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

During an inspection conducted from April 15 to April 24, 2024, the Food and Drug Administration (FDA) issued a Form 483 to Gilberto M. Cruz, M.D., operating as Reliable Clinical Research Llc, a clinical investigator establishment in Hialeah, FL. The inspection identified two significant observations related to the conduct of clinical investigations. Firstly, the investigation was not carried out in adherence to the established investigational plan. Specifically, for one protocol, a subject was enrolled and randomized into the study who did not meet the predefined inclusion criteria, despite subsequently receiving the investigational product. Secondly, there was a failure to prepare and maintain accurate case histories with respect to study observations and data. Issues included recorded times for various subject assessments being impossibly close, indicating potential data integrity concerns for at least 12 subjects. Additionally, discrepancies were noted between original paper source times and transcribed electronic source times for a specific assessment scale in multiple subjects. These observations signify non-compliance with regulatory requirements for conducting clinical trials. Gilberto M. Cruz, M.D., is expected to review these findings and respond to the FDA with corrective actions to address the identified issues and ensure future compliance.