Boehringer Ingelheim GmbH, the world’s largest family-owned drugmaker, agreed to stop production at an Ohio plant until it fixes manufacturing practices that led to about 40 product recalls in a decade.
U.S. District Judge Lesley Wells in Cleveland today approved a consent decree against Boehringer’s Ben Venue Laboratories plant in Bedford, Ohio, and three company officers after quality assurance rules were violated, leading to particles found in injectable drugs, the Food and Drug Administration said in a statement. Marjorie Moeling, a spokeswoman for the Ingelheim, Germany-based drugmaker, didn’t immediately return a call or an e-mail requesting comment.
Drugs produced by Ben Venue have been withdrawn about 40 times since 2002, reflecting “a continuing pattern of significant deviations from current good manufacturing practices,” the U.S. Justice Department said in a statement. Among the medicines was Sanofi’s Fludara leukemia therapy, pulled in February 2012 because it may not have been sterile.
“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,” Melinda K. Plaisier, acting associate commissioner for regulatory affairs at the FDA, said in the statement. “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.”
Supplies of the cancer drug methotrexate ran low in 2011 when the Ohio factory closed because of the manufacturing flaws.
The FDA will help the company to make sure that medically necessary treatments will be produced soon to drug shortages, the agency said in the statement.
Ben Venue makes drugs for a variety of companies as well as under its own label, Bedford Laboratories, the FDA said.
The case is U.S. v. Ben Venue Laboratories Inc., 1:13-cv- 00154, U.S. District Court, Northern District of Ohio (Cleveland).
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