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|
|July 15, 2016||Karen Roche||New England District Office||New Drug/Misbranded||Not Issued *|
|July 15, 2016||Annemarie Gianni Skin Care LLC||New England District Office||New Drug/Labeling/Misbranded||Not Issued *|
|July 11, 2016||Regional Radiology||New Jersey District Office||Mammography Quality Standards||Not Issued *|
|July 08, 2016||Health Innovations Pharmacy, Inc||Atlanta District Office||CGMP/Compounded Drugs/Misbranding||Not Issued *|
|July 01, 2016||Reser's Fine Foods Inc.||Atlanta District Office||CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated||Not Issued *|
|June 30, 2016||SmithKline Beecham Limited||Center for Drug Evaluation and Research||CGMP/Active Pharmaceutical Ingredient (API)/Adulterated||Not Issued *|
|June 29, 2016||Monroe Grain & Supply, Inc.||Detroit District Office||Illegal Drug Residue||Not Issued *|
|June 23, 2016||Skipanon Brand Seafoods, LLC||Seattle District Office||Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions||Not Issued *|
|June 21, 2016||Kohman Dairy LLC||Kansas City District Office||Illegal Drug Residue Animal Tissue/Adulterated||Not Issued *|
|June 03, 2016||Diabetes Corporation of America||New Orleans District Office||Drug Product/Adulterated||Not Issued *|