FDA 483 - Ning Z. Wu, M.D. - April 13, 2021

The FDA inspected Ning Z. Wu, M.D., a clinical investigator in Lake Barrington, IL, from April 5-13, 2021. The inspection revealed that an investigation was not conducted in accordance with the investigational plan. Specifically, Investigational Product treatment was continued for a subject without completing required assessments as stipulated by the study protocol.