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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
July 07, 2011 El Guanaco Bakery & Cafe Minneapolis District Office Labeling/False & Misleading Claims/Misbranded July 08, 2013
July 07, 2011 Confidence Inc. New York District Office CGMP/Manufacturing, Packaging, Labeling or Holding Operations for Dietary Supplements Regulation/Adulterated Not Issued *
July 07, 2011 Northern Boulevard Corporation dba Despana Brand Foods New York District Office Seafood HACCP/Adulterated Not Issued *
July 06, 2011 Punjab Trading, Inc. Seattle District Office CGMP For Manfacturing, Processing, Packing, Storage & Holding/Adulterated Not Issued *
July 06, 2011 De Jong Dairy, Inc. Detroit District Office Illegal Drug Residue August 17, 2011
July 06, 2011 Michelson, Joseph B., M.D. Center for Drug Evaluation and Research Clinical Investigator Not Issued *
July 06, 2011 Sogo Foods Inc. San Francisco District Office CGMP/Misbranded Not Issued *
July 05, 2011 Redwood Memorial Hospital San Francisco District Office Mammography Quality Standards Act Not Issued *
July 05, 2011 Mayer Laboratories, Inc. San Francisco District Office Lacks Premarket Approval Application/Adulterated/Misbranded March 09, 2012
July 01, 2011 Premium Gold Flax Products & Processing Inc. Minneapolis District Office Unapproved New Drug/Misbranded August 17, 2012
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 30, 2011 Signal Medical Corporation Detroit District Office CGMP/QSR/Medical Devices/Adulterated 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 Cytosport Inc San Francisco District Office False & Misleading Claims/Misbranded 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 October 01, 2014
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 Cook Group Inc. Atlanta District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *



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