Wegovy weight-loss injection factory plagued by sterile-safety failures

A general view of the drug product manufacturing laboratory in biologics and sterile injectables, Catalent, in Brussels, Belgium June 27, 2023. REUTERS/Yves Herman

LONDON (Reuters) - The factory that fills the self-injection pens for booming weight-loss drug Wegovy has repeatedly breached U.S. sterile-safety rules in recent years and staff have failed to perform required quality checks, a Reuters review of regulatory documents shows.

The breaches at Catalent, the Wegovy pen filler, were found by inspectors from the U.S. Food and Drug Administration who visited the plant in Brussels in October 2021 and August 2022 to check on its compliance with manufacturing regulations, according to detailed FDA reports on the inspections, obtained by Reuters under freedom of information laws.