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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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2014 Warning Letters

Letter Issue Date Company Name Issuing Office Subject Close Out Date
December 16, 2014 Little Brown Smoke Shack Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
December 16, 2014 William Tisinger Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
December 15, 2014 Gerratt Dairy Seattle District Office Illegal Drug Residue Animal Tissue/Adulterated Not Issued *
December 09, 2014 Sagemax Bioceramics, Inc. Seattle District Office CGMP/QSR/Medical Devices/Adulterated/Misbranded Not Issued *
December 09, 2014 Delta Pharma, Inc. New Orleans District Office CGMP/Drug/Prepared, Packed or Held Under Insanitary Conditions/Adulterated Not Issued *
December 09, 2014 NYWP Enterprise LLC. Philadelphia District Office CGMP/Manufacturing, Packing or Holding Human Food/Adulterated/Insanitary Conditions Not Issued *
December 08, 2014 Yandi New York Trading Co Ltd New York District Office Seafood HACCP/CGMP for Foods/Adulterated Not Issued *
December 08, 2014 Oxysure Systems, Inc. Dallas District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
December 08, 2014 baccycafe.com Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
December 08, 2014 Emerald Dairy, LLC and Emerald Dairy II, LLC Minneapolis District Office Illegal Drug Residue January 05, 2015
December 08, 2014 Karl Storz Endovision, Inc. New England District Office CGMP/QSR/Medical Devices/Adulterated/Misbranded Not Issued *
December 05, 2014 Murmac Farms LLC Philadelphia District Office Illegal Drug Residue Not Issued *
December 05, 2014 Pacific Hi - Tak Inc San Francisco District Office Seafood HACCP/CGMP for Foods/Adulterated Not Issued *
December 04, 2014 DG Farms San Francisco District Office Illegal Drug Residue Not Issued *
December 04, 2014 Maquet Cardiopulmonary Ag Center for Devices and Radiological Health Premarket Approval/Misbranded/Adulterated Not Issued *
December 03, 2014 Michael A Hatcher Cincinnati District Office Illegal Drug Residue Not Issued *
November 28, 2014 Hyland Acres Jerseys, Ltd. Cincinnati District Office Illegal Drug Residue Not Issued *
November 26, 2014 Buffalo Gills LLC Baltimore District Office Acidified Foods/Emergency Permit Control/Adulterated/Misbranded Not Issued *
November 24, 2014 Crimasa Criaderos De Mariscos S. A. Center for Food Safety and Applied Nutrition Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
November 24, 2014 Cell Vitals Center for Food Safety and Applied Nutrition New Drug/Labeling/Misbranded Not Issued *



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