FDA EIR - Kenia Castro, M.D. - January 07, 2022

An FDA inspection of Dr. Kenia Castro’s clinical research site in Hialeah, FL, was conducted from December 27, 2021, to January 7, 2022. This comprehensive "High Priority" inspection, carried out under Compliance Program 7348.811 for Clinical Investigators, evaluated Dr. Castro’s conduct in two drug efficacy studies.The inspection resulted in the issuance of a Form FDA 483, detailing two significant observations. Firstly, the investigation was not conducted in accordance with the investigational plan (21 CFR 312.60), as two subjects were improperly randomized into one study despite failing to meet critical inclusion or exclusion criteria. One subject was not on stable antipsychotic medication for the required 12 weeks, and another, taking a moderate enzyme inhibitor, was not genotyped as mandated by the protocol. This issue regarding inclusion/exclusion criteria was a repeat observation from a previous inspection in 2016. Secondly, the site failed to promptly report serious adverse effects to the sponsor, as required. Additional discussion points included a subject randomized with abnormal lab results and an adverse event not properly entered into the electronic data capture system.Dr. Castro acknowledged the findings, committing to a written response within 15 days and promising to implement stricter prescreening and more careful review of inclusion/exclusion criteria for all future studies. She also indicated staff changes related to trust in reviewing study details. The final classification of the inspection will be determined by the FDA's Center office, with a verbal warning issued regarding potential regulatory actions.