FDA posted 54 warning letters in September 2026. By issuing office: Center for Drug Evaluation and Research (CDER) 22; Office of Inspections and Investigations 12; Human Foods Program 8; Center for Veterinary Medicine 6; Center for Devices and Radiological Health 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 |
|---|---|---|---|---|---|
| 2026-09-29 | 2026-08-04 | American Pharma Mfg. Inc. | Human Foods Program | CGMP/Dietary Supplement/Adulterated/Misbranded | Read the letter |
| 2026-09-29 | 2026-08-27 | Andrighetto Produce Inc dba Shasta Produce Inc | Office of Inspections and Investigations | Foreign Supplier Verification Program (FSVP) | Read the letter |
| 2026-09-29 | 2026-09-21 | Babikian Healthcare Products CJSC | Center for Drug Evaluation and Research (CDER) | CGMP/Finished Pharmaceuticals/Adulterated | Read the letter |
| 2026-09-29 | 2026-09-17 | Bentley Laboratories LLC | Center for Drug Evaluation and Research (CDER) | CGMP/Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated | Read the letter |
| 2026-09-29 | 2026-08-13 | Bo Wah Enterprises Inc | Office of Inspections and Investigations | Foreign Supplier Verification Program (FSVP) | Read the letter |
| 2026-09-29 | 2026-09-14 | Celmade | Center for Drug Evaluation and Research (CDER) | Review of Website/Unapproved New Drug/Misbranded | Read the letter |
| 2026-09-29 | 2026-09-18 | Curia New York, Inc. | Center for Drug Evaluation and Research (CDER) | CGMP/Active Pharmaceutical Ingredient (API)/Adulterated | Read the letter |
| 2026-09-29 | 2026-07-20 | Fil-Bay Import, Inc. | Office of Inspections and Investigations | Foreign Supplier Verification Program (FSVP) | Read the letter |
| 2026-09-29 | 2026-09-22 | Fresenius Kabi USA LLC | Center for Drug Evaluation and Research (CDER) | CGMP/Finished Pharmaceuticals/Adulterated | Read the letter |
| 2026-09-29 | 2026-07-02 | Good Stuff Cacao | Human Foods Program | New Drug/Misbranded | Read the letter |
| 2026-09-29 | 2025-11-06 | Kellin Chemicals Co., Ltd. - Zhangjiagang | Center for Drug Evaluation and Research (CDER) | CGMP/Active Pharmaceutical Ingredient (API)/Adulterated | Read the letter |
| 2026-09-29 | 2026-03-06 | Middlefield Original Cheese Cooperative | Human Foods Program | CGMP/Manufacturing, Packing or Holding Human Food/Adulterated/Insanitary Conditions | Read the letter |
| 2026-09-29 | 2026-09-23 | Neogen Corporation | Center for Veterinary Medicine | CGMP/Drugs for Animals/Prepared, Packed or Held Under Insanitary Conditions/Adulterated | Read the letter |
| 2026-09-29 | 2026-09-23 | Sciarra Aeromed, Inc. | Center for Veterinary Medicine | CGMP/Drugs for Animals/Prepared, Packed or Held Under Insanitary Conditions/Adulterated | Read the letter |
| 2026-09-29 | 2026-09-25 | sfshoply.com | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | Read the letter |
| 2026-09-29 | 2026-08-20 | South Asian Food Inc. | Human Foods Program | Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions | Read the letter |
| 2026-09-29 | 2026-08-04 | Stokes Healthcare Inc. dba Epicur Pharma | Center for Veterinary Medicine | Animal Drugs/Adulterated | Read the letter |
| 2026-09-29 | 2026-02-02 | Stream2Sea, LLC | Center for Drug Evaluation and Research (CDER) | CGMP/Finished Pharmaceuticals/Adulterated | Read the letter |
| 2026-09-29 | 2026-02-09 | VeganicSKN Limited | Center for Drug Evaluation and Research (CDER) | CGMP/Finished Pharmaceuticals/Adulterated | Read the letter |
| 2026-09-29 | 2026-04-20 | Wellmill, LLC dba Vitamix Laboratories | Human Foods Program | Juice HACCP/CGMP for Foods/Adulterated/Insanitary Conditions | Read the letter |
| 2026-09-29 | 2026-07-24 | Wilson Livestock | Center for Veterinary Medicine | New Animal Drug/Adulterated | Read the letter |
| 2026-09-22 | 2026-04-10 | Accra Supermarket | Office of Inspections and Investigations | Foreign Supplier Verification Program (FSVP) | Read the letter |
| 2026-09-22 | 2026-08-25 | Advance-Esthetic LLC | Center for Devices and Radiological Health | Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated Device | Read the letter |
| 2026-09-22 | 2026-08-18 | Binh Minh Tofu | Human Foods Program | CGMP/Hazard Analysis/Risk-Based Preventive Controls for Food/Adulterated | Read the letter |
| 2026-09-22 | 2026-08-24 | BioDrive, Inc. | Human Foods Program | Dietary Supplement/Adulterated | Read the letter |
| 2026-09-22 | 2026-09-18 | Empower Clinic Services, LLC dba Empower Pharmacy | Center for Drug Evaluation and Research (CDER) | CGMP/Finished Pharmaceuticals/Adulterated/Unapproved New Drug | Read the letter |
| 2026-09-22 | 2026-09-08 | kdc/one Chatsworth, Inc. | Center for Drug Evaluation and Research (CDER) | CGMP/Finished Pharmaceuticals/Adulterated | Read the letter |
| 2026-09-22 | 2026-07-15 | LDNN Produce Inc. | Office of Inspections and Investigations | Foreign Supplier Verification Program (FSVP) | Read the letter |
| 2026-09-22 | 2026-08-21 | Lion Street Medical, d/b/a Pensar Medical LLC | Center for Devices and Radiological Health | Medical Device Reporting/Misbranded | Read the letter |
| 2026-09-22 | 2026-09-11 | NexCell Scientific Inc | Center for Biologics Evaluation and Research | Unapproved New Drugs/Unlicensed Biological Product Violations | Read the letter |
| 2026-09-22 | 2026-07-22 | Ohom Padmaavathii, LLC | Office of Inspections and Investigations | Foreign Supplier Verification Program (FSVP) | Read the letter |
| 2026-09-22 | 2026-08-05 | Quantum Star LLC | Office of Inspections and Investigations | Foreign Supplier Verification Program (FSVP) | Read the letter |
| 2026-09-22 | 2026-08-21 | Raaw Energy LLC | Center for Veterinary Medicine | Adulterated Animal Foods/Misbranded | Read the letter |
| 2026-09-22 | 2026-06-26 | Shouly Import Corp. | Office of Inspections and Investigations | Foreign Supplier Verification Program (FSVP) | Read the letter |
| 2026-09-22 | 2026-07-07 | Specialty Health Products CO, LLC | Center for Devices and Radiological Health | CGMP/QSR/Medical Devices/Adulterated | Read the letter |
| 2026-09-22 | 2026-08-27 | Union Trade Inc. | Office of Inspections and Investigations | Foreign Supplier Verification Program (FSVP) | Read the letter |
| 2026-09-22 | 2026-08-05 | Viva Raw LLC | Center for Veterinary Medicine | Adulterated Animal Foods/Misbranded | Read the letter |
| 2026-09-22 | 2026-06-01 | Yam Man Foods LLC | Office of Inspections and Investigations | Foreign Supplier Verification Program (FSVP) | Read the letter |
| 2026-09-15 | 2026-09-04 | Bausch & Lomb Inc. | Center for Drug Evaluation and Research (CDER) | CGMP/Finished Pharmaceuticals/Adulterated | Read the letter |
| 2026-09-15 | 2026-07-31 | H2 BEV, LLC and H2 RENU, INC | Human Foods Program | Acidified Foods/Emergency Permit Control/Adulterated/Misbranded | Read the letter |
| 2026-09-08 | 2026-09-01 | Happy Farm Botanicals, Inc. | Center for Drug Evaluation and Research (CDER) | CGMP/Finished Pharmaceuticals/Adulterated | Read the letter |
| 2026-09-08 | 2026-08-27 | Stephen J. Fallon, Ph.D. | Center for Biologics Evaluation and Research (CBER) | Bioresearch Monitoring Program/Institutional Review Board (IRB) | Read the letter |
| 2026-09-01 | 2026-08-18 | B&P Mutual Corp | Office of Inspections and Investigations | Foreign Supplier Verification Program (FSVP) | Read the letter |
| 2026-09-01 | 2026-08-25 | Fresenius Medical Care AG & Co. KGaA | Center for Drug Evaluation and Research (CDER) | CGMP/Finished Pharmaceuticals/Adulterated | Read the letter |
| 2026-09-01 | 2026-08-27 | Jabil Inc. | Center for Drug Evaluation and Research (CDER) | CGMP/Finished Pharmaceuticals/Adulterated | Read the letter |
| 2026-09-01 | 2026-08-04 | Mesquite Gourmet LLC | Office of Inspections and Investigations | Foreign Supplier Verification Program (FSVP) | Read the letter |
| 2026-09-01 | 2026-08-24 | NuScience Peptides LLC | Center for Drug Evaluation and Research (CDER) | Unapproved New Drugs/Misbranded | Read the letter |
| 2026-09-01 | 2026-08-24 | Peak Performance Peptides | Center for Drug Evaluation and Research (CDER) | Unapproved New Drugs/Misbranded | Read the letter |
| 2026-09-01 | 2026-08-24 | Peptide Partners LLC | Center for Drug Evaluation and Research (CDER) | Unapproved New Drugs/Misbranded | Read the letter |
| 2026-09-01 | 2026-08-18 | PReye, LLC | Center for Drug Evaluation and Research (CDER) | CGMP/Finished Pharmaceuticals/Adulterated/Unapproved New Drug | Read the letter |
| 2026-09-01 | 2026-08-18 | Reliance Life Sciences Private Limited | Center for Drug Evaluation and Research (CDER) | CGMP/Finished Pharmaceuticals/Adulterated | Read the letter |
| 2026-09-01 | 2026-08-24 | Royal Peptides LLC | Center for Drug Evaluation and Research (CDER) | Unapproved New Drugs/Misbranded | Read the letter |
| 2026-09-01 | 2026-08-18 | Shoolin Pharma Chem LLP | Center for Drug Evaluation and Research (CDER) | CGMP/Active Pharmaceutical Ingredient (API)/Adulterated | Read the letter |
| 2026-09-01 | 2026-08-24 | TXP Innovations LLC dba Tex Peptides | Center for Drug Evaluation and Research (CDER) | Unapproved New Drugs/Misbranded | 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/2026-09