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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Enforcement Actions

2013 Warning Letters

Letter Issue Date Company Name Issuing Office Subject Close Out Date
July 11, 2013 Health King Enterprise & Balanceuticals Group, Inc. Chicago District Office Unapproved new drug/Misbranded Not Issued *
July 11, 2013 Dutch Dairy Los Angeles District Office Illegal Drug Residue Not Issued *
July 11, 2013 Falling Star Farm, Ltd. Cincinnati District Office Illegal Drug Residue Not Issued *
July 11, 2013 Castle Cheese, Inc. Philadelphia District Office Adulterated/Misbranded Food Not Issued *
July 11, 2013 Precise Nutrition International, Inc. Los Angeles District Office CGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated Not Issued *
July 08, 2013 Grant's Smokehouse Ltd. Center for Food Safety and Applied Nutrition Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
July 05, 2013 Enraf-Nonius B.V. Center for Devices and Radiological Health Adulterated Device Not Issued *
July 05, 2013 Hilltop Jersey Farm Dallas District Office Illegal Drug Residue Not Issued *
July 03, 2013 Leroy C. Wormell, Jr. and Son, Inc. New England District Office Illegal Drug Residue Not Issued *
July 03, 2013 Rusty Knoll Farm, Inc New England District Office Illegal Drug Residue Not Issued *
July 03, 2013 SCM True Air Technologies LLC Cincinnati District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
July 03, 2013 Meridian Medical Systems LLC Cincinnati District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
July 02, 2013 Productos Alimentios Centroamericanos, S.A. Center for Food Safety and Applied Nutrition CGMP/Acidified Foods/Adulterated November 22, 2013
July 02, 2013 Chan Yee Jai Center for Food Safety and Applied Nutrition CGMP/Manufacturing, Packing or Holding Human Food/Adulterated/Insanitary Conditions Not Issued *
July 02, 2013 Cispharma Inc. New Jersey District Office CGMP/Finished Pharmaceuticals/Adulterated Not Issued *
July 01, 2013 Wesley Bourcy New York District Office Illegal Drug Residue Not Issued *
July 01, 2013 Sabila SRL Center for Food Safety and Applied Nutrition CGMP/Acidified Foods/Adulterated October 17, 2013
July 01, 2013 Fresenius Kabi Oncology Ltd Center for Drug Evaluation and Research CGMP/Finished Pharmaceuticals/Adulterated Not Issued *
July 01, 2013 NINGBO LINGGUANG ELECTRIC APPLIANCE CO., LTD. Center for Devices and Radiological Health Medical Device/Adulterated/Misbranded/Lacks PMA and/or 510(k) Not Issued *
June 27, 2013 AYGUN CERRAHI ALETIER A.S.SURGICAL INSTRUMENTS CO. Center for Devices and Radiological Health Quality System Regulation for Medical Devices/Adulterated Not Issued *



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