US federal judge approves consent decree with Boehringer's Ben Venue Labs

The US Food and Drug Administration announced today that a federal judge has approved a consent decree of permanent injunction against USA-based Ben Venue Laboratories, a unit of family-owned German drug major Boehringer Ingelheim, and three of its corporate officers for failing to comply with current Good Manufacturing Practice (cGMP) requirements as required by federal law.

The action restrains Ben Venue from manufacturing and distributing drugs from its Bedford, Ohio, facility until the 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 US District Court for the Northern District of Ohio on January 31, 2013.