FDA 483 - Sanofi Winthrop Industrie - April 25, 2023

During an FDA inspection conducted from April 17-25, 2023, Sanofi Winthrop Industrie, a licensed biological manufacturer located in Le Trait, France, received a Form FDA 483 detailing several significant observations. The primary issues identified related to the company's quality control unit, which failed to fully follow established procedures. This included deficient controls for primary packaging materials, leading to recurring foreign particulates in products such as Dupixent and Kevzara, with 391 deviations and numerous consumer complaints noted since March 2021 without adequate site-level corrective actions. Additional concerns involved insufficient frequency of GMP training, with operators performing critical aseptic filling and visual inspection tasks while their requalifications were overdue. The inspection also highlighted non-representative sampling practices for AQL testing during visual inspection and inadequate validation of aseptic and sterilization processes, specifically Media Fill Tests that did not accurately simulate maximum campaign durations or critical process steps. Lastly, environmental monitoring in aseptic processing areas was found deficient, lacking non-viable particulate monitoring at a critical transfer point for stoppered syringes. To address these findings and comply with regulatory requirements for biological manufacturers, Sanofi Winthrop Industrie is required to submit a comprehensive response outlining its corrective actions.