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 |
|---|---|---|---|---|---|---|---|
| Germaphobix | Center for Biologics Evaluation and Research (CBER) | Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) | |||||
| Genetrace | Center for Biologics Evaluation and Research (CBER) | Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) | |||||
| ProDx Health | Center for Biologics Evaluation and Research (CBER) | Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) | |||||
| Genovate | Center for Biologics Evaluation and Research (CBER) | Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) | |||||
| Integrity Partners Group | Center for Drug Evaluation and Research (CDER) | CGMP/Finished Pharmaceuticals/Adulterated | |||||
| Prodrome Sciences USA, LLC | Center for Drug Evaluation and Research (CDER) | Sponsor/Unapproved Misbranded | |||||
| LXR Biotech, LLC | Human Foods Program | CGMP/Dietary Supplement/Adulterated/Misbranded | |||||
| ASP Global, LLC. dba Anatomy Supply Partners, LLC. | Center for Devices and Radiological Health | CGMP/QSR/Medical Devices/Adulterated | |||||
| Pan-African Food Distributors Inc./East Africa Boutique LLC | Human Foods Program | CGMP/Dietary Supplement/Adulterated/Misbranded | |||||
| Middle East/Soli's Baking Company, Inc. dba Middle East Baking Co. | Human Foods Program | CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated |