Sanofi receives FDA warning over contamination at manufacturing site

Sanofi Framingham facility, MA, USA. Image c/o google images

The FDA issues a warning letter to Sanofi over contamination violations found at the Framingham biologics facility, in Boston, MA, USA. 

On January 15, following a US Food and Drug Administration (FDA) inspection of a biologics facility located 30 km west of Boston, Massachusetts that took place in June and July of last year, a warning letter has been issued to Sanofi. The inspection identified numerous deviations from current Good Manufacturing Practice (cGMP) in drug substance production, detailed in the letter.

“FDA documented that approximately 20 percent of bioreactor runs attempted between January 2022 and July 2024 were rejected for contamination or other quality failures,” the Agency wrote in the warning letter. “This rate is excessive and calls into question the state of control of your process.”

The FDA stated that Sanofi had failed to conduct sufficient investigations into these deviations, which included contamination events with microbiological particles. The letter specifically noted several examples of inadequate investigations with an undisclosed drug substance. Further investigations into product leakage were also highlighted by the FDA as being insufficient during their assessment. 

Several other causes of concern were identified from the audit, including a failure to demonstrate a manufacturing process that can reproduce an API with predetermined quality attributes. Improper use of equipment of the manufacture of drug substances was also brought to attention in the letter, even eluding that this could have been a contributing factor in some instances of contamination: 

“Mobile carts used in the setup of [undisclosed] units required previously determining equipment proximity to the floor as a contributing root cause in microbiological contamination events.”

In another example, the Agency cited: “[Undisclosed equipment] used to establish temporary sterile boundaries for tubing continue to be used despite being identified in a June 2023 microbial contamination event investigation as possessing a ‘design flaw’ that may allow microbial ingress.”

Last year, Sanofi had identified several factors that could have caused some of the failures in the facility, these included:

“Excessive personnel attrition of trained investigators, process knowledge gaps amongst newer investigators, prioritisation of investigations associated with lots pending release, and inconsistent communication of ‘deviation performance metrics’”. 

Although this sounds like a step in the right direction, the FDA made further comments stating that the detail provided on how to rectify these issues was insufficient. This time around, they have asked Sanofi to respond to the warning letter with detailed plans of corrective action with 15 days. 

A Sanofi spokesperson 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."

They added there has been "no interruption to manufacturing or to the continued supply of medicines from the Framingham site as a result of these findings."

Source:

BioProcess International. FDA cites contamination concerns in warning to Sanofi MA plant. [Date Accessed 11/02/2025] www.bioprocessintl.com/facilities-capacity/fda-cites-contamination-concerns-in-warning-to-sanofi-ma-plant