2001 Warning Letters

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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
December 31, 2001	Matthews, Dana C., M.D.	Center for Biologics Evaluation and Research	Sponsor/Clinical Investigator	N/A *
December 28, 2001	Green Gold Wholesale Produce Inc.	Baltimore District Office	Avocados/Lacks	N/A *
December 28, 2001	Hen-Lin Dairy	Minneapolis District Office	Animal Drug/Adulterated	N/A *
December 28, 2001	Trotters Importers	Baltimore District Office	Dried Fig Spread/Lacks	N/A *
December 27, 2001	N TECH Instrument Repair, Inc.	Chicago District Office	Quality System Regulation for Medical Devices/Adulterated	N/A *
December 27, 2001	2-2-0 Laboratories	Los Angeles District Office	Current Good Manufacturing Practices for Finished Pharmaceuticals/Adulterated	N/A *
December 27, 2001	Premium Fresh Juice and Food Company, Inc.	Los Angeles District Office	GMP in Manufacturing, Packing, Holding Human Food/Insanitary Practices	N/A *
December 27, 2001	B.N.S Uni, Inc.	Los Angeles District Office	Seafood HACCP	N/A *
December 27, 2001	Island Kinetics Inc	Los Angeles District Office	CGMP for Finished Pharmaceutical/Adulterated	N/A *
December 21, 2001	Feldman Mark H. D.P.M.	Center for Devices and Radiological Health	Clinical Investigator	N/A *
December 21, 2001	Forever Young Products, Inc.	New Orleans District Office	Current Good Manufacturing Practice Regulation for Finished Pharmaceuticals	N/A *
December 21, 2001	West Agro, Inc.	Chicago District Office	Current Good Manufacturing Practices for Finished Pharmaceuticals/Adulterated	N/A *
December 20, 2001	Medical Center at Lancaster	Dallas District Office	Mammography Quality Standards	N/A *
December 20, 2001	Norton Suburban Hospital	Cincinnati District Office	Mammography Quality Standards	N/A *
December 20, 2001	Misonix, Inc.	Denver District Office	GMP Requirements for the Quality System Regulation/Adulterated	N/A *
December 20, 2001	Van de Graaf Racnhes, Inc.	Seattle District Office	Current Good Manufacturing Practice for Medicated Feeds/Adulterated	N/A *
December 20, 2001	Carolina Seafood Ventures, LLC	Atlanta District Office	Seafood HACCP	N/A *
December 20, 2001	NCOIC	Dallas District Office	Mammography Quality Standards	N/A *
December 20, 2001	Breast Cancer Detection Center of Alaska	Seattle District Office	Mammography Quality Standards	N/A *
December 20, 2001	Luskin-Hawk, M.D., Roberta L	Center for Biologics Evaluation and Research	Clinical Investigator	N/A *
December 20, 2001	Port Bolivar Fisheries, Inc.	Dallas District Office	Seafood HACCP	N/A *
December 19, 2001	Conklin Enterprises, Inc.	Atlanta District Office	Seafood HACCP	N/A *
December 19, 2001	Diagnostic Medical Imaging Associates	Cincinnati District Office	Mammography Quality Standards	N/A *
December 19, 2001	Jensen Tuna, Inc.	New Orleans District Office	Seafood HACCP	N/A *
December 19, 2001	King's Oriental Foods Company	Seattle District Office	GMP for Manufacturing, Packing, Holding Food/Seafood HACCP	N/A *
December 19, 2001	The Medical Group	New Orleans District Office	Mammography Quality Standards	N/A *
December 19, 2001	Wayzata Bay Products Inc	Minneapolis District Office	Good Manufacturing Practice for Finished Pharmaceuticals/Adulterated	N/A *
December 18, 2001	Michigan Trading Post	Dallas District Office	Food Labeling/NexCite Dietary Supplement/Misbranded	N/A *
December 18, 2001	Multidata Systems International Corporation	Center for Devices and Radiological Health	Electronic Product Radiation Control/Premarket Notification Requirements/Adulterated/Misbranded	N/A *
December 18, 2001	Atlantic General Hospital	Baltimore District Office	Mammography Quality Standards Act	N/A *
December 18, 2001	Community Radiology Inc.	Cincinnati District Office	Mammography Quality Standards	N/A *
December 17, 2001	Women's Diagnostic Imaging Center	Seattle District Office	Mammography Quality Standards	N/A *
December 17, 2001	King's Fish Market, Inc.	Detroit District Office	Current Good Manufacturing Pratice Requirements for Foods/Seafood HACCP	N/A *
December 17, 2001	Camtrade Enterprises, Inc.	San Francisco District Office	Good Manufacturing Practice Requirement for Foods/Seafood HACCP/Adulterated	N/A *
December 17, 2001	Sibley Medical Associates	Baltimore District Office	Mammography Quality Standards	N/A *
December 17, 2001	Carl & Don Frazier, Inc.	Detroit District Office	Seafood HACCP	N/A *
December 14, 2001	Shelly Smith Farm	Atlanta District Office	Illegal Drug Residue/Adulterated	N/A *
December 14, 2001	Van Haitsma Dairy Farm	Detroit District Office	Illegal Drug Tissue Residue/Adulterated	N/A *
December 14, 2001	Natural Technology, Inc.	Dallas District Office	Current Good Manufacturing Practices for Finished Pharmaceuticals/Adulterated	N/A *
December 14, 2001	Trusted Care	New England District Office	Current Good Manufacturing Practices for Finished Pharmaceuticals/Adulterated	N/A *
December 14, 2001	Trilogy Crab Company, Inc.	Seattle District Office	Seafood HACCP/Adulterated	N/A *
December 14, 2001	Rowan Animal Clinic	Atlanta District Office	Illegal Drug Residue/Adulterated	N/A *
December 14, 2001	Biorem s.r.l.	Center for Devices and Radiological Health	Medical Device/Lacks Premarket Approval/Adulterated/Misbranded	N/A *
December 14, 2001	Bollinger Quick Repair, Inc.	New Orleans District Office	Interstate Conveyance Sanitation Regulations	N/A *
December 13, 2001	Signature Flight Support	Dallas District Office	Interstate Conveyance Sanitation Regulations	N/A *
December 13, 2001	Dallas County Hospital District	Dallas District Office	Mammography Quality Standards	N/A *
December 13, 2001	Dextrum Laboratories Inc	Florida District Office	CGMP for Drugs/Manufacture Processing Packing Holding/Adulterated	N/A *
December 13, 2001	Quinault Tribal Enterprises	Seattle District Office	Seafood HACCP	N/A *
December 13, 2001	Kittery Lobster Co., Inc.	New England District Office	Seafood HACCP	N/A *
December 13, 2001	Rose Breast Center	Dallas District Office	Mammography Quality Standards	N/A *

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