Recently Requested 483s

September 2018

District Inspection Date Firm Name
BLT-DO 9/12/2018 AcariaHealth Pharmacy, Inc.
BLT-DO 9/25/2018 Loop Plaza Pharmacy Company DBA Loop Compounding Pharmacy
BLT-DO 9/27/2018 FUJIFILM Wako Chemicals U.S.A. Corporation
CBER 9/14/2018 ALBA Bioscience Limited dba Quotient Biodiagnostics Inc.
CDER 9/1/2018 Vital Laboratories Pvt Ltd Plant II
CDER 9/6/2018 ATLAS R&D Inc
CDER 9/7/2018 PCAS
CDER 9/13/2018 Changzhou Ruiming Pharmaceuticals Co. Ltd.
CDER 9/13/2018 Kumho Dental Pharmaceutical Co., Ltd.
CDER 9/13/2018 Genic Co., Ltd.
CDER 9/14/2018 Sun Pharmaceutical Industries, Inc.
CDER 9/14/2018 Patheon Inc.
CDER 9/14/2018 Chr. Olesen Synthesis A/S
CDER 9/14/2018 China Ningbo Shangge Cosmetic Technology Corp.
CDER 9/14/2018 Jiangxi Long Life Bio-Pharmaceutical Co., Ltd
CDER 9/21/2018 Laboratoires Clarins
CDER 9/21/2018 SICOR Societa Italiana Corticosteroidi s.r.l.
CDER 9/28/2018 Dong Yuan Technology Co., Ltd.
CDRH 9/4/2018 Osteotec Limited
CDRH 9/6/2018 Hsiner Co., Ltd.
CDRH 9/6/2018 Fournitures Hospitalieres Industrie
CDRH 9/6/2018 aap Biomaterials, GmbH
CDRH 9/6/2018 SYMATESE DEVICE
CDRH 9/13/2018 Institut Virion/Serion Gmbh
CDRH 9/25/2018 MICROLAB ELETTRONICA
CHI-DO 9/28/2018 Myerson LLC
CIN-DO 9/13/2018 Great Lakes Neurotechnologies Inc
CIN-DO 9/17/2018 DimcoGray Inc. 
CIN-DO 9/24/2018 Frantz Medical Development Ltd
CIN-DO 9/26/2018 Surface Dynamics LLC
CIN-DO 9/27/2018 Kiltex Corporation
DAL-DO 9/6/2018 Microlight Corporation of America
DAL-DO 9/6/2018 EMIT Corporation
DAL-DO 9/13/2018 Alan Neuromedical Technologies
DAL-DO 9/21/2018 Footprint Medical, Inc.
DAL-DO 9/25/2018 Winfield Laboratories, Inc.
DAL-DO 9/28/2018 CareFusion 2200, Inc.
DEN-DO 9/11/2018 Tolmar Inc.
DEN-DO 9/17/2018 Zevex Incorporated (dba MOOG Medical Devices Group)
DEN-DO 9/18/2018 Thatcher Company
DEN-DO 9/19/2018 SPS National Labs-Tempe
DET-DO 9/10/2018 Symmetry Medical, Inc.
DET-DO 9/26/2018 Kennametal Stellite L.P.
FLA-DO 9/4/2018 Acorn Stairlifts Inc
FLA-DO 9/11/2018 Southeast Signal Inc.
FLA-DO 9/14/2018 AMMD Labs, LLC
FLA-DO 9/14/2018 Myolyn LLC
FLA-DO 9/20/2018 Debut Development, LLC
KAN-DO 9/6/2018 Primus Corporation dba Trinity Biotech
KAN-DO 9/19/2018 Accurate RX Pharmacy Consulting LLC
KAN-DO 9/19/2018 HomeChoice Partners, Inc. dba Bioscrip Infusion Services
KAN-DO 9/20/2018 Streck
KAN-DO 9/27/2018 Reed Pharmacy
LOS-DO 9/7/2018 Blue Cross Laboratories, Inc
LOS-DO 9/13/2018 MAST Biosurgery USA, Inc
LOS-DO 9/13/2018 BCG Medical Inc
LOS-DO 9/14/2018 Neutraderm Inc.
LOS-DO 9/17/2018 VicTorch Meditek, Inc
LOS-DO 9/26/2018 P&L Developments, LLC
LOS-DO 9/27/2018 Aurident Inc
LOS-DO 9/27/2018 MedisourceRx
LOS-DO 9/28/2018 Diasol Inc.
MIN-DO 9/6/2018 Medspira, Llc
MIN-DO 9/20/2018 Unipower Corp
NWE-DO 9/5/2018 Pharmasol 
NWE-DO 9/7/2018 Ecometics, Inc.
NWE-DO 9/7/2018 Valeritas, Incorporated
NWE-DO 9/7/2018 Conformis, Inc.
NWE-DO 9/19/2018 Beekley Corporation
NWE-DO 9/20/2018 BG Medicine, Inc.
NWE-DO 9/25/2018 Sheffield Pharmaceuticals, LLC
NWJ-DO 9/27/2018 Pentax of America Inc
NYK-DO 9/11/2018 GlaxoSmithKline LLC
NYK-DO 9/13/2018 SPS Medical Supply Corporation
NYK-DO 9/14/2018 ULTRAtab Laboratories, Inc.
NYK-DO 9/14/2018 Kings Park Slope Inc
NYK-DO 9/26/2018 Nalge Nunc International Corporation
NYK-DO 9/26/2018 Circulatory Technology Inc
NYK-DO 9/26/2018 Hyperbaric Technologies Inc.
NYK-DO 9/28/2018 OndaMed Inc
PHI-DO 9/21/2018 KVK-Tech, Inc.
PHI-DO 9/25/2018 Allegheny Health Network Home Infusion, LLC
SAN-DO 9/14/2018 White House Pharmacy Inc. dba San Jose Compounding Pharmacy
SEA-DO 9/12/2018 21st Century Scientific Inc
SJN-DO 9/14/2018 Agropharma Laboratories Inc.

 

August 2018

District Inspection Date Firm Name
ATL-DO 8/3/2018 Sciteck Diagnostics
ATL-DO 8/17/2018 HomeChoice Partners, Inc.
ATL-DO 8/29/2018 Amann Girrbach North America, L.P.
BLT-DO 8/3/2018 PARI Respiratory Equipment, Inc.
BLT-DO 8/6/2018 Sentara Enterprises Inc., dba Sentara Home Infusion Pharmacy Services
BLT-DO 8/16/2018 PCCI, Inc.
BLT-DO 8/17/2018 AstraZeneca Pharmaceuticals LP
BLT-DO 8/22/2018 Rebuilder Medical, Inc.
CBER 8/3/2018 Laboratorios Silanes SA de CV
CDER 8/1/2018 Porton Biopharma Limited
CDER 8/2/2018 EEJE
CDER 8/3/2018 Lusochimica S.p.A.
CDER 8/3/2018 Gador S.A.
CDER 8/3/2018 Zhejiang Huahai Pharmaceutical
CDER 8/3/2018 K Patel Phyto Extractions Pvt Ltd
CDER 8/3/2018 Livzon Group Fuzhou Fuxing Pharmaceutical Co., Ltd.
CDER 8/3/2018 Anicare Pharmaceuticals Pvt Ltd.
CDER 8/3/2018 Indena India Pvt. Ltd.
CDER 8/3/2018 Jiangsu Tianhe Pharmaceutical Co.
CDER 8/7/2018 Pfizer Healthcare India Private Limited
CDER 8/8/2018 Jubilant Generics Limited
CDER 8/8/2018 Therapure Biopharma Inc
CDER 8/9/2018 Soleo
CDER 8/9/2018 Hangzhou SunKing Nonwovens Co., Ltd.
CDER 8/10/2018 Excella GmbH
CDER 8/10/2018 North China Pharmaceutical Huasheng Co., LTD
CDER 8/10/2018 Jiangsu Baozong & Baoda Pharmachem Co., Ltd.
CDER 8/16/2018 Kalpesh Corporation
CDER 8/17/2018 Loba Feinchemie GmbH
CDER 8/17/2018 Lights Medical Manufacture Co Ltd
CDER 8/23/2018 Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd
CDER 8/24/2018 Apothecon Pharmaceuticals Private Limited
CDER 8/28/2018 Antibioticos Do Brasil Ltda
CDRH 8/2/2018 Flexicare Medical Ltd.
CDRH 8/2/2018 Wu's Tech (Vietnam) Co., Ltd.
CDRH 8/8/2018 PT. TEAM-METAL INDONESIA
CDRH 8/9/2018 Macromedics BV
CDRH 8/15/2018 Smithstown Light Engineering Limited
CDRH 8/16/2018 Zyno Electric & Machinery Ltd, Shanghai
CDRH 8/23/2018 Medico Electrodes International LTD.
CDRH 8/23/2018 Tec Com Gmbh
CDRH 8/23/2018 Viax Dental Lab
CDRH 8/30/2018 Mattioli Engineering Italia SpA
CHI-DO 8/8/2018 M D Technologies, Inc.
CHI-DO 8/10/2018 Dolan Central Illinois Compounding LLC dba Preckshot Professional Pharmacy
CIN-DO 8/29/2018 Western / Scott Fetzer Company
DAL-DO 8/3/2018 Quest Specialty Corp
DAL-DO 8/3/2018 KR Medical Technologies, LLC.
DAL-DO 8/9/2018 Anesthetic Gas Reclamation LLC
DAL-DO 8/9/2018 Now Diagnostics Inc
DAL-DO 8/15/2018 D & D Video Specialist, Inc.
DAL-DO 8/23/2018 Biotex Inc.
DAL-DO 8/23/2018 American Specialty Pharmacy
DAL-DO 8/27/2018 Ultrasonic Services, Inc.
DEN-DO 8/1/2018 Surefire Medical Inc.
DEN-DO 8/17/2018 Abraxis Bioscience LLC
DEN-DO 8/30/2018 Cyclotron Radiochemistry Lab, Huntsman Cancer Institute
DET-DO 8/6/2018 Miller Technical Services, Inc.
DET-DO 8/9/2018 PAR Sterile Products LLC
DET-DO 8/22/2018 Surge Medical Sales, LLC (DBA Surge Cardiovascular)
FLA-DO 8/2/2018 Laboratorios Quantium Llc
FLA-DO 8/10/2018 Bausch & Lomb, Inc.
FLA-DO 8/15/2018 Westlab Pharmacy, Inc. dba Westlab Pharmacy
FLA-DO 8/17/2018 Horizon Pharmaceuticals, Inc.
FLA-DO 8/21/2018 BASF Corporation
FLA-DO 8/23/2018 Poiesis Medical, LLC
FLA-DO 8/24/2018 ProSun International, LLC
KAN-DO 8/7/2018 OCCK Inc
KAN-DO 8/8/2018 Hospira Inc
KAN-DO 8/10/2018 Oceanic Medical Products, Inc.
KAN-DO 8/23/2018 General Physiotherapy Inc
LOS-DO 8/1/2018 Next Life Medical Corp. dba Emergent Respiratory
LOS-DO 8/2/2018 LED Intellectual Properties, LLC
LOS-DO 8/2/2018 Auro Pharmacies, Inc.
LOS-DO 8/8/2018 Fill It Pack It Inc
LOS-DO 8/16/2018 Medical Chemical Corporation
LOS-DO 8/16/2018 Health Plus Incorporated
LOS-DO 8/23/2018 Cardinal Health 414 LLC
LOS-DO 8/24/2018 Lumanosity Inc
LOS-DO 8/31/2018 DiamoDent
MIN-DO 8/1/2018 Becton Dickinson Medical Systems
MIN-DO 8/10/2018 Preservation Solutions, Inc.
MIN-DO 8/15/2018 Mayo Clinic Pharmacy
MIN-DO 8/23/2018 Clarus Medical, Llc
NOL-DO 8/3/2018 Cardinal Health 414, LLC
NOL-DO 8/16/2018 Quinn Pharmacy dba Northlaurel Discount Drugs, Inc.
NOL-DO 8/22/2018 Diasol East, Inc.
NWE-DO 8/2/2018 Atrium Medical Corporation
NWE-DO 8/7/2018 Val-U-Dent Laboratories
NWE-DO 8/9/2018 Bayscience Formulators, LLC
NWE-DO 8/14/2018 K. W. Griffen Company DBA Biomed Packaging Systems
NWE-DO 8/20/2018 Pharmasol Corporation
NWE-DO 8/24/2018 Trividia Manufacturing Solutions, Inc.
NWE-DO 8/28/2018 Lighthouse Imaging, LLC
NWE-DO 8/29/2018 Mossman Associates, Inc.
NWJ-DO 8/7/2018 PharmScript, LLC
NWJ-DO 8/14/2018 Immunomedics, Inc.
NWJ-DO 8/16/2018 AS Software, Inc.
NWJ-DO 8/17/2018 Ohm Laboratories Inc.
NWJ-DO 8/22/2018 Replication Medical, Inc.
NYK-DO 8/15/2018 Carestream Health, Inc.
NYK-DO 8/21/2018 Equashield LLC
SAN-DO 8/17/2018 James Consolidated, Inc.
SAN-DO 8/20/2018 Microfit, Inc.
SEA-DO 8/6/2018 Sound Ergonomics, LLC
SEA-DO 8/10/2018 Peripheral Visions, Inc.
SEA-DO 8/13/2018 Natus Medical Incorporated
SEA-DO 8/23/2018 InBios International, Inc.
SJN-DO 8/6/2018 Amgen Manufacturing Limited
SJN-DO 8/17/2018 Baxter Healthcare SA / dba Baxter Healthcare of Puerto Rico
SJN-DO 8/17/2018 Wyeth Pharmaceuticals Company dba Pfizer Consumer Healthcare

 

July 2018

District Inspection Date Firm Name
ATL-DO 7/2/2018 Sarstedt Inc
ATL-DO 7/11/2018 Enviropak LLC
ATL-DO 7/16/2018 Intelligent Implant Systems
ATL-DO 7/17/2018 Patheon Manufacturing Services, LLC
ATL-DO 7/18/2018 Winder Laboratories, LLC
ATL-DO 7/26/2018 Hinson and Hale Medical Technologies, Inc.
BLT-DO 7/3/2018 Lonza Walkersville, Inc.
BLT-DO 7/3/2018 Izeen Pharma Inc
BLT-DO 7/19/2018 Hunter Holmes McGuire Veterans Affairs Medical Center
CDER 7/5/2018 Lab-Service S.A.
CDER 7/6/2018 Delta Synthetic Co. Ltd.
CDER 7/6/2018 Teikoku Seiyaku Company, Ltd.
CDER 7/6/2018 Haupt Pharma Muenster GmbH
CDER 7/6/2018 Evertogen Life Sciences Ltd.
CDER 7/10/2018 Boehringer Ingelheim Pharma Gmbh & Co Kg
CDER 7/10/2018 Nippon Kayaku Co., Ltd.
CDER 7/10/2018 Corden Pharma S.p.A.
CDER 7/12/2018 SV Labs Private Limited
CDER 7/12/2018 Unilever Manufacturera S De R.L De C.V.
CDER 7/13/2018 Fortune Pharmacal Co Ltd
CDER 7/13/2018 Helixor Heilmittel GmbH
CDER 7/13/2018 TWI Pharmaceuticals, Inc.
CDER 7/13/2018 Aizant Drug Research Solutions Pvt. Ltd.
CDER 7/13/2018 Royal Pharma Chem Pvt. Ltd.
CDER 7/17/2018 Istituto Biochimico Italiano Giovanni Lorenzini S.p.A.
CDER 7/18/2018 Vindhya Organics Pvt Ltd
CDER 7/19/2018 Anjan Drug Private Limited
CDER 7/20/2018 ACS Dobfar s.p.a. (Plant #1)
CDER 7/20/2018 Icrom Spa
CDRH 7/5/2018 Nipro Corporation - Odate Factory
CDRH 7/5/2018 Single Use Surgical
CDRH 7/5/2018 Rapid Biomedical GmbH
CDRH 7/5/2018 Signature Orthopedics Pty Limited
CDRH 7/5/2018 Medimaging Integrated Solution, Inc.
CDRH 7/5/2018 KOWA CO. LTD. CHOFU
CDRH 7/11/2018 Pfm Medical Cpp SA
CDRH 7/12/2018 Modern Medical Equipment Mfg Ltd
CDRH 7/12/2018 ScandiDos AB
CDRH 7/13/2018 Fujifilm Corporation
CDRH 7/20/2018 Cefla s.c
CDRH 7/20/2018 Celfa s.c.
CHI-DO 7/3/2018 Catalent Pharma Solutions, LLC
CHI-DO 7/13/2018 Bella Elevator LLC
CHI-DO 7/17/2018 Richard Wolf Medical Instruments Corp.
CHI-DO 7/25/2018 Orsini Pharmaceutical Services, Inc.
CIN-DO 7/2/2018 Integra LifeSciences Corporation
CIN-DO 7/17/2018 Innovative Medical Equipment
CIN-DO 7/19/2018 Forbes Rehab Services Inc
CIN-DO 7/26/2018 Nutrishare Inc
DAL-DO 7/5/2018 OriGen Biomedical, Inc.
DAL-DO 7/11/2018 CFP Acquisitions Inc.
DAL-DO 7/11/2018 Microlight Corporation of America
DAL-DO 7/11/2018 Drug Crafters
DEN-DO 7/12/2018 Lincare, Inc
DEN-DO 7/13/2018 OraLabs, Incorporated
DEN-DO 7/17/2018 LSVT Global, LLC
DEN-DO 7/26/2018 Ulthera Inc
DET-DO 7/2/2018 Ionetix Corporation
DET-DO 7/18/2018 Nanovis LLC
FLA-DO 7/12/2018 Winco Mfg., LLC
FLA-DO 7/12/2018 Heartware, Inc.
FLA-DO 7/13/2018 PETNET Solutions, Inc.
FLA-DO 7/13/2018 Pharmcore Inc.
FLA-DO 7/18/2018 Andapharm, LLC
FLA-DO 7/19/2018 Actavis Laboratories FL, Inc.
FLA-DO 7/20/2018 Xcelience, LLC
KAN-DO 7/13/2018 Oakmont Products, LLC
KAN-DO 7/18/2018 Nesher Pharmaceuticals (USA) LLC
LOS-DO 7/13/2018 Mark Berman, M.D.
LOS-DO 7/20/2018 Codan US Corporation
LOS-DO 7/20/2018 Classic Wire Cut Co Inc
LOS-DO 7/25/2018 Naturalena Brands Inc
MIN-DO 7/19/2018 Agnitio Inc
NOL-DO 7/2/2018 People's Custom Rx and Clinical Care, LLC
NWE-DO 7/2/2018 Brown Urology, Inc.
NWE-DO 7/16/2018 Etex Corporation
NWE-DO 7/18/2018 Pfizer, Inc.
NWE-DO 7/24/2018 Jali Medical, Incorporated
NWE-DO 7/27/2018 Cynosure, Inc.
NWE-DO 7/31/2018 PolyCarbon Industries, Inc.
NWJ-DO 7/19/2018 Dimensional Merchandising Inc
NYK-DO 7/6/2018 A.M. Surgical, Inc.
NYK-DO 7/9/2018 Polymer Conversions Inc.
NYK-DO 7/13/2018 Novum Medical Products of NY, LLC
NYK-DO 7/13/2018 DuoProSS Meditech Corporation
NYK-DO 7/13/2018 Sharp Drugs, Inc.
NYK-DO 7/19/2018 Medtek Skin Care, Inc. d/b/a UVBiotek
NYK-DO 7/26/2018 Lena Cup LLC.
PHI-DO 7/3/2018 Accutome, Inc
PHI-DO 7/18/2018 Forge Medical Inc.
PHI-DO 7/20/2018 Genus Lifesciences Inc.
PHI-DO 7/27/2018 Digestive Care Inc
SAN-DO 7/5/2018 Pontis Orthopaedics, LLC
SAN-DO 7/20/2018 Veniti, Inc.
SEA-DO 7/10/2018 Vector Research and Development
SEA-DO 7/13/2018 Tec Laboratories, Inc.
SEA-DO 7/27/2018 Bend Research Inc.
SEA-DO 7/30/2018 PETNET Solutions Inc

 

June 2018

District Inspection Date Firm Name
ATL-DO 6/18/2018 Bright Enterprises, Inc
ATL-DO 6/22/2018 Dentonics, Inc
ATL-DO 6/28/2018 Anewmed Corporation
BLT-DO 6/22/2018 PureOxyWash Inc
CBER 6/14/2018 Transmed Medizintechnik
CDER 6/1/2018 Canadian Custom Packaging Co.
CDER 6/1/2018 Bayer OY
CDER 6/1/2018 Selder S.A. de C.V.
CDER 6/1/2018 Jubilant HollisterStier General Partnership
CDER 6/1/2018 Pekana Naturheilmittel GmbH
CDER 6/1/2018 Cosmetica Laboratories Inc.
CDER 6/1/2018 Mallinckrodt Medical BV
CDER 6/1/2018 Glaxo Wellcome Manufacturing Pte Limited
CDER 6/1/2018 Biotika a.s.
CDER 6/1/2018 Apotek Produktion & Laboratorier AB
CDER 6/1/2018 Windlas Healthcare Private Limited
CDER 6/1/2018 Dasami Lab Private Limited
CDER 6/6/2018 Moss S.p.A.
CDER 6/8/2018 Parfums Christian Dior
CDER 6/8/2018 Sicor De Mexico S.A. de C.V.
CDER 6/8/2018 MSD International GmbH (Singapore Branch)
CDER 6/8/2018 Laboratorios Baxter S A
CDER 6/8/2018 Patheon France S.A.S.
CDER 6/8/2018 Gipharma Srl
CDER 6/12/2018 Janssen Pharmaceutica, N.V.
CDER 6/14/2018 Proandre SL
CDER 6/15/2018 Procter & Gamble Manufactura S. de R.L. de C.V.
CDER 6/15/2018 Hanmi Fine Chemical Co Ltd
CDER 6/15/2018 CMIC CMO Korea Co., Ltd.
CDER 6/21/2018 Alfasigma S.p.A.
CDER 6/22/2018 Ajinomoto Omnichem NV
CDER 6/29/2018 Ajinomoto Omnichem
CDRH 6/1/2018 Bayer OY
CDRH 6/1/2018 BMR MEDICAL, Ltda.
CDRH 6/6/2018 Cane S.p.A.
CDRH 6/7/2018 Canadian Hospital Specialties
CDRH 6/7/2018 Biegler GmbH
CDRH 6/7/2018 DiaSource ImmunoAssays, SA
CDRH 6/7/2018 RANDOX TEORANTA
CDRH 6/13/2018 Cortex Technology ApS
CDRH 6/13/2018 Anhui Kangda Medical Products Co., Ltd.
CDRH 6/14/2018 Labotect Labor-Technik Gottingen GmbH
CDRH 6/14/2018 Medical Packaging
CDRH 6/21/2018 Nouvag Ag
CDRH 6/28/2018 Cantor & Nissel Ltd.
CHI-DO 6/5/2018 A-S Medication Solutions LLC.
CHI-DO 6/27/2018 Kalman Health & Wellness, Inc. dba Essential Wellness Pharma 2
CIN-DO 6/8/2018 Perma Laboratories LLC
DAL-DO 6/5/2018 Aggredyne, Inc.
DAL-DO 6/6/2018 Ingeneron, Inc
DAL-DO 6/11/2018 Stonegate Pharmacy LP
DAL-DO 6/14/2018 Beauty Manufacturing Solutions Corp.
DAL-DO 6/20/2018 Haelen Medical, Inc
DAL-DO 6/25/2018 Ultrapure & Industrial Services LLC
DEN-DO 6/14/2018 Neuromechanical Innovations, LLC
DEN-DO 6/22/2018 GE OEC Medical Systems, Inc
DEN-DO 6/26/2018 WalkMed, LLC
DEN-DO 6/27/2018 Pixation Corp.
DET-DO 6/5/2018 Future Pak, Ltd
DET-DO 6/8/2018 Biomedix, Inc.
DET-DO 6/14/2018 Cook Inc.
FLA-DO 6/13/2018 Anu Life Sciences
FLA-DO 6/14/2018 Catalent Pharma Solutions, LLC
FLA-DO 6/15/2018 Electrostim Medical Services Inc.dba EMSI
FLA-DO 6/22/2018 Wells Pharmacy Network LLC
KAN-DO 6/8/2018 Oxyband Technologies Inc
LOS-DO 6/7/2018 Shadow Holdings DBA Bocchi Labs
LOS-DO 6/8/2018 La Vita Compounding Pharmacy, LLC
LOS-DO 6/15/2018 Silhouette Lift, Inc.
LOS-DO 6/22/2018 Genetech Inc
LOS-DO 6/27/2018 Analytical Industries Inc
MIN-DO 6/14/2018 GE Healthcare, LLC
NOL-DO 6/7/2018 Arkema Inc
NOL-DO 6/19/2018 Insightra Medical Inc
NOL-DO 6/25/2018 GOODHEW, LLC
NWE-DO 6/7/2018 Tender Corporation
NWE-DO 6/8/2018 Organogenesis, Inc.
NWE-DO 6/11/2018 Unetixs Vascular Inc.
NWE-DO 6/11/2018 Criticare Technologies Inc
NWE-DO 6/14/2018 Karl Storz Endovision, Inc.
NWE-DO 6/18/2018 Acorda Therapeutics, Inc.
NWJ-DO 6/7/2018 Mycone Dental Supply Co., Inc. dba Keystone Industries
NWJ-DO 6/11/2018 Datascope Corporation
NWJ-DO 6/14/2018 Aurolife Pharma, LLC
NWJ-DO 6/14/2018 Origami Surgical LLC
NWJ-DO 6/15/2018 Guest Packaging LLC
NWJ-DO 6/19/2018 Stokes Healthcare Inc.
NYK-DO 6/8/2018 CPAC Equipment, Inc.
NYK-DO 6/21/2018 Harmac Medical Products, Inc.
PHI-DO 6/11/2018 New Era Orthopaedics, LLc
PHI-DO 6/21/2018 Pharmaloz Manufacturing Inc.
PHI-DO 6/27/2018 Vilvet Pharmaceutical
SAN-DO 6/6/2018 ITG-Medev Inc
SAN-DO 6/6/2018 Spectrum International, Inc.
SAN-DO 6/8/2018 Clareblend Inc
SAN-DO 6/27/2018 Well Care Discount Pharmacy, LLC
SEA-DO 6/15/2018 Formula Corp
SEA-DO 6/22/2018 Dental Alliance Holdings LLC
SJN-DO 6/1/2018 Abbvie Biotechnology Ltd.
SJN-DO 6/1/2018 AIAC International Pharma, LLC
SJN-DO 6/7/2018 Artifex Solutions LLC
SJN-DO 6/14/2018 IPR Pharmaceuticals, Inc.

 

May 2018

District Inspection Date Firm Name
ATL-DO 5/1/2018 Global Products International Group, DBA Althea Medical Group
ATL-DO 5/4/2018 Biogen US Corporation
CBER 5/17/2018 CSL Behring GmbH
CBER 5/25/2018 GSK Vaccines GmbH
CDER 5/3/2018 Cadila Pharmaceuticals Limited
CDER 5/4/2018 Actavis Italy S.p.A.
CDER 5/4/2018 Boehringer Ingelheim Pharma GmbH & Co. KG
CDER 5/4/2018 Swedish Orphan Biovitrum AB
CDER 5/4/2018 F. Hoffmann - La Roche Ltd.
CDER 5/4/2018 UBI Pharma, Inc.
CDER 5/4/2018 Inogent Laboratories Private Ltd
CDER 5/4/2018 Symed Labs Ltd (Unit I)
CDER 5/4/2018 Innova Pharmactive Private Limited
CDER 5/4/2018 HanBangMeIn Cosmetics
CDER 5/4/2018 Aurobindo Pharma Limited
CDER 5/8/2018 Xellia Pharmaceuticals ApS
CDER 5/9/2018 Merck Serono SA Aubonne
CDER 5/10/2018 GE Healthcare Shanghai Co., Ltd.
CDER 5/10/2018 Pietrobon e Cia Ltda.
CDER 5/11/2018 Isomers Laboratories
CDER 5/11/2018 Unique Chemicals
CDER 5/11/2018 Symed Labs Limited (Unit II)
CDER 5/11/2018 Indoco Remedies Limited
CDER 5/11/2018 Recipharm Pharmaservices Private Limited
CDER 5/11/2018 Umicore Argentina S.A.
CDER 5/11/2018 Samsung Biologics Co. Ltd.
CDER 5/16/2018 Unimed Pharmaceuticals, Inc.
CDER 5/17/2018 CSL Behring GmbH
CDER 5/18/2018 Pharmacosmos A/S
CDER 5/18/2018 Baxter Hospitalar Ltda
CDER 5/25/2018 Zaklady Farmaceutyczne Polpharma S.A.
CDER 5/25/2018 Biocodex
CDER 5/25/2018 New Zealand Pharmaceutical Ltd.
CDER 5/25/2018 Laboratorios Leon Farma SA
CDER 5/31/2018 Sanofi S.p.A.
CDRH 5/2/2018 Xiantao Shuangyan Plastics Co., Ltd.
CDRH 5/3/2018 Nipro (Thailand) Corporation Limited
CDRH 5/3/2018 Seodong Medical Co
CDRH 5/10/2018 Hill-Rom Services Private Limited
CDRH 5/11/2018 Boule Medical AB
CDRH 5/16/2018 PROMEPLA
CDRH 5/17/2018 Duckworth & Kent, Ltd.
CDRH 5/17/2018 Ceragem Co., Ltd.
CDRH 5/17/2018 Mauna Kea Technologies
CDRH 5/17/2018 Noras MRI Products GmbH
CDRH 5/17/2018 Crystalvue Medical Corporation
CDRH 5/17/2018 ENDOMAGNETICS LTD
CDRH 5/23/2018 Home Care Technology Co., Ltd.
CDRH 5/24/2018 Medi-Globe s.r.o.
CDRH 5/25/2018 Laboratorios Leon Farma SA
CDRH 5/30/2018 Nical S.p.A.
CHI-DO 5/11/2018 Wondfo USA Co Ltd
CHI-DO 5/15/2018 Dhaliwal Labs
CHI-DO 5/16/2018 Akorn, Inc.
CHI-DO 5/28/2018 A-S Medication Solutions LLC.
DAL-DO 5/2/2018 Trilliant Surgical Ltd.
DAL-DO 5/10/2018 Mibo Medical Group
DAL-DO 5/14/2018 Chemtrade Solutions, LLC
DAL-DO 5/25/2018 Strukmyer Medical
DEN-DO 5/2/2018 American Sleep Dentistry Marketing, LLC
DEN-DO 5/14/2018 Shippert Medical Technologies
DEN-DO 5/16/2018 Gergens Orthodontic Lab
DET-DO 5/1/2018 Cook Pharmica, LLC
DET-DO 5/2/2018 Tower Laboratories Ltd.
DET-DO 5/10/2018 NG Instruments, Inc.
DET-DO 5/23/2018 Ultrasound Medical Devices, Inc.
DET-DO 5/30/2018 Centre Light Solutions, LLC
FLA-DO 5/7/2018 Coast Quality Pharmacy LLC
FLA-DO 5/8/2018 Ziptek LLC
FLA-DO 5/9/2018 HNM Total Recon, LLC
FLA-DO 5/11/2018 LifeLink Foundation, Inc. dba Lifelink Tissue Bank
FLA-DO 5/15/2018 Bioflo LLC
FLA-DO 5/16/2018 Erchonia Corporation, LLC
FLA-DO 5/18/2018 Hill Dermaceuticals, Inc.
FLA-DO 5/30/2018 Tropical Seas, Inc.
KAN-DO 5/4/2018 University of Iowa Pharmaceuticals (UIP)
KAN-DO 5/10/2018 Zutron Medical LLC
KAN-DO 5/10/2018 Keller Laboratories
KAN-DO 5/24/2018 American Contract Systems, Inc.
LOS-DO 5/1/2018 Acro Biotech Inc.
LOS-DO 5/15/2018 Haemonetics Manufacturing, Inc.
LOS-DO 5/15/2018 Clinical Resolution Laboratory
LOS-DO 5/17/2018 220 Laboratories, Inc.
LOS-DO 5/18/2018 Staar Surgical Co.
LOS-DO 5/18/2018 Bachem Americas, Inc.
LOS-DO 5/21/2018 Lusys Laboratories, Inc.
LOS-DO 5/24/2018 Ra Medical Systems Inc
MIN-DO 5/2/2018 Implant Logistics Inc
MIN-DO 5/4/2018 Rockline Industries, Inc
MIN-DO 5/14/2018 Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
NWE-DO 5/2/2018 Jeio Tech Inc.
NWE-DO 5/4/2018 Alnylam Pharmaceuticals Inc.
NWE-DO 5/10/2018 Nitto Denko Avecia Inc.
NWE-DO 5/21/2018 Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc.
NWE-DO 5/24/2018 Saphena Medical, Inc.
NWE-DO 5/31/2018 Ushio America, Inc.
NWJ-DO 5/3/2018 Ferring Production Inc.
NWJ-DO 5/4/2018 Swissray International Inc.
NWJ-DO 5/8/2018 CMIC CMO USA Corporation
NWJ-DO 5/16/2018 Vynacron Dental Resins, Inc.
NWJ-DO 5/17/2018 Advanced Accelerator Applications USA, Inc.
NWJ-DO 5/23/2018 Austarpharma LLC
NWJ-DO 5/30/2018 Halo Pharmaceutical, Inc.
NYK-DO 5/1/2018 Biodex Medical Systems, Inc.
NYK-DO 5/2/2018 Respire Medical
NYK-DO 5/8/2018 Wolf X-Ray Corp
NYK-DO 5/11/2018 Mana Products, Inc.
NYK-DO 5/14/2018 Graphic Controls Acquisition Corporation
NYK-DO 5/25/2018 First Source, Inc.
NYK-DO 5/29/2018 Fougera Pharmaceuticals, Inc.
NYK-DO 5/29/2018 Fougera Pharmaceuticals Inc.
PHI-DO 5/17/2018 Carlco Technical Plastics - Latrobe
PHI-DO 5/22/2018 Ranier's Compounding Laboratory
SAN-DO 5/4/2018 Transamerican Technologies International
SAN-DO 5/7/2018 Optiscan Biomedical Corporation
SAN-DO 5/16/2018 Novabay Pharmaceuticals Inc
SAN-DO 5/23/2018 Nuvolase Inc.
SAN-DO 5/25/2018 PETNET SOLUTIONS, INC.
SEA-DO 5/25/2018 Unicep Packaging, LLC
SEA-DO 5/30/2018 Meditherm Inc.
SJN-DO 5/15/2018 Medtronic Puerto Rico Operations Co.

 

April 2018

District Inspection Date Firm Name
BLT-DO 4/20/2018 Aphena Pharma Solutions-Maryland LLC
CDER 4/3/2018 Nanjing King-Friend Biochemical Pharmaceutical Co., Ltd.
CDER 4/11/2018 Fresenius Kabi Deutschland GmbH
CDRH 4/5/2018 NINGBO HECAI MEDICAL EQUIPMENT CO. LTD.
CDRH 4/19/2018 Humanoptics Ag.
CHI-DO 4/6/2018 Sterling Pharmceutical Svcs
CHI-DO 4/13/2018 Plexus Corporation
CHI-DO 4/27/2018 Blue Sky Bio, LLC
DAL-DO 4/9/2018 United 1 International Laboratories, LLC
DAL-DO 4/20/2018 Guardian Pharmacy Services
DEN-DO 4/12/2018 LED Technologies, LLC
DEN-DO 4/12/2018 Neo Innovations, Inc.
DEN-DO 4/19/2018 Mytrex, Inc. dba Rescue Alert
DET-DO 4/6/2018 Global Isotopes LLC dba Zevacor Molecular
FLA-DO 4/10/2018 C2C Development, LLC
FLA-DO 4/12/2018 ADMA Biologics Inc.
FLA-DO 4/13/2018 Quasar Bio-Tech, Inc.
KAN-DO 4/6/2018 eScreen Inc
KAN-DO 4/12/2018 TJN Mfg Inc
KAN-DO 4/18/2018 DynaFlex Ltd
KAN-DO 4/19/2018 Q A Laboratories Inc
LOS-DO 4/3/2018 Chen Shwezin, Inc. dba Park Compounding Pharmacy
LOS-DO 4/20/2018 Cardinal Health 414, LLC
MIN-DO 4/2/2018 Nortech Systems, Inc.
MIN-DO 4/6/2018 Bell Pharmaceuticals, Inc
MIN-DO 4/18/2018 NorthStar Medical Radioisotopes, LLC
MIN-DO 4/18/2018 Fairview Compounding Phamacy
NOL-DO 4/10/2018 Reliance Mobility, LLC
NWE-DO 4/4/2018 pSivida Inc.
NWE-DO 4/4/2018 Mobius Imaging, LLC
NWE-DO 4/5/2018 Conseal International, Inc.
NWE-DO 4/11/2018 Prototype & Plastic Mold Company, Inc.
NWE-DO 4/12/2018 Sarepta Therapeutics, Inc.
NWE-DO 4/13/2018 Coherent, Inc.
NWE-DO 4/13/2018 Berkshire Sterile Manufacturing, Inc.
NWE-DO 4/19/2018 Beaver Visitec
NWE-DO 4/26/2018 Cirrus Healthcare Products, LLC
NYK-DO 4/10/2018 Bio Gen Technologies, Inc
NYK-DO 4/11/2018 Luitpold Pharmaceuticals, Inc.
NYK-DO 4/18/2018 PHARBEST Pharmaceuticals, Inc.
PHI-DO 4/6/2018 DNE LLC
SAN-DO 4/4/2018 Hand Biomechanics Lab Inc
SAN-DO 4/11/2018 ABCO Laboratories, Inc.
SAN-DO 4/19/2018 Anigan, Inc.
SEA-DO 4/2/2018 Tricol Biomedical, Inc.
SEA-DO 4/13/2018 Nutritional Laboratories International Inc.

 

March 2018

District Inspection Date Firm Name
ATL-DO 3/7/2018 BOV Solutions
BLT-DO 3/7/2018 Euclid Systems Corporation
BLT-DO 3/20/2018 Nutravail, LLC.
CDER 3/1/2018 Rhodia Poliamida e Especialidades Ltda.
CDER 3/2/2018 Hetero Drugs Ltd. - Unit 1
CDER 3/2/2018 Rohto Pharmaceutical Company, Ltd. (Ueno Plant)
CDER 3/2/2018 Sandoz GmbH
CDER 3/2/2018 AmLion Toothpaste Mfg Sdn
CDER 3/2/2018 Mylan Laboratories Limited, Speciality Formulation Facility
CDER 3/2/2018 HnG Co., Ltd.
CDER 3/6/2018 Hisun Pharmaceutical Hangzhou Co Ltd
CDER 3/6/2018 Auronext Pharma
CDER 3/9/2018 Saurav Chemicals Limited
CDER 3/9/2018 Bharat Pharma
CDER 3/14/2018 Samsung Biologics Co. Ltd.
CDER 3/16/2018 Eli Lilly Kinsale Ltd.
CDER 3/16/2018 Vamsi Labs Ltd
CDER 3/22/2018 Zhejiang Huazhou Pharmaceutical Co., Ltd.
CDER 3/22/2018 Glenmark Pharmaceuticals Ltd.
CDER 3/23/2018 Jabones Y Productos Especializados SA de CV
CDER 3/29/2018 Contract Pharmaceuticals Ltd.
CDRH 3/1/2018 Pega Medical Inc.
CDRH 3/1/2018 Fluoptics SAS
CDRH 3/8/2018 Mi Gwang Contact Lens Co., Ltd.
CDRH 3/8/2018 Actegy Limited
CDRH 3/22/2018 Schiller Medical
CIN-DO 3/1/2018 American Thermal Instruments Inc
CIN-DO 3/1/2018 GEM City Enginnering and Manufacturing Corporation
CIN-DO 3/8/2018 Amylin Ohio LLC
CIN-DO 3/13/2018 Vital Connections, Inc.
CIN-DO 3/15/2018 Checkpoint Surgical Inc
CIN-DO 3/16/2018 Gendron Inc.
CIN-DO 3/20/2018 Electro Cap International Inc
CIN-DO 3/21/2018 Sonogage Inc
DAL-DO 3/20/2018 University Of Texas MD Anderson Cancer Center
DEN-DO 3/1/2018 Zimmer Biomet Spine Inc.
DEN-DO 3/16/2018 Cardinal Health 414 LLC
DET-DO 3/6/2018 Arcamed LLC
DET-DO 3/15/2018 Greenwald Surgical Company, Inc.
DET-DO 3/23/2018 Renton Surgical, LLC
FLA-DO 3/1/2018 Belcher Pharmaceuticals, LLC
FLA-DO 3/1/2018 Pure Source LLC
FLA-DO 3/14/2018 Republic Spine, LLC
KAN-DO 3/1/2018 Surmasis Pharmaceutical
KAN-DO 3/2/2018 Grato Holdings, Inc.
KAN-DO 3/5/2018 Southwest Technologies Inc
KAN-DO 3/13/2018 Apollo Care
KAN-DO 3/20/2018 Fuller Industries, LLC
KAN-DO 3/22/2018 Primus Sterilizer Company LLC
LOS-DO 3/6/2018 The Micro Connection Enterprises, Inc. DBA Personal Care Performance Group
LOS-DO 3/9/2018 TECHNICHEM CORP
LOS-DO 3/13/2018 Product Packaging West, Inc.
LOS-DO 3/15/2018 Thibiant International, Inc.
LOS-DO 3/16/2018 Amgen, Inc.
LOS-DO 3/21/2018 NuCare Pharmaceuticals Inc
MIN-DO 3/7/2018 Sybaritic, Inc
MIN-DO 3/9/2018 Summit Medical, LLC
NOL-DO 3/9/2018 Exxon Mobil Chemical Company
NOL-DO 3/9/2018 CNMC Company, Inc.
NOL-DO 3/15/2018 Edge Biologicals Inc
NOL-DO 3/23/2018 rms Surgical, Inc.
NWE-DO 3/2/2018 Siemens Healthcare Diagnostics, Inc
NWE-DO 3/2/2018 New England Life Care, Inc.
NWE-DO 3/16/2018 Biosensics
NWE-DO 3/23/2018 Tower Laboratories, Ltd.
NWJ-DO 3/9/2018 ImClone Systems, LLC. d.b.a. Eli Lilly and Company
NYK-DO 3/8/2018 Varex Imaging Corporation
NYK-DO 3/8/2018 OptumHealth Care Solutions Inc.
NYK-DO 3/15/2018 Aqua Sciences Inc
NYK-DO 3/16/2018 Genalstrap Inc.
NYK-DO 3/22/2018 American Bio Medica Corp
NYK-DO 3/29/2018 Advanced Monitored Caregiving
NYK-DO 3/30/2018 Alliance Precision Plastics Corporation
SAN-DO 3/8/2018 Partell Specialty Pharmacy
SEA-DO 3/14/2018 The Feminina Group, Inc.
SJN-DO 3/23/2018 Caribe Holdings (Cayman) Co. Ltd dba PuraCap Caribe
ATL-DO 3/1/2018 David Stickler
CDER 3/23/2018 Michal Nowicki, Prof. Uniwersytecki Szpital Kliniczny NR 1
CIN-DO 3/30/2018 Sergio D. Bergese
KAN-DO 3/2/2018 Mazen M. Dimachkie, MD
LOS-DO 3/20/2018 Maria Greenwald, MD
MIN-DO 3/9/2018 Hardten, David R., MD, Clinical Investigator
MIN-DO 3/9/2018 Morie A. Gertz, M.D., Clinical Investigator
PHI-DO 3/9/2018 Giacomina Massaro-Giordano M.D.
SEA-DO 3/16/2018 Paul Nghiem

 

February 2018

District Inspection Date Firm Name
ATL-DO 2/2/2018 Hospira a Pfizer Company
CBER 2/2/2018 Baxalta Inc. Baxter AG
CDER 2/2/2018 DSM Nutritional Products GmbH
CDER 2/2/2018 Solupharm Pharmazeutische Erzeugnisse Gmbh
CDER 2/6/2018 Hanlim Pharm Co., Ltd.
CDER 2/8/2018 Katwijk Chemie Bv
CDRH 2/1/2018 Beijing Polycon Medical Engineering Ltd.
CDRH 2/1/2018 CL Medical
CDRH 2/8/2018 Dannoritzer Medizintechnik GmbH & Co. KG
CDRH 2/8/2018 Copious International Inc.
CDRH 2/8/2018 Beijing ADSS Development Co., Ltd.
CDRH 2/15/2018 Cair LGL
CHI-DO 2/7/2018 Physician Software Systems LLC
CIN-DO 2/2/2018 MHC Medical Products LLC
CIN-DO 2/14/2018 Patheon Pharmaceuticals Inc
CIN-DO 2/15/2018 Vantage Specialty Ingredients Inc
CIN-DO 2/22/2018 SPR Therapeutics Inc.
DAL-DO 2/6/2018 Monarch PCM, LLC
DAL-DO 2/16/2018 Insys Manufacturing, LLC
DEN-DO 2/6/2018 Natural Health Supply
DEN-DO 2/9/2018 Genesee BioMedical, Inc.
DEN-DO 2/16/2018 Yusef Manufacturing Laboratories, LLC
DEN-DO 2/16/2018 Wallsburg Farms Inc.
DET-DO 2/2/2018 Lannett Company Inc.
DET-DO 2/8/2018 THS International, Inc.
DET-DO 2/23/2018 Serim Research Corporation
FLA-DO 2/2/2018 Lexington International, LLC
FLA-DO 2/5/2018 Clearwater Colon Hydrotherapy, Inc.
KAN-DO 2/6/2018 PTI Union LLC
KAN-DO 2/8/2018 Morton Salt Inc
KAN-DO 2/23/2018 Veran Medical Technologies Inc
LOS-DO 2/2/2018 FNC Medical Corporation
LOS-DO 2/9/2018 Samson Pharmaceuticals, Inc
MIN-DO 2/2/2018 Alpha Source, Inc.
MIN-DO 2/2/2018 DeVere Company, Inc.
NOL-DO 2/1/2018 ProMED Concepts, LLC
NOL-DO 2/1/2018 The Compounding Pharmacy of America
NWE-DO 2/1/2018 Conair Corporation
NWE-DO 2/1/2018 Shire Human Genetic Therapies Inc
NWE-DO 2/1/2018 Sun Capsule Corporation
NWE-DO 2/2/2018 The Original Bradford Soap Works, Inc.
NWE-DO 2/8/2018 New England Life Care, Inc.
NWE-DO 2/21/2018 Fresh Pond Ventures, LLC
NWE-DO 2/23/2018 Brymill Corporation
NWE-DO 2/28/2018 Braintree Laboratories, Inc.
NWJ-DO 2/6/2018 Heritage Pharma Labs, Inc.
NYK-DO 2/1/2018 Transonic Systems Inc
NYK-DO 2/1/2018 Quicklook Inc
NYK-DO 2/2/2018 Geritrex Corp
NYK-DO 2/8/2018 Premier Heart, LLC
NYK-DO 2/16/2018 Gemini Pharmaceuticals, Inc.
PHI-DO 2/7/2018 Bio-pharm, Inc.
SAN-DO 2/1/2018 Alza Corporation
SAN-DO 2/1/2018 All Quality & Services, Inc.
SAN-DO 2/2/2018 Botanic Beauty Products, Inc.
SAN-DO 2/23/2018 NeuroField, Inc.
SEA-DO 2/7/2018 D. E. Hokanson, Inc.

 

January 2018

District Inspection Date Firm Name
CDER 1/11/2018 Tianjin Weijie Pharmaceutical Co., Ltd.
CDER 1/11/2018 Ningbo Liyuan Daily Chemical Products Co.
CDER 1/11/2018 Satya Deeptha Pharmaceuticals Limited
CDER 1/12/2018 Inner Mongolia Huashu Biological Technology Co., Ltd.
CDER 1/12/2018 Shandong Zouping Dazhan New Materials Co., Ltd.
CDER 1/19/2018 Indoco Remedies Limited (Plant I)
CDER 1/23/2018 Wasserburger Arzneimittelwerk GmbH
CDER 1/25/2018 Cipla Limited
CDRH 1/9/2018 BMC Medical Co., Ltd.
CDRH 1/12/2018 BMC (Tianjin) Medical Co., Ltd.
CDRH 1/16/2018 Carestream Health, Inc., Global R&D Center (Shanghai)
CDRH 1/18/2018 Fresenius Vial Sa
CDRH 1/18/2018 Covalon Technologies Inc.
CDRH 1/18/2018 BEIJING SINCOHEREN SCIENCE & TECHNOLOGY DEVELOPMENT CO., LTD
CDRH 1/18/2018 Jago-Pro Sp.Z O.O.
CHI-DO 1/10/2018 Weiman Products, LLC
CHI-DO 1/11/2018 Asahi Kasei Medical America, Inc
CHI-DO 1/17/2018 Waldmann Lighting USA
CIN-DO 1/4/2018 Endoprime Inc
CIN-DO 1/19/2018 Bio-Thesiometer USA
CIN-DO 1/26/2018 Teva Womens Health Inc
DAL-DO 1/12/2018 Sovereign Pharmaceuticals, LLC
DAL-DO 1/12/2018 Seno Medical Instrument Inc
DAL-DO 1/24/2018 Empower Clinic Services, LLC
DEN-DO 1/5/2018 UNITED STATES DEPT OF ENERGY
DEN-DO 1/5/2018 Value Plastics, Inc.
DEN-DO 1/12/2018 MBi Distributing Inc. dba MBi Nutraceuticals
DEN-DO 1/17/2018 College Pharmacy, Inc.
DEN-DO 1/29/2018 WAVi Co.
DET-DO 1/9/2018 Grind Guard Technologies, Llc
DET-DO 1/31/2018 R2 Diagnostics, Inc.
FLA-DO 1/17/2018 Oxygen Development Llc
FLA-DO 1/26/2018 Noven Pharmaceuticals, Inc.
MIN-DO 1/3/2018 Cornell Llc
MIN-DO 1/12/2018 Webb Business Promotions
NOL-DO 1/11/2018 Permobil Inc
NOL-DO 1/31/2018 Medegen Medical Products, LLC
NWE-DO 1/3/2018 Medtronic Navigation, Inc.-Littleton
NWE-DO 1/3/2018 Provent Sleep Therapy LLC
NWE-DO 1/10/2018 O2 Concepts, LLC
NWE-DO 1/11/2018 Cetro America
NWE-DO 1/18/2018 Bio2 Technologies Inc.
NWE-DO 1/26/2018 Bandwagon, Inc.
NWE-DO 1/29/2018 Boston Eye Design, LLC
NWJ-DO 1/5/2018 Austarpharma LLC
NWJ-DO 1/8/2018 Raritan Pharmaceuticals, Inc.
NWJ-DO 1/18/2018 Sunrise Pharmaceutical, Inc.
NYK-DO 1/11/2018 Ivoclar Vivadent, Inc.
NYK-DO 1/18/2018 Amneal Pharmaceuticals
NYK-DO 1/26/2018 Len-Ron Manufacturing Division of Aramis Inc.
PHI-DO 1/18/2018 American Dental Sleep Medicine, IP, LLC
SAN-DO 1/11/2018 Qview Medical, Inc.
SEA-DO 1/11/2018 Micro Current Technology, Inc.
SEA-DO 1/25/2018 Cortex Manufacturing Inc.
SEA-DO 1/25/2018 Shift Labs Inc
SJN-DO 1/26/2018 Pfizer Pharmaceuticals LLC

 

December 2017

District Inspection Date Firm Name
ATL-DO 12/7/2017 Deb USA Inc.
ATL-DO 12/8/2017 Ajinomoto North America, Inc.
ATL-DO 12/15/2017 Alcami Carolinas Corporation
CDER 12/1/2017 Les Emballages Facoteck Inc
CDER 12/1/2017 Les Importations Herbasante Inc.
CDER 12/1/2017 Par Active Technologies Private Limited
CDER 12/1/2017 Kyongbo Pharmaceutical Co., Ltd.
CDER 12/1/2017 Douglas Manufacturing Limited
CDER 12/1/2017 Hanbul Cosmetics Co., Ltd
CDER 12/1/2017 Yancheng Youhua Pharmaceutical and Chemical Tech. Co. Ltd.
CDER 12/1/2017 Institutt For Energiteknikk
CDER 12/1/2017 Higiene + Salud, S.A. de C.V.
CDER 12/1/2017 The United Laboratories (Inner Mongolia) Co. Ltd.
CDER 12/5/2017 Health Biotech Limited
CDER 12/8/2017 Church & Dwight Canada Corp.
CDER 12/8/2017 IDT Australia Ltd.
CDER 12/13/2017 Jalco Cosmetics Pty Ltd.
CDER 12/13/2017 Panacea Biotec Limited
CDER 12/13/2017 Reliance Life Sciences PVT LTD
CDER 12/14/2017 Henan Lihua Pharmaceutical Co., Ltd.
CDER 12/15/2017 Eau Zone Huiles Et Fragrances Lee
CDER 12/15/2017 Cosmaceutical Research Laboratory Inc.
CDER 12/15/2017 LCC Ltd.
CDER 12/22/2017 AutekBio FTZ
CDRH 12/6/2017 Zhangzhou Austrialian Proplastics Co., Ltd.
CDRH 12/7/2017 Tonica Elektronik A/S
CDRH 12/14/2017 Laboratoires Urgo
CHI-DO 12/4/2017 Universal Beauty Products Inc
CHI-DO 12/14/2017 Alpha Bedding, LLC. DBA Alpha Tekniko
CHI-DO 12/15/2017 AbbVie Inc.
CIN-DO 12/13/2017 CIL Isotope Separations, LLC
DAL-DO 12/5/2017 CBI Laboratories, Inc.
DAL-DO 12/7/2017 People's Pharmacy, Inc
DAL-DO 12/7/2017 Peoples Pharmacy, Inc.
DEN-DO 12/6/2017 Arrowhead Dental Inc.
DEN-DO 12/7/2017 A Cute Baby, Inc.
DEN-DO 12/8/2017 Cody Laboratories, Inc.
DEN-DO 12/11/2017 Optikem International, Inc.
DEN-DO 12/13/2017 DIGITAL HEAT CORPORATION
DET-DO 12/1/2017 Spectra Therapy, LLC.
DET-DO 12/14/2017 Kath Khemicals LLC
DET-DO 12/15/2017 BioLyte Laboratories, LLC
DET-DO 12/22/2017 Pharmacia & Upjohn Company, LLC
FLA-DO 12/1/2017 Fen Dental Mfg, Inc.
FLA-DO 12/8/2017 Formulated Solutions, LLC
FLA-DO 12/8/2017 Modal Manufacturing, LLC
FLA-DO 12/11/2017 Oculus Surgical, Inc.
FLA-DO 12/28/2017 Webrx dba RxPalace.com
KAN-DO 12/1/2017 American Laboratories Inc
KAN-DO 12/1/2017 American Laboratories Inc
KAN-DO 12/5/2017 Mid-America Medical Innovations, LLC.
KAN-DO 12/8/2017 Nanova Biomaterials Inc
KAN-DO 12/8/2017 PlasmaDent, Inc.
LOS-DO 12/7/2017 I. Shay Cosmetics Inc
LOS-DO 12/18/2017 bB BIOCHEM LABORATORIES INC.
LOS-DO 12/19/2017 Endotec, Inc.
MIN-DO 12/5/2017 HLPR, Inc. dba Lakewood Products
MIN-DO 12/18/2017 Enteromedics, Inc.
NOL-DO 12/15/2017 Comit Developers Llc
NOL-DO 12/22/2017 The Wellness Center Pharmacy, Inc., dba Designer Drugs
NWE-DO 12/5/2017 Ipsen Bioscience, Inc.
NWE-DO 12/14/2017 Catachem, Inc.
NWE-DO 12/15/2017 J-PAC, LLC
NWE-DO 12/15/2017 Zyno Medical LLC
NWE-DO 12/18/2017 Schlotterbeck & Foss Company Inc.
NWE-DO 12/27/2017 Milbar Laboratories, Inc.
NWJ-DO 12/4/2017 GERI-GENTLE CORPORATION
NWJ-DO 12/14/2017 Ingenus Pharmaceuticals NJ, LLC.
NYK-DO 12/6/2017 Medical Acoustics, LLC
NYK-DO 12/8/2017 NCM USA LLC
NYK-DO 12/15/2017 Kreitchman PET Center
NYK-DO 12/18/2017 Polygen Pharmaceuticals Llc
NYK-DO 12/18/2017 Elite Medical Supply of New York, LLC
SAN-DO 12/4/2017 Abbott Diabetes Care, Inc.
SAN-DO 12/14/2017 Laser Dental Innovations
SEA-DO 12/8/2017 International Isotopes Inc.
SEA-DO 12/15/2017 Physio-Control, Inc.

 

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