A bucket of urine: the story of a sterile injections plant
All fixed now, thank goodness. Yay
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 wor…
