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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 15, 2011 Natural Guidance, LLC Florida District Office Labeling/False & Misleading Claims/New Drug/Misbranded Not Issued *
July 15, 2011 Advance Pierre Foods Atlanta District Office CGMP Regulation For Food/Adulterated Not Issued *
July 15, 2011 Nutt Dairy Denver District Office Illegal Drug Residue Not Issued *
July 15, 2011 George Packing Company, Inc. Seattle District Office Insanitary Conditions/Adulterated January 31, 2012
July 15, 2011 Grand Cakes Inc. San Juan District Office Food Labeling/Adulterated/Misbranded May 13, 2013
July 15, 2011 Seattle Sperm Bank, LLC Seattle District Office Human Cells, Tissues & Cellular Products Not Issued *
July 15, 2011 Hardy Peanuts, Inc. Atlanta District Office New Drug/Misbranded Not Issued *
July 15, 2011 Lehigh Valley Technologies, Inc. Philadelphia District Office CGMP for Finished Pharmaceuticals/Adulterated January 09, 2012
July 14, 2011 Pharmaceutical Company Jelfa SA Center for Drug Evaluation and Research CGMP for Finished Pharmaceuticals/Adulterated February 28, 2013
July 14, 2011 Rose Acre Farms, Inc. White County Egg Farm Detroit District Office PHS Act/Shell Egg Regulation/Adulterated February 12, 2014
July 14, 2011 Nemschoff Chairs, Inc. Minneapolis District Office CGMP for Medical Devices/QS/Adulterated Not Issued *
July 14, 2011 Shaping Beauty, Inc. / H & S GMP Factory Philadelphia District Office Unapproved New Drug/Misbranded January 03, 2012
July 13, 2011 Online-Smokes Center for Tobacco Products Modified Risk Tobacco Products Not Issued *
July 13, 2011 Roy and Louise Noble Dairy Farm Philadelphia District Office Illegal Drug Residue Not Issued *
July 13, 2011 Wayan Sumartini Saraswati Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded August 25, 2011
July 12, 2011 Valmont Dairy LLC New York District Office Animals for Sale for Slaughter as Food/Adulterated Not Issued *
July 12, 2011 Peace Medical Inc. New Jersey District Office CGMP/QSR/Medical Devices/Adulterated July 05, 2012
July 08, 2011 Veeser Farms Minneapolis District Office Animals for Sale for Slaughter as Food/Adulterated Not Issued *
July 07, 2011 Cody L Emberton Cincinnati District Office Illegal Drug Residue March 08, 2012
July 07, 2011 Northern Boulevard Corporation dba Despana Brand Foods New York District Office Seafood HACCP/Adulterated Not Issued *



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