FDA 483 - Sanofi Pasteur Inc. - April 22, 2023

Sanofi Pasteur Inc. in Swiftwater, PA, was inspected regarding its drug manufacturing operations. The inspection revealed significant deficiencies in equipment design and aseptic processing, including an operational dead leg in a syringe filling line and improper handling of sterilized components. Additionally, the firm failed to adequately validate cleaning processes for shared equipment and did not correct objectionable airflow patterns in aseptic areas, posing risks of contamination to drug products like Praluent and Flu vaccine.