FDA announces federal judge approval of Ben Venue consent decree

Published on February 2, 2013 at 1:07 AM · No Comments

The U.S. Food and Drug Administration announced today that a federal judge has approved a consent decree of permanent injunction against Ben Venue Laboratories, Inc., and three of its corporate officers for failing to comply with current good manufacturing practice requirements as required by federal law.

The action restrains Ben Venue Laboratories, a Boehringer Ingelheim Company, from manufacturing and distributing drugs from its Bedford, Ohio, facility until FDA determines that its operations are compliant with the Federal Food, Drug, and Cosmetic Act. Recent FDA inspections found several product quality problems, including particles in some sterile products and basic facility cleaning and maintenance issues. Poorly maintained equipment deteriorated to the point that it shed particles into injectable drugs.

Ben Venue's chief executive officer, vice president of operations, and vice president of quality operations were named defendants in the consent decree, which was signed by Judge Lesley Wells of the U.S. District Court for the Northern District of Ohio on Jan. 31, 2013.

"The company's failure to promptly address these problems put patients at risk of receiving poor quality drugs and compromises the availability of medically necessary products," said Melinda K. Plaisier, acting associate commissioner for regulatory affairs. "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."

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