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 March 11, 2010

Letter Issue Date	Company Name	Issuing Office	Subject	Close Out Date
September 11, 2009	Cumberland Farms, Inc.	New England District Office	CGMP for Foods/Seafood HACCP/Adulterated	February 25, 2010
September 11, 2009	Schlegel Dairy Farms Inc	Cincinnati District Office	Illegal Drug Residue	Not Issued *
September 11, 2009	Customed, Inc	San Juan District Office	CGMP/QSR/Medical Devices/Adulterated	September 02, 2010
September 11, 2009	La Hacienda Tortilleria Inc	New Orleans District Office	CGMP Regulation For Food/Adulterated	Not Issued *
September 10, 2009	Baxter Healthcare Corp.	Chicago District Office	Medical Devices/Adulterated/Misbranded	April 05, 2012
September 10, 2009	Pelican Packers, Inc.	Seattle District Office	Seafood HACCP/CGMP for Foods/Adulterated	Not Issued *
September 10, 2009	United Metro Distribution Co. 9/10/09	Detroit District Office	CGMP Manufacturing, Packing, or Holding Human Food/Adulterated	Not Issued *
September 09, 2009	Ferris, Henry J.	New York District Office	Illegal Drug Residue	Not Issued *
September 09, 2009	Witmer Foods, Inc.	Baltimore District Office	Seafood HACCP/CGMP for Foods/Adulterated	June 08, 2011
September 09, 2009	Border Foods, Incorporated	Denver District Office	Acidified Foods/Adulterated	December 01, 2010
September 09, 2009	Szarek, Francis J	New York District Office	Illegal Drug Residue	Not Issued *
September 09, 2009	Lloyd T. Smith & Sons	New York District Office	Illegal Drug Residue	Not Issued *
September 04, 2009	Pressure-Tech, Inc.	New York District Office	Premarket Approval/Misbranded/Adulterated	Not Issued *
September 04, 2009	Gambro Dialysatoren, GmbH	Center for Devices and Radiological Health	Medical Device Reporting Regulation/Misbranded	Not Issued *
September 03, 2009	Pantheon Research 9/3/09	Center for Devices and Radiological Health	Premarket Approval/Misbranded/Adulterated	Not Issued *
September 03, 2009	Supplements To WeightLoss, LLC	Center for Food Safety and Applied Nutrition	Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus	Not Issued *
September 02, 2009	Solafeet, Inc	Center for Devices and Radiological Health	Radiological Health/Records & Report/Performance Standards	Not Issued *
September 01, 2009	WHB Cattle LLC 9/1/09	Dallas District Office	Illegal Drug Residue	Not Issued *
September 01, 2009	Beekman Foods Inc	New England District Office	Seafood HACCP/CGMP for Foods/Adulterated	April 15, 2010
August 31, 2009	Therasage, LLC.	Florida District Office	Medical Devices/Adulterated/Misbranded	N/A *

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