Ben Venue Laboratories has resumed production on a limited number of manufacturing lines in the company’s Bedford, Ohio, facilities. The company reported last week that it continues to make progress toward upgrading the company’s manufacturing facilities and anticipates that production will resume on additional lines as corrective measures to address facility and equipment issues are implemented. For most of the products it manufacturers, however, supplies will not be available for at least several months, according to the company.
Late last year, Ben Venue Laboratories announced that it was extending its voluntary suspension of manufacturing at its Bedford 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 were overdue. These issues also were noted in inspection findings by FDA, EMA, 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.
In an Oct. 16, 2012, press release, Ben Venue says it continues to work in close collaboration with FDA and other global regulatory agencies. Following FDA’s inspection of Ben Venue’s manufacturing operations in May 2011, the company began the implementation of a remediation effort and says it has invested more than $300 million to upgrade its facilities by making necessary improvements and changes to its processes to resolve the manufacturing-related issues that resulted in the voluntary shutdown last year.