The U.S. Food and Drug Administration (FDA) issued a warning letter to Sanofi’s Genzyme Ireland Limited facility in Waterford, Ireland. Inspectors identified significant manufacturing violations and labeled products from the site as adulterated.
The Waterford facility employs more than 950 people. The warning specifically concerns the production of Thymoglobulin, used for kidney transplant rejection, and Altuviiio, a hemophilia treatment.
Sanofi stated it is taking immediate action to address the FDA’s observations. The company does not expect the warning to impact the current supply of these medicines.