Ben Venue problems continue for Boehringer
pharmafile | September 2, 2014 | News story | Manufacturing and Production, Sales and Marketing | Ben Venue, Boehringer, fad, german, manufacturing, recall
Boehringer Ingelheim’s tribulations at its US production site Ben Venue Laboratories are refusing to leave as more of its products are forced into a recall over quality issues.
According to the FDA’s latest Enforcement Report, the private German company is recalling two lots of CYTARAbine, an injected sterile drug for treating a number of blood cancers.
The US regulator says the sterility of 7,172 vials is suspect – after a visual inspection found crimp defects that could affect the integrity of the container closure.
Boehringer called time on its troubled facility in Ohio at the end of 2013 and sold it last month, but is still having to recall products produced there.
The plant was run by Ben Venue Laboratories and had been operating under an FDA consent decree since January last year following a series of Good Manufacturing Practice (GMP) violations.
These included sterility failures for injectable products and inadequate hygiene standards.
Boehringer had looked to shore up the plant, spending $350 million on remediation at the site, which makes sterile injectables sold under the Bedford Laboratories brand, as well as producing drugs for other companies.
But the firm said it would have to absorb operating losses of around $700 million or more in order to bring it up to code, something it ultimately wasn’t willing to do.
The closure saw the loss of around 1,100 jobs. Jordan-based Hikma bought the facility as part of a $300 million deal in July.
But Hikma has already said that it has no plans to reopen the facility, and is instead moving the newest equipment to plants in the US and Europe.
Ben Adams
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