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
October 03, 2001	Tuna Fresh, Inc.	New Orleans District Office	Seafood HACCP	N/A *
October 03, 2001	Frank's Fish, Inc.	New Jersey District Office	Seafood HACCP	N/A *
October 03, 2001	American Spice Company, Inc.	Florida District Office	Import/Not Held Intact	N/A *
October 03, 2001	Custom Care Pharmacy	Center for Drug Evaluation and Research	Strontium Chloride SR-89/New Drug/Labeling/Misbranded	N/A *
October 03, 2001	Licking Memorial Women's Health	Cincinnati District Office	Mammography Quality Standards	N/A *
October 02, 2001	Northeast General Pharmaceutical Factory	Center for Biologics Evaluation and Research	Current Good Manufacturing Practices for Finished Pharmaceuticals/Adulterated	N/A *
October 02, 2001	Allied Health Association	Center for Devices and Radiological Health	Lacks Premarket Approval/Not Substantially Equivalent/Adulterated	N/A *
October 02, 2001	Pacific Presicion	Los Angeles District Office	CGMP Requirements for the Quality System Regulation/Adulterated/Misbranded	N/A *
October 02, 2001	AJD Laboratories - Ulmer Pharmacal	Minneapolis District Office	Current Good Manufacturing Practices for Finished Pharmaceuticals/Adulterated	N/A *
October 02, 2001	Minneapolis Radiology Associates, Ltd.	Minneapolis District Office	Mammography Quality Standards	N/A *
October 02, 2001	Neil Laboratories, Inc.	New Jersey District Office	CGMP for Finished Pharmaceuticals/OTC Drug Manufacturing/Adulterated	N/A *
October 02, 2001	Medical Cables, Inc.	Los Angeles District Office	GMP Requirements for the Quality System Regulation/Adulterated	N/A *
October 02, 2001	Med Prep Consulting, Inc.	New Jersey District Office	Current Good Manufacturing Practices for Finished Pharmaceuticals/Adulterated	N/A *
October 02, 2001	Empire Seafood, Inc.	Florida District Office	Seafood HACCP	N/A *
October 01, 2001	Ken's Meat and Deli	Minneapolis District Office	Food Labeling/Misbranded	N/A *
October 01, 2001	Michigan Instruments, Inc.	Detroit District Office	Medical Device Reporting Regulations/Lacks Premarket Notification/Adulterated/Misbranded	N/A *
September 28, 2001	Fort Collins Mammography Center	Dallas District Office	Mammography Quality Standards	N/A *
September 28, 2001	John W. Stone Oil Distributors, L.L.C.	New Orleans District Office	Interstate Conveyance Sanitation Regulations	N/A *
September 28, 2001	Thousand Oaks Imaging Center	Dallas District Office	Mammography Quality Standards	N/A *
September 28, 2001	Milan General Hospital	New Orleans District Office	Mammography Quality Standards	N/A *
September 28, 2001	Grapevine Imaging and Pain Management Center	Dallas District Office	Mammography Quality Standards	N/A *
September 28, 2001	Advanced Medical Imaging Center	New Orleans District Office	Mammography Quality Standards	N/A *
September 28, 2001	Tidewater Dock, Inc.	New Jersey District Office	Interstate Conveyance Sanitation Regulations	N/A *
September 28, 2001	Doctor's Clinic Imaging Center	San Francisco District Office	Mammography Quality Standards	N/A *
September 27, 2001	American Blending and Filling	Chicago District Office	Current Good Manufacturing Practices for Finished Pharmaceuticals/Adulterated	N/A *
September 27, 2001	Focal Pointe Women	Atlanta District Office	Mammography Quality Standards	N/A *
September 27, 2001	Christ Hospital	Chicago District Office	Current Good Manufacturing Practices for Blood and Blood Components	N/A *
September 27, 2001	Unilever HPC-USA	Chicago District Office	Current Good Manufacturing Practices for Finished Pharmaceuticals/Adulterated	N/A *
September 27, 2001	Gloucester Seafood Display Auction	New England District Office	Seafood HACCP/Bluefish	N/A *
September 27, 2001	Interstate Brands Corporation	Chicago District Office	Food Labeling/Misbranded	N/A *
September 27, 2001	Duck Delivery Produce, Inc.	Seattle District Office	Seafood HACCP/Adulterated	N/A *
September 27, 2001	Mrs. Seibold's Bakery, Inc.	Chicago District Office	Insanitary Conditions/Adulterated	N/A *
September 27, 2001	International Science & Technology, L.P.	Dallas District Office	CGMP Requirements of the Quality System Regulations/Adulterated/Misbranded	N/A *
September 26, 2001	Dentsply International, Inc.	Chicago District Office	Quality System Regulation for Medical Devices/Adulterated	N/A *
September 26, 2001	Cameron-Miller, Inc.	Chicago District Office	Quality System Regulation for Medical Devices/Adulterated	N/A *
September 26, 2001	Kabco, Inc.	New York District Office	Cholestrol Support Capsules/Unapproved New Drug Application/Misbranded	N/A *
September 26, 2001	Black River Produce Earth Brothers Ltd.	New England District Office	Seafood HACCP	N/A *
September 25, 2001	Schuster Services & Blue Mountain Water	San Juan District Office	Food Labeling/Processing & Standard Identity for Bottled Drinking Water/Adulterated/Misbranded	N/A *
September 25, 2001	Hako-Med Electromedicine, Incorporated	Center for Devices and Radiological Health	Device/Lacks Approved Premarket Application/Adulterated/Misbranded	N/A *
September 24, 2001	Saint Croix Dairy Products, Inc.	San Juan District Office	GMP in Manufacturing, Packing, Holding Human Food/Adulterated	N/A *
September 24, 2001	Advanced Bionics Corporation	Center for Devices and Radiological Health	CII Bionic Ear/Lacks Approved Premarket Approval/Adulterated	N/A *
September 24, 2001	AMA Therapeutics, Inc.	Florida District Office	Shipment/Entry Not Held Intact	N/A *
September 24, 2001	Hull Street Diagnostic Center	Baltimore District Office	Mammography Quality Standards	N/A *
September 24, 2001	Selma Regional Medical Center	New Orleans District Office	Mammography Quality Standards	N/A *
September 24, 2001	Nino's Enterprises, Inc.	Chicago District Office	Seafood HACCP/Adulterated	N/A *
September 24, 2001	Saint Thomas Catering Corporation	San Juan District Office	Interstate Conveyance Sanitation Regulation/Misbranded	N/A *
September 24, 2001	Caviar Royale, Inc.	San Francisco District Office	Seafood HACCP/Adulterated	N/A *
September 24, 2001	Caledonian Springs, Inc.	San Juan District Office	Food Labeling/Processing & Standard Identity for Bottled Drinking Water/Adulterated/Misbranded	N/A *
September 24, 2001	Hinsdale Hospital Bllod Bank	Chicago District Office	Current Good Manufacturing Practices for Blood and Blood Components	N/A *
September 24, 2001	Robin Drug Corporation	Minneapolis District Office	CGMP for Finished Pharmaceuticals/Drugs Repacking Facility/Adulterated	N/A *

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