FDA 483 - Lisa S. Wang, M.D. - October 13, 2023

An FDA inspection of Lisa S. Wang, M.D., a clinical investigator in Whittier, CA, revealed significant deficiencies in the conduct of clinical investigations. The firm failed to report a serious adverse event to the sponsor within the required 24-hour timeframe as per protocol. Additionally, the inspection found a failure to maintain adequate and accurate case histories, with numerous discrepancies identified between various source documents for adverse events.