FDA Shuts Down Boehringer Ingelheim Plant Due to Quality Issues

Federal drug regulators have shut down a Boehringer Ingelheim production plant in Ohio, following problems with quality control that have led to recalls for contaminated injectable drugs. 

On January 31, the FDA announced that a federal judge has granted the agency a consent decree of permanent injunction against Ben Venue Laboratories Inc., a subsidiary of Boehringer Ingelheim, closing down a factory in Bedford, Ohio.

The consent decree was signed by Judge Lesley Wells of the U.S. District Court for the Northern District of Ohio, which will keep the factory closed until the FDA can see that operations there comply with federal drug safety standards.

Ben Venue makes a number of drugs for other companies, as well as for its own label, Beford Laboratories.

The injunction came following recent FDA inspections, which revealed contamination in products that were supposed to be sterile and deficiencies in how the plant was cleaned and maintained. Of primary concern was that some poorly maintained equipment was shedding particles into drugs designed to be injected into patients’ bodies.

“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,” according to a statement by the FDA’s acting associate commissioner for regulatory affairs, Melinda K. Plaisier. “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 products have been plagued by recalls, with about 40 drug recalls issued since 2002. In 2011, supplies of the cancer drug methotrexate were low because of problems at the factory.

In February 2012, the company was forced to announce a recall of three lots of the injection cancer drug Cytarabine because of sterility concerns. That recall came less than a month after it had to recall one lot of acetylcysteine, used to treat acetaminophen overdoses, because glass fragments were found in some vials.

The FDA said it is working with Ben Venue to make certain there is not a shortage of medically necessary drugs due to the shutdown.

The consent decree reached with the FDA requires the plant to follow a strict time table toward rehabilitating its manufacturing processes. Failure to do so could result in fines and other consequences.