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

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.