The inspection of the Sanofi (SNY) Pasteur facility located at 1541 avenue Marcel Merieux in Marcy-l’Etoile in France, conducted from June 16 to 20, 2025, revealed significant non-conformities and deficiencies, the French regulatory that oversees the safety of health products said. These were notified to the facility in a preliminary injunction letter dated August 26, 2025. Following this inspection and the responses provided by the facility on September 11, September 24, and October 16, 2025, the ANSM said there was unsatisfactory management of contamination; a lack of control in managing the risk of cross-contamination; problems receiving and qualifying raw materials, and deficiencies in managing subcontractors. The company subsequently attempted to address the issues, but failed to do so, according to ANSM, which wants various corrective steps to be implemented over the next nine months.
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