The Ben Venue unit of Boehringer Ingelheim has temporarily suspended drug manufacture and distribution at its Bedford, OH, facility. The voluntary action is expected to further strain supplies of Johnson & Johnson's ($JNJ) cancer treatment Doxil, already in short supply.
Ben Venue said in a statement Saturday that preventive maintenance and the requalification of some manufacturing equipment had been overlooked and were past due. It discovered the oversight while reviewing internal records. The manufacturer now wants to check additional site documentation, and begin whatever corrective actions may be necessary.
FDA officials noted 48 observations--an unusually high count--in a Form 483 report after a May inspection of the Bedford site.
The plant shut-down will likely extend the shortage of Doxil that began in July, leading to missed treatment doses for some patients, according to a Fox News report. In addition, about 2,700 people are on a waiting list for the drug, the report said. The shortage has also caused delays and cancellations of clinical trials that use the drug as part of a combination treatment, or as a comparator.
Ben Venue said it's working with the FDA and is assessing stock and anticipated demand to minimize market impact. The drugmaker announced in August it would exit the contract manufacturing business over the next several years. It plans to turn over the plant to its Bedford Labs unit for the manufacture of generic injectables.
- here's the statement
- see the Fox story