Ben Venue Laboratories is extending its voluntary suspension of manufacturing at its Bedford, Ohio, facility. The company had originally announced the suspension on Nov. 19, 2011, and announced the extension of the suspension on Dec. 23, 2011.
Ben Venue had suspended manufacturing at the Bedford facility after an internal review indicated that routine preventive maintenance and requalification of some manufacturing equipment was overdue. These issues also were noted in recent inspection findings by FDA, the European Medicines Agency, and other global regulatory agencies. Ben Venue’s operations in Bedford include sterile injectable facilities with aseptic filling, lyophilization, and cytotoxic manufacturing in four factories.
The company says it is looking to restore some manufacturing in the first quarter of 2012. “As we address the facility and equipment issues in each factory, we will resume production, likely one line at a time,” according to a Dec. 23, 2011, company press release. “We are now working to restore some manufacturing in the first quarter of 2012 and will provide updates as they become available.” The company says it 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.
Ben Venue, however, said that the resumption of certain other manufacturing activities will take longer. “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,” according to the company statement. “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.”