Ben Venue Laboratories, Inc. Update on Drug Manufacturing
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.
Ben Venue Laboratories, Inc. Temporarily Suspends Manufacturing and Distribution of Drug Products
November 19, 2011 – Ben Venue Laboratories, Inc, (“Ben Venue”) has voluntarily and temporarily suspended manufacture and distribution of products produced in its Bedford, OH facility.
A recent internal review of documentation indicated that routine preventive maintenance and requalification of some manufacturing equipment did not occur at the specified time interval, and is overdue. To uphold our commitment to quality and product safety, Ben Venue is completing a site-wide assessment in order to fully understand the potential impact, if any, 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 notified the global regulatory agencies of this voluntary preventive measure and is assessing stock levels and anticipated demand to minimize impact to product supply in the market place. The U.S. Food and Drug Administration has been and will continue to work closely with Ben Venue to address these issues and help resume manufacturing and distribution of products as soon as possible.
Ben Venue is committed to providing pharmaceutical products that improve the health and quality of life of patients. As a provider of many medically-necessary drugs, including several products for which we are the sole-source manufacturer, we recognize the importance of ensuring that healthcare professionals and patients have access to the products they need, when they need them, with the highest attention to quality and product safety.
Questions regarding this notice can be directed to our Bedford Laboratories Client Services Team at 1.800.562.4797 - Monday – Friday, 8am – 5pm EST.
Ben Venue Laboratories, Inc. to Transition Out of the Contract Manufacturing Services Business Over the Next Several Years
CLEVELAND, OH – August 18, 2011 – After more than 70 years of continuous service, Ben Venue Laboratories, Inc. (BVL) has decided to transition out of the Contract Manufacturing Services business over the next several years. BVL is working with its customers to develop and implement comprehensive long-term transition plans in order to minimize potential impact of product supply. Throughout this transition process, our highest priority will remain the supply of medically necessary products for patients.
Following the multi-year transition out of contract manufacturing, BVL will dedicate its facility to manufacturing product for its Bedford Laboratories generic injectable business.
This decision is specific to the facility located in Cleveland, OH and does not alter Boehringer Ingelheim’s dedication and firm commitment to its global contract manufacturing business and its valued customers.
About Ben Venue Laboratories, Inc.
Ben Venue Laboratories, Inc. is a U.S. subsidiary of Boehringer Ingelheim Corporation (Ridgefield, CT) and a member of the Boehringer Ingelheim group of companies.
About Boehringer Ingelheim
The Boehringer Ingelheim group is one of the world’s 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates globally with 145 affiliates and more than 42,000 employees. Since it was founded in 1885, the family-owned company has been committed to researching, developing, manufacturing and marketing novel products of high therapeutic value for human and veterinary medicine.
For more information, please visit http://us.boehringer-ingelheim.com
Ben Venue Laboratories, Inc. Named Recipient of the Governor’s Award for Outstanding Achievement in Environmental Stewardship
BEDFORD, OH – December 8, 2008 – Ben Venue Laboratories, Inc. is pleased to be the recipient of the 2008 Governor’s Award for Outstanding Achievement in Environmental Stewardship presented by Governor Ted Strickland and the State of Ohio Environmental Protection Agency on December 3, 2008. The award recognizes Ben Venue for its environmental, health and safety management system that strives to promote a safe and healthy manufacturing environment, including brownfield reuse and re-development, LEED (Leadership in Energy and Environmental Design) construction design and application for Silver Certification for its recently completed 90,000 square foot Lab and Office facility, recycling and reuse, energy saving, and water conservation.
Coordinated by the Ohio EPA, the award seeks to acknowledge Ohio businesses and organizations demonstrating a commitment to go above and beyond compliance, maintain aggressive environmental performance goals, and provide a process for communicating with others about program activities and progress toward established goals. Submitted nominations were rated and the Ohio EPA completed site audits with the finalists to select the eight chosen honorees. "I'm honored to recognize these forward-thinking award winners, which have all demonstrated cutting-edge achievements and a commitment to environmental stewardship in Ohio," said Ohio EPA Director Chris Korleski in a press release issued by the Governor’s office. Governor Ted Strickland added "These companies are leaders in protecting Ohio's natural resources while implementing innovative approaches that reduced the cost of doing business, improved company efficiency, and enhanced the quality of life and the environment in their communities. I commend their efforts," More information about the award is available at: http://www.epa.state.oh.us/ocapp/stewardship.html
Ben Venue Laboratories, Inc. Cares
Caring for the environment is one of the many ways Ben Venue works to make a difference. Each day, employees work to fulfill the company mission to provide their customers with pharmaceutical products that improve people’s health and quality of life. This commitment to others also stems deeply into how the organization gives back to the community through many avenues including responsible environmental stewardship. With support from all levels of the organization, the environmental health and safety management system continues to take on new life with each passing year. From activities including the careful consideration for environmentally-friendly construction design to numerous grass-roots employee efforts, Ben Venue cares about the footprint it maintains and the impact on the environment. Employees started a Waste Minimization and Recycling Team in 2005 to identify routes to recycle waste streams. Successes include saving valuable landfill space and significantly reducing waste disposal costs. The company recycled and reused 35 tons of material in 2005, 360 tons in 2006 and over 730 tons in 2007. A precious-metal recycling program that began in 2007 recovered over 170 troy ounces of platinum for a return of more than $265,000. A water reclamation system installed in 2006 saved more than 7 million gallons of water in 2006 with a cost savings of $57,000. The most recent accomplishment was the completion of the LEED Silver Certification application for its newest facility, a 90,000 square foot Lab and Office building. President and COO, Thomas Murphy stated, “This commitment is at the heart of how we conduct business today and is sure to bring about even greater results for the future.”
Pictured Above: EPA Director Chris Korleski, Cheryl May - BVL Manager of EHS, and Governor Ted Strickland
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