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 |
|---|---|---|---|---|---|---|---|
| Americo F. Padilla, M.D./Miami Dade Medical Research Institute | Center for Drug Evaluation and Research (CDER) | Clinical Investigator | |||||
| Kardesler Ucan Yaglar Sanayi Anonim Sirketi | Center for Drug Evaluation and Research (CDER) | CGMP/Finished Pharmaceutical/Adulterated | |||||
| Evolutionary Biologics Inc. | Center for Biologics Evaluation and Research | Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps) | |||||
| Chara Biologics, Inc. | Center for Biologics Evaluation and Research (CBER) | CGMP/Deviations/Biologics License Application (BLA) | |||||
| ProRx, LLC | Center for Drug Evaluation and Research (CDER) | Compounding Pharmacy/Adulterated Drug Products | |||||
| Mihon Corp. d/b/a VitalityVita and Boulla, LLC | Center for Drug Evaluation and Research (CDER) | Unapproved New Drugs/Misbranded | |||||
| Sanofi | Center for Drug Evaluation and Research (CDER) | CGMP/Active Pharmaceutical Ingredient (API)/Adulterated | |||||
| Salt City Baking Company, LLC | Human Foods Program | CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated | |||||
| INCELL Corporation LLC | Center for Biologics Evaluation and Research (CBER) | CGMP/Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated | |||||
| Atlanta Supersource, Inc. | Center for Drug Evaluation and Research (CDER) | CGMP/Finished Pharmaceuticals/Adulterated |