FDA 483 - Sanofi Pasteur Limited - March 18, 2025

During an FDA inspection conducted from March 10-18, 2025, vaccine manufacturer Sanofi Pasteur Limited was issued a Form FDA 483, identifying significant deficiencies in their manufacturing processes. The primary observation highlighted issues with the bioburden sample collection process for drug substance components. Inspectors observed that the design of the sampling system consistently led to the leaking and spilling of critical materials, including aluminum phosphate suspension, during collection in a controlled environment. Company operators confirmed this problem was a routine occurrence. These materials are vital components used in the production of sterile vaccines. A critical concern was also the lack of documentation on batch records regarding these frequent leaking and spilling incidents. This observation, made under the Federal Food, Drug, and Cosmetic Act, indicates a potential risk of product contamination due to insanitary conditions during manufacturing. Sanofi Pasteur Limited is now required to provide a comprehensive response detailing corrective and preventive actions to rectify these process control and documentation failures, ensuring compliance and maintaining product safety and quality.