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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
Umbrella Division of Pharmaceutical Quality Operations IV Dietary Supplement/Misbranded
Molecular BioLife International, Inc. Office of Human and Animal Foods West Division II New Drug/Misbranded
Fresh Nutrition Inc Office of Human and Animal Food Operations –West Division 5 Unapproved New Drugs/Misbranded
Daisy Global Trading Co Division of West Coast Imports Foreign Supplier Verification Program (FSVP)
Jaramillo Spices Corp. Division of Southwest Imports Foreign Supplier Verification Program (FSVP)
Pure Vapor USA LP Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
Mr Lukas LLC Division of Southwest Imports Foreign Supplier Verification Program (FSVP)
DRF LLC Office of Human and Animal Foods Operations- West Division New Drug/Misbranded
Tuty Usa LLC Division of Southwest Imports Foreign Supplier Verification Program (FSVP)
Session Supply Company Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded

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