FDA 483 - Sanofi Pasteur Inc. - August 02, 2024

Sanofi Pasteur Inc., a vaccine manufacturer in Swiftwater, PA, was inspected by the FDA. The inspection revealed that input and output from systems controlling manufacturing formulas and data are not checked for accuracy. Specifically, critical adjustments to capping/crimping equipment and selected fill recipe parameters for Fluzone® Influenza Virus Vaccine were not documented, failing to ensure adherence to validated ranges.