FDA 483 - Amit G. Shah, MD - April 02, 2026

An FDA inspection of Amit G. Shah, MD, a clinical investigator in Fort Mill, SC, revealed two significant observations related to the timely reporting of adverse events. The firm failed to promptly report both serious and non-serious adverse events to the study sponsor, as required by the study protocol. These findings indicate deficiencies in adherence to clinical trial reporting requirements.