Alnylam Pharmaceuticals Inc. – FDA 483, Feb 25, 2025

An FDA inspection of Alnylam Pharmaceuticals Inc. in Cambridge, MA, revealed significant deficiencies in manufacturing practices. Observations included inadequate testing of components for impurities, distribution of drug product lots prior to complete quality unit approval, and failure to maintain production and control records for the required duration. These issues indicate potential risks to drug product quality and regulatory compliance.