UPDATED: Ben Venue Bedford plant still missing GMP standards

Consent decree says recent inspections found particles in sterile products
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Boehringer Ingelheim's Ben Venue Laboratories plant in Bedford, OH, continues to struggle to make sterile products more than a year after it came under heightened FDA review for serious manufacturing problems.

In announcing a consent decree for the plant last week, the agency pointed out that, "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."

"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, the FDA's 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."

The consent decree, approved by a federal judge last week, said the plant is "constrained from manufacturing and distributing drugs from" the Bedford plant "until FDA determines that its operations are compliant." But in fact, the FDA finds itself straddling two areas of responsibility, compliance and keeping essential drugs from being in short supply. And as a result the consent decree is a bit of Frankenstein.

Ben Venue can't make and distribute products from the plant, except for more than 100 drugs the company has indicated that the FDA will continue to allow it to produce because they are too important and too likely to be in short supply if it stops.

The 483 reports from earlier inspections showed deep problems at the plant. Investigators found more than 100 basic preventative maintenance activities that hadn't been taken care of for at least a month. Ben Venue issued 40 product recalls from 2002 until the plant voluntarily closed in November 2011. The closing, however, immediately led to shortages of important drugs such as Johnson & Johnson's ($JNJ) cancer drug Doxil and others and so the FDA is now permitting it to continue to manufacture some products.

The arrangement does not leave Ben Venue off the hook, however. The FDA's Sarah Clark-Lynn said via email that the plant must meet strict timelines to get back up to FDA standards or face financial penalties. The company then "is required to have an outside expert review its records and processes to verify conformance with quality standards, including current good manufacturing practice (CGMP) requirements.

"In the meantime, to help address shortages of medically necessary drugs, the decree permits manufacturing with enhanced controls for certain products," she said.

The agency has worked hard to find other suppliers for some of those drugs and on Monday announced the approval of a generic version of Doxil from India's Sun Pharmaceutical Industries. Since last February, the FDA had been allowing Sun to import its unapproved version of the Doxil substitute as one way for the agency to address the shortage. Once Sun gets supplies of the approved product in the supply chain, the FDA said it would stop the import of the other drug.

- here's the FDA's release
- get the company's release

Special Report: Boehringer Ingelheim, Ben Venue Laboratories - Fierce's 2012 Top 10 FDA Red Flags

Related Articles:
Ben Venue consent decree softened to account for drug shortages
J&J releases Doxil batch; Ben Venue troubles detailed in FDA report
FDA approves generic Doxil to combat drug shortage

Editor's note: Story updated to include a statement from the FDA's Sarah Clark-Lynn.