Mark A. Stein, Ph.D. – FDA 483, Aug 4, 2023

Mark A. Stein, Ph.D., a clinical investigator in Seattle, WA, was cited for significant deviations during human clinical studies. The inspection revealed failures to adhere to investigational plans and study protocols, including enrolling ineligible subjects, improper drug dosing, and not conducting required safety and efficacy assessments. Additionally, the firm failed to maintain adequate and accurate case histories, exhibiting discrepant data, unreported adverse events, and unattributable or unexplained record changes.