FDA 483 - Alexion Pharma International Operations Unlimited Co.

An FDA inspection of Alexion Athlone Manufacturing Facility in Athlone, Ireland, identified significant issues in drug substance production, quality control, and cleaning validation. Observations included multiple deviations from standard operating procedures, inadequate in-process testing in QC labs, and incomplete cleaning validation processes. These findings highlight deficiencies in operational control, quality assurance, and validation practices at the facility.