(Reuters) - Ben Venue Laboratories Inc., a unit of German drug company Boehringer Ingelheim, may not freely make or distribute drugs from its facility in Bedford, Ohio, until U.S. regulators have determined it is in compliance with good manufacturing standards.
The U.S. Food and Drug Administration said a federal judge approved a consent decree on Thursday under which the company must bring its facility into compliance with regulatory requirements or face fines and other penalties.
Ben Venue has repeatedly violated good manufacturing practices, the FDA said in a statement. Recent FDA inspections found that poorly maintained equipment deteriorated to the point that it shed particles into injectable drugs.
"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 Plaisier, acting associate commissioner for regulatory affairs.
Ben Venue's chief executive officer, its vice president of operations and its 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.
A spokesperson for Boehringer Ingelheim was not immediately available for comment. The company this month said in a statement it had voluntarily entered a consent decree and would be permitted to continue manufacturing more than 100 drugs. The agreement was subject to approval by the judge.
Ben Venue manufactures products including sterile injectable drugs. It also makes drugs for other companies. FDA said it is working with Ben Venue to prioritize and ensure the availability of the company's medically necessary drugs to respond to and prevent potential drug shortages.
(Reporting by Toni Clarke; Editing by James Dalgleish)