# FDA 483 - Alexion Pharmaceuticals, Inc. - July 17, 2017

Source: https://www.keypedia.com/records/483/alexion-pharmaceuticals-inc/3f1d401c-ec68-4b5a-9e22-eab41a4d6494

> FDA 483 for Alexion Pharmaceuticals, Inc. on July 17, 2017. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Alexion Pharmaceuticals, Inc.
- Inspection Date: 2017-07-17
- Product Type: biologics
- Office Name: Division of Northeast Imports 
- Summary: An FDA inspection of Alexion Pharmaceuticals, Inc. in Smithfield, RI, a biological drug substance manufacturer, identified significant deficiencies in equipment and facility maintenance. Observations included inadequate maintenance of tanks and bioreactors with noted rouging and discoloration, and a failure to remediate these issues within required timeframes. Additionally, the firm failed to prevent repeated pest contamination in aseptic controlled manufacturing areas, indicating a lack of environmental control.

## Related Documents

- [483 - 2012-08-06](https://www.keypedia.com/records/483/alexion-pharmaceuticals-inc/a010dd2d-a2af-4445-8921-4a77795e40fa)
- [483_RESPONSE - 2012-08-06](https://www.keypedia.com/records/483_response/alexion-pharmaceuticals-inc/cd134dee-ba34-4656-9408-2174ed4228a3)

## Related Officers

- [Nealie C. Newberger](https://www.keypedia.com/people/nealie-c-newberger/4b7addde-1217-4495-bac2-2f7e3fe2e780)
- [Jose Hernandez-Guzman](https://www.keypedia.com/people/jose-hernandez-guzman/5e522aa9-a613-408f-b360-74c0fe4d8b30)

Company: https://www.keypedia.com/companies/alexion-pharmaceuticals-inc/125aa236-9807-4c76-8057-c66765afea64

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