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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 26, 2012

    Letter Issue Date Company Name Issuing Office Subject Close Out Date
    June 14, 2012 Metro Produce Distributors, Inc. Minneapolis District Office Juice/HACCP/Adulterated Not Issued *
    June 14, 2012 Pinook-USA Florida District Office Medical Device/Adulterated/Misbranded Not Issued *
    June 14, 2012 American· Optisurgical Inc. Los Angeles District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
    June 13, 2012 Compania Internacional de Comercio, S.A. de C.V. Center for Drug Evaluation and Research CGMP/Finished Pharmaceuticals/Adulterated Not Issued *
    June 12, 2012 King Ransom Farm LLC New York District Office Illegal Drug Residue Not Issued *
    June 12, 2012 Set-N-Me-Free Aloe Vera Co. Seattle District Office New Drug/Labeling/False & Misleading Claims/Misbranded Not Issued *
    June 12, 2012 International Specialty Supply Holding, Inc. Nashville District Office Food/Insanitary Conditions/Adulterated Not Issued *
    June 12, 2012 F Care Systems USA Florida District Office Medical Device Reporting/Misbranded/Adulterated Not Issued *
    June 11, 2012 Oertel Medical GmbH Center for Devices and Radiological Health Adulterated Device Not Issued *
    June 11, 2012 Cal Valls Center for Food Safety and Applied Nutrition Misbranding/Labeling Violation of Acidified Foods August 24, 2012


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