Last week, Ben Venue Laboratories decided to exit the contract-manufacturing business for the next several years, thus ending more than 70 years of service in this field. To ensure the supply of medically necessary products, the company will work with its customers to develop and execute long-term transition plans.
After the transition is complete, the Ben Venue Laboratories facility in Cleveland, Ohio, will manufacture generic injectable drugs for the company’s Bedford Laboratories business. Ben Venue’s decision affects only the Cleveland facility, and not the operations of Boehringer Ingelheim, of which Ben Venue is a subsidiary. Boehringer Ingelheim will continue operating its global contract-manufacturing business.
Ben Venue’s decision followed one day after Health Canada notified hospitals that it had identified GMP deficiencies at the company’s manufacturing site. Because the agency believed that the deficiencies could affect product quality, it forbade the import of all but medically necessary drugs from the site. The deficiencies already had limited Ben Venue’s manufacturing capacity, thus creating potential problems in the supply of medically necessary drugs imported into Canada.
Health Canada also implemented controls, including increased international regulatory oversight of the company’s site and products. Ben Venue agreed to improve its facility to rectify the identified quality deficiencies, according to a Health Canada press release. The agency planned to monitor Ben Venue’s activities and products to minimize risk to Canadians’ health and allow uninterrupted access to medically necessary drugs in Canada.
Ben Venue’s facility also had come under FDA’s scrutiny in recent years. In November 2007, the agency issued Ben Venue Laboratories a Warning Letter, citing CGMP deviations it had found during an inspection of the company’s Propofol injectable emulsion manufacturing facility. Ben Venue had failed to conduct a thorough investigation to determine the source of excessive levels of in-process endotoxin of multiple lots of Propofol, according to FDA. In the letter, the agency expressed concern that the company “may lack an adequate understanding of the product and the process for manufacturing Propofol.”
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