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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

 
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Letter Issue Date Company Name Issuing Office Subject Close Out Date
June 28, 2011 Aerscher Diagnostics, LLC [ARCHIVED] Baltimore District Office CGMP/QSR/Medical Devices/Adulterated/Misbranded March 19, 2012
June 27, 2011 Belcorp of America [ARCHIVED] Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded November 17, 2011
June 24, 2011 Cook Group Inc. [ARCHIVED] Atlanta District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
June 24, 2011 3V Dairy [ARCHIVED] Denver District Office Illegal Drug Residue November 21, 2012
June 24, 2011 Musco Food Corp [ARCHIVED] New York District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
June 24, 2011 Velocity Pharma LLC [ARCHIVED] New York District Office CGMP/Manufacturing, Packaging, Labeling or Holding Operations for Dietary Supplements Regulation/Adulterated Not Issued *
June 24, 2011 Pro Paks, LLC [ARCHIVED] New England District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
June 24, 2011 Buddy Squirrel LLC [ARCHIVED] Minneapolis District Office Food Labeling Misbranded February 03, 2012
June 24, 2011 National Creative Enterprises, Inc. [ARCHIVED] Minneapolis District Office CGMP/QSR/Medical Devices/Adulterated July 03, 2013
June 23, 2011 Dynamic Pharmaceuticals, Inc. [ARCHIVED] Florida District Office Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling or Holding Operations for Dietary Supplements Not Issued *
June 22, 2011 Da Silva Dairy San Francisco District Office Illegal Drug Residue Not Issued *
June 21, 2011 Cadila Healthcare Limited [ARCHIVED] Center for Drug Evaluation and Research CGMP/Finished Pharmaceuticals/Adulterated July 11, 2012
June 17, 2011 Wild Foods, Inc. dba Ma Baensch's, Baensch Food Products Co. [ARCHIVED] Minneapolis District Office Seafood HACCP/CGMP for Foods/Adulterated December 19, 2011
June 17, 2011 WHB Cattle, LP (Braum Dairy Farms) [ARCHIVED] Dallas District Office Illegal Drug Residue Not Issued *
June 17, 2011 Wild Foods, Inc [ARCHIVED] Minneapolis District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
June 17, 2011 La Fiesta Food Products, Inc. [ARCHIVED] San Francisco District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
June 17, 2011 BioSan Laboratories, Inc. [ARCHIVED] New England District Office Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated September 02, 2014
June 16, 2011 Heraeus Kulzer GmbH [ARCHIVED] Center for Devices and Radiological Health Medical Device Reporting/Misbranded Not Issued *
June 15, 2011 Commonwealth Serum Laboratories (CSL), Ltd. [ARCHIVED] Center for Biologics Evaluation and Research CGMP Deviations August 10, 2012
June 15, 2011 New Century Foods Corp. [ARCHIVED] Baltimore District Office Labeling/False & Misleading Claims/Misbranded Not Issued *
June 15, 2011 Landaverde Cattle Ranch [ARCHIVED] Denver District Office Illegal Drug Residue November 21, 2012
June 15, 2011 Syracuse Dairy LLP [ARCHIVED] Kansas City District Office Illegal Drug Residue October 29, 2012
June 15, 2011 Ozark Bottling Co [ARCHIVED] Kansas City District Office Acidified Foods/Adulterated Not Issued *
June 15, 2011 Inversiones Himalaya S.A [ARCHIVED] Center for Food Safety and Applied Nutrition Low Acid Canned Food Regulation/Adulterated Not Issued *
June 15, 2011 Biolife, LLC [ARCHIVED] Florida District Office Premarket Approval/Misbranded/Adulterated Not Issued *
June 14, 2011 Pointcare Technologies, Inc [ARCHIVED] New England District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
June 14, 2011 Culinary Crossing Inc. [ARCHIVED] Philadelphia District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions July 12, 2012
June 14, 2011 Advanced Fertility Group, PC [ARCHIVED] Detroit District Office Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products May 08, 2012
June 13, 2011 Sally Jackson Cheeses [ARCHIVED] Seattle District Office CGMP for Manufacturing, Packing or Holding Human Food/Adulterated/Insanitary Conditions Not Issued *
June 13, 2011 Mother Frances Hospital IRB [ARCHIVED] Center for Devices and Radiological Health Institutional Review Board (IRB) Not Issued *
June 13, 2011 Centra Health Inc IRB [ARCHIVED] Center for Devices and Radiological Health Institutional Review Board (IRB) Not Issued *
June 10, 2011 Abiomed, Inc. [ARCHIVED] Center for Devices and Radiological Health Medical Device/Adulterated/Misbranded/Lacks PMA and/or 510(k) Not Issued *
June 09, 2011 FSC Laboratories, Inc. [ARCHIVED] Atlanta District Office CGMP/QSR/Medical Devices/Adulterated February 21, 2012
June 09, 2011 Northside Farms LLC [ARCHIVED] Dallas District Office Illegal Drug Residue July 11, 2012
June 08, 2011 Applied Medical Technology Inc [ARCHIVED] Cincinnati District Office CGMP/QSR/Medical Devices/Adulterated May 01, 2012
June 07, 2011 Philips Medical Systems (Cleveland) Inc [ARCHIVED] Cincinnati District Office CGMP/QSR/Manufacture/Packing/Storage/Installation/Adulterated September 18, 2012
June 07, 2011 Kellogg Company [ARCHIVED] Atlanta District Office CGMP for Manufacturing, Packing or Holding Human Food/Adulterated/Insanitary Conditions August 15, 2012
June 06, 2011 Orion Vision Group [ARCHIVED] Atlanta District Office CGMP/QSR/Manufacture/Packing/Storage/Installation/Adulterated Not Issued *
June 03, 2011 Matrixx Initiatives Inc [ARCHIVED] Los Angeles District Office New Drug/Misbranded May 30, 2013
June 03, 2011 Artsana S.p.A [ARCHIVED] Center for Devices and Radiological Health CGMP/QSR/Medical Devices/Adulterated Not Issued *
June 03, 2011 Bradley D Spear [ARCHIVED] Cincinnati District Office Illegal Drug Residue January 10, 2012
June 03, 2011 Dr. Reddys de Mexico [ARCHIVED] Center for Drug Evaluation and Research CGMP for Active Pharmaceutical Ingredient (API)/Adulterated July 12, 2012
June 03, 2011 Gloria's Pantry [ARCHIVED] San Francisco District Office CGMP For Manufacturing, Packing, or Holding Human Food/Adulterated/Insanitary Conditions November 04, 2011
June 02, 2011 Los Genuinos, Inc. [ARCHIVED] San Juan District Office CGMP for Manufacturing, Packing or Holding Human Food/Adulterated/Insanitary Conditions Not Issued *
June 01, 2011 Tatra Herb Company [ARCHIVED] Philadelphia District Office New Drug/Labeling/Misbranded June 01, 2012
June 01, 2011 Rolf's Patisserie [ARCHIVED] Chicago District Office CGMP For Manufacturing, Packing, or Holding Human Food/Adulterated/Insanitary Conditions Not Issued *
May 31, 2011 Butterfly Bakery Inc [ARCHIVED] New Jersey District Office Food Labeling/False & Misleading/Misbranded Not Issued *
May 31, 2011 Impax Laboratories, Inc [ARCHIVED] San Francisco District Office CGMP for Finished Pharmaceuticals/Adulterated Not Issued *
May 27, 2011 Columbine Specialty Products Inc. [ARCHIVED] Denver District Office CGMP For Manfacturing, Processing, Packing, Storage & Holding/Adulterated Not Issued *
May 27, 2011 Euro International Foods, Inc. [ARCHIVED] Seattle District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions April 10, 2012

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