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 |
|---|---|---|---|---|---|---|---|
| Joyetech Shenzhen Electronics Co., Ltd. | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | |||||
| Premier Nutra Pharma Inc. | Division of Pharmaceutical Quality Operations IV | CGMP/Finished Pharmaceuticals/Adulterated | |||||
| Drivergent, Inc. | Division of Pharmaceutical Quality Operations III | CGMP/Finished Pharmaceuticals/Adulterated | |||||
| Juicer Connections, Inc. | Division of Human and Animal Food Operations West V | Juice HACCP/CGMP for Foods/Adulterated/Insanitary Conditions | |||||
| Milky Way International Trading Corporation | Division of West Coast Imports | Foreign Supplier Verification Program (FSVP) | |||||
| Promar Seafood S. de R.L. | Center for Food Safety and Applied Nutrition (CFSAN) | Seafood HACCP/CGMP for Foods/Adulterated | |||||
| Santa Cruz Produce, Inc. | Division of Southeast Imports | Foreign Supplier Verification Program (FSVP) | |||||
| Tager Online, Inc. DBA Volt Candy; Volt Candy Wholesale Club | Center for Drug Evaluation and Research | CDER | Unapproved New Drugs/Misbranded | |||||
| Hot Grabba LLC d/b/a Buttas Hot Grabba | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | |||||
| Accra-Pac, Inc. dba Voyant Beauty | Division of Pharmaceutical Quality Operations III | CGMP/Finished Pharmaceuticals/Adulterated |