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On Oct. 1, 2024, the FDA began implementing a reorganization impacting many parts of the agency. We are in the process of updating FDA.gov content to reflect these changes.

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  2. Inspections, Compliance, Enforcement, and Criminal Investigations
  3. Compliance Actions and Activities
  4. Warning Letters
  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
Ecig Charleston LLC Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
Evolution Pets LLC Center for Veterinary Medicine New Animal Drug/Adulterated
Nutrition Strength Ltd. Center for Veterinary Medicine New Animal Drug/Adulterated
HDFrenchies LLC dba Bully Baum Center for Veterinary Medicine New Animal Drug/Adulterated
Veterinary Select Formula dba Allergic Pet Center for Veterinary Medicine New Animal Drug/Adulterated
Intermarket Industries Inc. dba Doc Ackerman Pet Products Center for Veterinary Medicine New Animal Drug/Adulterated
Energetic Essences, LLC dba Pet Essences Center for Veterinary Medicine New Animal Drug/Adulterated
Indoco Remedies Limited Center for Drug Evaluation and Research (CDER) CGMP/Finished Pharmaceuticals/Adulterated
XO Biologix, LLC Center for Biologics Evaluation and Research (CBER) Unapproved New Drugs/Adulterated
Candymar Produce Inc Division of Southwest Imports Foreign Supplier Verification Program (FSVP)

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