2009 Warning Letters

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Warning Letters issued in 2009

 

* 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 13, 2009

Letter Issue Date	Company Name	Issuing Office	Subject	Close Out Date
October 13, 2009	Glenmark Pharmaceuticals Inc. USA 10/13/09	Center for Drug Evaluation and Research	Unapproved New Drug/Misbranded	Not Issued *
October 13, 2009	Dynamic Surgery, Inc.	New England District Office	CGMP/QSR/Medical Devices/Adulterated	February 28, 2011
October 13, 2009	DAVA Pharmaceuticals, Inc.	Center for Drug Evaluation and Research	Unapproved New Drug/Misbranded	March 22, 2011
October 13, 2009	Lehigh Valley Technologies, Inc. 10/13/09	Center for Drug Evaluation and Research	Unapproved New Drug/Misbranded	Not Issued *
October 09, 2009	Philips Healthcare Inc. 10/9/09	New England District Office	CGMP/QSR/Medical Devices/Adulterated	Not Issued *
October 09, 2009	LCA Vision Inc	Center for Devices and Radiological Health	Medical Device Reporting Regulation/Misbranded	Not Issued *
October 09, 2009	LasikPlus Vision Center	Center for Devices and Radiological Health	Medical Device Reporting Regulation/Misbranded	Not Issued *
October 09, 2009	LasikPlus Vision Center	Center for Devices and Radiological Health	Medical Device Reporting Regulation/Misbranded	Not Issued *
October 09, 2009	LasikPlus Vision Center	Center for Devices and Radiological Health	Medical Device Reporting Regulation/Misbranded	Not Issued *
October 09, 2009	Pacific Nutritional Foods, Inc.	Seattle District Office	Low Acid Canned Food Regulation/Adulterated	Not Issued *
October 09, 2009	LasikPlus	Center for Devices and Radiological Health	Medical Device Reporting Regulation/Misbranded	Not Issued *
October 09, 2009	Lasik Vision Institute	Center for Devices and Radiological Health	Medical Device Reporting Regulation/Misbranded	Not Issued *
October 09, 2009	Lasik Vision Institute	Center for Devices and Radiological Health	Medical Device Reporting Regulation/Misbranded	Not Issued *
October 09, 2009	Lasik Plus	Center for Devices and Radiological Health	Medical Device Reporting Regulation/Misbranded	Not Issued *
October 09, 2009	LCA Vision, Inc	Center for Devices and Radiological Health	Medical Device Reporting Regulation/Misbranded	Not Issued *
October 09, 2009	Lasik Vision Institute	Center for Devices and Radiological Health	Medical Device Reporting Regulation/Misbranded	Not Issued *
October 09, 2009	Laser Eye Care of California	Center for Devices and Radiological Health	Medical Device Reporting Regulation/Misbranded	Not Issued *
October 09, 2009	Evergreen Acres	Minneapolis District Office	Illegal Drug Residue	April 29, 2010
October 09, 2009	TLC Laser Eye Center d/b/a TLC Pittsburgh	Center for Devices and Radiological Health	Medical Device Reporting Regulation/Misbranded	Not Issued *
October 09, 2009	TLC Laser Eye Centers	Center for Devices and Radiological Health	Medical Device Reporting Regulation/Misbranded	Not Issued *

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