Recently Requested 483s

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.

 

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