FDA 483 - John M Wo MD - July 23, 2021

John M Wo, MD, a Sponsor-Investigator in Indianapolis, IN, was inspected by the FDA from 7/19/2021-7/23/2021. The inspection revealed two significant issues: a failure to maintain adequate case histories for an investigational product, specifically regarding EKG timing, and a lapse in IRB approval for a clinical study. These findings indicate deficiencies in clinical trial conduct and oversight.