Companies: Boehringer Ingelheim, Ben Venue Laboratories
Plant: Bedford, OH
The problems uncovered at the Ben Venue plant are extensive but the crux of this one is the widespread fallout because it was the primary source of some crucial pharmaceuticals, like Johnson & Johnson's ovarian cancer drug Doxil, and methotrexate, which is used in the treatment of childhood leukemia. Ben Venue has left its clients and the FDA scrambling to find alternatives, like allowing the temporary importation of a non-FDA approved drug from India for patients who had been taking Doxil.
The plant shut down in December and at last report does not expect to be fully operational until the end of this year, so shortages of drugs for which it was the key supplier may last for some time yet.
There was no warning letter issued, ostensibly because the company voluntarily shut the plant down to make upgrades, but the 11-page inspection report includes problems that range from more than 100 instances of overdue maintenance, to media fill issues that could lead to contamination, to metal particles found in some products, to the discovery of a 10-gallon can that appeared to contain urine. And the list goes on, all amounting to significant problems at a plant that is making a large number of critical drugs that require sterility. In fact, the problems there were so severe, Canada banned 17 drugs from the facility.