Health, safety lapses in lab tied to fungal meningitis outbreakReprints
Investigators found “serious health and safety deficiencies” at the compound pharmaceutical lab tied to the fungal meningitis outbreak, according to a preliminary report released Monday.
Tacky mats used to trap dirt and other contaminants from workers’ shoes prior to entering a clean room “were visibly soiled with assorted debris,” according to the report from Massachusetts’ Executive Office of Health and Human Services.
Investigators from the Massachusetts Department of Public Health also found a leaky boiler adjacent to the clean room with a pool of water creating unsanitary conditions inside the Framingham, Mass.-based New England Compounding Center. Culture results from that potential contaminant are still pending, the report states.
Investigators also reported the compounding center distributed large batches of products in bulk, which was not allowed under the terms of its pharmacy license.
“If NEC was appropriately licensed as a manufacturer with the (Food and Drug Administration) the company would have been subject to additional levels of scrutiny,” the report states.
As of Tuesday, the Centers for Disease Control and Prevention reported 317 meningitis cases across several states, including 24 deaths.
Investigators who inspected the NECC facility found several other problematic conditions.
“Powder hoods, intended to protect pharmacists from inhaling substances during medication preparation, within the sterile compounding area were not thoroughly cleaned,” the report states. Residual powder observed within the hood may also have led to contamination of compounded medications, the report says.