Staffers at the specialty pharmacy that is linked to the growing meningitis outbreak documented dozens of mold and bacteria cases growing in rooms that were supposed to be sterile, according to the Food and Drug Administration (FDA).
Even when the contamination exceeded the company’s safety levels, the FDA found, there is no evidence that staffers at the New England Compounding Center corrected or investigated the program. The FDA discovered around four dozen reports of possible contamination in company records that stretch back to January.
The findings come from an FDA inspection of the Framingham, Mass.-based company earlier this month after steroid injections created by the specialty pharmacy were tied to an outbreak of fungal meningitis. Currently, there are 344 cases and 25 deaths throughout the country.
A lawyer for the New England Compounding Center announced on Friday that the pharmacy “will review this report and will continue our cooperation with the FDA.”
Inspectors found a host of potential contaminants in or around the pharmacy’s clean rooms, including green and yellow residues, water droplets and standing water from a leaking boiler.
In addition, they uncovered a “greenish yellow discoloration” inside an autoclave, a piece of equipment used to sterilized vials and stoppers. In another room that was reportedly sterile, inspectors found a “dark, hair-like discoloration” along the wall. FDA staff said dust from a nearby recycling facility appeared to be drifting into the pharmacy’s rooftop air-conditioning system.
“The entire pharmacy was an incubator of bacteria and fungus,” said Sarah Sellers, a former FDA officer who left the agency in 2008 after unsuccessfully pushing it to increase regulation of compounding pharmacies. She is now a consultant for drug manufacturers. “The pharmacy knew this through monitoring results, and chose to do nothing.”
The FDA is emphasizing that the report is based on “initial observations.” An investigation is ongoing.
Based on reporting by the Associated Press.