Date Listed |
Date of Letter |
Name of Company |
Issuing Department |
Topic |
11/05/2024 |
06/03/2024 |
Top Health Manufacturing, LLC |
Division of Human and Animal Food Operations West IV |
CGMP/Dietary Supplement/Adulterated |
11/05/2024 |
10/10/2024 |
Analytical Food Laboratories, Inc. |
Center for Drug Evaluation and Research (CDER) |
CGMP/Finished Pharmaceuticals/Adulterated |
11/05/2024 |
10/22/2024 |
Ardent Animal Health, LLC |
Center for Veterinary Medicine |
Unapproved New Animal Drug Products |
11/05/2024 |
10/29/2024 |
Armstrong County Memorial Hospital |
Center for Drug Evaluation and Research (CDER) |
Institutional Review Board (IRB) |
11/05/2024 |
10/24/2024 |
Fancy Drops Beauty LLC |
Center for Drug Evaluation and Research (CDER) |
Unapproved New Drugs/Misbranded |
11/06/2024 |
11/04/2024 |
Global Source Distribution, LLC |
Center for Tobacco Products |
Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded |
11/08/2024 |
10/18/2024 |
Rolence Ent. Inc. |
Center for Devices and Radiological Health |
CGMP/QSR/Medical Devices/Adulterated |
11/08/2024 |
09/10/2024 |
Micro-X Ltd. |
Center for Devices and Radiological Health |
CGMP/QSR/Medical Devices/Adulterated |
11/08/2024 |
11/06/2024 |
Daddy’s Vapor Distro Inc. |
Center for Tobacco Products |
Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded |
11/12/2024 |
11/07/2024 |
Zhejiang Qimei Cosmetics Co., Ltd. |
Center for Drug Evaluation and Research (CDER) |
CGMP/Finished Pharmaceuticals/Adulterated |
11/12/2024 |
11/01/2024 |
Owens & Minor, Inc. dba American Contract Systems, Inc. |
Center for Devices and Radiological Health |
CGMP/QSR/Medical Devices/Adulterated |
11/12/2024 |
11/05/2024 |
Multaler et Cie SAS |
Center for Drug Evaluation and Research (CDER) |
CGMP/Finished Pharmaceuticals/Adulterated/Unapproved New Drug |
11/12/2024 |
05/31/2024 |
Rongcheng Jiayuan Food Co., Ltd |
Center for Food Safety and Applied Nutrition (CFSAN) |
Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions |
11/19/2024 |
11/06/2024 |
Unexo Lifesciences, Private Limited |
Center for Drug Evaluation and Research (CDER) |
CGMP/Finished Pharmaceuticals/Adulterated |
11/19/2024 |
11/05/2024 |
Colgate-Palmolive/Tom’s of Maine, Inc. |
Center for Drug Evaluation and Research (CDER) |
CGMP/Finished Pharmaceuticals/Adulterated |
11/19/2024 |
11/07/2024 |
Originitalia SRL |
Center for Drug Evaluation and Research (CDER) |
CGMP/Finished Pharmaceuticals/Adulterated |
11/19/2024 |
10/30/2024 |
Tianjin Darentang Jingwanhong Pharmaceutical Co., Ltd. |
Center for Drug Evaluation and Research (CDER) |
CGMP/Finished Pharmaceuticals/Adulterated |
11/19/2024 |
11/01/2024 |
Frontier Biologics, LLC |
Center for Biologics Evaluation and Research |
Unapproved New Drug/Unlicensed Biological Product Violations |
11/19/2024 |
11/06/2024 |
Richard W. Foltin, Ph.D. |
Center for Drug Evaluation and Research (CDER) |
Clinical Investigator (Sponsor) |
11/19/2024 |
05/13/2024 |
Golden Shrimp Seafood Joint Stock Company |
Center for Food Safety and Applied Nutrition |
Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions |
11/26/2024 |
10/11/2024 |
Adept Medical Ltd. |
Center for Devices and Radiological Health |
CGMP/QSR/Medical Devices/Adulterated/Misbranded |
11/26/2024 |
11/18/2024 |
Hangzhou Huiji Biotechnology Co., Ltd. |
Center for Drug Evaluation and Research (CDER) |
CGMP/Finished Pharmaceuticals/Adulterated |
11/26/2024 |
06/24/2024 |
Advance Nature Sdn Bhd |
Center for Food Safety and Applied Nutrition |
Low Acid Canned Food Regulation/Adulterated |
11/26/2024 |
08/13/2024 |
Agustson A/S |
Center for Food Safety and Applied Nutrition |
Acidified Foods/Emergency Permit Control/Adulterated |
11/26/2024 |
11/20/2024 |
Eurosirel S.P.A |
Center for Drug Evaluation and Research (CDER) |
CGMP/Finished Pharmaceuticals/Adulterated |
11/26/2024 |
03/06/2024 |
Procesadora Vikingo C.A. |
Center for Food Safety and Applied Nutrition |
Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions |
11/26/2024 |
11/18/2024 |
Stew Leonard’s Holdings LLC |
Human Foods Program |
Food Labeling/Misbranded |
11/26/2024 |
10/17/2024 |
Maruhachi Muramatsu Inc., Danchi Factory |
Human Foods Program |
Seafood HACCP/CGMP for Foods/Adulterated |
11/26/2024 |
11/15/2024 |
Centura Pharmaceuticals Inc |
Center for Drug Evaluation and Research (CDER) |
Finished Pharmaceuticals/Unapproved New Drug/Misbranded |
11/26/2024 |
10/17/2024 |
Grupo VPAS C.A. |
Human Foods Program |
Seafood HACCP/CGMP for Foods/Adulterated |
11/26/2024 |
10/25/2024 |
Rise N’ Shine Farm, Inc. |
Human Foods Program |
PHS Act/Shell Egg Regulation/Adulterated |
11/26/2024 |
08/30/2024 |
Kyokuyo Global Seafoods Co. LTD. |
Center for Food Safety and Applied Nutrition |
Seafood HACCP/CGMP for Foods/Adulterated |
11/26/2024 |
08/28/2024 |
Barohup Inc. |
Division of West Coast Imports |
Foreign Supplier Verification Program (FSVP) |
11/26/2024 |
11/21/2024 |
Catwalk Cosmetic Laboratories Pty Ltd. |
Center for Drug Evaluation and Research (CDER) |
CGMP/Finished Pharmaceuticals/Adulterated |
11/26/2024 |
10/29/2024 |
Tova Industries, LLC |
Human Foods Program |
Acidified Foods/Emergency Permit Control/Adulterated |