A voluntary recall was issued Friday after there was a report of a single visible glass particle in a vial in a lot that was produced for Genco Pharmaceutical Services.
When Boehringer Ingelheim began closing its Ben Venue site, it justified the decision by describing a grim future for the plant, with operating losses of $700 million forecast over the next 5 years. Now it hopes someone can look past the losses and troubled quality control record to see a business worth buying.
After investing more than $350 million in upgrades, Boehringer Ingelheim has decided it is not worth continuing to pour money into its aging Ben Venue Laboratories plant in Bedford, OH, and will shut it down instead, canning the 1,100 people who work there.
After years of regulatory woes and drug shortages, Boehringer Ingelheim is calling it quits for Ben Venue, planning to shut down its contract manufacturing arm by year's end and lay off about 1,100 workers.
Fallout from the manufacturing mess pinpointed by the FDA at a Ben Venue Laboratories contract manufacturing plant two years ago continues to reverberate for Johnson & Johnson. Its Janssen unit yesterday notified doctors it expects further shortages of its cancer drug Doxil, for which Boehringer Ingelheim's Ben Venue is the sole supplier.
Just months after signing a consent decree for the manufacturing mess in its Ben Venue subsidiary, Boehringer Ingelheim finds itself on the firing line with the FDA again, this time for particle contamination in an API produced 4 and 5 years ago.
While the FDA has yet to give its final sign-off to this creative work-around, it has permitted the Johnson & Johnson subsidiary to release a lot at a time, the latest last week.
Ben Venue, the contract manufacturing arm of Boehringer Ingelheim, got a lighter sentence than expected in its consent decree with the FDA, as the agency is still allowing it to manufacture 100 drugs it considers "essential for patient care," looking to stave off possible shortages.
By jumping through some manufacturing hoops, Johnson & Johnson hopes to ease the shortage of its cancer drug Doxil by this fall.
The drug was in short supply for weeks after a change in where the anti-anxiety drug is manufactured.