Recently Requested 483s
For a list of BIMO 483s FDAnews has requested, click here.
January 2024 |
||
District | Inspection Date | Firm Name |
CDER | 1/5/2024 | Jiangxi Starry Pharmaceutical Co., Ltd. |
NYK-DO | 1/5/2024 | Nalge Nunc International Corporation |
BLT-DO | 1/9/2024 | Cardinal Health 414 LLC |
MIN-DO | 1/10/2024 | JSM SOLUTIONS LLC |
NOL-DO | 1/10/2024 | Vulcan Custom Dental |
CDRH | 1/11/2024 | A & D Electronics (Shenzhen) Co., Ltd. |
CDRH | 1/11/2024 | Maco Productions S.A.S. |
CDRH | 1/11/2024 | NOTE TORSBY AB |
DEN-DO | 1/11/2024 | Dynasthetics LLC |
DET-DO | 1/11/2024 | Dipharma Inc. |
KAN-DO | 1/11/2024 | Reynolds Engineering & Equipment |
NYK-DO | 1/11/2024 | Radienz Living LLC |
NYK-DO | 1/11/2024 | Chartwell Pharmaceuticals Carmel LLC |
CDER | 1/12/2024 | Changzhou Pharmaceutical Factory |
CDER | 1/12/2024 | Amoli Organics (A Division of Umedica Laboratories Pvt. Ltd.) |
CDER | 1/12/2024 | Yuhan Chemical Inc. |
CDER | 1/12/2024 | Henan Huashang Pharmaceutical Co., Ltd. |
CDER | 1/12/2024 | SUMAR BIOTECH LLP |
FLA-DO | 1/12/2024 | Richline Group |
LOS-DO | 1/12/2024 | National Advanced Endoscopy Devices Inc |
NOL-DO | 1/12/2024 | U.S. Zinc Corporation |
NOL-DO | 1/12/2024 | ARCH Medical Solutions - Olive Branch |
NYK-DO | 1/12/2024 | Pharmalogic New York City, LLC |
PHI-DO | 1/12/2024 | First Time US Generics LLC |
SAN-DO | 1/12/2024 | Paragon Swiss |
CDER | 1/16/2024 | Jiangsu Hengrui Pharmaceuticals Co., Ltd. (Huanghe Road Site) |
CDER | 1/16/2024 | Lexenpharm (Suzhou) Limited |
MIN-DO | 1/16/2024 | Medspira, Llc |
CDER | 1/17/2024 | Omega Laboratories Ltd. |
CIN-DO | 1/17/2024 | POET Biorefining - Leipsic, LLC |
NWE-DO | 1/17/2024 | Global Blood Resources, LLC |
PHI-DO | 1/17/2024 | Oakworks Inc |
CDRH | 1/18/2024 | LED SpA |
CDRH | 1/18/2024 | Systagenix Wound Management Manufacturing, Ltd |
CDRH | 1/18/2024 | Centro de Construccion de Cardioestimuladores del Uruguay SA |
CDRH | 1/18/2024 | Macromedics BV |
CDRH | 1/18/2024 | SPINOLOGICS, INC. Also DBA Spino Modulation Inc And Numalogics Inc |
CDRH | 1/18/2024 | JOOWON INNOVATION CO, LTD |
CDRH | 1/18/2024 | Senzime AB |
DAL-DO | 1/18/2024 | AutoMedx, LLC |
FLA-DO | 1/18/2024 | Little Moon Essentials LLC |
NWJ-DO | 1/18/2024 | Trutek Corp |
NYK-DO | 1/18/2024 | Promade POC Center for Complex Orthopedic Solutions at HHS |
PHI-DO | 1/18/2024 | Henkel US Operations Corporation |
SEA-DO | 1/18/2024 | Fluke Biomedical LLC |
CDER | 1/19/2024 | Chifeng Pharmaceutical Company, Ltd. |
CDER | 1/19/2024 | Fukuzyu Pharmaceutical Co., Ltd. |
CDER | 1/19/2024 | Mitsubishi Tanabe Pharma Factory Ltd. |
CDER | 1/19/2024 | Nanjing Xingyin Pharmaceutical Group Co. Ltd. |
CDER | 1/19/2024 | Alvotech HF |
CDER | 1/19/2024 | Brassica Pharma Private Ltd |
DAL-DO | 1/19/2024 | Sharps Compliance, Inc. |
DET-DO | 1/19/2024 | Delphinus Medical Technologies, Inc. |
MIN-DO | 1/19/2024 | Kleen Test Products Corporation |
PHI-DO | 1/19/2024 | Ionetix Corporation |
CDER | 1/20/2024 | BrightGene Fine Chemical Co., Ltd (Tongyuan Road) |
BLT-DO | 1/22/2024 | AG Essence, Inc. |
CHI-DO | 1/22/2024 | MEDLINE INDUSTRIES, LP - Northfield |
FLA-DO | 1/22/2024 | Sofie Co., dba Sofie |
LOS-DO | 1/22/2024 | MEDIPINES CORPORATION |
PHI-DO | 1/22/2024 | Nasorcap Medical, Inc. |
SEA-DO | 1/22/2024 | Omega Tech Labs, LLC |
CDER | 1/24/2024 | Intas Pharmaceuticals Ltd. |
CDRH | 1/24/2024 | Nihon Kohden Corporation - Tokorozawa Technical Center |
CDRH | 1/24/2024 | GMV SRL |
NWE-DO | 1/24/2024 | Med Pen Concepts, LLC |
CDER | 1/25/2024 | Nanjing White Whale Pharmaceutical Co., Ltd. |
CDER | 1/25/2024 | BGP Healthcare Private Limited |
CDER | 1/25/2024 | Laboratoires KABS Inc. |
CDER | 1/25/2024 | BrightGene Pharmaceutical Co., Ltd |
CDRH | 1/25/2024 | Goodman Company, Ltd. |
CDRH | 1/25/2024 | Schiller, Ag |
CDRH | 1/25/2024 | Jung Rim Medical Industrial Co., Ltd |
CDRH | 1/25/2024 | Goodman Co., Ltd |
CDRH | 1/25/2024 | Goodman Co., Ltd. Goodman Research Center |
CDRH | 1/25/2024 | Atl Technology Cr Limitada |
CDRH | 1/25/2024 | EMPATICA SRL |
CDRH | 1/25/2024 | Laboratoires KABS Inc. |
FLA-DO | 1/25/2024 | Atofil LLC |
NWE-DO | 1/25/2024 | scPharmaceuticals Inc. |
NWE-DO | 1/25/2024 | Corindus, Inc. |
ATL-DO | 1/26/2024 | Novartis Gene Therapies Inc. |
BLT-DO | 1/26/2024 | Randmark Dental Products LLC |
CBER | 1/26/2024 | GlaxoSmithKline Vaccines Srl |
CDER | 1/26/2024 | Delpharm Boucherville Canada, Inc. |
CDER | 1/26/2024 | MicroBiopharm Japan Co., Yatsushiro Plant |
CDER | 1/26/2024 | Hainan Shuangcheng Pharmaceuticals Co Ltd |
CDER | 1/26/2024 | Taiho Pharmaceutical Co., Ltd. |
CDER | 1/26/2024 | FANCYSTAGE, UNIPESSOAL, LDA. |
CDRH | 1/26/2024 | Flextronics International GmbH |
DEN-DO | 1/26/2024 | Optikem International, Inc. |
DEN-DO | 1/26/2024 | Specialty Process Labs LLC |
LOS-DO | 1/26/2024 | McGuff Pharmaceuticals, Inc. |
NYK-DO | 1/26/2024 | Long Island Technology Group LLC |
CHI-DO | 1/29/2024 | TJA Health LLC |
CIN-DO | 1/29/2024 | ISP Chemicals LLC |
LOS-DO | 1/29/2024 | Genuine Virgin Aloe Corp dba Triderma |
LOS-DO | 1/29/2024 | PR Personal Care Laboratories |
SEA-DO | 1/29/2024 | Episciences Inc |
LOS-DO | 1/30/2024 | WHPM Inc. |
DAL-DO | 1/31/2024 | 3D Imaging Drug Design and Development |
DAL-DO | 1/31/2024 | Baylab USA, LLC |
DAL-DO | 1/31/2024 | Bound Tree Medical, LLC |
FLA-DO | 1/31/2024 | Spinalight, Inc. |
SEA-DO | 1/31/2024 | Siemens Medical Solutions USA, Inc. |
LOS-DO | 1/3/2024 | David Liao, M.D. |
MIN-DO | 1/8/2024 | Lynn Malec, M.D. |
FLA-DO | 1/10/2024 | Guenther Koehne, M.D. |
DAL-DO | 1/11/2024 | Philip NMI Raskin |
LOS-DO | 1/11/2024 | Jay Patel, M.D. |
PHI-DO | 1/17/2024 | Jason J Luke, M.D. |
ATL-DO | 1/18/2024 | Lisa M. Cohen, D.O. |
LOS-DO | 1/23/2024 | Krishnansu S. Tewari, M.D. |
NWE-DO | 1/25/2024 | Herman Ayvazyan, M.D. |
ATL-DO | 1/26/2024 | David M. Weitzman, M.D. |
CDER | 1/26/2024 | Myung-Ju Ahn, M.D., Ph.D. |
CDER | 1/26/2024 | Prof. Binghe Xu |
KAN-DO | 1/26/2024 | Brian Van Tine |