FDA 483 - MSD International GmbH (Singapore Branch) - September 03, 2021

MSD International GmbH Singapore Branch, a sterile drug product manufacturer in Singapore, was cited for significant deficiencies during an FDA inspection. Observations included failures in aseptic processing procedures, lack of assurance in manufacturing process consistency, inadequate written procedures for foreign matter investigation, and insufficient verification of supplier COAs. Additionally, the facility exhibited design and maintenance issues, posing risks to product quality and sterility.