Alexion Pharma International Operations Unlimited Co. – FDA 483, Jan 24, 2023

Alexion Pharma International Operations Limited in Dublin, Ireland, a drug substance manufacturer, was cited for significant deficiencies in its manufacturing operations, primarily concerning contamination control, data integrity, and adherence to standard operating procedures. The inspection revealed issues such as shared equipment posing viral cross-contamination risks, inadequate cleaning validation, and insufficient protection for electronic data acquisition systems. Furthermore, the firm's quality unit demonstrated inadequate oversight of GMP operations, including contractor qualification and batch record management.