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 maintaining accurate case histories and adhering to the investigational plan. The firm failed to ensure subjects completed required study entries, with discrepancies noted between actual completion and documented records. Additionally, a substantial number of subject records showed missed visits and diary reviews mandated by the study protocol.