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.
