FDA 483 - Ashley L. Devonshire, M.D., MPH - November 20, 2025

An FDA inspection of Cincinnati Children's Hospital Medical Center (CCHMC) identified two significant observations related to a clinical investigation. The inspection revealed failures in maintaining adequate case histories, specifically regarding the documentation of serum sample processing steps. Additionally, an investigation was not conducted in accordance with the established investigational plan, as evidenced by deviations in serum sample centrifugation times.