Boehringer Ingelheim To Close Troubled Ben Venue Unit For Good

REPEATING FROM LAST NIGHT: More than two years after Ben Venue Laboratories began encountering serious quality control issues that resulted in numerous product shortages, the troubled manufacturer is closing down permanently by the end of the year. The move comes less than a year after Ben Venue, which is owned Boehringer Ingelheim, a large, privately held drugmaker, entered into a consent decree with the FDA. “Despite the ongoing support of the US FDA, the tremendous dedication of employees and significant investments in facility upgrades, the company cannot return to sustainable production,” according to a statement sent to us. “Although interim controls implemented to assure product quality have been effective to date, in the long term, they are not sustainable.” The drugmaker project losses of about $750 million over the next five years on top of $350 million spent on remediation. About 1,100 employees are expected to lose their jobs. The decision caps a three-year slide in which Ben Venue became something of a poster child for drugmakers with serious manufacturing problems. Despite dozens of inspections, a warning letter and numerous conferences with regulatory officials, Ben Venue repeatedly failed to comply with manufacturing regulations and, at one point, blamed capacity constraints for its problems (see this). Along the way, Ben Venue gained notoriety when a 10-gallon can containing urine was found in a storage area in one of its facilities, prompting a polic...
Source: Pharmalot - Category: Pharma Commentators Authors: Source Type: blogs