# FDA 483 - Alexion Pharmaceuticals, Inc. - February 13, 2026

Source: https://www.keypedia.com/records/483/alexion-pharmaceuticals-inc/56114bbd-bcc2-4c92-b99d-a827c364f0cc

> FDA 483 for Alexion Pharmaceuticals, Inc. on February 13, 2026. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Alexion Pharmaceuticals, Inc.
- Inspection Date: 2026-02-13
- Product Type: biologics
- Office Name: Division of Northeast Imports 
- Summary: Synageva Biopharma Corp. in Holden, MA, a drug substance manufacturer, was cited for significant deficiencies in its quality unit, analytical testing, material controls, contamination prevention, environmental monitoring, and equipment qualification. The inspection revealed a pattern of inadequate investigations into microbial contamination, scientifically unsound testing procedures, and a lack of robust controls to ensure product quality and purity, particularly concerning its unpurified bulk active pharmaceutical ingredient. These issues indicate a serious lack of adherence to good manufacturing practices.

## Related Documents

- [EIR - 2015-02-19](https://www.keypedia.com/records/eir/alexion-pharmaceuticals-inc/192328c9-0591-44c8-b3cd-ffed6f634f9f)

## Related Officers

- [Consumer Safety Officer](https://www.keypedia.com/people/arie-c-menachem/01bacbef-a3ae-4eb0-a56f-e8a70b67a524)
- [Assuring that quality medicines are available to the American public](https://www.keypedia.com/people/maya-m-davis/4180239e-5b21-4f9c-9ff0-6bbe5222f740)

Company: https://www.keypedia.com/companies/alexion-pharmaceuticals-inc/2c0ca8b5-cf21-4cfb-b33e-6cf8b519ec74

Office: https://www.keypedia.com/offices/division-of-northeast-imports/b20599cf-9797-41fd-947f-6589ef596a94