FDA 483 - Taizo A. Nakano, M.D. - February 28, 2025

An FDA inspection of Taizo A. Nakano, Clinical Investigator, in Aurora, CO, revealed significant deficiencies in the conduct of a clinical study. The firm failed to maintain accurate case histories, specifically by not reporting concomitant medications and adverse events to the study sponsor. Additionally, the investigation was not conducted according to the investigational plan, as a required eGFR value was not calculated for a subject.