FDA Finds Serious Problems in Cancer Drug Factory
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. The company did not immediately return messages seeking comment.
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.
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