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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 August 21, 2012

    Letter Issue Date Company Name Issuing Office Subject Close Out Date
    July 18, 2012 Meditech Kft. Center for Devices and Radiological Health Adulterated Device/Misbranding Not Issued *
    July 17, 2012 Sybron Dental Specialties Center for Devices and Radiological Health Premarket Approval/Adulterated Not Issued *
    July 17, 2012 Medtronic, Inc. Minneapolis District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
    July 16, 2012 Quanta Aesthetic Lasers USA, LLC Center for Devices and Radiological Health Premarket Approval/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 Gooten Innolife Corp Center for Devices and Radiological Health Adulterated Device/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 Sanofi Pasteur Center for Biologics Evaluation and Research CGMP Deviations Not Issued *


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