WASHINGTON — Federal health inspectors say staffers at a pharmacy linked to the meningitis outbreak over the past year documented dozens of cases of mold and bacteria growing in rooms that were supposed to be sterile.
The Food and Drug Administration inspectors said that even though the mold and bacterial contamination at the Massachusetts pharmacy exceeded the company’s own safety levels, there is no evidence that the pharmacy investigated or corrected the problem.
The FDA released its preliminary report on conditions at the New England Compounding Center in Framingham, Mass., after inspecting the company earlier this month.
Federal inspectors found a host of potential contaminants in or around rooms that were supposed to be kept sterile, including green and yellow discoloration, water droplets and standing water from a leaking boiler. Many of the findings echo observations reported by state inspectors earlier this week.
Steroid injections made by the New England Compounding Center have been tied to an outbreak of fungal meningitis that has sickened 338 people across the U.S., causing 25 deaths. Last week FDA officials confirmed that the black fungus found in company vials is the same as that which has sickened patients.
Compounding pharmacies prepare their medications in clean rooms, which are supposed to be temperature-controlled and air-filtered to maintain sterility. But FDA inspectors noted that workers at the pharmacy turned off the room’s air conditioning every night.