According to the Food and Drug Administration, New England Compounding Center, the pharmaceutical company at the center of the meningitis outbreak, had been warned by internal environmental auditors that the company had a problem with bacterial contamination of its facility.
CNN reported yesterday that, “Mold, and in some cases, an overgrowth of bacteria was detected in different areas of the New England Compounding Center’s two “clean rooms” nearly 90 times since January, the Food and Drug Administration report said.
Clean rooms are intended to be sterile environments in which drugs are produced.
Despite the warnings from its own monitors, the FDA report says the compounding center did not investigate the reports of the contamination nor is there documented evidence it worked to decontaminate the affected areas.
Tainted medications from the compounding center have been blamed for the outbreak of fungal meningitis that has caused 25 deaths and 338 illnesses.”
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