FDA 483 - Sanofi Winthrop Industrie - June 15, 2018

Sanofi Winthrop Industrie in Tours, France, was cited for failing to fully follow quality control unit responsibilities and procedures. Specifically, the firm did not revalidate a manufacturing process for a drug after making significant changes to parameters, equipment, and chemicals. This lapse resulted in the production of a batch for the US market using a non-validated process.