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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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2012 Warning Letters

Letter Issue Date Company Name Issuing Office Subject Close Out Date
December 17, 2012 Daniel W. Siegert Kansas City District Office Illegal Drug Residue Not Issued *
December 17, 2012 Taiwan Three Mast Pharmaceutical Co.Ltd. Center for Drug Evaluation and Research CGMP/Finished Pharmaceuticals/Misbranded Not Issued *
December 14, 2012 Raca Enterprises, Inc. dba Life Cycle Herbal Products Los Angeles District Office CGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated Not Issued *
December 14, 2012 Chamberlain Farms, Inc. Detroit District Office Food Labeling/Adulterated November 05, 2013
December 13, 2012 TMS International Center for Devices and Radiological Health Quality System Regulation for Medical Devices/Adulterated Not Issued *
December 13, 2012 Cross Country Dairy Denver District Office Illegal Drug Residue January 02, 2014
December 12, 2012 Hangzhou Jinlin Medical Appliances Co., Ltd. Center for Devices and Radiological Health Medical Device Reporting Regulation/Misbranded May 21, 2013
December 12, 2012 Novo Nordisk A/S Center for Drug Evaluation and Research CGMP/Finished Pharmaceuticals/Adulterated January 23, 2014
December 12, 2012 Spring Water Farm, LLC New York District Office Illegal Drug Residue Not Issued *
December 12, 2012 Contract Medical International Spol. S.o.r. Center for Devices and Radiological Health Medical Device Reporting Regulation/Adulterated/Misbranded Not Issued *
December 11, 2012 Kennys Farmhouse Cheese Cincinnati District Office CGMP/Manufacturing, Packing or Holding Human Food/Adulterated/Insanitary Conditions Not Issued *
December 11, 2012 Braaksma Partnership Seattle District Office New Animal Drug/Adulterated Not Issued *
December 11, 2012 Amarc Enterprises Los Angeles District Office New Animal Drug/Adulterated Not Issued *
December 11, 2012 Jack Dei Dairy San Francisco District Office Illegal Drug Residue Not Issued *
December 11, 2012 Souza Dairy Los Angeles District Office Illegal Drug Residue Not Issued *
December 10, 2012 Mary Borba Parente dba: L&M Dairy Los Angeles District Office Illegal Drug Residue Not Issued *
December 10, 2012 Missa Bay, LLC New Jersey District Office CGMP for Food, Prepared, Packaged or Held Under Insanitary Conditions/Adulterated July 24, 2013
December 10, 2012 Barton-Carey Products, Inc. Cincinnati District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
December 10, 2012 Prime Herbs Corporation San Francisco District Office CGMP for Medical Devices/QSR/Adulterated/Misbranded Not Issued *
December 07, 2012 Cherry Point Products Inc. New England District Office CGMP for Foods/Adulterated Not Issued *



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