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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Enforcement Actions

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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

Posted on July 05, 2011

Letter Issue Date Company Name Issuing Office Subject Close Out Date
June 24, 2011 3V Dairy Denver District Office Illegal Drug Residue November 21, 2012
June 24, 2011 Buddy Squirrel LLC Minneapolis District Office Food Labeling Misbranded February 03, 2012
June 23, 2011 Dynamic Pharmaceuticals, Inc. 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 Animals for Sale for Slaughter as Food/Adulterated Not Issued *
June 21, 2011 Cadila Healthcare Limited 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. Minneapolis District Office Seafood HACCP/CGMP for Foods/Adulterated December 19, 2011
June 17, 2011 WHB Cattle, LP (Braum Dairy Farms) Dallas District Office Illegal Drug Residue Not Issued *
June 17, 2011 BioSan Laboratories, Inc. New England District Office Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated Not Issued *
June 17, 2011 Wild Foods, Inc Minneapolis District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
June 17, 2011 La Fiesta Food Products, Inc. San Francisco District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
June 16, 2011 Heraeus Kulzer GmbH Center for Devices and Radiological Health Medical Device Reporting/Misbranded Not Issued *
June 15, 2011 Ozark Bottling Co Kansas City District Office Acidified Foods/Adulterated Not Issued *
June 15, 2011 Landaverde Cattle Ranch Denver District Office Illegal Drug Residue November 21, 2012
June 15, 2011 New Century Foods Corp. Baltimore District Office Labeling/False & Misleading Claims/Misbranded Not Issued *
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 Commonwealth Serum Laboratories (CSL), Ltd. Center for Biologics Evaluation and Research CGMP Deviations August 10, 2012
June 15, 2011 Biolife, LLC Florida District Office Premarket Approval/Misbranded/Adulterated Not Issued *
June 15, 2011 Syracuse Dairy LLP Kansas City District Office Illegal Drug Residue October 29, 2012
June 14, 2011 Advanced Fertility Group, PC Detroit District Office Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products May 08, 2012
June 14, 2011 My Company New England District Office asdfasdf Not Issued *


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