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The sterile injectable manufacturer Ben Venue decides to end production despite efforts to remediate cGMP violations.
The much troubled manufacturing operations of Ben Venue Laboratories, the Bedford-Ohio-based sterile injectables manufacturing arm of Bedford Laboratories, a Boehringer Ingelheim company, has come to an end with Ben Venue announcing it will cease production by the end of 2013. The company said that despite investments to remediate its manufacturing operations, it will not be able to return to sustainable production.
"Given the age and condition of some of our facilities, combined with the findings from our third-party current good manufacturing practice experts and ongoing remediation needs, Ben Venue projects, in addition to the more than $350 million invested to date, significant additional cumulative operating losses of approximately $700 million over the next five years," said Ben Venue in an Oct. 3, 2013 statement. "The effort, magnitude of investment, and additional years required to remediate the facility before Ben Venue can return to sustainable production is not feasible."
The closure will affect all of Ben Venue’s employees (approximately 1100) over a phased reduction starting this month in October and continuing into 2014 as Ben Venue executes wind-down activities. Ben Venue has notified FDA of its decision to cease operations. "Boehringer Ingelheim recognizes the importance of Bedford Laboratories, Ben Venue’s generic sterile injectables business, and is exploring strategic options to try to continue the supply of these products to patients," said the company in a statement.
In January 2013, Ben Venue Laboratories voluntarily entered into a consent decree with FDA over violations of cGMP, which followed the company's decision to voluntary halt manufacturing in November 2011.
Source: Ben Venue