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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
East Coast Liquids d/b/a Planet Vapor Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
McCraney Enterprises Corporation d/b/a Vapors Heaven Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
Glicerinas Industriales, S.A. de C.V. Center for Drug Evaluation and Research | CDER CGMP/Finished Drug Products/Refusal/Limited Inspection
Splash Ecig and Vapor Emporium Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
DKD Vapor LLC d/b/a Phoenix Rising Vapor Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
Smokalo, Inc. Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
Equine Podiatry Solutions, LLC Center for Veterinary Medicine Unapproved New Animal Drug Products
Hybrid Pharma, LLC Office of Pharmaceutical Quality Operations, Division II Compounding Pharmacy/Adulterated Drug Products
Smitha C. Reddy, M.D./ACRC Studies, LLC Center for Drug Evaluation and Research | CDER Clinical Investigator
Vaporize & Accessorize, LLC, d/b/a Cloud Factory Vapes Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded

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