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 March 09, 2010

Letter Issue Date	Company Name	Issuing Office	Subject	Close Out Date
February 22, 2010	Sunsweet Growers Inc	Center for Food Safety and Applied Nutrition	Labeling/False & Misleading Claims/Adulterated/Misbranded	Not Issued *
February 22, 2010	Gorton's, Inc.	Center for Food Safety and Applied Nutrition	Labeling/False & Misleading Claims/Adulterated/Misbranded	Not Issued *
February 18, 2010	Vertical Pharmaceuticals, Inc.	New Jersey District Office	Premarket Approval/Misbranded/Adulterated	March 08, 2011
February 18, 2010	Lucky Farm Inc	Seattle District Office	Adulterated	Not Issued *
February 18, 2010	Stardust Dairy, LLC	Cincinnati District Office	Illegal Drug Residue	May 30, 2012
February 17, 2010	Amasha	Center for Devices and Radiological Health	Premarket Approval/Misbranded/Adulterated	Not Issued *
February 17, 2010	Unisource, Inc.	Denver District Office	Unapproved New Drug/Misbranded	Not Issued *
February 17, 2010	Indian Mountain Center	Center for Devices and Radiological Health	Premarket Approval/Misbranded/Adulterated	Not Issued *
February 17, 2010	Bobalee Originals Manufacturing	Center for Devices and Radiological Health	Premarket Approval/Misbranded/Adulterated	Not Issued *
February 17, 2010	International Ear Candle, LLC	Center for Devices and Radiological Health	Premarket Approval/Misbranded/Adulterated	Not Issued *

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