2000 Warning Letters

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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
December 08, 2000	JFC International Inc.	San Francisco District Office	Seafood Processing Regulations/HACCP	N/A *
December 08, 2000	Tonnage and Applied Gas Solutions	New Orleans District Office	Liquid Carbon Dioxide/Good Manufacturing Practices for Finished Pharmaceuticals/Adulterated	N/A *
December 08, 2000	Ellis Hospital	New York District Office	Mammography Standards	N/A *
December 07, 2000	Coolidge Dairy Farm	Kansas City District Office	Dairy Operation/Adulterated	N/A *
December 06, 2000	Women's Diagnostic Center at Enumclaw Community Hospital	Seattle District Office	Mammography Standards	N/A *
December 06, 2000	SHARP Chula Vista Imaging Center	Los Angeles District Office	Mammography Standards	N/A *
December 06, 2000	Port of Stockton Ore Dock 2-13	San Francisco District Office	Insanitary Conditions/Backflow Prevention Devices	N/A *
December 06, 2000	Duramed Pharmaceuticals Inc.	New Jersey District Office	Good Manufacturing Processing Packing Holding/Finished Pharmaceuticals/Adulterated	N/A *
December 06, 2000	Societa Italiana Medicinali Scandicci	Center for Drug Evaluation and Research	Good Manufacturing Practices for Active Pharmaceutical Ingredient	N/A *
December 06, 2000	Farmers Coop Association	Kansas City District Office	Good Manufacturing Practice Regulation for Medicated Feeds/Medicated Feed Mill/Adulterated	N/A *
December 05, 2000	Control Solutions Inc.	Dallas District Office	Veterinary Drug Manufacturing Facility for Finished Pharmaceuticals/Adulterated	N/A *
December 05, 2000	MedLean Inc.	New England District Office	New Drug/Labeling/Misbranded	N/A *
December 05, 2000	Taylorsville Veterinary Clinic	Baltimore District Office	Illegal Tissue Residue/Adulterated	N/A *
December 05, 2000	Medtronic Inc.	Dallas District Office	Quality System Regulations/ Medical Device Rpt Regs/Misbranded/Adulterated	N/A *
December 05, 2000	Bearson Diary	Denver District Office	Illegal Drug Residues/Adulterated	N/A *
December 05, 2000	Port Royal Medical Center	Atlanta District Office	Mammography Standards	N/A *
December 05, 2000	Arctic Pacific Fisheries Inc.	Denver District Office	Seafood HACCP	N/A *
December 05, 2000	Busker Diary	Denver District Office	Illegal Drug Residues/Adulterated	N/A *
December 05, 2000	Yuma Dairy	Denver District Office	Illegal Drug Residues/Adulterated	N/A *
December 05, 2000	America cheritable Fund Inc.	Center for Devices and Radiological Health	IRB (Institutional Review Board)	N/A *
December 04, 2000	Community Memorial Hospital	Minneapolis District Office	Mammography Standards	N/A *
December 04, 2000	Health-n-Home Inc.	Kansas City District Office	Medical Gas/Adulterated	N/A *
December 04, 2000	Mercy Community Hospital	Philadelphia District Office	Mammography Standards	N/A *
December 04, 2000	Chilemex Inc.	Chicago District Office	Seafood Processing Regulations/HACCP	N/A *
December 04, 2000	Atlanta Oriental Food Wholesale	Atlanta District Office	Instant Ramen Noodles and Snacks/Lacks "May Proceed Notice" or "Release Notice"	N/A *
December 01, 2000	Western Medica	Cincinnati District Office	OPC-830 Oxygen Conserving Regulator/Adulterated/Misbranded	N/A *
November 30, 2000	Maui Medical Group Inc.	San Francisco District Office	Mammography Standards	N/A *
November 30, 2000	US Airways Group Inc.	New York District Office	Control of Communicable Diseases and Interstate Conveyance Regulations Violations	N/A *
November 30, 2000	Maui Medical Group	San Francisco District Office	Mammography Standards	N/A *
November 30, 2000	Clifton-Fine Hospital	New York District Office	Mammography Standards	N/A *
November 30, 2000	St. Margaret Mercy Healthcare Center-North	Detroit District Office	Mammography Standards	N/A *
November 30, 2000	Perkin Elmer Instuments	Center for Devices and Radiological Health	Linescan 222 & Sys 107/ Performance Standards for Ionizing Radiation Emitting Products	N/A *
November 30, 2000	Monongahela Valley Hospital Inc.	Philadelphia District Office	Mammography Standards	N/A *
November 30, 2000	SportPharma USA Inc.	San Francisco District Office	Dietary Supplements/Food Labeling/Misbranded	N/A *
November 30, 2000	Ballert Orthopedic of Chicago	Chicago District Office	Quality System Regulation/Cranial Helmets/Adulterated	N/A *
November 30, 2000	Medical Marketing & Management L.L.C.	Philadelphia District Office	Mammography Standards	N/A *
November 30, 2000	Buchman Alan L. M.D.	Center for Biologics Evaluation and Research	Clinical Investigator	N/A *
November 30, 2000	Raper Steven E. M.D.	Center for Biologics Evaluation and Research	Clinical Investigator	N/A *
November 30, 2000	Batshaw Mark L. M.D.	Center for Biologics Evaluation and Research	Clinical Investigator	N/A *
November 30, 2000	Optimum Nutrition	Center for Food Safety and Applied Nutrition	Protein Diet Bar/Misbranded/Labeling	N/A *
November 29, 2000	Jiangsu Hengrui Medicine Co. LTD.	Center for Drug Evaluation and Research	Good Manufacturing Practices for Active Pharmaceutical Ingredient	N/A *
November 29, 2000	David Solomon Co. Inc.	Florida District Office	Fresh Whole Salmon/Lacks "May Proceed Notice" or "Release Notice"	N/A *
November 29, 2000	West Broward X-Ray Center	Florida District Office	Mammography Standards	N/A *
November 29, 2000	Westfield Memorial Hospital	New York District Office	Mammography Standards	N/A *
November 29, 2000	Koch Poultry Company Inc.	New Orleans District Office	Medicated Feeds/Adulterated	N/A *
November 29, 2000	San Juan Hopital-Mobile	Dallas District Office	Mammography Standards	N/A *
November 29, 2000	Sampo Corporation of America	Center for Devices and Radiological Health	Television Product/Electronic Product Radiation Control	N/A *
November 29, 2000	Cariba International	Florida District Office	Cosmetics/Lacks "May Proceed Notice" or "Release Notice"	N/A *
November 29, 2000	Columbia Regional Hospital	Dallas District Office	Mammography Standards	N/A *
November 29, 2000	Charlton Methodist Hopital	Dallas District Office	Mammography Standards	N/A *

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