The letter, dated Dec. 16, 2024, and amended Jan. 15, 2025, follows an inspection conducted from June 12 to July 9, 2024, and outlines multiple manufacturing violations for pharmaceuticals.
Key issues identified during the inspection include:
- The FDA found that nearly 20% of bioreactor runs between January 2022 and July 2024 were rejected due to contamination or other quality issues with inadequate investigations into microbiological contamination events and product quality failures.
- Sanofi was found to have deviated from its manufacturing processes, including the use of unapproved materials and procedures that increase risk of contamination.
- The FDA flagged the use of equipment that was unsuitable for microbiologically controlled environments, contributing to contamination risks.
- The facility’s quality unit failed to address multiple overdue deviation investigations and did not adequately oversee the manufacturing process to ensure process compliance.
The FDA demanded that Sanofio take corrective actions, including conducting comprehensive investigations into the causes of the deviations, reassessing its manufacturing processes, and updating corrective and preventative actions.
In an email shared with Becker’s, Sanofi stated, “Patient safety and the quality of our products are our highest priorities. We take all inspections extremely seriously and we are fully committed to working with the FDA to resolve all findings holistically, robustly and promptly to meet the agency’s requirements and expectations. There has been no interruption to manufacturing or to the continued supply of medicines from the Framingham site as a result of these findings.”
