# FDA 483 - Alexion Pharmaceuticals, Inc. - November 07, 2024

Source: https://www.keypedia.com/records/483/alexion-pharmaceuticals-inc/5c1598d5-e9ae-4a35-a2ce-a0faf49e2c58

> FDA 483 for Alexion Pharmaceuticals, Inc. on November 07, 2024. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Alexion Pharmaceuticals, Inc.
- Inspection Date: 2024-11-07
- Product Type: biologics
- Office Name: New England District Office
- Summary: An FDA inspection of Alexion Pharmaceuticals, Inc. in Boston, MA, revealed significant deficiencies in their postmarketing adverse drug experience reporting. The firm failed to promptly review adverse event information from commercial marketing experience, leading to numerous late reports of serious and unexpected adverse events, and a failure to submit required individual case safety reports. Additionally, Alexion lacked approved written procedures for the surveillance of postmarketing adverse drug experiences.

## Related Documents

- [WARNING_LETTER - 2012-08-06](https://www.keypedia.com/records/warning_letter/alexion-pharmaceuticals-inc/87338350-6bc1-4400-affa-2b9ced0020aa)
- [483 - 2025-03-07](https://www.keypedia.com/records/483/alexion-pharmaceuticals-inc/a419172e-26c2-47cb-9836-f572daa92416)

## Related Officers

- [issuing_officer](https://www.keypedia.com/people/kent-a-conforti/8d3d3e82-cd97-420e-8840-df92d6eeba09)

Company: https://www.keypedia.com/companies/alexion-pharmaceuticals-inc/ff74d8e2-db98-41ca-9f7b-b8e9cb8b4015

Office: https://www.keypedia.com/offices/new-england-district-office/aa458072-2f1d-4231-89f5-21ba7a3b7144