BOSTON – State officials investigating a pharmacy linked to a deadly outbreak of meningitis said Tuesday they found shoddy sterilization practices and unclean conditions there, including debris-covered floor mats and standing water from a leaking boiler.
State officials also said the New England Compounding Center shipped steroids from the possibly contaminated batches suspected in the outbreak before it received its own test results confirming the drugs were sterile.
Gov. Deval Patrick said he’s ordered state pharmacy regulators to conduct surprise inspections – the first of which happened Tuesday – at companies similar to the NECC and take other steps to tighten oversight. The state also has moved to revoke the company’s operating license and the licenses of its top three pharmacists.
“Those whose laboratory practices caused this outbreak should never practice pharmacy or manufacture in Massachusetts again,” Patrick said.
The outbreak of fungal meningitis, an inflammation of the lining of the brain and spinal cord, has sickened 308 people, including 23 who have died, in 17 states. The outbreak has been linked to a steroid made by the NECC and taken mainly for back pain.
The federal government is conducting a criminal investigation.
Dr. Madeleine Biondolillo, director of the state Department of Public Health’s Bureau of Healthcare Safety, detailed signs of flawed sterilization procedures, including black specks of fungus in sealed vials of the steroids, which were returned to the company during a recall.
Investigators found the company didn’t sterilize its products long enough and didn’t adequately test whether its sterilization equipment was working, she said.
None of what’s been found is enough to definitively determine what caused the contamination, and the investigation is ongoing, Biondolillo said.
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