FDA 483 - Children's Mercy Hospital - October 24, 2025

An FDA inspection conducted from October 20-24, 2025, at Eric T. Rush M.D. Children's Mercy Hospital in Kansas City, MO, resulted in a Form 483 detailing significant observations. The inspection focused on clinical investigation practices, highlighting two main areas of concern: deviations from investigational plans and insufficient Institutional Review Board (IRB) oversight.

The investigation observed that clinical study visits and activities were not performed or rescheduled according to protocol for multiple subjects, including missed clinical trial visits, unperformed hematology blood draws, and failures to obtain required imaging or confirmation for suspected medical events. Additionally, several serious adverse events were not reported to the sponsor within the required 24-hour timeframe, and abnormal laboratory values were not documented as adverse events.

Concerning regulatory framework, a critical issue identified was the failure to assure continuous IRB approval for a clinical study. The site experienced an approval lapse from March 3-15, 2023, because necessary documentation for continuing review was submitted late, despite multiple deadline notices. These observations indicate non-compliance with regulations governing clinical investigations and the protection of human subjects. The firm is expected to thoroughly investigate these findings and implement comprehensive corrective actions to address all identified deficiencies and ensure adherence to study protocols and regulatory requirements.