# FDA 483 - H. Lee Moffitt Cancer Center - August 25, 2004

Source: https://www.keypedia.com/records/483/h-lee-moffitt-cancer-center/c82f30c9-a458-41e3-b3e3-22a8e2c191c1

> FDA 483 for H. Lee Moffitt Cancer Center on August 25, 2004. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: H. Lee Moffitt Cancer Center
- Inspection Date: 2004-08-25
- Product Type: drugs
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: An FDA inspection of H. Lee Moffitt Cancer Center in Tampa, FL, identified significant issues in the conduct of clinical studies. Observations included failures to adhere to study protocols and investigator agreements, specifically regarding patient assessments and enrollment criteria. Additionally, the facility failed to report adverse events to the Institutional Review Board (IRB) in a timely manner.

## Related Officers

- [Virginia R. Meeks](https://www.keypedia.com/people/virginia-r-meeks/f69c56a6-2439-49fd-8d98-cd5e50dc539b)

Company: https://www.keypedia.com/companies/h-lee-moffitt-cancer-center/287ae537-a85e-42c8-a854-05fde371e772

Office: https://www.keypedia.com/offices/office-of-medical-device-and-radiological-health-division-ii/ae9bd439-479a-420d-9dd8-9fe1fc0863d6