FDA warning letters, updated daily
The newest warning letters FDA has published, with the company, the issuing center and what the letter is about. 73 letters were posted in the last 30 days, the latest on October 13, 2026. Updated October 18, 2026.
Latest letters
- Lovelace Biomedical Research Institute
Posted Oct 13, 2026
Good Laboratory Practice (GLP) for Nonclinical Laboratory Studies
Center for Drug Evaluation and Research (CDER), letter dated Oct 6, 2026
- Eurofins SF Analytical Laboratories, Inc.
Posted Oct 13, 2026
CGMP/Finished Pharmaceuticals/Adulterated
Center for Drug Evaluation and Research (CDER), letter dated Oct 6, 2026
- Silgan Dispensing Systems
Posted Oct 13, 2026
CGMP/Finished Pharmaceuticals/Adulterated/Unapproved New Drug
Center for Drug Evaluation and Research (CDER), letter dated Oct 5, 2026
- originalc.co.uk
Posted Oct 13, 2026
Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
Center for Tobacco Products, letter dated Oct 2, 2026
- John & Nicole Santos Dairy
Posted Oct 13, 2026
New Animal Drug/Adulterated
Center for Veterinary Medicine, letter dated Oct 2, 2026
- Hanlim Pharm Co., Ltd.
Posted Oct 13, 2026
CGMP/Finished Pharmaceuticals/Adulterated
Center for Drug Evaluation and Research (CDER), letter dated Oct 2, 2026
- Dreyer’s Grand Ice Cream, Inc.
Posted Oct 13, 2026
CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated
Human Foods Program, letter dated Sep 29, 2026
- Jiangmen Shuizirun Sanitary Articles Co., Ltd.
Posted Oct 13, 2026
CGMP/Finished Pharmaceuticals/Adulterated
Center for Drug Evaluation and Research (CDER), letter dated Sep 23, 2026
- Datil Fresh Produce LLC
Posted Oct 13, 2026
Foreign Supplier Verification Program (FSVP)
Office of Inspections and Investigations, letter dated Sep 22, 2026
- SCA Pharmaceuticals, LLC
Posted Oct 13, 2026
CGMP/Finished Pharmaceuticals/Adulterated
Center for Drug Evaluation and Research (CDER), letter dated Sep 14, 2026
- RDM Express Inc.
Posted Oct 13, 2026
CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated
Human Foods Program, letter dated Sep 11, 2026
- Ocean Pride Seafood, Inc.
Posted Oct 13, 2026
Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions
Human Foods Program, letter dated Sep 11, 2026
- Moda Food LLC
Posted Oct 13, 2026
Foreign Supplier Verification Program (FSVP)
Office of Inspections and Investigations, letter dated Sep 9, 2026
- Distribuidora Jazmin LLC
Posted Oct 13, 2026
Foreign Supplier Verification Program (FSVP)
Office of Inspections and Investigations, letter dated Aug 13, 2026
- Lewis Sausage Company Inc.
Posted Oct 13, 2026
CGMP/Food for Animals/Prepared, Packed or Held Under Insanitary Conditions/Adulterated
Center for Veterinary Medicine, letter dated Aug 5, 2026
- Ruukoo International Food Market Inc.
Posted Oct 13, 2026
Foreign Supplier Verification Program (FSVP)
Office of Inspections and Investigations, letter dated Jul 22, 2026
- The Platinum Healthcare LLC
Posted Oct 6, 2026
Unapproved New Drugs
Center for Drug Evaluation and Research (CDER), letter dated Oct 1, 2026
- Walmart, Inc.
Posted Oct 6, 2026
Unapproved New Drugs
Center for Drug Evaluation and Research (CDER), letter dated Oct 1, 2026
- Aidance Scientific, Inc.
Posted Oct 6, 2026
Unapproved New Drugs
Center for Drug Evaluation and Research (CDER), letter dated Oct 1, 2026
- Graceful Touch, LLC
Posted Oct 6, 2026
Unapproved New Drugs
Center for Drug Evaluation and Research (CDER), letter dated Oct 1, 2026
- Amazon.com, Inc.
Posted Oct 6, 2026
Unapproved New Drugs
Center for Drug Evaluation and Research (CDER), letter dated Oct 1, 2026
- OrganiCare, LLC / OrganiCare Nature’s Science, LLC
Posted Oct 6, 2026
Unapproved New Drugs
Center for Drug Evaluation and Research (CDER), letter dated Oct 1, 2026
- Terramed
Posted Oct 6, 2026
Unapproved New Drugs
Center for Drug Evaluation and Research (CDER), letter dated Oct 1, 2026
- Bioactive Services USA, LLC / Herstat Inc.
Posted Oct 6, 2026
Unapproved New Drugs
Center for Drug Evaluation and Research (CDER), letter dated Oct 1, 2026
- DesBio/Deseret Biologicals, Inc.
Posted Oct 6, 2026
Unapproved New Drugs
Center for Drug Evaluation and Research (CDER), letter dated Oct 1, 2026
- RoyceDerm LLC
Posted Oct 6, 2026
Unapproved New Drugs
Center for Drug Evaluation and Research (CDER), letter dated Oct 1, 2026
- Cheap Medicine Shop/www.cheapmedicineshop.com
Posted Oct 6, 2026
Unapproved New Drugs/Misbranded (Internet Pharmacy)
Center for Drug Evaluation and Research (CDER), letter dated Sep 24, 2026
- Online Generic Medicine/www.onlinegenericmedicine.com
Posted Oct 6, 2026
Unapproved New Drug/Misbranded (Internet Pharmacy)
Center for Drug Evaluation and Research (CDER), letter dated Sep 23, 2026
- Unilam Co., LTD
Posted Oct 6, 2026
CGMP/QSR/Medical Devices/Adulterated
Center for Devices and Radiological Health, letter dated Sep 22, 2026
- TCI Co., Ltd BioCosme PABP BRANCH
Posted Oct 6, 2026
CGMP/Finished Pharmaceuticals/Adulterated
Center for Drug Evaluation and Research (CDER), letter dated Sep 2, 2026
- O.N. Diagnostics, LLC
Posted Oct 6, 2026
Medical Device Reporting/Misbranded
Center for Devices and Radiological Health, letter dated Sep 1, 2026
- Star Ocean Wholesale Foods, Inc.
Posted Oct 6, 2026
Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions
Office of Inspections and Investigations, letter dated Sep 1, 2026
- Tipical Latin Food, Corp. DBA La Pradera
Posted Oct 6, 2026
CGMP/Manufacturing, Packing or Holding Human Food/Adulterated/Insanitary Conditions
Human Foods Program, letter dated Aug 28, 2026
- Importaciones La Bufa LLC
Posted Oct 6, 2026
Foreign Supplier Verification Program (FSVP)
Office of Inspections and Investigations, letter dated Aug 17, 2026
- Pine Pharmaceuticals, LLC
Posted Oct 6, 2026
Compounding Pharmacy/Adulterated Drug Products
Center for Drug Evaluation and Research (CDER), letter dated Aug 7, 2026
- sfshoply.com
Posted Sep 29, 2026
Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
Center for Tobacco Products, letter dated Sep 25, 2026
- Sciarra Aeromed, Inc.
Posted Sep 29, 2026
CGMP/Drugs for Animals/Prepared, Packed or Held Under Insanitary Conditions/Adulterated
Center for Veterinary Medicine, letter dated Sep 23, 2026
- Neogen Corporation
Posted Sep 29, 2026
CGMP/Drugs for Animals/Prepared, Packed or Held Under Insanitary Conditions/Adulterated
Center for Veterinary Medicine, letter dated Sep 23, 2026
- Fresenius Kabi USA LLC
Posted Sep 29, 2026
CGMP/Finished Pharmaceuticals/Adulterated
Center for Drug Evaluation and Research (CDER), letter dated Sep 22, 2026
- Babikian Healthcare Products CJSC
Posted Sep 29, 2026
CGMP/Finished Pharmaceuticals/Adulterated
Center for Drug Evaluation and Research (CDER), letter dated Sep 21, 2026
- Curia New York, Inc.
Posted Sep 29, 2026
CGMP/Active Pharmaceutical Ingredient (API)/Adulterated
Center for Drug Evaluation and Research (CDER), letter dated Sep 18, 2026
- Bentley Laboratories LLC
Posted Sep 29, 2026
CGMP/Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated
Center for Drug Evaluation and Research (CDER), letter dated Sep 17, 2026
- Celmade
Posted Sep 29, 2026
Review of Website/Unapproved New Drug/Misbranded
Center for Drug Evaluation and Research (CDER), letter dated Sep 14, 2026
- Andrighetto Produce Inc dba Shasta Produce Inc
Posted Sep 29, 2026
Foreign Supplier Verification Program (FSVP)
Office of Inspections and Investigations, letter dated Aug 27, 2026
- South Asian Food Inc.
Posted Sep 29, 2026
Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions
Human Foods Program, letter dated Aug 20, 2026
- Bo Wah Enterprises Inc
Posted Sep 29, 2026
Foreign Supplier Verification Program (FSVP)
Office of Inspections and Investigations, letter dated Aug 13, 2026
- Stokes Healthcare Inc. dba Epicur Pharma
Posted Sep 29, 2026
Animal Drugs/Adulterated
Center for Veterinary Medicine, letter dated Aug 4, 2026
- American Pharma Mfg. Inc.
Posted Sep 29, 2026
CGMP/Dietary Supplement/Adulterated/Misbranded
Human Foods Program, letter dated Aug 4, 2026
- Wilson Livestock
Posted Sep 29, 2026
New Animal Drug/Adulterated
Center for Veterinary Medicine, letter dated Jul 24, 2026
- Fil-Bay Import, Inc.
Posted Sep 29, 2026
Foreign Supplier Verification Program (FSVP)
Office of Inspections and Investigations, letter dated Jul 20, 2026
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Letters posted per month
| Month | Drugs | Inspections and imports | Food | Tobacco | Veterinary | Other | Total |
|---|---|---|---|---|---|---|---|
| Oct 2026 | 20 | 6 | 4 | 1 | 2 | 2 | 35 |
| Sep 2026 | 22 | 12 | 8 | 1 | 6 | 5 | 54 |
| Aug 2026 | 12 | 2 | 1 | 2 | 4 | 3 | 24 |
| Jul 2026 | 21 | 13 | 5 | 5 | 3 | 5 | 52 |
| Jun 2026 | 62 | 11 | 6 | 0 | 1 | 7 | 87 |
| May 2026 | 23 | 7 | 14 | 15 | 3 | 4 | 66 |
Counted by the date FDA posted the letter. The current month is partial.
Most cited issues in the last 90 days
- Adulterated73 letters
- CGMP55 letters
- Finished Pharmaceuticals34 letters
- Unapproved New Drugs29 letters
- Misbranded28 letters
- Foreign Supplier Verification Program (FSVP)28 letters
- Family Smoking Prevention and Tobacco Control Act7 letters
- Insanitary Conditions6 letters
- Active Pharmaceutical Ingredient (API)6 letters
- Prepared, Packed or Held Under Insanitary Conditions5 letters
- QSR5 letters
- Medical Devices5 letters
Frequently asked questions
What is an FDA warning letter?
It is FDA's written notice to a company that it found significant violations of the laws FDA enforces, usually after an inspection or a review of products, labels or a website. The letter lists the violations and asks the company to explain how it will correct them. Warning letters are advisory and carry no penalty on their own, but FDA can follow up with enforcement such as a seizure, an injunction or an import alert if the problems are not fixed.
How long does a company have to respond?
Usually 15 working days. The letter asks for a written reply that describes the corrections made and the steps taken to keep the violations from happening again.
What is the difference between a Form 483 and a warning letter?
A Form FDA 483 lists the inspectors' observations at the end of an inspection. A warning letter comes later, if FDA decides the violations are significant and the company's response did not resolve them. Not every 483 leads to a warning letter.
How soon after it is issued does FDA publish a letter?
FDA posts letters after removing confidential information. Across the 500 most recent letters, the median gap between the date on the letter and the date FDA posted it was 12 days.
How often is this page updated?
Every day. We read FDA's public warning letter index each morning and list the newest letters first. Each company name links to the full letter on fda.gov.
Can I get alerts for letters about my product category?
Yes. Use the alert box on this page to say what you care about, such as a product type, a violation or a competitor's name, and WebMonitor emails you when a new letter matches. Alerts run on paid plans from $29 a month.
How this works
Every morning we read FDA's public warning letter index and list the 250 most recent letters, newest first. Company names link to the full letter on fda.gov, which is the official source. WebMonitor is not affiliated with FDA. To watch other regulator pages the same way, see regulatory compliance monitoring.