On October 26, 2012, the FDA released its inspection report of the New England Compound Center, the facility responsible for the production of the recalled steroid injection that caused the recent meningitis outbreak. The report details a frighteningly dirty environment where this recalled compounded drug was produced. Namely, the FDA found several types of bacteria, mold, fungus, and even human hair out in the open where the compounded drugs were being produced. Much of the fungus was found within the drug itself. The report also noted that the staff working at NECC stated that the air conditioning within the “clean room” was shut off entirely every night, further increasing the likelihood of contamination. A clean room is an enclosed room designed to have a controlled interior environment so as to prevent airborne particles and surface contamination. Shutting off air-conditioning, while economical for NECC, is not recommended for clean rooms.
This report detailed months of these filthy conditions and notes that each and every time the amount of mold and bacteria exceeded healthy levels; there was zero evidence the NECC ever attempted to correct or remove the contamination. More troubling was the amount of contamination and fungal residue found within the areas used to sterilize equipment used in drug production.
Not only were the sterile areas unsanitary, but several other areas of NECC were dirty as well. For example, the HVAC system, located 100 feet from a dusty recycling plant, was covered with “dark particulate and white, filamentous substances.” Additionally, the report found a leaking boiler, a soiled floor mat, and residue on several of the interior areas including a ledge and a wall.
The full NECC report has not been completed and the FDA is still in the process of determining what actions, if any, it will take against NECC.
With the release of this shocking report, it is important to remember that NECC is just one of many drug compounding facilities across the United States, including some in Illinois. NECC, and other drug compounding facilities like it, must be held to a high standard of care and such negligence cannot go unpunished. Our lawyers to monitor and investigate the legal issues involved in this case. If you or someone you know has possibly been infected with meningitis due to NECC’s negligence, please consider reaching out to the meningitis outbreak and product liability attorneys at our firm who can protect your legal rights and ensure that justice will be done.