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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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2012 Warning Letters

Posted on January 08, 2013

Letter Issue Date Company Name Issuing Office Subject Close Out Date
December 17, 2012 Lifewatch Services, Inc. Chicago District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
December 14, 2012 Chamberlain Farms, Inc. Detroit District Office Food Labeling/Adulterated 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 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 Not Issued *
December 12, 2012 Novo Nordisk A/S Center for Drug Evaluation and Research CGMP/Finished Pharmaceuticals/Adulterated 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 12, 2012 Hangzhou Jinlin Medical Appliances Co., Ltd. Center for Devices and Radiological Health Medical Device Reporting Regulation/Misbranded Not Issued *
December 11, 2012 Amarc Enterprises Los Angeles District Office New Animal Drug/Adulterated Not Issued *
December 11, 2012 Braaksma Partnership Seattle District Office New Animal Drug/Adulterated 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 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 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 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 Not Issued *
December 07, 2012 Gonsalves Ranch San Francisco District Office Illegal Drug Residue Not Issued *
December 07, 2012 Basic Organics, Inc. Cincinnati District Office CGMP Regulations For Dietary Supplements/Adulterated Not Issued *
December 07, 2012 Cherry Point Products Inc. New England District Office CGMP for Foods/Adulterated Not Issued *


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