For Boehringer, A Pot Of Gold Is Now A Can Of Urine
December 12th, 2011 // 1:42 pm @ jmpickett
Until a spate of serious manufacturing issues cropped up, Boehringer Ingelheim seemed to be pleased with its Ben Venue Laboratories unit, which had been making a variety of different drugs for other companies. But after the FDA and European Medicines Agency repeatedly found violations, Ben Venue last month “voluntarily and temporarily†suspended operations at its troubled Bedford, Ohio, facility (back stories here and here).
The problems, not surprisingly, persist. A report for the latest FDA inspection, which ran from November 7 through December 2, found a host of ongoing problems. For instance, the 11-page report notes there was a lack of documentation to verify Ben Venue senior managers were notified of some safety and quality problems, and that internal investigations were not begun fast enough.
Routine preventative maintenance activities are not performed at scheduled intervals. As of November 11, there were approximately 107 required preventative maintenance activities for equipment past their scheduled due date. And the FDA inspectors wrote that there was no evidence showing the so-called quality team took action, according to the report, which was first noted by Dow Jones.
But here is the most puzzling mystery contained in the report. An unknown liquid was found in a 10-gallon can in a storage area in one of its facilities, and an independent lab determined this was urine, yet a detailed risk assessment had not been performed (read page 4 of the report here). Ben Venue did, however, eventually filed a report with the local police, but handed them an empty can.
The police examined the stainless-steel mixing vessel, which resembled an old milk jug, but they were unable to find fingerprints and DNA evidence would have been contaminated because the vessel may have been sitting around for up to three months before it was discovered, Bedford Police Detective Lieutenant Kris Nietert tells us. Up to 700 people may have passed through the room, thwarting efforts to do polygraphs. “From our perspective, to invest that kind of time and effort to polygraph that many people is just not worth it,†he says. “…We’re at a dead end.â€
This is quite a reversal of fortunes for Boehringer, although certainly not the only usual problem found at Ben Venue. An FDA inspection report last May noted a leaky roof that was allowing rain water into the facility, stainless steel particles in two products, bacterial contamination in batches of some drugs, mold in manufacturing areas and rusty equipment.
Small wonder that operations were eventually halted, which is cold comfort to the many patients who were prescribed medicines made by Ben Venue for other drugmakers, such as Johnson & Johnson, which is still struggling to find another supplier for its Doxil cancer med. Ben Venue, which is operated by another Boehringer unit called Bedford Laboratories, has accounted for a large degree of the drug shortages nationwide . Meanwhile, the European Medicines Agency has recommended a precautionary recall of two medicines.
