# FDA EIR - Alexion Pharmaceuticals, Inc. - February 19, 2015

Source: https://www.keypedia.com/records/eir/alexion-pharmaceuticals-inc/192328c9-0591-44c8-b3cd-ffed6f634f9f

> FDA EIR for Alexion Pharmaceuticals, Inc. on February 19, 2015. Product: Biologics. Access full analysis and detailed observations.

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## Details

- Record Type: EIR
- Company Name: Alexion Pharmaceuticals, Inc.
- Inspection Date: 2015-02-19
- Product Type: Biologics
- Office Name: New England District Office
- Summary: An FDA pre-approval inspection was conducted at Synageva Biopharma Corp.'s Holden, MA facility from February 10-19, 2015. The inspection focused on the manufacturing of bulk unpurified sebelipase alfa, an active pharmaceutical ingredient, under a Biologics License Application (BLA 125561) and followed pre-license inspection guidelines. Operations at the site involve colony breeding, egg harvest, and egg white processing.
The inspection resulted in an FDA-483, citing several significant observations related to quality systems and manufacturing controls. Main issues included the quality unit's failure to thoroughly investigate deviations, such as microbial contamination in rejected batches and HEPA filter leaks, without adequately assessing risk to other products. Analytical test procedures were deemed unsound, lacking data to support bioburden testing on frozen samples, and exhibiting deficiencies in endotoxin testing method validation, pH control, and sample mixing. Media growth promotion testing was also found inadequate, not utilizing all required USP challenge microorganisms. Furthermore, the firm failed to ensure the quality of critical materials and supplies, including non-sterile media and inadequately qualified suppliers for challenge microorganisms and manufacturing plastics. Contamination control procedures were deficient, with observed poor personnel practices during egg white harvest and visible debris in production areas.
Management committed to addressing these deficiencies by implementing measures such as discarding disposables between lots, conducting studies to validate bioburden testing on frozen samples, and revising quality control and supplier qualification practices.

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## Related Officers

- [Consumer Safety Officer](https://www.keypedia.com/people/arie-c-menachem/01bacbef-a3ae-4eb0-a56f-e8a70b67a524)
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Company: https://www.keypedia.com/companies/alexion-pharmaceuticals-inc/2c0ca8b5-cf21-4cfb-b33e-6cf8b519ec74

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