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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.
 


Posted Date Letter Issue Date Company Name Issuing Office Subject Response Letter Closeout Letter Excerpt
You Suck Vapes Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
Sabra Dipping Company, LLC Division of Human and Animal Food Operations East II CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated
Vape Craft Inc. Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
VitaStik, Inc. Center for Drug Evaluation and Research | CDER Unapproved New Drugs/Misbranded
VitaCig, Inc. Center for Drug Evaluation and Research | CDER Unapproved New Drugs/Misbranded

NV Nutrition, LLC Center for Drug Evaluation and Research | CDER Unapproved New Drugs/Misbranded
Vitamin Vape, Inc. Center for Drug Evaluation and Research | CDER Unapproved New Drugs/Misbranded

Induction Therapies, LLC Center for Devices and Radiological Health Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated Device
Golden Medal Mushroom Inc. Division of West Coast Imports Foreign Supplier Verification Program (FSVP)
Synaptent, LLC Office of Human and Animal Food Operations-East 6 New Drug/Misbranded

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