FDA 483 - Rosario Hidalgo, MD - December 04, 2026

During an FDA inspection conducted from November 27 to December 4, 2012, at the University of South Florida, specifically involving Clinical Investigator Rosario Hidalgo, MD, two significant observations were noted. The first observation indicated a failure to obtain informed consent from a human subject in accordance with 21 CFR Part 50 prior to initiating study-related tests. For instance, a psychiatric evaluation was performed on a subject on April 15, 2010, while informed consent was only obtained on April 16, 2010. The second observation highlighted that the investigation was not conducted according to the signed statement of investigator and the approved investigational plan. A specific example detailed a subject receiving three doses of erythromycin for an upper respiratory infection on October 28, 2010, despite erythromycin being a prohibited medication within the study protocol. These findings underscore deviations from regulatory requirements for human subject protection and adherence to study protocols. The firm is expected to implement corrective actions to address these issues, ensuring full compliance with informed consent procedures and strict adherence to investigational plans in future clinical studies.