On Nov. 19, 2011, Ben Venue Laboratories voluntarily and temporarily suspended the manufacture and distribution of products made at its Bedford, Ohio, facility. These products include Doxil (doxorubicin HCl liposome injection), which the company produces for Johnson & Johnson. The company’s clients include Pfizer, Hospira, and Teva.
An internal review of documentation at the site indicated that routine preventive maintenance and requalification of manufacturing equipment was overdue, according to a company press release. Ben Venue is assessing the site to fully understand the potential effect of the lapses and to implement appropriate corrective actions. The company has alerted global regulatory agencies about its actions and is assessing stock levels and anticipated demand to minimize the disruption to product supply.
FDA is working with Ben Venue to address concerns so that the company may resume manufacturing and distribution of products as soon as possible. After a May 2011 inspection of the Bedford site, the agency sent Ben Venue a Form 483 listing 48 observations, including the failure to identify the root cause of foreign material in two products.
The manufacturing suspension follows a string of problems at the Bedford plant. In August 2011, Health Canada notified hospitals that it had identified GMP deficiencies at the site and forbade the import of all but medically necessary drugs from it. The agency also increased international regulatory oversight of the company’s plant and products. Ben Venue agreed to improve its facility and rectify quality deficiencies.
One day after Health Canada’s actions, Ben Venue decided to exit the contract-manufacturing business. To ensure the supply of medically necessary products, the company plans to work with its customers to develop and execute long-term transition plans.
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