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 |
---|---|---|---|---|---|---|---|
Dulces La Mejor, LLC | Southwest Imports | Foreign Supplier Verification Program (FSVP) | |||||
The Vape Lounge, Inc. d/b/a The Vape Lounge 760 | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded |
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21 Century Smoking, Inc. | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | |||||
Dominant Nutrition LLC formerly 8 Weeks Out Labs | Office of Human and Animal Foods West | Dietary Supplement/Adulterated | |||||
DongBang Cosmetics Co., Ltd. | Center for Drug Evaluation and Research | CDER | CGMP/Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated | |||||
CellEra LLC | Office of Medical Device and Radiological Health Division 1 – East | CGMP/QSR/Medical Devices/Adulterated | |||||
Jule's Foods | Office of Human and Animal Food Operations- West Division 5 | CGMP Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated | |||||
Custom Vapor Blends LLC | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | |||||
Electric Smoke Vapor House | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded |
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HRE Investments LLC d/b/a Vaporifics | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded |