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 a simple search by entering criteria into the search box below.
- 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.
- Warning letters posted before June 25, 2001, are in PDF format. Warning letters posted after that date are available in HTML format.
- Persons with disabilities having problems accessing PDF files may call 301-827-6567 for assistance.
- 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), 5600 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|
|April 11, 2014||Han Yang Oriental Food Mfg||Seattle District Office||Food CGMP Violations||Not Issued *|
|April 10, 2014||American Medical Systems, Inc.||Minneapolis District Office||CGMP/QSR/Medical Devices/Adulterated||Not Issued *|
|April 10, 2014||Montana Fish Company||Seattle District Office||Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions||Not Issued *|
|April 09, 2014||Sunrise Meats, Inc.||Seattle District Office||Seafood HACCP/CGMP for Foods/Adulterated/Misbranded||Not Issued *|
|April 09, 2014||Boyko Foods, LLC||Minneapolis District Office||Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions||Not Issued *|
|April 01, 2014||Cytophil, Inc.||Minneapolis District Office||CGMP/QSR/Medical Devices/Adulterated||Not Issued *|
|April 01, 2014||Bio-Recovery Inc.||Minneapolis District Office||CGMP/Dietary Supplement/Adulterated/Misbranded||Not Issued *|
|March 14, 2014||Pattanam D. Srinivasan, MD||Center for Devices and Radiological Health||Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated Device||Not Issued *|
|March 11, 2014||Colorado Histo-Prep||Center for Drug Evaluation and Research||Good Laboratory Practice (GLP) for Nonclinical Laboratory Studies||Not Issued *|
|March 11, 2014||Teleflex Medical||Chicago District Office||CGMP/QSR/Medical Devices/Adulterated||Not Issued *|
|February 28, 2014||Richard Wolf Medical Instruments Corp.||Chicago District Office||CGMP/QSR/Medical Devices/Adulterated||Not Issued *|
|February 07, 2014||Advanced Interventional Pain Ctr IRB||Center for Devices and Radiological Health||Institutional Review Board (IRB)/Investigational Device Exemptions||Not Issued *|
|November 15, 2013||Kootenai Medical Center IRB||Center for Devices and Radiological Health||Institutional Review Board (IRB)/Investigational Device Exemptions||Not Issued *|