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

Source: https://www.keypedia.com/records/483/amgen-technology-ireland-unlimited-company/ed2f7364-851f-4cd9-b023-2e00dd6ca113

> FDA 483 for Amgen Technology (Ireland) Unlimited Company on September 08, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Amgen Technology (Ireland) Unlimited Company
- Inspection Date: 2025-09-08
- Product Type: drugs
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: 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.

## Related Documents

- [483 - 2025-09-16](https://www.keypedia.com/records/483/amgen-technology-ireland-unlimited-company/2e595c05-4e97-492a-ba3c-e4bd3aba9279)

## Related Officers

- [Senior Regulatory Specialist](https://www.keypedia.com/people/wayne-e-seifert/e92e1f10-c61e-4b08-9156-25907e5e2942)

Company: https://www.keypedia.com/companies/amgen-technology-ireland-unlimited-company/576ab93b-ec8d-4b76-b25c-a1c473d6ae61

Office: https://www.keypedia.com/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd