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 February 02, 2009

Letter Issue Date	Company Name	Issuing Office	Subject	Close Out Date
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 *

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