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 a simple search by entering criteria into the search box below.
- 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.
- Warning letters posted before June 25, 2001, are in PDF format. Warning letters posted after that date are available in HTML format.
- Persons with disabilities having problems accessing PDF files may call 301-827-6567 for assistance.
- 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), 5600 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|
|July 22, 2014||K-Fat Inc.||New York District Office||Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions||Not Issued *|
|July 22, 2014||Hoke Farms||Philadelphia District Office||Unapproved New Animal Drug/Adulterated||Not Issued *|
|July 21, 2014||Smoker Friendly International LLC||Center for Tobacco Products||Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded||Not Issued *|
|July 21, 2014||Med-Mizer, Inc.||Detroit District Office||CGMP/QSR/Medical Devices/Adulterated||Not Issued *|
|July 17, 2014||Opada Alzohalli, M.D.||Center for Drug Evaluation and Research||Clinical Investigator||Not Issued *|
|July 17, 2014||Klein Laboratories, Inc.||New England District Office||Unapproved New Drug/Adulterated||Not Issued *|
|July 17, 2014||Schindele Enterprises dba Midwest Wholesale||Kansas City District Office||Unapproved/Misbranded drugs||Not Issued *|
|July 14, 2014||Abrams Royal Pharmacy||Dallas District Office||Compounding Pharmacy/Adulteration/Misbranding||Not Issued *|
|July 09, 2014||Zhejiang Jiuzhou Pharmaceutical Co., Ltd.||Center for Drug Evaluation and Research||CGMP/Active Pharmaceutical Ingredient (API)/Adulterated||Not Issued *|
|July 03, 2014||Double D Dairy||Detroit District Office||Unapproved New Animal Drug/Adulterated||Not Issued *|
|July 03, 2014||Solace International, Inc.||San Francisco District Office||Unapproved New Drug/Misbranded||Not Issued *|
|June 30, 2014||Corporacion Avicola Morovis Inc||San Juan District Office||PHS Act/Shell Egg Regulation/Adulterated||Not Issued *|
|June 24, 2014||Sushi Den Japan||Center for Food Safety and Applied Nutrition||Seafood HACCP/CGMP for Foods/Adulterated||Not Issued *|
|June 02, 2014||Accelerated Freeze Drying Co. Ltd.||Center for Food Safety and Applied Nutrition||Seafood HACCP/CGMP for Foods/Adulterated||Not Issued *|
|May 20, 2014||Bliss Dairy, LLC||Denver District Office||Illegal Drug Residue||Not Issued *|
|May 14, 2014||SSE Manufacturing, Inc||Dallas District Office||Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions||Not Issued *|
|April 30, 2014||FRANZESE S.P.A.||Center for Food Safety and Applied Nutrition||Low Acid Canned Food Regulation/Adulterated||Not Issued *|
|August 19, 2013||Good Fish||Center for Food Safety and Applied Nutrition||Seafood HACCP/CGMP for Foods/Adulterated||Not Issued *|
|October 01, 2007||Bradford, Michael, MD [ARCHIVED]||Center for Devices and Radiological Health||Clinical Investigator||N/A *|