FDA 483 - Sanofi Pasteur Limited - March 18, 2025

An FDA inspection of Sanofi Pasteur Limited in North York, Ontario, a vaccine manufacturer, identified a critical issue with their bioburden sample collection process. The design of this process consistently leads to leaking and spilling of materials in a controlled environment. This observation highlights significant concerns regarding quality control and the potential for contamination in the manufacturing of sterile products.