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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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    2011 Warning Letters

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    Warning Letters issued in 2011

     

    * Not issued: A close-out letter may issue when, based on FDA’s evaluation, the firm has taken corrective action to address the violations contained in the Warning Letter. This procedure applies to Warning Letters issued on or after September 1, 2009.

    * N/A: Not applicable, the Warning Letter was issued prior to September 1, 2009.

    Read more about warning and close-out letters

    Posted on February 08, 2012

    Letter Issue Date Company Name Issuing Office Subject Close Out Date
    December 30, 2011 Okamoto Rubber Products Co., Ltd. Center for Devices and Radiological Health Medical Device Reporting/Misbranded June 07, 2012
    December 30, 2011 NAImco Inc dba Richmar Inc New Orleans District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
    December 29, 2011 Sharn, Inc. Florida District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
    December 29, 2011 Changzhou Jialing Medicine Industry Co Ltd Center for Drug Evaluation and Research Failure to Register and List Not Issued *
    December 28, 2011 Jang Soo Farm Inc. dba Rainier Sprouts, Inc. Seattle District Office CGMP for Manufacturing, Packing or Holding Human Food/Adulterated/Insanitary Conditions Not Issued *
    December 28, 2011 Midmark Corporation Cincinnati District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
    December 28, 2011 Natural Health Team New Orleans District Office Unapproved New Drug Not Issued *
    December 28, 2011 Vaughan Foods Inc. (Allison's Gourmet Kitchen) Dallas District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
    December 28, 2011 Greencore OARS, LLC New England District Office Seafood HACCP/CGMP for Foods/Adulterated /Sanitation Not Issued *
    December 27, 2011 Intersurgical, Ltd. Center for Devices and Radiological Health CGMP/QSR/Medical Devices/Misbranded April 27, 2012


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