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 |
|---|---|---|---|---|---|---|---|
| Vapor Plus OK LLC | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | |||||
| "David M. Lubeck, M.D./Arbor Centers for EyeCare | Center for Drug Evaluation and Research | CDER | Clinical Investigator (Sponsor) |
|||||
| Jam Jam Services, Inc. | Division of Southeast Imports | Foreign Supplier Verification Program (FSVP) | |||||
| La Serranita Import and Export LLC | Division of Northeast Imports | Foreign Supplier Verification Program (FSVP) | |||||
| J R Imports LLC | Division of Southwest Imports | Foreign Supplier Verification Program (FSVP) | |||||
| Shuzy Rock Inc. | Division of Pharmaceutical Quality Operations I | CGMP/Finished Pharmaceuticals/Adulterated | |||||
| Pepe’s Foods Inc. | Division of West Coast Imports | Foreign Supplier Verification Program (FSVP) | |||||
| Effingham Equity | Division of Human and Animal Food Operations East VI | CGMP/Medicated Feeds/Adulterated | |||||
| yourtramadol.com | Center for Drug Evaluation and Research | CDER | Finished Pharmaceuticals/Unapproved New Drug/Misbranded | |||||
| goodimmuno.com | Center for Drug Evaluation and Research | CDER | Finished Pharmaceuticals/Unapproved New Drug/Misbranded |