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 27, 2010

Letter Issue Date	Company Name	Issuing Office	Subject	Close Out Date
April 13, 2010	Shreeji Homeo Clinic	Center for Drug Evaluation and Research	Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus	Not Issued *
April 13, 2010	Super Body Care	Center for Drug Evaluation and Research	Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus	Not Issued *
April 13, 2010	Mid South Produce Distributors, LLC	New Orleans District Office	CGMP/Adulterated	November 16, 2010
April 12, 2010	Hospira, Inc.	Atlanta District Office	CGMP for Finished Pharmaceuticals/Deviations/Adulterated	Not Issued *
April 12, 2010	E-holistic Health /Hanna Cooper	Center for Drug Evaluation and Research	Unapproved/Uncleared/Unauthori zed Products Related to the H1N1 Flu Virus	Not Issued *
April 09, 2010	J & F International, Inc.	Baltimore District Office	Federal Food Drug and Cosmetic Act Violations, Compounded Drugs	December 13, 2010
April 09, 2010	Pfizer Inc.	Center for Drug Evaluation and Research	Sponsor	Not Issued *
April 08, 2010	Shamrock Medical Solutions Group LLC	New England District Office	CGMP for Finished Pharmaceuticals/Misbranded/Adulterated	Not Issued *
April 08, 2010	Physician Therapeutics, LLC	Los Angeles District Office	New Drug/Labeling/Misbranded/Adulterated	Not Issued *
April 08, 2010	Storz Medical, AG	Center for Devices and Radiological Health	Premarket Approval/Misbranded/Adulterated	Not Issued *

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