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
December 09, 2005	Milk Flow Dairy	Denver District Office	Illegal Drug Residue /Adulterated	N/A *
December 08, 2005	Michael Mumbulo	New York District Office	Illegal Drug Residue	N/A *
December 07, 2005	LifeScan, Inc.	San Francisco District Office	CGMP requirements for the Quality System Regulation/Medical Device Reporting/Adulterated/Misbranded	N/A *
December 07, 2005	American Eagle/Executive Airlines, Inc.	San Juan District Office	CGMP for Foods/Adulterated	N/A *
December 06, 2005	WaJa Farms, Inc	New York District Office	Illegal Drug Residue	N/A *
December 05, 2005	Two Brothers Seafood, Inc.	San Juan District Office	CGMP for Foods/Seafood HACCP/Adulterated	N/A *
December 05, 2005	Pedro Barba & Sons Inc.	San Juan District Office	Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions	N/A *
December 05, 2005	IIT Research Institute	Center for Drug Evaluation and Research	GLP for non-clincal laboratory studies	N/A *
December 05, 2005	Carrington Laboratories, Inc	Dallas District Office	Insanitary Conditions/Adulterated/Misbranded	N/A *
December 02, 2005	Fabulous Fish Co.	Kansas City District Office	CGMP for Foods/Seafood HACCP/Adulterated	N/A *
December 02, 2005	Restorative Products, Inc.	Florida District Office	Medical Device Reporting Regulations/Quality System Regulation/Adulterated/Misbranded	N/A *
December 02, 2005	Rite-Dent Manufacturing Corp.	Florida District Office	Medical Device Reporting Regulations/Quality System Regulation/Adulterated/Misbranded	N/A *
December 01, 2005	Life Enhancement Products, Inc.	Center for Food Safety and Applied Nutrition	Food Labeling/Food Additive Misbranded	N/A *
December 01, 2005	Yu I Hsiang U.S.A. corp	Los Angeles District Office	Seafood HACCP/Adulterated	N/A *
December 01, 2005	Samson Medical Technologies, Inc.	New Jersey District Office	Labeling/New Drug/Misbranded	N/A *
November 30, 2005	YSIS, Incorporated	Cincinnati District Office	Current Good Manuafacturing Practice for Medical Devices/Adulterated/Misbranded	N/A *
November 30, 2005	Healthworks 2000	Dallas District Office	Labeling/Promotional Claims False & Misleading/New Drug/Misbranded	N/A *
November 30, 2005	Iceland Health, Inc	Kansas City District Office	Labeling/Promotional Claims False & Misleading/New Drug/Misbranded	N/A *
November 30, 2005	Vitacost.com	Florida District Office	Labeling/Promotional Claims False & Misleading/New Drug/Misbranded	N/A *
November 29, 2005	Chozyn, LLC	New Jersey District Office	Labeling/Promotional Claims False & Misleading/New Drug/Misbranded	N/A *

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