Troubled Boehringer Unit Suspends Manufacturing

Troubled Boehringer Unit Suspends Manufacturing

November 21st, 2011 // 1:31 pm @

Five months after reluctantly acknowledging that quality-control problems had caused severe shortages of several medicines, Ben Venue Laboratories has disclosed plans to “voluntarily and temporarily” suspend production and distribution at its Bedford, Ohio, facility.

“A recent internal review of documentation indicated that routine preventive maintenance and requalification of some manufacturing equipment did not occur at the specified time interval, and is overdue,” the Boehringer Ingelheim unit announced in a statement released over the weekend, when the drugmaker hoped fewer people might notice the bad news.

The move comes just one month after Ben Venue – which supplies various meds to others, such as the Doxil cancer drug sold by Johnson & Johnson – announced it was suspending contract manufacturing operations. That decision has further exacerbated shortages for existing patients and, in some cases, those enrolled in clinical trials (read the letter from J&J to patients).

Prior to our report last June, Ben Venue publicly blamed capacity constraints, but did not acknowledge ongoing quality control problems. However, 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. At the time, a spokesman insisted the inspections did not cause a change in production capability, although Ben Venue later exited contract manufacturing (see here and here).

As we previously reported, the FDA issued a 483 inspection report last May, and inspectors found numerous problems, many of which Ben Venue failed to properly investigate. 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).

Now, Ben Venue is completing a site-wide assessment, although the drugmaker has not indicated how long this may take, so it remains unclear when production may resume. We have a spokesman for clarity and will update you accordingly. This was not the first time, by the way, that Ben Venue ran afoul of FDA standards for manufacturing. A 2007 warning letter noted numerous problems.



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