FDA posted 37 warning letters in February 2026. By issuing office: Center for Drug Evaluation and Research (CDER) 12; Center for Tobacco Products 6; Center for Devices and Radiological Health 5; Human Foods Program 5; Center for Biologics Evaluation and Research (CBER) 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 |
|---|---|---|---|---|---|
| 2026-02-24 | 2026-02-12 | AQ USA Inc., d.b.a Ross Healthcare Inc. | Center for Drug Evaluation and Research (CDER) | CGMP/Finished Pharmaceuticals/Adulterated | Read the letter |
| 2026-02-24 | 2026-01-28 | Beta Bionics, Inc. | Center for Devices and Radiological Health | CGMP/QSR/Medical Devices/Adulterated | Read the letter |
| 2026-02-24 | 2026-02-11 | Dynamic Stem Cell Therapy | Center for Biologics Evaluation and Research | Unapproved New Drugs/Unlicensed Biological Product Violations | Read the letter |
| 2026-02-24 | 2026-01-16 | East CK Trading Inc. | Division of Northeast Imports | Foreign Supplier Verification Program (FSVP) | Read the letter |
| 2026-02-24 | 2026-02-06 | ExThera Medical Corporation | Center for Devices and Radiological Health | Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) | Read the letter |
| 2026-02-24 | 2025-12-12 | MedisourceRx | Center for Drug Evaluation and Research (CDER) | Compounding Pharmacy/Adulterated Drug Products | Read the letter |
| 2026-02-24 | 2026-02-12 | A. Nelson & Co. Ltd. | Center for Drug Evaluation and Research (CDER) | CGMP/Finished Pharmaceuticals/Adulterated | Read the letter |
| 2026-02-24 | 2026-02-13 | The Sabagh Group Inc/lighterusa.com | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | Read the letter |
| 2026-02-24 | 2026-02-13 | swedishproducts.online | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | Read the letter |
| 2026-02-24 | 2026-01-22 | Tombak LLC | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | Read the letter |
| 2026-02-17 | 2026-02-02 | Bertrand P. Cole, D.O. | Center for Drug Evaluation and Research (CDER) | Clinical Investigator | Read the letter |
| 2026-02-17 | 2026-02-06 | Cosmetic Manufacturers Pty Ltd. | Center for Drug Evaluation and Research (CDER) | CGMP/Finished Pharmaceuticals/Adulterated | Read the letter |
| 2026-02-17 | 2026-01-08 | Elanco Animal Health USA | Center for Veterinary Medicine | False & Misleading Claims/Misbranded | Read the letter |
| 2026-02-17 | 2026-01-29 | Fidelity Melon, Inc | Office of Inspections and Investigations | Foreign Supplier Verification Program (FSVP) | Read the letter |
| 2026-02-10 | 2026-02-05 | Beach Weekend Management LLC dba Nic and Jet Fuel | Center for Drug Evaluation and Research (CDER) | Unapproved New Drugs | Read the letter |
| 2026-02-10 | 2026-02-05 | Bio-Medical Pharmaceutical Manufacturing Corporation | Center for Drug Evaluation and Research (CDER) | CGMP/Finished Pharmaceuticals/Adulterated | Read the letter |
| 2026-02-10 | 2025-12-11 | BNC Distribution Inc. | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | Read the letter |
| 2026-02-10 | 2026-01-16 | Boothwyn Pharmacy, LLC | Center for Drug Evaluation and Research (CDER) | Compounding Pharmacy/Adulterated Drug Products | Read the letter |
| 2026-02-10 | 2026-01-29 | Central Coast Multispecialty Medical Group, Inc. | Center for Biologics Evaluation and Research (CBER) | Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps) | Read the letter |
| 2026-02-10 | 2026-01-27 | Conceive Fertility Center | Center for Biologics Evaluation and Research (CBER) | Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps) | Read the letter |
| 2026-02-10 | 2026-01-23 | Louisville Reproductive Center | Center for Biologics Evaluation and Research | Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps) | Read the letter |
| 2026-02-10 | 2026-02-02 | Mark S. Dacey, M.D. | Center for Drug Evaluation and Research (CDER) | Clinical Investigator | Read the letter |
| 2026-02-10 | 2025-12-10 | Maui Seafood LLC | Human Foods Program | Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions | Read the letter |
| 2026-02-10 | 2026-01-30 | niqpouches.com | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | Read the letter |
| 2026-02-10 | 2026-02-10 | ProDx Health | Center for Biologics Evaluation and Research (CBER) | Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) | Read the letter |
| 2026-02-10 | 2026-01-21 | Signature Formulations, LLC | Center for Drug Evaluation and Research (CDER) | CGMP/Finished Pharmaceuticals/Adulterated | Read the letter |
| 2026-02-03 | 2026-01-23 | Abbott Diabetes Care, Inc. | Center for Devices and Radiological Health | CGMP/QSR/Medical Devices/Adulterated | Read the letter |
| 2026-02-03 | 2025-08-21 | Carolina Seafood Inc. | Human Foods Program | Seafood HACCP/CGMP for Foods/Adulterated | Read the letter |
| 2026-02-03 | 2026-01-09 | CC Pollen Company | Human Foods Program | CGMP/Dietary Supplement/Adulterated/Misbranded | Read the letter |
| 2026-02-03 | 2026-01-09 | Christopher Dale Butler | Human Foods Program | Acidified Foods/Emergency Permit Control/Adulterated | Read the letter |
| 2026-02-03 | 2026-01-30 | Cohance Lifesciences Limited | Center for Drug Evaluation and Research (CDER) | CGMP/Finished Pharmaceuticals/Adulterated | Read the letter |
| 2026-02-03 | 2025-09-10 | Eniva USA, Inc. | Human Foods Program | CGMP/Dietary Supplement/Adulterated/Misbranded | Read the letter |
| 2026-02-03 | 2026-01-27 | Flextronics America LLC | Center for Devices and Radiological Health | CGMP/QSR/Medical Devices/Adulterated | Read the letter |
| 2026-02-03 | 2026-01-30 | gotpouches.com | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | Read the letter |
| 2026-02-03 | 2026-01-15 | The Great Smart African Food LLC | Division of Northern Border Imports | Foreign Supplier Verification Program (FSVP) | Read the letter |
| 2026-02-03 | 2026-01-27 | HTO Nevada, Inc. dba Kirkman | Center for Drug Evaluation and Research (CDER) | CGMP/Finished Pharmaceuticals/Adulterated | Read the letter |
| 2026-02-03 | 2026-01-08 | Unomedical Device S.A. de C.V. | Center for Devices and Radiological Health | CGMP/QSR/Medical Devices/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
https://mentionfox.com/fda/warning-letters/2026-02