FDA 483 - Amid Hamidi, M.D. - October 23, 2025

An FDA inspection of Ascendant Research Clinic, LLC in Marion, SC, a clinical investigator site, revealed a significant deviation from the investigational plan. The firm failed to ensure that blood samples were collected according to protocol for multiple subjects during Visit 2 (Day 2) and Visit 5 (Day 14) of the study. This indicates a failure to conduct the investigation in accordance with the signed statement of investigator and investigational plan.