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
November 13, 2001	New Japan International Inc.	Los Angeles District Office	Salmonella Contamination/Adulterated	N/A *
November 13, 2001	OB/GYN Group/Imaging	Dallas District Office	Mammography Quality Standards	N/A *
November 13, 2001	Holy Cross Hospital	Dallas District Office	Mammography Quality Standards	N/A *
November 13, 2001	Medical Imaging Center	Dallas District Office	Mammography Quality Standards	N/A *
November 13, 2001	Sally Jobe Breast Diagnostic & Counseling Center	Dallas District Office	Mammography Quality Standards	N/A *
November 09, 2001	Accumed, Inc.	New Jersey District Office	Current Good Manufacturing Practice Regulation for Finished Pharmaceuticals	N/A *
November 09, 2001	F.A.V. International Corp.	Florida District Office	Stoneware Mugs/Lacks "May Proceed Notice" or "Release Notice"	N/A *
November 09, 2001	Sea Market Inc.	Florida District Office	Seafood HACCP	N/A *
November 09, 2001	St. Anthony Hospital	Seattle District Office	Mammography Quality Standards	N/A *
November 09, 2001	George Weston Bakeries, Inc.	Chicago District Office	Food Labeling/Misbranded	N/A *
November 09, 2001	AstraZeneca AB	Center for Devices and Radiological Health	Deviations from CGMP for Finished Pharmaceuticals	N/A *
November 09, 2001	Landshire of Florida, Inc.	Florida District Office	Seafood HACCP	N/A *
November 09, 2001	LifeGas, Ltd.	New Orleans District Office	Current Good Manufacturing Practice Regulations/Oxygen USP/Adulterated	N/A *
November 09, 2001	Purdue Pharma Inc.	New Jersey District Office	Current Good Manufacturing Practice Regulation for Finished Pharmaceuticals	N/A *
November 09, 2001	ScienceBased Health	Center for Food Safety and Applied Nutrition	New Drug/Labeling/Misbranded	N/A *
November 09, 2001	Kaytrad Commodities, Ltd.	Center for Food Safety and Applied Nutrition	Seafood HACCP	N/A *
November 09, 2001	Colt, Inc.	New Orleans District Office	Current Good Manufacturing Practice in manufacturing, packing, or holding human food	N/A *
November 09, 2001	Jackson Clinic North	New Orleans District Office	Mammography Quality Standards	N/A *
November 09, 2001	Mid-Columbia Medical Center	Seattle District Office	Mammography Quality Standards	N/A *
November 09, 2001	Neptune Manufacturing, Inc.	Los Angeles District Office	Seafood HACCP	N/A *
November 08, 2001	Watuga Medical Center	Atlanta District Office	Mammography Quality Standards	N/A *
November 08, 2001	Far Ocean Sea Products Pte., Ltd.	Center for Food Safety and Applied Nutrition	Seafood HACCP	N/A *
November 08, 2001	Kimball Foods, Inc.	Chicago District Office	Seafood HACCP	N/A *
November 08, 2001	Iso-Tex Diagnostics, Inc.	Dallas District Office	Current Good Manufacturing Practices for Finished Pharmaceuticals/Adulterated	N/A *
November 08, 2001	Quality Crab Company, Inc.	Atlanta District Office	Seafood HACCP	N/A *
November 08, 2001	Finlayson Ag Center	Minneapolis District Office	Animal Proteins Prohibited in Ruminant Feed/Adulterated	N/A *
November 08, 2001	Greenwood Imaging Center, P.A.	Atlanta District Office	Mammography Quality Standards	N/A *
November 08, 2001	Charles A. Cannon, Jr. Memorial Hospital	Atlanta District Office	Mammography Quality Standards	N/A *
November 08, 2001	Genzyme Corporation	New Jersey District Office	Quality System/Good Manufacturing Practice for Medical Devices/Synvisc Hylan G-F 20/Adulterated	N/A *
November 07, 2001	Community Radiology, P.A.	New Jersey District Office	Mammography Quality Standards	N/A *
November 07, 2001	Aventura Diagnostic Center	Florida District Office	Mammography Quality Standards	N/A *
November 07, 2001	Fair Oaks Hospital Medical Plaza	Baltimore District Office	Mammography Quality Standards	N/A *
November 07, 2001	Sea-Lect Wholesale Seafood Inc.	New Jersey District Office	Seafood HACCP	N/A *
November 06, 2001	Eye Centers of Florida	Florida District Office	Human Tissue Intended for Transportation	N/A *
November 05, 2001	Miller II, Damon P., M.D.	Center for Devices and Radiological Health	Labeling/Lacks Premarket Notification	N/A *
November 05, 2001	Art's Trading Company	San Francisco District Office	Good Manufacturing Practice Requirements for Foods/Seafood HACCP/Adulterated	N/A *
November 05, 2001	ARJO, Ltd.	Center for Devices and Radiological Health	Quality System Regulation/Adulterated	N/A *
November 05, 2001	Westchester-Bronx OB/Gyn Group, P.C.	Buffalo District Office	Mammography Quality Standards	N/A *
November 05, 2001	Saint Dominic's Hospital	San Francisco District Office	Mammography Quality Standards	N/A *
November 05, 2001	Borgess- Pipp Health Center	Detroit District Office	Mammography Quality Standards	N/A *
November 05, 2001	Diomed Inc.	Center for Devices and Radiological Health	Lacks Premarket Notification/Misbranded/Adulterated	N/A *
November 02, 2001	Baxter Healthcare Corporation	Chicago District Office	Current Good Manufacturing Practice Regulation for Finished Pharmaceuticals	N/A *
November 01, 2001	Gorman, John F., M.D.	Buffalo District Office	Mammography Quality Standards	N/A *
October 31, 2001	Stewarts Seafood Inc.	New Orleans District Office	Seafood HACCP	N/A *
October 31, 2001	Four Star Dairy	Cincinnati District Office	Illegal Drug Residue/Adulterated	N/A *
October 31, 2001	Fairfield Medical Center	Cincinnati District Office	Mammography Quality Standards	N/A *
October 31, 2001	Fairfield Medical Center Diagnostic Health Services	Cincinnati District Office	Mammography Quality Standards Act	N/A *
October 30, 2001	Emergent Innovations, LLC.	Detroit District Office	Quality System Regulations/Medical Device Reporting/Adulterated/Misbranded	N/A *
October 30, 2001	Avax Technologies, Inc.	Center for Biologics Evaluation and Research	Sponsor/Monitor/Contract Research Organization	N/A *
October 29, 2001	Trans Caribbean Dairy Corporation	San Juan District Office	Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Human Food/Adulterated	N/A *

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