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 10, 2017||Aspen Hills, Inc.||Kansas City District Office||CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated/L. monocytogenes||Not Issued *|
|January 10, 2017||Hawaiian Ono Services, Inc.||San Francisco District Office||Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions||Not Issued *|
|January 06, 2017||Suzhou Pharmaceutical Technology Co.,Ltd||Center for Drug Evaluation and Research||CGMP/Active Pharmaceutical Ingredient (API)/Adulterated||Not Issued *|
|January 06, 2017||Sato Yakuhin Kogyo Co., Ltd.||Center for Drug Evaluation and Research||CGMP/Finished Pharmaceuticals/Adulterated||Not Issued *|
|December 23, 2016||Horizon Pharmaceuticals, Inc.||Florida District Office||CGMP/Finished Pharmaceuticals/Adulterated||Not Issued *|
|December 22, 2016||Northern Health Products||Atlanta District Office||Unapproved New Drugs/Misbranded||Not Issued *|
|December 22, 2016||Florida Key West, Inc.||Florida District Office||Juice/HACCP/Adulterated||Not Issued *|
|December 08, 2016||Pharm D Solutions, LLC||Dallas District Office||Compounding Pharmacy/Adulterated Drug Products||Not Issued *|
|December 07, 2016||Esteem Products LTD||Seattle District Office||Internet Marketing of Unapproved and Misbranded Drugs||Not Issued *|