FDA 483 - Naoto Ueno, M.D. - July 06, 2022

An FDA inspection of Naoto Ueno, M.D., a clinical investigator in Houston, TX, revealed a significant procedural issue in a clinical study. The firm failed to conduct an investigation in accordance with the signed statement of investigator and investigational plan. Specifically, concomitant medications received by subjects during the study period were not reported to the sponsor.