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Ben Venue Laboratories announced that it has voluntarily entered into a consent decree with FDA over violations of cGMP.
Ben Venue Laboratories announced that it has voluntarily entered into a consent decree with FDA over violations of cGMP. Under the terms of the consent decree, Ben Venue is still permitted to manufacture and distribute more than 100 drugs that are essential for patient care. Ben Venue is also permitted to continue drug-development activities, and may file abbreviated new drug applications (ANDAs), and, as remediation progresses to FDA’s satisfaction, receive ANDA approvals and manufacture other products.
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.