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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 27, 2012

    Letter Issue Date Company Name Issuing Office Subject Close Out Date
    February 17, 2012 Winn Dixie Logistics, Inc. Florida District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
    February 17, 2012 Biochem Laboratories Inc. New Jersey District Office CGMP Regulations for Finished Pharmaceuticals/Adulterated Not Issued *
    February 16, 2012 Synthes USA HQ, Inc. Philadelphia District Office CGMP/QSR/Manufacture/Packing/Storage/Installation/Adulterated Not Issued *
    February 15, 2012 Schwabe North America, Inc. Minneapolis District Office Unapproved New Drug/Misbranded Not Issued *
    February 15, 2012 Octopus Garden, Inc. New York District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
    February 14, 2012 Omron (Dalian) Co., Ltd. Plant 1 Center for Devices and Radiological Health CGMP for Medical Devices/QSR/Medical Device Reporting/Adulterated Not Issued *
    February 14, 2012 The Hershey Company Center for Food Safety and Applied Nutrition Food Labeling/Misbranded Not Issued *
    February 14, 2012 Edge Biologicals, Inc. New Orleans District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
    February 14, 2012 Jenis, Louis G., M.D. Center for Devices and Radiological Health Bioresearch Monitoring Program/IRB Not Issued *
    February 14, 2012 Ginsberg's Institutional Foods, Inc. New York District Office Seafood HACCP/Adulterated August 01, 2012


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