FDA 483 - Hai Shao, M.D. - July 15, 2021

An FDA inspection of Hai Shao, M.D., a clinical investigator in Chula Vista, CA, revealed significant deficiencies in the conduct of a clinical investigation. Observations included failures to adhere to the investigational plan by not performing required subject procedures and inadequate documentation of informed consent and adverse events in case histories. These issues indicate a lack of proper oversight and record-keeping during the clinical trial.