FDA 483 - MSD International GmbH - March 28, 2023

This FDA Form 483 report details three observations at MSD International GmbH T/A MSD Ireland (Biotech Dublin), a drug substance manufacturer in Swords, Ireland. The inspection revealed deficiencies in written procedures for deviation management, inadequate validation and control of QC microbiology testing, and insufficient sampling and testing for component identity and microbial contamination of drug substance bags. These issues indicate significant concerns regarding the firm's quality control and manufacturing processes.