Recently Requested 483s
December 2019 |
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District | Inspection Date | Firm Name |
ATL-DO | 12/13/2019 | Greiner Bio-One North America, Inc. |
ATL-DO | 12/17/2019 | Love Rehab Solutions |
BLT-DO | 12/6/2019 | Tetracore, Inc. |
BLT-DO | 12/18/2019 | Figure 8 Surgical, Inc. |
CBER | 12/17/2019 | Allergan Pharmaceuticals Ireland |
CDER | 12/6/2019 | BOEHRINGER INGELHEIM PROMECO S.A. de C.V. |
CDER | 12/6/2019 | Dabur India Limited |
CDER | 12/6/2019 | Kyongbo Pharmaceutical Co., Ltd. |
CDER | 12/6/2019 | Laboratorios Rety de Colombia S A S |
CDER | 12/6/2019 | Ecorganicos de Colombia SAS |
CDER | 12/6/2019 | Cartibras Beneficiadora De Produtos Animais Ltda |
CDER | 12/6/2019 | Qingdao BAHEAL Pharmaceutical Co.,Ltd. |
CDER | 12/6/2019 | Tianjin Asymchem Pharmaceuticals Co., Ltd. |
CDER | 12/6/2019 | Luoyang MuChun pharmaceutical Co., LTD |
CDER | 12/10/2019 | Tubilux Pharma Spa |
CDER | 12/13/2019 | Sinsin Pharmaceutical Co., Ltd. |
CDER | 12/13/2019 | Sun Pharmaceutical Industries Ltd. |
CDER | 12/13/2019 | Bel Star S.A. |
CDER | 12/20/2019 | Zenara Pharma Pvt Ltd |
CDRH | 12/4/2019 | Umano Medical, Inc. |
CDRH | 12/5/2019 | Medicrea International |
CDRH | 12/5/2019 | Exmoor Plastics Ltd. |
CDRH | 12/11/2019 | Caltag Medsystems Ltd |
CDRH | 12/12/2019 | Future Diagnostics Solutions B.V. |
CDRH | 12/12/2019 | Blue Ortho |
CDRH | 12/13/2019 | Vacutest Kima SRL |
CHI-DO | 12/4/2019 | Oceanic Dental Laboratory LLC |
CHI-DO | 12/11/2019 | Coapt LLC |
CHI-DO | 12/19/2019 | Avatar Corporation |
CIN-DO | 12/13/2019 | Patheon Pharmaceuticals Inc |
DAL-DO | 12/3/2019 | Assurance Infusion |
DAL-DO | 12/11/2019 | Trilliant Surgical, LLC |
DAL-DO | 12/12/2019 | MPM Medical LLC |
DAL-DO | 12/12/2019 | Sovereign Pharmaceuticals, LLC |
DEN-DO | 12/11/2019 | Westmed, Inc. |
DEN-DO | 12/12/2019 | Mayo Clinic PET Radiochemistry Facility |
DEN-DO | 12/18/2019 | Medinatura Inc |
DET-DO | 12/11/2019 | Keystone Manufacturing LLC. |
DET-DO | 12/12/2019 | Future Pak, Ltd |
DET-DO | 12/13/2019 | EKF Diagnostics, Inc. dba EFK Life Sciences |
DET-DO | 12/13/2019 | Tenderneeds Fertility LLC |
DET-DO | 12/18/2019 | BioLyte Laboratories, LLC |
DET-DO | 12/19/2019 | Analytical Control Systems, Inc |
DET-DO | 12/19/2019 | Integrated Biomedical Technology, Inc. |
FLA-DO | 12/3/2019 | Transdermal Delivery Solutions Corp. dba Hypospray Pharma |
FLA-DO | 12/10/2019 | Magnatone Hearing Aid Corp. DBA Persona Medical |
FLA-DO | 12/11/2019 | Maguire Enterprises, Inc. |
FLA-DO | 12/11/2019 | Strides Pharma, Inc. |
FLA-DO | 12/11/2019 | Neocis, Inc. |
FLA-DO | 12/13/2019 | LD Technology, LLC |
FLA-DO | 12/13/2019 | FloSpine, LLC |
FLA-DO | 12/17/2019 | Infusion Systems of SW Florida Inc. dba Myerlee Pharmacy |
FLA-DO | 12/18/2019 | Gulf Fiberoptics, Inc. |
FLA-DO | 12/20/2019 | Stingray Surgical Products, LLC |
KAN-DO | 12/5/2019 | Hi-Dow International Inc |
KAN-DO | 12/6/2019 | Grato Holdings, Inc. |
KAN-DO | 12/6/2019 | Marcus Research Lab Inc |
LOS-DO | 12/2/2019 | Implant Direct Sybron Manufacturing LLC |
LOS-DO | 12/4/2019 | AutoGenomics, Inc. |
LOS-DO | 12/5/2019 | Mark Berman, M.D. |
LOS-DO | 12/11/2019 | BIT Group USA, Inc. |
LOS-DO | 12/11/2019 | Ra Medical Systems, Inc. |
LOS-DO | 12/12/2019 | DLC Laboratories, Inc |
LOS-DO | 12/12/2019 | Resolution Biomedical Inc |
LOS-DO | 12/13/2019 | Bachem Americas, Inc. |
LOS-DO | 12/13/2019 | Amgen, Inc. |
LOS-DO | 12/16/2019 | V Manufacturing & Logistics, Inc. |
LOS-DO | 12/20/2019 | ABC Pharmacy, Inc. |
MIN-DO | 12/11/2019 | Minnesota MedTec, Inc. |
MIN-DO | 12/20/2019 | Mainstay Medical Limited US, Inc. |
NOL-DO | 12/20/2019 | Natureplex LLC |
NWE-DO | 12/11/2019 | Applied Tissue Technologies LLC |
NWE-DO | 12/13/2019 | Proven Process Medical Devices, Inc. |
NWE-DO | 12/18/2019 | Liberty Engineering Inc |
NWE-DO | 12/19/2019 | Autumn Harp |
NWE-DO | 12/23/2019 | Pharmalucence, Inc. |
NWJ-DO | 12/12/2019 | Tulex Pharmaceuticals Inc. |
NWJ-DO | 12/20/2019 | Cetylite Industries, Inc. |
NYK-DO | 12/4/2019 | Circulatory Technology Inc. |
NYK-DO | 12/6/2019 | InvaGen Pharmaceuticals, Inc. |
NYK-DO | 12/12/2019 | Harmac Medical Products, Inc. |
NYK-DO | 12/13/2019 | Homeocare Laboratories, Inc. |
NYK-DO | 12/16/2019 | Vasomedical Inc |
NYK-DO | 12/16/2019 | Lannett Company, Inc. |
NYK-DO | 12/18/2019 | Time-Cap Laboratories, Inc. |
NYK-DO | 12/20/2019 | Asept Pak Inc. |
NYK-DO | 12/20/2019 | YFS Pharma, inc. |
NYK-DO | 12/31/2019 | Anschel Technology Inc. |
PHI-DO | 12/12/2019 | Gentell, Inc |
PHI-DO | 12/16/2019 | Gentell |
SAN-DO | 12/10/2019 | Rollins Medical Solutions, Inc. |
SAN-DO | 12/12/2019 | OcuMetrics, Inc. |
SAN-DO | 12/13/2019 | Hawaii Health Systems Corporation dba Kona Community Hospital Pharmacy |
SAN-DO | 12/19/2019 | Matheson Tri-Gas, Inc. |
SEA-DO | 12/5/2019 | Qualitel Corporation |
SEA-DO | 12/12/2019 | Carrot Medical, LLC |
SEA-DO | 12/13/2019 | Advantage Manufacturing Technologies, Inc. |
SEA-DO | 12/17/2019 | Davryan Laboratories, Inc. |
SEA-DO | 12/19/2019 | Ziemek Dental Laboratory, Inc. |
SEA-DO | 12/20/2019 | Controltek, Inc. |
SJN-DO | 12/20/2019 | Pfizer Pharmaceuticals LLC |
November 2019 |
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District | Inspection Date | Firm Name |
ATL-DO | 11/14/2019 | Drake Precision Dental Laboratory |
ATL-DO | 11/15/2019 | Nephron Sterile Compounding Center, LLC |
ATL-DO | 11/22/2019 | Gen Trak, Inc. |
ATL-DO | 11/22/2019 | The See Clear Company |
ATL-DO | 11/26/2019 | Robling Medical Inc |
BLT-DO | 11/4/2019 | Catalent Maryland |
BLT-DO | 11/7/2019 | Apex Pharmacy, LLC |
BLT-DO | 11/13/2019 | Clear Guide Medical, Inc. |
BLT-DO | 11/21/2019 | Trapollo LLC |
CBER | 11/11/2019 | CSL Behring Australia Proprietary Ltd |
CDER | 11/1/2019 | Suven Life Sciences Limited |
CDER | 11/1/2019 | Herbal and Homeopathic (Pty) Ltd. |
CDER | 11/1/2019 | Jiangsu Province Jianerkang Medical Dressing Co., Ltd |
CDER | 11/1/2019 | Andhra Organics Limited |
CDER | 11/1/2019 | Rohto-Mentholatum (Vietnam) Co., Ltd. |
CDER | 11/1/2019 | Gland Pharma Limited |
CDER | 11/1/2019 | Dae Hwa Pharmaceutical Co., Ltd. |
CDER | 11/1/2019 | Samsung Biologics Co. Ltd. |
CDER | 11/5/2019 | Baxter Oncology GmbH |
CDER | 11/5/2019 | Eriochem SA |
CDER | 11/5/2019 | CMC Biologics A/S |
CDER | 11/6/2019 | Jubilant Generics Limited |
CDER | 11/6/2019 | Qilu Pharmaceutical (Hainan) Co. Ltd |
CDER | 11/7/2019 | Rotem Industries Limited |
CDER | 11/7/2019 | Gland Pharma Limited |
CDER | 11/7/2019 | Jeju Love Co., Ltd. |
CDER | 11/8/2019 | Kothari Phytochemicals International |
CDER | 11/8/2019 | Kyowa Hakko Bio Co., Ltd. |
CDER | 11/8/2019 | Calyx Chemicals and Pharmaceuticals Ltd. |
CDER | 11/8/2019 | Sun Pharmaceutical Industries Ltd. |
CDER | 11/8/2019 | Laurus Labs Limited |
CDER | 11/8/2019 | Aurobindo Pharma Limited |
CDER | 11/12/2019 | Recipharm Monts |
CDER | 11/12/2019 | Liof Pharma S.L. |
CDER | 11/13/2019 | Cipla, Ltd. |
CDER | 11/13/2019 | Hubei Xunda Pharmaceutical Co., Ltd. |
CDER | 11/13/2019 | Aurobindo Pharma Limited - Unit IV |
CDER | 11/14/2019 | Kumar Organic Products Limited |
CDER | 11/15/2019 | Venkata Narayana Active Ingredients Private Limited |
CDER | 11/15/2019 | PT. MegaSurya Mas |
CDER | 11/15/2019 | PolyPeptide Laboratories Private Limited |
CDER | 11/15/2019 | Honour Lab Limited |
CDER | 11/15/2019 | MSN Laboratories Private Limited (Formulations Division, Unit-II) |
CDER | 11/15/2019 | MSN Life Sciences Private Limited, Unit II |
CDER | 11/21/2019 | Canton Laboratories Pvt. Ltd. |
CDER | 11/21/2019 | Laurus Labs Limited |
CDER | 11/21/2019 | Yiling Pharmaceutical Ltd. |
CDER | 11/22/2019 | Sumitomo Dainippon Pharma Co., Ltd. |
CDER | 11/22/2019 | Cosmaceutical Research Lab Inc. |
CDER | 11/22/2019 | Zhejiang Cheng Yi Pharmaceutical Co., Ltd. |
CDER | 11/22/2019 | Unilab Chemicals and Pharmaceuticals Pvt. Ltd. |
CDER | 11/22/2019 | Visum Pharmaceutical Co Ltd |
CDER | 11/22/2019 | Reliance Life Sciences |
CDER | 11/22/2019 | Hy-Gro Chemicals Pharmtek Pvt. Ltd. |
CDER | 11/22/2019 | Euticals SAS |
CDER | 11/22/2019 | Kovas Co., Ltd. |
CDER | 11/22/2019 | Sydler Remedies Pvt. Ltd. |
CDER | 11/22/2019 | Maithri Drugs Private Limited |
CDER | 11/22/2019 | Essentials Biotech Co, Ltd. |
CDER | 11/25/2019 | Rafa Laboratories Ltd. |
CDER | 11/25/2019 | Zhejiang Regen Chemical Co., Ltd. |
CDER | 11/26/2019 | Takeda Pharmaceutical Company Limited |
CDER | 11/26/2019 | Fuji Yakuhin Co., Ltd. |
CDRH | 11/6/2019 | Somatex Medical Technologies GmbH |
CDRH | 11/7/2019 | Moor Instruments Ltd |
CDRH | 11/7/2019 | AAP Implantate Ag |
CDRH | 11/7/2019 | Cablon Medical B.V. |
CDRH | 11/7/2019 | Wandy Rubber Industrial Co., Ltd. |
CDRH | 11/7/2019 | Degania Medical Devices Pvt. Ltd. |
CDRH | 11/7/2019 | Fink Engineering Pty. Ltd. |
CDRH | 11/7/2019 | Longfian Scitech Co., Ltd. |
CDRH | 11/7/2019 | Telea Electronic Engineering S.R.L. |
CDRH | 11/8/2019 | IDS Co., LTD |
CDRH | 11/13/2019 | Amo Groningen BV |
CDRH | 11/13/2019 | DORO INC ( O/S DORO SAFETY & SECURITY) |
CDRH | 11/14/2019 | SMT Schilling Metalltechnik GmbH |
CDRH | 11/14/2019 | Molteno Ophthalmic Limited |
CDRH | 11/14/2019 | Inion Oy |
CDRH | 11/14/2019 | Lightmed Corporation |
CDRH | 11/14/2019 | Intermedic Arfran S.A. |
CDRH | 11/14/2019 | DyAnsys India Pvt. Ltd. |
CDRH | 11/14/2019 | Laser Light & Life S.ar.l, Luxembourg, Branch of Geneva |
CDRH | 11/21/2019 | Leventon S. A. U. |
CDRH | 11/21/2019 | Polyganics BV |
CDRH | 11/21/2019 | Otto Bock Healthcare Products GmbH |
CHI-DO | 11/7/2019 | Asami Tanaka Dental Enterprises, Inc. |
CHI-DO | 11/15/2019 | Concept Laboratories, Inc. |
CHI-DO | 11/20/2019 | Avalign German Specialty Instruments Division |
CHI-DO | 11/21/2019 | Prime Dental Manufacturing, Inc. |
CIN-DO | 11/14/2019 | Casco Manufacturing Solutions Inc |
CIN-DO | 11/20/2019 | Remel Inc. |
CIN-DO | 11/26/2019 | Philips Medical Systems (Cleveland) Inc |
DAL-DO | 11/7/2019 | NovoSci Corporation |
DAL-DO | 11/7/2019 | Abilene Nuclear LLC dba National Central Pharmacy |
DAL-DO | 11/20/2019 | XENEX Disinfection Services Inc. |
DAL-DO | 11/20/2019 | D&D Essential Oils, Llc. |
DAL-DO | 11/22/2019 | MPRX, Inc. dba Medical Park Pharmacy |
DEN-DO | 11/7/2019 | USL Pharma Inc. dba Upsher-Smith Laboratories, LLC |
DEN-DO | 11/15/2019 | Tecomet, Inc. |
DET-DO | 11/1/2019 | Centurion Medical Products Corporation |
FLA-DO | 11/1/2019 | Pathen Medical LLC |
FLA-DO | 11/4/2019 | Redi-2-PaQ Home Products LLC |
FLA-DO | 11/6/2019 | Innova Cosmetic Solutions LLC |
FLA-DO | 11/15/2019 | Trigen Laboratories, Inc. |
FLA-DO | 11/15/2019 | All Pharma, LLC |
FLA-DO | 11/25/2019 | Ceragroup Industries Inc |
LOS-DO | 11/5/2019 | International Medication Systems Ltd. |
LOS-DO | 11/8/2019 | Dendreon Pharmaceuticals, LLC |
LOS-DO | 11/12/2019 | CA Botana International, Inc |
LOS-DO | 11/22/2019 | Ajinomoto Althea, Inc. |
LOS-DO | 11/22/2019 | McGuff Compounding Pharmacy Services, Inc. |
LOS-DO | 11/27/2019 | WIDE USA CORPORATION |
MIN-DO | 11/25/2019 | Escalon Medical Corp. |
MIN-DO | 11/26/2019 | Microbiologics Inc |
NWE-DO | 11/7/2019 | Next Health, LLC |
NWE-DO | 11/14/2019 | GF Health Products, Inc. |
NWE-DO | 11/15/2019 | CND Global Technologies Inc. |
NWE-DO | 11/19/2019 | MassBiologics |
NWE-DO | 11/25/2019 | Tender Corporation |
NWE-DO | 11/27/2019 | Consolidated Machine Corp. |
NWJ-DO | 11/5/2019 | Cardio Medical Products |
NWJ-DO | 11/7/2019 | Ingen Orthopedics LLC |
NWJ-DO | 11/8/2019 | Quagen Pharma, LLC |
NWJ-DO | 11/14/2019 | Far Hills Pharmacy |
NWJ-DO | 11/15/2019 | Lingraphicare America, Inc. |
NYK-DO | 11/7/2019 | Arnold Tuber Industries, LLC |
NYK-DO | 11/20/2019 | Life Science Pharmacy Inc |
PHI-DO | 11/8/2019 | SEKO MedTec Solutions |
PHI-DO | 11/21/2019 | Drucker Diagnostics |
PHI-DO | 11/22/2019 | Straight Arrow Products, Inc. |
SAN-DO | 11/5/2019 | Osseofuse International Inc. |
SAN-DO | 11/8/2019 | KBD, Inc. DBA Sperti Sunlamps |
SAN-DO | 11/21/2019 | Bayer HealthCare, LLC |
SAN-DO | 11/25/2019 | One Way Drug DBA Partell Specialty Pharmacy |
SEA-DO | 11/26/2019 | Physio-Control, Inc. |
SEA-DO | 11/26/2019 | Lloyd Central Compounding Pharmacy |
SEA-DO | 11/27/2019 | New Era Pharmacy, LLC |
SJN-DO | 11/1/2019 | Galephar Pharmaceutical Research, Inc. |
October 2019 |
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District | Inspection Date | Firm Name |
ATL-DO | 10/10/2019 | Monitor Instruments, Inc. |
ATL-DO | 10/10/2019 | Atlanta Hyperbaric Center LLC |
ATL-DO | 10/24/2019 | Vero Biotech, LLC |
BLT-DO | 10/11/2019 | Air-Tite Products Co Inc |
CDER | 10/3/2019 | Supriya Lifescience Limited |
CDER | 10/4/2019 | Kyowa Hakko Kirin Co., Ltd. |
CDER | 10/8/2019 | Astellas Pharma Tech Co. Ltd. |
CDER | 10/11/2019 | Douglas Manufacturing Limited |
CDER | 10/11/2019 | Catalent Nottingham Ltd. |
CDER | 10/11/2019 | Alphora Research Inc. |
CDER | 10/11/2019 | Botanical Resources Australia-Manufacturing Services Pty Ltd |
CDER | 10/11/2019 | Hisamitsu Pharmaceutical Co., Inc. |
CDER | 10/11/2019 | Amphastar Nanjing Pharmaceuticals Inc |
CDER | 10/15/2019 | Cis Bio International |
CDER | 10/15/2019 | Indoco Remedies Limited |
CDER | 10/15/2019 | Sawai Pharmaceutical Co., Ltd. |
CDER | 10/15/2019 | Taejoon Pharm Co., Ltd. |
CDER | 10/18/2019 | Changzhou Pharmaceutical Factory |
CDER | 10/18/2019 | Shiratori Pharmaceutical Co. Ltd. |
CDER | 10/18/2019 | Lonza AG |
CDER | 10/18/2019 | Mayne Pharma International PTY LTD |
CDER | 10/18/2019 | Bluepharma Industria Farmaceutica, S.A. |
CDER | 10/18/2019 | Huons Co., Ltd. |
CDER | 10/18/2019 | Viwit Pharmaceutical Co., Ltd. |
CDER | 10/18/2019 | Ningbo Shuangcheng Pharmaceutical Co., Ltd. |
CDER | 10/22/2019 | Otsuka Pharmaceutical Co., Ltd. |
CDER | 10/22/2019 | Zydus Hospira Oncology Pvt. Ltd. |
CDER | 10/25/2019 | Allergan Pharmaceuticals Ireland |
CDER | 10/25/2019 | Anidro Do Brasil Extracoes S.A. |
CDER | 10/25/2019 | Aurobindo Pharma Ltd. (Unit V) |
CDER | 10/25/2019 | Sato Pharmaceutical Co., Ltd. |
CDER | 10/25/2019 | Laboratorios Liconsa SA |
CDER | 10/25/2019 | Mylan Laboratories Limited |
CDRH | 10/10/2019 | Itg Electronics (Malaysia) Sdn Bhd |
CDRH | 10/10/2019 | Global Medical Technology SL |
CDRH | 10/17/2019 | Techtronic Industries (Dongguan) Co. Ltd. |
CDRH | 10/17/2019 | Sekisui Medical Co., Ltd |
CDRH | 10/17/2019 | MANDELAY KFT |
CDRH | 10/23/2019 | Anqing Jiaxiin Medical Technology Co., Ltd. |
CDRH | 10/24/2019 | M.R.S. SRL |
CDRH | 10/25/2019 | E-Care Technology Corp. |
CDRH | 10/30/2019 | Hubei Weikang Protective Products Co., Ltd. |
CDRH | 10/31/2019 | DRG Instruments GmbH |
CDRH | 10/31/2019 | Arrow Medical Limited |
CDRH | 10/31/2019 | CORENTEC CO., LTD |
CHI-DO | 10/1/2019 | Liquid Crystal Resources Hallcrest LLC |
CHI-DO | 10/1/2019 | Bajaj Medical, LLC |
CHI-DO | 10/10/2019 | Techni Med, Inc. dba The Compounder |
CHI-DO | 10/30/2019 | BURTON MEDICAL |
CIN-DO | 10/11/2019 | Tosoh Bioscience Inc |
CIN-DO | 10/23/2019 | Norman Noble Inc |
CIN-DO | 10/24/2019 | Maxtown Medical Corporation LLC |
CIN-DO | 10/29/2019 | Valtronic Technologies Inc. |
DAL-DO | 10/3/2019 | MCALISTER DRUG CORPORATION |
DAL-DO | 10/10/2019 | Wello, Inc. |
DEN-DO | 10/3/2019 | Diacor, Inc |
DEN-DO | 10/8/2019 | Banner Pharmacy Services, LLC |
DEN-DO | 10/24/2019 | Cerapedics, Inc. |
DEN-DO | 10/25/2019 | Airgas USA LLC |
DET-DO | 10/10/2019 | Oxus, Inc. |
DET-DO | 10/22/2019 | L. Perrigo Company |
DET-DO | 10/31/2019 | Biomedix WAI |
FLA-DO | 10/9/2019 | SpineNet LLC. |
FLA-DO | 10/15/2019 | Miami Device Solutions, LLC. |
FLA-DO | 10/15/2019 | Biedermann Motech, Inc. |
FLA-DO | 10/16/2019 | Carroll-Baccari, Inc. |
FLA-DO | 10/17/2019 | PN Medical, Inc. |
FLA-DO | 10/17/2019 | Myriad Medical Llc |
FLA-DO | 10/18/2019 | Airgas USA, LLC |
FLA-DO | 10/24/2019 | Healthline Medical Products, Inc. |
KAN-DO | 10/15/2019 | Certified Safety Mfg Inc |
KAN-DO | 10/30/2019 | Aesculap Inc |
LOS-DO | 10/8/2019 | Natren, Inc. |
LOS-DO | 10/8/2019 | Honest Globe, Inc. |
LOS-DO | 10/11/2019 | Transfer Technology |
LOS-DO | 10/18/2019 | VicTorch Meditek, Inc |
LOS-DO | 10/24/2019 | Prestige Medical |
LOS-DO | 10/25/2019 | Stason Pharmaceuticals, Inc. |
LOS-DO | 10/29/2019 | SHE IS ORGANIC LLC |
LOS-DO | 10/30/2019 | The Micro Connection Enterprises, Inc. DBA Personal Care Performance Group |
LOS-DO | 10/30/2019 | Micro Medical Devices, Inc |
LOS-DO | 10/30/2019 | NucleusHealth, LLC |
MIN-DO | 10/1/2019 | Skyline Medical, Inc. |
MIN-DO | 10/1/2019 | Deerfield Imaging, Inc. |
MIN-DO | 10/10/2019 | APN Health LLC |
MIN-DO | 10/17/2019 | Medtronic Neuromodulation |
NOL-DO | 10/1/2019 | Armand Products Company |
NOL-DO | 10/10/2019 | Medegen Medical Products, LLC |
NWE-DO | 10/3/2019 | MicroVision, Inc. |
NWE-DO | 10/7/2019 | ATC Technologies, Inc. |
NWE-DO | 10/11/2019 | Milbar Laboratories, Inc. |
NWE-DO | 10/11/2019 | Flowonix Medical Inc |
NWE-DO | 10/21/2019 | Magellan Diagnostics, Inc. |
NWE-DO | 10/22/2019 | Braintree, A part of SEBELA Pharmaceuticals |
NWE-DO | 10/23/2019 | LaunchWorks LLC |
NWE-DO | 10/24/2019 | McNeil Healthcare, Inc. |
NWE-DO | 10/29/2019 | Unetixs Vascular, Inc. |
NWJ-DO | 10/21/2019 | Life Recovery Systems HD, LLC |
NWJ-DO | 10/22/2019 | Aurolife Pharma, LLC |
NYK-DO | 10/8/2019 | Netech Corp. |
NYK-DO | 10/10/2019 | Caliber Imaging and Diagnostics, Inc. |
NYK-DO | 10/18/2019 | Regeneron Pharmaceuticals Inc |
NYK-DO | 10/25/2019 | Airsep Corporation |
PHI-DO | 10/10/2019 | Perryman Company |
SEA-DO | 10/10/2019 | Orthocare Innovations, LLC |
SEA-DO | 10/25/2019 | Celestica Oregon, LLC. |
SJN-DO | 10/15/2019 | Patheon part of Thermo Fisher |
September 2019 |
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District | Inspection Date | Firm Name |
ATL-DO | 9/5/2019 | IR Techology LLC |
ATL-DO | 9/11/2019 | Greer Laboratories Inc |
ATL-DO | 9/12/2019 | CDB Corporation |
ATL-DO | 9/24/2019 | Simpex Medical Inc |
ATL-DO | 9/26/2019 | Tektone Sound & Signal Mfg.Inc. |
BLT-DO | 9/16/2019 | C-Care, LLC |
BLT-DO | 9/19/2019 | Cupron Inc. |
CBER | 9/13/2019 | PCAS Finland Oy |
CDER | 9/3/2019 | Fresenius Kabi Norge As |
CDER | 9/3/2019 | Advanced Accelerator Applications |
CDER | 9/3/2019 | Yash Pharma Laboratories Pvt Ltd |
CDER | 9/5/2019 | FICOSOTA LTD |
CDER | 9/6/2019 | Sumitomo Chemical Co., Ltd. |
CDER | 9/6/2019 | Glaxo Operations UK Limited |
CDER | 9/6/2019 | Alchem International Ltd. |
CDER | 9/6/2019 | Orion Corporation - Turku Plant |
CDER | 9/6/2019 | Frutarom (UK) Limited |
CDER | 9/6/2019 | Wuxi Fortune Pharmaceutical Co., Ltd. |
CDER | 9/6/2019 | Recipharm Strangnas AB |
CDER | 9/6/2019 | Sidmak Laboratories India Pvt Ltd |
CDER | 9/6/2019 | Pfizer Healthcare India Private Limited |
CDER | 9/6/2019 | Shilpa Medicare Limited |
CDER | 9/6/2019 | Nowcos Co., Ltd |
CDER | 9/6/2019 | Ortin Laboratories Ltd Unit II |
CDER | 9/10/2019 | Pierre Fabre Medicament Production |
CDER | 9/10/2019 | Otsuka Pharmaceutical Co., Ltd. - Second Tokushima Factory |
CDER | 9/10/2019 | Samsung Biologics Co. Ltd. |
CDER | 9/11/2019 | Peer Pharm Ltd. |
CDER | 9/12/2019 | Yung Shin Pharmaceutical Industry Co., Ltd. |
CDER | 9/12/2019 | Zhejiang Chiral Medicine Chemicals Co., Ltd. |
CDER | 9/12/2019 | Jiangsu Grand Xinyi Pharmaceutical Co., Ltd |
CDER | 9/12/2019 | Willard Manufacturing Inc |
CDER | 9/13/2019 | LVMH Fragrance Brands |
CDER | 9/13/2019 | Olon S.p.A. |
CDER | 9/13/2019 | Bayer Weimar GmbH und Co. KG |
CDER | 9/13/2019 | Corden Pharma Chenove |
CDER | 9/13/2019 | PCAS Finland Oy |
CDER | 9/13/2019 | MicroBiopharm Japan Co., Ltd. |
CDER | 9/13/2019 | Aurena Laboratories AB |
CDER | 9/13/2019 | Almac Sciences Limited |
CDER | 9/13/2019 | Aspen Oss B.V. |
CDER | 9/13/2019 | Global Treat Srl |
CDER | 9/13/2019 | ESSND GLOBAL |
CDER | 9/13/2019 | NEW WORLD HEALTHCARE PRIVATE LIMITED |
CDER | 9/14/2019 | Arch Pharmalabs Limited |
CDER | 9/17/2019 | Glaxo Operations U.K. Ltd. |
CDER | 9/17/2019 | USV Limited |
CDER | 9/17/2019 | Shenzhen Techdow Pharmaceutical Co., Ltd. |
CDER | 9/17/2019 | Hangzhou Linkeweier Daily Chemicals Co., Ltd. |
CDER | 9/19/2019 | Hainan Poly Pharm. Co., Ltd. |
CDER | 9/19/2019 | DermaPharm A/S |
CDER | 9/19/2019 | Ancorotti Cosmetics Srl |
CDER | 9/20/2019 | Lupin Limited |
CDER | 9/20/2019 | Lonza Biologics Tuas Pte Ltd |
CDER | 9/20/2019 | Lyocontract GmbH |
CDER | 9/24/2019 | 8046255 Canada Inc. DBA Viatrexx |
CDER | 9/25/2019 | Isomers Laboratories |
CDER | 9/26/2019 | Chugai Pharma Manufacturing Co. Ltd. |
CDER | 9/27/2019 | Interquim S.A. |
CDER | 9/27/2019 | Luohe Nanjiecun Pharmaceutical Group Pharmacy Co. Ltd. |
CDRH | 9/5/2019 | Novatech S.A. |
CDRH | 9/5/2019 | Directa AB |
CDRH | 9/5/2019 | Chongqing Kanghua Ruiming S&T Co., Ltd. |
CDRH | 9/5/2019 | Ningbo Luke Medical Devices Co., Ltd. |
CDRH | 9/5/2019 | Something High Electric (Xiamen) Company Inc. |
CDRH | 9/11/2019 | Duerr Dental SE |
CDRH | 9/12/2019 | Duerr Optronik Gmbh & Co. KG |
CDRH | 9/12/2019 | Corin Ltd |
CDRH | 9/12/2019 | Omnimate Enterprise Co., Ltd. |
CDRH | 9/18/2019 | Adeor Medical AG |
CDRH | 9/19/2019 | M.D.L. S.r.l. |
CDRH | 9/19/2019 | Technix SPA |
CDRH | 9/19/2019 | Jiangsu JDC Medical Devices Co., Ltd. |
CDRH | 9/20/2019 | DFS Diamon Gmbh |
CDRH | 9/23/2019 | Venture Corporation Limited |
CDRH | 9/24/2019 | Innonix Technologies Limited |
CDRH | 9/26/2019 | Neuromedex GmbH |
CDRH | 9/27/2019 | VALLEY ELECTRONICS AG |
CDRH | 9/27/2019 | TQ Systems Gmbh |
CHI-DO | 9/10/2019 | Rockford Specialties |
CHI-DO | 9/18/2019 | X-Cel X-Ray Corp |
CHI-DO | 9/19/2019 | AltaThera Pharmaceuticals, LLC |
CHI-DO | 9/25/2019 | Takeda |
CIN-DO | 9/9/2019 | Control-X Medical Inc |
CIN-DO | 9/23/2019 | Isopure Corp |
DAL-DO | 9/5/2019 | Curewave Lasers LLC |
DAL-DO | 9/12/2019 | Innoveix Pharmaceuticals Inc |
DAL-DO | 9/13/2019 | University of Texas Southwestern Medical Center |
DAL-DO | 9/18/2019 | Emu Products and Management, Inc. (EPMI) |
DAL-DO | 9/18/2019 | Dynofit Inc. |
DAL-DO | 9/19/2019 | Metric Medical Devices Inc |
DEN-DO | 9/13/2019 | Yusef Manufacturing Laboratories, LLC |
DEN-DO | 9/19/2019 | Dolor Technologies LLC |
DEN-DO | 9/20/2019 | Encision Inc. |
DEN-DO | 9/20/2019 | Evergreen Research, Inc |
DET-DO | 9/5/2019 | Unique Instruments, Inc. |
DET-DO | 9/18/2019 | Advanced Engineering, Inc. |
FLA-DO | 9/11/2019 | Apollo Renal Therapeutics, LLC |
FLA-DO | 9/18/2019 | Toby Orthopaedics, Inc. |
FLA-DO | 9/20/2019 | Oscor, Inc. |
FLA-DO | 9/25/2019 | A.I.G Technologies, Inc. |
FLA-DO | 9/27/2019 | Tarmac Products, Inc. |
KAN-DO | 9/5/2019 | Ortho Solution LC, dba DynaFlex |
KAN-DO | 9/10/2019 | American Contract Systems, Inc. |
KAN-DO | 9/12/2019 | SpecGx LLC |
KAN-DO | 9/12/2019 | Lloyd Industries Inc. |
KAN-DO | 9/25/2019 | Eco Lips Inc |
LOS-DO | 9/6/2019 | Diamond Wipes International, Inc. |
LOS-DO | 9/6/2019 | Anchen Pharmaceuticals, Inc |
LOS-DO | 9/9/2019 | Pacifica Pharmacy |
LOS-DO | 9/12/2019 | Grifols Biologicals Inc. |
LOS-DO | 9/12/2019 | Grifols Biologicals Inc. |
LOS-DO | 9/13/2019 | Private Label Partners, Inc. |
LOS-DO | 9/19/2019 | Tower Pharmacy and Compounding |
LOS-DO | 9/23/2019 | Polymerex Medical Corp |
LOS-DO | 9/25/2019 | Integrated Health Concepts Inc. dba Conversio Health |
LOS-DO | 9/30/2019 | Blaine Labs Inc |
MIN-DO | 9/3/2019 | Apothecary Products, LLC |
MIN-DO | 9/12/2019 | GenTrac, Inc. |
MIN-DO | 9/19/2019 | Prism Clinical Imaging Inc. |
NOL-DO | 9/4/2019 | Amplion Clinical Communications, Inc. |
NOL-DO | 9/12/2019 | Turner Medical Inc |
NOL-DO | 9/13/2019 | Dee Cee Laboratories Inc |
NOL-DO | 9/27/2019 | Nature's Natural Products, INC. DBA Nature's Skin and Body Food |
NWE-DO | 9/5/2019 | NCS Pearson |
NWE-DO | 9/10/2019 | ONC Solutions Incorporated |
NWE-DO | 9/13/2019 | Cadence Science, Inc. |
NWE-DO | 9/18/2019 | J.G. Machine Co |
NWE-DO | 9/20/2019 | Zoe Medical Incorporated |
NWE-DO | 9/20/2019 | Conformis Inc. |
NWE-DO | 9/20/2019 | Conformis, Inc. |
NWE-DO | 9/24/2019 | Illuminoss Medical |
NWJ-DO | 9/10/2019 | Hikma Pharmaceuticals USA Inc. |
NWJ-DO | 9/11/2019 | Bergen Medical Products, Inc. |
NWJ-DO | 9/25/2019 | AptaPharma Inc. |
NYK-DO | 9/3/2019 | Syntho Pharmaceuticals, Inc. |
NYK-DO | 9/5/2019 | Reprobiotech Corp |
NYK-DO | 9/13/2019 | Kreitchman PET Center |
NYK-DO | 9/25/2019 | DICOM GRID INC ( dba) Ambra Health |
NYK-DO | 9/27/2019 | Advanced Pharmaceutical Technology LLC |
PHI-DO | 9/20/2019 | Merck Sharp & Dohme Corp. |
PHI-DO | 9/20/2019 | Genus Lifesciences Inc. |
PHI-DO | 9/26/2019 | Sonic Systems Inc |
PHI-DO | 9/27/2019 | Globus Medical, Inc. |
SAN-DO | 9/18/2019 | Isorx Corp |
SAN-DO | 9/20/2019 | PETNET Solutions, Inc. |
SEA-DO | 9/10/2019 | Applied Technical Services Corporation |
SEA-DO | 9/11/2019 | Paragon Manufacturing Corp. |
SEA-DO | 9/13/2019 | Korvis, LLC |
SJN-DO | 9/26/2019 | Fenwal International, Inc. |
SJN-DO | 9/27/2019 | Amgen Manufacturing Limited |
August 2019 |
||
District | Inspection Date | Firm Name |
ATL-DO | 8/12/2019 | Recro Gainesville LLC |
ATL-DO | 8/14/2019 | Life Sensing Instruments, Inc. |
ATL-DO | 8/14/2019 | Cancer Diagnostics Inc. |
ATL-DO | 8/23/2019 | WatchChild, LLC |
ATL-DO | 8/29/2019 | DeGen Medical Inc. |
BLT-DO | 8/7/2019 | LUBRINOVATION, Inc. |
BLT-DO | 8/26/2019 | Friendship Industries Inc. |
CDER | 8/1/2019 | Teva Pharmaceutical Industries |
CDER | 8/2/2019 | Intas Pharmaceuticals Limited |
CDER | 8/2/2019 | Zhejiang Starry Pharmaceutical Co. Ltd. |
CDER | 8/2/2019 | Guangzhou Tinci Materials Technology Co., Ltd. |
CDER | 8/2/2019 | Shanghai Desano Bio-Pharmaceutical Co., Ltd. |
CDER | 8/2/2019 | Oxalis Labs |
CDER | 8/2/2019 | Global Pharmatech Private Limited |
CDER | 8/3/2019 | THERAPIVA PRIVATE LIMITED |
CDER | 8/6/2019 | Yibin Lihao Bio-technical Co., Ltd. |
CDER | 8/6/2019 | Nippon Shikizai, Inc. |
CDER | 8/8/2019 | Ernest Jackson & Co., Ltd. |
CDER | 8/8/2019 | Croda Iberica SA |
CDER | 8/9/2019 | Takeda Pharmaceutical Company Limited |
CDER | 8/9/2019 | Allessa GmbH |
CDER | 8/9/2019 | Natco Pharma Ltd. - Chemical Division |
CDER | 8/9/2019 | Lake Chemicals Private Limited |
CDER | 8/9/2019 | Panacea Biotec Limited |
CDER | 8/9/2019 | IOL Chemicals and Pharmaceuticals Ltd |
CDER | 8/16/2019 | Hubei Granules Biocause Pharmaceutical Co. Ltd. |
CDER | 8/16/2019 | Madhu Instruments Private Limited |
CDER | 8/17/2019 | BAPS Swaminarayan Herbal Care, A Unit of Divine Energy |
CDER | 8/20/2019 | RA Chem Pharma Limited |
CDER | 8/22/2019 | JHS Svendgaard Hygiene Products Ltd |
CDER | 8/22/2019 | Chemland Co., Ltd. |
CDER | 8/23/2019 | Zhejiang Xianju Pharmaceutical Co., Ltd. |
CDER | 8/27/2019 | Mylan Laboratories Limited |
CDER | 8/28/2019 | Therapure Biopharma Inc |
CDRH | 8/1/2019 | San-M Package Co., Ltd. |
CDRH | 8/1/2019 | Silfradent Srl |
CDRH | 8/1/2019 | Xiantao Zhongtai Protective Products Co.,Ltd |
CDRH | 8/6/2019 | Sivshree Medittex (India) Pvt. Ltd. |
CDRH | 8/14/2019 | SCHOTT AG |
CDRH | 8/15/2019 | Biometrix Ltd. |
CDRH | 8/15/2019 | Greatbatch Medical S. De R.L. De C.V. |
CDRH | 8/16/2019 | SCHOTT CR, S.R.O. |
CDRH | 8/22/2019 | Waldemar Link GmbH & Co. KG (Mfg Site) |
CDRH | 8/28/2019 | McRoberts B.V. |
CHI-DO | 8/7/2019 | Polyconversions, Inc. |
CHI-DO | 8/22/2019 | Whitney Products Inc. |
CIN-DO | 8/9/2019 | Amylin Ohio LLC |
CIN-DO | 8/30/2019 | HealthCare Products, Inc. |
DAL-DO | 8/1/2019 | EVOLUTION SPINE, LLC |
DAL-DO | 8/2/2019 | Libra Industries, LLC |
DAL-DO | 8/2/2019 | Medical Informatics Corp. |
DAL-DO | 8/6/2019 | Randol Mill Pharmacy |
DAL-DO | 8/9/2019 | Stonegate Pharmacy LP |
DAL-DO | 8/12/2019 | Texas Eye Prosthetics, LLC |
DAL-DO | 8/21/2019 | Domino Pads, LLC |
DAL-DO | 8/26/2019 | Medical Accessories and Cables LLC |
DEN-DO | 8/2/2019 | Agilent Technologies Inc |
DEN-DO | 8/2/2019 | Vitalab Pharmacy, Inc. DBA Vasco Rx Specialty Pharmacy |
DEN-DO | 8/12/2019 | Septodont Inc. |
DEN-DO | 8/21/2019 | Colorado Therapeutics LLC |
DEN-DO | 8/29/2019 | Certol International, LLC |
DEN-DO | 8/29/2019 | ARP Manufacturing, LLC |
DET-DO | 8/7/2019 | Panoramic Rental Corp. |
DET-DO | 8/15/2019 | Beds by George |
DET-DO | 8/20/2019 | Centurion Medical Products Corporation |
DET-DO | 8/23/2019 | Lantz Medical, Inc. |
FLA-DO | 8/2/2019 | Alt Medical Devices |
FLA-DO | 8/6/2019 | Mark Two Engineering Inc. |
FLA-DO | 8/8/2019 | AcuLux, Inc. |
FLA-DO | 8/9/2019 | Medoz Pharmacy of Polk Inc |
FLA-DO | 8/14/2019 | Pure Source LLC |
FLA-DO | 8/16/2019 | American Contract Systems, Inc. |
FLA-DO | 8/23/2019 | 3D Medical Manufacturing, Inc. |
FLA-DO | 8/28/2019 | Catalent Pharma Solutions, LLC |
FLA-DO | 8/30/2019 | HQ, Inc. |
FLA-DO | 8/30/2019 | QOL Medical LLC |
KAN-DO | 8/1/2019 | Bayer Healthcare US, LLC. |
KAN-DO | 8/2/2019 | Care-Tech Laboratories, Inc. |
KAN-DO | 8/2/2019 | Thermo Fisher Scientific dba Patheon Biologics LLC |
KAN-DO | 8/8/2019 | Protek Medical Products, Inc. |
KAN-DO | 8/8/2019 | Ekcomed LLC |
KAN-DO | 8/9/2019 | Hot Shots Nuclear Medicine |
KAN-DO | 8/9/2019 | Bio-Mechanical Composites, Inc. |
KAN-DO | 8/20/2019 | Biomerieux Inc |
KAN-DO | 8/22/2019 | S & B Pharma Inc. dba Alkem Laboratories |
LOS-DO | 8/1/2019 | Southern California Compounding Pharmacy, LLC |
LOS-DO | 8/2/2019 | Abbott/St Jude Medical Inc. |
LOS-DO | 8/2/2019 | Westwood Laboratories, Inc. |
LOS-DO | 8/2/2019 | AveXis, Inc. |
LOS-DO | 8/14/2019 | University of Southern California, DBA USC Molecular Imaging Center |
LOS-DO | 8/16/2019 | The Compounding PHY of Beverly Hills |
LOS-DO | 8/19/2019 | CLARIFY MEDICAL INC |
LOS-DO | 8/23/2019 | Calmo Manufacturing, Inc |
LOS-DO | 8/30/2019 | National Advanced Endoscopy Devices Inc |
MIN-DO | 8/2/2019 | Brenntag Great Lakes LLC |
MIN-DO | 8/14/2019 | Bemis Manufacturing Co. |
MIN-DO | 8/22/2019 | Guy & O'Neill Inc. |
NOL-DO | 8/2/2019 | CrossRoads Extremity Systems, LLC |
NOL-DO | 8/9/2019 | Emilia Resources, LLC |
NOL-DO | 8/23/2019 | Health Science Products Inc |
NWE-DO | 8/1/2019 | PerkinElmer Health Sciences, Inc. |
NWE-DO | 8/2/2019 | Fresenius Medical Care Holdings, Inc. |
NWE-DO | 8/8/2019 | Stickman Dialysis Industries, LLC |
NWE-DO | 8/14/2019 | Roger Williams Medical Center |
NWE-DO | 8/15/2019 | Kelyniam Global, Inc. |
NWE-DO | 8/22/2019 | Specialty Minerals, Inc. |
NWE-DO | 8/22/2019 | Brigham and Women's Hospital |
NWE-DO | 8/23/2019 | Holistic Technologies, LLC |
NWE-DO | 8/28/2019 | EyePoint Pharmaceuticals, Inc. |
NWJ-DO | 8/22/2019 | Renaissance Lakewood, LLC |
NYK-DO | 8/1/2019 | CooperSurgical, Inc |
NYK-DO | 8/8/2019 | Aerolase Corporation |
NYK-DO | 8/15/2019 | Respire Medical Holdings, LLC |
PHI-DO | 8/1/2019 | Environmental Tectonics Corp |
PHI-DO | 8/8/2019 | Legend Spine, LLC |
PHI-DO | 8/14/2019 | Xodus Medical Inc |
SAN-DO | 8/2/2019 | Terrain Pharmaceuticals |
SAN-DO | 8/8/2019 | PerkinElmer Medical Imaging |
SAN-DO | 8/14/2019 | G S Cosmeceutical USA Inc |
SAN-DO | 8/16/2019 | SonoCine Inc. |
SAN-DO | 8/22/2019 | Abaxis Inc |
SAN-DO | 8/22/2019 | Algomedica, Inc. |
SAN-DO | 8/26/2019 | Suture Ease, Inc. |
SEA-DO | 8/1/2019 | RAM Pharma, Inc |
SEA-DO | 8/2/2019 | Kobold, LLC |
SEA-DO | 8/8/2019 | G. Dundas Co Inc |
SEA-DO | 8/9/2019 | Tec Laboratories Inc |
SEA-DO | 8/9/2019 | Melaleuca, Inc. |
SEA-DO | 8/16/2019 | Columbia River Pharmacy LLC (DBA Malley's Compounding Pharmacy) |
SEA-DO | 8/26/2019 | Hummingbird Med Devices, Inc. |
SJN-DO | 8/23/2019 | Integra CI Inc. dba Integra Neurosciences PR, Inc. |
July 2019 |
||
District | Inspection Date | Firm Name |
ATL-DO | 7/2/2019 | Shertech Pharmacy |
ATL-DO | 7/2/2019 | Allwell Medical Corporation |
ATL-DO | 7/3/2019 | Sunnex, LLC |
ATL-DO | 7/10/2019 | Medfaxx, Inc. |
ATL-DO | 7/12/2019 | Mayne Pharma Inc |
ATL-DO | 7/19/2019 | Custom Assemblies, Inc. |
ATL-DO | 7/25/2019 | Highland Industries,Inc. |
BLT-DO | 7/2/2019 | Washington Homeopathic Products, Inc. |
BLT-DO | 7/11/2019 | Detectamet, Inc. |
BLT-DO | 7/18/2019 | Med-Tex, LLC dba Med Textile |
BLT-DO | 7/24/2019 | Engineered Medical Systems Baltimore |
BLT-DO | 7/31/2019 | Harvest Digital, LLC |
CDER | 7/2/2019 | AMO (Hangzhou) Co., Ltd. |
CDER | 7/2/2019 | Sasa Cosmetics ACS Ltd |
CDER | 7/4/2019 | Alteya Organics |
CDER | 7/5/2019 | Liuzhou LMZ Co., Ltd. |
CDER | 7/5/2019 | Glenmark Life Sciences Limited |
CDER | 7/5/2019 | Kolmar Korea Co. Ltd. |
CDER | 7/5/2019 | C.P.M. Contract Pharma GmbH & Co. KG |
CDER | 7/5/2019 | Huaian Zongheng Bio-Tech Co., Ltd |
CDER | 7/5/2019 | Inventia Healthcare Limited |
CDER | 7/5/2019 | Symbiotec Pharmalab Limited |
CDER | 7/5/2019 | PicoBio Co., Ltd. |
CDER | 7/5/2019 | Biocon Sdn Bhd |
CDER | 7/9/2019 | Scental Pacific Pty. Ltd. |
CDER | 7/11/2019 | Bio-Technology General (Israel), Ltd. |
CDER | 7/11/2019 | Taro Pharmaceutical Industries, Ltd. |
CDER | 7/11/2019 | Zhejiang Raybow Pharmaceutical Co., Ltd. |
CDER | 7/12/2019 | Herbalgy Pharmaceutical Ltd. |
CDER | 7/12/2019 | Dr. Reddy's Laboratories Limited (Unit II) |
CDER | 7/12/2019 | allphamed PHARBIL Arzneimittel GmbH |
CDER | 7/12/2019 | Excellence Medical Supplies Co., Ltd. |
CDER | 7/12/2019 | C3 Co Ltd. |
CDER | 7/12/2019 | fmg Co., Ltd. |
CDER | 7/12/2019 | Wuhan Calmland Pharmaceuticals Co., Ltd. |
CDER | 7/12/2019 | Beijing HKKY Medical Tech. Co., Ltd. |
CDER | 7/12/2019 | Englewood Lab, Inc. |
CDER | 7/13/2019 | PAB Organics Private Limited |
CDER | 7/16/2019 | Zhuhai United Laboratories Co. Ltd. |
CDER | 7/17/2019 | Vetter Pharma-Fertigung GmbH & Co. KG |
CDER | 7/17/2019 | Dexcel Pharma Technologies Ltd |
CDER | 7/18/2019 | Dead Sea Periclase |
CDER | 7/18/2019 | Global Chemical Co. Ltd. |
CDER | 7/18/2019 | Zhuhai Aofute Medical Technology Co., Ltd. |
CDER | 7/19/2019 | Dental-Kosmetik GmbH & Co. KG |
CDER | 7/19/2019 | Cipla, Ltd. |
CDER | 7/19/2019 | Laboratorios Senosiain SA de CV |
CDER | 7/19/2019 | GK Cosmetic Co., Ltd. |
CDER | 7/23/2019 | Wintac Limited |
CDER | 7/24/2019 | Dexcel Pharma Ltd. |
CDER | 7/25/2019 | Teva Pharmaceutical Industies, Ltd. |
CDER | 7/26/2019 | Granules India Limited |
CDER | 7/26/2019 | G.B. Ambrosoli SpA |
CDER | 7/26/2019 | Baccinex Sa |
CDER | 7/26/2019 | Reckitt Benckiser Healthcare |
CDRH | 7/4/2019 | Derungs Licht AG |
CDRH | 7/5/2019 | Biocon Sdn Bhd |
CDRH | 7/11/2019 | Boule Medical AB |
CDRH | 7/11/2019 | Fomed Industries Inc. |
CDRH | 7/17/2019 | IQ PRODUCTS B.V. |
CDRH | 7/18/2019 | Spineway |
CDRH | 7/18/2019 | NINGBO ALBERT NOVOSINO, LTD. |
CDRH | 7/24/2019 | Leonhard Lang Medizintechnik GmbH |
CDRH | 7/24/2019 | PSM Medical Solutions |
CDRH | 7/25/2019 | Peramed Medizintechnik |
CDRH | 7/25/2019 | Femcare, Ltd. |
CDRH | 7/26/2019 | ZhongHong (DongGuan) Abrasives Co. Ltd. |
CIN-DO | 7/22/2019 | Slice Manufacturing LLC |
DAL-DO | 7/1/2019 | Dougherty's Pharmacy |
DAL-DO | 7/11/2019 | Woodfield Pharmaceutical, LLC |
DAL-DO | 7/19/2019 | Mary Kay, Inc |
DAL-DO | 7/23/2019 | Tristar Dental Laboratory, Inc |
DEN-DO | 7/16/2019 | Rocky Mountain Research, Inc. |
DEN-DO | 7/16/2019 | Custom Milling Center Inc |
DEN-DO | 7/23/2019 | Itc Compounding |
DEN-DO | 7/30/2019 | CPAPNEA MEDICAL SUPPLY |
DET-DO | 7/17/2019 | Medscript Compounding Pharmacy |
DET-DO | 7/25/2019 | Roche Diabetes Care, Inc. |
FLA-DO | 7/11/2019 | SHL Pharma, LLC |
FLA-DO | 7/16/2019 | DB Diagnostic Systems Inc. |
FLA-DO | 7/18/2019 | Klyo Medical Systems, Inc. |
FLA-DO | 7/19/2019 | Atlas Spine, Inc. |
FLA-DO | 7/23/2019 | General Medical Company |
FLA-DO | 7/26/2019 | AVEVA Drug Delivery Systems, Inc. |
FLA-DO | 7/30/2019 | The Web 2U Com LLC |
KAN-DO | 7/9/2019 | Titronics Research & Development Co. |
KAN-DO | 7/11/2019 | Iowa Adaptive Technologies Inc. |
KAN-DO | 7/12/2019 | Ionetix Corporation |
KAN-DO | 7/17/2019 | Breathe E-Z Systems, Inc. |
KAN-DO | 7/26/2019 | Eurofins Viracor, Inc. |
KAN-DO | 7/30/2019 | Continental Manufacturing Chemist, Inc. |
KAN-DO | 7/30/2019 | Continental Manufacturing Chemist |
KAN-DO | 7/31/2019 | Nesher Pharmaceuticals (USA) LLC |
LOS-DO | 7/3/2019 | Sunrider Manufacturing L P |
LOS-DO | 7/3/2019 | Global Health Solutions LLC dba Turn Therapeutics |
LOS-DO | 7/9/2019 | Freedom Laser Therapy Inc |
LOS-DO | 7/12/2019 | Anacom General Corporation DBA Anacom MedTek |
LOS-DO | 7/17/2019 | American Laser Healthcare Corp |
MIN-DO | 7/17/2019 | Little Rapids Corporation |
MIN-DO | 7/18/2019 | DRAPER PRODUCTS, INC./R. SABEE CO. LLC |
MIN-DO | 7/22/2019 | Shape Medical Systems, Inc |
MIN-DO | 7/25/2019 | Radix Laboratories Inc |
MIN-DO | 7/25/2019 | MaxPax, LLC |
MIN-DO | 7/25/2019 | Kimberly-Clark Corp. |
NOL-DO | 7/24/2019 | People's Custom Rx and Clinical Care, LLC |
NWE-DO | 7/9/2019 | Broad Peak Manufacturing, LLC |
NWE-DO | 7/18/2019 | DERMAL PHOTONICS CORPORATION |
NWE-DO | 7/19/2019 | M Drug, LLC dba Northern Light Pharmacy |
NWE-DO | 7/24/2019 | FHC, Inc. |
NWE-DO | 7/24/2019 | Cogstate Healthcare LLC |
NWE-DO | 7/31/2019 | Sofregen Medical Inc. |
NWJ-DO | 7/25/2019 | Mandell's Clinical Pharmacy |
NYK-DO | 7/3/2019 | Memory MD, Inc. |
NYK-DO | 7/16/2019 | Avery Biomedical Devices, Inc. |
NYK-DO | 7/22/2019 | Bellaire Aesthetics Inc. |
NYK-DO | 7/26/2019 | Ram K. Shrivastava, M.D. |
NYK-DO | 7/30/2019 | Dentorium Products Co. Inc. |
PHI-DO | 7/2/2019 | Neuro Kinetics, Inc. |
PHI-DO | 7/12/2019 | Keystone Rx LLC |
PHI-DO | 7/17/2019 | Hieber's Pharmacy |
PHI-DO | 7/19/2019 | Frontida BioPharm Inc |
SAN-DO | 7/19/2019 | Prescient Surgical, Inc. |
SAN-DO | 7/23/2019 | ULab Systems, Inc. |
SAN-DO | 7/26/2019 | Jazz Imaging |
SEA-DO | 7/19/2019 | Personal Medical Corp. |
SEA-DO | 7/30/2019 | Ladd Family Pharmacy LLC |
SJN-DO | 7/12/2019 | Lilly del Caribe, Inc. (PR01) |
June 2019 |
||
District | Inspection Date | Firm Name |
BLT-DO | 6/11/2019 | AG Essence, Inc. |
BLT-DO | 6/27/2019 | SISU Global Health |
CBER | 6/6/2019 | GSK Vaccines S.r.l |
CBER | 6/6/2019 | GlaxoSmithKline Vaccines S.r.l. |
CDER | 6/4/2019 | Indoco Remedies Limited |
CDER | 6/6/2019 | Xinxiang Tuoxin Biochemical Co. Ltd |
CDER | 6/6/2019 | Innocore Sales & Marketing Inc. |
CDER | 6/7/2019 | K-G Spray-Pak Inc. |
CDER | 6/7/2019 | Hetero Labs, Ltd. - Unit III |
CDER | 6/11/2019 | Encube Ethicals Pvt. Ltd. |
CDER | 6/13/2019 | Jiangsu Hansoh Pharmaceutical Co., Ltd |
CDER | 6/14/2019 | Caplin Steriles Limited |
CDER | 6/14/2019 | IntelliPharmaCeutics Corp. |
CDER | 6/14/2019 | Ningbo BST Clean and Care Products Co., Ltd |
CDER | 6/14/2019 | Laboratorio Reig Jofre S.A. |
CDER | 6/20/2019 | UBI Pharma, Inc. |
CDER | 6/28/2019 | Zhejiang Huahai Pharmaceutical Co., Ltd. |
CDER | 6/28/2019 | Yichang Humanwell Oral Solid Dosage Plant |
CDRH | 6/5/2019 | The Lune Group Oy Ltd. |
CDRH | 6/6/2019 | Saluda Medical Pty Ltd |
CDRH | 6/6/2019 | ApiFix, Ltd. |
CDRH | 6/11/2019 | ApiFix, Ltd. |
CDRH | 6/12/2019 | NINGBO BESMED MEDICAL EQUIPMENT |
CDRH | 6/12/2019 | KANG ZE INDUSTRIAL CO., LTD |
CDRH | 6/19/2019 | Holymed Products Co., Ltd. |
CHI-DO | 6/4/2019 | Clariance Inc |
CHI-DO | 6/20/2019 | Jeron Electronic Systems Inc. |
CHI-DO | 6/25/2019 | Catalent Pharma Solutions, LLC |
CIN-DO | 6/4/2019 | Philips Medical Systems (Cleveland) Inc |
CIN-DO | 6/6/2019 | Johnson Medtech LLC |
CIN-DO | 6/7/2019 | Santanello Surgical LLC |
DAL-DO | 6/4/2019 | Custom Compounding Center |
DAL-DO | 6/5/2019 | Truemed Group LLC |
DAL-DO | 6/6/2019 | TAKA USA, INC. dba Cosmetic Innovations |
DEN-DO | 6/5/2019 | CAO Group, Inc. |
DEN-DO | 6/5/2019 | MATIA ROBOTICS US INC |
DEN-DO | 6/12/2019 | BPI Labs, Inc. |
DEN-DO | 6/14/2019 | First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy |
DEN-DO | 6/17/2019 | Professional Pharmacy Services Inc dba Good Day Pharmacy |
DEN-DO | 6/19/2019 | Signature Formulations, LLC |
DEN-DO | 6/20/2019 | Vevazz LLC |
DEN-DO | 6/21/2019 | Wise Pharmacy |
DET-DO | 6/28/2019 | Lebanon Corp, The |
FLA-DO | 6/10/2019 | Ingenious Technologies Corp. |
FLA-DO | 6/12/2019 | Orthopedic Designs North America, Inc. |
FLA-DO | 6/12/2019 | 4FRONT Solutions, LLC |
FLA-DO | 6/17/2019 | Pharmalab Enterprises, Inc. |
FLA-DO | 6/17/2019 | Iradimed Corporation |
FLA-DO | 6/17/2019 | Maitland Labs of Central Florida |
FLA-DO | 6/20/2019 | Hybrid Pharma LLC |
FLA-DO | 6/26/2019 | Ecotec Manufacturing, Inc. |
KAN-DO | 6/6/2019 | TJN Mfg Inc |
LOS-DO | 6/12/2019 | Bachem Americas, Inc. |
LOS-DO | 6/14/2019 | PLAYGRO USA LLC |
LOS-DO | 6/18/2019 | Regenesis Pharmaceutical Inc. |
LOS-DO | 6/21/2019 | Kyowa Textile USA Inc |
LOS-DO | 6/26/2019 | T D Dental Supply, Inc. |
MIN-DO | 6/7/2019 | Northland Nuclear Medicine, LLC |
MIN-DO | 6/17/2019 | Premier Biotech, Inc. |
MIN-DO | 6/27/2019 | Ad-Tech Medical Instrument Corporation |
NOL-DO | 6/18/2019 | Emilia Resources, LLC |
NOL-DO | 6/20/2019 | Zavation Medical Products, LLC |
NWE-DO | 6/5/2019 | Access Vascular, Inc. |
NWE-DO | 6/7/2019 | HydroCision, Inc. |
NWE-DO | 6/11/2019 | Silex Medical, LLC |
NWE-DO | 6/17/2019 | The General Hospital Corporation |
NWE-DO | 6/20/2019 | JW North America, Inc. |
NWE-DO | 6/20/2019 | Amsel Medical Corporation |
NWJ-DO | 6/3/2019 | Health Pharma USA LLC |
NWJ-DO | 6/11/2019 | LTS Lohmann Therapy Systems Corp |
NWJ-DO | 6/12/2019 | Acino Products, LLC |
NWJ-DO | 6/13/2019 | American Bio Medica Corporation |
NWJ-DO | 6/14/2019 | LifeCell Corporation, A Wholly Owned Subsidiary of Allergan PLC |
NYK-DO | 6/4/2019 | Cognivue Inc. |
NYK-DO | 6/5/2019 | Bristol-Myers Squibb Co., Pharmaceutical Research Institute |
NYK-DO | 6/5/2019 | Par Pharmaceutical, Inc. |
NYK-DO | 6/10/2019 | RDI Inc. |
NYK-DO | 6/18/2019 | Flex Operating Room, LLC |
NYK-DO | 6/19/2019 | Xtreem Pulse LLC |
NYK-DO | 6/28/2019 | DDC Technologies Inc. |
PHI-DO | 6/11/2019 | Rinovum Subsidiary 2 LLC |
SAN-DO | 6/20/2019 | SYNCTHINK, INC. |
SEA-DO | 6/5/2019 | Vanguard EMS, Inc. |
SEA-DO | 6/13/2019 | Puget Sound Drug Corporation dba Key Pharmacy and Compounding Center |
SEA-DO | 6/13/2019 | Good Clean Love, Inc. |
May 2019 |
||
District | Inspection Date | Firm Name |
ATL-DO | 5/14/2019 | Nature's Innovation, Inc. |
ATL-DO | 5/16/2019 | Synthetopes Inc |
BLT-DO | 5/23/2019 | Theragen, Inc |
CDER | 5/3/2019 | Taro Pharmaceuticals Inc. |
CDER | 5/3/2019 | Cadila Healthcare Limited |
CDER | 5/3/2019 | Sun Pharmaceutical Industries, Ltd. |
CDER | 5/3/2019 | Chemi Pharma Ltd |
CDER | 5/8/2019 | Ebewe Pharma Ges.m.b.H.Nfg. KG |
CDER | 5/10/2019 | Faes Farma, S.A. |
CDER | 5/10/2019 | Bingbing Pharmaceutical (Hubei) Co., Ltd |
CDER | 5/14/2019 | Sentiss Pharma Pvt. Ltd. |
CDER | 5/14/2019 | Hetero Labs Ltd. - Unit IX |
CDER | 5/15/2019 | Lupin Ltd. |
CDER | 5/17/2019 | Alkem Laboratories Limited |
CDER | 5/21/2019 | GP Pharm SA |
CDER | 5/24/2019 | Aurobindo Pharma Ltd |
CDER | 5/24/2019 | Bluepharma Industria Farmaceutica, S.A. |
CDER | 5/31/2019 | Merck Serono S.p.A. |
CDER | 5/31/2019 | Orchid Healthcare |
CDRH | 5/2/2019 | Hangzhou AGS Meditech Co., Ltd. |
CDRH | 5/2/2019 | EXACT MEDICAL MANUFACTURING |
CDRH | 5/3/2019 | I.T.S. GmbH |
CDRH | 5/9/2019 | Asteelflash Design Solutions Hamburg GmbH |
CDRH | 5/9/2019 | Shenzhen Jiacom Technology Co., Ltd |
CDRH | 5/14/2019 | P L Overseas Limited |
CDRH | 5/15/2019 | Solid Group Plastic Products (Shenzhen) Ltd. |
CDRH | 5/15/2019 | AQUISEL S.L.U. |
CDRH | 5/16/2019 | Everyway Medical Instruments Co., Inc. |
CDRH | 5/16/2019 | Zhejiang Runqiang Medical Instruments Co., Ltd. |
CDRH | 5/22/2019 | Theo Manufacturing BV |
CDRH | 5/23/2019 | GOOD DOCTORS CO., LTD. |
CHI-DO | 5/6/2019 | Patrin Pharma Inc |
CHI-DO | 5/14/2019 | Hospital Therapy Products Inc. |
CHI-DO | 5/23/2019 | CSL Behring LLC |
CIN-DO | 5/15/2019 | Smithfield Bioscience Inc |
CIN-DO | 5/30/2019 | CellEra LLC |
DAL-DO | 5/9/2019 | Cytovance Biologics Inc. |
DAL-DO | 5/9/2019 | Total Vein Pharmacy |
DAL-DO | 5/13/2019 | Medco Manufacturing |
DAL-DO | 5/14/2019 | CBI Laboratories, Inc. |
DAL-DO | 5/17/2019 | Isotherapeutics Group LLC |
DAL-DO | 5/20/2019 | Acuity Surgical Devices, LLC |
DEN-DO | 5/1/2019 | DeChoker LLC |
DEN-DO | 5/8/2019 | MSM Nutraceuticals, LLC dba MSM Health Solutions |
DEN-DO | 5/8/2019 | Velocity Production and Packaging |
DEN-DO | 5/10/2019 | Key Distributed Products dba Advanced Vision Technologies, Inc. |
DEN-DO | 5/31/2019 | Newman Medical |
DET-DO | 5/6/2019 | EHOB, Inc. |
FLA-DO | 5/3/2019 | OSKO, Inc. |
FLA-DO | 5/6/2019 | Denterprise International, Inc. |
FLA-DO | 5/7/2019 | MobileHelp, LLC |
FLA-DO | 5/7/2019 | Unipharma, Llc. |
FLA-DO | 5/9/2019 | Coast Quality Pharmacy, LLC dba Anazao Health |
FLA-DO | 5/15/2019 | Infinium Medical, Inc |
FLA-DO | 5/17/2019 | PHOTONIC HEALTH, LLC |
FLA-DO | 5/17/2019 | Durisan |
FLA-DO | 5/31/2019 | Accessibility Services, Inc. |
LOS-DO | 5/3/2019 | Kenlor Industries, Inc. |
LOS-DO | 5/7/2019 | Rancho Park Compounding Pharmacy |
LOS-DO | 5/8/2019 | SM Power, LLC. |
LOS-DO | 5/15/2019 | Diversified Healthcare Development LLC |
LOS-DO | 5/17/2019 | California Specialty Pharmacy Inc. |
LOS-DO | 5/21/2019 | Dental Engineering Laboratories, LLC |
LOS-DO | 5/24/2019 | Nitto Avecia Pharma Services, Inc |
LOS-DO | 5/24/2019 | MODULATED IMAGING, INC. |
LOS-DO | 5/31/2019 | Hoosier Plastic Fabrication Inc. |
MIN-DO | 5/3/2019 | Pharmaceutical Specialties, Inc. |
MIN-DO | 5/7/2019 | Team Innovations Inc. |
MIN-DO | 5/16/2019 | Vasamed, Inc. |
MIN-DO | 5/23/2019 | University of Wisconsin System |
MIN-DO | 5/24/2019 | Osprey Medical Inc |
NOL-DO | 5/2/2019 | Advanced Machine, Inc |
NOL-DO | 5/9/2019 | Ashlar Medical LLC |
NOL-DO | 5/10/2019 | Melaleuca Inc |
NOL-DO | 5/16/2019 | Pharmacy Plus, Inc. dba Vital Care Compounder |
NWE-DO | 5/3/2019 | InfuTronix LLC |
NWE-DO | 5/7/2019 | Medical Components Specialists |
NWE-DO | 5/9/2019 | Smiths Medical ASD, Inc. |
NWE-DO | 5/16/2019 | N-Molecular Inc. d.b.a. SOFIE |
NWE-DO | 5/23/2019 | Etex Corporation |
NWE-DO | 5/24/2019 | M&K Engineering, Inc. |
NWJ-DO | 5/2/2019 | A.P. Deauville, LLC |
NWJ-DO | 5/10/2019 | Tecomet, Inc. |
NWJ-DO | 5/15/2019 | Davion Inc |
NWJ-DO | 5/23/2019 | Church & Dwight Co., Inc. |
NYK-DO | 5/7/2019 | Tecomet, Inc. |
NYK-DO | 5/10/2019 | Ortho Clinical Diagnostics |
NYK-DO | 5/13/2019 | Accord Media, LLC |
NYK-DO | 5/22/2019 | Unither Manufacturing LLC. |
NYK-DO | 5/29/2019 | Evaric Pharmaceuticals Inc. |
PHI-DO | 5/3/2019 | Playtex Manufacturing Inc. |
PHI-DO | 5/17/2019 | C4 Imaging LLC |
SAN-DO | 5/10/2019 | Wykle, Inc. |
SAN-DO | 5/15/2019 | Aesthetic and Reconstructive Technologies, Inc. |
SAN-DO | 5/23/2019 | Anigan, Inc. |
SEA-DO | 5/10/2019 | International Isotopes Inc. |
SEA-DO | 5/13/2019 | NeoBiotech Global Corporation |
SEA-DO | 5/14/2019 | Elite Performance and Learning Center, PS |
April 2019 |
||
District | Inspection Date | Firm Name |
ATL-DO | 4/1/2019 | PF Consumer Healthcare 1 LLC |
ATL-DO | 4/5/2019 | Diamond Orthopedic |
ATL-DO | 4/8/2019 | The Compounding Pharmacy |
ATL-DO | 4/11/2019 | Scientific Intake |
ATL-DO | 4/11/2019 | Cape Fear Naturals, LLC |
ATL-DO | 4/11/2019 | D R Burton Healthcare LLC |
ATL-DO | 4/12/2019 | Patheon API Services |
ATL-DO | 4/12/2019 | Concord, Inc. dba Carlton's Dunwoody Pharmacy |
ATL-DO | 4/18/2019 | Kids II, Inc |
ATL-DO | 4/30/2019 | Hinson and Hale Medical Technologies, Inc. |
BLT-DO | 4/10/2019 | Visual Telecommunication Network, LLC dba Vitel Net |
CDER | 4/2/2019 | Cadila Healthcare Ltd. |
CDER | 4/5/2019 | Alps Pharmaceutical Industrial Co., Ltd. |
CDER | 4/5/2019 | Laboratorio Reig Jofre, S.A. |
CDER | 4/5/2019 | Jiangsu NHWA Pharmaceutical Co., Ltd. |
CDER | 4/5/2019 | Hangzhou Facecare Cosmetics Co., Ltd. |
CDER | 4/5/2019 | Amneal Pharmaceuticals Pvt Ltd. |
CDER | 4/9/2019 | Baxter Healthcare Pty Ltd |
CDER | 4/10/2019 | Hisun Pharmaceutical Hangzhou Co Ltd |
CDER | 4/12/2019 | Specialty Electronic Materials Switzerland GmbH |
CDER | 4/12/2019 | Patheon Inc. - Toronto Region Operations |
CDER | 4/12/2019 | Sandoz Private Limited |
CDER | 4/12/2019 | Cyndea Pharma |
CDER | 4/12/2019 | Jilin Asymchem Laboratories Co., Ltd. |
CDER | 4/12/2019 | Suzhou Homesun Pharmaceutical Co., Ltd. |
CDER | 4/12/2019 | Zhejiang Tianyu Pharmaceutical Co Ltd |
CDER | 4/16/2019 | Torrent Pharmaceuticals Limited |
CDER | 4/16/2019 | Sumitomo Dainippon Pharma Co., Ltd. |
CDER | 4/16/2019 | Teva API India Ltd- Malanpur |
CDER | 4/16/2019 | Wuxi Biologics Co Ltd |
CDER | 4/17/2019 | ANSTO Nuclear Medicine |
CDER | 4/19/2019 | Linhai Tianyu Pharmaceutical Co., Ltd. |
CDER | 4/20/2019 | Glenmark Pharmaceuticals Limited |
CDER | 4/24/2019 | Hainan Shuangcheng Pharmaceuticals Co Ltd |
CDER | 4/26/2019 | Zenara Pharma Pvt Ltd |
CDER | 4/26/2019 | Bloomage Freda Biopharm Co., Ltd. |
CDRH | 4/4/2019 | Global Fabtech Wheelchair (Shanghai) Co., Ltd. |
CDRH | 4/4/2019 | JW ICU Medical Limited |
CDRH | 4/11/2019 | Won Industry Co. LTD |
CDRH | 4/11/2019 | Philips Healthcare - VSS ? Shanghai CDC |
CDRH | 4/12/2019 | Inventus Power Design Center |
CDRH | 4/17/2019 | Lac-Mac Limited |
CDRH | 4/17/2019 | SurgiTools (Shanghai) Medical Instruments Co., Ltd. |
CDRH | 4/18/2019 | Jingzhou Haixin Green Cross Medical Products Co. Ltd. |
CDRH | 4/19/2019 | Dongguan Kepler Special Cabling Company Limited |
CDRH | 4/25/2019 | IDS LTD |
CIN-DO | 4/10/2019 | Akron Coating & Adhesives Inc |
CIN-DO | 4/12/2019 | C&W Swiss Inc |
CIN-DO | 4/24/2019 | GFS Chemicals Inc |
DAL-DO | 4/4/2019 | Mission Pharmacal Company |
DAL-DO | 4/9/2019 | Immuno Concepts, N.A., Ltd |
DAL-DO | 4/15/2019 | Bound Tree Medical, LLC |
DAL-DO | 4/19/2019 | ADB INTERESTS, LLC |
DEN-DO | 4/4/2019 | ICU Medical, Inc. |
DEN-DO | 4/11/2019 | CoRE labs, LLC |
DEN-DO | 4/11/2019 | NUTRIX LLC |
DEN-DO | 4/16/2019 | Sandoz Incorporated |
DEN-DO | 4/17/2019 | Gobiquity, Inc |
DEN-DO | 4/24/2019 | Global Vitality, Inc. dba Enzyme Process International |
DEN-DO | 4/24/2019 | ZYTO Technologies, Inc. |
DEN-DO | 4/26/2019 | Transtracheal Systems, Inc. |
DEN-DO | 4/26/2019 | PARAGON VISION SCIENCES |
DET-DO | 4/2/2019 | Capstone Surgical Technologies LLC |
DET-DO | 4/9/2019 | Vertellus LLC |
DET-DO | 4/10/2019 | Petoskey Plastics, Inc. |
DET-DO | 4/17/2019 | 3M |
FLA-DO | 4/2/2019 | OneBlood, Inc. |
FLA-DO | 4/5/2019 | Xhale Assurance, Inc. |
FLA-DO | 4/11/2019 | Dermazone Solutions, Inc. |
FLA-DO | 4/12/2019 | Sofie Co., dba Sofie |
FLA-DO | 4/12/2019 | Mayo Clinic PET Radiochemistry Facility |
FLA-DO | 4/16/2019 | Medibio USA LLC |
FLA-DO | 4/17/2019 | Capillus LLC |
FLA-DO | 4/18/2019 | Ward Photonics, LLC |
FLA-DO | 4/18/2019 | Surgentec, LLC |
FLA-DO | 4/24/2019 | Pompano Precision Products, Inc. |
KAN-DO | 4/3/2019 | AML Riverside, LLC |
KAN-DO | 4/19/2019 | Sentio Biosciences LLC |
KAN-DO | 4/25/2019 | The Metrix Company |
LOS-DO | 4/3/2019 | Invitrx Therapeutics Inc. |
LOS-DO | 4/4/2019 | Clinicon Corp |
LOS-DO | 4/5/2019 | Lifetech Resources, LLC |
LOS-DO | 4/11/2019 | Swabplus, L.P. |
LOS-DO | 4/16/2019 | ARMM Inc |
LOS-DO | 4/17/2019 | Kohana Pharmacy and Center for Regenerative Medicine Inc. |
LOS-DO | 4/19/2019 | Herbal Doctor Remedies |
LOS-DO | 4/19/2019 | Diamond Wipes International, Inc. |
LOS-DO | 4/22/2019 | Biospace Inc. |
LOS-DO | 4/26/2019 | Emerge Diagnostics Inc. |
LOS-DO | 4/29/2019 | Viking Rubber Products Inc. |
LOS-DO | 4/30/2019 | Nihon Kohden America Inc |
MIN-DO | 4/10/2019 | Fagron, Inc |
MIN-DO | 4/17/2019 | Performance Health Supply Inc. |
MIN-DO | 4/18/2019 | Phelan Mfg Corp |
MIN-DO | 4/24/2019 | Caerus Corp. dba Orthocor Medical |
MIN-DO | 4/26/2019 | Heraeus Medical Components LLC FKA Evergreen Medical |
NOL-DO | 4/5/2019 | Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy |
NOL-DO | 4/11/2019 | Adroit Medical Systems Inc |
NOL-DO | 4/12/2019 | UPM Pharmaceuticals |
NWE-DO | 4/2/2019 | Elucid Bioimaging Inc. |
NWE-DO | 4/3/2019 | Precise Packaging, LLC |
NWE-DO | 4/5/2019 | PETNET Solutions Inc. |
NWE-DO | 4/8/2019 | High Technology, Inc. |
NWE-DO | 4/10/2019 | InfoBionic, Inc. |
NWE-DO | 4/11/2019 | Bite Tech Inc. |
NWE-DO | 4/12/2019 | Deringer-Ney, Inc. |
NWE-DO | 4/12/2019 | United Service Solutions, LLC |
NWE-DO | 4/17/2019 | Acme Monaco Corporation |
NWE-DO | 4/22/2019 | Interscope, Inc. |
NWE-DO | 4/23/2019 | Alden Medical LLC |
NWJ-DO | 4/1/2019 | Precious Cosmetics Packaging and Consulting Corp. |
NWJ-DO | 4/9/2019 | ImprimisRx NJ |
NWJ-DO | 4/11/2019 | Aurohealth LLC |
NWJ-DO | 4/15/2019 | Appco Pharma, LLC |
NWJ-DO | 4/22/2019 | Colonia Care Pharmacy |
NYK-DO | 4/4/2019 | The Skin Atelier, Inc. |
NYK-DO | 4/8/2019 | AHA Hyperbarics USA Corp. |
NYK-DO | 4/11/2019 | Jerome Stevens Pharmaceuticals, Inc. |
NYK-DO | 4/19/2019 | Altaire Pharmaceuticals, Inc. |
NYK-DO | 4/25/2019 | HHS Systems Inc. |
NYK-DO | 4/30/2019 | Apothecus Pharmaceutical Corp. |
PHI-DO | 4/4/2019 | Flexicare, Inc. |
PHI-DO | 4/5/2019 | Hercon Pharmaceuticals, LLC |
PHI-DO | 4/9/2019 | Torrent Pharma Inc |
SAN-DO | 4/18/2019 | Laser Dental Innovations |
SEA-DO | 4/2/2019 | OLIVE BRANCH NATURAL BODY CARE LLC |
SEA-DO | 4/12/2019 | Evergreen Orthopedic Research Lab, LLC dba Opertiv |
SEA-DO | 4/16/2019 | Geneva Woods Pharmacy Inc |
SEA-DO | 4/17/2019 | LPE Holdings, LLC |
SEA-DO | 4/17/2019 | Poulsbo Compounding Pharmacy LLC, dba Cascade Specialty Pharmacy |
SEA-DO | 4/18/2019 | Bloodworks |
SEA-DO | 4/19/2019 | Comfort Acrylics, Inc. |
SEA-DO | 4/19/2019 | Bio-Med Diagnostics Inc |
SEA-DO | 4/25/2019 | Spencer Specialty Products Inc |
SJN-DO | 4/11/2019 | Amgen Manufacturing Limited |
March 2019 |
||
District | Inspection Date | Firm Name |
ATL-DO | 3/1/2019 | BD Life Sciences, Preanalytical Solutions |
ATL-DO | 3/21/2019 | Innomed, Inc. |
ATL-DO | 3/22/2019 | Dixon Investments, Inc. DBA ARI |
ATL-DO | 3/26/2019 | Enuresis Solutions, LLC |
BLT-DO | 3/6/2019 | NIH Clinical Center Pharmacy Department |
CBER | 3/5/2019 | Dynavax GmbH |
CDER | 3/1/2019 | Haw Par Healthcare Limited |
CDER | 3/1/2019 | Aurobindo Pharma Limited |
CDER | 3/5/2019 | Biocon Limited |
CDER | 3/5/2019 | Astellas Pharma Tech Co Ltd |
CDER | 3/6/2019 | Marksans Pharma Limited |
CDER | 3/7/2019 | Henan Kangdi Medical Devices Co. Ltd |
CDER | 3/7/2019 | Taizhou Kangping Medical Science And Technology Co., Ltd. |
CDER | 3/8/2019 | Pfizer Manufacturing Deutschland GmbH |
CDER | 3/8/2019 | Siegfried PharmaChemikalien Gmbh & Co. KG |
CDER | 3/8/2019 | MSD International GmbH (Singapore Branch) |
CDER | 3/8/2019 | Kingkey MBC Life Technology Group Co., Ltd. |
CDER | 3/8/2019 | MSN Laboratories Pvt. Ltd. (Formulations Division, Unit-II) |
CDER | 3/15/2019 | Actavis Italy S.p.A. |
CDER | 3/15/2019 | Shionogi & Co., Ltd. |
CDER | 3/15/2019 | Pfizer Asia Pacific Pte Ltd. |
CDER | 3/15/2019 | Glenmark Pharmaceuticals Limited |
CDER | 3/15/2019 | Shanghai Techwell Biopharmaceutical Co.,Ltd. |
CDER | 3/15/2019 | Enprani Co., Ltd. |
CDER | 3/15/2019 | Pharmadax (Foshan) Co., Ltd. |
CDER | 3/19/2019 | Laboratorios Farmalan, S.A |
CDER | 3/20/2019 | Cipla, Ltd. |
CDER | 3/21/2019 | Hangzhou Badi Daily Use Chemical Company |
CDER | 3/21/2019 | Shanghai Co-Fun Biotech Corp., Ltd. |
CDER | 3/22/2019 | Icrom Spa |
CDER | 3/22/2019 | Zhejiang Kangle Pharmaceutical Co., Ltd (Binhai Plant) |
CDER | 3/22/2019 | NingBo Huize Commodity Co.,Ltd. |
CDER | 3/29/2019 | Sun Pharmaceutical Industries Limited |
CDRH | 3/6/2019 | Md Diagnostics Ltd |
CDRH | 3/7/2019 | Xinyu Electronic Co Ltd |
CDRH | 3/14/2019 | Wittenstein Intens Gmbh |
CDRH | 3/14/2019 | MedicalSystem Biotechnology Co., Ltd. |
CDRH | 3/21/2019 | Guangzhou Health & Health Medical Equipment Co., Ltd. |
CDRH | 3/21/2019 | Charder Electronic Co., Ltd. |
CDRH | 3/21/2019 | MEDAX S.R.L. UNIPERSONALE |
CHI-DO | 3/12/2019 | Dental Technologies Inc. |
CIN-DO | 3/8/2019 | American Regent Inc. |
CIN-DO | 3/20/2019 | SMART TOOLS PLUS LLC. |
CIN-DO | 3/21/2019 | INDUCTION THERAPIES LLC |
DAL-DO | 3/12/2019 | TROPHY SKIN, INC. |
DAL-DO | 3/27/2019 | Prestige Ameritech |
DAL-DO | 3/27/2019 | Unysen Health, Inc |
DAL-DO | 3/28/2019 | TALON, an S & S Technology company |
DEN-DO | 3/7/2019 | Toro Management Llc Dba Sylk |
DEN-DO | 3/8/2019 | Customceutical Compounding |
DEN-DO | 3/15/2019 | OSO BioPharmaceuticals Manufacturing, LLC |
DEN-DO | 3/15/2019 | Clinical Innovations, LLC |
DEN-DO | 3/19/2019 | International Hospital Products, Inc. |
DEN-DO | 3/26/2019 | Bloxr Solutions, LLC |
DEN-DO | 3/28/2019 | Myriad Genetics Laboratories, Inc. |
DET-DO | 3/7/2019 | Freeman Enterprise LLC |
DET-DO | 3/7/2019 | Division of Nuclear Medicine PET Radiopharmaceutical Production Program |
DET-DO | 3/29/2019 | SonarMed Inc |
FLA-DO | 3/8/2019 | Med-Nap LLC |
FLA-DO | 3/11/2019 | Bonafix Surgical and Dental Implants, LLC |
FLA-DO | 3/13/2019 | Excel Medical Electronics, Inc. |
FLA-DO | 3/13/2019 | InNeuroCo |
FLA-DO | 3/14/2019 | Innova SoftGel LLC |
FLA-DO | 3/15/2019 | Inneuroco, Inc. |
FLA-DO | 3/15/2019 | Pulsaderm, LLC |
FLA-DO | 3/18/2019 | Dharma Research, Inc. |
FLA-DO | 3/20/2019 | PrecisionMed Pharmacy |
FLA-DO | 3/29/2019 | Pharma-Natural Inc. |
KAN-DO | 3/6/2019 | ulrich medical USA Inc |
KAN-DO | 3/20/2019 | Southwest Technologies Inc |
KAN-DO | 3/29/2019 | Rhein Manufacturing Inc |
LOS-DO | 3/1/2019 | International Medication Systems Limited |
LOS-DO | 3/1/2019 | Merlyn Associates, Inc dba Merlyn Medical |
LOS-DO | 3/6/2019 | Sotera Wireless, Inc. |
LOS-DO | 3/8/2019 | CARDIOBIOMEDICAL CORPORATION |
LOS-DO | 3/8/2019 | FMKLABS |
LOS-DO | 3/11/2019 | Digital Science Tech, Inc |
LOS-DO | 3/14/2019 | Scantibodies Laboratory, Inc. |
LOS-DO | 3/14/2019 | Anesthesia Associates Inc |
LOS-DO | 3/14/2019 | Pacific Medical Group Inc. |
LOS-DO | 3/18/2019 | PresbiBio, LLC |
LOS-DO | 3/19/2019 | True Function Laboratory, Inc. |
LOS-DO | 3/21/2019 | OrthoSource Inc |
LOS-DO | 3/21/2019 | WCM Waste & Compliance Management Inc |
LOS-DO | 3/22/2019 | Carol Cole Company, Inc. dba NuFACE |
MIN-DO | 3/4/2019 | Acist Medical Systems |
MIN-DO | 3/5/2019 | PROXIMAGEN LLC |
MIN-DO | 3/6/2019 | Halo Innovations Inc |
MIN-DO | 3/12/2019 | Preservation Solutions, Inc. |
MIN-DO | 3/15/2019 | Aum Cardiovascular Inc. |
MIN-DO | 3/29/2019 | Simple Science, LLC |
NOL-DO | 3/7/2019 | Ralston Group |
NOL-DO | 3/7/2019 | Lexia LLC |
NOL-DO | 3/8/2019 | In2bones USA, LLC |
NOL-DO | 3/28/2019 | Blephex, LLC |
NWE-DO | 3/1/2019 | AllerQuest LLC |
NWE-DO | 3/14/2019 | On Site Gas Systems Inc. |
NWE-DO | 3/15/2019 | Sheffield Pharmaceuticals, LLC |
NWE-DO | 3/18/2019 | Triumvirate Environmental, Inc. |
NWJ-DO | 3/7/2019 | Suite K Value Added Services LLC |
NWJ-DO | 3/11/2019 | Inspirx, Inc. |
NWJ-DO | 3/15/2019 | Quagen Pharma, LLC |
NWJ-DO | 3/19/2019 | Accupac, Inc |
NWJ-DO | 3/26/2019 | InvaDerm, Inc. |
NYK-DO | 3/1/2019 | Pall Corporation |
NYK-DO | 3/5/2019 | Radformaton, Inc. |
NYK-DO | 3/6/2019 | TURBETT SURGICAL, LLC |
NYK-DO | 3/13/2019 | ALLIED PHARMACY PRODUCTS, INC. |
NYK-DO | 3/18/2019 | Hard Manufacturing Co., Inc. |
NYK-DO | 3/18/2019 | Blue Chip Medical Products, Inc. |
NYK-DO | 3/25/2019 | Cyberlogic, Inc. |
NYK-DO | 3/27/2019 | Bruce Henry Properties, LLC DBA Bonadent |
PHI-DO | 3/6/2019 | Epic Extremity, LLC |
PHI-DO | 3/12/2019 | Polysciences, Inc. |
PHI-DO | 3/15/2019 | Oberg Medical Products Company |
PHI-DO | 3/28/2019 | Wilsey Tool Company Inc |
SAN-DO | 3/5/2019 | Citragen Pharmaceuticals Inc |
SAN-DO | 3/6/2019 | Intersect ENT, Inc. |
SAN-DO | 3/20/2019 | ACRX Specialty Pharmacy Inc |
SAN-DO | 3/21/2019 | W. L. Gore & Associates, Inc. |
SAN-DO | 3/29/2019 | ITG-Medev, Inc. |
SEA-DO | 3/8/2019 | Fabtech Precision Manufacturing, Inc. |
SEA-DO | 3/15/2019 | Kirkman Laboratories, Inc. |
SEA-DO | 3/21/2019 | US Vascular LLC |
SEA-DO | 3/28/2019 | KATALYST, Inc. |
SJN-DO | 3/6/2019 | Caribe Holdings (Cayman) Co. Ltd dba PuraCap Caribe |
SJN-DO | 3/25/2019 | Abbvie Biotechnology Ltd. |
SJN-DO | 3/29/2019 | Boehringer Ingelheim Animal Health Puerto Rico LLC |
February 2019 |
||
District | Inspection Date | Firm Name |
ATL-DO | 2/5/2019 | Fresenius Kabi USA, LLC |
ATL-DO | 2/8/2019 | Pavilion Compounding Pharmacy |
ATL-DO | 2/14/2019 | Alchemix Corporation |
ATL-DO | 2/19/2019 | Monarch Medical Technologies |
BLT-DO | 2/8/2019 | Jbc Corp |
CBER | 2/20/2019 | Oxford Biomedica (UK) Limited |
CDER | 2/1/2019 | Industria Farmaceutica Andromaco S.A. de C.V. |
CDER | 2/1/2019 | Compania Internacional de Comercio, S.A. P.I. de C.V. |
CDER | 2/1/2019 | Biologische Heilmittel Heel Gmbh |
CDER | 2/1/2019 | Otsuka Pharmaceutical Co., Ltd. |
CDER | 2/1/2019 | Rxhomeo Private Limited |
CDER | 2/1/2019 | Recipharm Pharmaservices Private Limited |
CDER | 2/1/2019 | Biofortuna Limited |
CDER | 2/1/2019 | Gelnova Laboratories (India) Pvt. Ltd. |
CDER | 2/1/2019 | Strides Pharma Global Pte Limited |
CDER | 2/2/2019 | Aurobindo Pharma Limited (Unit I) |
CDER | 2/2/2019 | Aurobindo Pharma Limited - Unit 9 |
CDER | 2/5/2019 | Sun Pharmaceutical Medicare Limited |
CDER | 2/5/2019 | Strides Pharma Science Limited |
CDER | 2/7/2019 | National Centre for Nuclear Research |
CDER | 2/7/2019 | Shree Mahadev Intermediate |
CDER | 2/8/2019 | Catalent Ontario Limited |
CDER | 2/8/2019 | Alfresa Fine Chemical Corporation |
CDER | 2/8/2019 | Dr. Reddy's Laboratories Ltd. |
CDER | 2/8/2019 | Kumar Organic Products Ltd. |
CDER | 2/8/2019 | Avra Laboratories Private Ltd. |
CDER | 2/8/2019 | Altergon Italia s.r.l. |
CDER | 2/8/2019 | Hemmo Pharmaceuticals Private Limited |
CDER | 2/8/2019 | Polimeros y Servicios S.A. |
CDER | 2/8/2019 | Aleor Dermaceuticals Ltd. |
CDER | 2/8/2019 | Stern Chempharm LLP |
CDER | 2/9/2019 | Aurobindo Pharma Limited (Unit XI) |
CDER | 2/15/2019 | Otsuka Pharmaceutical Co., Ltd. |
CDER | 2/15/2019 | Biocon Limited |
CDER | 2/15/2019 | Catalent Belgium SA |
CDER | 2/15/2019 | Deva Holding AS - Cerkezkoy Subesi |
CDER | 2/15/2019 | Alkali Metals Limited |
CDER | 2/16/2019 | CTX Lifesciences Private Ltd. |
CDER | 2/19/2019 | Lilly France S.A.S. |
CDER | 2/20/2019 | Emcure Pharmaceuticals Limited |
CDER | 2/22/2019 | Ajinomoto Co., Inc. |
CDER | 2/22/2019 | Qilu Antibiotics (Linyi) Pharmaceutical Co. Ltd. |
CDER | 2/22/2019 | Sharon Bio-Medicine Ltd |
CDER | 2/28/2019 | Ningbo Pulisi Daily Chemical Products Co., Ltd |
CDRH | 2/7/2019 | ELOS MEDTECH PINOL A/S |
CDRH | 2/7/2019 | Design Specific, Ltd. |
CDRH | 2/7/2019 | Handicare Accessibility, Ltd. |
CDRH | 2/7/2019 | Mesi D.O.O. |
CDRH | 2/7/2019 | REMIDIO INNOVATIVE SOLUTIONS PVT. LTD |
CDRH | 2/13/2019 | FLEXMEDICAL SOLUTIONS LIMITED |
CDRH | 2/14/2019 | Cogent Technology, Ltd. |
CDRH | 2/14/2019 | Molecular Products, Ltd. |
CDRH | 2/14/2019 | Orthosoft, Inc. dba Zimmer CAS |
CDRH | 2/14/2019 | Biovation Orthopaedic Solutions Ltd |
CDRH | 2/14/2019 | Sharplight Technologies |
CDRH | 2/21/2019 | Bionet Co., Ltd. |
CDRH | 2/21/2019 | Meko |
CDRH | 2/22/2019 | Imediplus Inc. |
CDRH | 2/28/2019 | Enter Medical Corporation |
CDRH | 2/28/2019 | Hitachi High-Technologies Corp., Omuta Center |
CHI-DO | 2/13/2019 | Trigon International LLC |
CHI-DO | 2/22/2019 | John's Pharmacy Inc. |
CHI-DO | 2/26/2019 | Dot International |
CIN-DO | 2/14/2019 | National Biological Corp |
CIN-DO | 2/14/2019 | Buderer Drug Company |
CIN-DO | 2/15/2019 | Patheon Pharmaceuticals Inc |
DAL-DO | 2/1/2019 | Kelada Creative Group, LLC |
DAL-DO | 2/27/2019 | Allergan Sales, LLC |
DEN-DO | 2/6/2019 | Corden Pharma Colorado, Inc. |
DEN-DO | 2/7/2019 | International Medical Development Corporation |
DEN-DO | 2/11/2019 | Vista Lifesciences, Inc. |
DEN-DO | 2/13/2019 | Arlington Scientific, Inc |
DEN-DO | 2/13/2019 | Vitrolife, Inc. |
DEN-DO | 2/20/2019 | Specialty Formulations & Manufacturing, LLC |
DEN-DO | 2/26/2019 | Maple Rose Enterprises, Inc, dba Pencol Pharmacy |
DET-DO | 2/4/2019 | VHS Children's Hospital of Michigan, PET Site |
DET-DO | 2/7/2019 | Haven Manufacturing |
DET-DO | 2/7/2019 | De Good Dimensional Concepts, Inc |
DET-DO | 2/15/2019 | Polymer Technology Systems, Inc. |
DET-DO | 2/15/2019 | Orchid Orthopedic Solutions, LLC |
DET-DO | 2/22/2019 | Industrial Woodworking Corp. |
FLA-DO | 2/5/2019 | Invotec International Inc. |
FLA-DO | 2/12/2019 | Chemco Corp. |
FLA-DO | 2/15/2019 | TG United, Inc. |
FLA-DO | 2/15/2019 | Stimwave Technologies Inc |
FLA-DO | 2/19/2019 | Schiller America, Inc. |
FLA-DO | 2/20/2019 | Health-Chem Acquisitions, LLC |
FLA-DO | 2/22/2019 | Catalent Pharma Solutions, LLC |
KAN-DO | 2/5/2019 | S and B Pharma, Inc., dba Alkem Laboratories |
KAN-DO | 2/6/2019 | Sigma-Aldrich Mfg LLC |
LOS-DO | 2/7/2019 | KDL Precision Molding |
LOS-DO | 2/7/2019 | Lusys Laboratories, Inc. |
LOS-DO | 2/7/2019 | Ajinomoto Althea, Inc. |
LOS-DO | 2/12/2019 | Amphastar Pharmaceuticals, Inc. |
LOS-DO | 2/13/2019 | Patterson Dental Supply, Inc |
LOS-DO | 2/15/2019 | AIDI Biomedical LLC |
LOS-DO | 2/21/2019 | Lifetime Value Pharmacy III Inc. |
LOS-DO | 2/27/2019 | NEW LIFE DIAGNOSTICS LLC |
LOS-DO | 2/27/2019 | Vitae Enim Vitae Scientific, Inc. |
MIN-DO | 2/8/2019 | LOHMAN TECHNOLOGIES LLC |
MIN-DO | 2/11/2019 | 3M Company - Health Care Business |
MIN-DO | 2/15/2019 | Electro Kinetic Technologies, LLC |
MIN-DO | 2/28/2019 | Williams Sound LLC |
NOL-DO | 2/6/2019 | Stetrix, Inc. |
NOL-DO | 2/14/2019 | Talbot's Pharmaceuticals Family Products, LLC |
NOL-DO | 2/28/2019 | GSB LLC |
NWE-DO | 2/4/2019 | Memtec Corporation |
NWE-DO | 2/8/2019 | Convexity Scientific Inc. |
NWE-DO | 2/13/2019 | Globus Medical, Inc. |
NWE-DO | 2/22/2019 | Madison Polymeric Engineering |
NWE-DO | 2/26/2019 | Ipsen Bioscience, Inc. |
NWE-DO | 2/26/2019 | R.E.C. Manufacturing Corp. |
NWJ-DO | 2/4/2019 | Novitium Pharma LLC |
NWJ-DO | 2/7/2019 | InvaTech Pharma Solutions, LLC |
NWJ-DO | 2/27/2019 | James Alexander Corp. |
NWJ-DO | 2/28/2019 | Endymed Medical Inc. |
NYK-DO | 2/1/2019 | Epic Pharma, LLC |
NYK-DO | 2/4/2019 | 4QImaging, LLC DBA Qmetrics |
NYK-DO | 2/8/2019 | LNK International, Inc. |
NYK-DO | 2/13/2019 | Hi-Tech Pharmacal Co. Inc., An AKORN Company |
NYK-DO | 2/14/2019 | IEC Electronics Corp |
PHI-DO | 2/7/2019 | Troy Manufacturing, Inc. |
PHI-DO | 2/8/2019 | High Chemical Company, Div of National Generic Distributors |
PHI-DO | 2/14/2019 | PhytogenX, Inc. |
PHI-DO | 2/14/2019 | Cadence Device Assembly, Inc. |
SAN-DO | 2/1/2019 | Channel Medsystems, Inc. |
SAN-DO | 2/5/2019 | SOFIE Co. dba SOFIE |
SAN-DO | 2/8/2019 | SMC Ltd. |
SAN-DO | 2/15/2019 | Grifols Diagnostic Solutions Inc. |
SEA-DO | 2/13/2019 | ELITechGroup Inc. |
SJN-DO | 2/5/2019 | Neolpharma, Inc. |
SJN-DO | 2/6/2019 | Bristol-Myers Squibb Holdings Pharma Ltd. Liability Company |
January 2019 |
||
District | Inspection Date | Firm Name |
ATL-DO | 1/18/2019 | Mikart Inc |
ATL-DO | 1/18/2019 | Osmotica Pharmaceutical Corp |
CDER | 1/10/2019 | Jiangxi Synergy Pharmaceutical, Co., Ltd. |
CDER | 1/10/2019 | Xi'an Livingbond Nonwoven Products Corp., Ltd. |
CDER | 1/11/2019 | Les Produits Chimiques B.G.R., Inc. |
CDER | 1/11/2019 | Guilin China Resources Tianhe Pharmaceutical Co., Ltd. |
CDER | 1/11/2019 | Mankind Pharma Limited |
CDER | 1/12/2019 | Haimen Pharma. Co., Ltd. |
CDER | 1/15/2019 | Dr Reddy's Laboratories Limited |
CDER | 1/16/2019 | Daki Ltee |
CDER | 1/17/2019 | Aino Co., Ltd. of North China Pharma. Group |
CDER | 1/17/2019 | Lab Douce Cosmetics Co., Ltd. |
CDER | 1/18/2019 | Mylan Laboratories Limited, (Nashik FDF) |
CDER | 1/18/2019 | FarmaSino Pharmaceuticals (Anhui) Co. Ltd. |
CDER | 1/23/2019 | Esteve Huayi Pharmaceutical Co. Ltd. |
CDER | 1/25/2019 | Avmor Ltd. |
CDER | 1/25/2019 | Aurisco Pharmaceutical Co Ltd |
CDER | 1/25/2019 | Macleods Pharmaceuticals Limited |
CDER | 1/25/2019 | Indoco Remedies Limited (Plant I) |
CDER | 1/25/2019 | Jiangsu Alpha Pharmaceutical Group |
CDER | 1/29/2019 | Amgen Singapore Manufacturing Pte Ltd |
CDRH | 1/10/2019 | SESMED (CAMBODIA) HEALTHCARE PRODUCT CO. LTD. |
CDRH | 1/10/2019 | COOPERVISION MANUFACTURING LTD |
CDRH | 1/17/2019 | Asahi Intecc (Thailand) Co., Ltd. |
CDRH | 1/24/2019 | HGR Instrumente GmbH |
CDRH | 1/31/2019 | Vygon Verneuil |
CIN-DO | 1/31/2019 | Full Range Rehab LLC |
DAL-DO | 1/15/2019 | SOFIE Co. dba SOFIE |
DAL-DO | 1/18/2019 | 3D Imaging Drug Design and Development LLC |
DAL-DO | 1/30/2019 | MedCAD a subsidiary of Van Duzen, Inc. |
DEN-DO | 1/29/2019 | Pharmacy Resources Incorporated |
FLA-DO | 1/23/2019 | Complete Pharmacy and Medical Solutions, LLC dba Complete Pharmaceutics |
FLA-DO | 1/25/2019 | Rockledge Pharmaceutical Manufacturing LLC |
FLA-DO | 1/30/2019 | PLD Acquisitions LLC |
FLA-DO | 1/30/2019 | Poiesis Medical, LLC |
FLA-DO | 1/31/2019 | Chambermaid Products, Inc. |
KAN-DO | 1/31/2019 | Veran Medical Technologies Inc |
LOS-DO | 1/11/2019 | Alere San Diego, Inc. |
LOS-DO | 1/18/2019 | Teva Parenteral Manufacturing |
LOS-DO | 1/18/2019 | Accriva Diagnostics, Inc. |
LOS-DO | 1/25/2019 | HBT Labs, Inc. |
MIN-DO | 1/25/2019 | 3M Company |
MIN-DO | 1/31/2019 | Tapemark Company |
NWE-DO | 1/18/2019 | Wyeth BioPharma Division of Wyeth Pharmaceuticals LLC |
NWE-DO | 1/29/2019 | SpineFrontier, Inc. |
NWE-DO | 1/31/2019 | Tedor Pharma, Inc. |
NWJ-DO | 1/15/2019 | REGI US INC |
NWJ-DO | 1/23/2019 | Tris Pharma Inc. |
NWJ-DO | 1/31/2019 | Leading Pharma, LLC |
NYK-DO | 1/2/2019 | Scientific Solutions Global LLC |
NYK-DO | 1/22/2019 | Perrigo New York, Inc. |
SEA-DO | 1/17/2019 | Vioguard, Inc. |
SEA-DO | 1/28/2019 | Micro Current Technology, Inc. |