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 September 07, 2001

Letter Issue Date	Company Name	Issuing Office	Subject	Close Out Date
September 07, 2001	MacKnight Smoked Food Inc.	New York District Office	Frozen Mackerel Fillets/Lacks "May Proceed" or "Release Notice"	N/A *
September 07, 2001	Pharmakon Labs, Inc.	Florida District Office	CGMP/Lack Approved New Drug Application/Adulterated/Misbranded	N/A *
September 07, 2001	Hallmark Sales Corporation	Dallas District Office	CGMP Requirements of the Quality System Regulations/First Aid Kits & Sterile Kits/Adulterated	N/A *
September 07, 2001	Eastern Carolina Internal Medicine, P.A.	Atlanta District Office	Mammography Quality Standards	N/A *
September 06, 2001	Presbyterian Hospital of Greenville	Dallas District Office	Mammography Quality Standards	N/A *
September 06, 2001	Regional West Medical Center-Mobile	Dallas District Office	Mammography Quality Standards	N/A *
September 06, 2001	Regional West Medical Center	Dallas District Office	Mammography Quality Standards	N/A *
September 06, 2001	Sera-Tec Biologicals Limited Partnership	Cincinnati District Office	Current Good Manufacturing Practices for Blood and Blood Components	N/A *
September 06, 2001	Sierra Kings District Hospital	San Francisco District Office	Mammography Quality Standards	N/A *
September 06, 2001	Mary Chiles Hospital	Cincinnati District Office	Mammography Quality Standards	N/A *
September 06, 2001	Classic Charter, Inc.	San Francisco District Office	Control of Communicable Diseases and Interstate Conveyance Sanitation	N/A *
September 06, 2001	Bindley Western Industries, Inc.	New England District Office	Guidelines for State Licensing of Wholesale Prescription Drug Distributors	N/A *
September 06, 2001	Memorial Hospital of Sweetwater County	Dallas District Office	Mammography Quality Standards	N/A *
September 05, 2001	Goya Foods, Inc.	New Jersey District Office	Food Labeling/Adulterated/Misbranded	N/A *
September 05, 2001	Trans World Airlines	New York District Office	Control of Communicable Diseases and Interstate Conveyance Sanitation	N/A *
September 05, 2001	Syncor International Corporation	Denver District Office	Current Good Manufacturing Practices for Finished Pharmaceuticals/Adulterated	N/A *
September 05, 2001	Radiological Associates of Sacramento Medical Group, Inc.	San Francisco District Office	Mammography Quality Standards	N/A *
September 05, 2001	Seafood Warehouse, Inc.	New Orleans District Office	CGMP in Manufacturing, Packing, or Holding Food for Human Consumption/Seafood HACCP/Adulterated	N/A *
September 04, 2001	Utah Medical Products, Inc.	Denver District Office	Quality System Regulation/Good Manufacturing Practice for Medical Devices/Adulterated	N/A *
September 04, 2001	Radiation Products Design, Inc.	Minneapolis District Office	Quality System Regulation/Medical Devices/Adulterated	N/A *
September 04, 2001	Greyhound Lines, Inc.	San Francisco District Office	Control of Communicable Diseases and Interstate Conveyance Sanitation	N/A *
September 04, 2001	Chalgren Enterprises, Inc.	San Francisco District Office	Quality System Regulations for Medical Devices/Electromyographic Electrodes/Adulterated	N/A *
September 03, 2001	King's Oriental Foods Company	Seattle District Office	Seafood HACCP/Adulterated	N/A *
August 31, 2001	Hugh Cox Livestock	Atlanta District Office	Illegal Drug Tissue Residue/Adulterated	N/A *
August 31, 2001	Gainesville Seafood	Dallas District Office	Seafood HACCP	N/A *
August 30, 2001	Mar-Lees Seafood, Inc.	New England District Office	Seafood HACCP/Shrimp	N/A *
August 30, 2001	Patterson, William M., M.D.	Center for Drug Evaluation and Research	Clinical Investigator	N/A *
August 30, 2001	Scharf, Martin B., Ph.D.	Center for Drug Evaluation and Research	Clinical Investigator	N/A *
August 30, 2001	Laomerica Seafood Inc.	New Orleans District Office	CGMP in Manufacturing, Packing, or Holding Food for Human Consumption/Seafood HACCP/Adulterated	N/A *
August 30, 2001	Laomerica Seafood Inc.	New Orleans District Office	CGMP in Manufacturing, Packing, or Holding Food for Human Consumption/Seafood HACCP/Adulterated	N/A *
August 30, 2001	Mid Hudson Medical Group	New York District Office	Mammography Quality Standards	N/A *
August 30, 2001	Norquest Seafoods, Inc.	Seattle District Office	Seafood HACCP/Dungeness Crab	N/A *
August 30, 2001	Brave Coast, Inc.	Florida District Office	Swordfish/Entry Not Held Intact	N/A *
August 30, 2001	Wheatland Memorial Hospital	Seattle District Office	Mammography Quality Standards	N/A *
August 29, 2001	Bristol-Myers Squibb Company	Detroit District Office	Infant Formula/Adulterated/Misbranded	N/A *
August 29, 2001	UHHS-Saint Michael Hospital	Cincinnati District Office	Mammography Quality Standards	N/A *
August 29, 2001	Hirzel Canning Company	Cincinnati District Office	Food Labeling/Canned Tomato Products/Misbranded	N/A *
August 29, 2001	Hammer Medical Supply	Kansas City District Office	CGMP for Finished Pharmaceuticals/Medical Oxygen/Adulterated	N/A *
August 29, 2001	World Yacht Cruises	New York District Office	Control of Communicable Diseases and Interstate Conveyance Sanitation	N/A *
August 29, 2001	Dixon Fisheries, Inc.	Detroit District Office	Current Good Manufacturing Practice Requirements for Foods/Seafood HACCP/Adulterated	N/A *
August 29, 2001	Citarella Fish Company	New York District Office	Seafood HACCP	N/A *
August 29, 2001	United Hospital Medical Center	New York District Office	Mammography Quality Standards	N/A *
August 28, 2001	Sonar Products, Inc.	New Jersey District Office	GMP for Finished Pharmaceuticals/Prescription & Over-the-Counter Products	N/A *
August 28, 2001	Little Rock Diagnostic Clinic	Dallas District Office	Mammography Quality Standards	N/A *
August 28, 2001	Paskewitz Cattle Company	Minneapolis District Office	Illegal Drug Tissue Residue/Adulterated	N/A *
August 28, 2001	Inland Vending Expand O Systems, LLC	Seattle District Office	Seafood HACCP/Tuna Fish Sandwiches	N/A *
August 28, 2001	Modern Products, Inc.	Minneapolis District Office	CGMP for Finished Pharmaceuticals/OTC Drug Manufacturing/Adulterated	N/A *
August 27, 2001	J & A Business, Inc.-Johnny & Alan's Sandwiches	New Orleans District Office	Seafood HACCP	N/A *
August 27, 2001	F.W. Renner & Sons, Inc.	Cincinnati District Office	Animal Proteins Prohibited in Ruminant Feed/Misbranded	N/A *
August 27, 2001	American Home Health Care Company	Kansas City District Office	CGMP for Finished Pharmaceuticals/Medical Gas Transfilling Operation/Adulterated	N/A *

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