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 |
|---|---|---|---|---|---|---|---|
| ZIIP, Inc. | Center for Devices and Radiological Health | CGMP/QSR/Medical Devices/Adulterated | |||||
| snusblast.co.uk | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | |||||
| International Medication Systems Limited | Center for Drug Evaluation and Research (CDER) | CGMP/Finished Pharmaceuticals/Adulterated | |||||
| Spa De Soleil, Inc. | Center for Drug Evaluation and Research (CDER) | CGMP/Finished Pharmaceuticals/Adulterated |
|||||
| Win Woo Trading, LLC / HF Foods Group | Office of Inspections and Investigations | Foreign Supplier Verification Program (FSVP) | |||||
| Allandale Dairy | Center for Veterinary Medicine | New Animal Drug/Adulterated | |||||
| Ketacyn Pharmaceuticals / www.ketacynpharma.com | Center for Drug Evaluation and Research (CDER) | Unapproved New Drugs/Misbranded | |||||
| Extra Medication / www.extramedication.com | Center for Drug Evaluation and Research (CDER) | Unapproved New Drugs/Misbranded | |||||
| Pure Arylcyclohexylamine Store / www.arylcyclohexylamine.com | Center for Drug Evaluation and Research (CDER) | Unapproved New Drugs/Misbranded | |||||
| All Ketamine HCL / www.allketaminehcl.com | Center for Drug Evaluation and Research (CDER) | Unapproved New Drugs/Misbranded |