2007 Warning Letters

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Warning Letters for 2007

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* 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 27, 2007	Mullet, Ivan	New York District Office	Illegal Drug Residue	N/A *
December 27, 2007	Absolutely Fresh Seafood Company	Kansas City District Office	Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions	N/A *
December 21, 2007	Northwest Medical Physics Equipment, Inc.	Seattle District Office	CGMP/QSR/Manufacture/Packing/Storage/Installation/Adulterated	N/A *
December 21, 2007	Medical Device Resource Corporation	San Francisco District Office	Premarket Approval/Misbranded/Adulterated	N/A *
December 21, 2007	Cemac Foods Corporation	Philadelphia District Office	CGMP/Misbranded	N/A *
December 21, 2007	Ambassador Meat Distributors Inc	Kansas City District Office	Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions	N/A *
December 20, 2007	Universal Enterprises Inc dba Air Service Hawaii	San Francisco District Office	Interstate Conveyance Sanitation Regulations/Provisional	N/A *
December 19, 2007	Abbott Vascular, Inc.	Center for Devices and Radiological Health	Medical Devices/Adulterated/Misbranded	N/A *
December 18, 2007	Keystone Food Products Inc	Philadelphia District Office	CGMP For Manufacturing, Packing, or Holding Human Food/Adulterated/Insanitary Conditions	N/A *
December 18, 2007	P-Ryton Corporation	New York District Office	CGMP/QSR/Manufacture/Packing/Storage/Installation/Adulterated	N/A *
December 17, 2007	Siemens Medical Solutions, Ultrasound Division	Center for Devices and Radiological Health	Premarket Approval/Misbranded/Adulterated	N/A *
December 13, 2007	Moisan Dairy	Seattle District Office	Illegal Drug Residue	N/A *
December 13, 2007	G. Dundas Company Inc	Seattle District Office	CGMP/QSR/Medical Devices/Adulterated/Misbranded	N/A *
December 07, 2007	Polychrome Medical, Inc	Minneapolis District Office	CGMP/QSR/Manufacture/Packing/Storage/Installation/Adulterated	N/A *
December 07, 2007	Spinal, USA	New Orleans District Office	CGMP For Manufacturing, Packing, Storage or Installation/Adulterated/Misbranded	N/A *
December 05, 2007	Wheatley, Susan J., M.D.	Center for Devices and Radiological Health	Clinical Investigator	N/A *
December 04, 2007	G.D. Mathews and Sons Corporation dba Mathews Salad House Food Products	New England District Office	Seafood HACCP/Adulterated	N/A *
December 04, 2007	Wild Edibles, Inc.	New York District Office	Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions	N/A *
December 04, 2007	Wild Edibles, Inc.	New York District Office	Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions	N/A *
December 03, 2007	Pacific Consolidated Industries LLC	Los Angeles District Office	CGMP For Manufacturing, Packing, Storage or Installation/Adulterated	N/A *
November 30, 2007	Barnacle Seafod, Inc.	Florida District Office	Seafood HAACP/CGMP for Foods/Adulterated	N/A *
November 30, 2007	Avicenna Laser Technology Inc	Florida District Office	CGMP/QSR/Manufacture/Packing/Storage/Installation/Adulterated	N/A *
November 29, 2007	E-Med Future, Inc.	Cincinnati District Office	Devices/Quality System Regulation	N/A *
November 28, 2007	Stryker Orthopaedics Corp.	New Jersey District Office	CGMP/QSR/Manufacture/Packing/Storage/Installation/Adulterated	N/A *
November 28, 2007	Precision Biometrics, Inc.	Center for Devices and Radiological Health	Device/Lacks Premarket Approval Application/Adulterated/Misbranded	N/A *
November 26, 2007	Glenn Foods, Inc.	Center for Food Safety and Applied Nutrition	Food Labeling Regulation	N/A *
November 21, 2007	GlaxoSmithKline	Center for Drug Evaluation and Research	Drug Labeling/Promotional Claims/Misbranded	N/A *
November 21, 2007	Venosan North America	Center for Devices and Radiological Health	Medical Device Reporting	N/A *
November 19, 2007	Winchester Bay Fisheries, LLC	Seattle District Office	Seafood HACCP/CGMP for Foods/Adulterated	N/A *
November 19, 2007	Imperial Trading Company, Inc.	New Orleans District Office	CGMP For Manufacturing, Packing, or Holding Human Food	N/A *
November 16, 2007	GE Healthcare/General Electric Company	Minneapolis District Office	Devices/X-ray Equipment	N/A *
November 16, 2007	Ben Venue Laboratories, Inc.	Cincinnati District Office	CGMP/Deviations/Adulterated	N/A *
November 16, 2007	Custom Assemblies, Inc.	Atlanta District Office	CGMP/QSR/Medical Devices/Adulterated/Misbranded	N/A *
November 14, 2007	Simco Dairy	Seattle District Office	Illegal Drug Residue	N/A *
November 14, 2007	Visser Ranch	Denver District Office	Illegal Drug Residue	N/A *
November 09, 2007	Nurse Assist, Inc.	Dallas District Office	CGMP/QSR/Medical Devices/Adulterated	N/A *
November 07, 2007	Marjon Specialty Food, Inc	Florida District Office	CGMP/Misbranded	N/A *
November 07, 2007	C.V. Indotropic Fishery	Center for Food Safety and Applied Nutrition	Seafood HACCP/Adulterated	N/A *
November 07, 2007	Amerifit Brands, Inc	New England District Office	CGMP for Drugs/Manufacture, Processing, Packing, Holding/Adulterated/Misbranded	N/A *
November 06, 2007	Ole' Mexican Foods, Inc.	Atlanta District Office	Promotional Claims False & Misleading/Misbranded	N/A *
November 02, 2007	Fisheries Research Laboratory- SIU-C	Center for Veterinary Medicine	GLP/Bioresearch Monitoring Program	N/A *
November 01, 2007	Troy Innovative Instruments, Inc.	Cincinnati District Office	CGMP for Medical Devices/QS/Adulterated	N/A *
October 31, 2007	Northeast General Pharmaceutical Factory	Center for Drug Evaluation and Research	Current Good Manufacturing Practice Regulation/Adulterated	N/A *
October 31, 2007	Belford Seafood Co-Op	New Jersey District Office	Seafood HACCP/CGMP for Foods/Adulterated	N/A *
October 30, 2007	VAN Oriental Food, Inc.	Dallas District Office	Seafood HACCP/Adulterated	N/A *
October 30, 2007	A La Carte Foods, Inc.	New Orleans District Office	CGMP for Foods/Seafood HACCP/Adulterated	N/A *
October 30, 2007	International Technidyne Corporation	New Jersey District Office	CGMP/QSR/Medical Device Reporting/Adulterated	N/A *
October 30, 2007	Cytosol Laboratories, Inc.	New England District Office	CGMP/Deviations/Adulterated	N/A *
October 30, 2007	Chung's Products, LP	Dallas District Office	Seafood HACCP/Adulterated	N/A *
October 29, 2007	VDS Farms, L.L.C.	Detroit District Office	Illegal Drug Residue	N/A *

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