Inspections, Compliance, Enforcement, and Criminal Investigations
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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