The QMN Weekly Bulletin
Pharmaceuticals / Quality / Commercial Operations

BI Continues to Be Plagued by Quality Problems at Ben Venue

Sept. 5, 2014

Shuttered Boehringer Ingelheim subsidiary Ben Venue continues to create quality headaches for the German manufacturer with the recall of a chemotherapy drug due to a container defect.
BI pulled 7,172 glass vials of cyatabine for injection USP manufactured by Ben Venue because of crimp defects that could affect whether the vial containers closed properly, according to an FDA enforcement alert issued last week.

The recall was announced by the FDA nearly a year after BI said it would close its Bedford, Ohio-based subsidiary where the drugs were made to avoid a $1 billion price tag to remediate the company’s facilities.

The sterile injectable maker was beset by quality issues over the years. A few months before the shutdown, Ben Venue temporarily stopped production at two older facilities responsible for recalled lots of drug products due to visible particles.

The drugmaker took the same action in 2011, voluntarily suspending manufacturing after an internal review found some equipment overdue for maintenance and requalification.

In May, BI sold Ben Venue’s four manufacturing facilities to Hikma Pharmaceuticals. 

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