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.
| Posted Date | Letter Issue Date | Company Name | Issuing Office | Subject | Response Letter | Closeout Letter | Excerpt |
|---|---|---|---|---|---|---|---|
| Wipro Unza Singapore Private, Limited | Drug | Refusal to Provide Access to and Copying of Records | |||||
| Distribuidora Jocorena Inc. | Division of Northeast Imports | Foreign Supplier Verification Program (FSVP) | |||||
| Cooperstown Cheese Company, LLC | Division of Human and Animal Food Operations East I | CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated/L. monocytogenes | |||||
| Omeza LLC | Office of Pharmaceutical Quality | CGMP/Finished Pharmaceuticals/Adulterated |
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| Dextrum Laboratories Inc. | Division of Pharmaceutical Quality Operations II | CGMP/Finished Pharmaceuticals/Adulterated |
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| Desserts by Helen, Inc. | Division of Human and Animal Food Operations East V | CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated | |||||
| Patcos Cosmetics Pvt. Ltd. | Center for Drug Evaluation and Research | CDER | CGMP/Finished Pharmaceuticals/Adulterated | |||||
| US Gulf Coast Trading Co., Inc. | Division of Human and Animal Food Operations West III | CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated | |||||
| Hua Da Trading, Inc. | Center for Drug Evaluation and Research | CDER | Finished Pharmaceuticals/Unapproved New Drug/Misbranded |
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| Botanical Be | Center for Drug Evaluation and Research | CDER | Finished Pharmaceuticals/Unapproved New Drug/Misbranded |