FDA 483 - Amgen Technology (Ireland) Unlimited Company - September 08, 2025

An FDA inspection of Amgen Technology (Ireland) Unlimited Company in Dun Laoghaire, Ireland, revealed significant deficiencies in drug product manufacturing. Observations included failures in establishing adequate process controls for sterile filling and stoppering equipment, leading to potential contamination risks. Additionally, the firm was cited for inadequate revalidation of equipment systems and poor maintenance of equipment and facilities supporting drug product manufacture.