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 |
|---|---|---|---|---|---|---|---|
| DO&CO Aktiengesellschaft/DO&CO, Inc. | Human Foods Program | CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated/L. monocytogenes | |||||
| jadepouch.com | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | |||||
| Respilon Production S.R.O. | Center for Drug Evaluation and Research (CDER) | CGMP/OTC/Finished Pharmaceuticals/Adulterated |
|||||
| South Bay Cold Storage & Handling, Inc. | Human Foods Program | Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions | |||||
| Diamond-Herpanacine of PA, Inc. | Human Foods Program | New Drug/Misbranded | |||||
| Min Jiang Food Store Inc dba Koi Koi Trading | Human Foods Program | Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions | |||||
| Intelligent Remedies, Inc. | Human Foods Program | New Drug/Misbranded | |||||
| Unetixs Vascular, Inc. | Center for Devices and Radiological Health | Premarket Approval/Adulterated | |||||
| Naumes, Inc. | Human Foods Program | Food/Prepared Packed or Held Under Insanitary Conditions/Adulterated | |||||
| Supersmart USA, LLC | Human Foods Program | New Drug/Misbranded |