Warning Letters
Learn about the types of warning letters on FDA's website.
- Matters described in FDA warning letters may have been subject to subsequent interaction between FDA and the letter recipient that may have changed the regulatory status of issues discussed in the letter.
- To obtain additional available information, contact FDA. Requests to FDA for agency records should be sent to: Food and Drug Administration Division of Freedom of Information (HFI-35), 5630 Fishers Lane, Rockville, MD 20857. Instructions for how to submit an FOI request can be found at How to Make a FOIA Request.
- Frequently requested records may be accessed on the Reading Room page.
| Posted Date | Letter Issue Date | Company Name | Issuing Office | Subject | Response Letter | Closeout Letter | Excerpt |
|---|---|---|---|---|---|---|---|
| Dabur India Limited | Center for Drug Evaluation and Research (CDER) | CGMP/Finished Pharmaceuticals/Adulterated | |||||
| Maria E. De La Torre Silva, M.D. | Center for Drug Evaluation and Research (CDER) | Clinical Investigator | |||||
| ABS Corporation | Center for Veterinary Medicine | CGMP/Finished Pharmaceuticals/Adulterated | |||||
| Koven Technologies, Inc. | Center for Devices and Radiological Health | CGMP/QSR/Medical Devices/Adulterated | |||||
| AAL Trading Inc. | Office of Inspections and Investigations | Foreign Supplier Verification Program (FSVP) |
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| Friend’s Stable and Orchard, Inc. | Human Foods Program | Food/Prepared Packed or Held Under Insanitary Conditions/Adulterated | |||||
| Woodbine Products Company Inc. | Center for Drug Evaluation and Research (CDER) | CGMP/Finished Pharmaceuticals/Adulterated | |||||
| Thomas Brunner Hygiene GmbH | Center for Drug Evaluation and Research (CDER) | CGMP/Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated | |||||
| Delight Distribution Inc. | Office of Inspections and Investigations | Foreign Supplier Verification Program (FSVP) | |||||
| Piquin Y Sabores Distributors LLC | Office of Inspections and Investigations | Foreign Supplier Verification Program (FSVP) |