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 29, 2005	Edgar Martin Dairy	Minneapolis District Office	Illegal Drug Residue /Adulterated	N/A *
December 27, 2005	Wellness Resources, Inc.	Minneapolis District Office	Labeling/Promotional Claims False & Misleading/New Drug/Misbranded	N/A *
December 23, 2005	Siouxland Community Blood Bank	Kansas City District Office	Current Good Manufacturing Practices Regulations for Blood & Blood Components/Adulterated	N/A *
December 23, 2005	Fujian Sky Food Company	Los Angeles District Office	Seafood HACCP/Adulterated	N/A *
December 22, 2005	Fukumaru Seafood Company	Los Angeles District Office	Seafood HACCP	N/A *
December 22, 2005	Paradise Farm Corporation	New England District Office	Juice HACCP/Adulterated	N/A *
December 22, 2005	Guidant Corporation	Minneapolis District Office	CGMP for Medical Devices/QS/Adulterated	N/A *
December 21, 2005	Lawsons Farm	New England District Office	Illegal Drug Residue /Adulterated	N/A *
December 21, 2005	Gold Eagle Cooperative	Kansas City District Office	Animal Proteins Prohibited in Ruminant Feed/Misbranded	N/A *
December 21, 2005	Clarkdale Fruit Farms Inc.	New England District Office	Juice HACCP	N/A *
December 21, 2005	Dore, David D., M.D.	Center for Devices and Radiological Health	Clinical Investigator	N/A *
December 19, 2005	Tidman, Raymond E., M.D.	Center for Drug Evaluation and Research	Clinical Investigator	N/A *
December 16, 2005	Seecor, Inc.	Dallas District Office	CGMP Requirements for Medical Devices/Quality System Regulations/Adulterated	N/A *
December 16, 2005	Midwest Seafood, Inc.	Cincinnati District Office	Seafood HACCP/Adulterated	N/A *
December 15, 2005	Baltimore City Health Department	Center for Biologics Evaluation and Research	Institutional Review Board (IRB)	N/A *
December 14, 2005	Shelhigh, Inc.	New Jersey District Office	CGMP Requirement for Medical Devices/Lacks Premarket Approval Application/Adulterated	N/A *
December 14, 2005	Topway Enterprises, Inc.	Dallas District Office	CGMP Regulations for Foods/Seafood (HACCP)	N/A *
December 13, 2005	Ise Newberry, Inc.	Atlanta District Office	Control of Communicable Diseases/Adulterated	N/A *
December 12, 2005	Morrell Farm	New York District Office	Illegal Drug Residue	N/A *
December 09, 2005	MCT Medical Products	Dallas District Office	Current Good Manufacturing Practice for Medical Devices/Adulterated	N/A *
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 *
November 29, 2005	BODeSTORE.com	New Jersey District Office	Labeling/Promotional Claims False & Misleading/New Drug/Misbranded	N/A *
November 28, 2005	Spectrum Chemicals & Laboratory Products, Inc	New Jersey District Office	Active Pharmaceutical Ingredients/Misbranded	N/A *
November 28, 2005	Sacred Mountain Management Inc	Denver District Office	Labeling/Promotional Claims False & Misleading/New Drug/Misbranded	N/A *
November 23, 2005	PRB Pharmaceuticals	Los Angeles District Office	Labeling/Promotional Claims False & Misleading/New Drug/Misbranded	N/A *
November 23, 2005	PolyCil Health Inc	Los Angeles District Office	Labeling/Promotional Claims False & Misleading/New Drug/Misbranded	N/A *
November 23, 2005	The Electrode Store, Inc.	Seattle District Office	Current Good Manufacturing Practices Requirements for Medical Devices/Adulterated	N/A *
November 22, 2005	NativeRemedies.com	Center for Biologics Evaluation and Research	Promotional Claims False & Misleading/Misbranded	N/A *
November 22, 2005	Milbank Mills Inc	Kansas City District Office	CGMP for Medicated Feeds/Adulterated	N/A *
November 22, 2005	Corin USA	Center for Devices and Radiological Health	Lacks Premarket Approval Application Adulterated	N/A *
November 22, 2005	Kramer Laboratories Inc.	Florida District Office	Labeling/Promotional Claims False & Misleading/New Drug/Misbranded	N/A *

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