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|
|May 18, 2016||khahan LLC||Center for Tobacco Products||Family Smoking Prevention and Tobacco Control Act/Section 301(tt) Violation||Not Issued *|
|May 16, 2016||David Bridgewater||Cincinnati District Office||New Animal Drug/Adulterated||Not Issued *|
|May 16, 2016||N.A. Sales Company Inc.||San Francisco District Office||Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions||Not Issued *|
|May 16, 2016||BBT Biotech Gmbh||Center for Drug Evaluation and Research||CGMP/Active Pharmaceutical Ingredient (API)/Adulterated||Not Issued *|
|May 16, 2016||Qiagen Sciences LLC||Baltimore District Office||CGMP/QSR/Medical Devices/Adulterated/Misbranded||Not Issued *|
|May 13, 2016||Rocky Fork Formulas Inc||Cincinnati District Office||CGMP/Dietary Supplement/Adulterated/Misbranded||Not Issued *|
|May 12, 2016||Hannibal Company Inc||Cincinnati District Office||CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated||Not Issued *|
|May 12, 2016||Somnowell, Inc.||New Orleans District Office||CGMP/QSR/Medical Devices/Adulterated||Not Issued *|
|May 12, 2016||Tai Heng Industry Co., Ltd.||Center for Drug Evaluation and Research||CGMP/Active Pharmaceutical Ingredient (API)/Adulterated||Not Issued *|
|May 05, 2016||www.baracoatobacconist.com||Center for Tobacco Products||Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded||Not Issued *|
|May 05, 2016||Renovis Surgical Technologies, Inc.||Los Angeles District Office||CGMP/QSR/Medical Devices/Adulterated||Not Issued *|
|May 05, 2016||Banner Pharmacy Services, LLC||Los Angeles District Office||CGMP/Compounded Drugs/Misbranding||Not Issued *|
|February 05, 2016||Beauty & Health International Inc.||Los Angeles District Office||CGMP/Dietary Supplement/Adulterated/Misbranded||Not Issued *|