Recently Requested 483s
December 2023 |
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District | Inspection Date | Firm Name |
ATL-DO | 12/6/2023 | Carsgen Therapeutics Corporation |
ATL-DO | 12/13/2023 | WatchChild, LLC |
ATL-DO | 12/15/2023 | Tex-Care Medical |
ATL-DO | 12/15/2023 | Avanos Medical, Inc. |
BLT-DO | 12/1/2023 | C. B. Fleet, Inc. dba Fleet Laboratories |
BLT-DO | 12/11/2023 | GlaxoSmithKline dba Human Genome Sciences Inc |
BLT-DO | 12/15/2023 | Granules Pharmaceuticals Inc. |
BLT-DO | 12/18/2023 | Aerosol and Liquid Packaging, Inc. |
BLT-DO | 12/1/2023 | Corbin Clinical Resources, Llc |
BLT-DO | 12/21/2023 | Shikani Medical, LLC dba The Airway Company |
CBER | 12/5/2023 | Boehringer Ingelheim RCV GmbH & Co KG |
CDER | 12/1/2023 | Avon Manufacturing (Guangzhou) Ltd. |
CDER | 12/1/2023 | TAYCA CORPORATION |
CDER | 12/1/2023 | Hanacos Co., Ltd. |
CDER | 12/2/2023 | Shreepati Pharmaceuticals Private Ltd. |
CDER | 12/5/2023 | Sicor de Mexico S.A. de C.V. |
CDER | 12/7/2023 | Zolberg Corporation |
CDER | 12/8/2023 | Micro Labs Limited |
CDER | 12/8/2023 | Guangzhou Baiyunshan Jingxiutang Pharmaceutical Co. Ltd. |
CDER | 12/8/2023 | CIT Co., Ltd. |
CDER | 12/8/2023 | Titan Kogyo, Ltd. |
CDER | 12/11/2023 | Torrent Pharmaceuticals Limited |
CDER | 12/12/2023 | Laurus Synthesis Private Limited |
CDER | 12/15/2023 | Pillar5 Pharma Inc. |
CDER | 12/15/2023 | Nissui Corporation |
CDER | 12/15/2023 | Sun Pharmaceutical Industries Limited |
CDER | 12/15/2023 | Shanghai Kyowa Amino Acid Co., Ltd. |
CDER | 12/19/2023 | Daito Pharmaceutical Co., Ltd. |
CDER | 12/19/2023 | MICROTROL STERILISATION SERVICES PRIVATE LIMITED |
CDER | 12/19/2023 | Xiamen Tiger Medical Co., Ltd. |
CDER | 12/21/2023 | YAHON ENTERPRISE CO., LTD |
CDER | 12/22/2023 | Zydus Lifesciences Limited |
CDRH | 12/7/2023 | Machida Endoscope Co., Ltd. |
CDRH | 12/7/2023 | TR Equipment AB |
CDRH | 12/7/2023 | THOR Photomedicine Ltd |
CDRH | 12/7/2023 | Agency for Medical Innovations GmbH |
CDRH | 12/7/2023 | ADVIHAIR SpA |
CDRH | 12/13/2023 | EMS Physio Ltd. |
CDRH | 12/14/2023 | Nicolay GmbH |
CDRH | 12/14/2023 | Amplivox Ltd |
CDRH | 12/14/2023 | HUNTER SCIENTIFIC LTD |
CDRH | 12/14/2023 | STG24 CO.,LTD. |
CDRH | 12/21/2023 | Implants International Ltd. |
CDRH | 12/21/2023 | Greiner Bio-One GmbH |
CDRH | 12/21/2023 | Longfian Scitech Co., Ltd. |
CDRH | 12/21/2023 | MALSCH GMBH |
CHI-DO | 12/11/2023 | Vee Pak LLC |
CHI-DO | 12/5/2023 | Instrumed International Inc |
CHI-DO | 12/20/2023 | Cardinal Health 200, LLC |
CHI-DO | 12/20/2023 | Sol-Millennium Medical Inc. |
CHI-DO | 12/21/2023 | Stericycle Inc |
CIN-DO | 12/1/2023 | Art of Beauty Company, Inc |
CIN-DO | 12/8/2023 | Pharmalogic Cincinnati, LLC |
CIN-DO | 12/19/2023 | Tri Tech Laboratories LLC dba KDC/One Columbus |
CIN-DO | 12/21/2023 | Neogen Corporation |
CIN-DO | 12/21/2023 | Ekso Bionics Inc. |
DAL-DO | 12/1/2023 | Organicare Nature's Science, LLC |
DAL-DO | 12/6/2023 | ErgoMed, Inc. |
DAL-DO | 12/8/2023 | Encore Medical, LP |
DAL-DO | 12/15/2023 | Liberty Mask LLC |
DEN-DO | 12/13/2023 | Neuromechanical Innovations, LLC |
DET-DO | 12/13/2023 | Emergent Biodefense Operations Lansing LLC |
DET-DO | 12/20/2023 | Exelead, Inc. |
DET-DO | 12/6/2023 | Single Source Medical LLC. |
DET-DO | 12/14/2023 | NG Instruments, Inc. |
FLA-DO | 12/6/2023 | Eagle Labs Inc. |
KAN-DO | 12/1/2023 | Aura Cacia |
KAN-DO | 12/8/2023 | Patheon Biologics LLC |
KAN-DO | 12/15/2023 | TriRx Shawnee, LLC |
KAN-DO | 12/6/2023 | May Dental Arts, LLC |
LOS-DO | 12/7/2023 | Den-Mat Holdings, LLC |
LOS-DO | 12/15/2023 | B. Braun Medical Inc |
LOS-DO | 12/15/2023 | Blaine Labs Inc |
LOS-DO | 12/8/2023 | VITANG TECHNOLOGY LLC |
LOS-DO | 12/13/2023 | Cognita Labs LLC |
LOS-DO | 12/14/2023 | Gecko Labs, LLC |
LOS-DO | 12/18/2023 | Anesthesia Associates Inc |
MIN-DO | 12/20/2023 | Athea Laboratories Inc |
MIN-DO | 12/1/2023 | Winter Innovations, Inc. |
MIN-DO | 12/7/2023 | Aquila Corporation |
MIN-DO | 12/11/2023 | Beckman Coulter, Inc. |
MIN-DO | 12/13/2023 | Midwest Eye Laboratories Inc |
MIN-DO | 12/15/2023 | Arch - MedTorque Inc. |
NOL-DO | 12/7/2023 | Max Mobility LLC |
NOL-DO | 12/12/2023 | TMJ Services LLC |
NWE-DO | 12/19/2023 | Bolger & O'Hearn Inc |
NWE-DO | 12/13/2023 | Philips North America |
NWJ-DO | 12/8/2023 | Roche Molecular Systems, Inc. |
NYK-DO | 12/19/2023 | Phoenix Wipes Inc |
NYK-DO | 12/5/2023 | Novum Medical Products of NY, LLC |
NYK-DO | 12/5/2023 | Huron Tool & Cutter Grinding Co |
NYK-DO | 12/18/2023 | You First Services, Inc. |
PHI-DO | 12/7/2023 | Frontida BioPharm Inc |
PHI-DO | 12/12/2023 | Alpha Aromatics |
PHI-DO | 12/4/2023 | Azer Scientific, Inc. |
PHI-DO | 12/19/2023 | Alva Prototypes Inc |
SAN-DO | 12/14/2023 | Intuitive Surgical, Inc. |
SJN-DO | 12/8/2023 | Gasco Industrial Corp. |
BLT-DO | 12/5/2023 | Tae H. Chung, M.D. |
CDER | 12/15/2023 | Tae Min Kim, M.D., Ph.D. |
CIN-DO | 12/7/2023 | Matthew J. Zirwas, M.D. |
DEN-DO | 12/5/2023 | Adam J. Wolff, M.D. |
DEN-DO | 12/15/2023 | Allen Cohn |
DEN-DO | 12/1/2023 | Thomas E. Waggoner, D.O. |
DET-DO | 12/15/2023 | Leslie H. Lundahl, PhD |
FLA-DO | 12/20/2023 | Dr. James A. Thompson, M.D. |
NYK-DO | 12/5/2023 | J. John Mann, M.D. |
November 2023 |
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District | Inspection Date | Firm Name |
CIN-DO | 11/1/2023 | IncludeHealth |
DEN-DO | 11/1/2023 | Specialty Process Labs LLC |
NYK-DO | 11/1/2023 | Curia New York, Inc. |
CDER | 11/2/2023 | AGC WAKASA CHEMICALS CO., LTD. |
CDRH | 11/2/2023 | Biomet UK Ltd. |
CDRH | 11/2/2023 | DK MEDICAL SYSTEMS CO., LTD. |
KAN-DO | 11/2/2023 | Raye's Inc. |
LOS-DO | 11/2/2023 | Natren, Inc. |
ATL-DO | 11/3/2023 | Halocarbon Life Sciences, LLC |
ATL-DO | 11/3/2023 | Sani-Care Salon Products, Inc |
BLT-DO | 11/3/2023 | Healthy Spirit, LLC |
CDER | 11/3/2023 | Natures Formulae Health Products Ltd. |
CDER | 11/3/2023 | Contract Pharmaceuticals Limited Canada |
CDER | 11/3/2023 | Distribuidora de Alimentos Naturales y Nutricionales S.A de C.V. |
CDER | 11/3/2023 | Sanofi Winthrop Industrie |
CDER | 11/3/2023 | Ningbo Shuangcheng Pharmaceutical Co., Ltd. |
CDRH | 11/3/2023 | APS Materials Inc. Ireland |
LOS-DO | 11/3/2023 | Adonis Inc. |
NOL-DO | 11/3/2023 | Pinnacle Labs of Tennessee, LLC |
NOL-DO | 11/3/2023 | Oxford Pharmaceuticals, LLC |
NWJ-DO | 11/3/2023 | Hikma Pharmaceuticals USA Inc. |
SEA-DO | 11/3/2023 | Philips North America LLC |
CDER | 11/6/2023 | Takeda Pharmaceutical Company Limited |
CDER | 11/6/2023 | Daizo Corporation |
KAN-DO | 11/6/2023 | Steris PLC |
NYK-DO | 11/6/2023 | W.A. Baum Co. Inc. |
CBER | 11/7/2023 | Bavarian Nordic A/S |
DAL-DO | 11/7/2023 | FUJIFILM Diosynth Biotechnologies Texas, LLC |
DEN-DO | 11/7/2023 | AnuMed International LLC |
FLA-DO | 11/8/2023 | Infinium Medical, Inc |
FLA-DO | 11/8/2023 | Curonix LLC |
KAN-DO | 11/8/2023 | Allied Medical LLC |
MIN-DO | 11/8/2023 | Daniels Manufacturing Operations Inc |
NWE-DO | 11/8/2023 | Remote Technologies, Inc. |
CDER | 11/9/2023 | Diversey Canada, Inc. |
CDER | 11/9/2023 | Shilpa Medicare Limited |
CDRH | 11/9/2023 | Medicore Co., Ltd. |
CDRH | 11/9/2023 | Jiangsu Xinbei Electrical Appliance Co., LTD. |
CDRH | 11/9/2023 | AHA Hyperbarics GmbH |
CDRH | 11/9/2023 | BIOPTIMAL INTERNATIONAL PTE. LTD. |
CDRH | 11/9/2023 | Prollenium Medical Technologies Inc. |
DET-DO | 11/9/2023 | Biomet, Inc. |
FLA-DO | 11/9/2023 | Scientific Supplies & Technology, Inc. |
FLA-DO | 11/9/2023 | Hybrid Pharma LLC |
LOS-DO | 11/9/2023 | AVASOL LLC |
NWE-DO | 11/9/2023 | J-PAC LLC DBA Life Science Outsourcing |
NWE-DO | 11/9/2023 | Hamilton Thorne, Inc |
CDER | 11/10/2023 | Hamari PFST, Ltd. |
CDER | 11/10/2023 | Laboratorio Magnachem International, S.A. |
CDER | 11/10/2023 | Nouryon Chemicals, S.A. de C.V. |
CDER | 11/10/2023 | SC Johnson Professional CA Inc |
CDER | 11/10/2023 | Eurofins PROXY Laboratories B.V. |
CDER | 11/10/2023 | Nanjing King-Friend Biochemical Pharmaceutical Co., Ltd. (FDF Site) |
CDER | 11/10/2023 | Alcool Ferreira S/A |
CDER | 11/10/2023 | C&T Dream Co., Ltd. |
CDER | 11/10/2023 | Betone, S.A. de C.V. |
CDRH | 11/10/2023 | Vega Technologies Inc. |
KAN-DO | 11/10/2023 | Patheon Biologics LLC |
CHI-DO | 11/13/2023 | Amsino Healthcare (USA) Inc |
DEN-DO | 11/13/2023 | OsteoCentric Technologies, Inc. |
NYK-DO | 11/13/2023 | Orthodent Laboratory, Inc. |
ATL-DO | 11/14/2023 | Hospira, Inc. |
CDER | 11/14/2023 | Laboratorios Farmalan, S.A. |
CDER | 11/14/2023 | Sichuan Huiyu Pharmaceutical Co., Ltd. |
CDER | 11/14/2023 | Guangdong Sunho Pharmaceutical Co., Ltd |
KAN-DO | 11/14/2023 | Ajinomoto Health & Nutrition North America Inc |
LOS-DO | 11/14/2023 | ORTHO PRECISION PRODUCTS |
MIN-DO | 11/14/2023 | Carma Laboratories, Inc. |
DET-DO | 11/15/2023 | Catalent Indiana, LLC |
FLA-DO | 11/15/2023 | EmCyte Corporation |
LOS-DO | 11/15/2023 | CC Wellness, LLC |
PHI-DO | 11/15/2023 | Stoner Incorporated |
CDER | 11/16/2023 | Boehringer Ingelheim RCV GmbH & Co KG |
CDER | 11/16/2023 | Aruba Aloe Balm N.V. |
CDRH | 11/16/2023 | Motion Concepts LP |
CDRH | 11/16/2023 | Shanghai ISO Medical Products Co., Ltd. |
CDRH | 11/16/2023 | I.T.S. GmbH |
CDRH | 11/16/2023 | Tianjin Medis Medical Device Co., LTD. |
CDRH | 11/16/2023 | Abbott Vascular |
CDRH | 11/16/2023 | DOT Gmbh |
CDRH | 11/16/2023 | Vision Science Co., Ltd. |
CDRH | 11/16/2023 | Foshan Gaunying Electronics Co., Ltd |
DAL-DO | 11/16/2023 | AEI Technologies, Inc |
DET-DO | 11/16/2023 | Advantage Dental Products, Inc. |
LOS-DO | 11/16/2023 | DIAMOND ORTHOTIC LABORATORY |
PHI-DO | 11/16/2023 | Particle Size Technology, Inc. |
ATL-DO | 11/17/2023 | Thunderbird Molding Greensboro, LLC |
CBER | 11/17/2023 | Sanofi Winthrop Industrie |
CBER | 11/17/2023 | Pfizer Manufacturing Austria GmbH |
CDER | 11/17/2023 | Aekyung Industrial Co. Ltd. |
CDER | 11/17/2023 | Analytecon S.A. |
CDER | 11/17/2023 | Distribuidora Comercial Jafra S.A. de C.V. |
CDER | 11/17/2023 | Laboratorios Zepol S.A. |
CDER | 11/17/2023 | Jiangsu Intco Medical Products Co., Ltd. |
CDER | 11/17/2023 | Terry SA |
CDER | 11/17/2023 | Sakai Chemical Industry Co., Ltd. |
CDER | 11/17/2023 | Amneal Oncology Private Limited |
CDER | 11/17/2023 | Shanghai Desano Chemical Pharmaceutical Co., Ltd. |
CDER | 11/17/2023 | Ken Prima Cosmeceuticals, Sdn. Bhd. |
CDER | 11/17/2023 | Advance Zinctek Limited |
CDRH | 11/17/2023 | Jabil Circuit Sdn. Bdh. |
CIN-DO | 11/17/2023 | GFS Chemicals Inc |
FLA-DO | 11/17/2023 | Oxygen Therapy Institute |
FLA-DO | 11/17/2023 | GLOBAL WIDGET LLC |
LOS-DO | 11/17/2023 | Universal Packaging Systems, Inc. dba PakLab |
MIN-DO | 11/17/2023 | Datex-Ohmeda, Inc. |
SJN-DO | 11/17/2023 | Nyx Inc. |
CDER | 11/20/2023 | Abryl Laboratories Private Limited |
DET-DO | 11/20/2023 | Vintage Chemical, Inc. |
LOS-DO | 11/20/2023 | Westwood Laboratories, LLC. |
BLT-DO | 11/21/2023 | WES Pharma Inc. |
CBER | 11/21/2023 | Adimmune Corporation |
CDER | 11/21/2023 | NanChang Anobri Pharmaceutical Co., Ltd. |
NOL-DO | 11/21/2023 | Princeton Medical Group Inc |
DEN-DO | 11/22/2023 | Signature Formulations, LLC |
CDRH | 11/23/2023 | Lepu Medical Technology (Beijing) Co., Ltd. |
CDRH | 11/23/2023 | TAIWAN AULISA MEDICAL DEVICES TECHNOLOGIES, INC. |
CDER | 11/24/2023 | MOEHS IBERICA S.L., MGRC |
CIN-DO | 11/27/2023 | Johnson Medtech LLC |
SJN-DO | 11/29/2023 | Baxter Healthcare Corporation |
CDRH | 11/30/2023 | Konan Medical Inc. |
CDRH | 11/30/2023 | Eurolatex Sdn.Bhd. |
LOS-DO | 11/30/2023 | Health Specialty |
LOS-DO | 11/13/2023 | Michael Chung, M.D. |
DAL-DO | 11/14/2023 | Parvez Mantry |
DAL-DO | 11/17/2023 | Carl P. Griffin, M.D. |
DET-DO | 11/17/2023 | Nehal J. Lakhani, M.D. |
NWE-DO | 11/17/2023 | Jennifer L. Crombie, M.D. |
SAN-DO | 11/20/2023 | Douglas Glenn Young, M.D. |
October 2023 |
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District | Inspection Date | Firm Name |
LOS-DO | 10/2/2023 | Synovo Production |
DEN-DO | 10/5/2023 | TAMA Research Corporation |
KAN-DO | 10/5/2023 | Examinetics Inc |
BLT-DO | 10/6/2023 | Afton Scientific, LLC |
DEN-DO | 10/6/2023 | Abraxis Bioscience, LLC |
DET-DO | 10/6/2023 | Eli Lilly & Company |
NYK-DO | 10/6/2023 | Apothecus Pharmaceutical Corp. |
CDER | 10/10/2023 | Fresenius Kabi Oncology Limited |
DAL-DO | 10/10/2023 | Nelson Enviromental Technologies, Inc. |
DET-DO | 10/11/2023 | Davryan Laboratories, Inc. |
LOS-DO | 10/11/2023 | Stoll Metalcraft Inc |
NWE-DO | 10/11/2023 | SRS Medical Systems Inc. |
CDER | 10/12/2023 | Panacea Biotec Pharma Limited |
CDER | 10/12/2023 | DR. REDDY'S LABORATORIES LTD |
LOS-DO | 10/12/2023 | DSP Skin Care LLC |
NWE-DO | 10/12/2023 | Medical Technical Gases, Inc. |
NWE-DO | 10/12/2023 | Cirtronics Corporation |
NWE-DO | 10/12/2023 | Q30 Sports Science, Llc |
NWJ-DO | 10/12/2023 | Case Medical, Inc. |
NYK-DO | 10/12/2023 | DJ Acquisition FTT LLC, DBA Weco Manufacturing Group - Hennrietta |
CDER | 10/13/2023 | Kaneka Corporation Takasago Plant |
CDER | 10/13/2023 | Dermolab Pharma Ltd. |
DAL-DO | 10/13/2023 | Eminent Spine, LLC |
DAL-DO | 10/13/2023 | Post Oak Innovations, Inc. |
KAN-DO | 10/13/2023 | Jost Chemical Co. |
NYK-DO | 10/13/2023 | Fresenius Kabi USA, LLC |
NYK-DO | 10/13/2023 | Xtreem Pulse LLC |
FLA-DO | 10/16/2023 | Ultrum Labs LLC |
ATL-DO | 10/17/2023 | Biogen U.S. Corporation |
CDER | 10/17/2023 | Patheon Biologics Australia Pty Ltd |
FLA-DO | 10/17/2023 | Bing Innovations Llc |
MIN-DO | 10/17/2023 | ProMed Pharma, LLC |
SJN-DO | 10/17/2023 | Master Paints & Chemical Corp |
CDER | 10/18/2023 | NATCO Pharma Limited |
CDER | 10/18/2023 | Indoco Remedies Limited (Plant I) |
CIN-DO | 10/18/2023 | Surgical Appliance Industries Inc |
FLA-DO | 10/18/2023 | J&T Health and Wellness LLC |
LOS-DO | 10/18/2023 | Links Medical Products Inc |
LOS-DO | 10/18/2023 | OSI Optoelectronics Inc. |
NWE-DO | 10/18/2023 | 3-D Matrix, Inc. |
BLT-DO | 10/19/2023 | Sleepsafe Beds, LLC |
CDER | 10/19/2023 | Vegewax Candleworx Ltd. |
CDER | 10/19/2023 | Aromas Para El Alma S.A. |
CDRH | 10/19/2023 | Nulatex Sdn. Bhd. |
CIN-DO | 10/19/2023 | Alkermes Inc |
NOL-DO | 10/19/2023 | Linde Gas & Equipment Inc |
CDER | 10/20/2023 | Du-Var Laboratory |
CDER | 10/20/2023 | E-Z-EM Canada, Inc |
CDER | 10/20/2023 | Macleods Pharmaceuticals Limited |
CDER | 10/20/2023 | Shionogi Pharma Co. Ltd. |
CDER | 10/20/2023 | Aqualex Co., Ltd. |
CDER | 10/20/2023 | Kilitch Healthcare India Limited |
DAL-DO | 10/20/2023 | Seatex LLC |
FLA-DO | 10/20/2023 | OPTIMOTION IMPLANTS LLC |
LOS-DO | 10/20/2023 | THE HAIN CELESTIAL |
NYK-DO | 10/20/2023 | A.M. Surgical, Inc. |
SEA-DO | 10/20/2023 | TZ Medical, Inc. |
CIN-DO | 10/23/2023 | ROE DENTAL LAB INC |
FLA-DO | 10/23/2023 | Products By O2, Inc |
NYK-DO | 10/23/2023 | Epic Pharma, LLC |
SJN-DO | 10/23/2023 | Omega & Delta Co., Inc. |
SJN-DO | 10/23/2023 | Artesanales P.R. LLC |
DEN-DO | 10/24/2023 | Dechoker, LLC |
KAN-DO | 10/24/2023 | Excite Pharma Services, LLC |
NYK-DO | 10/24/2023 | TMRW Life Sciences, Inc. |
CDRH | 10/26/2023 | Avery Dennison Belgie BV |
CDRH | 10/26/2023 | Vipamat SARL |
CDRH | 10/26/2023 | Philips Healthcare (Suzhou) Co., Ltd. |
CIN-DO | 10/26/2023 | Stephens Instruments, Inc |
FLA-DO | 10/26/2023 | VapoCoolShot, Inc. |
LOS-DO | 10/26/2023 | Morgan Gallacher, Inc DBA Custom Chemical Formulators Inc. |
LOS-DO | 10/26/2023 | LATE NIGHT CONCEPTS INC. (DBA BRUX NIGHT GUARD) |
NWE-DO | 10/26/2023 | Aero-Med LLC |
CDER | 10/27/2023 | PF Consumer Healthcare Canada ULC |
CDER | 10/27/2023 | Astellas Pharma Inc. |
CDER | 10/27/2023 | AGC, Inc. |
CDER | 10/27/2023 | Sumitomo Osaka Cement Co.,Ltd. |
CDER | 10/27/2023 | Eisai Company Ltd. |
CDER | 10/27/2023 | Brands International Corporation |
CDER | 10/27/2023 | Duchesnay Inc. |
CDER | 10/27/2023 | First Cham Co., Ltd. |
DAL-DO | 10/27/2023 | MARY KAY INC. |
DAL-DO | 10/27/2023 | Neuro Rehab VR |
DEN-DO | 10/27/2023 | Carrio Cabling Corporation |
DET-DO | 10/27/2023 | Applied Laboratories, Inc. |
DET-DO | 10/27/2023 | Novartis Manufacturing LLC |
LOS-DO | 10/27/2023 | Cosway Company, Inc. |
NYK-DO | 10/27/2023 | Viant AS&O Holdings, LLC |
PHI-DO | 10/27/2023 | Quotient Sciences |
DEN-DO | 10/30/2023 | BOULDER BIOMED DBA BOULDER IQ |
SJN-DO | 10/30/2023 | Abbvie Biotechnology Ltd. |
ATL-DO | 10/31/2023 | Baxter Healthcare Corporation |
CIN-DO | 10/31/2023 | Vesco Medical Llc |
DAL-DO | 10/31/2023 | XENEX Disinfection Services Inc. |
FLA-DO | 10/31/2023 | CFS Dental, Inc |
SAN-DO | 10/31/2023 | Nordson Medical Design and Development, Inc. |
CHI-DO | 10/6/2023 | Steven H. Dayan, MD |
NWE-DO | 10/6/2023 | Boris N. Bloch, M.D. |
FLA-DO | 10/10/2023 | Elena Valor, M.D. |
PHI-DO | 10/11/2023 | Kwabena Ntoso M.D |
LOS-DO | 10/13/2023 | Lisa S. Wang, M.D. |
NOL-DO | 10/13/2023 | Lawrence W. Johnson, M.D. |
LOS-DO | 10/17/2023 | Daniel Norman, M.D. |
PHI-DO | 10/19/2023 | Diwakar Davar, M.D. |
CDER | 10/20/2023 | Dimitar Shishkov, MD |
CIN-DO | 10/26/2023 | James Melvin Rajan, M.D. |
PHI-DO | 10/26/2023 | Adam Peyton, D.O. |
SEA-DO | 10/27/2023 | Clark, Wayne M. |
September 2023 |
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District | Inspection Date | Firm Name |
ATL-DO | 9/1/2023 | Grifols Therapeutics LLC |
ATL-DO | 9/1/2023 | CMP Pharma Inc |
CDER | 9/1/2023 | Delpharm Montreal Inc. |
CDER | 9/1/2023 | SRI Krishna Pharmaceuticals Ltd - Unit I |
CDER | 9/1/2023 | Jiangsu NHWA Pharmaceutical Co., Ltd. |
CDER | 9/1/2023 | Oishi Koseido Co., Ltd. |
CDER | 9/1/2023 | Samsung Biologics Co., Ltd. |
CDER | 9/1/2023 | Packpharm Limited |
FLA-DO | 9/1/2023 | Prime Matter Labs |
FLA-DO | 9/1/2023 | AVEVA Drug Delivery Systems, Inc. |
FLA-DO | 9/1/2023 | ARCADLAB LLC |
MIN-DO | 9/1/2023 | APN Health LLC |
CDER | 9/5/2023 | Patheon Italia S.p.A. |
CIN-DO | 9/5/2023 | CIT Ortho |
DEN-DO | 9/5/2023 | B & D Dental Corp. |
CDER | 9/6/2023 | Zencore Biologics Co., Ltd. |
FLA-DO | 9/6/2023 | McPherson Enterprises, Inc., dba Implantable Devices |
CDRH | 9/7/2023 | Inno Health Technology, Inc. |
CDRH | 9/7/2023 | Immunodiagnostic Systems Sa |
CDRH | 9/7/2023 | SWORD HEALTH S.A. |
CDRH | 9/7/2023 | ZOT ENGINEERING LTD |
DAL-DO | 9/7/2023 | Medco Manufacturing |
MIN-DO | 9/7/2023 | University of Wisconsin System Radiopharmaceutical Production Facility |
NWE-DO | 9/7/2023 | Fresenius Kabi USA, LLC |
CBER | 9/8/2023 | IDT Biologika GmbH |
CDER | 9/8/2023 | Aso Pharmaceutical Company, Ltd |
CDER | 9/8/2023 | Hetero Labs Limited |
CDER | 9/8/2023 | OrBion Pharmaceuticals Private Limited |
CDER | 9/8/2023 | Jakemans (Confectioners) Ltd. |
CDER | 9/8/2023 | Chengdu Shengnuo Biopharm Co Ltd |
CDER | 9/8/2023 | Wanbang Biopharmaceuticals |
CDER | 9/8/2023 | Reckitt Benckiser Healthcare Manufacturing (Thailand) Ltd. |
CDER | 9/8/2023 | Jiangsu Grand Xianle Pharmaceutical Co., Ltd. |
CDER | 9/8/2023 | Alcon Singapore Manufacturing Pte Ltd. |
CDER | 9/8/2023 | Sichuan Deebio Pharmaceutical Co., Ltd. |
CDER | 9/8/2023 | Zhejiang Peptites Biotech Co.,Ltd. |
DAL-DO | 9/8/2023 | Strive Pharmacy Texas LLC dba Strive Pharmacy |
DEN-DO | 9/8/2023 | PETNET Solutions, Inc |
NWE-DO | 9/8/2023 | DUSA Pharmaceuticals, Inc. |
NWJ-DO | 9/11/2023 | Life Recovery Systems HD, LLC |
CDER | 9/12/2023 | Fournier Laboratories Ireland, Ltd. (Abbvie Cork) |
CDER | 9/12/2023 | APARNA ORGANICS LIMITED |
LOS-DO | 9/12/2023 | Medwaves Inc |
NYK-DO | 9/12/2023 | Banyan USA LLC |
CDER | 9/13/2023 | Wuxi Fortune Pharmaceutical Co., Ltd. |
CHI-DO | 9/13/2023 | Inventex Medical |
LOS-DO | 9/13/2023 | Vacumed, Div of Vacumetrics Inc |
LOS-DO | 9/13/2023 | Biomat USA, Inc |
NOL-DO | 9/13/2023 | Computer Programs & Systems Inc |
CDER | 9/14/2023 | Herbamed AG |
CDRH | 9/14/2023 | Sanmina Ireland Unlimited Company |
CDRH | 9/14/2023 | Barco N.V. |
CDRH | 9/14/2023 | Celltrion Pharm, Inc. |
CDRH | 9/14/2023 | Remeda AB |
CHI-DO | 9/14/2023 | MIE America, Inc. |
CHI-DO | 9/14/2023 | Immersivetouch Inc |
DAL-DO | 9/14/2023 | Ionetix Corporation |
NYK-DO | 9/14/2023 | Psoria Shield, Inc. |
BLT-DO | 9/15/2023 | Contour Healer LLC |
CDER | 9/15/2023 | Central Glass Co., Ltd. |
CDER | 9/15/2023 | McCallum Manufacturing Limited |
CDER | 9/15/2023 | MF Productions Saumur |
CDER | 9/15/2023 | Aesthetic Plus Company Limited |
CDER | 9/15/2023 | Italfarmaco S.A. |
CDER | 9/15/2023 | Smilax Laboratories Limited |
CDER | 9/15/2023 | Yangzhou Liberty Pharmaceuticals Co. Ltd. |
CDER | 9/15/2023 | Linhai Tianyu Pharmaceutical Co., Ltd. |
CDER | 9/15/2023 | Zhejiang Yongtai Technology Co., Ltd |
KAN-DO | 9/15/2023 | Lloyd Inc. of Iowa |
NWE-DO | 9/15/2023 | Agile Devices, Inc. |
PHI-DO | 9/15/2023 | Rinovum Subsidiary 2 LLC |
BLT-DO | 9/18/2023 | Fareva Richmond, Inc. |
KAN-DO | 9/18/2023 | SpecGx, LLC |
CBER | 9/19/2023 | Octapharma AB |
CDER | 9/19/2023 | LSNE-Leon, SLU |
CDER | 9/19/2023 | APL HEALTHCARE LIMITED |
DET-DO | 9/19/2023 | AstraZeneca Pharmaceuticals LP |
MIN-DO | 9/19/2023 | Bell International Laboratories, Inc. |
MIN-DO | 9/19/2023 | Augustine Temperature Management, LLC |
NWE-DO | 9/19/2023 | Light Sources, Inc. |
NWE-DO | 9/19/2023 | Wyeth BioPharma Division of Wyeth Pharmaceuticals LLC |
NWJ-DO | 9/19/2023 | CHEMOMOUTHPIECE, LLC DBA ICE COLD MOUTHPIECE |
NYK-DO | 9/19/2023 | First Source Inc |
NYK-DO | 9/19/2023 | Pine Pharmaceuticals, LLC |
NYK-DO | 9/19/2023 | InvaGen Pharmaceuticals, Inc. |
DAL-DO | 9/20/2023 | Cosmetic Specialty Labs, Inc |
DAL-DO | 9/20/2023 | ARG Laboratories, Inc. |
FLA-DO | 9/20/2023 | Sun Dental Laboratories, LLC |
LOS-DO | 9/20/2023 | Ajinomoto Althea, Inc. |
PHI-DO | 9/20/2023 | Dercher Enterprises, Inc., DBA Gordon Laboratories |
SAN-DO | 9/20/2023 | Iridex Corporation |
SEA-DO | 9/20/2023 | Juno Therapeutics, Inc. |
SJN-DO | 9/20/2023 | McNeil Healthcare, LLC |
CDER | 9/21/2023 | PharmaEssentia Corporation, Taichung Plant |
CDER | 9/21/2023 | Hetero Labs Ltd. Unit VI |
CDRH | 9/21/2023 | Micro-Technic SAS |
CDRH | 9/21/2023 | Tioga Limited |
CHI-DO | 9/21/2023 | Bridge to Life Ltd |
DAL-DO | 9/21/2023 | Colgin, Inc |
DAL-DO | 9/21/2023 | Nurse Assist, LLC |
DAL-DO | 9/21/2023 | Re-Gen Active Lab Inc |
DEN-DO | 9/21/2023 | Quicksilver Scientific |
DET-DO | 9/21/2023 | Arcamed LLC |
KAN-DO | 9/21/2023 | Higley Industries, Inc. |
LOS-DO | 9/21/2023 | Orange Lab, Inc. |
NWE-DO | 9/21/2023 | ModernaTX, Inc. |
NWJ-DO | 9/21/2023 | Portal 724 LLC |
NYK-DO | 9/21/2023 | Seaway Pharma Inc. |
CDER | 9/22/2023 | Mipharm S.p.A. |
CDER | 9/22/2023 | Stella Chemifa Corporation |
CDER | 9/22/2023 | Chongqing Biocare Pharmaceutical Ltd. |
CDER | 9/22/2023 | Alivira Animal Health Limited |
CDER | 9/22/2023 | Rovi Pharma Industrial Services S.A. |
CDRH | 9/22/2023 | Fujifilm Corporation |
FLA-DO | 9/22/2023 | Cosmetic Solutions LLC |
NOL-DO | 9/22/2023 | Somavac Medical Solutions Inc. |
NOL-DO | 9/22/2023 | Ionetix Corporation |
KAN-DO | 9/25/2023 | DynaFlex |
NWJ-DO | 9/25/2023 | Minaris Regenerative Medicine, LLC |
CIN-DO | 9/26/2023 | E-Beam Services Inc |
CIN-DO | 9/26/2023 | Robin Industries Healthcare Division |
FLA-DO | 9/26/2023 | Exactech, Inc. |
FLA-DO | 9/26/2023 | Naked Int'l Inc |
DAL-DO | 9/27/2023 | Germaine Laboratories, Inc |
NWE-DO | 9/27/2023 | Lyophilization Services of New England, Inc. DBA PCI Pharma Services |
NWJ-DO | 9/27/2023 | Siegfried USA, LLC |
PHI-DO | 9/27/2023 | Piramal Critical Care, Inc. |
CDER | 9/28/2023 | Halo Pharmaceutical Canada Inc |
CDRH | 9/28/2023 | Nipro (Thailand) Corporation Limited |
CDRH | 9/28/2023 | Swiss Bionic Solutions GmbH |
CDRH | 9/28/2023 | bioMerieux SA |
KAN-DO | 9/28/2023 | Innovative Medical Technologies Inc |
NOL-DO | 9/28/2023 | iScreen Vision, Inc. |
CBER | 9/29/2023 | Sanofi Pasteur |
CBER | 9/29/2023 | Patheon Italia S.p.A. |
CDER | 9/29/2023 | Aurobindo Pharma Limited, Unit-VI |
CDER | 9/29/2023 | Chiracon GmbH |
CIN-DO | 9/29/2023 | Xellia Pharmaceuticals USA LLC |
DAL-DO | 9/29/2023 | INCELL Corporation LLC |
DAL-DO | 9/29/2023 | CareFusion 213, LLC |
DET-DO | 9/29/2023 | Grand River Aseptic Manufacturing |
FLA-DO | 9/29/2023 | Lonza Tampa LLC |
LOS-DO | 9/29/2023 | Clinical Resolution Laboratory Inc. |
MIN-DO | 9/29/2023 | RR Donnelley - Supply Chain Solutions |
NWJ-DO | 9/29/2023 | Light Age, Inc. |
SAN-DO | 9/29/2023 | Generitech Corporation |
LOS-DO | 9/1/2023 | Eugene Chang |
NOL-DO | 9/1/2023 | Brian B. Borg, M.D. |
PHI-DO | 9/7/2023 | Timothy F. Burns, MD, PhD |
DAL-DO | 9/8/2023 | Joel Solis, MD |
FLA-DO | 9/8/2023 | Jennifer W. Leiding M.D. |
NWJ-DO | 9/14/2023 | Vinay Sikand, M.D. |
LOS-DO | 9/21/2023 | Sohan L. Dua, M.D |
CDER | 9/22/2023 | Jiyu Wen |
DEN-DO | 9/22/2023 | Daniel H. Ahn D.O. |
FLA-DO | 9/27/2023 | Dr. James A. Thompson, M.D. |
August 2023 |
||
District | Inspection Date | Firm Name |
CDER | 8/1/2023 | Zhejiang Jinhua Conba Bio-Pharm. Co., Ltd. |
DAL-DO | 8/1/2023 | SpineSmith Holdings, LLC |
NOL-DO | 8/1/2023 | BARKSDALE DENTAL LABORATORY INC |
NOL-DO | 8/1/2023 | Healing Innovations, Inc |
ATL-DO | 8/2/2023 | PAI Holdings, LLC. dba Pharmaceutical Associates Inc |
CIN-DO | 8/2/2023 | CO-AX Technology Inc |
DAL-DO | 8/2/2023 | Sovereign Pharmaceuticals, LLC |
MIN-DO | 8/2/2023 | Reciprocal Labs Corporation |
NWE-DO | 8/2/2023 | Fresenius Medical Care Holdings, Inc. |
BLT-DO | 8/3/2023 | InVitroCare, Inc |
CDER | 8/3/2023 | Zhuhai United Laboratories Co. Ltd. |
CDRH | 8/3/2023 | HOYA Corporation PENTAX Miyagi Factory |
CDRH | 8/3/2023 | Supercomal Medical Products, Sdn Bhd |
CDRH | 8/3/2023 | Heraeus Medical Components, Srl |
NWJ-DO | 8/3/2023 | Inopak Ltd |
CDER | 8/4/2023 | Teh Seng Pharmaceutical Mfg. Co., Ltd. 3rd Plant |
CDER | 8/4/2023 | Laboratorios Liomont, S.A. de C.V. |
CDER | 8/4/2023 | Catalent Argentina S.A.I.C. |
CDER | 8/4/2023 | Sri Krishna Pharmaceuticals Limited - Unit IV |
CDER | 8/4/2023 | Marksans Pharma Limited |
CDER | 8/4/2023 | Nortec Quimica SA |
CDER | 8/4/2023 | Deva Holding AS - Cerkezkoy 1 & 2 Uretim Tesisi Subesi |
CDER | 8/4/2023 | Shanghai Henlius Biologics Co., Ltd |
DAL-DO | 8/4/2023 | Ensemble Orthopedics, Inc. |
NOL-DO | 8/4/2023 | Oral Arts Dental Laboratories, Inc. |
NOL-DO | 8/4/2023 | SLEEP 8 LLC |
NWE-DO | 8/4/2023 | Biorez, Inc |
NYK-DO | 8/4/2023 | Asept Pak Inc. |
NYK-DO | 8/4/2023 | Ackermann Usa Inc |
SJN-DO | 8/4/2023 | Prime Lab LLC |
LOS-DO | 8/7/2023 | True Function Laboratory, Inc. |
NYK-DO | 8/7/2023 | Sciarra Laboratories, Inc. |
CDER | 8/8/2023 | Cyclomedica Australia Pty Ltd |
CDER | 8/8/2023 | Hybio Pharmaceutical Co., Ltd. (Pingshan Factory) |
FLA-DO | 8/8/2023 | Command Medical Products, Inc. |
NWJ-DO | 8/8/2023 | Burpee Materials Technology, LLC |
NWE-DO | 8/9/2023 | Titan Manufacturing, Inc. |
NWJ-DO | 8/9/2023 | Microcision Llc |
NWJ-DO | 8/9/2023 | Aeton Medical |
BLT-DO | 8/10/2023 | Cangene BioPharma, LLC |
CDRH | 8/10/2023 | Dongguan Polygreen Technology Co., Ltd. |
CDRH | 8/10/2023 | Hoya Corporation - Pentax Life Division |
CDRH | 8/10/2023 | Control-X Medical Zrt. |
CIN-DO | 8/10/2023 | PT Solutions LLC |
LOS-DO | 8/10/2023 | Dendreon Pharmaceuticals LLC |
CDER | 8/11/2023 | Ajinomoto do Brasil Industria e Comercio de Alimentos Ltda |
CDER | 8/11/2023 | RB Salute Mexico SA de CV |
CDER | 8/11/2023 | Aspiro Pharma Limited |
CHI-DO | 8/11/2023 | Mak-System Corp. |
FLA-DO | 8/11/2023 | Ultra Clean Systems, Inc. |
MIN-DO | 8/11/2023 | Apex International Mfg, LLC |
NWJ-DO | 8/11/2023 | SOFIE Co |
CDER | 8/15/2023 | AMMAN PHARMACEUTICAL INDUSTRIES |
LOS-DO | 8/15/2023 | Spinergy, Inc (SM Power LLC) |
ATL-DO | 8/16/2023 | Green Sprouts |
DET-DO | 8/16/2023 | Pure Simple Products aka Northern Elderberry |
FLA-DO | 8/16/2023 | Refine USA, LLC |
NWE-DO | 8/16/2023 | Emergent Biosolutions LLC |
NWE-DO | 8/16/2023 | Zyno Medical LLC |
NWE-DO | 8/16/2023 | InfuTronix LLC |
CDER | 8/17/2023 | H&N HOMEOPATIA E PRODUTOS NATURAIS LTDA |
CDRH | 8/17/2023 | Ambu Sdn. Bhd. |
CDRH | 8/17/2023 | Attract Kft. |
FLA-DO | 8/17/2023 | Myriad Medical, LLC |
LOS-DO | 8/17/2023 | ACI Medical LLC |
NOL-DO | 8/17/2023 | Sunshine USA, LLC |
NWE-DO | 8/17/2023 | Contech Medical, Inc. |
NYK-DO | 8/17/2023 | Welch Allyn Inc |
SAN-DO | 8/17/2023 | Sleep Science Partners, Inc. |
BLT-DO | 8/18/2023 | ZIMMER BIOMET dba Embody, Inc. |
CDER | 8/18/2023 | Guilin Pharmaceutical Co., Ltd. |
CDER | 8/18/2023 | Phytex Australia Pty Ltd |
CDER | 8/18/2023 | Les Importations Herbasante Inc. |
CDER | 8/18/2023 | Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd |
CDER | 8/18/2023 | Bio-Thera Solutions |
CDER | 8/18/2023 | Jiangsu Anbison Pharmaceutical Co., Ltd. |
CDRH | 8/18/2023 | Foamtec International Co., Ltd. |
CHI-DO | 8/18/2023 | Baxter Healthcare Corporation |
DAL-DO | 8/18/2023 | CieloWorks, Inc |
DET-DO | 8/18/2023 | OrthoPediatrics Corp |
KAN-DO | 8/18/2023 | AML Riverside, LLC |
KAN-DO | 8/18/2023 | Curium US, LLC |
SJN-DO | 8/18/2023 | Bard Shannon Limited |
NWE-DO | 8/21/2023 | Falck Medical Incorporated |
DEN-DO | 8/22/2023 | CD Acquisitions, LLC DBA Certa Dose |
BLT-DO | 8/23/2023 | Washington Homeopathic Products, Inc. |
DAL-DO | 8/23/2023 | Dentlight Inc |
NWE-DO | 8/23/2023 | Reliant Compounded Solutions Monroe, LLC |
SEA-DO | 8/23/2023 | CurvaFix, Inc. |
CDRH | 8/24/2023 | Johnson & Johnson Medical (Suzhou) Ltd. |
CDRH | 8/24/2023 | GPV Asia (Thailand) Co., Ltd. |
CDRH | 8/24/2023 | R A Medical Services |
CDRH | 8/24/2023 | SINO MEDICAL SCIENCES TECHNOLOGY INC. |
CHI-DO | 8/24/2023 | Fresenius Kabi USA LLC |
NWJ-DO | 8/24/2023 | Paramesh Banerji Life Sciences, LLC |
ATL-DO | 8/25/2023 | Bleep, LLC |
CDER | 8/25/2023 | Tayca Corporation |
CDER | 8/25/2023 | Bostal Drug Delivery Co., Ltd. |
CDER | 8/25/2023 | Groupe Parima Inc. |
CDER | 8/25/2023 | Zhejiang Liaoyuan Pharmaceutical Co., Ltd. |
CDER | 8/25/2023 | Jiangxi Qingfeng Pharmaceutical Co., Ltd. |
CDER | 8/25/2023 | Porton Pharma (Jiangxi) Co., Ltd. |
CHI-DO | 8/25/2023 | Photonicare Inc |
DAL-DO | 8/25/2023 | Neos Therapeutics, LP |
MIN-DO | 8/25/2023 | Biomerics LLC |
NWE-DO | 8/25/2023 | Berkshire Sterile Manufacturing, LLC |
CDRH | 8/26/2023 | Gland Pharma Limited |
BLT-DO | 8/28/2023 | MacroGenics, Inc |
SAN-DO | 8/28/2023 | North Coast Medical Inc |
DAL-DO | 8/29/2023 | SMITHWORKS, INC. |
NWJ-DO | 8/29/2023 | Appco Pharma LLC |
PHI-DO | 8/29/2023 | Boothwyn Pharmacy LLC |
PHI-DO | 8/29/2023 | Lifeaire Systems |
CDER | 8/30/2023 | Basis Laboratories Private Limited |
DAL-DO | 8/30/2023 | Cardionics, Inc |
DET-DO | 8/30/2023 | SunMed Holdings, LLC |
NWE-DO | 8/30/2023 | Brammer Bio MA, LLC |
NYK-DO | 8/30/2023 | Fresenius Kabi USA, LLC |
BLT-DO | 8/31/2023 | Biomic Sciences, LLC dba ION Intelligence of Nature |
CDER | 8/31/2023 | Shanghai Aucyun Pharmaceuticals Co., Ltd |
CDRH | 8/31/2023 | Jiangsu Guangda Medical Material Group Co., Ltd. |
CDRH | 8/31/2023 | Payer Industries Hungary Kft |
CDRH | 8/31/2023 | Amata Medicare Co., Ltd. |
CDRH | 8/31/2023 | ECTOSENSE NV |
CDRH | 8/31/2023 | Tianjin MasterVision Technology Co., Ltd. |
CIN-DO | 8/31/2023 | Dynavision Global Holdings LLC |
DAL-DO | 8/31/2023 | Carrollclean, LLC |
DET-DO | 8/31/2023 | O3UV, LLC |
FLA-DO | 8/31/2023 | Pure Source LLC |
LOS-DO | 8/1/2023 | Dwayne Logan, M.D. |
FLA-DO | 8/2/2023 | Jeanne-Elyse G. Cedeno, M.D. |
CIN-DO | 8/4/2023 | Firas B. Badin, M.D. |
DAL-DO | 8/4/2023 | Steven Sarkisian, M.D |
NWE-DO | 8/4/2023 | Andrew C. Siesennop, MD |
SEA-DO | 8/4/2023 | Mark A. Stein, Ph.D. |
DEN-DO | 8/7/2023 | Lewis, Karl D. MD |
CDRH | 8/11/2023 | Atul Verma |
DAL-DO | 8/16/2023 | Aslan T Turer, M.D. |
ATL-DO | 8/17/2023 | Angela D. Ritter, M.D. |
ATL-DO | 8/18/2023 | R. Doyle Stulting, MD |
CDER | 8/18/2023 | Monica Mosescu, MD PhD |
DEN-DO | 8/18/2023 | Mimi Liu, MD |
NWJ-DO | 8/21/2023 | Ahsan A. Abdulghani, M.D. |
DET-DO | 8/25/2023 | Miguelangelo J. Perez-Cruet, M.D., M.S. |
MIN-DO | 8/25/2023 | Paul Sorajja, M.D., Clinical Investigator |
July 2023 |
||
District | Inspection Date | Firm Name |
ATL-DO | 7/13/2023 | Novo Nordisk Pharmaceutical Industries LP |
ATL-DO | 7/21/2023 | Cosette Pharmaceuticals NC Laboratories, LLC |
BLT-DO | 7/14/2023 | Sentara Enterprises dba Sentara Infusion Services (Blue Ridge) |
CDER | 7/4/2023 | UCB Farchim SA |
CDER | 7/7/2023 | Kaysersberg Pharmaceuticals SAS |
CDER | 7/7/2023 | Excelvision |
CDER | 7/7/2023 | K.S. PEARL Co., Ltd. |
CDER | 7/7/2023 | BE Pharmaceuticals Private Ltd. |
CDER | 7/11/2023 | Lupin Limited |
CDER | 7/12/2023 | Zile Bonbons Ag |
CDER | 7/14/2023 | Gland Pharma Limited |
CDER | 7/14/2023 | Roche Diagnostics GmbH |
CDER | 7/14/2023 | AmLion Toothpaste Mfg Sdn |
CDER | 7/14/2023 | Novast Laboratories Ltd. |
CDER | 7/14/2023 | Bright Future Pharmaceutical Laboratories Ltd |
CDER | 7/14/2023 | ST Pharm Co., Ltd. |
CDER | 7/20/2023 | Biocon Sdn Bhd |
CDER | 7/21/2023 | Hetero Labs, Ltd. - Unit III |
CDER | 7/21/2023 | Kolmar Korea Co. Ltd. - Gwanjeong 2 Branch |
CDER | 7/21/2023 | Novugen Oncology Sdn. Bhd. |
CDER | 7/25/2023 | OP NanoPharma Co., Ltd. |
CDER | 7/28/2023 | SM Biomed Sdn Bhd |
CDRH | 7/6/2023 | TheraBionic GmbH |
CDRH | 7/13/2023 | Rehabtronics Inc. |
CDRH | 7/20/2023 | Biocon Sdn Bhd |
CDRH | 7/20/2023 | TT Electronics Dongguan |
CDRH | 7/27/2023 | Deymed Diagnostic SRO |
CIN-DO | 7/5/2023 | New Vitalis Pharmacy LLC |
CIN-DO | 7/12/2023 | Church & Dwight Co., Inc. |
CIN-DO | 7/28/2023 | Cleveland Medical Devices Inc |
CIN-DO | 7/28/2023 | Full Range Rehab LLC |
DAL-DO | 7/13/2023 | Tiller MIND BODY, Inc. |
DAL-DO | 7/14/2023 | Immuno-Mycologics, Inc |
DAL-DO | 7/27/2023 | Nelson Environmental Technologies, Inc. |
DEN-DO | 7/18/2023 | Med-Surgical Services Inc., dba CBYON |
DET-DO | 7/14/2023 | Johns Dental Laboratories Inc. |
FLA-DO | 7/14/2023 | Fettech |
FLA-DO | 7/18/2023 | Dextrum Laboratories Inc. |
FLA-DO | 7/20/2023 | Precision Align LLC |
FLA-DO | 7/28/2023 | OMEZA LLC |
KAN-DO | 7/14/2023 | Eco Lips, Inc. |
KAN-DO | 7/28/2023 | Virbac Corporation |
LOS-DO | 7/18/2023 | Product Packaging West, Inc. |
LOS-DO | 7/18/2023 | Synthasome, Inc |
LOS-DO | 7/20/2023 | SPINE INNOVATION, LLC |
LOS-DO | 7/21/2023 | BALT USA, LLC |
LOS-DO | 7/24/2023 | Advanced Cosmetic Research Laboratories, Inc. |
MIN-DO | 7/13/2023 | Northland Nuclear Medicine, LLC |
MIN-DO | 7/14/2023 | Preservation Solutions, Inc. |
MIN-DO | 7/14/2023 | Culligan Soft Water Service Co |
MIN-DO | 7/17/2023 | A-Ox Welding Supply Co., Inc. |
MIN-DO | 7/18/2023 | GE Healthcare - Repair Operations Center |
MIN-DO | 7/19/2023 | Wisconsin Aluminum Foundry Co, Inc. |
MIN-DO | 7/20/2023 | Creation Technologies Wisconsin Inc |
NOL-DO | 7/7/2023 | Avanti Polar Lipids |
NOL-DO | 7/7/2023 | Surgery Pharmacy Services Inc |
NOL-DO | 7/27/2023 | Aeropres Corp |
NWE-DO | 7/12/2023 | eCordum, Inc. |
NWE-DO | 7/18/2023 | Whele LLC DBA Perch |
NWE-DO | 7/21/2023 | Lonza Biologics, Inc. |
NWE-DO | 7/25/2023 | Novo Nordisk US Bio Production Inc. |
NWE-DO | 7/31/2023 | Barkey Corporation |
NWJ-DO | 7/6/2023 | Garonit Pharmaceutical, Inc. |
NWJ-DO | 7/7/2023 | Carnegie Pharmaceutical Llc |
NWJ-DO | 7/14/2023 | Aspire Pharmaceuticals, Inc. |
NYK-DO | 7/21/2023 | Oximeter Plus, Inc |
NYK-DO | 7/25/2023 | G21 USA, Inc. |
PHI-DO | 7/13/2023 | Medical Products Laboratories, Inc. |
SJN-DO | 7/5/2023 | Amgen Manufacturing Ltd |
DEN-DO | 7/21/2023 | Alan G. Garscadden, M.D. |
NWJ-DO | 7/11/2023 | Suneet Mittal, MD |
June 2023 |
||
District | Inspection Date | Firm Name |
LOS-DO | 6/1/2023 | Asahi Intecc Usa Inc |
NWE-DO | 6/1/2023 | The W.S. Badger Company, Inc. |
CDER | 6/2/2023 | Rovi Pharma Industrial Services S.A. |
CDER | 6/2/2023 | Oxalis Labs |
CDER | 6/2/2023 | Fujian Genohope Biotech Ltd |
CDRH | 6/2/2023 | HUREV Co., Ltd. |
FLA-DO | 6/5/2023 | Boca Dental Regenerative LLC |
CDER | 6/6/2023 | UBI Pharma, Inc. |
NWJ-DO | 6/6/2023 | Renaissance Lakewood, LLC |
CDER | 6/7/2023 | Evive Biopharmaceutical (Beijing), Ltd. |
CDRH | 6/7/2023 | Sonesta Medical AB |
NWJ-DO | 6/7/2023 | Aucta Pharmaceuticals, Inc. |
NYK-DO | 6/7/2023 | Amneal Pharmaceuticals of New York, LLC |
CDER | 6/8/2023 | Aarti Phosphates |
CDRH | 6/8/2023 | Pfizer Manufacturing Belgium NV |
CDRH | 6/8/2023 | City Technology Ltd. |
CDRH | 6/8/2023 | Trexo Robotics Holdings Inc. |
DAL-DO | 6/8/2023 | Med Shop Total Care Inc. |
FLA-DO | 6/8/2023 | MAXXION TECHNOLOGY , LLC |
NWE-DO | 6/8/2023 | Proxtalker.Com, Llc |
CDER | 6/9/2023 | Hebei Jiheng Pharmaceutical Co., Ltd. |
CDER | 6/9/2023 | PAB Organics Private Limited |
CDER | 6/9/2023 | Qilu Pharmaceutical Co., Ltd. |
CDER | 6/9/2023 | Boehringer Ingelheim Biopharmaceuticals (China) Ltd. |
CDER | 6/9/2023 | FRESENIUS KABI IPSUM S.R.L. |
CDRH | 6/9/2023 | Samhall AB |
CDRH | 6/9/2023 | LightTech Lamp Technology Ltd. |
CDRH | 6/9/2023 | Shima Laboratories Co., Ltd. |
CDRH | 6/9/2023 | TERRAGENE S.A. |
LOS-DO | 6/9/2023 | Hardy Diagnostics |
MIN-DO | 6/9/2023 | SMITHS MEDICAL ASD, INC. |
MIN-DO | 6/9/2023 | Annex Medical, Inc. |
NWJ-DO | 6/9/2023 | InvaTech Pharma Solutions, LLC |
NYK-DO | 6/9/2023 | Delcath Systems Inc. |
FLA-DO | 6/12/2023 | Awareness Technology, Inc. |
ATL-DO | 6/13/2023 | Fresenius Kabi USA, LLC |
CDER | 6/13/2023 | Ipca Laboratories Limited |
CDER | 6/13/2023 | Symbiosis Pharmaceutical Services Limited |
CDER | 6/13/2023 | Ningbo Shuangcheng Pharmaceutical Co., Ltd. |
DAL-DO | 6/13/2023 | Green Dental Lab |
ATL-DO | 6/14/2023 | CivaTech Oncology Inc. |
DAL-DO | 6/14/2023 | Footprint Medical, Inc. |
KAN-DO | 6/14/2023 | Vi-Jon, LLC |
NWJ-DO | 6/14/2023 | Parker Laboratories, Inc. |
ATL-DO | 6/15/2023 | Carolon Company |
ATL-DO | 6/15/2023 | Span Packaging Services LLC dba Multi-Pack Solutions |
CDER | 6/15/2023 | Apex Healthcare Limited |
CDRH | 6/15/2023 | Innosys Co., Ltd. |
CDRH | 6/15/2023 | Dispo-Med (Malaysia) Sdn Bhd |
CDRH | 6/15/2023 | Acrostak (Schweiz) AG |
CDRH | 6/15/2023 | 3D SYSTEMS - LAYERWISE |
CDRH | 6/15/2023 | OXITONE MEDICAL LTD |
DET-DO | 6/15/2023 | Jatex, Inc. |
LOS-DO | 6/15/2023 | Biofilm, Inc. |
LOS-DO | 6/15/2023 | Gobiquity, Inc |
NOL-DO | 6/15/2023 | Orchid Orthopedic Solutions Alabama LLC |
NOL-DO | 6/15/2023 | M D I Corporation |
NWJ-DO | 6/15/2023 | Datascope Corp. |
SEA-DO | 6/15/2023 | Parks Medical Electronics, Inc |
CDER | 6/16/2023 | Celgene International Sarl |
CDER | 6/16/2023 | Apothecon Pharmaceuticals Private Limited |
CDER | 6/16/2023 | Beigene (Suzhou) Co., Ltd. |
CDER | 6/16/2023 | Milan Laboratories (India) Private Limited |
CDER | 6/16/2023 | TOYO Pharmaceutical Co., Ltd. |
CDER | 6/16/2023 | Qilu Pharmaceutical Co., Ltd. (Dongjia Site) |
CHI-DO | 6/16/2023 | Diversified CPC International |
CIN-DO | 6/16/2023 | Grimm Scientific Industries |
DAL-DO | 6/16/2023 | QUALITY CDMO, Inc. |
DET-DO | 6/16/2023 | Pharmacia & Upjohn Company LLC |
DET-DO | 6/16/2023 | Eli Lilly & Company |
MIN-DO | 6/16/2023 | Axcesor Inc. |
NWJ-DO | 6/16/2023 | Celgene Corporation |
SAN-DO | 6/16/2023 | Theos Medical Systems, Inc. |
CDER | 6/20/2023 | Astral SteriTech Private Ltd. |
CDER | 6/20/2023 | Lexenpharm (Suzhou) Limited |
CDRH | 6/21/2023 | Mag & More Gmbh |
CIN-DO | 6/21/2023 | Tytek Medical Inc |
DAL-DO | 6/21/2023 | Wello, Inc. |
DEN-DO | 6/21/2023 | CoRE labs, LLC |
NWE-DO | 6/21/2023 | Biowave Corporation |
CDRH | 6/22/2023 | Stepac L.A., LTD. |
CDRH | 6/22/2023 | Techlem Medical Corporation |
CDRH | 6/22/2023 | Thai Hospital Products Co., Ltd. |
CDRH | 6/22/2023 | Pharmasept Medical Products 1995 Ltd. |
CDRH | 6/22/2023 | Hmt Medizintechnik Gmbh |
CHI-DO | 6/22/2023 | Aeropres Corporation |
KAN-DO | 6/22/2023 | University of Iowa Pharmaceuticals (UIP) |
KAN-DO | 6/22/2023 | Securitas Healthcare LLC |
CDER | 6/23/2023 | Crystal Claire Cosmetics Inc. |
CDER | 6/23/2023 | ASM Aerosol Service AG |
CDER | 6/23/2023 | Ipca Laboratories Limited |
CDER | 6/23/2023 | Laboratorio Reig Jofre S.A. |
CDER | 6/23/2023 | Optimus Pharma Private Limited |
CDER | 6/23/2023 | Raphas Co., Ltd. |
DAL-DO | 6/23/2023 | Lifecycle Biotechnologies, LP |
FLA-DO | 6/23/2023 | 3D Medical Manufacturing, Inc. |
FLA-DO | 6/23/2023 | Regenerative Processing Plant LLC |
SAN-DO | 6/23/2023 | NeuroField, Inc. |
CIN-DO | 6/26/2023 | Zuga Medical Inc. |
NWJ-DO | 6/26/2023 | Turncare, Inc |
NYK-DO | 6/26/2023 | Turbett Surgical, Inc. |
CDER | 6/27/2023 | Recipharm HC Limited |
CDER | 6/27/2023 | Syntho Chirals Pvt. Ltd. |
CDER | 6/27/2023 | Gland Pharma Limited |
CDRH | 6/27/2023 | NEOSS AB |
CHI-DO | 6/27/2023 | Aeropres Corp |
CIN-DO | 6/27/2023 | Vantage Specialty Ingredients Inc |
CIN-DO | 6/27/2023 | Frantz Medical Development Ltd |
PHI-DO | 6/27/2023 | Digestive Care Inc |
CDRH | 6/28/2023 | Boyd Technologies (Thailand) Co., Ltd. |
FLA-DO | 6/28/2023 | Maguire Enterprises, Inc. |
LOS-DO | 6/28/2023 | Abbott Medical |
NWJ-DO | 6/28/2023 | InvaDerm, Inc. |
NYK-DO | 6/28/2023 | US Merchandise LLC |
CDRH | 6/29/2023 | KEN Hygiene Systems A/S |
CDRH | 6/29/2023 | Tegra Medical Costa Rica Sa |
DEN-DO | 6/29/2023 | RCS Management Corporation dba Lincare AAC |
LOS-DO | 6/29/2023 | SUPERIOR MACHINED PRODUCTS, INC. |
NWE-DO | 6/29/2023 | Boston Brace International Inc |
NWJ-DO | 6/29/2023 | Navinta, LLC |
ATL-DO | 6/30/2023 | Advance Medical Designs, Inc. |
CDER | 6/30/2023 | Cosmetica Laboratories Inc. |
CDER | 6/30/2023 | Hainan Poly Pharm. Co., Ltd. |
CDER | 6/30/2023 | Zydus Hospira Oncology Private Ltd. |
CDER | 6/30/2023 | Virupaksha Organics Limited Unit-II |
CDRH | 6/30/2023 | Wesley Coe (Cambridge) Ltd. |
FLA-DO | 6/30/2023 | Regenerative Processing Plant, LLC |
KAN-DO | 6/30/2023 | Hospira, Inc. |
LOS-DO | 6/30/2023 | Dr. Joel Kaplan Inc. |
PHI-DO | 6/1/2023 | Suken A. Shah, MD |
FLA-DO | 6/2/2023 | Syed K. Lateef, M.D. |
FLA-DO | 6/5/2023 | Beth E. Safirstein, M.D. |
KAN-DO | 6/6/2023 | Melody L. Stone, M.D. |
FLA-DO | 6/8/2023 | Orlando L. Rivero, MD |
NWJ-DO | 6/13/2023 | Cassie L. Blanchard, PhD |
CIN-DO | 6/14/2023 | Gery F Tomassoni MD |
DET-DO | 6/20/2023 | Dennis Hammond |
NWJ-DO | 6/20/2023 | Michael A. Hassman, DO |
DEN-DO | 6/23/2023 | Ernie Riffer MD |
LOS-DO | 6/23/2023 | Namita A. Goyal, M.D. |
BLT-DO | 6/27/2023 | Wayne Farnsworth, MD |
DEN-DO | 6/27/2023 | David J Cahn, M.D. |
FLA-DO | 6/28/2023 | Maria I. Bermudez, M.D. |
DAL-DO | 6/30/2023 | Ravi Ganeshappa, M.D. |
FLA-DO | 6/30/2023 | Vladimir A. Guevara Vazquez, M.D. |
May 2023 |
||
District | Inspection Date | Firm Name |
ATL-DO | 5/5/2023 | Kor-Chem Inc |
ATL-DO | 5/5/2023 | Structure Medical LLC |
ATL-DO | 5/11/2023 | Clear Choice Therapeutics, Inc. |
ATL-DO | 5/12/2023 | restor3d Inc. |
ATL-DO | 5/12/2023 | Lux Therapeutics LLC |
CBER | 5/4/2023 | Novo Nordisk A/S |
CBER | 5/12/2023 | JMS Healthcare PHL Inc. |
CBER | 5/19/2023 | FUJINOMIYA FACTORY OF TERUMO CORP |
CDER | 5/2/2023 | Puniska Healthcare Private Limited (A Subsidary of Amneal Pharmaceuticals Private Limited) |
CDER | 5/4/2023 | Olon Active Pharmaceutical Ingredients India Private Ltd. |
CDER | 5/5/2023 | Dr. Reddy's Laboratories Ltd, CTO Unit 1 |
CDER | 5/5/2023 | Apicore Pharmaceuticals Private Ltd |
CDER | 5/10/2023 | Fresenius Kabi Norge As |
CDER | 5/11/2023 | Pfizer Ireland Pharmaceuticals |
CDER | 5/12/2023 | Intas Pharmaceuticals Limited |
CDER | 5/12/2023 | Megafine Pharma (P) Limited |
CDER | 5/12/2023 | Micro Labs Limited |
CDER | 5/12/2023 | Fujimoto Chemicals Co., Ltd. |
CDER | 5/12/2023 | Dr. Reddy's Laboratories Ltd. |
CDER | 5/13/2023 | Sidmak Laboratories India Pvt Ltd |
CDER | 5/16/2023 | ACS Dobfar SPA (Plant #2) |
CDER | 5/19/2023 | Rxhomeo Private Limited |
CDER | 5/19/2023 | Sri Krishna Pharmaceuticals Limited |
CDER | 5/19/2023 | Medley Pharmaceuticals Limited |
CDER | 5/19/2023 | Morishita Jintan Co., Ltd. |
CDER | 5/19/2023 | Qilu Pharmaceutical (Hainan) Co. Ltd |
CDER | 5/19/2023 | Laboratorios Farmaceuticos Rovi S. A. |
CDER | 5/19/2023 | Aurobindo Pharma Limited, Unit XIV |
CDER | 5/23/2023 | Teva Pharmaceutical Industries Ltd. |
CDER | 5/25/2023 | Sinopharm Weiqida Pharmaceutical Co. Ltd. |
CDER | 5/25/2023 | Torrent Pharmaceuticals Limited |
CDER | 5/25/2023 | Lyocontract GmbH |
CDER | 5/26/2023 | Alps Pharmaceutical Industrial Co., Ltd. |
CDER | 5/26/2023 | Patheon Italia S.p.A. |
CDER | 5/26/2023 | Macleods Pharmaceuticals Limited |
CDER | 5/26/2023 | NEULAND LABORATORIES LIMITED |
CDER | 5/26/2023 | Hetero Labs Limited |
CDER | 5/30/2023 | Qilu Antibiotics Pharmaceutical Co. , Ltd. |
CDER | 5/31/2023 | Caplin Steriles Limited |
CDER | 5/31/2023 | Glaropharm Ag |
CDRH | 5/4/2023 | Caltag Medsystems Ltd |
CDRH | 5/4/2023 | Aus Systems Pty Ltd |
CDRH | 5/4/2023 | MedDev Manufacturing Sdn Bhd |
CDRH | 5/5/2023 | Precision Concepts Costa Rica S.A. |
CDRH | 5/10/2023 | SSN MEDICAL PRODUCTS SDN BHD |
CDRH | 5/11/2023 | P.T. Sankei Medical Industries |
CDRH | 5/11/2023 | Waldemar Link GmbH & Co. KG (Mfg Site) |
CDRH | 5/11/2023 | Contract Medical International GmbH |
CDRH | 5/11/2023 | ManukaMed Limited Partnership |
CDRH | 5/11/2023 | DreamCon Co. Ltd. |
CDRH | 5/17/2023 | OPULENT SOLUTIONS SDN BHD |
CDRH | 5/18/2023 | Unisis Corp. |
CDRH | 5/18/2023 | Intelligent System Co., Ltd. |
CDRH | 5/19/2023 | Neitz Instruments Co., Ltd. |
CDRH | 5/19/2023 | FONA S.R.L. |
CDRH | 5/19/2023 | Nishizawa Electric Meters Manufacturing Co Ltd |
CDRH | 5/25/2023 | Hakko Co., Ltd. |
CDRH | 5/25/2023 | Sirona Hygiene Private Limited |
CDRH | 5/26/2023 | Byd Precision Manufacture Co., Ltd |
CHI-DO | 5/11/2023 | ISOVAC Products, LLC |
CHI-DO | 5/19/2023 | WISE PLASTICS TECHNOLOGIES INC |
CIN-DO | 5/11/2023 | Mirac LLC |
CIN-DO | 5/19/2023 | DRE Medical Group Inc |
DAL-DO | 5/3/2023 | Slow Wave, Inc. |
DAL-DO | 5/4/2023 | Anesthetic Gas Reclamation Inc. |
DAL-DO | 5/11/2023 | BTI Filtration |
DAL-DO | 5/12/2023 | Morgan Newton Comp. |
DAL-DO | 5/22/2023 | Wintech Medipro LLC |
DEN-DO | 5/11/2023 | Alpha ProTech Inc. |
DEN-DO | 5/12/2023 | D. O. Weaver and Company |
DEN-DO | 5/24/2023 | HepQuant, LLC |
DEN-DO | 5/24/2023 | Matia Robotics US, Inc. |
DET-DO | 5/12/2023 | Catalent Indiana, LLC |
FLA-DO | 5/1/2023 | Spinal Resources, Inc. |
FLA-DO | 5/2/2023 | Faico Medical LLC |
FLA-DO | 5/4/2023 | Suncoast Dental, Inc. dba Tatum Surgical |
FLA-DO | 5/5/2023 | Arthrex, Inc. |
FLA-DO | 5/11/2023 | USpharma Ltd |
FLA-DO | 5/17/2023 | Medical Energy, Inc. |
FLA-DO | 5/18/2023 | Ascom (US) Inc. |
FLA-DO | 5/30/2023 | Biomedical Regenerative GF, LLC |
FLA-DO | 5/31/2023 | NeuroVention, LLC |
KAN-DO | 5/10/2023 | Continental Manufacturing Chemist, Inc. |
KAN-DO | 5/10/2023 | Continental Manufacturing Chemist |
KAN-DO | 5/17/2023 | S-Comm, Inc. |
KAN-DO | 5/17/2023 | Geneoscopy, Inc. |
KAN-DO | 5/25/2023 | Helget Gas Products Inc |
LOS-DO | 5/4/2023 | MICROVENTION INC. |
LOS-DO | 5/31/2023 | Baxalta US Incorporated |
MIN-DO | 5/5/2023 | Brenntag Great Lakes, LLC |
MIN-DO | 5/5/2023 | Medtronic Neuromodulation |
MIN-DO | 5/31/2023 | Dynamic Group, Inc |
NOL-DO | 5/16/2023 | Specialty Water Technologies, Inc. |
NOL-DO | 5/19/2023 | Medegen Medical Products, LLC |
NWE-DO | 5/4/2023 | Vertex Pharmaceuticals Incorporated |
NWE-DO | 5/5/2023 | Bristol-Myers Squibb Company |
NWE-DO | 5/5/2023 | Interscope, Inc. |
NWE-DO | 5/16/2023 | LeMaitre Vascular, Inc. |
NWE-DO | 5/17/2023 | TEI Biosciences, Inc. |
NWE-DO | 5/25/2023 | MicroVision, Inc. |
NWJ-DO | 5/15/2023 | AptaPharma Inc. |
NWJ-DO | 5/23/2023 | Parker Laboratories, Inc. |
NYK-DO | 5/24/2023 | Chartwell Pharmaceuticals LLC |
PHI-DO | 5/26/2023 | National Chemical Laboratories |
SAN-DO | 5/3/2023 | Abbott Vascular |
SAN-DO | 5/5/2023 | Gener8 |
SEA-DO | 5/10/2023 | Modus Health, LLC |
SEA-DO | 5/24/2023 | Lonza Bend Inc. |
SJN-DO | 5/31/2023 | Auro PR Inc |
ATL-DO | 5/26/2023 | Raymond E. Easley, D.O. |
BLT-DO | 5/5/2023 | James A. Simon, MD |
CBER | 5/19/2023 | Konrad Rejdak, M.D. |
CDER | 5/5/2023 | Dean L. Harris |
CIN-DO | 5/24/2023 | Richard B. Powell, MD |
DAL-DO | 5/25/2023 | Veronique Sebastian, M.D. |
DAL-DO | 5/26/2023 | Vincent A. Restivo |
DEN-DO | 5/16/2023 | Arthur R. Cabrera, M.D. |
DET-DO | 5/10/2023 | Cem Akin, M.D. |
DET-DO | 5/19/2023 | Suresh Anne, M.D. |
FLA-DO | 5/18/2023 | Maria Cuesta Torres, M.D. |
SAN-DO | 5/18/2023 | Piangwarin Phaosawasdi, M.D. |
April 2023 |
||
District | Inspection Date | Firm Name |
ATL-DO | 4/4/2023 | Emage Medical LLC |
ATL-DO | 4/27/2023 | O&M HALYARD INC |
BLT-DO | 4/6/2023 | Afton Scientific, LLC |
CBER | 4/25/2023 | Fenwal International, Inc. |
CBER | 4/25/2023 | Sanofi Winthrop Industrie |
CDER | 4/4/2023 | Similasan AG |
CDER | 4/6/2023 | Merck Serono SA (Vevey) |
CDER | 4/6/2023 | Norbitec GmbH |
CDER | 4/6/2023 | ACI HealthCare Limited |
CDER | 4/7/2023 | Oy Finnsusp Ab |
CDER | 4/14/2023 | R.L. Fine Chem Private Limited |
CDER | 4/18/2023 | PharmaEssentia Corporation, Taichung Plant |
CDER | 4/21/2023 | Laboratorios Dr. Collado S.A. |
CDER | 4/21/2023 | Hikma Farmaceutica, (Portugal) S.A. |
CDER | 4/21/2023 | MSN Pharmachem Private Limited |
CDER | 4/21/2023 | Kumar Organic Products Limited |
CDER | 4/25/2023 | Thymoorgan Pharmazie Gmbh |
CDER | 4/25/2023 | Sanofi Winthrop Industrie |
CDER | 4/25/2023 | Ciron Drugs and Pharmaceuticals Private Limited |
CDER | 4/28/2023 | K Patel Phyto Extractions Private Ltd |
CDER | 4/28/2023 | Steriscience SP. Z O.O. |
CDRH | 4/5/2023 | Konica Minolta, Inc. |
CDRH | 4/6/2023 | Valtronic Technologies SA |
CDRH | 4/6/2023 | MEDISIZE CZ |
CDRH | 4/6/2023 | Dana Medical Co., Ltd |
CDRH | 4/6/2023 | HOYA LAMPHUN LTD |
CDRH | 4/13/2023 | GEO Medical Co., Ltd. |
CDRH | 4/13/2023 | BroadMaster Biotech Corp. |
CDRH | 4/13/2023 | MD Instruments Mfg. Co., Ltd. |
CDRH | 4/14/2023 | Creation Technologies Ltd |
CDRH | 4/14/2023 | The Yoshida Dental Manufacturing Co., Ltd. |
CDRH | 4/14/2023 | Lune Group Oy Ltd. |
CDRH | 4/20/2023 | Biosensors Interventional Technologies Pte Ltd |
CDRH | 4/20/2023 | National Therapy Products Inc. |
CDRH | 4/26/2023 | Mediso KFT. |
CDRH | 4/27/2023 | GlobalMed Inc. |
CDRH | 4/27/2023 | Spectrum Medical Ltd. |
CDRH | 4/27/2023 | Tech Group Europe Limited |
CDRH | 4/27/2023 | MEDICAL TARGETING TECHNOLOGIES GMBH |
CHI-DO | 4/13/2023 | Nanophase Technologies Corporation |
CIN-DO | 4/20/2023 | AVT Technologies LLC. |
DAL-DO | 4/6/2023 | DPT Laboratories Ltd |
DAL-DO | 4/27/2023 | Lone Star Medical Products, Inc. |
DEN-DO | 4/14/2023 | Tensentric, LLC |
DET-DO | 4/6/2023 | CXMedUS, Inc. |
DET-DO | 4/10/2023 | Signal Medical Corporation |
DET-DO | 4/12/2023 | Vintage Chemical, Inc. |
DET-DO | 4/12/2023 | BBS Enterprises, DBA Complexus Medical |
DET-DO | 4/14/2023 | Par Sterile Products LLC |
DET-DO | 4/27/2023 | BioLyte Laboratories, LLC |
FLA-DO | 4/7/2023 | Balassa Laboratories, Inc. |
FLA-DO | 4/19/2023 | Playtex Manufacturing Inc |
FLA-DO | 4/20/2023 | Ecotec Manufacturing, Inc. |
FLA-DO | 4/25/2023 | Nuline Sensors LLC |
FLA-DO | 4/28/2023 | Ion Labs Inc. |
FLA-DO | 4/28/2023 | Toby Orthopaedics, Inc. |
KAN-DO | 4/5/2023 | Apollo Care, LLC |
KAN-DO | 4/19/2023 | Eurofins Viracor, LLC. |
KAN-DO | 4/20/2023 | Dental Prosthetic Services Inc |
LOS-DO | 4/7/2023 | Arch Medical Solutions - Escondido LLC |
LOS-DO | 4/12/2023 | COLONIAL DAMES CO LTD |
LOS-DO | 4/14/2023 | Sanitor Corporation |
LOS-DO | 4/19/2023 | Pacira Pharmaceuticals, Inc. |
LOS-DO | 4/21/2023 | Health Plus Incorporated |
LOS-DO | 4/25/2023 | Teledyne Analytical Instruments |
LOS-DO | 4/25/2023 | Alcon Research, LLC |
LOS-DO | 4/25/2023 | Neurotris, Inc. dba A1 Engineering |
LOS-DO | 4/26/2023 | Exquisite Corporation |
LOS-DO | 4/28/2023 | Epitope Diagnostics, Inc. |
LOS-DO | 4/28/2023 | RADIANCE BEAUTY & WELLNESS INC. |
MIN-DO | 4/11/2023 | ChemRite CoPac, Inc. |
MIN-DO | 4/11/2023 | QSUM Biopsy Disposables, LLC. |
MIN-DO | 4/14/2023 | Nortech Systems, Inc. |
MIN-DO | 4/17/2023 | Wisconsin Medical Radiopharmacy, LLC. |
MIN-DO | 4/17/2023 | IntriCon Corp |
MIN-DO | 4/21/2023 | Midwest Products and Engineering Inc |
MIN-DO | 4/27/2023 | LISI MEDICAL Remmele, Inc |
NOL-DO | 4/3/2023 | Odyssey Medical Technologies, LLC. |
NOL-DO | 4/4/2023 | Edge Biologicals Inc |
NOL-DO | 4/21/2023 | PETNET Solutions Inc |
NWE-DO | 4/4/2023 | ROM Technologies, Inc. |
NWE-DO | 4/7/2023 | Biosensics LLC |
NWE-DO | 4/13/2023 | Abiomed, Inc. |
NWE-DO | 4/26/2023 | The Tender Corporation |
NWJ-DO | 4/5/2023 | Austarpharma LLC |
NWJ-DO | 4/7/2023 | Next Medical Products Company, LLC |
NWJ-DO | 4/13/2023 | Artegraft, Inc. |
NWJ-DO | 4/18/2023 | Dimensional Merchandising Inc DBA: DMI Personal Care |
NWJ-DO | 4/27/2023 | E-Beam Services, Inc. |
NYK-DO | 4/11/2023 | Lornamead Inc. |
NYK-DO | 4/14/2023 | Netech Corp. |
PHI-DO | 4/20/2023 | Hearing Lab Technology, LLC |
PHI-DO | 4/22/2023 | Sanofi Pasteur Inc. |
PHI-DO | 4/24/2023 | Copperhead Chemical Company, Inc. |
SAN-DO | 4/5/2023 | Eyenovia, Inc. |
SAN-DO | 4/24/2023 | PETNET Solutions, Inc. |
SEA-DO | 4/4/2023 | JD & SN Inc. |
SEA-DO | 4/4/2023 | Toaster Labs, Inc. |
SJN-DO | 4/18/2023 | Customed, Inc |
CDER | 4/6/2023 | Maxwell B. Sauder, M.D. |
CDER | 4/6/2023 | James Whitlock, M.D. |
CDER | 4/28/2023 | Jacek Mackiewicz, MD, PhD |
CHI-DO | 4/28/2023 | Priya U. Kumthekar, M.D. |
CIN-DO | 4/13/2023 | Don A. Stevens, M.D. |
CIN-DO | 4/26/2023 | Amy Lightner MD |
DAL-DO | 4/21/2023 | Fayz A. Hudefi, M.D. |
DEN-DO | 4/21/2023 | John F. Foley, MD |
DEN-DO | 4/21/2023 | Sara J Haug, M.D., Ph.D. |
DET-DO | 4/4/2023 | Francis P. Worden, M.D. |
DET-DO | 4/12/2023 | Dipenkumar Modi, M.D. |
KAN-DO | 4/18/2023 | Lisa A. Clough, M.D. |
KAN-DO | 4/28/2023 | Kamran Qureshi, M.D. |
NWE-DO | 4/11/2023 | Elijah W. Stommel, M.D. |
March 2023 |
||
District | Inspection Date | Firm Name |
ATL-DO | 3/1/2023 | Carolina Sports and Orthopedics Sales Inc |
ATL-DO | 3/2/2023 | MiMedx Group, Inc. |
ATL-DO | 3/2/2023 | MiMedx Group, Inc. |
ATL-DO | 3/3/2023 | Prisma Health Outsourcing Facility |
ATL-DO | 3/8/2023 | WEG Surgical Solutions |
ATL-DO | 3/10/2023 | The Procter & Gamble Manufacturing Company |
ATL-DO | 3/13/2023 | Alcami Carolinas Corporation |
ATL-DO | 3/17/2023 | Novan, Inc. |
ATL-DO | 3/31/2023 | Artivion, Inc |
CBER | 3/2/2023 | Kamada Ltd. |
CBER | 3/10/2023 | Unigen Inc. |
CBER | 3/24/2023 | Delcon Srl |
CBER | 3/27/2023 | SciVac Ltd |
CDER | 3/2/2023 | Global Pharma Healthcare Private Limited |
CDER | 3/3/2023 | BWXT Medical Ltd. |
CDER | 3/3/2023 | Wuxi STA Pharmaceutical Co., Ltd |
CDER | 3/3/2023 | Teyro Labs Private Limited |
CDER | 3/7/2023 | Rentschler Biopharma SE |
CDER | 3/7/2023 | BioConnection B.V. |
CDER | 3/8/2023 | Rohto Pharmaceutical Co., Ltd. (Ueno Plant) |
CDER | 3/10/2023 | Roche Diagnostics GmbH |
CDER | 3/10/2023 | Hovione FarmaCiencia SA |
CDER | 3/10/2023 | Nectar Lifesciences Limited |
CDER | 3/14/2023 | Debiopharm Research & Manufacturing S.A. |
CDER | 3/14/2023 | Regeneron Ireland Designated Activity Company |
CDER | 3/14/2023 | Immacule Lifesciences Private Limited |
CDER | 3/15/2023 | OLIC (Thailand) Limited |
CDER | 3/16/2023 | Bio-Technology General (Israel), Ltd. |
CDER | 3/17/2023 | Rechon Life Science AB |
CDER | 3/17/2023 | Esteve Quimica, S.A. |
CDER | 3/17/2023 | Intermed Laboratories Private Limited |
CDER | 3/17/2023 | Jell Pharmaceuticals Pvt. Ltd. |
CDER | 3/17/2023 | Bliss GVS Pharma Limited |
CDER | 3/17/2023 | CONCORD BIOTECH LIMITED |
CDER | 3/17/2023 | Torrent Pharmaceuticals Limited |
CDER | 3/17/2023 | JW Pharmaceutical Corporation - Sihwa Plant |
CDER | 3/21/2023 | KOFU FACTORY OF TERUMO CORP. |
CDER | 3/24/2023 | IBSA INSTITUT BIOCHIMIQUE SA |
CDER | 3/24/2023 | Deretil, S.A. |
CDER | 3/24/2023 | Handock Cosmetics Co., Ltd. |
CDER | 3/24/2023 | Sanovel Ilac Sanayi Ve Ticaret A.S. |
CDER | 3/24/2023 | Patcos Cosmetics (India) Private Limited |
CDER | 3/24/2023 | Avesta Pharma Private Limited |
CDER | 3/24/2023 | Huatai Pharma Inc. |
CDER | 3/24/2023 | Stallion Laboratories Private Limited |
CDER | 3/24/2023 | Alembic Pharmaceuticals Limited |
CDER | 3/28/2023 | Lonza AG |
CDER | 3/29/2023 | Lupin Limited |
CDER | 3/30/2023 | TERUMO YAMAGUCHI CORPORATION |
CDER | 3/31/2023 | Xylo Chem Industries |
CDER | 3/31/2023 | MSN Organics Private Limited |
CDRH | 3/2/2023 | Apotek Production & Laboratorier AB |
CDRH | 3/3/2023 | Unimicro Medical Systems (Shenzhen) Co., Ltd. |
CDRH | 3/9/2023 | Creation Technologies LTD |
CDRH | 3/9/2023 | MELOQ AB |
CDRH | 3/10/2023 | Trophy SAS |
CDRH | 3/10/2023 | Ming Fai Industrial (Shenzhen) Co LTD |
CDRH | 3/10/2023 | FUJIFILM Healthcare Manufacturing Corp. |
CDRH | 3/16/2023 | INTER MEDICAL MEDIZINTECHNIK GMBH |
CDRH | 3/16/2023 | TELEMED |
CDRH | 3/16/2023 | CANADIAN GENERAL FILTERS LIMITED |
CDRH | 3/16/2023 | ADRIA SRL |
CDRH | 3/16/2023 | T-MED SRL |
CDRH | 3/17/2023 | A&D Company Manufacturing, Ltd. |
CDRH | 3/17/2023 | REMEDI CO., LTD. |
CDRH | 3/22/2023 | Safersonic Medizinprodukte Handelsges MBH |
CDRH | 3/22/2023 | Icecure Medical Ltd |
CDRH | 3/22/2023 | IMANI |
CDRH | 3/23/2023 | Yoshida Denzai Kogyo Co. Ltd |
CDRH | 3/23/2023 | GTG Wellness Co., Ltd. |
CDRH | 3/23/2023 | GTG WELLNESS CO LTD |
CDRH | 3/23/2023 | LASERNEEDLE GMBH |
CDRH | 3/24/2023 | NRT X-RAY A/S |
CDRH | 3/24/2023 | Sakura Seiki Co., Ltd. Chikuma Factory |
CDRH | 3/29/2023 | HERAMED LTD. |
CDRH | 3/30/2023 | Moeller Medical GmbH |
CDRH | 3/30/2023 | Sivantos PTE LTD |
CDRH | 3/30/2023 | Philosys Co. Ltd |
CHI-DO | 3/2/2023 | CSL Behring L.L.C. |
CHI-DO | 3/8/2023 | Tricor Systems |
CHI-DO | 3/16/2023 | Landauer |
CHI-DO | 3/28/2023 | INVENTUS POWER, INC |
CIN-DO | 3/3/2023 | Surgical Theater Inc |
CIN-DO | 3/10/2023 | Natural Essentials Incorporated |
CIN-DO | 3/15/2023 | APS Materials, Inc. |
CIN-DO | 3/24/2023 | Norman Noble Inc |
CIN-DO | 3/30/2023 | Invacare Corporation |
DAL-DO | 3/1/2023 | G Surgical LLC |
DAL-DO | 3/7/2023 | Micro Distributing I I, Ltd |
DAL-DO | 3/7/2023 | EMIT Corporation |
DAL-DO | 3/10/2023 | NEXALIN TECHNOLOGY INC. |
DAL-DO | 3/16/2023 | Turnco Tool & Instrument, Inc. |
DAL-DO | 3/17/2023 | Orthofix U.S. LLC |
DAL-DO | 3/31/2023 | Fruit Of The Earth Research Laboratories, Inc. |
DEN-DO | 3/10/2023 | DentiMax , Inc |
DEN-DO | 3/22/2023 | Promedtek, Inc. |
DEN-DO | 3/22/2023 | SteriGear, LLC |
DEN-DO | 3/29/2023 | WAVi Co. |
DEN-DO | 3/30/2023 | Gergens Orthodontic Lab, Inc. |
DET-DO | 3/2/2023 | Snf Holdings, LLC |
FLA-DO | 3/6/2023 | US Infusion, Inc. |
FLA-DO | 3/9/2023 | Best Image Optical, Inc. |
FLA-DO | 3/16/2023 | Cambridge Diagnostic Products, Inc. |
FLA-DO | 3/17/2023 | SteriCube, LLC |
FLA-DO | 3/23/2023 | Gulf Fiberoptics, Inc. |
FLA-DO | 3/23/2023 | New Vision Pharmaceuticals LLC |
KAN-DO | 3/2/2023 | Patheon Biologics LLC |
KAN-DO | 3/16/2023 | Rockwell Medical Inc. |
KAN-DO | 3/17/2023 | National Dentex LLC, dba NDX Keller |
KAN-DO | 3/30/2023 | Mission Systems Davenport Inc. |
LOS-DO | 3/10/2023 | Medtronic MiniMed, Inc. |
LOS-DO | 3/15/2023 | COSMOBEAUTI LABORATORIES & MANUFACTURING, INC. |
LOS-DO | 3/15/2023 | Palisades Compounding Pharmacy |
LOS-DO | 3/15/2023 | Generica Medical International |
LOS-DO | 3/17/2023 | Paklab |
LOS-DO | 3/17/2023 | Coastal Contract Packaging, Inc |
LOS-DO | 3/23/2023 | Tandem Diabetes Care, Inc. |
LOS-DO | 3/24/2023 | kdc/one Chatsworth, Inc. |
LOS-DO | 3/27/2023 | Bachem Americas, Inc. |
MIN-DO | 3/3/2023 | Smiths Medical ASD Inc. |
NOL-DO | 3/9/2023 | CryoSurgery, Inc. |
NWE-DO | 3/2/2023 | Azurity Pharmaceuticals, Inc. |
NWE-DO | 3/7/2023 | MIRA, Inc. |
NWE-DO | 3/7/2023 | Barrett Technology, LLC |
NWE-DO | 3/9/2023 | Conformis, Inc. |
NWE-DO | 3/13/2023 | Shawsheen Rubber Co., Inc. dba Arrowhead Athletics |
NWE-DO | 3/16/2023 | Safecor Health, LLC |
NWE-DO | 3/24/2023 | Rentschler Biopharma Inc. |
NWE-DO | 3/31/2023 | Precision Optics Corporation, Inc. |
NWE-DO | 3/31/2023 | Kal-Med LLC |
NWJ-DO | 3/2/2023 | Cetylite Industries, Inc. |
NWJ-DO | 3/10/2023 | Enterix, Inc. |
NWJ-DO | 3/10/2023 | MEDIA PLUS, LLC |
NWJ-DO | 3/16/2023 | Titan Implants, Inc |
NWJ-DO | 3/17/2023 | FORDOZ PHARMA CO. |
NWJ-DO | 3/24/2023 | AirScan Inc. d/b/a HemaTechnologies |
NYK-DO | 3/9/2023 | Alk-abello, Inc. |
NYK-DO | 3/9/2023 | Maimonides Medical Center - Pharmacy |
NYK-DO | 3/15/2023 | Fisher Wallace Laboratories Inc. |
NYK-DO | 3/17/2023 | Saptalis Pharmaceuticals LLC |
NYK-DO | 3/22/2023 | Red Medical Solutions, Inc. |
PHI-DO | 3/3/2023 | I3 PHARMACEUTICALS LLC |
PHI-DO | 3/23/2023 | Tesla Biohealing, Inc. |
PHI-DO | 3/30/2023 | Thrombolex Inc |
SAN-DO | 3/8/2023 | Cirtec Medical |
SAN-DO | 3/10/2023 | Antibodies Inc |
SJN-DO | 3/28/2023 | Janssen Ortho LLC |
BLT-DO | 3/6/2023 | Howard M. Richard, III M.D. |
CIN-DO | 3/1/2023 | Michael J Rosen MD |
DAL-DO | 3/10/2023 | Joseph C Gathe, Jr, MD, CI |
DAL-DO | 3/17/2023 | Kathleen N. Moore, M.D. |
DAL-DO | 3/23/2023 | Brian Flowers |
DEN-DO | 3/10/2023 | Nicola Longo, M.D., Ph.D. |
FLA-DO | 3/3/2023 | Tory P. Sullivan, M.D., P.A. |
FLA-DO | 3/10/2023 | Rosa M. Suarez, M.D. |
LOS-DO | 3/30/2023 | Fred K. Kurata, M.D. |
MIN-DO | 3/3/2023 | John C. Lieske, M.D., Clinical Investigator |
NWE-DO | 3/10/2023 | Glenn Gandelman, M.D. |
NWE-DO | 3/10/2023 | Maryellen Fitzgerald, M.D. |
NYK-DO | 3/3/2023 | Mrinal M. Gounder, M.D. |
NYK-DO | 3/17/2023 | Richard W. Foltin, Ph.D. |
February 2023 |
||
District | Inspection Date | Firm Name |
ATL-DO | 2/2/2023 | Cutting Edge Spine |
ATL-DO | 2/3/2023 | Winder Laboratories, LLC |
ATL-DO | 2/9/2023 | AmbioPharm, Inc |
ATL-DO | 2/17/2023 | Magic Race, LLC |
ATL-DO | 2/21/2023 | Luminelle Inc |
BLT-DO | 2/1/2023 | Imagine Milling Technologies, LLC |
CBER | 2/28/2023 | Samsung Biologics Co., Ltd. |
CDER | 2/1/2023 | BROOKS STERISCIENCE LIMITED |
CDER | 2/3/2023 | Seoul Cosmetics Co., Ltd. |
CDER | 2/3/2023 | Corden Pharma Fribourg SA |
CDER | 2/3/2023 | Natco Pharma Limited |
CDER | 2/8/2023 | Centaur Pharmaceuticals Private Ltd. |
CDER | 2/8/2023 | Arene Life Sciences Limited |
CDER | 2/10/2023 | Eli Lilly Italia SPA |
CDER | 2/10/2023 | Laurus Labs Limited |
CDER | 2/10/2023 | Nenter & Co., Inc. |
CDER | 2/16/2023 | Emcure Pharmaceuticals Limited |
CDER | 2/17/2023 | ANI Pharmaceuticals Canada, Inc. |
CDER | 2/17/2023 | Patheon Inc. |
CDER | 2/17/2023 | Sun Pharmaceutical Industries Limited- Madhuranthagam |
CDER | 2/17/2023 | Cipla Limited |
CDER | 2/24/2023 | Patheon Inc. - Toronto Region Operations |
CDER | 2/24/2023 | Vetter Pharma Fertigung GmbH & Co. KG |
CDER | 2/24/2023 | Strides Pharma Science Limited |
CDER | 2/28/2023 | Jubilant HollisterStier General Partnership |
CDER | 2/28/2023 | Indoco Remedies Limited |
CDRH | 2/1/2023 | IQ PRODUCTS B.V. |
CDRH | 2/1/2023 | MediTop Bv |
CDRH | 2/1/2023 | MEDOVATE LIMITED |
CDRH | 2/2/2023 | Morcher Gmbh |
CDRH | 2/2/2023 | Sanofi S.r.l. |
CDRH | 2/2/2023 | De Soutter Medical Ltd |
CDRH | 2/2/2023 | PHC Corporation |
CDRH | 2/2/2023 | Sivantos GmbH |
CDRH | 2/2/2023 | Laser Nova AB |
CDRH | 2/2/2023 | RAUMEDIC - MUENCHBERG |
CDRH | 2/2/2023 | DORO INC ( O/S DORO SAFETY & SECURITY) |
CDRH | 2/2/2023 | JEB TECHNOLOGIES LIMITED |
CDRH | 2/9/2023 | Etymonic Design Inc |
CDRH | 2/9/2023 | Manatec Biomedical |
CDRH | 2/9/2023 | Diatron MI Plc |
CDRH | 2/9/2023 | MAXSTAR INDUSTRIAL CO LTD |
CDRH | 2/10/2023 | DiaSorin S.p.A UK Branch |
CDRH | 2/10/2023 | NINGBO HESI ELECTRIC CO., LTD |
CDRH | 2/15/2023 | Cablon Medical B.V. |
CDRH | 2/15/2023 | Rigicon AS |
CDRH | 2/16/2023 | Bien-Air Surgery SA |
CDRH | 2/16/2023 | Bernd Richter GmbH |
CDRH | 2/16/2023 | Horizons International Corporation |
CDRH | 2/16/2023 | Saehan Corporation |
CDRH | 2/16/2023 | Custom Tube Manufacturing LLC |
CDRH | 2/22/2023 | NARVA Lichtquelle GmbH + Co. KG |
CDRH | 2/22/2023 | Racer Technology Pte Ltd |
CDRH | 2/23/2023 | Dexcowin Co. Ltd. |
CHI-DO | 2/10/2023 | Sunstar Americas, Inc. |
CHI-DO | 2/16/2023 | Uberlube, Inc. |
CIN-DO | 2/9/2023 | DimcoGray Inc. |
CIN-DO | 2/16/2023 | Klarity Medical Products LLC |
CIN-DO | 2/16/2023 | M3 Global Enterprises LLC |
CIN-DO | 2/17/2023 | Criterion Tool & Die Inc |
DAL-DO | 2/7/2023 | TAKA USA, INC. dba Cosmetic Innovations |
DAL-DO | 2/10/2023 | Iso-Tex Diagnostics, Inc. |
DAL-DO | 2/15/2023 | PETNET SOLUTIONS, INC. |
DET-DO | 2/1/2023 | JAC Custom Pouches, Inc. |
DET-DO | 2/3/2023 | KP Pharmaceutical Technology |
FLA-DO | 2/2/2023 | Slater Endoscopy, LLC |
FLA-DO | 2/8/2023 | Freelance Formulations LLC |
FLA-DO | 2/9/2023 | Stingray Surgical Products, LLC |
FLA-DO | 2/17/2023 | Gadal Laboratories Inc. |
FLA-DO | 2/17/2023 | New Wave Endo-Surgical, Corp. |
FLA-DO | 2/21/2023 | Neobiosis LLC |
FLA-DO | 2/28/2023 | Lex, Inc. |
KAN-DO | 2/9/2023 | Vortex Surgical Inc. |
KAN-DO | 2/17/2023 | Fuller Industries, Inc |
KAN-DO | 2/23/2023 | Veran Medical Technologies Inc |
LOS-DO | 2/3/2023 | The Flex Company |
LOS-DO | 2/9/2023 | Verde Cosmetic Labs, LLC |
LOS-DO | 2/13/2023 | K.C. Pharmaceuticals, Inc. |
LOS-DO | 2/15/2023 | International Medication Systems Ltd. |
LOS-DO | 2/16/2023 | Pensar Medical LLC |
LOS-DO | 2/24/2023 | Cosway Company, Inc. |
NOL-DO | 2/10/2023 | Engineered Medical Systems, LLC |
NOL-DO | 2/16/2023 | Amplion Clinical Communications, Inc. |
NWE-DO | 2/6/2023 | Ecometics, Inc. |
NWE-DO | 2/6/2023 | SoClean, Inc |
NWE-DO | 2/8/2023 | Nitto Denko Avecia Inc. |
NWE-DO | 2/9/2023 | Denison Pharmaceuticals, LLC |
NWE-DO | 2/9/2023 | PHASE-N Corporation |
NWE-DO | 2/15/2023 | Linemaster Switch Corporation |
NWE-DO | 2/22/2023 | AADCO Medical Inc. |
NWJ-DO | 2/7/2023 | Almark Tool & Manufacturing Company, Inc. |
NWJ-DO | 2/15/2023 | Veranova LP |
NWJ-DO | 2/17/2023 | Halo Pharmaceutical, Inc. d/b/a Cambrex Whippany |
NWJ-DO | 2/17/2023 | Ashland Specialty Ingredients, G.P. |
NYK-DO | 2/10/2023 | Biodex Medical Systems, Inc. |
NYK-DO | 2/21/2023 | Homeocare Laboratories, Inc. |
PHI-DO | 2/3/2023 | Flex-Cell Precision, Inc |
PHI-DO | 2/14/2023 | Respironics, Inc. |
SAN-DO | 2/2/2023 | Genentech, Inc. |
SAN-DO | 2/10/2023 | Outset Medical, Inc. |
SAN-DO | 2/15/2023 | Phoenix Deventures |
SJN-DO | 2/17/2023 | Lilly del Caribe, Inc. |
DAL-DO | 2/17/2023 | Scott R. Bartley, M.D. |
DEN-DO | 2/16/2023 | Cameron G. Javid, M.D. |
FLA-DO | 2/6/2023 | Scott H. Schecter, O.D. |
FLA-DO | 2/17/2023 | Manuel F. Fernandez, M.D. |
LOS-DO | 2/15/2023 | Merrill K. Shum, M.D. |
LOS-DO | 2/24/2023 | Donald M Brandon MD |
NWE-DO | 2/3/2023 | Francine M. Foss |
SAN-DO | 2/13/2023 | Kent L. Wellish, M.D. |
SJN-DO | 2/17/2023 | Jorge L. Martinez Trabal, MD |
January 2023 |
||
District | Inspection Date | Firm Name |
ATL-DO | 1/27/2023 | Life Sensing Instruments, Inc. |
BLT-DO | 1/13/2023 | Weinert Fiber Optics Inc. |
BLT-DO | 1/27/2023 | Modavar Pharmaceuticals, LLC |
CDER | 1/13/2023 | Keshava Organics Private Ltd. |
CDER | 1/13/2023 | Granules India Limited |
CDER | 1/13/2023 | Centaur Pharmaceuticals Private Limited |
CDER | 1/13/2023 | Shandong Anxin Pharmaceutical Co., Ltd. (Laoling site) |
CDER | 1/16/2023 | Elysium Pharmaceuticals Limited |
CDER | 1/16/2023 | Mylan Laboratories Limited |
CDER | 1/20/2023 | Catalent Ontario Limited |
CDER | 1/20/2023 | Zenara Pharma Pvt Ltd |
CDER | 1/20/2023 | Intas Pharmaceuticals Ltd. |
CDER | 1/20/2023 | Indoco Remedies Limited (Plant I) |
CDER | 1/20/2023 | Anicare Pharmaceuticals Pvt Ltd. |
CDER | 1/20/2023 | Annora Pharma Private Limited |
CDER | 1/20/2023 | Cadila Pharmaceuticals Limited |
CDER | 1/24/2023 | Megafine Pharma (P) Limited |
CDER | 1/27/2023 | KDC/ONE Development Corporation, Inc. |
CDER | 1/27/2023 | Baxter Pharmaceuticals India Pvt Ltd |
CDER | 1/27/2023 | Rubicon Research Private Limited |
CDER | 1/27/2023 | GPT Pharmaceuticals Private Ltd |
CDER | 1/27/2023 | Apothecon Pharmaceuticals Private Limited |
CDER | 1/27/2023 | MEDGEL PRIVATE LIMITED |
CDER | 1/27/2023 | V-Ensure Pharma Technologies Pvt. Limited |
CDER | 1/27/2023 | Rubicon Research Private Limited |
CDER | 1/27/2023 | Naari Pharma Private Limited |
CDRH | 1/12/2023 | neuroConn GmbH |
CDRH | 1/12/2023 | Sandoz GmbH |
CDRH | 1/12/2023 | Meril Endo Surgery Pvt. Ltd. |
CDRH | 1/12/2023 | Philips Medical Systems Technologies Ltd |
CDRH | 1/12/2023 | Pfm Medical Cpp SA |
CDRH | 1/13/2023 | Fujikura Fiber Optics Vietnam Ltd |
CDRH | 1/18/2023 | BM Korea Co. Ltd. |
CDRH | 1/19/2023 | CeramTec GmbH, Medical Products Division |
CDRH | 1/19/2023 | Future Diagnostics Solutions B.V. |
CDRH | 1/19/2023 | Terumo BCT Ltd |
CDRH | 1/19/2023 | I.T.S. GmbH |
CDRH | 1/19/2023 | Huons Co., Ltd. - Jecheon Factory |
CDRH | 1/19/2023 | Advanced Medical Design Co., Ltd. |
CDRH | 1/23/2023 | Fujimori Kogyo Co., Ltd. |
CDRH | 1/26/2023 | Bio-Technology General (Israel), Ltd. |
CDRH | 1/26/2023 | Siemens AG/Siemens Healthcare GmbH |
CDRH | 1/26/2023 | PFM Medical Mepro GMBH |
CDRH | 1/26/2023 | Mt.Derm Gmbh |
CDRH | 1/27/2023 | FUJIFILM Healthcare Manufacturing Corporation Sano Office |
CHI-DO | 1/20/2023 | Luminex Corporation |
CHI-DO | 1/24/2023 | Avlon Industries, Inc |
CHI-DO | 1/27/2023 | Abbott Molecular, Inc. |
CHI-DO | 1/31/2023 | AbbVie Inc. |
CIN-DO | 1/10/2023 | Piramal Pharma Solutions Inc |
CIN-DO | 1/11/2023 | Catalent Pharma Solutions LLC |
CIN-DO | 1/24/2023 | Ferno-Washington Inc |
CIN-DO | 1/30/2023 | Med-Dyne, Inc. |
DAL-DO | 1/5/2023 | MPM Medical LLC |
DAL-DO | 1/9/2023 | Genesis Biosystems, Inc |
DAL-DO | 1/12/2023 | Amcor Rigid Packaging USA, LLC |
DAL-DO | 1/13/2023 | Luminex Corporation |
DAL-DO | 1/30/2023 | Bond Pharmacy dba Advanced Infusion Solutions |
DAL-DO | 1/31/2023 | Sharps Compliance, Inc. |
DEN-DO | 1/31/2023 | Tolmar, Inc. |
DET-DO | 1/20/2023 | LXR Biotech |
DET-DO | 1/20/2023 | CofixRX, LLC |
DET-DO | 1/24/2023 | Stryker Corporation |
FLA-DO | 1/5/2023 | Silq Technologies Corporation |
FLA-DO | 1/10/2023 | Allied Pharmacy Products. Inc. |
FLA-DO | 1/19/2023 | Ward Photonics, LLC |
FLA-DO | 1/19/2023 | Lummacups LLC |
FLA-DO | 1/20/2023 | The Pyure Company Inc |
FLA-DO | 1/20/2023 | Petnet Solutions Inc |
FLA-DO | 1/23/2023 | THEWEB2U.COM, LLC |
FLA-DO | 1/27/2023 | Avotec, Inc. |
KAN-DO | 1/10/2023 | The Peavey Corporation dba Lynn Peavey Co. |
KAN-DO | 1/19/2023 | TRIUMPH PHARMACEUTICALS INC |
LOS-DO | 1/13/2023 | Packaging On Demand, Inc. |
LOS-DO | 1/16/2023 | Ajinomoto Althea, Inc. |
LOS-DO | 1/18/2023 | Westridge Laboratories Inc |
LOS-DO | 1/24/2023 | Neodontics Inc |
LOS-DO | 1/24/2023 | Tanvex BioPharma USA, Inc |
LOS-DO | 1/25/2023 | SOCIETAL CDMO SAN DIEGO, LLC |
LOS-DO | 1/26/2023 | OrthoSource Inc |
LOS-DO | 1/31/2023 | VITANG TECHNOLOGY LLC |
MIN-DO | 1/13/2023 | Electromed, Inc. |
MIN-DO | 1/20/2023 | Nexus Pharmaceuticals Inc |
NOL-DO | 1/13/2023 | RWM Technologies LLC |
NOL-DO | 1/26/2023 | Matrix Machining Technologies, Inc. |
NWE-DO | 1/13/2023 | Miyoshi America, Inc |
NWE-DO | 1/19/2023 | UniSoft Medical Corporation |
NWE-DO | 1/25/2023 | Gelesis, Inc. |
NWJ-DO | 1/12/2023 | Jamol Laboratories, Inc. |
NWJ-DO | 1/13/2023 | Novel Laboratories, Inc. d.b.a Lupin Somerset |
NWJ-DO | 1/18/2023 | Micro Stamping Corp |
NWJ-DO | 1/20/2023 | SOFIE Co. dba SOFIE |
NYK-DO | 1/9/2023 | Vasomedical Inc |
NYK-DO | 1/20/2023 | Sleep Joy International LLC |
PHI-DO | 1/13/2023 | PEL Healthcare LLC |
SAN-DO | 1/19/2023 | Embolx, Inc. |
SAN-DO | 1/20/2023 | Forces of Nature, Inc. |
SAN-DO | 1/26/2023 | Avantec Vascular Corporation |
SEA-DO | 1/6/2023 | Siemens Medical Solutions USA, Inc. |
SJN-DO | 1/20/2023 | Galephar Pharmaceutical Research Inc. |
BLT-DO | 1/31/2023 | Sharleen St. Surin-Lord, M.D. |
CDRH | 1/20/2023 | Garen Koloyan, M.D., PhD. |
CIN-DO | 1/13/2023 | Steven D. Folkerth, M.D. |
DAL-DO | 1/13/2023 | Madeleine Duvic, M.D. |
DAL-DO | 1/26/2023 | Sloan W. Rush, M.D. |
DEN-DO | 1/13/2023 | Sri Sundaram, M.D. |
DET-DO | 1/27/2023 | Robert M. Pascuzzi, M.D. |
FLA-DO | 1/23/2023 | Luis Pena-Hernandez, M.D. |
FLA-DO | 1/27/2023 | Banji Awosika, M.D. |
FLA-DO | 1/30/2023 | Antonio E. Blanco, M.D. |
KAN-DO | 1/13/2023 | Kathleen Jones, M.D., Clinical Investigator |
NYK-DO | 1/10/2023 | Bret R. Rutherford, M.D. |