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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
June 15, 2011 Inversiones Himalaya S.A Center for Food Safety and Applied Nutrition Low Acid Canned Food Regulation/Adulterated Not Issued *
June 15, 2011 Biolife, LLC Florida District Office Premarket Approval/Misbranded/Adulterated Not Issued *
June 14, 2011 My Company New England District Office asdfasdf Not Issued *
June 14, 2011 Pointcare Technologies, Inc New England District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
June 14, 2011 Culinary Crossing Inc. Philadelphia District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions July 12, 2012
June 14, 2011 Advanced Fertility Group, PC Detroit District Office Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products May 08, 2012
June 13, 2011 Sally Jackson Cheeses Seattle District Office CGMP for Manufacturing, Packing or Holding Human Food/Adulterated/Insanitary Conditions Not Issued *
June 13, 2011 Mother Frances Hospital IRB Center for Devices and Radiological Health IRB (Institutional Review Board) Not Issued *
June 13, 2011 Centra Health Inc IRB Center for Devices and Radiological Health IRB (Institutional Review Board) Not Issued *
June 10, 2011 Abiomed, Inc. Center for Devices and Radiological Health Medical Device/Adulterated/Misbranded/Lacks PMA and/or 510(k) Not Issued *
June 09, 2011 FSC Laboratories, Inc. Atlanta District Office CGMP/QSR/Medical Devices/Adulterated February 21, 2012
June 09, 2011 Northside Farms LLC Dallas District Office Illegal Drug Residue July 11, 2012
June 08, 2011 Applied Medical Technology Inc Cincinnati District Office CGMP/QSR/Medical Devices/Adulterated May 01, 2012
June 07, 2011 Philips Medical Systems (Cleveland) Inc Cincinnati District Office CGMP/QSR/Manufacture/Packing/Storage/Installation/Adulterated September 18, 2012
June 07, 2011 Kellogg Company Atlanta District Office CGMP for Manufacturing, Packing or Holding Human Food/Adulterated/Insanitary Conditions August 15, 2012
June 06, 2011 Orion Vision Group Atlanta District Office CGMP/QSR/Manufacture/Packing/Storage/Installation/Adulterated Not Issued *
June 03, 2011 Matrixx Initiatives Inc Los Angeles District Office New Drug/Misbranded May 30, 2013
June 03, 2011 Artsana S.p.A Center for Devices and Radiological Health CGMP/QSR/Medical Devices/Adulterated Not Issued *
June 03, 2011 Bradley D Spear Cincinnati District Office Illegal Drug Residue/Adulterated January 10, 2012
June 03, 2011 Dr. Reddys de Mexico Center for Drug Evaluation and Research CGMP for Active Pharmaceutical Ingredient (API)/Adulterated July 12, 2012



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