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 12, 2016||TerraVare, Inc.||New York District Office||CGMP/Dietary Supplement/Misbranded||Not Issued *|
|July 12, 2016||GenPak Solutions LLC||Cincinnati District Office||CGMP/Finished Pharmaceuticals/Adulterated/Misbranded||Not Issued *|
|June 30, 2016||SmithKline Beecham Limited||Center for Drug Evaluation and Research||CGMP/Active Pharmaceutical Ingredient (API)/Adulterated||Not Issued *|
|June 30, 2016||Mc-Cor, LLC||San Juan District Office||New Drug/Misbranded||Not Issued *|
|June 14, 2016||Pescatlantic, LLC||Florida District Office||Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions||Not Issued *|
|June 13, 2016||Oscor, Inc.||Florida District Office||CGMP/QSR/Medical Devices/Adulterated||Not Issued *|
|February 11, 2016||Gasco Industrial||San Juan District Office||CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated||Not Issued *|