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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 June 05, 2012

    Letter Issue Date Company Name Issuing Office Subject Close Out Date
    March 15, 2012 Orlane S.A. Center for Drug Evaluation and Research Failure to Register and List April 19, 2012
    March 15, 2012 NeuroTrax Israel Ltd. Center for Devices and Radiological Health Premarket Approval/Medical Device/Adulterated Not Issued *
    March 13, 2012 Sushi Boy Inc Los Angeles District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
    March 13, 2012 A&M Farms San Francisco District Office Illegal Drug Residue Not Issued *
    March 13, 2012 IntelliCell Biosciences, Inc. Center for Biologics Evaluation and Research Current Good Manufacturing Practice(CGMP)/Current Good Tissue Practice(CGTP) Not Issued *
    March 12, 2012 Mysnus AB Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded May 21, 2012
    March 09, 2012 Pax-All Manufacturing Inc. Center for Drug Evaluation and Research CGMP/Finished Pharmaceuticals/Adulterated Not Issued *
    March 09, 2012 Double Aught Dairy Denver District Office Illegal Drug Residue Not Issued *
    March 09, 2012 Sebastian Joe's Ice Cream Commissary Minneapolis District Office Food Labeling Misbranded Not Issued *
    March 09, 2012 Cosmed S.R.L. Center for Devices and Radiological Health CGMP for Medical Devices/QSR/Medical Device Reporting/Misbranded Not Issued *


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