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.
If 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 |
| 05/08/2015 | FDA/OMPT/CDER/ORP/DIDP/ | EAS CONSULTING GROUP LLC | OMPI PHARMA – ALUMINOSILICARE GLASS CORR, MINS, REGULATORY OPINIONS, ETC |
| 05/08/2015 | FDA/OMPT/CDER/ORP/DIDP/ | EAS CONSULTING GROUP LLC | CORNING – ALUMINOSILICATE GLASS CORR, MINS, REGULAOTRY OPINIONS, ETC |
| 05/08/2015 | OC/ORA/ORM/ | FDAAWARE | LIST OF INSPECTIONS 02/17/2015 – 05/15/2015 |
| 05/08/2015 | FDA/OC/OES/DDM/ | Federal Instistution for Drugs and Medical Devices – Library | DRAFT GUIDANCE HEART VALVES – INVESTIGATIONAL DEVICE EXEMPTIONS AND PREMARKET APPROVAL APPLICATIONS 02/20/2010 – 04/27/2015 |
| 01/20/2015 | FDA/OGROP/ORA/SE-FO/FLA-DO/FLA-CB/ | Doe J | ALOE MAN INTERNATIONAL CORP, ALOE MAN INC – INSPECTION REPORTS, WARNING LETTER RESPONSE 01/16/2009 – 01/16/2015 |
| 05/08/2015 | FDA/OMPT/CDER/ORP/DIDP/ | Food and Drug information: Drug Shortages | DRUG SHORTAGE DATA 01/01/2008 – 12/31/2013 |
| 05/08/2015 | FDA/OMPT/CDER/ORP/DIDP/ | COHEN, MIRIAM | PROMETHAZINE – OUTCOME OF THE DRUG EFFICACY SAFETY IMPLEMENTATION (DESI) RVWS |
| 05/08/2015 | FDA/OC/OES/DFOI/ | Food Engineering Magazine | BLUE BELL CREAMERIES |
| 05/08/2015 | FDA/OC/OES/DFOI/ | BNP Media, Food Engineering Magazine | BLUE BELL CREAMERIES |
| 05/11/2015 | FDA/OC/OES/DFOI/ | COVINGTON BURLING LLP | DKT 1998P-0547 |
| 05/11/2015 | FDA/OC/OES/DFOI/ | FDA NEWS | DKT 2013N-0500 |
| 05/11/2015 | FDA/OC/OES/DFOI/ | DAN, SHIRLEY | DKT 2015P-0091 |
| 05/11/2015 | FDA/OC/OES/DFOI/ | VENABLE LLP | DKT 1975-0184 |
| 05/11/2015 | FDA/OC/OES/DFOI/ | Wilson Sonsini Goodrich & Rosati | DKT 2013N-0500 |
| 05/11/2015 | FDA/OC/OES/DFOI/ | AMERICAN CLEANING INSTITUTE | 1975N-0183 |
| 01/20/2015 | FDA/OMPT/CDER/ORP/DIDP/ | Venable, LLP | NDA 20782, 21168 S004 – APPROVAL LETTER (CERTIFIED) |
| 05/11/2015 | FDA/OC/OES/DFOI/ | National Sustainable Agriculture Coalition | DKT 2011N-0920, 2011N-0921 |
| 05/11/2015 | FDA/OC/OES/DFOI/ | MERCURY PUBLIC AFFAIRS | DKT 2007N-0363-0040 |
| 05/11/2015 | FDA/OC/OES/DFOI/ | KPW LAW | DKT 2015P-0569 |
| 05/11/2015 | FDA/OC/OES/DFOI/ | Wilson Sonsini Goodrich & Rosati | DKT 2011N-0830, 2007N-0363, 2013N-0500 |
| 05/11/2015 | FDA/OC/OES/DFOI/ | EAS CONSULTING GROUP LLC | DKT 2003N-0196, 2005N-0453, 20060-0314, ETC |
| 05/11/2015 | FDA/OC/OES/DFOI/ | EAS CONSULTING GROUP LLC | FEDERAL REGISTER VOL 50 N062 PG 12821-12825 |
| 05/11/2015 | FDA/OC/OES/DFOI/ | VENABLE LLP | DKT 75N-0184 |
| 05/11/2015 | FDA/OC/OES/DFOI/ | MERCURY PUBLIC AFFAIRS | DKT 2007N-0363-0040 |
| 05/11/2015 | FDA/OC/OES/DFOI/ | FDA NEWS | DKT 2014N-1168-0029 |
| 05/11/2015 | FDA/OC/OES/DFOI/ | LATHAM & WATKINS | DKT 2014N-1051 |
| 01/05/2015 | FDA/OMPT/CDER/ORP/DIDP/ | J.P. Morgan India Pvt Ltd | SUN PHARMACEUTICAL, INDIA – 483 09/01/2014 – 09/30/2014 |
| 01/20/2015 | FDA/OMPT/CDER/ORP/DIDP/ | Venable, LLP | NDA 21168 S012 – APPROVAL LETTER (CERTIFIED) |
| 05/11/2015 | FDA/OMPT/CDER/ORP/DIDP/ | ROCKY MOUNTAIN POISON DRUG CTR | COUGH & COLD PREPARATIONS – ISRS 91691343, 94455812, 96810154, ETC |
| 05/11/2015 | FDA/OGROP/ORA/PA-FO/LOS-DO/LOS-CB/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OC/OES/DFOI/ FDA/OGROP/ORA/PA-FO/SAN-DO/SAN-CB/ | Hound Partners | IMPAX LABS, HAYWARD, CA, MIAOLI COUNTY 350, TAIWAN – EIRS |
| 05/11/2015 | OC/ORA/ FDA/OGROP/ORA/CE-FO/CIN-DO/CIN-CB/ | 89.7 NPR NEWS | JENI’S SPLENDID ICE CREAMS – EIRS 1/1/10 TO 5/8/15 |
| 05/11/2015 | OC/ORA/ORM/ | FDA NEWS | LIST OF 483S FOR PHARMACEUTICAL, BIOLOGICS & MEDICAL DVC MFG & CLNCL TRIAL FACILITIES IN THE US & OUTSIDE THE US 4/1-30/15 |
| 05/11/2015 | FDA/OC/OL/ | Mayer Brown LLP | SENATOR RICHARD DURBIN OR SENATOR DIANE FEINSTEIN – RESP LTR 3/11/15 |
| 05/11/2015 | FDA/OMPT/CDER/ORP/DIDP/ | Exeltis | NDA 016954 |
| 05/11/2015 | FDA/OGROP/ORA/SW-FO/KAN-DO/KAN-CB/ | Precision Biologic Inc. | BIO-MEDICAL INC, OVERLAND PARK, KS – EIR, INVESTIGATOR NOTES, 483 03/01/1994 – 10/31/2012 |
| 05/11/2015 | FDA/OMPT/CDER/ORP/DIDP/ | Exeltis | NDA 017031 |
| 05/11/2015 | FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDER/ORP/DIDP/ | Pharma Medica Research Inc. | PHARMA MEDICA RESEARCH INC, CANADA – EIR 03/16/2015 – 03/27/2015 |
| 05/11/2015 | FDA/OMPT/CDRH/OCER/DFOI/ | MIC International Corp. | K091935 |
| 01/20/2015 | FDA/OMPT/CDER/ORP/DIDP/ | MERCK & CO., INC. | 9797153, 9805305, 9921411 ETC |
| 05/11/2015 | FDA/OC/OES/DFOI/ | Govzilla, Inc. | LIST OF FOIA REQUESTS LAST 12 MONTHS |
| 05/11/2015 | FDA/OMPT/CDER/ORP/DIDP/ | Govzilla, Inc. | CANGENE CORPORATION, CANADA – EIR 02/03/2015 – 02/03/2015 |
| 05/11/2015 | FDA/OMPT/CDER/ORP/DIDP/ | Center for the Study of Empathic Therapy | 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 |
| 05/11/2015 | FDA/OMPT/CDER/ORP/DIDP/ | Coriell Life Sciences | ADR DATA 01/01/2012 – 12/31/2014 |
| 05/11/2015 | FDA/OMPT/CDRH/OCER/DFOI/ | Katecho, Inc | K110825 |
| 05/11/2015 | FDA/OMPT/CDRH/OCER/DFOI/ | Vikas Khurana | K003332, MEDITHERM RESPONSE TO WARNING LETTER |
| 05/11/2015 | FDA/OMPT/CDER/ORP/DIDP/ | Dr. Reddy’s Laboratories Inc. | NDA 017422 |
| 05/11/2015 | FDA/OMPT/CDRH/OCER/DFOI/ FDA/OC/OES/DFOI/ | MEDIVATORS INC | K09056 |
| 05/11/2015 | FDA/OMPT/CDRH/OCER/DFOI/ | MEDIVATORS INC | K123546 |
| 05/11/2015 | FDA/OMPT/CTP/OD/ | FOI Services, Inc. | CTP GRANDFATHER DETERMINATIONS LIST 03/01/2011 – 03/31/2015 |
| 01/20/2015 | FDA/OMPT/CDER/ORP/DIDP/ | MERCK & CO., INC. | 9922370, 10024182 – MEDWATCH, SOURCE DOCUMENTS, DIRECT REPORTS |
| 05/11/2015 | OC/ORA/ OC/ORA/ORM/ FDA/OMPT/CDRH/OCER/DFOI/ | SAINT JOSEPH HOSPITAL | CLASS I MEDICAL DEVICE RECALLS 11/1/2002 |
| 05/11/2015 | FDA/OMPT/CDER/ORP/DIDP/ | FOI Services, Inc. | NDA 17469 |
| 05/11/2015 | FDA/OMPT/CDER/ORP/DIDP/ | FOI Services, Inc. | NDA 12107 |
| 05/11/2015 | FDA/OMPT/CDRH/OCER/DFOI/ | SI-TECHNOLOGY, LLC | K122538 |
| 05/11/2015 | FDA/OGROP/ORA/PA-FO/SEA-DO/SEA-CB/ | Stray Dog Cafe | CORR BETWEEN FDA AND MY CHAI RE WARNING LETTER VIOLATIONS 11/07/2014 – 05/08/2015 |
| 05/11/2015 | FDA/OMPT/CDER/ORP/DIDP/ | chang, melody | DOCETAXEL, TAXOTERE – AERS |
| 05/11/2015 | FDA/OMPT/CDER/ORP/DIDP/ | Keck Graduate Institute | NDA 021336, NDA 021708 |
| 05/11/2015 | FDA/OFVM/CFSAN/OCD/EOS/ | AMERICAN HERBAL PRODUCTS ASSOCIATION | DIETARY SUPPLEMENT AERS 07/01/2013 – 12/31/2014 |
| 05/11/2015 | FDA/OMPT/CDER/ORP/DIDP/ | Pike Photocopy, Inc. | COUNTERFEIT BOTOX – AERS, TOXICOLOGICAL EFFECTS |
| 05/11/2015 | OC/ORA/ FDA/OGROP/ORA/SW-FO/DAL-DO/DAL-CB/ | HOUSTON CHRONICLE | BLUE BELL CREAMERIES – LAB RESULTS, ENVIRONMENTAL ASSESSMENTS, ETC 02/01/2015 – 05/08/2015 |
| 01/20/2015 | FDA/OMPT/CDER/ORP/DIDP/ | MERCK & CO., INC. | 9959011, 9796988, 9880454 ETC – DIRECT REPORTS, MEDWATCH REPORTS, ANY SOURCE DOCUMENTS |
| 05/11/2015 | FDA/OC/OES/DFOI/ | Ennis & Ennis, P.A. | ESSURE – APPROVAL RECS |
| 05/11/2015 | FDA/OMPT/CDER/ORP/DIDP/ | Kennedy Capital Management | ZIOPTAN – SBA |
| 05/12/2015 | FDA/OC/OES/DDM/ FDA/OMPT/CDRH/OCER/DFOI/ | SEACH LAW OFCS | DORNIER MEDICAL SYSTEMS INC – LITHOTRIPTERS SS&E |
| 05/12/2015 | FDA/OC/OES/DFOI/ | Doe J | SODIUM PERBORATE MONOHYDRATE, POTASSIUM MONOPERSULFATE WARNINGS, RPTS, CONSUMER ALERTS, ETC |
| 05/12/2015 | FDA/OMPT/CDER/ORP/DIDP/ | CHARLES RIVER LABS | EUROFINS MEDINET, BREDA, THE NETHERLANDS – EIR 11/3-7/08 (REDACTED) |
| 05/12/2015 | FDA/OMPT/CDER/ORP/DIDP/ | SHEPPARD MULLIN RICHTER & HAMPTON, LLP | NOVARTIS – SANOREX (MAZINDOL) NDA 17-247 PI |
| 05/12/2015 | OC/ORA/ | BIERMANN, SHARON | METHODS FOR CONDUCTING RECALL EFFECTIVENESS CHECKS |
| 05/12/2015 | FDA/OMPT/CDRH/OCER/DFOI/ | KGUN-TV | BAYER HEALTHCARE PHARMACEUTICALS INC – ESSURE INVESTIGATION RESULTS 3/26/15 |
| 05/12/2015 | FDA/OMPT/CDER/ORP/DIDP/ | Doe J | FORTEO – AERS |
| 05/12/2015 | FDA/OMPT/CDRH/OCER/DFOI/ | GERMAINE LABORATORIES INC | SHEATHING TECHNOLOGIES INC – SHEATHES STERILE ULTRASOUND GEL K130041 |
| 01/20/2015 | FDA/OGROP/ORA/SE-FO/FLA-DO/FLA-CB/ | P & L Development, LLC | TEVA BRANDED PHARMACEUTICAL PRODUCTS R & D, MIAMI, FL – 483 01/01/2005 – 01/16/2015 |
| 05/12/2015 | FDA/OMPT/CDER/ORP/DIDP/ | Doe J | RANTIDINE – RECS, RISK FACTORS |
| 05/12/2015 | FDA/OMPT/CDRH/OCER/DFOI/ | FOI Services, Inc. | K132031 |
| 05/12/2015 | FDA/OMPT/CDER/ORP/DIDP/ | UNIVERSITY OF PITTSBURGH | POST MARKET REQUIREMENTS AND COMMITTMENT DATA SINCE 1970 |
| 05/12/2015 | FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CBER/OCOD/DDOM/ALFB/ | CARDIUM THERAPEUTICS | BB-IND 7471 |
| 05/12/2015 | FDA/OGROP/ORA/CE-FO/DET-DO/DET-CB/ | American Pharmaceutical Ingredients, LLC | AMERICAN PHARAMCEUTICAL INGREDIENTS, LLC, WATERFORD, MI – 483, EIR 01/01/2015 – 05/05/2015 |
| 05/12/2015 | FDA/OMPT/CDER/ORP/DIDP/ | Toronto Star | SMITHKLINE BEECHAM, CORK, IRELAND HOSPIRA HEALTHCARE INDIA WYETH LEDERLE, ITALY ETC – 483 |
| 05/12/2015 | FDA/OGROP/ORA/SW-FO/DAL-DO/DAL-CB/ OC/ORA/ORM/ | THE DALLAS MORNING NEWS | LIST OF FOOD SAFETY INSPECTIONS IN TEXAS, LISTERIA RECS, BLUE BELL CORR 01/01/2012 – 05/10/2015 |
| 05/12/2015 | FDA/OGROP/ORA/SE-FO/FLA-DO/FLA-CB/ FDA/OMPT/CDRH/OCER/DFOI/ | Doe J | INDIVIDUAL RECS |
| 05/12/2015 | FDA/OFVM/CFSAN/OCD/EOS/ | The Dow Chemical Company | FCN 1505 |
| 05/12/2015 | FDA/OMPT/CDRH/OCER/DFOI/ FDA/OC/OES/DFOI/ | Epic International (Thailand) Co., Ltd. | K944692 |
| 01/20/2015 | FDA/OMPT/CDRH/OCER/DFOI/ | LC Therapeutics | K142120, K133017 |
| 05/12/2015 | FDA/OC/OES/DFOI/ | FOI Services, Inc. | 2013-5575, 2013-7111, 2014-8117 |
| 05/12/2015 | FDA/OC/OES/DFOI/ | MERCK & CO., INC. | 2015-3128 – REQUEST LETTER ONLY |
| 05/12/2015 | FDA/OC/OES/DFOI/ | MERCK & CO., INC. | 2015-2821 – REQUEST LETTER ONLY |
| 05/12/2015 | FDA/OC/OES/DFOI/ | MERCK & CO., INC. | 2015-3170 – REQUEST LETTER ONLY |
| 05/12/2015 | FDA/OC/OES/DFOI/ | MERCK & CO., INC. | 2015-2756 – REQUEST LETTER ONLY |
| 05/12/2015 | FDA/OC/OES/DFOI/ | MERCK & CO., INC. | 2015-3182 – REQUEST LETTER ONLY |
| 05/12/2015 | FDA/OC/OES/DFOI/ | MERCK & CO., INC. | 2015-2743 – REQUEST LETTER ONLY |
| 05/12/2015 | FDA/OC/OES/DFOI/ | MERCK & CO., INC. | 2015-3219 – REQUEST LETTER ONLY |
| 05/12/2015 | FDA/OC/OES/DFOI/ | MERCK & CO., INC. | 2015-2675 – REQUEST LETTER ONLY |
| 05/12/2015 | FDA/OC/OES/DFOI/ | MERCK & CO., INC. | 2015-3305 – REQUEST LETTER ONLY |
| 01/20/2015 | FDA/OMPT/CDRH/OCER/DFOI/ | Joseph Saveri Law Firm, Inc. | EMKINETICS, INC – RECS SUBMITTED BY OR PERTAINING TO CE MARK AND 510K CLEARANCE 07/01/2011 – 06/30/2013 |
| 05/12/2015 | FDA/OC/OES/DFOI/ | MERCK & CO., INC. | 2015-2655 – REQUEST LETTER ONLY |
| 05/12/2015 | FDA/OC/OES/DFOI/ | MERCK & CO., INC. | 2015-3332 – REQUEST LETTER ONLY |
| 05/12/2015 | FDA/OC/OES/DFOI/ | MERCK & CO., INC. | 2015-2653 – REQUEST LETTER ONLY |
| 05/12/2015 | FDA/OC/OES/DFOI/ | MERCK & CO., INC. | 2015-3431 – REQUEST LETTER ONLY |
| 05/12/2015 | FDA/OC/OES/DFOI/ | MERCK & CO., INC. | 2015-2634 – REQUEST LETTER ONLY |
| 05/12/2015 | FDA/OC/OES/DFOI/ | MERCK & CO., INC. | 2015-3336 – REQUEST LETTER ONLY |
| 05/12/2015 | FDA/OC/OES/DFOI/ | MERCK & CO., INC. | 2015-2622 – REQUEST LETTER ONLY |
| 05/12/2015 | FDA/OC/OES/DFOI/ | MERCK & CO., INC. | 2015-3443 – REQUEST LETTER ONLY |
| 05/13/2015 | FDA/OMPT/CDRH/OCER/DFOI/ | Medication Control Systems, LLC | DEN060002/K051338, K150174 |
| 05/13/2015 | FDA/OMPT/CDRH/OCER/DFOI/ | Imangel Consulting | K140306, K130943 |
| 01/20/2015 | FDA/OMPT/CDRH/OCER/DFOI/ FDA/OC/OES/DFOI/ | International Biophysics Corporation | K991864 |
| 05/13/2015 | FDA/OMPT/CDER/ORP/DIDP/ | Teva Pharmacueticals | PROAIR RESPCLICK 205636 AERS |
| 05/13/2015 | FDA/OMPT/CDER/ORP/DIDP/ | Teva Pharmacueticals | SYNRIBO AERS |
| 05/13/2015 | FDA/OMPT/CDER/ORP/DIDP/ | Teva Pharmaceuticals | QUARTETTE – AERS |
| 05/13/2015 | FDA/OMPT/CDER/ORP/DIDP/ | LACHMAN CONSULTANT SERVICES, INC. | NDA 021008 S030 |
| 05/13/2015 | FDA/OMPT/CDER/ORP/DIDP/ | Teva Pharmaceuticals | QNASL – AERS |
| 05/13/2015 | FDA/OMPT/CDER/ORP/DIDP/ | LACHMAN CONSULTANT SERVICES, INC. | NDA 021008 S030 |
| 05/13/2015 | FDA/OMPT/CDER/ORP/DIDP/ | Teva Pharmaceuticals | ADASUVE – AERS |
| 05/13/2015 | FDA/OMPT/CDER/ORP/DIDP/ | Teva Pharmaceuticals | TBO-FILGRASTIM – AERS |
| 05/13/2015 | FDA/OGROP/ORA/SE-FO/SJN-DO/SJN-CB/ | Ridout Lyon + Ottoson LLP | AMGEN, JUNCOS, PUERTO RICO – INSPECTION RECS, WARNING LETTERS 10/01/2013 – 05/01/2015 |
| 05/13/2015 | FDA/OMPT/CDRH/OCER/DFOI/ | FOI Services, Inc. | SENZA SYSTEM PMA |
| 01/20/2015 | FDA/OC/OL/ FDA/OGROP/ORA/SE-FO/ATL-DO/ATL-CB/ FDA/OMPT/CBER/OCOD/DDOM/ALFB/ FDA/OC/OES/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ | FOI Services, Inc. | CORR RE APLIGRAP, DERMAGRAF, EPIFIX, ETC |
| 05/13/2015 | OC/ORA/ FDA/OGROP/ORA/SW-FO/DAL-DO/DAL-CB/ FDA/OGROP/ORA/SE-FO/NOL-DO/NOL-CB/ | THE WALL STREET JOURNAL | BLUE BELL CREAMERIES – INSPECTION RECS 01/01/2012 – 05/12/2015 |
| 05/13/2015 | FDA/OMPT/CDER/ORP/DIDP/ | Teva Pharmaceuticals | ARGATROBAN – AERS |
| 05/13/2015 | FDA/OMPT/CDER/ORP/DIDP/ | Registrar Corp | DMF SPREADSHEET |
| 05/13/2015 | FDA/OMPT/CDRH/OCER/DFOI/ | COVINGTON & BURLING LLP | NEOMEDIX CORP – WARNING LTR, CO RESP 2/2/14 |
| 05/13/2015 | OC/ORA/ FDA/OGROP/ORA/SW-FO/DAL-DO/DAL-CB/ | PRITZKER OLSEN | BLU BELL CREAMERIES – LYSTERIA OUTBREAK |
| 05/13/2015 | FDA/OMPT/CDRH/OCER/DFOI/ | NATUS MANUFACTURING LTD | NATUS MANUFATURING LTD – EIR 1/20-23/14 |
| 05/13/2015 | FDA/OC/OES/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OO/OHR/ | Doe J | INDIVIDUAL RECS |
| 05/13/2015 | OC/ORA/ORM/ | ATTENTION TO DETAIL | DRUG, BIOLOGIC, MEDICAL DVC, DIETARY SUPPLEMENTS – ADDRESS DATABASE |
| 05/13/2015 | FDA/OMPT/CDER/ORP/DIDP/ | HOGAN LOVELLS US LLP | ROXANE LABORATORIES INC – REMS FOR ALOSETRON PRODUCTS |
| 05/13/2015 | FDA/OMPT/CBER/OCOD/DDOM/ALFB/ | Doe J | INDIVIDUAL RECS |
| 01/20/2015 | FDA/OGROP/ORA/PA-FO/LOS-DO/LOS-CB/ | Celerion, Inc. | CELERION, INC, TEMPE, AZ – EIR 08/13/2013 – 08/22/2013 |
| 05/13/2015 | FDA/OMPT/CBER/OCOD/DDOM/ALFB/ | MICHAEL S OLIN PA | INTRA LOCK INTL BK110053 |
| 05/13/2015 | FDA/OMPT/CDER/ORP/DIDP/ | GIDEON COOPER & ESSARY | CASE NOS 4184938, 5671663, 6034579 |
| 05/13/2015 | FDA/OMPT/CDER/ORP/DIDP/ | NAIR & LEVIN PC | DELALUTIN – AERS, STUDIES, CMPLNTS, ETC |
| 05/13/2015 | FDA/OC/OES/DFOI/ | FAEGRE BAKER DANIELS | GUIDANT ANCURE ENDOGRAFT SYS – RECALL, CORR, INVESTIGATION RECS, ETC |
| 05/14/2015 | FDA/OMPT/CDRH/OCER/DFOI/ | EMORY UNIVERSITY | K080650 |
| 05/14/2015 | FDA/OMPT/CDER/ORP/DIDP/ | PureTek Corporation | ANDA 088042, ANDA 74514 APPROVAL LETTERS |
| 05/14/2015 | FDA/OMPT/CDRH/OCER/DFOI/ | N/A | K123985 |
| 05/14/2015 | FDA/OMPT/CDER/ORP/DIDP/ | Real Life Sciences | HUMIRA, ENBREL – AERS |
| 05/14/2015 | FDA/OGROP/ORA/PA-FO/LOS-DO/LOS-CB/ | Drug Quality Assurance, LLC | ADVANCED COSMETIC RESEARCH LABORATORIES, CHATTSWORTH, CA – EIR, 483, WARNING LETTER 01/01/2011 – 05/12/2015 |
| 05/14/2015 | FDA/OC/OES/DFOI/ | LexisNexis CourtLink | 2015-3223 |
| 01/05/2015 | FDA/OMPT/CDER/ORP/DIDP/ | Doe J | ISR 3760332 |
| 01/20/2015 | FDA/OMPT/CDER/ORP/DIDP/ OC/ORA/ FDA/OGROP/ORA/ORO/DIOP/ | Fanwood Chemical Inc | TRICLOSAN NOTICE OF ARRIVALS |
| 05/14/2015 | FDA/OGROP/ORA/SW-FO/DAL-DO/DAL-CB/ | Carlton Fields Jorden Burt | DERMAMEDICS LLC – RECALL RECS ETC |
| 05/14/2015 | OC/ORA/ORM/ OC/CVM/OCD/ FDA/OMPT/CBER/OCOD/DDOM/ALFB/ FDA/OMPT/CDER/ORP/DIDP/ | Wendy Kowal | LIST OF FIRMS APPROVED FOR COLLECTION OF PMSG |
| 05/14/2015 | FDA/OGROP/ORA/PA-FO/SEA-DO/SEA-CB/ | FDA NEWS | CORTEX MANUFACTURING INC, LAKE STEVENS, WA DENTAL ALLIANCE HOLDINGS LLC, ALBANY, OR SPIRATION INC, REDMOND, WA, ETC – 483S 4/1-30/15 |
| 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 |
| 05/14/2015 | FDA/OGROP/ORA/SE-FO/FLA-DO/FLA-CB/ | FDA NEWS | CFS DENTAL INC, HIALEAH, FL ULTROID TECHNOLOGIES INC, TAMPA, FL GENICO INC, WINTER PARK, FL, ETC – 4/1-30/15 |
| 05/14/2015 | FDA/OGROP/ORA/SW-FO/KAN-DO/KAN-CB/ | FDA NEWS | PETNET SOLUTIONS INC, OVERLAND PARK, KS HOSPIRA INC, MCPHERSON, KS WEEKS & LEO CO INC, ETC – 483S 4/1-30/15 |
| 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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