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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Enforcement Actions

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2011 Warning Letters

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Warning Letters issued in 2011

 

* Not issued: A close-out letter may issue when, based on FDA’s evaluation, the firm has taken corrective action to address the violations contained in the Warning Letter. This procedure applies to Warning Letters issued on or after September 1, 2009.

* N/A: Not applicable, the Warning Letter was issued prior to September 1, 2009.

Read more about warning and close-out letters

Posted on June 14, 2011

Letter Issue Date Company Name Issuing Office Subject Close Out Date
May 19, 2011 Prostar, Inc. New England District Office CGMP For Manfacturing, Processing, Packing, Storage & Holding/Adulterated Not Issued *
May 19, 2011 Facet Technologies, LLC Atlanta District Office CGMP/QSR/Medical Devices/Adulterated October 27, 2011
May 18, 2011 Innolatex SDN. BHD. Center for Devices and Radiological Health CGMP/QSR/Devices/Adulterated January 11, 2012
May 18, 2011 Reese Pharmaceutical Company Cincinnati District Office CGMP for Finished Pharmaceuticals/Adulterated Not Issued *
May 18, 2011 Natural Choice Distribution Company San Francisco District Office CGMP for Foods/Seafood HACCP/Adulterated/Misbranded Not Issued *
May 18, 2011 Dick Van Dam Dairy Los Angeles District Office Animals for Sale for Slaughter as Food/Adulterated Not Issued *
May 17, 2011 Schneider's Fish & Seafood Corp. New York District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
May 17, 2011 Medrad Inc Center for Devices and Radiological Health Devices/Reports of Corrections and Removals/Misbranded Not Issued *
May 17, 2011 Culpeper Farmers' Cooperative, Inc. Baltimore District Office CGMP for Medicated Feeds/Adulterated February 12, 2013
May 16, 2011 Church & Dwight Inc New Jersey District Office Medical Device Reporting/Misbranded June 27, 2012
May 16, 2011 Manolo and Son, LLC Baltimore District Office Seafood HACCP/Adulterated October 26, 2011
May 16, 2011 Aubrey Inc. Los Angeles District Office CGMP/QSR/Manufacture/Packing/Storage/Installation/Adulterated Not Issued *
May 16, 2011 Contes Pasta Company, Inc. New Jersey District Office Seafood HACCP/CGMP for Food/Adulterated January 06, 2012
May 16, 2011 AZCigs.com Center for Tobacco Products Modified Risk Tobacco Products Not Issued *
May 16, 2011 Anatolli Larionov Center for Tobacco Products Modified Risk Tobacco Products Not Issued *
May 16, 2011 General Project Center for Devices and Radiological Health Medical Device Reporting/Misbranded Not Issued *
May 16, 2011 cigarettesforless.com Center for Tobacco Products Modified Risk Tobacco Products Not Issued *
May 16, 2011 Allen Winner Center for Tobacco Products Modified Risk Tobacco Products Not Issued *
May 16, 2011 Best Products Solution Limited Center for Tobacco Products Modified Risk Tobacco Products Not Issued *
May 16, 2011 Janis Larsen Center for Tobacco Products Modified Risk Tobacco Products Not Issued *


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