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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Enforcement Actions

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2001 Warning Letters

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Tobacco Retailer 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

 
Letter Issue Date Company Name Issuing Office Subject Close Out Date
April 18, 2001 Stough Enterprises Minneapolis District Office Biologics/Production and Process Controls N/A *
April 18, 2001 Starfish Sea Products Inc. Seattle District Office Seafood HACCP/Battered Halibut and Battered Cod N/A *
April 17, 2001 AvidCare Corporation Minneapolis District Office Quality System Regulation/Lacks Premarket Approval/Adulterated N/A *
April 17, 2001 Sun Food Trading Company Seattle District Office Seafood HACCP 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 Baxter Healthcare Atlanta District Office Good Manufacturing Practices/Biologicals N/A *
April 17, 2001 Jensen Dairy San Francisco District Office Dairy/Illegal Drug Residue/Adulterated 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 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 Banner Pharmacaps Inc. Los Angeles District Office CGMP/Finished Pharmaceuticals N/A *
April 16, 2001 IMI of Miami Florida District Office Mammography Quality Standards 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 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 14, 2001 Specialty Foods Boston Inc. New England District Office Seafood HACCP/Vacuum-Packed Smoked Seafood 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 13, 2001 Chembio Diagnostics Systems Inc. New York District Office Pregnancy Test Kits/Lack Approved Application for Premarket Approval N/A *



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ICECI Warning Letters

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