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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 March 13, 2012

Letter Issue Date Company Name Issuing Office Subject Close Out Date
February 14, 2012 Jenis, Louis G., M.D. Center for Devices and Radiological Health Clinical Investigator Not Issued *
February 14, 2012 The Hershey Company Center for Food Safety and Applied Nutrition Food Labeling/Misbranded Not Issued *
February 13, 2012 Meadowlark Dairy L.L.C. Minneapolis District Office Illegal Drug Residue April 13, 2012
February 12, 2012 I.E.M. GmbH Center for Devices and Radiological Health Medical Device Reporting/Misbranded Not Issued *
February 09, 2012 BioAnue Laboratories, Inc. Atlanta District Office Dietary supplement/New Drug Not Issued *
February 09, 2012 Mirrotek International, LLC New Jersey District Office Acidified Foods/Emergency Permit Control/Adulterated August 20, 2012
February 09, 2012 Pork Champ, LLC Cincinnati District Office Illegal Drug Residue Not Issued *
February 09, 2012 Home Care Technologies USA, Inc. Los Angeles District Office CGMP/QSR/Medical Devices/Adulterated/Misbranded October 19, 2012
February 08, 2012 Vitaganic Inc. San Francisco District Office Current Good Manufacturing Practice/Dietary Supplements/Adulterated Not Issued *
February 08, 2012 Probed Medical Technologies, Inc. Center for Devices and Radiological Health Adulterated Device August 28, 2012
February 08, 2012 Tree Top, Inc. Seattle District Office Adulterated Food Not Issued *
February 08, 2012 Intelligent Hospital Systems Center for Devices and Radiological Health Adulterated Device Not Issued *
February 08, 2012 Donut Factory, LLC. Seattle District Office CGMP for Manufacturing, Packing or Holding Human Food/Adulterated/Insanitary Conditions May 01, 2012
February 07, 2012 Fieser Dairy, Inc. Florida District Office Illegal Drug Residue Not Issued *
February 07, 2012 Blossom Enterprises LLC d/b/a Sea Blossom Seafoods Seattle District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
February 06, 2012 Productos del Convento, S.A. de C.V. Center for Food Safety and Applied Nutrition Low Acid Canned Food Regulation/Adulterated Not Issued *
February 06, 2012 Globe All Wellness, LLC Florida District Office New Drugs/Dietary Supplements/Misbranded Not Issued *
February 03, 2012 Ken Gonnering Livestock, Inc. Minneapolis District Office Illegal Drug Residue February 24, 2012
February 03, 2012 West-Ward Pharmaceuticals Corp. New Jersey District Office CGMP for Finished Pharmaceuticals/Adulterated Not Issued *
February 03, 2012 Orthopedic Alliance Los Angeles District Office CGMP/QSR/Adulterated/Misbranded Not Issued *


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