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Since entering the Decree in 2016, Xellia’s site has been regularly inspected by the FDA to determine compliance with rules and regulations.
April 29, 2024
By: Charlie Sternberg
Associate Editor
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 ...
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