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."
Ben Venue manufactures numerous products, including drugs that are sold under its own label, Bedford Laboratories. These products include sterile injectable drugs. The company also manufactures drugs for other companies. FDA 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.
Ben Venue has agreed to adhere to a strict timetable to bring the facility under compliance with regulatory requirements, or face substantial fines and other consequences as described in the decree. Under the decree, the FDA may order Ben Venue to stop manufacturing, recall products, and take other corrective action as necessary to ensure that patients receive safe and effective drugs.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.