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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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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

Letter Issue Date Company Name Issuing Office Subject Close Out Date
August 15, 2011 SCT Corporation Baltimore District Office Labeling/Misbranded Not Issued *
August 12, 2011 GD Designs, Inc. Los Angeles District Office CGMP/QSR/Medical Devices/Adulterated/Misbranded Not Issued *
August 12, 2011 Cohen, Yale M.D. Center for Drug Evaluation and Research Clinical Investigator Not Issued *
August 12, 2011 Askar Solutions, Ltd. Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded September 30, 2011
August 11, 2011 Dockside Fish Market Minneapolis District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
August 11, 2011 Shenberg Dental, dba Therozone Los Angeles District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
August 11, 2011 Michael P. Ferry Inc. New England District Office Illegal Drug Residue Not Issued *
August 10, 2011 Sampson, Clint Minneapolis District Office Illegal Drug Residue June 05, 2013
August 10, 2011 Hide A Way Dairy Denver District Office Illegal Drug Residue Not Issued *
August 10, 2011 H & L Jerch Sales, Inc. d/b/a Bell Lifestyle Products Inc Detroit District Office New Drug/Labeling/Misbranded June 07, 2013
August 10, 2011 Farm and Wild Fresh Paradise Gourmet Foods Seattle District Office CGMP for Manufacturing, Packing or Holding Human Food/Adulterated/Insanitary Conditions Not Issued *
August 09, 2011 American Quality Manufacturing, Inc. Florida District Office CGMP/QSR/Medical Devices/Adulterated/Misbranded January 31, 2012
August 09, 2011 Beckman Coulter, Inc. Los Angeles District Office CGMP/QSR/Medical Devices/Adulterated August 15, 2012
August 09, 2011 Philadelphia International Airport Philadelphia District Office Interstate Conveyance Sanitation Regulations/Provisional October 04, 2011
August 08, 2011 Kimriv Restaurant Group, LLC. (DBA) Royal Gourmet Foods Los Angeles District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
August 08, 2011 Porky Products Inc. New Jersey District Office Seafood HACCP/Adulterated February 21, 2012
August 08, 2011 Sivertson Fisheries Inc. dba Lake Superior Fish Company Minneapolis District Office Seafood HACCP/Adulterated June 27, 2012
August 08, 2011 The Best Chocolate In Town Detroit District Office CGMP for Manufacturing, Packing or Holding Human Food/Adulterated/Insanitary Conditions March 21, 2012
August 08, 2011 The North West Company International, Inc. Seattle District Office CGMP For Manufacturing, Packing, or Holding Human Food/Adulterated/Insanitary Conditions April 16, 2012
August 05, 2011 Lisbon Centre Farms New York District Office Illegal Drug Residue Not Issued *



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