2001 Warning Letters

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Tobacco Retailer Warning Letters

 

Warning Letters for 2001

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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 23, 2009

Letter Issue Date	Company Name	Issuing Office	Subject	Close Out Date
September 20, 2001	Buckeye Feed Mills, Inc.	Cincinnati District Office	Animal Proteins Prohibited in Ruminant Feed/Adulterated/Misbranded	N/A *
September 20, 2001	Pendelton Flour Mills, LLC	Seattle District Office	GMP in Manufacturing, Packing, Holding Food/Adulterated	N/A *
September 20, 2001	IV Systems	Dallas District Office	New Drug/GMP for Finished Pharmaceuticals/Misbranded	N/A *
September 19, 2001	Herb's Seafood, Inc.	New Jersey District Office	Seafood HACCP	N/A *
September 19, 2001	Camtronics LTD., Medical Systems	Florida District Office	Quality System Regulation for Medical Devices/Adulterated	N/A *
September 19, 2001	Candela Corporation	Center for Devices and Radiological Health	Smoothbeam/Premarket Notification Procedure/Adulterated	N/A *
September 19, 2001	Cardinal Laboratories	Los Angeles District Office	CGMP Regulations for Finished Pharmaceuticals/Adulterated	N/A *
September 18, 2001	Pharmacia & Upjohn	San Juan District Office	CGMP Regulations for Finished Pharmaceuticals/Adulterated	N/A *
September 18, 2001	Dade South Fruits & Vegetables	Florida District Office	Shipment/Entry Not Held Intact	N/A *
September 18, 2001	Vital Concepts, Inc.	Detroit District Office	Quality System Regulation/Lacks Premarket Notification/Adulterated/Misbranded	N/A *
September 18, 2001	AirTran Airways	New Orleans District Office	Interstate Conveyance Sanitation Regulations	N/A *
September 18, 2001	Donald Johnson Seafood, Inc.	New Orleans District Office	Seafood HACCP/Crabmeat Products	N/A *
September 17, 2001	Huckaby Pharmacal, Inc.	Cincinnati District Office	Stagesic -10/Lacks New Drug Approval Application/Misbranded	N/A *
September 17, 2001	B. Braun Medical, Inc.	Philadelphia District Office	Quality System/Good Manufacturing Practice for Medical Devices/Adulterated	N/A *
September 17, 2001	CBCDC-Johnston Memorial Hospital	Atlanta District Office	Mammography Quality Standards	N/A *
September 17, 2001	Women's Imaging Center - Johnston Memorial Hospital	Atlanta District Office	Mammography Quality Standards	N/A *
September 17, 2001	Cleveland Medical Devices, Inc.	Cincinnati District Office	Quality System Regulation for Medical Devices/Adulterated	N/A *
September 17, 2001	Cleveland Medical Devices, Inc.	Cincinnati District Office	Quality System Regulation for Medical Devices/Adulterated	N/A *
September 17, 2001	Dulles International Airport	Baltimore District Office	Interstate Conveyance Sanitation Regulations	N/A *
September 14, 2001	Gilmore Fish Smokehouse	Seattle District Office	Seafood HACCP	N/A *

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