FDA 483 - James W. Baker, MD - June 19, 2017

James W. Baker, MD, a clinical investigator in Portland, OR, was cited for significant deficiencies in clinical trial conduct. The inspection revealed failures in maintaining accurate case histories, non-adherence to investigational plans, and inadequate informed consent processes, particularly concerning pediatric subjects. These issues indicate a serious lack of oversight and compliance with regulatory requirements for human subject protection and data integrity.