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

The FDA conducted a pre-announced inspection of Dr. Gilberto M. Cruz, M.D., a Clinical Investigator at Reliable Clinical Research Llc in Hialeah, FL, from April 15 to April 24, 2024. This was Dr. Cruz's first FDA inspection, initiated by the Center for Drug Evaluation and Research for two clinical protocols. The inspection reviewed compliance with 21 CFR Parts 50, 56, and 312, under Compliance Program 7348.811 for Bioresearch Monitoring. The inspection resulted in an FDA Form 483, detailing two primary observations. First, Dr. Cruz failed to conduct an investigation according to the investigational plan (21 CFR 312.60), specifically by enrolling and randomizing a subject who did not meet required inclusion criteria for one protocol. Second, there was a failure to maintain accurate case histories (21 CFR 312.62(b)). This included inconsistent and implausible timing for subject assessments in one study, where multiple scales were recorded as completed in implausibly short durations or simultaneously. For another study, discrepancies were found between electronic and paper source record completion times, and subjects improperly used pencils or recorded information that should have been documented by study raters. Dr. Cruz, identified as the most responsible person, received the FDA Form 483 for not adhering to protocols and inaccurate record keeping. He was also given verbal warnings regarding potential regulatory actions under the FD&C Act. Dr. Cruz committed to reviewing the observations and submitting a written response, including a Corrective and Preventative Action (CAPA) plan, to the Agency within 15 business days.