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 October 14, 2010

Letter Issue Date	Company Name	Issuing Office	Subject	Close Out Date
October 12, 2010	Artery Health Institute LLC	New York District Office	Unapproved New Drugs/Misbranded	Not Issued *
October 12, 2010	World Health Products, Inc.	Denver District Office	Unapproved New Drugs/Misbranded	Not Issued *
October 12, 2010	Maxam Nutraceutics	Seattle District Office	Unapproved New Drugs/Misbranded	Not Issued *
October 12, 2010	Cardio Renew Inc	Minneapolis District Office	Unapproved New Drugs/Misbranded	August 29, 2011
October 08, 2010	Kanec USA, Inc.	Florida District Office	CGMP for Finished Pharmaceutical/Unapproved New Drugs/Adulterated/Misbranded	Not Issued *
October 08, 2010	Rx-promotion	Center for Drug Evaluation and Research	Internet Marketing of Unapproved and Misbranded Drugs	Not Issued *
October 07, 2010	Biostructures, LLC	Los Angeles District Office	Premarket Approval/Adulterated/Misbranded	Not Issued *
October 06, 2010	Thanh Son Tofu Inc	Los Angeles District Office	CGMP/Manufacturing, Packing or Holding Human Food/Adulterated/Insanitary Conditions	Not Issued *
October 06, 2010	Fresh Express Incorporated	San Francisco District Office	False & Misleading Claims/Misbranded	Not Issued *
October 05, 2010	Tropical Bakery Wholesale	Florida District Office	CGMP For Manufacturing, Packing, or Holding Human Food/Adulterated	April 13, 2011

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