FDA 483 - Sanofi Pasteur Limited

Sanofi Pasteur Limited, a vaccines manufacturer in Toronto, Canada, was cited for significant deficiencies during an FDA inspection. Observations included inadequate investigations into vaccine component leaks, deficient environmental monitoring in aseptic processing, a failure to maintain backups for critical electronic data, and poor equipment maintenance leading to contamination risks. These issues indicate a systemic breakdown in quality control and data integrity practices.