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