Mold, bacteria found at factory tied to meningitis outbreak
The outbreak of fungal meningitis has been traced to the New England Compounding Center in Framingham, Massachusetts.
Mold and bacteria has been found at the factory in Massachusetts linked to the deadly meningitis outbreak in the United States.
A Food and Drug Administration investigation found "greenish black foreign matter" in 83 vials of the steroid used to treat back pain and "white filamentous material" in 17 others produced by the New England Compounding Center, as the death toll rose to 25 on Friday, the Boston Globe reported.
The FDA also found that NECC did not properly test the steroid, sending out just one vial from their entire shipment for testing, though under national regulations a minimum of 20 vials should be tested, the Globe reported. The FDA tested 50 vials and found them all contaminated.
The probe, along with a report by Massachusetts investigators released Tuesday, also found that the surfaces in the company's clean rooms were contaminated with bacteria and mold that were visible to the naked eye, and far beyond the company's regulations, the New York Times reported.
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However, there was no evidence that the company had taken steps to remedy the safety issues at their plant in Framingham, Mass.
"Manufacturers and compounding firms know what to do," Paul Teitell, of the FDA's office of regulatory affairs, said in a conference call, Agence France Presse reported. "They have the responsibility to manufacture quality drugs and to have processes in place to make sure there's no breakdown in the supply or processes that would cause contamination."
The compounding center halted its operations and recalled its products October 3 after regulators found a link between one of its steroids and the meningitis outbreak, Bloomberg Businessweek reported. 14,000 people reportedly received shots of the steroid into their back; an additional 338 people were sickened from the infected injections.
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