FDA 483 - MSD International GmbH - April 11, 2025

MSD International GmbH, a drug substance manufacturer in Co. Cork, Ireland, was cited for inadequate validation of a critical system supporting V116 (Capvaxive) monovalent bulk conjugate drug substance manufacturing operations. This deficiency led to multiple deviations related to design limitations, impacting product quality, including issues with time out of controlled storage, hold time, and tolerance checks. Several CAPAs were initiated to address these design errors, with most awaiting effectiveness verification.