J&J Contract Manufacturer Ben Venue Slammed by FDA For Manufacturing Problems

J&J Contract Manufacturer Ben Venue Slammed by FDA For Manufacturing Problems

December 9th, 2011 // 2:09 pm @

Federal inspectors say the contract manufacturer for Johnson & Johnson’s cancer drug Doxil hasn’t been maintaining equipment or promptly investigating defective product batches and other serious problems at its Bedford, Ohio, factory.

The latest Food and Drug Administration inspection report details lax quality control, failure to follow standard procedures and even lack of follow-up about a container of urine found in the Ben Venue Laboratories Inc. facility, which makes sterile medicines.

Doxil is one of a record 251 medications reported unavailable or in short supply in the U.S. this year, most of them injected drugs crucial for hospital operations. The crisis, blamed on at least 15 deaths, is disrupting patient care and clinical testing of new drugs being compared to or combined with older drugs in short supply.

Short supply

Ben Venue is the sole supplier for Doxil, which has been in short supply since early summer and is no longer available for new patients.

First approved in 1995, Doxil is used to treat ovarian cancer, the bone cancer multiple myeloma and an HIV-related cancer called Kaposi’s sarcoma. Currently, only 2,000 U.S. patients are getting it, and another 2,240 are on a waiting list, according to New Brunswick, N.J.-based J&J.

Ben Venue, part of German drugmaker Boehringer Ingelheim, said three weeks ago that it was temporarily halting manufacture and distribution of products made at the Bedford plant. It cited an internal review indicating that routine maintenance and tests to ensure manufacturing equipment is operating properly “did not occur at the specified time interval and is overdue.”

Ben Venue spokesman Jason Kurtz said Thursday in an email that the company is “working diligently to assess and implement the appropriate corrective actions to address the observations of the FDA investigators.”

“Our highest priority is the delivery of safe and effective products to patients,” he wrote.


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