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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 April 03, 2012

    Letter Issue Date Company Name Issuing Office Subject Close Out Date
    March 27, 2012 UNAM, Facultad De Estudios Superiores Cuautitlan Center for Drug Evaluation and Research CGMP/Finished Pharmaceuticals/Adulterated Not Issued *
    March 27, 2012 Christian Hospital Northeast-Northwest Center for Biologics Evaluation and Research IRB May 07, 2012
    March 27, 2012 ThyssenKrupp Access Manufacturing, LLC Chicago District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
    March 27, 2012 Shanghai Shunlong Physical Therapy Equipment Co. Center for Devices and Radiological Health CGMP/QSR/Medical Devices/Adulterated Not Issued *
    March 27, 2012 Ogenix Corporation Cincinnati District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
    March 27, 2012 H & H Wholesale Services, Inc. Detroit District Office CGMP/QSR/Medical Devices/Adulterated/Misbranded Not Issued *
    March 26, 2012 Sullivan Lane Farm Philadelphia District Office Illegal Drug Residue Not Issued *
    March 26, 2012 Korea Pharma Company Ltd Center for Drug Evaluation and Research Failure to Register and List Not Issued *
    March 26, 2012 SEI Pharmaceuticals, Inc. Florida District Office CGMP For Manufacturing, Packaging, Labeling, or Holding for Dietary Supplements/Adulterated Not Issued *
    March 26, 2012 Custom Seafood Services Inc. Seattle District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *


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