483
MSD International GmbH (Singapore Branch)MSD International GmbH (Singapore Branch) – FDA 483, Jun 4, 2018
Record Details
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.
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ID · 2d68fcc1-12ab-42c3-b7e4-4d4deed5051c
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