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 |
|---|---|---|---|---|---|---|---|
| 3rd Rock Vapor | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | |||||
| Zombieland LLC dba Mafia Street Vapor Company | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | |||||
| North American Custom Laboratories, LLC dba FarmaKeio Superior Custom Compounding | Division of Pharmaceutical Quality Operations II | Compounding Pharmacy/Adulterated Drug Products | |||||
| Lineage Vapors LLC | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | |||||
| Larkin Community Hospital Institutional Review Board | Center for Drug Evaluation and Research | CDER | Bioresearch Monitoring Program/Institutional Review Board (IRB) | |||||
| Evimeria El Aztecano, Inc. | Division of Human and Animal Food Operations West V | Dietary Supplement/Misbranded | |||||
| Buzzagogo, LLC | Center for Drug Evaluation and Research | CDER | CGMP/Finished Pharmaceuticals/Adulterated/Unapproved New Drug | |||||
| Leimax, Corp. | Division of Northeast Imports | Foreign Supplier Verification Program (FSVP) | |||||
| Fuentes Farms LLC | Division of Southwest Imports | Foreign Supplier Verification Program (FSVP) | |||||
| TL State Management, Inc. | Division of Northeast Imports | Foreign Supplier Verification Program (FSVP) |