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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Warning Letters

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Recently Posted | 2014 | 2013 | 2012 | 2011 | 2010 | 2009 | 2008 | 2007 | 2006 | 2005 | 2004 | 2003 | 2002 | 2001 | 2000 | 1999 | 1998 | 1997 | 1996 |

Tobacco Retailer Warning Letters

 

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Types of Warning Letters on the FDA Website

Read more about types of warning letters

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Ways to View/Browse Warning Letters

To view Warning Letters by date:

Or:

  • 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.

 

 

 

 
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 *


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