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 May 26, 2009

Letter Issue Date	Company Name	Issuing Office	Subject	Close Out Date
April 19, 2001	First Season Inc.	Chicago District Office	Food Labeling Warning & Notice Statements/Orange Juice/Misbranded	N/A *
April 19, 2001	Truett Laboratories Inc.	Atlanta District Office	CGMP/Finished Pharmaceuticals/Adulterated	N/A *
April 19, 2001	Marutama Company Inc.	Los Angeles District Office	Seafood HACCP	N/A *
April 19, 2001	Granules India Limited	Center for Drug Evaluation and Research	Active Pharmaceutical Ingredient Manufacturing Facility/Adulterated	N/A *
April 18, 2001	Swissport USA Inc.	New York District Office	Airline Watering Point and Lavatory Service Operation/Interstate Conveyance Sanitation	N/A *
April 18, 2001	Slade Gorton & Co. Inc.	New England District Office	Seafood HACCP	N/A *
April 18, 2001	Stough Enterprises	Minneapolis District Office	Biologics/Production and Process Controls	N/A *
April 18, 2001	Control-X Medical Inc.	Cincinnati District Office	Quality System Regulation/Diagnostic X-Ray Equipment/Adulterated	N/A *
April 18, 2001	Starfish Sea Products Inc.	Seattle District Office	Seafood HACCP/Battered Halibut and Battered Cod	N/A *
April 18, 2001	Professional Health Imaging P.C.	New York District Office	Mammography Quality Standards	N/A *
April 18, 2001	Airgas Inc.	Dallas District Office	Medical Gas Manufacturing/Adulterated	N/A *
April 18, 2001	Terminal One Management Inc	New York District Office	Control of Communicable Disease and Interstate Conveyance Sanitation	N/A *
April 17, 2001	Sun Food Trading Company	Seattle District Office	Seafood HACCP	N/A *
April 17, 2001	Baxter Healthcare	Atlanta District Office	Good Manufacturing Practices/Biologicals	N/A *
April 17, 2001	AvidCare Corporation	Minneapolis District Office	Quality System Regulation/Lacks Premarket Approval/Adulterated	N/A *
April 17, 2001	Borinquen Biscuit Co.	San Juan District Office	Wheat Flour/Entry Not Held Intact for Inspection	N/A *
April 17, 2001	Jensen Dairy	San Francisco District Office	Dairy/Illegal Drug Residue/Adulterated	N/A *
April 16, 2001	Amtrak	Kansas City District Office	Control of Communicable Diseases/Interstate Conveyance Sanitation	N/A *
April 16, 2001	Medical Imaging Center of Southern California	Los Angeles District Office	Mammography Quality Standards	N/A *
April 16, 2001	Hiyi Export Company	Center for Devices and Radiological Health	Quality Systems Regulation/Patient Examination Gloves/Adulterated	N/A *
April 16, 2001	IMI of Miami	Florida District Office	Mammography Quality Standards	N/A *
April 16, 2001	Veterinary Laboratories Inc.	Kansas City District Office	CGMP/Finished Pharmaceuticals	N/A *
April 16, 2001	Jefferson Milling Company	Cincinnati District Office	Animal Proteins Prohibited in Ruminant Feed	N/A *
April 16, 2001	Perry Coal and Feed Company	Cincinnati District Office	Animal Proteins Prohibited in Ruminant Feed	N/A *
April 16, 2001	Dorset Milling	Cincinnati District Office	Animal Proteins Prohibited in Ruminant Feed	N/A *
April 16, 2001	Banner Pharmacaps Inc.	Los Angeles District Office	CGMP/Finished Pharmaceuticals	N/A *
April 14, 2001	Specialty Foods Boston Inc.	New England District Office	Seafood HACCP/Vacuum-Packed Smoked Seafood	N/A *
April 13, 2001	Chembio Diagnostics Systems Inc.	New York District Office	Pregnancy Test Kits/Lack Approved Application for Premarket Approval	N/A *
April 13, 2001	Cardiomedics Inc.	Los Angeles District Office	Quality System Regulation/Counter Pulsation Devices	N/A *
April 13, 2001	Wadsworth Rittman Hospital	Chicago District Office	Mammography Quality Standards	N/A *
April 12, 2001	Adams County Memorial Hospital	Minneapolis District Office	Mammography Quality Standards	N/A *
April 12, 2001	Appleton Medical Center	Minneapolis District Office	Mammography Quality Standards	N/A *
April 12, 2001	Intuitive Surgical Incorporated	Center for Devices and Radiological Health	Lacks Approved Premarket Approval Application/Da Vinci Surgical Systemn/Adulterated/Misbranded	N/A *
April 12, 2001	St. Luke's Roosevelt Hospital Center	New York District Office	Blood Bank/Standard Operating Procedures	N/A *
April 12, 2001	Eagle Distributors Inc.	Chicago District Office	Seafood HACCP	N/A *
April 12, 2001	Areias & Meneses Diary	San Francisco District Office	Dairy/Illegal Drug Residue/Adulterated	N/A *
April 12, 2001	Hanmi Inc.	Los Angeles District Office	Seafood HACCP/Adulterated	N/A *
April 12, 2001	Maricopa Medical Center	Los Angeles District Office	Mammography Quality Standards	N/A *
April 12, 2001	Healthsouth Diagnostic Center of Front Range	Dallas District Office	Mammography Quality Standards	N/A *
April 11, 2001	Wright Medical Technology Inc.	Center for Devices and Radiological Health	AlloMatrix/Lacks Approved Premarket Application/Adulterated	N/A *
April 11, 2001	Omicron Quimica S.A.	Center for Drug Evaluation and Research	CGMP/Manufacturing Facility/Active Pharmaceutical Ingredient	N/A *
April 11, 2001	Minor and James Medical PLLC	Seattle District Office	Mammography Quality Standards	N/A *
April 10, 2001	Classic Care Products Inc.	New Orleans District Office	Veterinary Drug Manufacturing Facility/CGMP's for Finished Pharmaceuticals	N/A *
April 10, 2001	Minister Farmers Cooperative Exchange Inc.	Cincinnati District Office	Animal Proteins Prohibited in Ruminant Feed/Feed Mill	N/A *
April 10, 2001	Ocean Beauty Seafoods, Inc.	Seattle District Office	Seafood HACCP/Whole Cooked Crab and Fresh Tuna	N/A *
April 10, 2001	Miami River Lobster and Stone Crab	Florida District Office	Seafood HACCP/Cooked Lobster	N/A *
April 10, 2001	GE Medical Systems Inc. SA	Center for Devices and Radiological Health	Quality System Regulations/Full Field Digital Mammography System/Adulterated	N/A *
April 10, 2001	Skintech 2000 Inc.	Florida District Office	Lack Approved Premarket Approval Application/Blue Cap Spray	N/A *
April 10, 2001	Sinco Inc.	New England District Office	Canned Tune/Entry Not Held Intact	N/A *
April 09, 2001	Aventis Pasteur Inc.	Office of Enforcement	GMP for Mfr Processing Packing Holding Drugs/Biological Products	N/A *

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