2008 Warning Letters

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Warning Letters issued in 2008

 

* 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 July 07, 2009

Letter Issue Date	Company Name	Issuing Office	Subject	Close Out Date
December 30, 2008	Dongkuk Techco Rubber Ind. Sdn Bhd	Center for Devices and Radiological Health	CGMP/QSR/Adulterated	N/A *
December 30, 2008	Kidron Auction Inc.	Cincinnati District Office	Illegal Drug Residue	N/A *
December 24, 2008	Aunt Kitty's Foods, Inc.	New Jersey District Office	Food Labeling Misbranded	N/A *
December 24, 2008	Stoney Acres Calves	Detroit District Office	Illegal Drug Residue	N/A *
December 22, 2008	I-Flow Corporation	Los Angeles District Office	CGMP/QSR/Medical Devices/Adulterated	N/A *
December 22, 2008	Troyer, Todd	Cincinnati District Office	Illegal Drug Residue	N/A *
December 22, 2008	Columbia Presbyterian Medical Center	New York District Office	Deviation/Adulterated	N/A *
December 22, 2008	Newman's Own Organics	Center for Food Safety and Applied Nutrition		N/A *
December 22, 2008	Newman's Own Organics	Center for Food Safety and Applied Nutrition	Federal Food, Drug and Cosmetic Act/Misbranded	N/A *
December 16, 2008	Ocean Beauty Seafoods, Inc.	Seattle District Office	Seafood HACCP	N/A *
December 16, 2008	Civic Center Pharmacy	Los Angeles District Office	New Drug, Unapproved	N/A *
December 15, 2008	Craig General Hospital	Dallas District Office	Deviation from Good Manufacturing Practice	N/A *
December 10, 2008	Virbac Inc.	Kansas City District Office	CGMP For Manufacturing, Packing, Storage or Installation/Adulterated/Misbranded	N/A *
December 10, 2008	Savec Health Systems	Center for Devices and Radiological Health	Premarket Approval/Misbranded/Adulterated	N/A *
December 10, 2008	High Tide Seafoods, Inc.	Seattle District Office	Seafood HACCP/CGMP for Foods/Adulterated	N/A *
December 10, 2008	Coca-Cola Company (The)	Center for Food Safety and Applied Nutrition	Labeling/False & Misleading Claims/Adulterated/Misbranded	N/A *
December 08, 2008	RGI Medical Manufacturing, Inc.	Florida District Office	CGMP/QSR/Manufacture/Packing/Storage/Installation/Adulterated	N/A *
December 05, 2008	Pneumex, Incorporated	Seattle District Office	Premarket Approval/Misbranded/Adulterated	N/A *
December 05, 2008	Douglas Bennett Farm	New England District Office	Illegal Drug Residue	N/A *
December 04, 2008	Haemonetics Corporation	Chicago District Office	CGMP/QSR/Medical Devices/Adulterated	N/A *

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