# FDA 483 - Alexion Pharma International Operations Unlimited Co. - January 24, 2023

Source: https://www.keypedia.com/records/483/alexion-pharma-international-operations-unlimited-co/1b0fed1f-247d-4950-a27f-5b9cd18b800d

> FDA 483 for Alexion Pharma International Operations Unlimited Co. on January 24, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Alexion Pharma International Operations Unlimited Co.
- Inspection Date: 2023-01-24
- Product Type: drugs
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: Alexion Pharma International Operations Limited in Dublin, Ireland, a drug substance manufacturer, was cited for significant deficiencies in its manufacturing operations, primarily concerning contamination control, data integrity, and adherence to standard operating procedures. The inspection revealed issues such as shared equipment posing viral cross-contamination risks, inadequate cleaning validation, and insufficient protection for electronic data acquisition systems. Furthermore, the firm's quality unit demonstrated inadequate oversight of GMP operations, including contractor qualification and batch record management.

## Related Officers

- [Mamta Kapoor-Bhushan, Pharmaceutical Scientist](https://www.keypedia.com/people/mamta-kapoor-bhushan-pharmaceutical-scientist/5a3b63c1-5098-4faf-bc13-55970643951e)
- [Jacek Cieslak, Ph.D., Lead Interdisciplinary](https://www.keypedia.com/people/jacek-cieslak-phd-lead-interdisciplinary/62581a76-407d-4666-8949-961d319345c2)
- [Zhong Li, Ph.D., Sr. Pharmaceutical Quality Assessor](https://www.keypedia.com/people/zhong-li-phd-sr-pharmaceutical-quality-assessor/cdc177bb-92f6-4d53-ba84-6e878c68917a)

Company: https://www.keypedia.com/companies/alexion-pharma-international-operations-unlimited-co/8da873c2-2cc1-4ece-9643-0f90227f6f9f

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