The U.S. Court has vacated the Modified Consent Decree imposed on Xellia Pharmaceuticals’ Cleveland, Ohio facility in 2016.
 
The original Consent Decree for the manufacturing site was entered into by the U.S. Food and Drug Administration (FDA) and the previous site owner, Ben Venue Laboratories Inc. (BVL) in January 2013. Because Consent Decrees are site-specific and do not relate to the owner, when Xellia acquired the site in November 2015, the Company entered an associated Modified Consent Decree with the FDA, which set out the processes with which Xellia must comply to conduct manufacturing activities at the Cleveland site.
 
Since entering the Decree, Xellia’s site has been regularly inspected by the FDA to determine compliance with rules and regulations.
 
In March 2024, Xellia received a VAI (Voluntary Action Indicated) classification, a milestone demonstrating a ‘continued state of compliance’, based on repeated positive feedback from inspections. On the back of this classification, the U.S. Court of Law vacated the Modified Consent Decree.
 
Michael Kocher, CEO at Xellia Pharmaceuticals, said: “Our team in Cleveland has done an excellent job of navigating the FDA’s inspections over the years, providing prompt and comprehensive responses to observations and information requests. The team’s perseverance has been rewarded with the lifting of the Decree, which is great news for Xellia. Our sincere thanks to everyone at the Cleveland site.”