Boehringer Ingelheim

Ingelheim, Germany
5 Class I recalls

The Boehringer Ingelheim plant in Bedford, OH, that was the source of so many problems for the German company is now closed. The contract manufacturing business Boehringer ran from it is gone and last year Boehringer sold off its own Ben Venue line of sterile injectable drugs, and the idle facility, to Jordan's Hikma. But when it was running, the Bedford plant was at the center of huge manufacturing and recall issues.

The site, the largest sterile injectable operation in the U.S., received a warning letter way back in 2007 for sterility issued tied to the manufacturing of anesthesia propofol. It racked up 40 product recalls between 2002 and 2011, when it voluntarily closed after an FDA inspection had so many issues for it to resolve that it made operating and remediation impossible. A 33-page Form 483 listed 48 infractions that included bacterial contamination in some batches of medicines, metal particles in some drugs and mold in some areas. There was a leaky roof and in a storage area a 10-gallon bucket of urine was discovered.

The problem with closing the plant was that Boehringer was the key manufacturer for so many drugs that it led to more than 80 drug shortages. That included shortages of cancer drugs used for treating children and Johnson & Johnson's ($JNJ) ovarian cancer drug Doxil, as well as drugs made by Pfizer ($PFE), Takeda and Bristol-Myers Squibb ($BMY). When the company in 2013 signed a consent decree with the FDA and Justice Department, it was allowed to keep manufacturing more than 100 drugs that were considered essential and the FDA didn't want to exacerbate an already bad situation.

But that year, after already having invested $350 million in upgrades, Boehringer Ingelheim decided it was not worth continuing to pour money into the site. It estimated the facility was facing $700 million in operating losses over the next 5 years. Instead it closed the plant and laid off the remaining 1,100 workers. Last year it sold the facility, along with its Ben Venue sterile drug business, to Hikma in a deal worth up to $300 million.

But even after it was closed, the plant's problems lingered for Boehringer Ingelheim. In February 2014, it had a Class I recall of a lot of acetylcysteine solution after a report of a single visible glass particle in a vial. Acetylcysteine solution is used as a treatment in conditions like chronic emphysema and chronic asthmatic bronchitis and so is delivered via direct instillation into a tracheostomy, or into the bronchial-pulmonary tree during bronchoscopy. That means any glass particles in the solution posed a risk of choking or infection.

Its 5 Class I recalls included two for acetylcysteine solution, and one each of cytarabine, vecuronium bromide and leucovorin calcium Injection. And then in late 2013, just at the plant was closing, it recalled all the rest of its Ben Venue sterile products from the market.

-- Eric Palmer (email | Twitter)

For more:
Ben Venue plant may be closed but it is still recalling products
Boehringer Ingelheim plant has become a money pit
Boehringer Ingelheim gives up on troubled Ben Venue plant, laying off 1,100
Ben Venue Bedford plant still missing GMP standards
Ben Venue consent decree softened to account for drug shortages
Boehringer Ingelheim handed FDA warning letter

Boehringer Ingelheim