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 01, 2010

Letter Issue Date	Company Name	Issuing Office	Subject	Close Out Date
May 17, 2010	Endocare, a Wholly Owned Subsidiary of HealthTronics, Inc.	Los Angeles District Office	CGMP for Medical Devices/Adulterated	Not Issued *
May 13, 2010	Jilin Shulan Synthetic Pharmaceutical Co. Ltd.	Center for Drug Evaluation and Research	CGMP for Deviations/Adulterated	May 31, 2012
May 12, 2010	Miller, David L.	New York District Office	Illegal Drug Residue	Not Issued *
May 12, 2010	Terry Yon & Associates, Inc./dba Tya Pharmaceuticals	Florida District Office	CGMP/QSR/Manufacture/Packing/Storage/Installation/Adulterated	Not Issued *
May 12, 2010	Laboratorios L.O., Oftalmi, C.A.	Center for Drug Evaluation and Research	CGMP for Finished Pharmaceuticals/Adulterated	Not Issued *
May 12, 2010	Cogent Solutions Group LLC	Cincinnati District Office	New Drug/Labeling/Misbranded	March 30, 2011
May 12, 2010	CMC Commodity Transport Inc.	Atlanta District Office	Animal Feed/Adulterated with shredded tire chips	Not Issued *
May 11, 2010	Artegraft, Inc.	New Jersey District Office	CGMP/QSR/Medical Devices/Adulterated	March 23, 2011
May 11, 2010	Healthy World Distributing	Seattle District Office	Promotional Claims/Misbranded	Not Issued *
May 11, 2010	Molteno Ophthalmic Ltd	Center for Devices and Radiological Health	CGMP/QSR/Manufacture/Packing/Storage/Installation/Adulterated/Misbranded	August 22, 2011

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