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 |
|---|---|---|---|---|---|---|---|
| Aerosol and Liquid Packaging, Inc. | Division of Pharmaceutical Quality Operations I | CGMP/Finished Pharmaceuticals/Adulterated | |||||
| Restorative Botanicals, LLC | Division of Human and Animal Food Operations West IV | CGMP/Dietary Supplement/Adulterated |
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| Accupack Midwest, Inc. | Division of Pharmaceutical Quality Operations III | CGMP/Finished Pharmaceuticals/Adulterated | |||||
| Warbucks Seafood NY LLC | Division of Northeast Imports | Foreign Supplier Verification Program (FSVP) | |||||
| Wittman Pharma, Inc. | Division of Pharmaceutical Quality Operations II | CGMP/Finished Pharmaceuticals/Adulterated | |||||
| Nomida.biz | Center for Drug Evaluation and Research (CDER) | Unapproved New Drugs/Misbranded |
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| Brewing Market Coffee | Division of Human and Animal Food Operations West IV | Acidified Foods/Emergency Permit Control/Adulterated |
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| Azurity Pharmaceuticals, Inc. | Center for Drug Evaluation and Research (CDER) | CGMP/Finished Pharmaceuticals/Adulterated/Unapproved New Drug | |||||
| Aromas Para El Alma S.A. | Center for Drug Evaluation and Research (CDER) | CGMP/Finished Pharmaceuticals/Adulterated/Unapproved New Drug/Misbranded |
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| St. Louis Calco, LLC | Division of Human and Animal Food Operations West II | Food/Prepared Packed or Held Under Insanitary Conditions/Adulterated |