FDA 483 - Shuo Ma, M.D. - May 06, 2022

An FDA inspection of Shuo Ma, M.D. in Chicago, IL, revealed significant non-compliance with an investigational plan for Protocol EA9161. Key issues included a subject receiving investigational product for an extended period beyond protocol guidelines and the failure to report eleven serious adverse events within required timeframes. Additionally, a subject was administered a drug that should have been withheld during a neutropenia event, contrary to protocol.