FDA 483 - SANOFI PASTEUR LIMITED

Sanofi Pasteur Limited, a vaccines manufacturer in Toronto, Canada, was cited for significant deficiencies across its quality control and manufacturing operations. Observations included inadequate laboratory controls for product testing, insufficient in-process specifications, poor batch record review, and environmental monitoring failures in aseptic areas. Additionally, equipment suitability, manufacturing record control, facility maintenance, and test equipment calibration were found to be deficient, indicating systemic issues in ensuring product quality and safety.