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 |
---|---|---|---|---|
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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