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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 July 31, 2012

Letter Issue Date Company Name Issuing Office Subject Close Out Date
July 17, 2012 Sybron Dental Specialties Center for Devices and Radiological Health Premarket Approval/Adulterated October 02, 2012
July 17, 2012 Medtronic, Inc. Minneapolis District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
July 16, 2012 Gooten Innolife Corp Center for Devices and Radiological Health Adulterated Device/Misbranded Not Issued *
July 16, 2012 Ningbo Huahui Medical Instruments Co., LTD Center for Devices and Radiological Health CGMP/QSR/Medical Devices/Adulterated/Misbranded Not Issued *
July 16, 2012 Quanta Aesthetic Lasers USA, LLC Center for Devices and Radiological Health Premarket Approval/Misbranded Not Issued *
July 14, 2012 Shijiazhuang Pharma. Group Zhongnuo Pharmaceuticals Co. Ltd Center for Drug Evaluation and Research CGMP/Finished Pharmaceuticals/Adulterated/Misbranded Not Issued *
July 13, 2012 P.T. Super Saku Bali Center for Food Safety and Applied Nutrition Seafood HACCP/Adulterated Not Issued *
July 12, 2012 Silva Foods Of Kansas City Kansas City District Office Acidified Foods/Acid Canned Food Regulation/Adulterated/Misbranded Not Issued *
July 12, 2012 Brunner Farm Minneapolis District Office Veterinary Medicine/Misbranded April 19, 2013
July 12, 2012 Sanofi Pasteur Center for Biologics Evaluation and Research CGMP Deviations Not Issued *
July 12, 2012 Alfa Vitamins Laboratories, Inc. Florida District Office New Drug/Labeling/False & Misleading Claims Not Issued *
July 11, 2012 Quantum Devices, Inc. Center for Devices and Radiological Health Device/Adulterated Not Issued *
July 11, 2012 Leisegang Feinmechanik-Optik GmbH Center for Devices and Radiological Health CGMP/QSR/Medical Devices/Adulterated/Misbranded Not Issued *
July 11, 2012 NeuroTherm, Inc. New England District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
July 10, 2012 Evol Nutrition Associates, Inc. Atlanta District Office Dietary Supplements/Food/New Drug/Adulterated/Misbranded Not Issued *
July 10, 2012 The American Bottling Company, Inc. Dallas District Office Juice HACCP/Adulterated Not Issued *
July 09, 2012 Ronald Andio, DBA Patron Farms, LLC Cincinnati District Office Illegal Drug Residue Not Issued *
July 09, 2012 www.storecigarettes.com Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
July 09, 2012 Franck's Lab Inc., d.b.a. Franck's Compounding Lab Florida District Office Labeling/False & Misleading Claims/Misbranded/Adulterated/Insanitary Conditions Not Issued *
July 09, 2012 Ciresa Formaggi Snc Center for Food Safety and Applied Nutrition CGMP/Manufacturing, Packing or Holding Human Food/Adulterated/Insanitary Conditions Not Issued *


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