Last June, we reported that a Boehringer Ingelheim division known as Bedford Laboratories, which operates a unit called Ben Venue Laboratories, was having difficulty supplying numerous meds that have appeared on the now infamous FDA list of drugs in short supply (look here). Until then, the drugmaker blamed capacity constraints, but did not publicly acknowledge ongoing quality control problems.

In fact, we learned that inspectors from both the European Medicines Agency and the FDA visited its facilities and cited Ben Venue for various deficiencies at one specific facility that contributed to production slowdowns. A spokesman insisted that the inspections did not cause a change of production capability (back story), although the next month, Ben Venue exited contract manufacturing.

Meanwhile, as we previously reported, the FDA issued a 483 inspection report last May, although a copy has just become available. So what did the inspectors find? The report is partially redacted but contains a laundry list of problems, many of which Ben Venue failed to properly investigate, according to the letter. These included metallic particles or flakes in some medicines, which inspectors suggested came from scrapes on metal doors or window frames; rain water leaking through a ceiling; operators were using gloves that were not sterile and shedding fibrous materials; bacterial contamination in some batches of medicines and mold in classified areas, including manufacturing areas (here is the 483 report).

As you know, drug shortages are worsening and have prompted a host of thorny issues - safety concerns, a thriving gray market, accusations of gouging by distributors and a Congressional investigation (see here, here and here).

And since Ben Venue was also doing contract manufacturing, this has caused a problem for other drugmakers, such as Johnson & Johnson, which used the Boehringer unit to provide its Doxil cancer med, as The Wall Street Journal notes. Of course, J&J did not need any help generating product shortages, thanks to its own manufacturing blunders.

pic thx to joguldi on flickr