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 |
|---|---|---|---|---|---|---|---|
| Par Health USA, LLC & Endo USA, Inc. | Center for Drug Evaluation and Research (CDER) | CGMP/Finished Pharmaceuticals/Adulterated | |||||
| New Life Pharma LLC | Center for Drug Evaluation and Research (CDER) | CGMP/Adulterated and Unapproved New Drug/Misbranded | |||||
| Espifresh Inc. | Office of Inspections and Investigations | Foreign Supplier Verification Program (FSVP) | |||||
| nicoprof.com | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | |||||
| SaNOtize | Center for Drug Evaluation and Research (CDER) | Unapproved New Drugs | |||||
| Eaglelionton Int'l Trading Co Inc | Office of Inspections and Investigations | Foreign Supplier Verification Program (FSVP) | |||||
| Pro Numb Tattoo Numbing Spray, LLC | Center for Drug Evaluation and Research (CDER) | CGMP/Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated |
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| UCSF Radiopharmaceutical Facility | Center for Drug Evaluation and Research (CDER) | CGMP/Finished Pharmaceuticals/Adulterated | |||||
| RC Outsourcing, LLC | Center for Drug Evaluation and Research (CDER) | Compounding Pharmacy/Adulterated Drug Products | |||||
| Apollo Care, LLC | Center for Drug Evaluation and Research (CDER) | Compounding Pharmacy/Adulterated Drug Products |