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|
|June 16, 2016||Adriatic Seafood Inc||New York District Office||Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions||Not Issued *|
|June 14, 2016||Suisan Company, Ltd||San Francisco District Office||Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions||Not Issued *|
|June 13, 2016||S.R. Burzynski Manufacturing Facility||Center for Drug Evaluation and Research||CGMP/Finished Pharmaceuticals/Adulterated||Not Issued *|
|June 07, 2016||Millers of Wyckoff, Inc.||New Jersey District Office||CGMP/Finished Pharmaceuticals/Adulterated/Misbranded||Not Issued *|
|June 03, 2016||Qualgen||Dallas District Office||Unapproved New Drug/Compounding/Misbranding/Adulterated||Not Issued *|
|June 02, 2016||Valley Processing, Inc.||Seattle District Office||Juice HACCP/CGMP for Foods/Adulterated/Insanitary Conditions||Not Issued *|
|June 02, 2016||TYRX Inc.||New Jersey District Office||CGMP/QSR/Medical Devices/Adulterated||Not Issued *|
|May 27, 2016||MGM Cattle Co. LTD||Dallas District Office||Illegal Drug Residue||Not Issued *|
|May 24, 2016||American Pure Whey||Atlanta District Office||CGMP/Dietary Supplement/Adulterated/Misbranded||Not Issued *|
|April 14, 2016||Neuralight HD, LLC||Center for Drug Evaluation and Research||Sponsor/Investigator||Not Issued *|
|February 04, 2016||Berwickshire Electronic Manufacturing Ltd.||Center for Devices and Radiological Health||CGMP/QSR/Medical Devices/Adulterated||Not Issued *|