FDA 483 - Huilai Tianjin Zhang - February 21, 2025

An FDA inspection of Hailai Zhang, MD, a clinical investigator in Tianjin, China, revealed significant failures to follow the investigational plan. Observations included delayed reporting of serious adverse events (SAE) and adverse events of special interest (AESI) to the sponsor, as well as incorrect administration of study medication dosages to multiple subjects. These findings indicate critical deviations from protocol requirements.