Keun-Wook Lee, M.D., Ph.D. – FDA 483, May 22, 2026

An FDA inspection of Keun-Wook Lee, M.D., Ph.D. in Seongnam, Gyeonggi, Korea, a clinical investigator site, revealed significant deficiencies in adverse event reporting and data accuracy. The firm failed to report numerous non-serious adverse events to the sponsor and did not maintain accurate case histories, leading to discrepancies between electronic medical records and electronic data capture systems. These findings indicate serious issues with clinical trial data integrity and compliance with study protocols.