FDA Meningitis Outbreak Investigation - Consumer Justice Foundation

FDA Meningitis Outbreak Investigation

Written by Faith Anderson on October 29, 2012
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Contaminants Found in NECC Clean Rooms

The FDA findings come from the agency’s inspection of the Massachusetts-based company earlier this month, after tainted steroid injections mixed by the pharmacy were linked to an outbreak of meningitis across the country. FDA inspectors found a host of potential contaminants in or around the NECC’s clean rooms, including yellow and green residues, water droplets and standing water from a leaking boiler. The agency also uncovered a “greenish yellow discoloration” inside an autoclave, which is a piece of equipment used to sterilize vials and stoppers. In another room that should have been sterile, inspectors found a “dark, hair-like discoloration” along the wall. According to FDA staff, dust from a nearby recycling facility appeared to be drifting into the pharmacy’s rooftop air-conditioning system.

FDA Accused of Inadequate Regulation

“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 the FDA to increase regulation of compounding pharmacies like NECC. “The pharmacy knew this through monitoring results, and chose to do nothing.” In addition to concerns about the NECC’s lack of action, the FDA has also come under fire in the midst of the meningitis crisis for failure to adequately regulate compounding pharmacies, which are designed to provide specialized medications for local patients with prescriptions. NECC however, was operating on a nationwide basis, engaging in large-scale drug manufacturing for the general public, without its medications being regulated or approved by the FDA.

Contact a Meningitis Outbreak Lawyer for Help

The fungal meningitis outbreak has been connected to an epidural steroid injection mixed by NECC, which was administered to as many as 14,000 people in many different states throughout the country. Because of the long incubation period of fungal meningitis, the current number of meningitis diagnoses and deaths is expected to grow throughout the next month or so. If you believe you may have been exposed to fungal meningitis from a tainted steroid injection, our consumer advocates at the Consumer Justice Foundation can help put you in touch with an experienced meningitis outbreak attorney in your area.

Posted Under: FDA - Food and Drug Administration
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