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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Enforcement Actions

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
July 07, 2011 Short Branch Farms LLC Cincinnati District Office Illegal Drug Residue February 07, 2012
July 07, 2011 El Guanaco Bakery & Cafe Minneapolis District Office Labeling/False & Misleading Claims/Misbranded July 08, 2013
July 06, 2011 De Jong Dairy, Inc. Detroit District Office Illegal Drug Residue August 17, 2011
July 06, 2011 Sogo Foods Inc. San Francisco District Office CGMP/Misbranded Not Issued *
July 06, 2011 Michelson, Joseph B., M.D. Center for Drug Evaluation and Research Clinical Investigator Not Issued *
July 06, 2011 Punjab Trading, Inc. Seattle District Office CGMP For Manfacturing, Processing, Packing, Storage & Holding/Adulterated Not Issued *
July 05, 2011 Mayer Laboratories, Inc. San Francisco District Office Lacks Premarket Approval Application/Adulterated/Misbranded March 09, 2012
July 05, 2011 Redwood Memorial Hospital San Francisco District Office Mammography Quality Standards Act Not Issued *
July 01, 2011 Premium Gold Flax Products & Processing Inc. Minneapolis District Office Unapproved New Drug/Misbranded August 17, 2012
June 30, 2011 Signal Medical Corporation Detroit District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
June 30, 2011 Mai's Bakery Corp Los Angeles District Office CGMP For Manufacturing, Packing, or Holding Human Food/Adulterated/Insanitary Conditions Not Issued *
June 29, 2011 Cytosport Inc San Francisco District Office False & Misleading Claims/Misbranded Not Issued *
June 29, 2011 Hunter Haven Farms Chicago District Office Animals for Sale for Slaughter as Food/Adulterated Not Issued *
June 29, 2011 JJ cake & Pastry, Corp San Juan District Office CGMP For Manufacturing, Packing, or Holding Human Food/Adulterated/Insanitary Conditions Not Issued *
June 29, 2011 First Commercial Kitchen, L.L.C. San Francisco District Office Acidified Foods/Adulterated Not Issued *
June 28, 2011 MICROspecialties, Inc. New England District Office CGMP/QSR/Manufacture/Packing/Storage/Installation/Adulterated Not Issued *
June 28, 2011 Aerscher Diagnostics, LLC Baltimore District Office CGMP/QSR/Medical Devices/Adulterated/Misbranded March 19, 2012
June 27, 2011 Belcorp of America Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded November 17, 2011
June 24, 2011 Pro Paks, LLC New England District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
June 24, 2011 Buddy Squirrel LLC Minneapolis District Office Food Labeling Misbranded February 03, 2012



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