28 October, 2012
The New England Compounding Center (AFP Photo / Jared Wickerham)
The compounding pharmacy responsible for mixing the drugs that caused the deadly meningitis outbreak was found to have ignored Food and Drug Administration regulations, containing mold and bacteria on its equipment.
A federal inspection of the New England Compounding Center found that the tainted steroid medication had been mixed with sterilization equipment containing greenish-yellow residue. Additionally, the surfaces where the drugs were created contained mold and bacteria, and the air-conditioning had been turned off nightly – even though cold temperatures and low humidity is necessary to maintain cleanliness.
The sanitation problem has been present for months. When the NECC discovered mold in its production areas in January, it did nothing to change it. The company also found mold in its “clean” rooms 79 times between January and September, the FDA said in its report.
“The entire pharmacy was an incubator of bacteria and fungus,” Sarah Sellers, a former FDA officer, told The Tennessean. “The pharmacy knew this through monitoring results and chose to do nothing.”
Inspectors have also found that 83 of 321 steroid drug vials it examined contained “greenish black foreign matter,” and 17 others had “white filamentous material.”
When the FDA tested another group of 50 vials, it found that all contained microbial growth.
But experts told the New York Times that their biggest worry was the dirty surfaces in rooms that were meant to be clean. Some of the petri dishes left in the compounding center were overgrown with bacteria.
“Think of a plant just growing out of control,” director of the Office of Manufacturing and Product Quality Steven Lynn told the Times.
A consultant on sanitary issues in pharmacies said this was the worst case of bacterial overgrowth she had seen in 45 years.
“The investigators also observed problems with NECC’s ability to maintain its clean room, which is the enclosed space that is designed and maintained to have a controlled environment with low levels of airborne particles and surface contamination,” the FDA wrote in a press release Friday.
The administration also expressed concern about the company’s proximity to a recycling plant, which may have spread dust to the pharmacy. In 2004, the Massachusetts Department of Environmental Protection received a complaint that the recycling center was producing a “gray plume, airborne and falling like a snowstorm.”
The FDA said all of these conditions likely violated their regulations, but it has not yet made final determinations on what counts as a violation.
In its turn, the agency has been scrutinized for conducting its inspections too late. Public Citizen, a nonprofit organization that advocates for public safety, has called for an independent investigation because of the FDA’s slow approach to the sanitation matter. Even though mold was found at least 79 times in the NECC’s “clean rooms” in a nine-month period, the agency did not investigate.
“An independent investigation must be conducted and should identify all agency officials whose actions and decisions contributed to the FDA’s failure to prevent this public health catastrophe,” said Dr. Michael Carome, deputy director of the nonprofit group, as quoted by the Tennessean.
The compounding center, which is responsible for infecting 337 patients with meningitis, 25 of which have died, provided steroid injections for some of the most highly regarded hospitals across the US. Hospitals linked to Harvard, Yale and the Mayo Clinic were among those who used NECC-produced medicine. The Center for Disease Control and Prevention has estimated that up to 14,000 people are at risk of acquiring the potentially fatal illness.