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

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.