FDA 483 - Kazutomo Toyofuku - September 19, 2025

An FDA inspection of Kazutomo Toyofuku, M.D. in Shinjuku-ku, Tokyo, Japan, a clinical investigator, revealed a significant deficiency in conducting a foreign clinical study. The study was not performed in accordance with Good Clinical Practices, specifically regarding inadequate justification for revisions made to source records weeks after initial entry. This indicates issues with data integrity and adherence to established research protocols.