FDA 483 - MSD International GmbH - April 11, 2025

MSD International GmbH in Co. Cork, Ireland, a drug substance manufacturer, was cited for inadequate validation of a system supporting V116 (Capvaxive) monovalent bulk conjugate drug substance manufacturing operations. This deficiency led to multiple deviations, including the release of batches without proper verification of critical parameters like time out of controlled storage and hold times, indicating potential impact to product quality. The firm has initiated several CAPAs in response to these identified design errors.