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 January 11, 2011

Letter Issue Date	Company Name	Issuing Office	Subject	Close Out Date
December 22, 2010	Access Bio, Inc.	New Jersey District Office	Lacks Premarket Approval/Adulterated	Not Issued *
December 21, 2010	Klinge Chemicals Limited	Center for Drug Evaluation and Research	CGMP for Deviations/Adulterated	Not Issued *
December 21, 2010	Tico's Mexican Foods, inc.	Denver District Office	Seafood HACCP/Insanitary Conditions/Adulterated	Not Issued *
December 21, 2010	Natural Zing, LLC	Baltimore District Office	Unapproved New Drug Promotional Claims/Misbranded	Not Issued *
December 21, 2010	CIBA Vision Puerto Rico, Inc.	San Juan District Office	CGMP/QSR/Medical Devices/Adulterated	September 14, 2011
December 21, 2010	Natural Options Corp	Florida District Office	New Drug/Adulterated/Misbranded	Not Issued *
December 21, 2010	Smith & Nephew Orthopaedics Gmbh	Center for Devices and Radiological Health	CGMP/QSR/Medical Devices/Adulterated	Not Issued *
December 20, 2010	Peregrine Surgical Ltd	Philadelphia District Office	CGMP/QSR/Medical Devices/Adulterated	Not Issued *
December 20, 2010	Wild Thymes Farm, Inc.	New York District Office	Acidified Foods/Adulterated	Not Issued *
December 16, 2010	Verichem Laboratories, Inc.	New England District Office	CGMP/QSR/Medical Devices/Adulterated	Not Issued *

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