FDA 483 - Neil Sheth, MD - November 24, 2020

An FDA inspection of Neil Sheth, MD, a clinical investigator in Glendale, AZ, revealed significant deficiencies in clinical trial conduct. The firm failed to maintain adequate and accurate case histories, with discrepancies noted in subject dose entries and eDiary completion. Additionally, investigations were not conducted according to the investigational plan, leading to numerous missed subject visits and diary reviews.