Inspections, Compliance, Enforcement, and Criminal Investigations
2001 Warning Letters
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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 |
---|---|---|---|---|
December 31, 2001 | Matthews, Dana C., M.D. | Center for Biologics Evaluation and Research | Sponsor/Clinical Investigator | N/A * |
December 28, 2001 | Green Gold Wholesale Produce Inc. | Baltimore District Office | Avocados/Lacks | N/A * |
December 28, 2001 | Hen-Lin Dairy | Minneapolis District Office | Animal Drug/Adulterated | N/A * |
December 28, 2001 | Trotters Importers | Baltimore District Office | Dried Fig Spread/Lacks | N/A * |
December 27, 2001 | N TECH Instrument Repair, Inc. | Chicago District Office | Quality System Regulation for Medical Devices/Adulterated | N/A * |
December 27, 2001 | 2-2-0 Laboratories | Los Angeles District Office | Current Good Manufacturing Practices for Finished Pharmaceuticals/Adulterated | N/A * |
December 27, 2001 | Premium Fresh Juice and Food Company, Inc. | Los Angeles District Office | GMP in Manufacturing, Packing, Holding Human Food/Insanitary Practices | N/A * |
December 27, 2001 | B.N.S Uni, Inc. | Los Angeles District Office | Seafood HACCP | N/A * |
December 27, 2001 | Island Kinetics Inc | Los Angeles District Office | CGMP for Finished Pharmaceutical/Adulterated | N/A * |
December 21, 2001 | Feldman Mark H. D.P.M. | Center for Devices and Radiological Health | Clinical Investigator | N/A * |
December 21, 2001 | Forever Young Products, Inc. | New Orleans District Office | Current Good Manufacturing Practice Regulation for Finished Pharmaceuticals | N/A * |
December 21, 2001 | West Agro, Inc. | Chicago District Office | Current Good Manufacturing Practices for Finished Pharmaceuticals/Adulterated | N/A * |
December 20, 2001 | Medical Center at Lancaster | Dallas District Office | Mammography Quality Standards | N/A * |
December 20, 2001 | Norton Suburban Hospital | Cincinnati District Office | Mammography Quality Standards | N/A * |
December 20, 2001 | Misonix, Inc. | Denver District Office | GMP Requirements for the Quality System Regulation/Adulterated | N/A * |
December 20, 2001 | Van de Graaf Racnhes, Inc. | Seattle District Office | Current Good Manufacturing Practice for Medicated Feeds/Adulterated | N/A * |
December 20, 2001 | Carolina Seafood Ventures, LLC | Atlanta District Office | Seafood HACCP | N/A * |
December 20, 2001 | NCOIC | Dallas District Office | Mammography Quality Standards | N/A * |
December 20, 2001 | Breast Cancer Detection Center of Alaska | Seattle District Office | Mammography Quality Standards | N/A * |
December 20, 2001 | Luskin-Hawk, M.D., Roberta L | Center for Biologics Evaluation and Research | Clinical Investigator | N/A * |
December 20, 2001 | Port Bolivar Fisheries, Inc. | Dallas District Office | Seafood HACCP | N/A * |
December 19, 2001 | Conklin Enterprises, Inc. | Atlanta District Office | Seafood HACCP | N/A * |
December 19, 2001 | Diagnostic Medical Imaging Associates | Cincinnati District Office | Mammography Quality Standards | N/A * |
December 19, 2001 | Jensen Tuna, Inc. | New Orleans District Office | Seafood HACCP | N/A * |
December 19, 2001 | King's Oriental Foods Company | Seattle District Office | GMP for Manufacturing, Packing, Holding Food/Seafood HACCP | N/A * |
December 19, 2001 | The Medical Group | New Orleans District Office | Mammography Quality Standards | N/A * |
December 19, 2001 | Wayzata Bay Products Inc | Minneapolis District Office | Good Manufacturing Practice for Finished Pharmaceuticals/Adulterated | N/A * |
December 18, 2001 | Michigan Trading Post | Dallas District Office | Food Labeling/NexCite Dietary Supplement/Misbranded | N/A * |
December 18, 2001 | Multidata Systems International Corporation | Center for Devices and Radiological Health | Electronic Product Radiation Control/Premarket Notification Requirements/Adulterated/Misbranded | N/A * |
December 18, 2001 | Atlantic General Hospital | Baltimore District Office | Mammography Quality Standards Act | N/A * |
December 18, 2001 | Community Radiology Inc. | Cincinnati District Office | Mammography Quality Standards | N/A * |
December 17, 2001 | Women's Diagnostic Imaging Center | Seattle District Office | Mammography Quality Standards | N/A * |
December 17, 2001 | King's Fish Market, Inc. | Detroit District Office | Current Good Manufacturing Pratice Requirements for Foods/Seafood HACCP | N/A * |
December 17, 2001 | Camtrade Enterprises, Inc. | San Francisco District Office | Good Manufacturing Practice Requirement for Foods/Seafood HACCP/Adulterated | N/A * |
December 17, 2001 | Sibley Medical Associates | Baltimore District Office | Mammography Quality Standards | N/A * |
December 17, 2001 | Carl & Don Frazier, Inc. | Detroit District Office | Seafood HACCP | N/A * |
December 14, 2001 | Shelly Smith Farm | Atlanta District Office | Illegal Drug Residue/Adulterated | N/A * |
December 14, 2001 | Van Haitsma Dairy Farm | Detroit District Office | Illegal Drug Tissue Residue/Adulterated | N/A * |
December 14, 2001 | Natural Technology, Inc. | Dallas District Office | Current Good Manufacturing Practices for Finished Pharmaceuticals/Adulterated | N/A * |
December 14, 2001 | Trusted Care | New England District Office | Current Good Manufacturing Practices for Finished Pharmaceuticals/Adulterated | N/A * |
December 14, 2001 | Trilogy Crab Company, Inc. | Seattle District Office | Seafood HACCP/Adulterated | N/A * |
December 14, 2001 | Rowan Animal Clinic | Atlanta District Office | Illegal Drug Residue/Adulterated | N/A * |
December 14, 2001 | Biorem s.r.l. | Center for Devices and Radiological Health | Medical Device/Lacks Premarket Approval/Adulterated/Misbranded | N/A * |
December 14, 2001 | Bollinger Quick Repair, Inc. | New Orleans District Office | Interstate Conveyance Sanitation Regulations | N/A * |
December 13, 2001 | Signature Flight Support | Dallas District Office | Interstate Conveyance Sanitation Regulations | N/A * |
December 13, 2001 | Dallas County Hospital District | Dallas District Office | Mammography Quality Standards | N/A * |
December 13, 2001 | Dextrum Laboratories Inc | Florida District Office | CGMP for Drugs/Manufacture Processing Packing Holding/Adulterated | N/A * |
December 13, 2001 | Quinault Tribal Enterprises | Seattle District Office | Seafood HACCP | N/A * |
December 13, 2001 | Kittery Lobster Co., Inc. | New England District Office | Seafood HACCP | N/A * |
December 13, 2001 | Rose Breast Center | Dallas District Office | Mammography Quality Standards | N/A * |
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