FDA: Contamination found at Mass. compounding pharmacy linked to meningitis deaths
SILVER SPRING, Md. — The Food and Drug Administration said it found a number of problems with cleanliness at a compounding pharmacy linked to a meningitis outbreak that has so far sickened hundreds of people and killed two dozen in a report released Friday.
The FDA released a copy of its inspection report of the New England Compounding Center, saying that during an inspection of the pharmacy at the beginning of this month, investigators found contaminated products and problems with the pharmacy's ability to maintain its clean room, an enclosed space designed to have a controlled environment to ensure a sterile environment for drug compounding at the NECC's Framingham, Mass., pharmacy.
The FDA said that the investigators "observed conditions and practices that, in their judgment, may indicate violations of the Federal Food, Drug and Cosmetic Act, or related regulations," but that the report was not a formal determination that the NECC had committed any violations.
These included contamination with mold, bacteria and "foreign matter" in several areas and on equipment in the pharmacy designed to be kept sterile and sanitary. Inspectors found 83 vials of methylprednisolone acetate, the injectable steroid linked to the meningitis outbreak, that contained "greenish black foreign matter," while 17 contained "white filamentous material."
The report also noted a boiler that was leaking water that collected in puddles on the floor, gaps between sliding doors at the transition area between the pharmacy's preparation room and warehouse, and contamination of storage areas for special clothing worn by pharmacy workers, while a mat in the transition area was described as "brown and soiled."
As of Friday, 24 people had died from meningitis linked to contaminated methylprednisolone acetate from the NECC, and 328 have become sick in 18 states, according to the Centers for Disease Control and Prevention.
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