FDA 483 - Elizabeth I. Buchbinder, M.D. - October 03, 2022

An FDA inspection of Dana Farber Cancer Institute in Boston, MA, revealed that a clinical investigation was not conducted in accordance with its investigational plan. Specifically, the firm failed to obtain required brain MRIs and CT scans for multiple subjects within the specified timeframes, with many scans being either missing or significantly delayed. This indicates a serious deviation from the study protocol.