Robert J. Hayashi, M.D./Washington University School of Medicine, Department of Pediatrics Warning Letter Details

Summary

Robert J. Hayashi, M.D. at Washington University School of Medicine's Department of Pediatrics failed to conduct investigational drug clinical trials in accordance with FDA regulations during an inspection conducted June-July 2022. The primary violation cited was failure to ensure clinical studies were conducted according to the investigational plan, as required under 21 CFR 312.60. The inspection was part of FDA's Bioresearch Monitoring Program, which evaluates whether the rights, safety, and welfare of human subjects in clinical research are adequately protected.