FDA 483 - MSD International GmbH (Singapore Branch) - June 20, 2025

MSD International GmbH (Singapore Branch), a drug substance manufacturer, received an FDA Form 483 observation regarding its quality systems. The inspection found that qualified utilities were not appropriately monitored, specifically noting that alert limits for water systems had not been updated in 17 years. This indicates a potential deficiency in maintaining current monitoring standards for critical manufacturing utilities.