2000 Warning Letters

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Tobacco Retailer Warning Letters

 

Warning Letters for 2000

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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
September 26, 2000	Stason Pharmaceuticals Inc.	Los Angeles District Office	Good Manufacturing Practices for Finished Pharmaceuticals	N/A *
September 26, 2000	Holy Cross Hospital IRB	Center for Devices and Radiological Health	IRB (Institutional Review Board)	N/A *
September 25, 2000	Nuclear Medicine of Central Florida Inc.	Florida District Office	Thallium-201(inj.)/Lacks Approved New Drug Application/Misbranded/Adulterated	N/A *
September 25, 2000	Baptist Memorial Hospital - Huntingdon	New Orleans District Office	Mammography Standards	N/A *
September 22, 2000	Leiner Health Products Inc.	Los Angeles District Office	CGMP/Finished Pharmaceuticals	N/A *
September 22, 2000	Cangene Corporation	Los Angeles District Office	Good Manufacturing Practices for Blood and Blood Products	N/A *
September 21, 2000	Clay-Park Laboratories Inc.	New York District Office	CGMP/Finished Pharmaceuticals	N/A *
September 21, 2000	Hudson Medical Center-Medical Imaging	Minneapolis District Office	Mammography Standards	N/A *
September 21, 2000	Ayundantes Inc.	Denver District Office	Narcotic Treatment Program Standards	N/A *
September 21, 2000	SDL Incorporated	Center for Devices and Radiological Health	Performance Standards for Laser Products	N/A *
September 20, 2000	Carl Zeiss Inc.	San Francisco District Office	Laser Products / Noncompliance	N/A *
September 20, 2000	TMJ Implants Inc.	Center for Devices and Radiological Health	Sponsor Obligations	N/A *
September 20, 2000	MCMI Food Company	Dallas District Office	Seafood Processing Regulations/HACCP	N/A *
September 20, 2000	Martin Robert Z.	Center for Drug Evaluation and Research	Clinical Investigator	N/A *
September 20, 2000	Coldwater Fish Farms	Kansas City District Office	Seafood Processing Regulations/HACCP	N/A *
September 19, 2000	Altair Corporation	San Francisco District Office	Current Good Manufacturing Practices for Medicated Feeds	N/A *
September 19, 2000	Summer Sprout	Denver District Office	Alfalfa Sprout/Insanitary Conditions/Adulterated	N/A *
September 19, 2000	Organon Inc.	New Jersey District Office	Current Good Manufacturing Practice Regulations/Steril & Non-Sterile Prodcuts	N/A *
September 19, 2000	Glaxo Wellcome S.p.A.	Center for Drug Evaluation and Research	Current Good Manufacturing Practices for Sterile Pharmaceuticals	N/A *
September 18, 2000	Hilton Head Medical Center	Atlanta District Office	Mammography Standards	N/A *
September 18, 2000	Indian Valley Meats Inc.	Seattle District Office	Seafood Processing Regulations/HACCP	N/A *
September 18, 2000	Department of Pathology and Laboratory Medicine	Chicago District Office	Good Manufacturing Practices for Blood and Blood Products	N/A *
September 15, 2000	British Airways	New York District Office	Control of Communicable Disease and Interstate Conveyance Sanitation	N/A *
September 15, 2000	Alves Family Dairy	San Francisco District Office	Food/Cattle	N/A *
September 15, 2000	Reynolds Industries Inc.	Denver District Office	Bean Sprout/Insanitary Conditions/Adulterated	N/A *
September 15, 2000	Eliseu and Theresa Cunha Dairy	San Francisco District Office	Food/Dairy Cow	N/A *
September 15, 2000	Manna Pro Corporation	San Francisco District Office	Current Good Manufacturing Practices for Medicated Feeds	N/A *
September 15, 2000	Delta Medical Center	New Orleans District Office	Medical Devices/Lacks Medication & Device Experience Report/Misbranded	N/A *
September 14, 2000	Fairmount Hospital	San Francisco District Office	Mammography Standards	N/A *
September 14, 2000	Kaiser Permanente Medical Offices - Antioch	San Francisco District Office	Mammography Standards	N/A *
September 14, 2000	Oak Rubber Inc.	New Orleans District Office	Quality System Regulation/Medical Examination Gloves	N/A *
September 14, 2000	Eastman Chemical Company	New Orleans District Office	Current Good Manufacturing Practices/Bulk Pharmaceutical Chemical	N/A *
September 14, 2000	Okanogan Douglas District Hospital	Seattle District Office	Mammography Standards	N/A *
September 14, 2000	Kaiser Permanente Medical Offices	San Francisco District Office	Mammography Standards	N/A *
September 14, 2000	Crystal Medical Technology	New Orleans District Office	Quality System Regulation/Dental Implant Devices	N/A *
September 14, 2000	Bessemer Carraway dba Alabama OB/GYN	New Orleans District Office	Mammography Standards	N/A *
September 14, 2000	Tuolumne General Hospital	San Francisco District Office	Mammography Standards	N/A *
September 13, 2000	St. Vincent Frankfort Hospital	Detroit District Office	Mammography Standards	N/A *
September 13, 2000	Carmel's Seafood	New Orleans District Office	Seafood Processing Regulations/HACCP	N/A *
September 13, 2000	Delta Airlines	Baltimore District Office	Interstate Conveyance Sanitation Regulations	N/A *
September 13, 2000	North Cascade Family Physicians	Seattle District Office	Mammography Standards	N/A *
September 13, 2000	Virginia Wholesale Co. Inc.	Baltimore District Office	Insanitary Conditions/Food Storage Warehouse	N/A *
September 13, 2000	Specialty Orthotics & Prosthetics Inc.	Florida District Office	Quality System Regulation/Pediatric Cranial Orthosis	N/A *
September 13, 2000	Chau Sprouting Company	New Orleans District Office	CGMP Packing or Holding Human Food/Insanitary Conditions/Sprouts	N/A *
September 13, 2000	JD Medical Services Inc.	Atlanta District Office	Medical Oxygen / CGMP	N/A *
September 12, 2000	Denver Tofu Company	Denver District Office	Seafood Processing Regulations/HACCP	N/A *
September 12, 2000	Living Foods Inc.	Detroit District Office	CGMP Packing or Holding Human Food/Insanitary Conditions/Sprouts	N/A *
September 12, 2000	Sera-Tec Biologicals Limited Partnership	Seattle District Office	Source Plasma/Plasmaphoresis/Production & Process Controls	N/A *
September 12, 2000	Nestle/Friskies PetCare Company	Kansas City District Office	Animal Food Processing Plant/Processing of Low Acid Canned Foods (LACF)	N/A *
September 11, 2000	SP Pharmaceuticals LLC	Office of Enforcement	Biological Products/GMP for Fisnished Pharmaceuticals	N/A *

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