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  1. Compliance Actions and Activities

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.
Archived Warning Letters (archive-it.org):
2016, 2015, 2014, 2013, 2012, 2011, 2010, 2009, 2008, 2007, 2006, 2005


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
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
HRE Investments LLC d/b/a Vaporifics Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded

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