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 June 08, 2010

Letter Issue Date	Company Name	Issuing Office	Subject	Close Out Date
May 21, 2010	AVEVA Drug Delivery Systems, Inc.	Florida District Office	CGMP for Finished Pharmaceuticals/Adulterated	Not Issued *
May 21, 2010	Feel Good Natural Health	Center for Drug Evaluation and Research	Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus	Not Issued *
May 21, 2010	Dexcom Inc	Los Angeles District Office	Medical Device Reporting/Misbranded	July 15, 2011
May 21, 2010	K. C. Pharmaceuticals Inc.	Los Angeles District Office	CGMP/QSR/Medical Devices/Finished Pharmaceuticals/Adulterated	Not Issued *
May 21, 2010	Amigo Mobility International, Inc	Detroit District Office	CGMP/QSR/Medical Devices/Adulterated	Not Issued *
May 21, 2010	Zone Of Natural Remedies	Center for Drug Evaluation and Research	Unapproved/Unauthorized Products Related to the H1N1 Flu Virus	Not Issued *
May 21, 2010	David Montanez Calf Farm	Dallas District Office	Illegal Drug Residue	Not Issued *
May 20, 2010	Hyperbaric for Life LLC	Los Angeles District Office	Medical Device Reporting Regulation/Misbranded	July 15, 2011
May 20, 2010	River's Edge Pharmaceuticals, LLC	Atlanta District Office	CGMP for Finished Pharmaceuticals/Adulterated/Misbranded	Not Issued *
May 17, 2010	A Simoes Family Dairy	Los Angeles District Office	Illegal Drug Residue	Not Issued *

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