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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
September 08, 2010 E-CigaretteDirect, LLC Center for Drug Evaluation and Research Unapproved New Drug/Misbranded Not Issued *
September 08, 2010 Johnson Creek Enterprises, LLC Minneapolis District Office Unapproved New Drug/Misbranded/CGMP for Finished Pharmaceuticals Not Issued *
September 08, 2010 Gamucci Center for Drug Evaluation and Research Unapproved New Drug/Misbranded Not Issued *
September 07, 2010 Quinault Indian Nation Seattle District Office CGMP for Foods/Adulterated Not Issued *
September 07, 2010 Hard-E Foods Inc Kansas City District Office Acidified Foods/Emergency Permit Control/Adulterated/Misbranded Not Issued *
September 03, 2010 Sutures India Pvy. Ltd. Center for Devices and Radiological Health CGMP/QSR/Medical Devices/Adulterated/Misbranded May 10, 2013
September 03, 2010 Intec Industries Inc New Orleans District Office Device/Adulterated Not Issued *
September 02, 2010 Quong Hop & Co San Francisco District Office CGMP for Foods/HACCP/Adulterated Not Issued *
September 01, 2010 Fairfield Gourmet Food Corp Center for Food Safety and Applied Nutrition Nutrition Labeling of Food/Misbranded Not Issued *
September 01, 2010 Cortechs Labs Inc Los Angeles District Office CGMP/QSR/Manufacture/Packing/Storage/Installation/Adulterated July 18, 2011
September 01, 2010 Frontier Medical Products Minneapolis District Office CGMP/QSR/Manufacture/Packing/Storage/Installation/Adulterated March 29, 2013
August 31, 2010 iVu Imaging Corporation Dallas District Office CGMP/QSR/Adulterated/Manufacture/Packing/Storage/Installation September 19, 2011
August 30, 2010 Bristol Myers Squibb Holdings Pharma., Ltd. San Juan District Office CGMP/QSR/Manufacture/Packing/Storage/Installation/Adulterated June 07, 2011
August 30, 2010 Reddick Dairy Philadelphia District Office Animal for Slaughter as Food/Adulterated Not Issued *
August 30, 2010 Dr Pepper Snapple Group Center for Food Safety and Applied Nutrition False & Misleading Claims/Misbranded Not Issued *
August 30, 2010 Unlimited Nutrition Atlanta District Office Dietary Supplement/Labeling/Misbranded Not Issued *
August 27, 2010 Matthew N. Songer, MD Center for Devices and Radiological Health Investigational Device Exemptions Not Issued *
August 25, 2010 Sun Pharmaceutical Industries Inc New Jersey District Office CGMP for Finished Pharmaceuticals/Adulterated September 13, 2011
August 25, 2010 Activa Brand Products, Inc. Center for Devices and Radiological Health CGMP/QSR/Manufacture/Packing/Storage/Installation/Adulterated Not Issued *
August 25, 2010 Flagship Niagara League Inc. Philadelphia District Office PHS Act/Violation July 12, 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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