# FDA 483 - Alexion Pharmaceuticals, Inc. - March 07, 2025

Source: https://www.globalkeysolutions.net/records/483/alexion-pharmaceuticals-inc/a419172e-26c2-47cb-9836-f572daa92416

> FDA 483 for Alexion Pharmaceuticals, Inc. on March 07, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Alexion Pharmaceuticals, Inc.
- Inspection Date: 2025-03-07
- Product Type: drugs
- Office Name: New England District Office
- Summary: An FDA inspection of Alexion Pharmaceuticals, Inc. in Boston, MA, revealed a significant issue regarding the firm's compliance with its approved REMS Implementation System for the drug Voydeya. The company failed to adhere to its audit plan and schedule for certified pharmacies and did not maintain adequate records to ensure restricted distribution of the medication. This indicates a moderate severity issue related to drug distribution controls and oversight.

## Related Documents

- [WARNING_LETTER - 2012-08-06](https://www.globalkeysolutions.net/records/warning_letter/alexion-pharmaceuticals-inc/87338350-6bc1-4400-affa-2b9ced0020aa)
- [483 - 2024-11-07](https://www.globalkeysolutions.net/records/483/alexion-pharmaceuticals-inc/5c1598d5-e9ae-4a35-a2ce-a0faf49e2c58)

## Related Officers

- [Meredith L. Miller](https://www.globalkeysolutions.net/people/meredith-l-miller/c775003b-4e5b-48d8-bc51-1a3ebe813dba)

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

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