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 |
|---|---|---|---|---|---|---|---|
| ProRx LLC | Center for Drug Evaluation and Research (CDER) | Compounding Pharmacy/Adulterated Drug Products | |||||
| Naveh Pharma LTD/Bigdam Inc. | Center for Drug Evaluation and Research (CDER) | CGMP/Finished Pharmaceuticals/Adulterated/Unapproved New Drug |
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| IDO Pharm Co., Ltd. | Center for Drug Evaluation and Research (CDER) | CGMP/OTC Finished Pharmaceuticals/Adulterated | |||||
| Ridley USA Inc. | Center for Veterinary Medicine | CGMP/Medicated Feeds/Adulterated |
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| Estar Technologies Ltd | Center for Biologics Evaluation and Research | Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated Device | |||||
| JMT Inter LLC | Office of Inspections and Investigations | Foreign Supplier Verification Program (FSVP) | |||||
| Baja Fresko Distributors Inc. | Office of Inspections and Investigations | Foreign Supplier Verification Program (FSVP) | |||||
| Minh Phung, Inc. | Human Foods Program | CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated | |||||
| The Fish Aid | Center for Veterinary Medicine | Unapproved New Animal Drug Products | |||||
| DK Hardware Supply | Center for Veterinary Medicine | Unapproved New Animal Drug Products |