The Massachusetts specialty pharmacy linked to the deadly fungal meningitis outbreak knew it had extensive contamination by mold and bacteria throughout its operations for making sterile drugs but failed to take corrective action, federal health officials said Friday.
In the first nine months of the year, New England Compounding Center’s internal monitoring program showed mold or bacterial contamination at more than 80 locations, including numerous places in its “clean rooms” where sterile drugs are made. In more than half the cases, the company’s own testing showed bacteria and mold above its “action” limits, but there is no evidence that it took action, according to a report issued by the Food and Drug Administration.
The report is based on FDA inspections at the Framingham company after the recall of tainted steroid shots implicated in the outbreak.
The U.S. Centers for Disease Control and Prevention said Friday there were 338 cases, including 25 deaths, in 18 states.