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 |
|---|---|---|---|---|---|---|---|
| Lady Boss Vapor Inc. | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | |||||
| DSAART, LLC. dba Alpha Aesthetics | Center for Devices and Radiological Health | CGMP/QSR/Manufacture/Packing/Storage/Installation/Adulterated | |||||
| Cosmic Fog Vapors Operating Company, LLC | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | |||||
| Spartan Chemical Company, Inc. | Division of Pharmaceutical Quality Operations III | CGMP/Finished Pharmaceuticals/Adulterated | |||||
| Western Herb Products, Inc. | Office of Human and Animal Food Operations – West Division 6 | CGMP/Dietary Supplement/Adulterated/Misbranded | |||||
| Ebenezer International Food, LLC | Division of Northern Border Imports | Foreign Supplier Verification Program (FSVP) | |||||
| Medtronic, Inc. | Center for Devices and Radiological Health | CGMP/QSR/Medical Devices/Adulterated | |||||
| Bogart Enterprises LLC d/b/a The Vapor Shop | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | |||||
| Sarita's Tortilla Factory, Inc | Office of Human and Animal Food Operations West Division 3 | CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated | |||||
| The Famous Lartigue Seafood | Office of Human and Animal Food Operations-East 5 | Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions |