FDA 483 - Gilberto M. Cruz, M.D. - April 24, 2024

Reliable Clinical Research Llc in Hialeah, FL, a clinical investigator, received a Form FDA 483 with two observations. The firm failed to conduct an investigation in accordance with the investigational plan, specifically by enrolling a subject who did not meet inclusion criteria. Additionally, the firm did not prepare or maintain accurate case histories, showing discrepancies in recorded assessment times and electronic source data.