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 |
|---|---|---|---|---|---|---|---|
| Insightra Medical Inc. | Center for Devices and Radiological Health | Medical Device Reporting/Misbranded | |||||
| Lystn LLC dba Answers Pet Food | Center for Veterinary Medicine | CGMP/Food for Animals/Prepared, Packed or Held Under Insanitary Conditions/Adulterated | |||||
| J.D. Heiskell Holdings LLC | Center for Veterinary Medicine | CGMP/Food for Animals/Prepared, Packed or Held Under Insanitary Conditions/Adulterated | |||||
| puff21.com | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | |||||
| bestvape.com | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | |||||
| Xtreme Tools International, Inc. | Center for Drug Evaluation and Research (CDER) | CGMP/Finished Pharmaceuticals/Adulterated | |||||
| Libby Laboratories, Inc. | Center for Drug Evaluation and Research (CDER) | CGMP/Finished Pharmaceuticals/Adulterated | |||||
| Voehlganic Farm LLC | Human Foods Program | PHS Act/Shell Egg Regulation/Adulterated | |||||
| Dynamic Blending Specialists, Inc. | Center for Drug Evaluation and Research (CDER) | CGMP/Finished Pharmaceuticals/Adulterated | |||||
| Exela Pharma Sciences, LLC | Center for Drug Evaluation and Research (CDER) | CGMP/Finished Pharmaceuticals/Adulterated |