Xellia and US FDA agree to modified consent decree at ex-Ben Venue site

By Dan Stanton contact

- Last updated on GMT

Image: iStock/varaphoto
Image: iStock/varaphoto

Related tags: Consent decree, Pharmaceutical drug

The US FDA has modified a 2013 consent decree issued to Ben Venue Laboratories, paving the way for new owners Xellia Pharmaceuticals to resume manufacturing at the dormant Ohio site.

In December 2013​, Boehringer Ingelheim shut down its sterile injectable site in Bedford, Ohio, run by its now disbanded contract manufacturing organisation (CMO) Ben Venue Laboratories.

The closure came, which after years of quality and GMP issues, resulted in a number of major drug shortages​. 

Eleven months earlier, Ben Venue had entered into a consent decree​ with the US Food and Drug Administration (FDA) restraining drug manufacture and distribution from the Bedford site – one of the oldest and largest sterile injectable sites in the world – and forcing the CMO to adhere to a strict timetable to bring the facility under compliance with regulatory requirements.

But Xellia, which acquired major parts of the site off Hikma in November last year​, announced Friday it had entered into a modified consent decree with the FDA aiding plans to restart production by the end of 2017.

“The modified decree sets out the process with which Xellia must comply in order to commence manufacturing activities at the site,”​ the company said in a release.

“[This] is the result of a constructive dialogue between Xellia and the FDA and is an important step in our plan to resume manufacturing at the Cleveland site,”​ CEO Carl-Åke Carlsson added.

Xellia currently employs around 50 staff at the site but Carlsson said the firm anticipates an extra 170 by the time manufacturing resumes.

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