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 April 19, 2010

Letter Issue Date	Company Name	Issuing Office	Subject	Close Out Date
April 08, 2010	Bryant Ranch Prepack Inc.	Los Angeles District Office	New Drug/Labeling/Misbranded/Adulterated	Not Issued *
April 08, 2010	The Children's Hospital Assoc. Transfusion Medicine Services	Denver District Office	CGMP for Blood & Blood Products/Adulterated	August 08, 2011
April 07, 2010	Wake Forest University Baptist Medical Center	Atlanta District Office	Device/Adulterated	Not Issued *
April 06, 2010	Pure Med Spa	Center for Drug Evaluation and Research	Lipodissolve/False & Misleading Claims/Misbranded	Not Issued *
April 06, 2010	Aloha Medicinals Inc.	San Francisco District Office	New Animal Drug/Labeling/Misbranded/Adulterated	Not Issued *
April 05, 2010	Innovative Directions in Health	Center for Drug Evaluation and Research	Lipdissolve/False & Misleading Claims/Misbranded	February 10, 2011
April 05, 2010	Spa 35	Center for Drug Evaluation and Research	Lipodissolve/False & Misleading Claims/Misbranded	May 21, 2010
April 05, 2010	Monarch Med Spa	Center for Drug Evaluation and Research	Lipodissolve/False & Misleading Claims/Misbranded	May 21, 2010
April 05, 2010	All About You Medspa, LLC	Center for Drug Evaluation and Research	Lipodissolve/False & Misleading Claims/Misbranded	May 21, 2010
April 05, 2010	Medical Cosmetic Enhancements	Center for Drug Evaluation and Research	Lipodissolve/False & Misleading Claims/Misbranded	May 21, 2010

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