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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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2010 Warning Letters

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Warning Letters issued in 2010

 

* 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

Letter Issue Date Company Name Issuing Office Subject Close Out Date
December 16, 2010 Karlsburger Foods, Inc. Minneapolis District Office CGMP for Foods/Seafood HACCP/Adulterated/Misbranded October 31, 2011
December 16, 2010 Mega Sun Inc Center for Devices and Radiological Health Electronic Product Radiation Control Not Issued *
December 16, 2010 Verichem Laboratories, Inc. New England District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
December 15, 2010 Innovative Medical Manufacturing Co Center for Devices and Radiological Health CGMP/QSR/Medical Devices/Adulterated Not Issued *
December 15, 2010 Invacare Corporation Florida District Office CGMP/QSR/Manufacture/Packing/Storage/Installation/Adulterated/Misbranded Not Issued *
December 15, 2010 NOC Management Co. Inc. Cincinnati District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions June 15, 2011
December 14, 2010 Cherokee Brands, LLC Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded February 10, 2011
December 14, 2010 E.A. Beck & Co. Los Angeles District Office CGMP/QSR/Medical Devices/Adulterated/Misbranded Not Issued *
December 13, 2010 Ray's Seafood Market, Inc. New England District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions October 17, 2011
December 10, 2010 Naturally For Her Center for Devices and Radiological Health Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Not Issued *
December 10, 2010 Ian's Natural Foods, Inc New England District Office CGMP Regulation For Food/Adulterated Not Issued *
December 10, 2010 Macco Organiques Center for Drug Evaluation and Research CGMP for Deviations/Adulterated March 10, 2014
December 09, 2010 Yuki Gosei Kogyo Co., Ltd. Center for Drug Evaluation and Research CGMP for Deviations/Adulterated November 23, 2012
December 09, 2010 American Seafood Company Inc New Orleans District Office CGMP for Foods/Seafood HACCP/Adulterated Not Issued *
December 09, 2010 New Life Alternatives New Orleans District Office Dietary Supplements Not Issued *
December 07, 2010 Profit & Loss Dairy Dallas District Office Animals for Sale for Slaughter as Food/Adulterated Not Issued *
December 07, 2010 VBM Medizintechnik GmbH Center for Devices and Radiological Health CGMP/QSR/Medical Devices/Adulterated/Misbranded Not Issued *
December 07, 2010 Newman's Fish Markets, Inc. Seattle District Office Seafood HACCP/CGMP for Foods/Adulterated Not Issued *
December 07, 2010 Copper River Seafoods, Inc. Seattle District Office CGMP for Foods/Seafood HACCP/Adulterated &Low Acid Canned Food Regulation Not Issued *
December 07, 2010 BioCheck Inc San Francisco District Office Premarket Approval/Adulterated/Misbranded February 16, 2011



 

Contact FDA

FDA's Office of Critical Path and Regulatory Science Initiatives

Frank F. Weichold, MD, PhD

Acting Director

Critical Path and Regulatory Science Initiatives

301-796-8187

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