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 December 07, 2010

Letter Issue Date	Company Name	Issuing Office	Subject	Close Out Date
September 27, 2010	Steris Isomedix Services, Inc.	Dallas District Office	CGMP/QSR/Medical Devices/Adulterated	Not Issued *
September 27, 2010	CVS Pharmacy, Inc.	New England District Office	New Drug/False Misleading Labeling	December 21, 2010
September 27, 2010	Walgreen Company	Chicago District Office	New Drug/False Misleading Labeling	March 21, 2011
September 24, 2010	Rohrer Dairy Farms Llc	Philadelphia District Office	Illegal Drug Residue	Not Issued *
September 24, 2010	Kranenburg Dairy	Dallas District Office	Illegal Drug Residue	Not Issued *
September 23, 2010	Mundt & Associates, Inc.	Center for Devices and Radiological Health	Electronic Product Radiation Control	December 15, 2010
September 22, 2010	Quality Plus Products, Inc.	Seattle District Office	Seafood HACCP/Adulterated	Not Issued *
September 22, 2010	Defibtech, LLC	New England District Office	CGMP/QSR/Medical Devices/Adulterated	February 02, 2012
September 22, 2010	Spineology, Inc.	Center for Devices and Radiological Health	Investigational Device Exemptions	June 28, 2012
September 21, 2010	Rohr Fish, Inc.	Cincinnati District Office	Seafood HACCP/Insanitary Conditions/Adulterated	Not Issued *

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