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|
|April 21, 2016||Rindts Wolf River Dairy, LLC||Minneapolis District Office||Illegal Drug Residue||Not Issued *|
|April 21, 2016||Constantine Poulos and Company dba International Foods, Inc.||New England District Office||Acidified Foods/Emergency Permit Control/Adulterated/Misbranded||Not Issued *|
|April 21, 2016||C K Frozen Fish and Food Inc.||New York District Office||Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions||Not Issued *|
|April 14, 2016||Lee Seed Company Inc||Kansas City District Office||Food/Prepared Packed or Held Under Insanitary Conditions/Adulterated||Not Issued *|
|April 14, 2016||Polydrug Laboratories Pvt. Ltd.||Center for Drug Evaluation and Research||CGMP/Active Pharmaceutical Ingredient (API)/Adulterated||Not Issued *|
|April 14, 2016||http://www.jccigs.com||Center for Tobacco Products||Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded||Not Issued *|
|April 13, 2016||Cross Street Tobacco||Center for Tobacco Products||Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded||Not Issued *|
|April 13, 2016||K's Tobacco and Brew||Center for Tobacco Products||Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded||Not Issued *|
|March 29, 2016||Benedict S. Liao, M.D.||Center for Drug Evaluation and Research||Bioresearch Monitoring Program/IRB||Not Issued *|
|March 23, 2016||Pharmaceutical Associates Inc||Center for Drug Evaluation and Research||Failure to Comply with Drug Listing Requirements||Not Issued *|
|March 21, 2016||Infusion Options, Inc.||New York District Office||CGMP/Compounded Drugs/Adulterated||Not Issued *|
|March 18, 2016||Atum Do Brasil Captura Industria e Comercio||Center for Food Safety and Applied Nutrition||Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions||Not Issued *|
|March 04, 2016||DMP Ltd.||Center for Devices and Radiological Health||CGMP/QSR/Medical Devices/Adulterated||Not Issued *|