# FDA 483 - Alexion Pharma International Operations Unlimited Co. - Unknown Date

Source: https://www.globalkeysolutions.net/records/483/alexion-pharma-international-operations-unlimited-co/0f3b428f-893b-4029-89f4-0891e62ee0e5

> FDA 483 for Alexion Pharma International Operations Unlimited Co. on Unknown Date. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Alexion Pharma International Operations Unlimited Co.
- Product Type: drugs
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: 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.

## Related Officers

- [Zhang Zhao](https://www.globalkeysolutions.net/people/zhang-zhao/30c01178-37ff-446c-8ade-e3515627e723)
- [Richard Ledwidge](https://www.globalkeysolutions.net/people/richard-ledwidge/aaf4f089-8f7a-4d1f-b2e1-5f2e476a22a9)

Company: https://www.globalkeysolutions.net/companies/alexion-pharma-international-operations-unlimited-co/7c523c79-b4b1-4a47-8393-141753fd60e8

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