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Bedford, OH – December 23, 2011 – Ben Venue Laboratories, Inc., ("Ben Venue") has announced its decision to extend the voluntary suspension of manufacturing at its Bedford, OH facility, originally announced on November 19, in order to uphold its commitment to providing the highest attention to quality and product safety, and to permit the implementation of lasting corrective actions. The original suspension took place after an internal review indicated that routine preventive maintenance and requalification of some manufacturing equipment was overdue. These issues have also been noted in recent inspection findings by the FDA, EMA, and other global regulatory agencies. Ben Venue continues to conduct a site-wide assessment in order to fully understand the potential impact and implement any appropriate corrective actions that may be needed as quickly as possible to ensure that healthcare providers and patients have access to the medicines they need.
Ben Venue has been working with global regulatory agencies over the past few years to balance the need to continue supplying patients and healthcare professionals with safe and effective critical medicines while addressing manufacturing and quality-related issues. However, Ben Venue is now in a position where it can no longer continue to manufacture and remediate simultaneously and must direct its focus on addressing manufacturing-related issues.
Ben Venue's operation in Bedford, OH is one of the largest sterile injectable facilities in the world, with aseptic filling, lyophilization and cytotoxic manufacturing in four factories. Due to the distinct technologies and manufacturing processes in each of Ben Venue's factories, issues are being addressed separately. As we address the facility and equipment issues in each factory, we will resume production, likely one line at a time. We are now working to restore some manufacturing in the first quarter of 2012, and will provide updates as they become available.
A substantial investment of time and resources will be required to make necessary improvements in the North facility, where several sterile injectable drugs currently in short supply are manufactured. The facility requires major reconstruction that may take up to nine months to complete. We anticipate that no products manufactured in the North facility will be available to patients and healthcare professionals before the fourth quarter of 2012. It should be noted that these expectations are based on our current plans and may be revised in the future.
As many of the products that Ben Venue produces are critical to patient care, the impact of our inability to produce these products weighs heavily on us. Our highest priority is to resume manufacturing and delivery of safe and effective products, and we are committed to working as quickly as possible to resolve the issues that have affected production.
We will provide periodic updates on our website as progress is made and additional information becomes available. Questions regarding this notice can be directed to our Bedford Laboratories Client Services Team at 1.800.562.4797 - Monday – Friday, 8am – 5pm EST.