Recently Requested 483s
December 2016 |
||
District | Inspection Date | Firm Name |
ATL-DO | 12/2/2016 | Bestcare, LLC |
ATL-DO | 12/14/2016 | STERIMED, Inc. |
ATL-DO | 12/21/2016 | medi Manufacturing Inc |
BLT-DO | 12/8/2016 | Ohmeda Medical |
BLT-DO | 12/19/2016 | Qiagen Sciences LLC |
CDER | 12/1/2016 | South Pacific Sera Limited |
CDER | 12/1/2016 | Sun Pharmaceutical Industries Ltd. |
CDER | 12/1/2016 | Qinhuangdao Zizhu Pharmaceutical, Co. |
CDER | 12/2/2016 | Aesica Pharmaceuticals GmbH |
CDER | 12/6/2016 | Divi's Laboratories Ltd. (Unit II) |
CDER | 12/9/2016 | Kothari Phytochemicals International |
CDER | 12/9/2016 | Tongling Jieya Biological Technology Stock Co. Ltd. |
CDER | 12/13/2016 | Pfizer Perth Pty Ltd. |
CDER | 12/14/2016 | Xiamen Nature Caring Products Co Ltd |
CDER | 12/14/2016 | Henan Kangdi Medical Devices Co. Ltd |
CDER | 12/16/2016 | Apollo Health And Beauty Care |
CDER | 12/16/2016 | Hetero Labs Limited Unit V |
CDRH | 12/1/2016 | Master And Frank Enterprise. Co., Ltd. |
CDRH | 12/1/2016 | Dio Medical Co. Ltd. |
CDRH | 12/8/2016 | Molteno Ophthalmic Limited |
CDRH | 12/8/2016 | The Binding Site Group, Ltd. |
CDRH | 12/8/2016 | Panpac Medical Corporation |
CDRH | 12/8/2016 | Alliance International Co., Ltd |
CDRH | 12/8/2016 | Rudischhauser Surgical Instruments Manufacturing GmbH |
CDRH | 12/8/2016 | Jiangsu Jumao Medical Equipment Co., Ltd. |
CDRH | 12/14/2016 | FUJIFILM Techno Products Co. Ltd. |
CDRH | 12/15/2016 | Tedec-Meiji Farma, S.A. |
CDRH | 12/15/2016 | Headstar Medical Products Co., Ltd. |
CDRH | 12/15/2016 | Hubei Haixin Protective Product Group Co., Ltd. |
CDRH | 12/22/2016 | Okamoto Rubber Products Co., Ltd. |
CHI-DO | 12/13/2016 | Prime Dental Manufacturing, Inc. |
CIN-DO | 12/2/2016 | Rhinosystems Inc |
CIN-DO | 12/2/2016 | CIL Isotope Separations, LLC |
CIN-DO | 12/7/2016 | US Endoscopy Group Inc |
CIN-DO | 12/9/2016 | Dick Medical Supply LLC |
DEN-DO | 12/8/2016 | BLA Enterprises, LLC |
DEN-DO | 12/9/2016 | Cerapedics, Inc. |
DEN-DO | 12/12/2016 | CoRE labs, LLC |
DET-DO | 12/22/2016 | TALEM TECHNOLOGIES LLC. |
FLA-DO | 12/6/2016 | Biorep Technologies, Inc. |
FLA-DO | 12/9/2016 | Acorn Stairlifts Inc |
FLA-DO | 12/13/2016 | VistaPharm, Inc. |
FLA-DO | 12/13/2016 | Command Medical Products, Inc. |
KAN-DO | 12/6/2016 | Heartland Tanning Inc |
KAN-DO | 12/14/2016 | Aire-Master of America Inc |
KAN-DO | 12/21/2016 | Fundus Photo, LLC |
LOS-DO | 12/2/2016 | University of Southern CA, DBA USC Molecular Imaging Center |
LOS-DO | 12/7/2016 | International Medication Systems Limited |
LOS-DO | 12/8/2016 | Lusys Laboratories, Inc. |
LOS-DO | 12/12/2016 | Vita-Herb Nutriceuticals Inc |
LOS-DO | 12/16/2016 | Strata Skin Sciences, Inc. |
LOS-DO | 12/23/2016 | Vitaminerals, Inc. |
NOL-DO | 12/13/2016 | Bayer Healthcare, LLC |
NWE-DO | 12/8/2016 | Suture Concepts |
NWE-DO | 12/9/2016 | OBP Medical Corporation |
NWE-DO | 12/13/2016 | Tesco Associates, Inc. |
NWJ-DO | 12/5/2016 | Actavis Elizabeth LLC |
NWJ-DO | 12/6/2016 | Guardian Drug Co. Inc. |
NYK-DO | 12/2/2016 | Ascent Consumer Products Inc. |
NYK-DO | 12/6/2016 | Fallon Wellness Pharmacy, L.L.C. |
NYK-DO | 12/16/2016 | Repro-Med Systems, Inc. |
NYK-DO | 12/21/2016 | Jd888 Llc |
NYK-DO | 12/22/2016 | Magellan Rx Pharmacy, LLC |
PHI-DO | 12/1/2016 | Premier Medical Manufacturing |
SAN-DO | 12/13/2016 | Bayer HealthCare, LLC |
SEA-DO | 12/7/2016 | Kent Laboratories, Inc. |
November 2016 |
||
District | Inspection Date | Firm Name |
ATL-DO | 11/4/2016 | Avadim Technologies Inc. |
ATL-DO | 11/4/2016 | The See Clear Company |
ATL-DO | 11/7/2016 | Ablexan Corporation |
BLT-DO | 11/3/2016 | Life Technologies Corporation |
BLT-DO | 11/8/2016 | DT MedTech, LLC |
CDER | 11/3/2016 | Guangzhou St Eva Fine Chemical Co. Ltd. |
CDER | 11/4/2016 | Eli Lilly Italia SPA |
CDER | 11/11/2016 | Aesica Queenborough Limited |
CDER | 11/11/2016 | Ebewe Pharma Ges.m.b.H.Nfg. KG |
CDER | 11/11/2016 | Suzhou Amerigen Pharmaceutical |
CDER | 11/18/2016 | Teva Canada Limited |
CDER | 11/18/2016 | Zhejiang Huahai Pharmaceutical Co., Ltd. |
CDRH | 11/3/2016 | Medos Sarl |
CDRH | 11/4/2016 | Eli Lilly Italia SPA |
CDRH | 11/10/2016 | Jabil Circuit Singapore Pte Ltd |
CDRH | 11/10/2016 | Fiagon GmbH |
CDRH | 11/10/2016 | Fujirebio Europe NV |
CDRH | 11/18/2016 | Roche Diagnostics GmbH |
CDRH | 11/18/2016 | Creganna Medical Pte Ltd |
CDRH | 11/24/2016 | Symmetry Medical Malaysia Sdn Bhd (758243-m) |
CHI-DO | 11/18/2016 | Bion Enterprises Ltd. |
CIN-DO | 11/8/2016 | Klarity Medical Products LLC |
CIN-DO | 11/9/2016 | Criterion Tool & Die Inc |
CIN-DO | 11/10/2016 | Teva Womens Health Inc |
CIN-DO | 11/16/2016 | Percuvision Llc |
CIN-DO | 11/16/2016 | Cardinal Spine |
DAL-DO | 11/10/2016 | Sovereign Pharmaceuticals, LLC |
DEN-DO | 11/3/2016 | NEBA Health LLC |
DEN-DO | 11/7/2016 | KORR Medical Technologies, Inc. |
DEN-DO | 11/10/2016 | Shippert Medical Technologies |
DET-DO | 11/10/2016 | Contour Fabricators Inc |
FLA-DO | 11/1/2016 | Dharma Research Inc |
FLA-DO | 11/10/2016 | CoreRx Inc. |
FLA-DO | 11/15/2016 | OMT, LLC |
FLA-DO | 11/17/2016 | Medical Energy, Inc. |
FLA-DO | 11/18/2016 | ECI Pharmaceuticals LLC |
KAN-DO | 11/28/2016 | Hi-Dow International Inc |
LOS-DO | 11/10/2016 | Illumina Inc. (Carroll Park facility) |
LOS-DO | 11/14/2016 | Koros USA, Inc. |
MIN-DO | 11/10/2016 | Cardiac Science Corporation |
NOL-DO | 11/3/2016 | Preferred Medical Products Inc |
NOL-DO | 11/17/2016 | Royal Precision Plastics |
NWE-DO | 11/4/2016 | SRS Medical Systems Inc. |
NWE-DO | 11/9/2016 | MIRA, Inc. |
NWE-DO | 11/15/2016 | Diabetic Dabs Inc. |
NWJ-DO | 11/4/2016 | Water-Jel Technologies, LLC |
NWJ-DO | 11/8/2016 | InvaTech Pharma Solutions, LLC |
NYK-DO | 11/1/2016 | Tangram Company Llc |
NYK-DO | 11/1/2016 | Chartwell Pharmaceuticals LLC |
NYK-DO | 11/2/2016 | Allegiant Health |
NYK-DO | 11/10/2016 | Fougera Pharmaceuticals, Inc. |
NYK-DO | 11/18/2016 | Intersurgical Inc |
PHI-DO | 11/29/2016 | Standard Homeopathic Company |
SAN-DO | 11/2/2016 | Depomed, Inc. |
SAN-DO | 11/8/2016 | AMPAC Fine Chemicals LLC |
SAN-DO | 11/8/2016 | Pulmonx, Corp. |
SAN-DO | 11/8/2016 | Thayer Intellectual Property, Inc. |
SEA-DO | 11/4/2016 | The Herbalist, Inc. |
SJN-DO | 11/16/2016 | Cardinal Health PR 218 Inc |
SJN-DO | 11/18/2016 | Bristol Myers Squibb Manufacturing Company |
SJN-DO | 11/28/2016 | AMO Puerto Rico Manufacturing, Inc. |
October 2016 |
||
District | Inspection Date | Firm Name |
ATL-DO | 10/5/2016 | Bausch & Lomb Inc- Greenville Solutions Plant |
BLT-DO | 10/17/2016 | Calwood Nutritionals, LLC. |
BLT-DO | 10/19/2016 | AIV, Inc |
CDER | 10/3/2016 | Star Lake Bioscience Co. Inc. Zhaoqing Guangdong |
CDER | 10/7/2016 | Vijayasri Organics Ltd |
CDER | 10/14/2016 | Dabur India Limited |
CDER | 10/18/2016 | Vikshara Trading & Investments Ltd. |
CDER | 10/24/2016 | Laboratorios Roldan S.A. |
CDER | 10/27/2016 | Nifty Labs Pvt Ltd |
CDER | 10/28/2016 | Caplin Point Laboratories Ltd |
CDRH | 10/13/2016 | Planer PLC |
CDRH | 10/13/2016 | Clement Clarke International, Ltd. |
CDRH | 10/13/2016 | Shalon Chemical Industries Ltd. |
CDRH | 10/26/2016 | Best Medical Canada |
CIN-DO | 10/25/2016 | Pemco Inc |
CIN-DO | 10/26/2016 | Nuvasive Inc |
DAL-DO | 10/7/2016 | Phillips Co. |
DAL-DO | 10/14/2016 | Cantrell Drug Company |
DEN-DO | 10/7/2016 | dBMEDx, Inc |
DEN-DO | 10/12/2016 | Nova Homeopathic Therapeutics Inc |
DEN-DO | 10/21/2016 | Sontec Instruments, Inc |
DEN-DO | 10/21/2016 | Inovar Inc |
DET-DO | 10/7/2016 | Acumedia Manufacturers, Inc. |
DET-DO | 10/12/2016 | Nice-Pak Products, Inc. |
FLA-DO | 10/5/2016 | XZeal Technologies, Inc. |
FLA-DO | 10/21/2016 | Oxygen Therapy Institute |
FLA-DO | 10/28/2016 | Protech Professional Products, Inc. |
KAN-DO | 10/4/2016 | Talk To Me Technologies |
KAN-DO | 10/12/2016 | Hansen Ophthalmic Development Lab Inc |
KAN-DO | 10/25/2016 | Care-Tech Laboratories, Inc. |
MIN-DO | 10/3/2016 | Spectrum Plastics Group, Inc. |
NOL-DO | 10/3/2016 | Precision Fabrics Group Inc. |
NOL-DO | 10/12/2016 | Compass Health Brands Corp. |
NOL-DO | 10/13/2016 | Cool Renewal LLC |
NOL-DO | 10/21/2016 | Customer Service Associates, LLC |
NWE-DO | 10/4/2016 | Corindus Inc |
NWE-DO | 10/14/2016 | Tropical Products Inc |
NWE-DO | 10/18/2016 | High Technology, Inc. |
NWE-DO | 10/20/2016 | Cardiopulmonary Corporation |
NWE-DO | 10/20/2016 | Bernoulli Enterprise, Inc. |
NWE-DO | 10/24/2016 | Ninepoint Medical Inc. |
NWE-DO | 10/25/2016 | Insulet Corporation |
NWE-DO | 10/25/2016 | Beacon Prescriptions |
NYK-DO | 10/5/2016 | Summit Research Labs, Inc. |
NYK-DO | 10/14/2016 | American Cleaning Solutions |
NYK-DO | 10/27/2016 | Cosco Enterprises Inc. |
SAN-DO | 10/7/2016 | Cell Marque Corporation |
SEA-DO | 10/12/2016 | United Contact Lens, Inc. |
SJN-DO | 10/3/2016 | Baxter Healthcare Corporation |
SJN-DO | 10/3/2016 | Warner Chilcott Company LLC |
SJN-DO | 10/7/2016 | Becton Dickinson Caribe LTD |
September 2016 |
||
District | Inspection Date | Firm Name |
ATL-DO | 9/16/2016 | East Coast Oxygen & Hydro Testing Inc. |
BLT-DO | 9/6/2016 | NovaSom, Inc. |
BLT-DO | 9/15/2016 | Terumo Cardiovascular Systems Corporation |
CDER | 9/1/2016 | Tianjin Tianyao Pharmaceuticals Co., Ltd |
CDER | 9/2/2016 | Cosmetique Active Production |
CDER | 9/2/2016 | Qilu Antibiotics (Linyi) Pharmaceutical Co. Ltd. |
CDER | 9/2/2016 | Bath Concept Cosmetics (DongGuan) Co., Ltd. |
CDER | 9/2/2016 | Tianjin Tianyao Pharmaceuticals Co., Ltd. |
CDER | 9/2/2016 | Auropeptides |
CDER | 9/6/2016 | Shashi Phytochemical Industries |
CDER | 9/7/2016 | Patheon Italia S.P.A. |
CDER | 9/8/2016 | Frike Cosmetic Ag |
CDER | 9/9/2016 | Laboratoire de Biologie Vegetal Yves Rocher |
CDER | 9/9/2016 | ILDONG PHARMACEUTICAL Co., Ltd. |
CDER | 9/14/2016 | Mylan Laboratories Limited, (Nashik FDF) |
CDER | 9/14/2016 | Shanghai Yinjing Medical Supplies Co., Ltd. |
CDER | 9/14/2016 | Xinyu Pharmaceutical Co., Ltd. |
CDRH | 9/1/2016 | Ashitaka Factory of Terumo Corporation |
CDRH | 9/2/2016 | Gynetech PTY LTD |
CDRH | 9/7/2016 | Jk Holding Gmbh |
CDRH | 9/8/2016 | Narishige Co. Ltd |
CHI-DO | 9/26/2016 | Anchor Products Company, Inc. |
CHI-DO | 9/27/2016 | Medstrat, Inc. |
CIN-DO | 9/6/2016 | Woodbine Products Co Inc |
CIN-DO | 9/7/2016 | Natural Essentials Inc |
CIN-DO | 9/8/2016 | Control Bionics |
CIN-DO | 9/16/2016 | Crosbys Drugs Inc |
DAL-DO | 9/1/2016 | MOORE'S PHARMACY INC |
DAL-DO | 9/14/2016 | Healix Infusion Therapy, Inc. |
DAL-DO | 9/15/2016 | Wal-Mart Optical Labs |
DAL-DO | 9/16/2016 | Surgik LC |
DET-DO | 9/1/2016 | Flotec, Inc. |
DET-DO | 9/7/2016 | Panoramic Rental Corp. |
FLA-DO | 9/1/2016 | Actigraph, LLC |
FLA-DO | 9/8/2016 | Powers Medical Devices, LLC |
FLA-DO | 9/14/2016 | Isolux, LLC |
FLA-DO | 9/28/2016 | LAR NE, LLC |
KAN-DO | 9/14/2016 | Aesculap Inc |
LOS-DO | 9/1/2016 | LTW Tech LLC |
LOS-DO | 9/2/2016 | CoValence, Inc. |
LOS-DO | 9/9/2016 | Cianna Medical, Inc. |
LOS-DO | 9/9/2016 | Crown Peak Industries, LLC |
LOS-DO | 9/15/2016 | Icrco, Inc. |
NOL-DO | 9/2/2016 | Mooney's Pharmacy, Inc. |
NOL-DO | 9/14/2016 | Owen Biosciences Inc. |
NOL-DO | 9/14/2016 | Advanced Breath Diagnostics, LLC dba Cairn Diagnostics |
NWE-DO | 9/1/2016 | Data Innovations, LLC |
NWE-DO | 9/2/2016 | Johnson Matthey Pharma Services |
NWE-DO | 9/8/2016 | WCW, Inc. |
NWE-DO | 9/8/2016 | Allurion Technologies, Inc. |
NWE-DO | 9/20/2016 | Concert Medical, LLC |
NWE-DO | 9/21/2016 | Codman & Shurtleff, Inc. |
NWE-DO | 9/23/2016 | Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc. |
NYK-DO | 9/1/2016 | Valeant Pharmacueticals International |
NYK-DO | 9/2/2016 | Accord Media, LLC |
PHI-DO | 9/7/2016 | MTI Precision Products LLC. |
SAN-DO | 9/9/2016 | Wei Laboratories, Inc. |
SAN-DO | 9/20/2016 | Covidien, LLC |
SEA-DO | 9/19/2016 | Precision Interconnect, LLC dba TE Connectivity Medical |
SEA-DO | 9/20/2016 | Montana Compounding Pharmacy P.C. |
August 2016 |
||
District | Inspection Date | Firm Name |
ATL-DO | 8/5/2016 | Illumination Technologies, LLC |
ATL-DO | 8/5/2016 | Absonutrix |
BLT-DO | 8/10/2016 | FiberTech RoMack, Leoni Fiber Optics, Inc. |
BLT-DO | 8/17/2016 | Agent Medical, LLC |
CDER | 8/5/2016 | Shionogi Pharma Chemicals Co., Ltd. |
CDER | 8/5/2016 | SHANDONG HAIYAN MEDICAL MANUFACTURE CO., LTD. |
CDER | 8/5/2016 | Auronext Pharma |
CDER | 8/12/2016 | 3M Health Care, Ltd. |
CDER | 8/17/2016 | Zhejiang Bangli Medical Products Co., Ltd |
CDER | 8/19/2016 | Merro Pharmaceutical Co., Ltd. |
CDER | 8/19/2016 | Lonza Guangzhou Nansha Ltd. |
CIN-DO | 8/1/2016 | Devicor Medical Products Inc |
CIN-DO | 8/3/2016 | Troy Innovative Instruments Inc |
CIN-DO | 8/12/2016 | Western / Scott Fetzer Company |
DAL-DO | 8/5/2016 | Chemtrade Solutions, LLC |
DAL-DO | 8/5/2016 | Mindways Software, Inc. |
DAL-DO | 8/11/2016 | Phillips Co. |
DAL-DO | 8/19/2016 | Morton Salt Inc |
DET-DO | 8/2/2016 | ROMD, LLC |
FLA-DO | 8/9/2016 | Pharmatech LLC |
LOS-DO | 8/18/2016 | World Club Supply Corp |
LOS-DO | 8/19/2016 | Denttio, Inc. |
NOL-DO | 8/3/2016 | Microtek Medical Inc |
NOL-DO | 8/3/2016 | Remendium Labs, LLC |
NWE-DO | 8/3/2016 | SRC Medical, Inc. |
NWE-DO | 8/3/2016 | Hamilton Thorne, Inc |
NWE-DO | 8/4/2016 | Pharmasol Corporation |
NWE-DO | 8/5/2016 | Cirtec Medical Systems, LLC |
NWE-DO | 8/11/2016 | Zyno Medical, LLC |
NWE-DO | 8/18/2016 | Bio-Med Devices, Inc. |
NWE-DO | 8/26/2016 | Renegade Wheelchairs, LLC |
NWE-DO | 8/31/2016 | The Helping Hand Company Alliance LLC |
NYK-DO | 8/1/2016 | Alexander Infusion LLC D/B/A Avanti Health Care |
NYK-DO | 8/9/2016 | Amneal Pharmaceuticals |
NYK-DO | 8/10/2016 | Aurora Labs, LLC |
PHI-DO | 8/1/2016 | ImprimisRx Pharmacy LLC |
PHI-DO | 8/2/2016 | Calumet Penreco LLC |
PHI-DO | 8/11/2016 | Copperhead Chemical Company, Inc. |
SAN-DO | 8/1/2016 | Miramar Labs, Inc. |
SAN-DO | 8/4/2016 | Everglo Natural Veterinary Services, Inc. |
SAN-DO | 8/4/2016 | Zevacor Pharma, Inc. |
SEA-DO | 8/22/2016 | Breast Microseed Inc |
SJN-DO | 8/9/2016 | Destileria Serralles, Inc. |
July 2016 |
||
District | Inspection Date | Firm Name |
ATL-DO | 7/22/2016 | Alexion Pharmaceuticals Inc |
ATL-DO | 7/28/2016 | St. Jude Medical |
BLT-DO | 7/1/2016 | Fareva Richmond, Inc. |
BLT-DO | 7/22/2016 | Eisai, Inc. |
CBER | 7/14/2016 | Octapharma AB |
CDER | 7/1/2016 | Bachem SA- Branch Vionnaz |
CDER | 7/1/2016 | Wanbury Limited |
CDER | 7/1/2016 | FDC Limited |
CDER | 7/1/2016 | Aurobindo Pharma Limited |
CDER | 7/1/2016 | Hospira Healthcare India Pvt. Ltd. |
CDER | 7/8/2016 | Biogen Idec (Denmark) Manufacturing ApS |
CDER | 7/8/2016 | Zhejiang Hisoar Chuannan Pharmaceutical Co. Ltd. |
CDER | 7/8/2016 | 4e De Mexico SA de CV |
CDER | 7/12/2016 | Ipsen Pharma Biotech |
CDER | 7/13/2016 | Zhejiang Huahai Pharmaceutical Co., Ltd. |
CDER | 7/22/2016 | Otsuka Pharmaceutical Co., Ltd. |
CDER | 7/28/2016 | Fukuzyu Pharmaceutical Co., Ltd. |
CDRH | 7/6/2016 | Sasmar Pharmaceutical SPRL |
CDRH | 7/7/2016 | Alcon Laboratories Ireland, Ltd |
CDRH | 7/7/2016 | TaeChang Industrial Co., Ltd. |
CDRH | 7/14/2016 | Labtician Ophthalmics Inc. |
CDRH | 7/14/2016 | Hong Qiangxing (Shen Zhen) Electronics Limited |
CDRH | 7/21/2016 | Takara Belmont Co. Ltd. |
CDRH | 7/21/2016 | Takara Medical Co Ltd |
CDRH | 7/27/2016 | DigiMed Corp |
CDRH | 7/28/2016 | Cardia Innovation AB |
CHI-DO | 7/11/2016 | Xttrium Laboratories, Inc. |
DAL-DO | 7/15/2016 | US Compounding Inc |
DET-DO | 7/28/2016 | Sterling Diagnostics, Inc. |
FLA-DO | 7/13/2016 | Ultroid Technologies, Inc. |
FLA-DO | 7/14/2016 | Audifon-USA, Inc. |
FLA-DO | 7/28/2016 | White Square Chemical |
LOS-DO | 7/22/2016 | Freudenberg Medical, LLC |
LOS-DO | 7/22/2016 | Neutraderm Inc. |
MIN-DO | 7/26/2016 | ARB Medical, LLC |
NOL-DO | 7/7/2016 | Vital Care Compounder, LLC |
NOL-DO | 7/19/2016 | Orchid Orthopedic Solutions Alabama LLC |
NOL-DO | 7/29/2016 | Dentsply Tulsa Dental Specialties |
NWE-DO | 7/7/2016 | AliMed Corporation |
NWE-DO | 7/12/2016 | VisionAid, Inc. |
NWE-DO | 7/13/2016 | Atrium Medical Corporation |
NWE-DO | 7/18/2016 | SleepNet Corporation |
NWE-DO | 7/21/2016 | Contract Medical Manufacturing |
NWE-DO | 7/26/2016 | Louis M. Gerson Co., Inc. |
NWE-DO | 7/27/2016 | Maine Oxygen Acetylene Supply Co., Inc. |
NYK-DO | 7/8/2016 | Circulatory Technology Inc |
NYK-DO | 7/12/2016 | Epimed International, Inc. |
NYK-DO | 7/15/2016 | Hi-Tech Pharmacal, an AKORN Company |
PHI-DO | 7/6/2016 | High Chemical Company, Div of National Generic Distributors |
SAN-DO | 7/6/2016 | Helio USA Inc |
SEA-DO | 7/27/2016 | Natus Medical Incorporated |
SEA-DO | 7/29/2016 | Langenburg Water Company |
SJN-DO | 7/22/2016 | Lantheus MI Radipharmaceuticals Inc. |
June 2016 |
||
District | Inspection Date | Firm Name |
BLT-DO | 6/2/2016 | Tubular Fabrications Industry, Inc. |
BLT-DO | 6/3/2016 | Triaid, Inc. |
BLT-DO | 6/6/2016 | Nuo Therapeutics |
BLT-DO | 6/16/2016 | Aerscher Diagnostics, LLC |
BLT-DO | 6/28/2016 | Option Care |
CBER | 6/15/2016 | Biofortuna Limited |
CDER | 6/1/2016 | Jinan Jinda Pharmaceutical Chemistry Co., Ltd. |
CDER | 6/1/2016 | Aurena Laboratories AB |
CDER | 6/2/2016 | Ningbo Dowland Daily Health Co., Ltd |
CDER | 6/3/2016 | Meiji Seika Pharma Co., Ltd. |
CDER | 6/3/2016 | Fermion OY |
CDER | 6/3/2016 | Sai Life Sciences Limited |
CDER | 6/3/2016 | American Hygienics Corporation |
CDER | 6/3/2016 | Delarange Cosmetics BV |
CDER | 6/7/2016 | Shenzhen Oriental Pharmaceutical Co Ltd |
CDER | 6/7/2016 | Shenyang Wanbang Tiansheng Biotechnology Co.,Ltd |
CDER | 6/8/2016 | N.V. Organon |
CDER | 6/8/2016 | Amneal Oncology Private Limited |
CDER | 6/9/2016 | Baoying County Fukang Medical Appliance Co., Ltd. |
CDER | 6/10/2016 | Mitsubishi Tanabe Pharma Factory Ltd. |
CDER | 6/10/2016 | Sato Yakuhin Kogyo Co., Ltd. |
CDER | 6/10/2016 | USV Limited |
CDER | 6/17/2016 | Sekisui Medical Co., Ltd. |
CDER | 6/17/2016 | MicroBiopharm Japan Co., Inc. |
CDER | 6/17/2016 | Temmentech AG |
CDER | 6/17/2016 | Syntese A/S |
CDER | 6/17/2016 | Meishan Tianxing Biological Products Co., Ltd. |
CDER | 6/22/2016 | Samsung Biologics Co. Ltd. |
CDER | 6/23/2016 | Laboratoire Sintyl S.A. |
CDER | 6/24/2016 | Henan Zhongpin Food Co., Ltd. |
CDER | 6/28/2016 | Linyi Xingcheng Jinluo Meat Products |
CDRH | 6/2/2016 | Anthogyr |
CDRH | 6/2/2016 | Envitec Wismar Gmbh |
CDRH | 6/2/2016 | Krell Precision (Yangzhou) Co Ltd |
CDRH | 6/2/2016 | TURON MEDTECH AB |
CDRH | 6/2/2016 | Hebumedical GMBH |
CDRH | 6/2/2016 | IMEDICOM CO., LTD |
CDRH | 6/3/2016 | Camurus Ab |
CDRH | 6/8/2016 | Shenzhen Pin Dental Laboratory Co Ltd |
CDRH | 6/9/2016 | Raimund Wenzler Gmbh |
CDRH | 6/9/2016 | Vygon Gmbh & Co. KG |
CDRH | 6/9/2016 | Hubei Weikang Protective Products Co., Ltd. |
CDRH | 6/9/2016 | Pendracare International B.V. |
CDRH | 6/9/2016 | Tontarra Medizintechnik Gmbh |
CDRH | 6/9/2016 | Alseal |
CDRH | 6/14/2016 | Bedfont Scientific, Ltd. |
CDRH | 6/15/2016 | Vygon |
CDRH | 6/15/2016 | Biofortuna Limited |
CDRH | 6/16/2016 | PSP Dental Co. Ltd. |
CDRH | 6/16/2016 | Leica Microsystems (Schweiz) Ag |
CDRH | 6/22/2016 | Qingdao O-Mec Medical Technology Co. Ltd |
CDRH | 6/23/2016 | TIANJIN SEASON TECHNOLOGY CO., LTD |
CDRH | 6/30/2016 | Implant Dental Technology Co., Ltd. |
CHI-DO | 6/2/2016 | E K Industries Inc |
CHI-DO | 6/9/2016 | Hydrox Laborataories |
CHI-DO | 6/10/2016 | Akorn, Inc. |
CHI-DO | 6/17/2016 | Medefil Incorporated |
CIN-DO | 6/24/2016 | Cintas Corporation |
CIN-DO | 6/28/2016 | Tosoh Bioscience Inc |
DAL-DO | 6/3/2016 | InterX Technologies |
DAL-DO | 6/9/2016 | Struckmyer Medical |
DAL-DO | 6/14/2016 | Dhaliwal Laboratories LLC |
DAL-DO | 6/15/2016 | Alphamed Inc |
DAL-DO | 6/23/2016 | Coastal Life Technologies, Inc. |
DAL-DO | 6/23/2016 | University of Texas Health Science Center RDRC |
DAL-DO | 6/29/2016 | Talon Compounding Pharmacy |
DAL-DO | 6/29/2016 | Cardiac Designs Inc. |
DEN-DO | 6/29/2016 | Isomeric Pharmacy Solution, LLC |
DET-DO | 6/10/2016 | PD Pharmatech, LLC |
DET-DO | 6/23/2016 | RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) |
DET-DO | 6/24/2016 | Ethox Medical, LLC |
DET-DO | 6/24/2016 | Physician's Technology, Llc |
FLA-DO | 6/6/2016 | Advanced Radiation Measurement, Inc. |
FLA-DO | 6/10/2016 | Valjean Corporation |
FLA-DO | 6/21/2016 | Synergy Pharmacy Services, Inc. |
FLA-DO | 6/27/2016 | Magnatone Hearing Aid Corp. DBA Persona Medical |
KAN-DO | 6/8/2016 | Hospira Inc |
KAN-DO | 6/21/2016 | Penner Mfg Inc |
LOS-DO | 6/1/2016 | Custom Research Labs Inc |
LOS-DO | 6/2/2016 | UNIVERSITY OF CALIFORNIA, LOS ANGELES |
LOS-DO | 6/6/2016 | A. R. Hinkel Company, Inc. |
LOS-DO | 6/6/2016 | Amgen, Inc. |
LOS-DO | 6/6/2016 | R & R Lotion Inc |
LOS-DO | 6/9/2016 | Vacumed, Div of Vacumetrics Inc |
LOS-DO | 6/10/2016 | Precision Pharmacy Center, LLC |
LOS-DO | 6/16/2016 | EEG Software LLC |
LOS-DO | 6/17/2016 | Private Label Partners, Inc. |
LOS-DO | 6/24/2016 | P&L Developments, LLC |
LOS-DO | 6/30/2016 | Life Science Outsourcing, Inc. |
MIN-DO | 6/16/2016 | American Orthodontics Corporation |
MIN-DO | 6/17/2016 | W & C dba The Apothecary |
NOL-DO | 6/28/2016 | Arciplex Llc |
NWE-DO | 6/3/2016 | Carwild Corporation |
NWE-DO | 6/3/2016 | Hologic, Inc. |
NWE-DO | 6/9/2016 | Hologic Incorporated |
NWE-DO | 6/16/2016 | Respiratory Delivery Systems |
NWE-DO | 6/17/2016 | EMD Serono, Inc. |
NWE-DO | 6/17/2016 | Wyeth BioPharma Division of Wyeth Pharmaceuticals Inc. |
NWE-DO | 6/24/2016 | Lymol Medical Corp |
NWE-DO | 6/27/2016 | Renchel Tool Inc. |
NWE-DO | 6/29/2016 | Tena Group LLC |
NWE-DO | 6/29/2016 | Focus Medical, LLC |
NWJ-DO | 6/22/2016 | Village Pharmacy |
NWJ-DO | 6/28/2016 | Sewaren Innovative Pharmaceutical Packaging dba SIPP |
NYK-DO | 6/10/2016 | Region Care, Inc. |
NYK-DO | 6/16/2016 | Ames Goldsmith Corporation |
NYK-DO | 6/30/2016 | Natrium Products Inc |
PHI-DO | 6/1/2016 | Troy Manufacturing, Inc. |
PHI-DO | 6/3/2016 | G&W PA Laboratories, LLC |
PHI-DO | 6/6/2016 | Enclara Pharmacia Inc |
PHI-DO | 6/20/2016 | Arrow International Inc |
SAN-DO | 6/3/2016 | Jajco, Inc. DBA Anchor Drugs Pharmacy |
SEA-DO | 6/3/2016 | Bend Research Inc. |
SEA-DO | 6/17/2016 | Parks Medical Electronics, Inc |
SEA-DO | 6/29/2016 | LightScalpel, LLC |
SJN-DO | 6/21/2016 | Patheon Puerto Rico, Inc. |
May 2016 |
||
District | Inspection Date | Firm Name |
ATL-DO | 5/3/2016 | Facet Technologies, LLC. |
ATL-DO | 5/5/2016 | Corning Incorporated |
ATL-DO | 5/12/2016 | Ultralite Enterprises Inc |
ATL-DO | 5/17/2016 | Pandah Co. |
ATL-DO | 5/17/2016 | Seqirus Inc |
BLT-DO | 5/18/2016 | Sanofi Pasteur Biologics, LLC |
CDER | 5/6/2016 | Interquim S.A. |
CDER | 5/6/2016 | Opocrin Laboratorio |
CDER | 5/6/2016 | Par Active Technologies Private Limited |
CDER | 5/11/2016 | Tien Yuan Chemical (Pte) Ltd. |
CDER | 5/11/2016 | Laboratoire Atlas Inc. |
CDER | 5/12/2016 | Trifarma S.p.A. |
CDER | 5/13/2016 | Hubei Gedian Humanwell Pharmaceutical Co., Ltd. |
CDER | 5/13/2016 | Changzhou Yinsheng Pharmaceutical Co. Ltd. |
CDER | 5/19/2016 | Chongqing Pharma Research Institute Co., Ltd. |
CDER | 5/20/2016 | MSD International GmbH (Singapore Branch) |
CDER | 5/20/2016 | Apotex Research Private Limited |
CDRH | 5/5/2016 | Shina Corporation |
CDRH | 5/5/2016 | Suzhou Avon Textile Co., Ltd. |
CDRH | 5/5/2016 | Inpeco Spa |
CDRH | 5/6/2016 | Eurotrol B. V. |
CDRH | 5/12/2016 | Kuraray Noritake Dental Inc. |
CDRH | 5/12/2016 | Nouvag Ag Dental Medical Laborgerae |
CDRH | 5/12/2016 | Boston Scientific de Costa Rica SRL |
CDRH | 5/12/2016 | Nitinol Devices and Components Costa Rica, S.R.L. |
CDRH | 5/12/2016 | Neo Vision Co., Ltd. |
CIN-DO | 5/5/2016 | PharmaForce Inc |
DAL-DO | 5/27/2016 | Zevacor Pharma, Inc. |
DEN-DO | 5/26/2016 | Yusef Manufacturing Laboratories, LLC |
DET-DO | 5/11/2016 | Pharmakon Long Term Care Pharmacy, Inc. |
DET-DO | 5/12/2016 | Baxter Pharmaceutical Solutions, LLC |
FLA-DO | 5/4/2016 | HeartWare, Inc |
FLA-DO | 5/10/2016 | Capillus LLC |
FLA-DO | 5/13/2016 | Belcher Pharmaceuticals, LLC |
KAN-DO | 5/6/2016 | The Metrix Company |
LOS-DO | 5/12/2016 | Ameditech Inc |
MIN-DO | 5/2/2016 | Cardia Inc |
NOL-DO | 5/24/2016 | Restore Medical Solutions, Inc. |
NWE-DO | 5/11/2016 | Medical Laser Systems Inc |
NWE-DO | 5/17/2016 | Milbar Laboratories, Inc. |
NWE-DO | 5/31/2016 | Tender Corporation |
NYK-DO | 5/10/2016 | Hersco-Orthotic Labs Corp |
NYK-DO | 5/24/2016 | Healthway Home Products, Inc. |
NYK-DO | 5/27/2016 | Equibal Inc |
PHI-DO | 5/23/2016 | Safe-Tec Clinical Products Inc |
SAN-DO | 5/6/2016 | Sunrise Medical (US) LLC |
SAN-DO | 5/11/2016 | Volcano AtheroMed Inc. |
SAN-DO | 5/12/2016 | Well Care Compounding Pharmacy |
SEA-DO | 5/17/2016 | Ballard Plaza Pharmacy I, Inc. |
SJN-DO | 5/6/2016 | Grafor, Inc. |
SJN-DO | 5/18/2016 | Janssen Ortho L.L.C. |
April 2016 |
||
District | Inspection Date | Firm Name |
ATL-DO | 4/8/2016 | Pisgah Labs Inc |
ATL-DO | 4/19/2016 | C.R. Bard, Inc. |
BLT-DO | 4/4/2016 | Pharmaceutics International, Inc. |
BLT-DO | 4/19/2016 | Reflexonic, LLC |
CBER | 4/1/2016 | Adimmune Corporation |
CBER | 4/6/2016 | SynCo Bio Partners Bv |
CDER | 4/1/2016 | Alchem International Ltd. |
CDER | 4/1/2016 | Farmea |
CDER | 4/1/2016 | Island Abbey Food Science Ltd. |
CDER | 4/8/2016 | Otsuka Pharmaceutical Co., Ltd. |
CDER | 4/8/2016 | Bayer Bitterfeld GmbH |
CDER | 4/9/2016 | Haupt Pharma Wolfratshausen GmbH |
CDER | 4/13/2016 | Mylan Laboratories Limited |
CDER | 4/14/2016 | Suven Life Sciences Limited |
CDER | 4/14/2016 | Novacyl Wuxi Pharmaceutical Co., Ltd. |
CDER | 4/15/2016 | Shanghai Techwell Biopharmaceutical Co.,Ltd. |
CDER | 4/15/2016 | Jiangsu Baozong & Baoda Pharmachem Co., Ltd. |
CDER | 4/15/2016 | Mappel Industria de Embalagens S.A. |
CDER | 4/19/2016 | Aspen SVP Pty Ltd. |
CDER | 4/21/2016 | Jari PHarmaceutical Co. Ltd. |
CDER | 4/22/2016 | Symrise AG |
CDER | 4/28/2016 | Ningxia Qiyuan Pharmaceutical Co Ltd |
CDER | 4/29/2016 | Rechon Life Science AB |
CDRH | 4/1/2016 | Cavex Holland B.V. |
CDRH | 4/1/2016 | Jossi Orthopedics AG |
CDRH | 4/6/2016 | A.R.C.O.S. Srl |
CDRH | 4/7/2016 | Sankei Co., Ltd. |
CDRH | 4/7/2016 | Creagh Medical Ltd. |
CDRH | 4/14/2016 | Pt Sankei Medical Industries |
CDRH | 4/14/2016 | Roche Diagnostics GmbH |
CDRH | 4/15/2016 | Ambu Sdn. Bhd. |
CDRH | 4/21/2016 | SHENZHEN LAUNCH ELECTRIAL CO., LTD |
CHI-DO | 4/13/2016 | Force Diagnostics Inc |
CHI-DO | 4/18/2016 | PQ Corporation |
CIN-DO | 4/21/2016 | Homewood Healthcare Products Inc. |
DAL-DO | 4/5/2016 | Aggredyne, Inc. |
DAL-DO | 4/28/2016 | Baptist Health Medical Towers Pharmacy and Infusion Services |
DET-DO | 4/15/2016 | CHEMATICS, INC. |
DET-DO | 4/19/2016 | Emergent BioDefense Operations Lansing LLC |
FLA-DO | 4/8/2016 | Amerx Health Care Corp. |
FLA-DO | 4/11/2016 | Absolute Pharmacy, LLC |
FLA-DO | 4/12/2016 | 2k Innovations Inc. |
FLA-DO | 4/15/2016 | Craftmatic Industries, Inc. |
KAN-DO | 4/1/2016 | Washington University School of Medicine |
LOS-DO | 4/1/2016 | PureTek Corporation |
LOS-DO | 4/5/2016 | EDRD Enterprises Inc |
LOS-DO | 4/7/2016 | Regene |
LOS-DO | 4/12/2016 | Rhino Pediatric Orthopedic Designs, Inc. |
LOS-DO | 4/22/2016 | Calmo Manufacturing, Inc |
NOL-DO | 4/6/2016 | Matrix Machining Technologies, Inc. |
NOL-DO | 4/28/2016 | MRP, LLC |
NWE-DO | 4/1/2016 | Bruker Daltonics Inc |
NWE-DO | 4/7/2016 | Precision Optics Corporation, Inc. |
NWE-DO | 4/7/2016 | Kat Implants, LLC |
NWE-DO | 4/12/2016 | Madison Polymeric Engineering |
NWE-DO | 4/13/2016 | W & R Investments, LLC |
NWE-DO | 4/19/2016 | Lacey Manufacturing, LLC |
NWE-DO | 4/22/2016 | CAS Medical Systems, Inc. |
NWJ-DO | 4/5/2016 | Mycone Dental Supply Co., Inc. dba Keystone Industries |
NYK-DO | 4/15/2016 | Angiodynamics Inc. (Navilyst Medical Inc.) |
NYK-DO | 4/15/2016 | Sonomed, Inc. |
NYK-DO | 4/18/2016 | Pine Pharmacy and Home Care Products Center, Inc. |
PHI-DO | 4/19/2016 | Aspire Bariatrics, Inc. |
PHI-DO | 4/22/2016 | Delavau LLC |
PHI-DO | 4/22/2016 | Spray-Tek, Inc. |
SEA-DO | 4/1/2016 | Viper Technologies, LLC dba Thortex |
SEA-DO | 4/27/2016 | Evangelical Christian Ministry dba Health & Herbs |
SJN-DO | 4/28/2016 | Medtronic Puerto Rico Operations Co. |
March 2016 |
||
District | Inspection Date | Firm Name |
ATL-DO | 3/3/2016 | Vesocclude Medical, Llc |
BLT-DO | 3/16/2016 | Safeop Surgical Inc. |
BLT-DO | 3/17/2016 | MicroAire Surgical Instruments, LLC |
BLT-DO | 3/23/2016 | Professional Arts Pharmacy |
CDER | 3/3/2016 | Lima & Pergher Industria e Comercio S/A |
CDER | 3/4/2016 | Juzen Chemical Corporation |
CDER | 3/4/2016 | Emcure Pharmaceuticals Limited |
CDER | 3/4/2016 | Korea Mcnulty Co., Ltd. |
CDER | 3/4/2016 | Meiji Seika Pharma Co., Ltd. - Gifu Plant |
CDER | 3/4/2016 | Codibel S.A. |
CDER | 3/4/2016 | Guang'an Kingday Pharma & Chem Co. Ltd. |
CDER | 3/4/2016 | Glaropharm Ag |
CDER | 3/7/2016 | NATCO Pharma Limited |
CDER | 3/8/2016 | Boehringer Ingelheim Pharma GmbH & Co. KG |
CDER | 3/8/2016 | Piramal Enterprises Ltd |
CDER | 3/10/2016 | Biocosmetica Excel Argentina S.R.L. |
CDER | 3/11/2016 | Sinsin Pharmaceutical Co., Ltd. |
CDER | 3/11/2016 | Coral Drugs Private Limited |
CDER | 3/11/2016 | Patheon France S.A.S. |
CDER | 3/11/2016 | Lupin Limited |
CDER | 3/11/2016 | Shandong Luwei Pharmaceutical Co.,Ltd. |
CDER | 3/16/2016 | Mylan Laboratories Limited |
CDER | 3/17/2016 | Chongqing Lummy Pharmaceutical Co. Ltd. |
CDER | 3/17/2016 | Intas Pharmaceuticals Limited |
CDER | 3/18/2016 | TTY Biopham Co. Ltd |
CDER | 3/18/2016 | Daizo Corporation |
CDER | 3/18/2016 | Optimus Drugs Private Limited |
CDER | 3/25/2016 | Apicore Pharmaceuticals PVT LTD |
CDER | 3/25/2016 | Yancheng Youhua Pharmaceutical and Chemical Tech. Co. Ltd. |
CDER | 3/30/2016 | Zambon Switzerland Ltd. |
CDER | 3/31/2016 | Synbiotics Limited |
CDRH | 3/4/2016 | APEX HEALTH CARE MFG., INC. |
CDRH | 3/10/2016 | Merit Medical Ireland Ltd. |
CDRH | 3/10/2016 | Biotronik SE & Co. KG |
CDRH | 3/10/2016 | JMS Singapore PTE Ltd. |
CDRH | 3/10/2016 | Safegard Medical (Hungary) Kft |
CDRH | 3/10/2016 | Microware Precision Co., Ltd |
CDRH | 3/17/2016 | Mitaka Kohki Co., Ltd. |
CDRH | 3/17/2016 | BTG International Germany |
CDRH | 3/17/2016 | Thai Nippon Rubber Industry Co., Ltd. |
CDRH | 3/18/2016 | B. Braun Medical Industries Sdn. Bhd |
CDRH | 3/24/2016 | Vtech Communications Ltd. |
CDRH | 3/24/2016 | Brivant Limited dba Lake Region Medical |
CDRH | 3/25/2016 | Coreleader Biotech Co., Ltd |
CDRH | 3/31/2016 | HMD Biomedical Inc. |
CHI-DO | 3/7/2016 | Mallinckrodt Inc. |
CHI-DO | 3/15/2016 | Pinnacle Biologics Inc |
CHI-DO | 3/30/2016 | Ava Inc |
CIN-DO | 3/11/2016 | Avery Dennison Corp/Avery Dennison Medical |
CIN-DO | 3/17/2016 | Vexos |
CIN-DO | 3/24/2016 | Circle Prime Manufacturing Inc. |
DAL-DO | 3/2/2016 | Stonegate Pharmacy LP |
DAL-DO | 3/29/2016 | ZS Pharma, Inc. |
DEN-DO | 3/2/2016 | IPAX, Incorporated |
DET-DO | 3/2/2016 | Ventlab LLC |
DET-DO | 3/10/2016 | Orchid Orthopedic Solutions, LLC |
DET-DO | 3/16/2016 | Pharmakon Pharmaceuticals, Inc. |
DET-DO | 3/31/2016 | Century Pharmaceuticals, Inc. |
FLA-DO | 3/4/2016 | Xcelience, LLC |
FLA-DO | 3/16/2016 | Medtronic Xomed, Inc. |
FLA-DO | 3/17/2016 | Oscor, Inc. |
FLA-DO | 3/18/2016 | Micro Typing Systems, Inc. |
FLA-DO | 3/25/2016 | Custom Meds, Inc. |
FLA-DO | 3/29/2016 | Medscience Inc |
LOS-DO | 3/2/2016 | W.T. Farley Inc |
LOS-DO | 3/8/2016 | Stason Pharmaceuticals, Inc. |
LOS-DO | 3/10/2016 | Neodontics Inc |
LOS-DO | 3/11/2016 | Dignity Health - Northridge Hospital Medical Center |
LOS-DO | 3/14/2016 | South Coast Specialty Compounding, Inc. |
LOS-DO | 3/18/2016 | Trimed Inc |
LOS-DO | 3/29/2016 | Dexcom Inc |
LOS-DO | 3/30/2016 | Medtronic Cardiovascular Surgery-the Heart Valve Division |
NOL-DO | 3/3/2016 | BioMimetic Therapeutics, LLC |
NOL-DO | 3/7/2016 | GelCool Systems, Inc |
NOL-DO | 3/10/2016 | Somnowell, Inc. |
NOL-DO | 3/11/2016 | Medaus, Inc. |
NOL-DO | 3/17/2016 | CryoSurgery, Inc. |
NOL-DO | 3/25/2016 | ORCHID Orthopedic Solutions- Memphis |
NOL-DO | 3/31/2016 | InvisionHeart, Inc. |
NWE-DO | 3/3/2016 | PETNET Solutions Inc. |
NWE-DO | 3/7/2016 | AdDent, Inc. |
NWE-DO | 3/10/2016 | Guidewire Technologies, Inc. |
NWE-DO | 3/15/2016 | Loon Medical, Inc. |
NWE-DO | 3/17/2016 | Medtronic Navigation, Inc.-Littleton |
NWE-DO | 3/24/2016 | Strem Chemicals, Inc. |
NWE-DO | 3/28/2016 | Pavo, Inc. |
NWJ-DO | 3/10/2016 | Leading Pharma, LLC |
NWJ-DO | 3/18/2016 | Us Organic Group Corp |
NYK-DO | 3/2/2016 | C.R. Bard Inc. |
NYK-DO | 3/10/2016 | Time-Cap Laboratories, Inc. |
NYK-DO | 3/29/2016 | MSKCC RMIPC |
PHI-DO | 3/31/2016 | Accupac, Inc. |
SAN-DO | 3/11/2016 | Proteus Digital Health, Inc. |
SAN-DO | 3/18/2016 | Meditech Laboratories, Inc |
SAN-DO | 3/29/2016 | Faencal Tartaric Product Inc |
SEA-DO | 3/22/2016 | Center for Life, Inc. DBA Rain Shadow Labs |
SEA-DO | 3/28/2016 | US Vascular LLC |
SJN-DO | 3/23/2016 | Blu Caribe Inc |
February 2016 |
||
District | Inspection Date | Firm Name |
BLT-DO | 2/3/2016 | Stressa Incorporated |
BLT-DO | 2/5/2016 | Qiagen Sciences LLC |
BLT-DO | 2/26/2016 | BTE Technologies, Inc. |
CBER | 2/5/2016 | Baxalta |
CDER | 2/5/2016 | Olon SpA |
CDER | 2/5/2016 | Eau Zone Huiles Et Fragrances Ltee |
CDER | 2/5/2016 | Edmond Pharma S.R.L. |
CDER | 2/5/2016 | Avon Organics Ltd. (Bio-Tech Division) |
CDER | 2/5/2016 | GMT Fine Chemicals |
CDER | 2/5/2016 | BENECHIM SPRL |
CDER | 2/5/2016 | Mylan Laboratories Limited |
CDER | 2/5/2016 | MSN Laboratories Pvt. Ltd. (Formulations Division, Unit-II) |
CDER | 2/11/2016 | G. Pohl-Boskamp GmbH & Co. KG |
CDER | 2/11/2016 | Dipharma Francis S.r.l. |
CDER | 2/12/2016 | Farmak, A.S. |
CDER | 2/12/2016 | Otsuka Pharmaceutical Co., Ltd. (Second Tokushima Factory) |
CDER | 2/12/2016 | Amoli Organics Pvt Limited |
CDER | 2/12/2016 | Olon S.p.A. |
CDER | 2/19/2016 | Ajinomoto Co. Inc. - Kyushu Plant |
CDER | 2/19/2016 | CTX Lifesciences Private Ltd. |
CDER | 2/26/2016 | Maruha Nichiro Corporation |
CDER | 2/26/2016 | Sanofi Chimie |
CDER | 2/26/2016 | Yunnan Hande Bio-Tech. Co. Ltd. |
CDRH | 2/3/2016 | Bioinfinity (M) Sdn Bhd |
CDRH | 2/3/2016 | Viroclinics Biosciences B.V. |
CDRH | 2/4/2016 | Spiegelberg Gmbh & Co. KG |
CDRH | 2/4/2016 | Terumo (Philippines) Corporation |
CDRH | 2/4/2016 | Philips and Neusoft Medical Systems Co., Ltd. |
CDRH | 2/4/2016 | Roland Consult, Stasche & Finger GmbH |
CDRH | 2/4/2016 | Inex Silicone |
CDRH | 2/4/2016 | Purple Surgical Manufacturing Limited |
CDRH | 2/4/2016 | Serres Oy |
CDRH | 2/5/2016 | Philips Medical Systems Nederlands |
CDRH | 2/5/2016 | Terumo Corporation |
CDRH | 2/5/2016 | Alien Technik |
CDRH | 2/5/2016 | Intermedic Arfran S.A. |
CDRH | 2/5/2016 | Hitachi Medical Corp., Medical System Operations G |
CDRH | 2/11/2016 | Sedecal S.A. |
CDRH | 2/11/2016 | RESPITEK PTY LIMITED |
CDRH | 2/12/2016 | Otsuka Pharmaceutical Co., Ltd. (Second Tokushima Factory) |
CDRH | 2/12/2016 | SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION |
CDRH | 2/12/2016 | Toshiba Medical Systems Corporation |
CDRH | 2/12/2016 | Permobil AB |
CDRH | 2/12/2016 | MILESMAN S.L. |
CDRH | 2/17/2016 | Pharma Systems AB |
CDRH | 2/18/2016 | Mediso KFT. |
CDRH | 2/19/2016 | Trokamed GmbH |
CDRH | 2/19/2016 | Pharma Systems Eesti OU |
CIN-DO | 2/5/2016 | LS Investment Group II LLC |
CIN-DO | 2/9/2016 | Fluke Biomedical LLC |
CIN-DO | 2/9/2016 | RC Outsourcing LLC |
DAL-DO | 2/3/2016 | Ideal Implant Incorporated |
DAL-DO | 2/19/2016 | iCAD, Inc. (formerly VuCOMP, Inc.) |
DEN-DO | 2/3/2016 | CME America, LLC |
DET-DO | 2/10/2016 | Battle Creek Equipment Co. |
DET-DO | 2/18/2016 | Axiobionics, LLC |
DET-DO | 2/18/2016 | CHENICA INC. |
DET-DO | 2/29/2016 | Analytical Control Systems, Inc |
FLA-DO | 2/10/2016 | All Pharma, LLC |
LOS-DO | 2/3/2016 | Advantar Laboratories Inc |
LOS-DO | 2/4/2016 | Renovis Surgical Technologies, Inc. |
LOS-DO | 2/12/2016 | Edwards Lifesciences, LLC |
LOS-DO | 2/18/2016 | LINE ONE Laboratories Inc (USA) |
MIN-DO | 2/12/2016 | Ototronix, LLC |
NOL-DO | 2/5/2016 | Keystone Laboratories Inc |
NWE-DO | 2/4/2016 | Phase II Medical Manufacturing, Inc. |
NWE-DO | 2/4/2016 | Neurotherm LLC |
NWE-DO | 2/9/2016 | Biogen, Inc. |
NWE-DO | 2/9/2016 | Emmy Medical, LLC |
NWE-DO | 2/10/2016 | Cellay, Inc |
NWE-DO | 2/10/2016 | Avedro, Inc. |
NWE-DO | 2/11/2016 | Cardinal Health 414, LLC |
NWE-DO | 2/12/2016 | Schuerch Corporation |
NWE-DO | 2/17/2016 | American Distilling Inc. |
NWE-DO | 2/18/2016 | Sheffield Pharmaceuticals, LLC |
NWE-DO | 2/19/2016 | Anderson Holdings Inc. |
NWJ-DO | 2/2/2016 | Elite Laboratories Inc. |
NWJ-DO | 2/12/2016 | Stokes Pharmacy |
PHI-DO | 2/9/2016 | Jeffreys Drug Store |
PHI-DO | 2/18/2016 | Total Molding Services Inc |
SEA-DO | 2/2/2016 | Bellegrove Medical Supply, Inc. |
SEA-DO | 2/17/2016 | Erickson Labs Northwest, LLC |
SEA-DO | 2/18/2016 | International Rehabilitative Sciences, Inc. dba RS Medical |
SJN-DO | 2/12/2016 | Agropharma Laboratories Inc. |
SJN-DO | 2/26/2016 | Janssen Ortho L.L.C. |
January 2016 |
||
District | Inspection Date | Firm Name |
ATL-DO | 1/12/2016 | Duke University Medical Center, Carolinas Cord Blood |
BLT-DO | 1/5/2016 | Best Medical International, Inc. |
CDER | 1/12/2016 | Institutt For Energiteknikk |
CDER | 1/12/2016 | Wockhardt Limited |
CDER | 1/15/2016 | Shandong Lukang Pharmaceutical Co. Ltd. |
CDER | 1/15/2016 | Cosma S.P.A. |
CDER | 1/19/2016 | FACTA Farmaceutici S.p.A. |
CDER | 1/22/2016 | Henan Lihua Pharmaceutical Co., Ltd. |
CDER | 1/29/2016 | Synthokem Labs Private Limited |
CDER | 1/29/2016 | Arch Pharmalabs Ltd. |
CDER | 1/29/2016 | Teva Pharmaceutical Works Co. Ltd. |
CDER | 1/29/2016 | Hainan Poly Pharm. Co., Ltd. |
CDRH | 1/13/2016 | Yangzhou Qionghua Sports Goods Co., Ltd. |
CDRH | 1/14/2016 | Hindustan Syringes & Medical Devices Ltd |
CDRH | 1/20/2016 | Medsorb Dominicana, S.A. |
CDRH | 1/21/2016 | Taizhou Xinkang Medical Materials Co., Ltd. |
CDRH | 1/22/2016 | Acute Ideas (Huizhou) Co., Ltd. |
CDRH | 1/28/2016 | LAUDA DR. R. WOBSER GMBH & CO. KG |
DAL-DO | 1/5/2016 | Richard E. Colgin I, Ltd. |
DAL-DO | 1/8/2016 | Sovereign Pharmaceuticals, LLC |
DEN-DO | 1/8/2016 | Soma Access Systems LLC |
DEN-DO | 1/21/2016 | Spectranetics Corporation |
DET-DO | 1/19/2016 | Oxus America, Inc. |
FLA-DO | 1/12/2016 | Ergoactives, Llc |
FLA-DO | 1/28/2016 | American Catheter Corp |
LOS-DO | 1/8/2016 | Cosmetic Laboratories Of America |
LOS-DO | 1/15/2016 | Respironics California Inc |
LOS-DO | 1/22/2016 | Boston Scientific Neuromodulation Corporation |
NWE-DO | 1/6/2016 | Kinetic Instruments, Inc. |
NWE-DO | 1/6/2016 | Rhode Island Novelty Inc. |
NYK-DO | 1/5/2016 | Nova Health Systems Inc |
NYK-DO | 1/8/2016 | C.R. Bard Inc. |
NYK-DO | 1/19/2016 | Feinstein Institute for Medical Research (Radiochemistry) |
NYK-DO | 1/29/2016 | Brookhaven National Labs |
PHI-DO | 1/21/2016 | Dialysis Medical Solutions, LLC |
SEA-DO | 1/28/2016 | ACUTE Innovations, LLC |
SJN-DO | 1/22/2016 | Amgen Manufacturing Limited |