
Ben Venue Laboratories Enters Consent Decree
Ben Venue Laboratories announced that it has voluntarily entered into a consent decree with FDA over violations of cGMP.
Ben Venue Laboratories
In November 2011, Ben Venue voluntarily suspended manufacturing at its Bedford, Ohio facility because of significant manufacturing and quality concerns. The Bedford site manufactured sterile injectable products, including the cancer drug Doxil, which was in critically short supply as a result of the suspension.
According to Ben Venue’s press release, the company has invested more than $300 million to upgrade its facilities, making necessary improvements and changes to processes to address the manufacturing-related issues that resulted in the company’s decision to halt manufacturing. Ben Venue has demonstrated progress in improving manufacturing processes and announced in October 2012 that limited production had resumed. Since that time, production has resumed on additional manufacturing lines.
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