FDA 483 - Diego A. Rielo, M.D. - June 21, 2024

Premier Clinical Research Institute, Inc. in Miami, FL, was inspected as a clinical investigator and found to have significant deficiencies. The firm failed to conduct an investigation in accordance with the investigational plan, including enrolling a subject who did not meet inclusion criteria and not capturing source data in real-time. Additionally, the firm did not maintain adequate and accurate case histories, with numerous reports containing obliterated and unattributable information.