FDA EIR - Ashley S. Plant, M.D. - November 20, 2025

From November 17 to November 20, 2025, the FDA conducted a clinical investigator inspection of Dr. Ashley L. Devonshire at the Cincinnati Children’s Hospital Medical Center (CCHMC). This audit, performed under the Federal Food, Drug, and Cosmetic Act’s Bioresearch Monitoring Program, focused on clinical research data intended to support a biologics license application. The inspection identified several administrative and procedural violations. Key issues included a failure to maintain accurate records regarding the processing of blood samples, such as the specific times samples were centrifuged or frozen. Additionally, the site did not follow the official study plan, as samples were centrifuged for only 10 minutes instead of the required 15 minutes. Inspectors also noted significant discrepancies in the handling of the study drug, including inconsistent tracking of the mandatory warming periods before administration. Other findings included an unreported minor illness in one participant and a late treatment visit. Dr. Devonshire acknowledged these findings and is required to implement corrective actions to prevent recurrence. The FDA will monitor the implementation of these improvements during future inspections to ensure the ongoing integrity of the research and the safety of participants.