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 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.
The Solution Lies with SOLBIOTE™: Achieving Sustainability, a Growing Focus in Biopharma
October 28th 2024The nexus between biopharmaceuticals and sustainability is seemingly far apart, however, it is increasingly recognized as an inevitable challenge. It is encouraged to take a sustainable approach to reducing the environmental impact of the production and supply of medicines while improving people's health; delivering the well-being of people and the planet. Yosuke Shimojo (Technical Value Support Section Manager, Nagase Viita) will unveil how SOLBIOTE™, a portfolio of injectable-grade saccharide excipients, would be a key for the biopharmaceutical development and achieving sustainability for a better future of the industry.
