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 |
|---|---|---|---|---|---|---|---|
| Moonlight Vapers | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | |||||
| Vapor Arts LLC d/b/a Main Street Vapor Co. | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | |||||
| El Dorado Imports Inc | Division of Southwest Imports | Foreign Supplier Verification Program (FSVP) | |||||
| LECS USA Inc. | Division of West Coast Imports | Foreign Supplier Verification Program (FSVP) |
|||||
| Fres Co, LLC | Division of Northeast Imports | Foreign Supplier Verification Program (FSVP) | |||||
| The Vapor Gypsy, LLC | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | |||||
| Specialty Process Labs LLC | Division of Pharmaceutical Quality Operations IV | CGMP/Active Pharmaceutical Ingredient (API)/Adulterated | |||||
| Lempira Distribution LLC | Division of Southeast Imports | Foreign Supplier Verification Program (FSVP) | |||||
| Red Shield Reserve Inc. | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | |||||
| Colorful Products Corporation | Division of Pharmaceutical Quality Operations IV | CGMP/Finished Pharmaceuticals/Adulterated |