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

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.