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16-Sep-2020 02:24

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The New England Compounding Center, the pharmacy connected to a deadly outbreak of fungal meningitis, was already on the radar of federal health inspectors a decade ago, according to congressional investigators.Back then, inspectors had wanted to close the facility down until it cleaned up its operations.That's significant because since the outbreak came to light in late September, public health officials have charged that NECC was operating more as a manufacturer than a pharmacy, shipping thousands of doses of drugs to all 50 states instead of small batches of drugs to individual patients.Manufacturers are regulated by the FDA and are subject to stricter quality standards than pharmacies.Y., hospital who came down with symptoms of bacterial meningitis after receiving a different NECC injection.The steroid, methylprednisolone acetate, is the same injectable linked to the current outbreak and is typically is used to treat back pain. In charges filed in Livingston County Circuit Court by outgoing Michigan Attorney General Bill Schuette, Barry J.

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Less than a year later, the company was cited by the state pharmacy board for providing doctors with blank prescription pads with NECC's information.

Both patients were treated with antibiotics and eventually recovered, according to FDA documents cited by the committee.

When officials from the FDA and Massachusetts Board of Pharmacy visited NECC later in the month, Cadden said vials of the steroid returned by the hospital had tested negative for bacterial contamination.

But during a second day of inspections, Cadden told officials "that he was no longer willing to provide us with any additional records," according to an FDA report cited by congressional investigators.

The inspectors ultimately issued a report citing NECC for poor sterility and record-keeping practices but said that "this FDA investigation could not proceed to any definitive resolution," because of "problems/barriers that were encountered throughout the inspection." *In October of 2002, the FDA received new reports that two patients at a Rochester, N.As of early November 9, 428 patients have been presumed to be diagnosed with fungal meningitis stemming from contaminated steroid shots distributed by New England Compounding Center, and more than 32 deaths have been reported since the outbreak began in September, according to the Centers for Disease Control and Prevention.



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