483
Sanofi Winthrop IndustrieSanofi Winthrop Industrie – FDA 483, Jun 15, 2018
Record Details
During an inspection, 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 product after significant changes, leading to the production of batches for the US market using a non-validated process. This indicates a significant lapse in quality assurance and process control.
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ID · bc069d2e-844a-4ab0-99be-5d6ddefbf69c
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