FDA 483 - Sanofi Pasteur Inc. - January 26, 2024

During an FDA inspection conducted from January 18-26, 2024, Sanofi Pasteur's manufacturing facility in Val De Reuil, France, received an FDA Form 483 outlining multiple significant observations. The primary issues centered on inadequate validation of aseptic processes, specifically a failed aseptic process simulation in a lyophilizer line due to mold contamination, which impacted US-licensed Dengvaxia® vaccine batches. The company had not successfully completed the required re-qualification simulations.

Further observations included a failure of the quality control unit to adhere to its own procedures, with numerous deviations not being initiated within the specified one working day. Inspectors also noted concerns with the facility's infrastructure, observing a compromised floor in a critical Grade B aseptic area lacking appropriate risk assessment and environmental monitoring. Lastly, an automated visual inspection machine, despite being qualified, necessitated a 100% manual re-inspection of all rejected products, indicating potential design or confidence issues in its intended use. Sanofi Pasteur is expected to provide comprehensive corrective actions to address these findings, as per the regulatory framework of the Federal Food, Drug and Cosmetic Act.