FDA 483 - MSD International GmbH (Singapore Branch) - June 04, 2018

An FDA inspection of MSD International GmbH (Singapore Branch) revealed a lack of written procedures for production and process controls to ensure drug product quality. The firm failed to validate adequate controls over process design, leading to out-of-specification impurity levels in a drug substance. This issue impacted numerous lots, necessitating a temporary halt in manufacturing and the implementation of interim controls.