FDA 483 - Aung M. Tun, M.D. / CI - January 24, 2025

Aung M. Tun, M.D. in Westwood, KS, a clinical investigator, was cited for failing to conduct an investigation in accordance with the signed statement of investigator and investigational plan. This involved multiple instances where required screening and non-screening laboratory assessments were not performed on study subjects. Consequently, participants were enrolled and dosed with investigational product without confirmed eligibility or complete safety monitoring, indicating significant deviations from protocol requirements.