FDA 483 - Sanofi Winthrop Industrie - April 17, 2023

An FDA inspection of Sanofi Winthrop Industrie in Le Trait, France, revealed significant deficiencies across multiple areas of their manufacturing operations. Key issues included recurrent foreign particulates in sterile products due to inadequate quality control and supplier management, and a lack of sufficient GMP training leading to unqualified operators performing critical tasks. Additionally, the firm failed to implement representative sampling for visual inspection, adequately validate aseptic processes through media fills, and properly monitor environmental conditions in aseptic areas.