FDA 483 - Merrill K. Shum, M.D. - February 15, 2023

Merrill K. Shum, M.D., a clinical investigator in Whittier, CA, was inspected by the FDA from January 25 to February 15, 2023. The inspection revealed a significant deficiency related to the failure to report serious adverse events to the sponsor within 24 hours of awareness for multiple subjects. This indicates a serious lapse in compliance with clinical trial reporting requirements.