2005 Warning Letters

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Warning Letters issued in 2005

 

* 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 February 02, 2009

Letter Issue Date	Company Name	Issuing Office	Subject	Close Out Date
November 15, 2005	Rainbow Acresa	New York District Office	Animals for Sale for Slaughter as Food/Adulterated	N/A *
November 15, 2005	De Groot Dairy, L.L.C.	Seattle District Office	Illegal Drug Residue /Adulterated	N/A *
November 14, 2005	Genetic Testing Institute, Incorporated	Minneapolis District Office	Lacks Premarket Approval Application Adulterated	N/A *
November 14, 2005	Memorial Blood Centers	Minneapolis District Office	CGMP/Finished Pharmaceuticals/Adulterated	N/A *
November 14, 2005	De Boer Dairy	Seattle District Office	Illegal Drug Residue /Adulterated	N/A *
November 10, 2005	Bobby Chez, Inc.	New Jersey District Office	Current Good Manufacturing Practice Requirements for Foods/Seafood HACCP/Adulterated	N/A *
November 10, 2005	Bartush-Schnitzius Foods Co.	Dallas District Office	CGMP for Foods/HACCP	N/A *
November 10, 2005	Custom Feed Services Corporation	Kansas City District Office	CGMP/Medicated Feeds/Adulterated	N/A *
November 10, 2005	Creative Clinical Concepts, Inc.	Center for Devices and Radiological Health	Lacks Premarket Approval Application Misbranded	N/A *
November 09, 2005	The Way Up	Center for Food Safety and Applied Nutrition	Promotional Claims False & Misleading/New Drug/Misbranded	N/A *
November 09, 2005	Sweet Dreems, Inc.	Cincinnati District Office	Quality System Reguation/Adulterated	N/A *
November 09, 2005	CHS International Research Ltd.	Center for Food Safety and Applied Nutrition	Promotional Claims False & Misleading/New Drug/Misbranded	N/A *
November 09, 2005	Wilderness Family Naturals	Minneapolis District Office	Labeling/Promotional Claims False & Misleading/New Drug/Misbranded	N/A *
November 09, 2005	Zlabs, LLC	Center for Drug Evaluation and Research	Promotional Claims False & Misleading/New Drug/Misbranded	N/A *
November 09, 2005	Suzanne's Natural Foods	Center for Food Safety and Applied Nutrition	Promotional Claims False & Misleading/New Drug/Misbranded	N/A *
November 09, 2005	HMS Crown, Inc	Center for Drug Evaluation and Research	Promotional Claims False & Misleading/New Drug/Misbranded	N/A *
November 09, 2005	Healthworks 2000	Center for Food Safety and Applied Nutrition	Promotional Claims False & Misleading/New Drug/Misbranded	N/A *
November 09, 2005	ESBA Laboratories, Inc.	Florida District Office	Labeling/Promotional Claims False & Misleading/New Drug/Misbranded	N/A *
November 09, 2005	One Life USA	Center for Drug Evaluation and Research	Promotional Claims False & Misleading/New Drug/Misbranded	N/A *
November 09, 2005	Heba Laboratories, LLC	Center for Food Safety and Applied Nutrition	Promotional Claims False & Misleading/New Drug/Misbranded	N/A *

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