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 |
|---|---|---|---|---|---|---|---|
| Premium Health Management Inc. dba Premium Health | Center for Drug Evaluation and Research (CDER) | Failure to Register and List/Misbranded |
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| GenoGenix LLC | Center for Drug Evaluation and Research (CDER) | Compounding Pharmacy/Adulterated Drug Products | |||||
| Supercan Bully Sticks LLC | Division of Southeast Imports | Foreign Supplier Verification Program (FSVP) | |||||
| Black Sheep Egg Company, LLC | Human Foods Program | PHS Act/Shell Egg Regulation/Adulterated | |||||
| The Father's Table, LLC | Human Foods Program | CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated/L. monocytogenes | |||||
| John Yoder Farm | Human Foods Program | PHS Act/Shell Egg Regulation/Adulterated | |||||
| Yuyao City Boss Vegetable Factory Co. Ltd. | Human Foods Program | Acidified Foods/Emergency Permit Control/Adulterated |
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| Diasol, Inc. | Center for Devices and Radiological Health | Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) | |||||
| Beta Bionics, Inc. | Center for Devices and Radiological Health | CGMP/QSR/Medical Devices/Adulterated | |||||
| Kare Solutions, LLC dba Zappy | Center for Drug Evaluation and Research (CDER) | False & Misleading Claims/Misbranded |