FDA 483 - Jing Zhou Hou, MD, PhD - October 12, 2018

An FDA inspection of Jing Zhou Hou, MD, PhD, a clinical investigator in Pittsburgh, PA, revealed significant deficiencies in the conduct of an investigational study. Observations included failure to follow the investigational plan, delayed reporting of unanticipated problems to the IRB, and inadequate maintenance of case histories. These issues suggest a lack of proper oversight and adherence to regulatory requirements in clinical trial management.