Amgen Technology (Ireland) Unlimited CompanySeptember 8, 2025

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

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Record Details

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.

Company: Amgen Technology (Ireland) Unlimited Company
Inspection Date: September 8, 2025
Product Type: Drugs
Office: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
Person: Wayne E. Seifert (Senior Regulatory Specialist)

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ID · ed2f7364-851f-4cd9-b023-2e00dd6ca113