/ORA/SW-FO/KAN-DO/KAN-CB/ Celerion, Inc. CELERION, LINCOLN, NE – EIR 06/20/2011 – 06/24/2011
05/18/2015 OC/ORA/ORM/ LACHMAN   CONSULTANT SERVICES INC DRUG COMPANIES, MEDICAL DVC MFRS, BLOOD ESTABLISHMENTS, ETC – FOREIGN AND DOMESTIC INSPS 2/15 TO 3/15
05/18/2015 FDA/OMPT/CDER/ORP/DIDP/ RIVERA, NELSON MYLAN, INDIA – 483 12/01/2014 – 03/01/2015
05/18/2015 FDA/OFVM/CFSAN/OCD/EOS/ DSM Information Services FOOD ADVISORY COMMITTEE MEETING TRANSCRIPT 2/24/03
05/18/2015 FDA/OFVM/CFSAN/OCD/EOS/ Wendy Lane MONSTER ENERGY ADVERSE EVENTS
05/18/2015 FDA/OMPT/CDRH/OCER/DFOI/ FOI Services, Inc. K091780
05/18/2015 FDA/OGROP/ORA/PA-FO/LOS-DO/LOS-CB/ David Gilbert REAL SCIENTIFIC HEMP OIL – LAB RESULTS
05/18/2015 FDA/OMPT/CDRH/OCER/DFOI/ FOI Services, Inc. K120301
05/18/2015 OC/ORA/OCI/ DALLAS MORNING NEWS BLUE BELL CREAMERIES – OCI INVESTIGATION RECS 01/01/2010 – 05/15/2015
05/18/2015 OC/ORA/ FDA/OGROP/ORA/ORO/DIOP/ Zetetic, Inc. FDA ENTRY RECS 5/1/15 TO 5/15/15
05/18/2015 FDA/OMPT/CDER/ORP/DIDP/ PFIZER BLA 103795 – SBA S-1004
01/20/2015 FDA/OGROP/ORA/SW-FO/KAN-DO/KAN-CB/ Celerion, Inc. CELERION, LINCOLN, NE – EIR 06/29/2010 – 07/02/2010
05/18/2015 FDA/OMPT/CDRH/OCER/DFOI/ STRYKER SUSTAINABILITY SOLUTIONS K133853
05/18/2015 FDA/OMPT/CDER/ORP/DIDP/ Doe J INDIVIDUAL RECS
05/18/2015 OC/ORA/ FDA/OGROP/ORA/SW-FO/DAL-DO/DAL-CB/ dallas morning news BLUE BELL CREAMERIES – ENVIRONMENTAL TESTING 01/01/2010 – 05/15/2015
05/18/2015 FDA/OMPT/CDRH/OCER/DFOI/ FOI Services, Inc. K120298
05/18/2015 FDA/OMPT/CDRH/OCER/DFOI/ FOI Services, Inc. K091781
05/18/2015 FDA/OFVM/CFSAN/OCD/EOS/ Nalco, An Ecolab Company FAP3B3696
05/18/2015 FDA/OGROP/ORA/SW-FO/DAL-DO/DAL-CB/ Contract In-House Counsel Consl. LLC ECLIPSE AESTHETICS – 483, RESPONSE, CLOSE OUT ETC 02/01/2014 – 01/31/2015
05/18/2015 FDA/OMPT/CDER/ORP/DIDP/ Sanders Phillips Grossman XARELTO – APPLICATION, INVESTIGATION, TESTING ETC
05/18/2015 OC/ORA/ORM/ Pitts, Jacqueline QUALITY ASSURANCE LABORATORIES FOR FOOD ANALYSIS
05/18/2015 FDA/OMPT/CDER/ORP/DIDP/ AbbVie 10175042, 10175158, 10355704, ETC
01/02/2015 FDA/OMPT/CDRH/OCER/DFOI/ VerAvanti Inc. K050808
01/05/2015 OC/ORA/ FDA/OGROP/ORA/CE-FO/NWJ-DO/NWJ-CB/ Doe J INDIVIDUAL RECS
01/20/2015 FDA/OMPT/CDRH/OCER/DFOI/ FDA/OC/OES/DFOI/ Contract In-House Counsel and Consultants, LLC K050174, K060846
05/18/2015 FDA/OMPT/CDRH/OCER/DFOI/ FOI Services, Inc. K120296
05/18/2015 FDA/OC/OES/DFOI/ Hydrite Chemical Co DOMESTIC FOOD FACILITY REGISTRATION
05/18/2015 FDA/OMPT/CDER/ORP/DIDP/ AbbVie 10069989, 10283699, 10353121 ETC
05/18/2015 FDA/OC/OES/DFOI/ THE WALL STREET JOURNAL ICE CREAM INSPECTIONS 01/01/2010 – 05/15/2015
05/19/2015 FDA/OMPT/CDRH/OCER/DFOI/ JOHNSON GRAFFE ET AL OLYMPUS – DUODENOSCOPE MDRS
05/19/2015 FDA/OMPT/CDER/ORP/DIDP/ MERRILL LYNCH DR REDDY’S LABS, ANDHRA PRADESH, INDIA – FTO 7 ORAL SOLID INJ FROMULATIONS 483
05/19/2015 FDA/OMPT/CDER/ORP/DIDP/ LAW OFC STEVEN R ANDREWS PA JANSSEN PIIARMS – LEVAQUIN (LEVOFLOXACIN) NDA 020-634/.004,012.013, ETC LABELS CERTIFIED
05/19/2015 FDA/OMPT/CDER/ORP/DIDP/ HUSCH BLACKWELL LLP 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
05/19/2015 FDA/OFVM/CFSAN/OCD/EOS/ Keller and Heckman LLP QUALITAS HEALTH – ALMEGA PL OMEGA-3 OIL NEW DIETARY INGREDIENT NOTIFICATION (NDIN)
05/19/2015 FDA/OFVM/CFSAN/OCD/EOS/ Keller and Heckman LLP BIS (2,2,6,6-TETRAMETHYI-4-PIPERIDINYL SEBACATE TINUVIN.770) – TOXICOLOGY RVWS
01/20/2015 FDA/OMPT/CDRH/OCER/DFOI/ Suneris, Inc. K140313
05/19/2015 OC/ORA/OCI/ LECLAIR RYAN INTEGRATED RESOURCES INC OR BIOGEN IDEC – MR LEI YIIN’S COMM 1/1/11-12/31/11
05/19/2015 FDA/OC/OES/DFOI/ OC/CVM/OCD/ GALLIHER, KATHLEEN IAMS DOG FOOD – SALMONELLA OUTBREAK RECS 8/13
05/19/2015 FDA/OGROP/ORA/CE-FO/CIN-DO/CIN-CB/ William Reed Business Media SHUR GREEN FARMS – WARNING LETTER RESPONSE TO APRIL 2015 WARNING LETTER
05/19/2015 FDA/OMPT/CDRH/OCER/DFOI/ Theranova, LLC K003289, K022287, K063442 ETC
05/19/2015 FDA/OMPT/CDRH/OCER/DFOI/ ADVERSEEVENTS INC FRESH MEDICAL LABORATORIES – REVIEW LETTERS 02/01/2015 – 02/28/2015
05/19/2015 OC/ORA/ FDA/OGROP/ORA/SW-FO/DAL-DO/DAL-CB/ CBS NEWS BLUE BELL CREAMERIES – COMMUNICATIONS WITH FDA 01/01/2015 – 05/18/2015
05/19/2015 FDA/OMPT/CDRH/OCER/DFOI/ Holly Rockweiler Consulting K133895
05/19/2015 FDA/OMPT/OSMP/OOPD/ Vestan, Inc. LYMPHOSEEK – ORPHAN DRUG DESIGNATION RECS
05/19/2015 FDA/OMPT/CDRH/OCER/DFOI/ Theranova, LLC K041771, K060963, K070201 ETC
05/19/2015 FDA/OMPT/CDRH/OCER/DFOI/ illumireg inc. K061515
01/20/2015 FDA/OMPT/CDER/ORP/DIDP/ LACHMAN   CONSULTANT SERVICES INC NDA 019188 SBA
05/19/2015 FDA/OMPT/CDER/ORP/DIDP/ EMC Analytics Group NATCO PHARMA LTD, HYDERABAD, INDIA – 483 07/01/2014 – 12/31/2014
05/19/2015 FDA/OMPT/CDER/ORP/DIDP/ Zydus Pharmaceuticals USA Inc. NDA 018687 SBA
05/19/2015 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CBER/OCOD/DDOM/ALFB/ Mauricio de la Garza TELESTA TEHRAPEUTICS INC – MEETING MINUTES RE BLA MCNA 01/19/2014 – 05/18/2015
05/19/2015 FDA/OMPT/CDER/ORP/DIDP/ Gerresheimer Glass Inc DMF 9543
05/19/2015 FDA/OMPT/CDER/ORP/DIDP/ Morgan Stanley COMM BETWEEN FDA AND MALLINCKRODT RE METHYLPHENIDATE EXTENDED RELEASE AND CONCERTA
05/19/2015 FDA/OMPT/CDER/ORP/DIDP/ The Dartmouth Institute for Health Policy and Clinical Practice APPROVAL RECS PREVIOUSLY RELEASED
05/19/2015 FDA/OMPT/CBER/OCOD/DDOM/ALFB/ FDA/OMPT/CDER/ORP/DIDP/ BRIDGER CAPITAL LLC COMPASSIONATE USE, INVESTIGATOR-SPONSORED OR PHYSICIAN-SPONSORED SINGLE PATIENT IND REQUESTS FOR USE OF BANKED TCELL THERAPIES FROM MEMORIAL SLOAN KETTERING
05/19/2015 OC/ORA/ORM/ Govzilla, Inc. LIST OF INSPECTIONS 03/15/2014 – 05/19/2015

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