FDA 483 - Stephane Leung Wai Sang, MD - February 24, 2026

An FDA inspection of Stephane Leung Wai Sang, MD, a clinical investigator in Grand Rapids, MI, revealed a significant failure to adhere to the investigational plan. The primary issue identified was the inadequate and untimely reporting and documentation of adverse events, including serious adverse event assessments. This indicates a serious lapse in clinical trial conduct and oversight of patient safety.