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
July 16, 2001	American Classic Voyages Co.	New Orleans District Office	Control of Communicable Diseases/Interstate Conveyance Sanitation	N/A *
July 16, 2001	Icicle Seafoods, Inc.	Seattle District Office	Seafood HACCP	N/A *
July 16, 2001	Esolyte, Inc.	Denver District Office	Good Manufacturing Practices for Blood & Blood Components/Adulterated	N/A *
July 16, 2001	Wanchese Fish Company, Inc.	Atlanta District Office	Seafood HACCP	N/A *
July 16, 2001	Simmons Farm Raised Catfish, Inc.	New Orleans District Office	Seafood HACCP/Frozen Catfish/Adulterated	N/A *
July 13, 2001	Ocean Pride Seafood	Los Angeles District Office	Seafood HACCP	N/A *
July 13, 2001	San Juan Bautista Medical Center	San Juan District Office	CGMP for Blood & Components/General Biological Products Standards/Adulterated	N/A *
July 13, 2001	Biomax Formulations	Los Angeles District Office	New Drug/Labeling/Misbranded	N/A *
July 13, 2001	Adventist Health Walla Walla General Hospital	Seattle District Office	GMP for Blood & Blood Components/General Biological Standards	N/A *
July 13, 2001	Alliance Medical Corporation	Atlanta District Office	Quality System Regulation/Adulterated	N/A *
July 13, 2001	Hawaiian Sun Products, Inc.	Los Angeles District Office	Food Labeling/Insanitary Conditions/Adulterated/Misbranded	N/A *
July 13, 2001	Aventis Bio-Sciences	Seattle District Office	Good Manufacturing Practice Regulations for Blood and Blood Components	N/A *
July 13, 2001	Prospect Enterprise, Inc.	Los Angeles District Office	Good Manufacturing Practice Requirements for Foods/Seafood HACCP/Adulterated	N/A *
July 13, 2001	Reddy, Duttala Obula, M.D.	Center for Drug Evaluation and Research	Clinical Investigator	N/A *
July 12, 2001	Pacific Seafood Group	Seattle District Office	GMP Regulations/Seafood HACCP/Frozen Shrimp/Adulterated	N/A *
July 12, 2001	Barrow Medical Center	Atlanta District Office	Mammography Quality Standards	N/A *
July 12, 2001	Sunset Deli	Seattle District Office	Seafood HACCP/Tuna Salad Sandwiches	N/A *
July 12, 2001	Tend Skin International, Inc.	Florida District Office	OTC Drugs/Adulterated/Misbranded	N/A *
July 12, 2001	Carrollton Farmers Exchange	Cincinnati District Office	Animal Proteins Prohibited in Ruminant Feed	N/A *
July 12, 2001	Sam Uk Fish Cake Company	Seattle District Office	Seafood HACCP/Vacuum-Packed Fried Fish Cakes	N/A *
July 12, 2001	Scotland Memorial Hospital	Atlanta District Office	Mammography Quality Standards	N/A *
July 12, 2001	Technical Products, Inc.	Atlanta District Office	Quality System Regulation/Adulterated	N/A *
July 12, 2001	Boehringer Ingelheim Corporation	Cincinnati District Office	Current Good Manufacturing Practices for Finished Pharmaceuticals/Adulterated	N/A *
July 12, 2001	Tend Skin International, Inc.	Florida District Office	OTC Drugs/Adulterated/Misbranded	N/A *
July 12, 2001	Newman's Fish Company	Seattle District Office	Seafood HACCP	N/A *
July 12, 2001	Panatrex, Inc.	Los Angeles District Office	Quality System Regulation/Skin Test Applicators/Adulterated	N/A *
July 11, 2001	McCann's Seafood	New Orleans District Office	Seafood HACCP/Crabmeat	N/A *
July 11, 2001	Salon Sciences Corporation	Florida District Office	GMP Regulation for Finished Pharmaceutical/Lacks Approved Drug Application/Adulterated/Misbranded	N/A *
July 11, 2001	True World Foods Inc	Chicago District Office	Good Manufacturing Practice Regulations for Foods/Seafood HACCP	N/A *
July 11, 2001	Garland, Paul E., M.D.	Center for Devices and Radiological Health	Lacks Application for Premarket Approval IDE/Adulterated	N/A *
July 11, 2001	Jones Memorial Hospital	New York District Office	Mammography Quality Standards	N/A *
July 11, 2001	Fisherman's Cooperative, Inc.	New Jersey District Office	Seafood HACCP	N/A *
July 11, 2001	Three Ann's Seafood	Baltimore District Office	Seafood HACCP/Crabmeat Processing Facility/Adulterated	N/A *
July 11, 2001	The Women's Place	New York District Office	Mammography Quality Standards	N/A *
July 10, 2001	Ameripure Processing Company, Inc.	New Orleans District Office	Seafood HACCP/Oysters	N/A *
July 10, 2001	Heron Bay Seafood	New Orleans District Office	Seafood HACCP/Crabmeat/Adulterated	N/A *
July 10, 2001	EP MedSystems	New Jersey District Office	Quality System Regulation/Cardiac Catheters/Adulterated	N/A *
July 10, 2001	Methodist Hospital Germantown	New Orleans District Office	Mammography Quality Standards	N/A *
July 10, 2001	John L. Hertle Dairy	Los Angeles District Office	Food/Adulterated	N/A *
July 10, 2001	Oliveira Dairy	Los Angeles District Office	Food/Adulterated	N/A *
July 10, 2001	Cardinal Health, Inc.	Cincinnati District Office	Current Good Manufacturing Practices for Finished Pharmaceuticals/Adulterated	N/A *
July 09, 2001	Henry Mayo Newhall Memorial Hospital	Los Angeles District Office	Mammography Quality Standards	N/A *
July 09, 2001	SciOptic International	Center for Devices and Radiological Health	Sponsor Obligations	N/A *
July 09, 2001	American Eagle Airlines, Inc.	Dallas District Office	Interstate Conveyance Sanitation Regulations	N/A *
July 09, 2001	World Diagnostics, Inc.	Florida District Office	Lacks Application for Premarket Approval/IDE Exemption/Lacks Export Authority	N/A *
July 07, 2001	Centura Health Avista Hospital	Dallas District Office	Mammography Quality Standards	N/A *
July 06, 2001	Ferro Corporation	Chicago District Office	CGMP/Active Pharmaceutical Ingredients/Adulterated	N/A *
July 06, 2001	Heinig, Robert E., M.D.	Center for Drug Evaluation and Research	Clinical Investigator	N/A *
July 06, 2001	Aultman Health Foundation	Cincinnati District Office	Good Manufacturing Practices for Blood and Blood Products	N/A *
July 06, 2001	Nesbitt, Lori A., Pharm. D., M.B.A.	Center for Drug Evaluation and Research	Clinical Investigator	N/A *

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