FDA 483 - Takashi Kamezawa - December 05, 2025

An FDA inspection of Takashi Kamezawa, a clinical investigator in Kasugai, Aichi, Japan, revealed significant deviations from an investigational plan. The firm failed to conduct an investigation in accordance with the signed statement of investigator and investigational plan, specifically by enrolling subjects who were using prohibited concomitant medications. This non-compliance raises concerns about subject safety and data integrity within the clinical study.