FDA 483 - Sanofi Pasteur Inc. - November 06, 2025

Sanofi Pasteur Inc. in Swiftwater, PA, a drug substance manufacturer, was cited for significant deficiencies during an FDA inspection. The inspection revealed inadequate routine environmental monitoring, leading to repeated out-of-specification events for Flublok® Quadrivalent and Flublok® Trivalent drug substances. Additionally, the facility was found to be in a state of disrepair and uncleanliness, with issues such as paint chipping, residue, and cracks observed in manufacturing areas.