For Boehringer, A Pot Of Gold Is Now A Can Of Urine
10 CommentsBy Ed Silverman // December 9th, 2011 // 10:33 am
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.”
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 (here is the report).
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 (see the FDA list here and search for Bedford). Meanwhile, the European Medicines Agency has recommended a precautionary recall of two medicines (see here).
urine pic thx to ajaytallam on flickr
Observer
Was this line from the post an attempt to continue the humor ….
“Up to 700 people may have PASSED through the room,…”
Or are you sitting a fact of the ‘urine gate’ (uh, can?) investigation
MC RPh
If I worked for the FDA I would be pissed that these folks are so lax…
Urine In The Army now
I say, piss on it and be done!
keystone kops
Looks from the story that Ben Venue doesn’t even have a pot to piss in.
dzieczko
How far away were the bathrooms for the workers? Could they make it there and back in time during their break time?
Same problem with facilities for the seasonal labor picking crops (they have to deposit out in th efields so wash your produce well.
Steve Asks
Yes, let’s focus on the bathroom proximity and if there is enough ancillary toilet facilities.
Let priorities such as turning out a viable product, be a distant second consideration.
Mike
Do they do drug testing there? Maybe the urine was a “clean” stash?
Steve Asks
Mike,
Good idea and could open up stand to sell the clean stuff and make a stipend here and there. Second job, sort of!
dzieczko
@Steve Asks “….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….”
Just addressing the “most puzzling mystery”….
You want to get into whether the conditions in which the workers are tying to manufacture a “viable product” matter…?
Steve Asks
D,
I have been involved in the biotech investment aspect for a very long time. Regardless if it is pharma or bio, it’s all the same, an end product. The safety and purity of the products are way beyond any other industry.
Some companies controls look good on paper and a few employees don’t even do what they said they did in their diaries.
Tight regulatory rules, both inside and outside are only as good as the person(s) doing the inspecting.
Reviewing the many Pharmalot stories, the industry is rift with carelessness and indifference. Some are just plain greedy, cutting back and taking chances. It’s sad to see that some just look for the blockbuster crown. It seems money rules in today’s very tenuous environment. The more you cut, the more you save.