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
June 21, 2000	Hillandale Farms of Florida Inc.	Florida District Office	Medicated Feeds/CGMP	N/A *
June 21, 2000	Jagg Marketing 2000 Inc.	San Juan District Office	May Proceed Notice/Release Notice	N/A *
June 21, 2000	Packers Provision Group	San Juan District Office	King Fish Product/Contaminated w/ Salmonella/Hold Entry Intact/	N/A *
June 20, 2000	Terebelo Howard R. D.O.	Center for Biologics Evaluation and Research	Clinical Investigator	N/A *
June 20, 2000	Nabi	Denver District Office	Blood Products/Facilities/Production and Process Controls/Records & Reports	N/A *
June 20, 2000	Canix Sterilizer	Center for Devices and Radiological Health	Quality System Regulation/contract Sterilizes Bandages	N/A *
June 20, 2000	St. Thomas More Hospital	Dallas District Office	Mammography Standards	N/A *
June 19, 2000	Jiangsu Hengrui Medicine Co. LTD.	Center for Drug Evaluation and Research	CGMP/Active Pharmaceutical Ingredient Manufacturing Facility	N/A *
June 19, 2000	Fresh Fish Management Inc.	Atlanta District Office	Seafood Processing Regulations/HACCP	N/A *
June 19, 2000	Laboratoires Prodimed	Center for Devices and Radiological Health	Quality System Regulation/Pipelle de Cornier & Assisted Pregnancy Devices	N/A *
June 19, 2000	Carolina Imaging Center	Atlanta District Office	Mammography Standards	N/A *
June 16, 2000	China farm Incorporated	Seattle District Office	CGMP/Manufacturing Packing & Holding Human Food	N/A *
June 16, 2000	Mikes Seafood	New Orleans District Office	Seafood Processing Regulations/HACCP	N/A *
June 16, 2000	New West Fisheries Inc.	Seattle District Office	Seafood Processing Regulations/HACCP	N/A *
June 16, 2000	Omak Clinic	Seattle District Office	Mammography Standards	N/A *
June 15, 2000	Gordon Enterprises Inc.	Atlanta District Office	Seafood Processing Regulations/HACCP	N/A *
June 15, 2000	DuPont Pharmaceutical Co. In.c	San Juan District Office	Good Manufacturing Practice Regulation for Finishes Pharmaceuticals/Drug Manufacturing Facility	N/A *
June 15, 2000	Wright John R. D.O.	Center for Devices and Radiological Health	Clinical Investigator	N/A *
June 15, 2000	Auxi Health Inc.	Atlanta District Office	Medical Oxygen / CGMP	N/A *
June 14, 2000	Poplar Tans	Nashville District Office	Performance Standards/Sunlamp Products	N/A *
June 14, 2000	Sani-Pure Food Laboratories	New Jersey District Office	CGMP/Finished Pharmaceuticals	N/A *
June 13, 2000	Global Marketing Enterprises Inc.	Chicago District Office	Insanitary Conditions	N/A *
June 13, 2000	Blue Ridge Pharmaceuticals Inc.	Atlanta District Office	Good Manufacturing Practices for Finished Pharmaceuticals	N/A *
June 13, 2000	Pharmaceutical Development Center	Atlanta District Office	Good Manufacturing Practices for Finished Pharmaceuticals	N/A *
June 12, 2000	Nu Weigh	Dallas District Office	Federal Performance Standard for Sunlamp Products	N/A *
June 12, 2000	NAHC of Wyoming	Dallas District Office	Mammography Standards	N/A *
June 12, 2000	Wood's Fishery Inc.	Florida District Office	Seafood Processing Regulations/HACCP	N/A *
June 12, 2000	Barnes-Jewish West County Hospital	Dallas District Office	Mammography Standards	N/A *
June 09, 2000	SmithKline Beecham Pharmaceuticals	New Jersey District Office	CGMP/Finished Pharmaceuticals	N/A *
June 09, 2000	Gate House Farms	New York District Office	Food/Cattle	N/A *
June 09, 2000	Holox Ltd.	Atlanta District Office	Quality System Regulation/Compressed Medical Gases	N/A *
June 09, 2000	United Feeds Inc.	Chicago District Office	Medicated Feeds/CGMP	N/A *
June 09, 2000	Medco Instruments Inc.	Chicago District Office	Medical Device Reporting/Circumcision Clamps	N/A *
June 09, 2000	Oxy-Health corporation	Los Angeles District Office	Quality System Regulation/Hyperbaric Chambers	N/A *
June 09, 2000	IOMED Inc.	Center for Devices and Radiological Health	Iontophoretic Drug Delivery Systems/Promo.Material/Lacks PMA for use w/Specific Drugs or Drug Use	N/A *
June 09, 2000	American Dent-All Inc.	Los Angeles District Office	Quality System Regulation/Dental Alloy Products	N/A *
June 09, 2000	Taproot Dairy LLC	Atlanta District Office	Food/Cattle	N/A *
June 09, 2000	Oxy-Health Corporation	Los Angeles District Office	Quality System Regulation/Hyper-Oxy Portable Hyperbaric Chambers	N/A *
June 08, 2000	L & L Oil Company and Gas Services Inc.	New Orleans District Office	Vessel Watering Points	N/A *
June 08, 2000	Cosmetic Corporation of America	Florida District Office	CGMP Regulations/Sunscreen Products	N/A *
June 08, 2000	Medical Industrial Equipment Ltd.	Center for Devices and Radiological Health	Good Manufacturing Practice for Medical Devices Regulations Deviations/Anesthesia Machines	N/A *
June 08, 2000	Hill-Rom Inc.	Atlanta District Office	Quality System Regulation/Obstetrical Patient Data Management Systems	N/A *
June 07, 2000	St. Claire Medical Center	Cincinnati District Office	Mammography Standards	N/A *
June 07, 2000	Palo Verde Hopital	Los Angeles District Office	Mammography Standards	N/A *
June 07, 2000	Osmonics	Seattle District Office	Quality System Regulation/Millenium Portable Reverse Osmosis System	N/A *
June 07, 2000	Advanced Surgical Associates Medical Office Inc.	Los Angeles District Office	Mammography Standards	N/A *
June 06, 2000	Allograft Resources of Wisconsin Inc.	Minneapolis District Office	CFR Deviations	N/A *
June 05, 2000	King Oyster Farms	New Jersey District Office	Seafood Processing Regulations/HACCP	N/A *
June 05, 2000	Visteon Systems LLC	Florida District Office	CD Player Combination Systems/Lacks "May Proceed Notice" or "Release Notice"	N/A *
June 02, 2000	Fruetel Mammography Inc.	Minneapolis District Office	Mammography Standards	N/A *

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