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 |
|---|---|---|---|---|
| September 26, 2000 | Stason Pharmaceuticals Inc. | Los Angeles District Office | Good Manufacturing Practices for Finished Pharmaceuticals | N/A * |
| September 26, 2000 | Holy Cross Hospital IRB | Center for Devices and Radiological Health | IRB (Institutional Review Board) | N/A * |
| September 25, 2000 | Nuclear Medicine of Central Florida Inc. | Florida District Office | Thallium-201(inj.)/Lacks Approved New Drug Application/Misbranded/Adulterated | N/A * |
| September 25, 2000 | Baptist Memorial Hospital - Huntingdon | New Orleans District Office | Mammography Standards | N/A * |
| September 22, 2000 | Leiner Health Products Inc. | Los Angeles District Office | CGMP/Finished Pharmaceuticals | N/A * |
| September 22, 2000 | Cangene Corporation | Los Angeles District Office | Good Manufacturing Practices for Blood and Blood Products | N/A * |
| September 21, 2000 | Clay-Park Laboratories Inc. | New York District Office | CGMP/Finished Pharmaceuticals | N/A * |
| September 21, 2000 | Hudson Medical Center-Medical Imaging | Minneapolis District Office | Mammography Standards | N/A * |
| September 21, 2000 | Ayundantes Inc. | Denver District Office | Narcotic Treatment Program Standards | N/A * |
| September 21, 2000 | SDL Incorporated | Center for Devices and Radiological Health | Performance Standards for Laser Products | N/A * |
| September 20, 2000 | Carl Zeiss Inc. | San Francisco District Office | Laser Products / Noncompliance | N/A * |
| September 20, 2000 | TMJ Implants Inc. | Center for Devices and Radiological Health | Sponsor Obligations | N/A * |
| September 20, 2000 | MCMI Food Company | Dallas District Office | Seafood Processing Regulations/HACCP | N/A * |
| September 20, 2000 | Martin Robert Z. | Center for Drug Evaluation and Research | Clinical Investigator | N/A * |
| September 20, 2000 | Coldwater Fish Farms | Kansas City District Office | Seafood Processing Regulations/HACCP | N/A * |
| September 19, 2000 | Altair Corporation | San Francisco District Office | Current Good Manufacturing Practices for Medicated Feeds | N/A * |
| September 19, 2000 | Summer Sprout | Denver District Office | Alfalfa Sprout/Insanitary Conditions/Adulterated | N/A * |
| September 19, 2000 | Organon Inc. | New Jersey District Office | Current Good Manufacturing Practice Regulations/Steril & Non-Sterile Prodcuts | N/A * |
| September 19, 2000 | Glaxo Wellcome S.p.A. | Center for Drug Evaluation and Research | Current Good Manufacturing Practices for Sterile Pharmaceuticals | N/A * |
| September 18, 2000 | Hilton Head Medical Center | Atlanta District Office | Mammography Standards | N/A * |
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