FDA 483 - Bailey, Timothy S., MD - October 13, 2020

An FDA inspection of Timothy S. Bailey, MD in Escondido, CA, from October 6-13, 2020, revealed a significant deficiency in clinical investigations involving children. The principal investigator failed to consistently obtain permission from both parents, as mandated by 21 CFR 50.53, and did not document reasons for non-feasibility on informed consent forms. This indicates a procedural oversight in protecting vulnerable subjects in clinical trials.