Sanofi Provides a Statement on FDA Letter

On June 22, 2026, the Food and Drug Administration issued a warning letter to a facility in Ireland. Sanofi shared the following statement with Hemophilia Federation of America:

Patient safety and the quality of our products are our highest priorities. 

We take the FDA Warning Letter issued to the Waterford (Ireland) facility with the utmost seriousness. We are taking immediate actions and are committed to fully addressing each of the Agency’s observations, robustly and sustainably. 

We will work with the FDA to ensure our action plans fully meet the Agency’s requirements and expectations. 

All products released from the Waterford facility meet established quality and safety specifications. We do not anticipate any impact on our ability to supply medicines at this time.

Contract your healthcare provider if you have questions or concerns about any of your treatment products.