Inspections, Compliance, Enforcement, and Criminal Investigations
Types of Warning Letters on the FDA Website
- General FDA Warning Letters
- Tobacco Retailer Warning Letters
- Drug Marketing and Advertising Warning Letters (and Untitled Letters to Pharmaceutical Companies)
Topics on this Page:
- Ways to View/Browse Warning Letters
- More Information About Warning Letters Posted Here
- Recently Posted Warning Letters
Ways to View/Browse Warning Letters
- Review the list of recently posted warning letters below.
- Select the year from the list above in which the warning letter was issued, and browse the chronological list of warning letters on the linked page.
To find specific Warning Letters:
- Perform an Advanced Search
- Use any of these "Browse" functions:
To download information about Warning Letters to an Excel document:
Use the Search and Export Warning Letters to Excel function.
- 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 available additional information on the current status of an issue in a particular warning letter on this site, 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.
|Letter Issue Date||Company Name||Issuing Office||Subject||Close Out Date|
|January 28, 2016||Merck Animal Health||Center for Veterinary Medicine||New Animal Drug/Unapproved/Levothyroxine||Not Issued *|
|January 27, 2016||Polette Cyril (Caribbean Variety Store)||New York District Office||Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions||Not Issued *|
|January 22, 2016||Terra Firma Botanicals||Seattle District Office||CGMP/Dietary Supplement/Adulterated/Misbranded||Not Issued *|
|January 13, 2016||Kirkman Laboratories, Inc.||Seattle District Office||Unapproved New Drugs/Misbranded||Not Issued *|
|December 31, 2015||www.ciga7.com||Center for Tobacco Products||Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded||Not Issued *|
|December 22, 2015||Flying Food Group, LLC.||Los Angeles District Office||CGMP Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated||Not Issued *|
|December 11, 2015||The One Minute Miracle Inc||Florida District Office||New Drug/Labeling/Misbranded||Not Issued *|
|November 10, 2015||Monmouth Medical Center IRB||Center for Drug Evaluation and Research||Institutional Review Board (IRB)||Not Issued *|