FDA 483 - Richard M Evans, MD - August 19, 2019

Richard M. Evans, M.D., Principal Investigator in San Antonio, TX, was cited for significant deficiencies in conducting a clinical investigation. The inspection revealed failures to adhere to the investigational plan, including enrolling ineligible subjects and untimely reporting of serious adverse events. Additionally, the firm did not maintain adequate case histories, with critical eligibility documentation missing for several study participants.