FDA 483 - Robert Hayashi M.D - July 08, 2022

An FDA inspection of Robert Hayashi M.D., a clinical investigator at Washington University School of Medicine in Saint Louis, MO, revealed significant deviations from an investigational plan. The inspection found failures to adhere to protocol requirements, including the omission of specific treatments for a pediatric subject and the administration of investigational product to an ineligible subject. These findings indicate a lack of adherence to clinical trial protocols.