Letters25
Issuing offices6
FDA posted 25 warning letters in January 2026. By issuing office: Center for Drug Evaluation and Research (CDER) 10; Office of Inspections and Investigations 4; Center for Devices and Radiological Health 3; Center for Biologics Evaluation and Research (CBER) 3; Human Foods Program 3; and others. Each row gives the agency's own subject line and links to the letter.
| Posted | Letter date | Company | Issuing office | Subject (FDA's words) | Letter |
|---|---|---|---|---|---|
| 2026-01-27 | 2025-09-08 | American Food Distributor Inc. | Office of Inspections and Investigations | Foreign Supplier Verification Program (FSVP) | Read the letter |
| 2026-01-27 | 2025-11-25 | Asli Foods, Inc | Office of Inspections and Investigations | Foreign Supplier Verification Program (FSVP) | Read the letter |
| 2026-01-27 | 2026-01-13 | Center For Immunology Science, LLC | Center for Drug Evaluation and Research (CDER) | Sponsor/Investigator | Read the letter |
| 2026-01-27 | 2026-01-14 | Fulijaya Manufacturing SDN. BHD. | Center for Drug Evaluation and Research (CDER) | CGMP/Finished Pharmaceuticals/Adulterated | Read the letter |
| 2026-01-27 | 2025-12-17 | MAST Biosurgery USA, Inc. | Center for Devices and Radiological Health | CGMP/QSR/Medical Devices/Adulterated | Read the letter |
| 2026-01-27 | 2025-12-22 | Meridian Bioscience, Inc | Center for Devices and Radiological Health | CGMP/QSR/Medical Devices/Adulterated | Read the letter |
| 2026-01-27 | 2025-10-23 | MG GROUP USA | Office of Inspections and Investigations | Foreign Supplier Verification Program (FSVP) | Read the letter |
| 2026-01-27 | 2026-01-16 | Zip Foods Importers, Inc | Office of Inspections and Investigations | Foreign Supplier Verification Program (FSVP) | Read the letter |
| 2026-01-20 | 2026-01-08 | Genetrace | Center for Biologics Evaluation and Research (CBER) | Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) | Read the letter |
| 2026-01-20 | 2026-01-08 | Genovate | Center for Biologics Evaluation and Research (CBER) | Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) | Read the letter |
| 2026-01-20 | 2026-01-09 | Germaphobix | Center for Biologics Evaluation and Research (CBER) | Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) | Read the letter |
| 2026-01-20 | 2025-12-15 | Integrity Partners Group | Center for Drug Evaluation and Research (CDER) | CGMP/Finished Pharmaceuticals/Adulterated | Read the letter |
| 2026-01-20 | 2026-01-08 | Prodrome Sciences USA, LLC | Center for Drug Evaluation and Research (CDER) | Sponsor/Unapproved Misbranded | Read the letter |
| 2026-01-13 | 2025-12-09 | ASP Global, LLC. dba Anatomy Supply Partners, LLC. | Center for Devices and Radiological Health | CGMP/QSR/Medical Devices/Adulterated | Read the letter |
| 2026-01-13 | 2025-12-23 | Chemspec Chemicals Private Limited | Center for Drug Evaluation and Research (CDER) | CGMP/Active Pharmaceutical Ingredient (API)/Adulterated | Read the letter |
| 2026-01-13 | 2025-12-23 | LXR Biotech, LLC | Human Foods Program | CGMP/Dietary Supplement/Adulterated/Misbranded | Read the letter |
| 2026-01-13 | 2025-07-25 | Middle East/Soli's Baking Company, Inc. dba Middle East Baking Co. | Human Foods Program | CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated | Read the letter |
| 2026-01-13 | 2025-11-13 | Pan-African Food Distributors Inc./East Africa Boutique LLC | Human Foods Program | CGMP/Dietary Supplement/Adulterated/Misbranded | Read the letter |
| 2026-01-13 | 2025-12-22 | Purushothaman Damodara Kumaran, M.D. / Senthil Specialty Hospital | Center for Drug Evaluation and Research (CDER) | In Vivo Bioavailability-Bioequivalence Studies – Clinical | Read the letter |
| 2026-01-13 | 2026-01-07 | Winder Laboratories, LLC | Center for Drug Evaluation and Research (CDER) | CGMP/Finished Pharmaceuticals/Adulterated | Read the letter |
| 2026-01-06 | 2025-12-30 | Absolutely Natural | Center for Drug Evaluation and Research (CDER) | CGMP/Finished Pharmaceuticals/Adulterated | Read the letter |
| 2026-01-06 | 2025-12-30 | bongsociety.com | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | Read the letter |
| 2026-01-06 | 2025-12-19 | LiquidCapsule Manufacturing, LLC | Center for Drug Evaluation and Research (CDER) | CGMP/Finished Pharmaceuticals/Adulterated | Read the letter |
| 2026-01-06 | 2025-12-30 | snuzyn.com | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | Read the letter |
| 2026-01-06 | 2025-12-23 | Tower Laboratories Ltd. | Center for Drug Evaluation and Research (CDER) | CGMP/Finished Pharmaceuticals/Adulterated | Read the letter |
Where this comes from
FDA publishes the warning letters it sends. Each row is one letter as the agency posted it: the company it is addressed to, the date on the letter, the date FDA posted it, the office that issued it and the agency's own subject line, with a link to the full letter. A warning letter states the agency's findings at the time it was written; it is not a final determination, and the company may have responded or since corrected the matter. Read the letter, and any response or close-out letter FDA has posted, before relying on it.
All monthsFDA device clearances
Cite this page
Permanent URL:
https://mentionfox.com/fda/warning-letters/2026-01Last updated 2026-10-18
FDA warning letters posted in January 2026: 25 letters. MentionFox, 2026-10-18. https://mentionfox.com/fda/warning-letters/2026-01