A bucket of urine: the story of a sterile injections plant

All fixed now, thank goodness. Yay

Boehringer Ingelheim headquarters in Ingelheim, Germany

Do you remember how in 2013, the biopharmaceutical giant Boehringer Ingelheim closed its sterile injectables plant in Bedford, OH, “which may be forever remembered for the bucket of urine that FDA inspectors found in the production area” in 2011? At the time of closing, the company laid off 1,100 employees. (Big thanks to the reader who brought that story up in comments a couple of weeks ago.)

The company said [in 2013] that interim steps to maintain quality have been effective [← I am sure], but given the age of the plant, the ‘magnitude of continued investment and time required to overcome the systemic manufacturing challenges is not viable.’ It said it had already spent $350 million on upgrades but projected $700 million in operating losses over the next 5 years to keep it open. It had previously said it would close the older parts of the facility, which is operated by its Ben Venue Laboratories unit, and lay off about 400 workers at the end of the year.

While the company had entered into a consent decree with the FDA this year to insure improvements at the plant, it was allowed to continue to manufacture about 100 essential drugs, like Johnson & Johnson's ($JNJ) ovarian cancer drug Doxil. J&J has been struggling to overcome shortages of Doxil since the contract manufacturing facility ran into issues with the FDA and had to be closed temporarily in 2011. J&J hinted at what was coming with the facility earlier this month when it notified doctors that new shortages of Doxil would start in mid-October. J&J said it was attempting to get new producers qualified by the FDA but in court filings said it would be the end of next year before that happens. J&J has sued Ben Venue over the problems.

This is the FDA record reflecting the “bucket of urine” (SOURCE):

In 2014, the facility was acquired by Hikma for 300 million, allegedly with glorious plans. In 2014, Hikma sold most of it to Xellia Pharmaceuticals, allegedly with equally glorious plans.

Xellia said it is getting substantial parts of the site, including the new manufacturing units for sterile injectables, which are not currently operational. Xellia says it will work closely with the FDA as it prepares the plant to manufacture again.

The FDA is very familiar with the plant, which operated under a court-ordered consent decree issued in 2013, two years after FDA citations led Boehringer Ingelheim to voluntarily close the facility to make improvements that would resolve problems there. By that point, the contract facility had issued more than 40 recalls in 9 years and the FDA had outlined a long list of issues which left its sterile drugs open to contamination, including finding a 10-gallon container of urine in a storage facility, ostensibly used by employees to avoid bathroom breaks.

In 2021, the city of Bedford expressed its excitement over the fact that the Xellia facility was now fully operational, with 300 employees on board.

As of December 2023, Xellia Pharmaceuticals is planning to lay off about 80 employees at the facility in early 2024.

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Meanwhile, the notorious bucket of urine or not, the original owner of the pharmaceutical plant, Boehringer Ingelheim is doing fine. This summer, Boehringer Ingelheim Venture Fund has invested in building a novel platform based on engineered enzymes from bacteria-killing viruses (bacteriophages) as a new way to tackle antimicrobial resistant (AMR) bacterial infections.

In the language of a five-year-old, all this “precision” business stands for “farming” a bunch of genetically edited microbes who are modified to produce the largest possible amount of the target molecule. This technology is getting increasingly dominant due to its being more “cost-effective” that the traditional methods , and it’s used for the production of proteins, enzymes, fake foods, etc.

Everyone’s hope is that all this microbial goo is then getting properly separated and purified—but hope is one thing, reality is another. I have recently written about David Stonebrook’s 2021 lawsuit alleging that the very buffers used to purify the proteins for the mRNA COVID vaccines were packaged in a room full of mold. How pure is the protein purified with a moldy buffer? Call me a skeptic but I am not sure it’s pure.

(Here is my Dr. Mercola article on precision fermentation.)

And here’s from the horse’s mouth:

All eyes on the traditional bugs: shifting the focus to (unfortunately real) non-viral infections

Please heed my prediction, this is a trend that is likely to impact our lives. We are going to hear more and more about “traditional” and novel non-viral infections (bacterial, fungal, parasitic, etc.)

I believe the myth of western cleanliness is going the way of the dinosaurs. I don’t mind that particular myth going the way of the dinosaurs because it deserves it—but the tragic part is the cynicism of the mob. The “investor” mafia gets to profit on every end of their game. The infections are not imaginary, however, the man-eating machine has no shame and no heart.

I have written about this many times in many ways but here is the gist:

First, the people with a particularly strong urge to dominate the world made an effort to “speed things up,” automate their domination operations as much as possible, and use various chemicals to poison any obstacles out of the way of their power and bottom line (which unfortunately meant confusing the minds and poisoning nature, people, plants, animals, soil, air, water, attacking our microbiome, and ultimately nuking people’s natural health and making people dependent on various lucrative pills.)

At the same time, the movers and the shakers came up with a financially brilliant idea of creating a cradle-to-grave conveyor of “vaccines.” The manufacturers never ever bothered to test them properly, or monitor their quality responsibly, the vaccines are made poorly, they are filled with toxins and contaminated as hell. But so what. From the mafia perspective, so what.

And now that a lot of people aren’t feeling so well, they are profiting on this end of the scam as they say, “Oh my, we got a new market opportunity threat on other hands, line up for more yummy pills and vaccines!” (And yes, there may be honest people working on the ground level of the scam but on a higher level, it is still a mafia scam.)

The well of their cruelty and cynicism seems to be a bottomless well.

The Myth of Progress

Grand Theory of COVID and Vaccine Injury

Not Just Plasmids: Biological Contamination of Vaccines

When No One Can Work, What Will We Do?

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