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|
|February 08, 2017||Fred & Tyler Kamp||Dallas District Office||New Animal Drug/Adulterated||Not Issued *|
|February 08, 2017||Humaworm||New Orleans District Office||Unapproved New Drugs/Misbranded||Not Issued *|
|February 08, 2017||Southern Aire Seafood, Inc.||Nashville District Office||Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions||Not Issued *|
|February 03, 2017||MBDR Foods, LLC||Kansas City District Office||Acidified Foods/Prepared Packed or Held Under Insanitary Conditions||Not Issued *|
|February 03, 2017||Resonance Laboratories Private Limited||Center for Drug Evaluation and Research||CGMP/Active Pharmaceutical Ingredient (API)/Adulterated||Not Issued *|
|February 02, 2017||Sato Pharmaceutical Co., Ltd.||Center for Drug Evaluation and Research||CGMP/Finished Pharmaceuticals/Adulterated||Not Issued *|
|February 01, 2017||Life Extension Foundation Buyers Club, Inc.||Florida District Office||New Drug/Labeling/Misbranded||Not Issued *|
|January 31, 2017||Ausmetics Daily Chemicals (Guangzhou) Co., Ltd||Center for Drug Evaluation and Research||CGMP/Finished Pharmaceuticals/Adulterated||Not Issued *|
|January 30, 2017||Bao International Inc||Los Angeles District Office||Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions||Not Issued *|
|January 26, 2017||Zhejiang Bangli Medical Products Co., Ltd||Center for Drug Evaluation and Research||CGMP/Finished Pharmaceuticals/Adulterated||Not Issued *|
|January 11, 2017||Mama Turney's Homemade Pies, Inc.||Nashville District Office||CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated||Not Issued *|
|December 14, 2016||Elec-cigs.co.uk||Center for Tobacco Products||Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded||Not Issued *|
|November 10, 2016||Thermogram Assessment Services||Center for Devices and Radiological Health||Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA)||Not Issued *|
|October 14, 2016||Fenwal Inc||Center for Biologics Evaluation and Research||False & Misleading Claims/Misbranded||Not Issued *|
|October 04, 2016||BroadMaster Biotech Corp.||Center for Devices and Radiological Health||CGMP/QSR/Medical Devices/Adulterated/Misbranded||Not Issued *|
|September 15, 2016||Hubei Hongkang Protective Products Co||Center for Devices and Radiological Health||CGMP/QSR/Medical Devices/Adulterated||Not Issued *|