An attention-getting read in today's Pharmalot illuminates the reasons why a division of Boehringer Ingelheim, the Bedford Laboratories unit Ben Venue Laboratories, was contending with what it classified as "capacity constraints". The reasons were tied to quality control:
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 . . . the FDA issued a 483 inspection report last May . . . [that] contains a laundry list of problems, many of which Ben Venue failed to properly investigate . . .
The takeaway? With the shortage and price constraints it will be harder and harder for manufacturers to keep up with quality standards. This should be apparent throughout the industry: You can't cut corners where quality of medicine is concerned.
