Sanofi Vaccines US Inc. – FDA EIR, Oct 26, 2018

A Pre-Approval Inspection (PAI) of Sanofi Pasteur, Inc.'s Swiftwater, PA facility was conducted by the FDA's Center for Biologics Evaluation and Research (CBER) from October 22 – 26, 2018. This inspection supported Prior Approval Supplement STN 103915/5213 for the formulation and filling of Yellow Fever Vaccine, YF-VAX. The regulatory framework for this inspection was CPGM 7345.848, governing the inspection of biological drug products.

During the inspection, two significant observations were noted and documented on Form FDA 483. First, production procedures for YF-VAX were not adequately followed. Specifically, operators failed to adjust conveyor speeds during automated lyophilizer unloading, despite approximately 26 interventions in a two-hour period to address vial jams and fallen vials for batch UJ090A. Second, the facility failed to adequately document or evaluate cycle failures associated with a specific line. Since September 2017, 17 out of 46 cycles had failed to complete, yet the causes were not consistently recorded, and no investigations were initiated to assess trends or potential impacts on process validation.

Sanofi Pasteur, Inc. acknowledged these observations, promising to implement corrective actions and submit a formal written response to the Agency.