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

Posted on September 09, 2010

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	Gamucci	Center for Drug Evaluation and Research	Unapproved New Drug/Misbranded	Not Issued *
September 08, 2010	Penguin Juice Company, Inc.	Detroit District Office	Juice HACCP	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	Intec Industries Inc	New Orleans District Office	Device/Adulterated	Not Issued *
September 03, 2010	Sutures India Pvy. Ltd.	Center for Devices and Radiological Health	CGMP/QSR/Medical Devices/Adulterated/Misbranded	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	Frontier Medical Products	Minneapolis District Office	CGMP/QSR/Manufacture/Packing/Storage/Installation/Adulterated	Not Issued *

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