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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
September 21, 2011 ECRS, LLC dba Big Chef Florida District Office Seafood HACCP/CGMP for Foods/Adulterated Not Issued *
September 21, 2011 Chippewa Valley Veterinary Clinic, Ltd. Minneapolis District Office Illegal Drug Residue February 03, 2012
September 21, 2011 Galyna / Ivan Podornikova Center for Drug Evaluation and Research Unapproved and Misbranded New Drugs Not Issued *
September 21, 2011 SPHERE Inc. Center for Drug Evaluation and Research Unapproved and Misbranded New Drugs Not Issued *
September 20, 2011 Botanic Oil Innovations, Inc. Minneapolis District Office CGMP Regulations For Dietary Supplements/Adulterated Not Issued *
September 20, 2011 Columbia University Medical Center RDRC Center for Drug Evaluation and Research Radioactive Drug Research Committee Not Issued *
September 20, 2011 Magic Mousse, Inc. dba Buttercream Minneapolis District Office Food Labeling Misbranded April 20, 2012
September 20, 2011 Heartland Products, Inc Kansas City District Office CGMP Regulation For Food/Adulterated Not Issued *
September 19, 2011 Nature's Rite Denver District Office Dietary Supplement/Labeling/False & Misleading Claims/Misbranded Not Issued *
September 16, 2011 Algonot, LLC Florida District Office New Drug/Misbranded Not Issued *
September 16, 2011 TCHO Ventures, Inc. San Francisco District Office CGMP for Manufacturing, Packing or Holding Human Food/Adulterated/Insanitary Conditions Not Issued *
September 16, 2011 Farriss Dairy Farms Cincinnati District Office Illegal Drug Residue Not Issued *
September 16, 2011 Euphoria Fancy Food Inc New York District Office Seafood HACCP/Adulterated Not Issued *
September 16, 2011 Capitol Food Services d.b.a Double A Provisions LLC New York District Office Seafood HACCP/Adulterated Not Issued *
September 15, 2011 Rausch Farms Minneapolis District Office Illegal Drug Residue November 22, 2011
September 15, 2011 Bednarek Brothers Minneapolis District Office Illegal Drug Residue November 22, 2011
September 15, 2011 Dental Technologies, Inc. Chicago District Office CGMP for Finished Pharmaceuticals/Adulterated May 29, 2012
September 14, 2011 Gilman Cheese Corporation Minneapolis District Office Low Acid Canned Food Regulation/Adulterated June 26, 2012
September 14, 2011 Hensley, Jimmy A. San Francisco District Office Illegal Drug Residue Not Issued *
September 14, 2011 P.T. Bonecom aka Bone Commercial Company Center for Food Safety and Applied Nutrition Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *



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