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news.The US Food and Drug Administration has announced that federal judge has issued a consent decree of permanent injunction against Ben Venue Laboratories and three of its corporate officers for failing to meet with current good manufacturing practice requirements as required by federal law.
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The decree was signed by US District Court for the Northern District judge Lesley Wells of Ohio on 31 January 2013 and was issued to Ben Venue’s chief executive officer, vice president of operations, and vice president of quality operations.
Under the decree Ben Venue Laboratories will be allowed to manufacture and distribute medically necessary drugs from its Bedford, Ohio, facility, until FDA determines that its operations meet with the Federal Food, Drug, and Cosmetic Act.
The move was taken as FDA in its recent inspections to the facility found that several products had quality problems, including particles in some sterile products and basic facility cleaning and maintenance issues.
The Agency said it is working with Ben Venue during the company’s remediation to prioritize and ensure the availability of the company’s medically necessary drugs to respond to and prevent potential drug shortages.
FDA’s regulatory affairs acting associate commissioner Melinda Plaisier said the company’s failure to promptly address the problems will result in patients at risk of receiving poor quality drugs and compromises the availability of medically necessary products.
"This company continued to violate the law, and the FDA took action to help ensure that medicines that consumers rely on are safe, effective, and of high quality," Plaisier added.