FDA 483 - MSD International GmbH (Singapore Branch) - January 23, 2026

MSD International GmbH (Singapore Branch) received a Form 483 for significant deficiencies in its sterile drug product manufacturing operations. The observations highlight inadequate validation of aseptic and sterilization processes, insufficient environmental monitoring, and failures in quality control and laboratory investigations. These issues indicate a lack of robust controls to prevent microbiological contamination and ensure product quality.