Conditions at the New England Compounding Center were practically filthy, according to the report the FDA issued to the now-closed pharmacy. The FDA observed and has since confirmed contaminated products and listed a number of observations regarding conditions in the clean-room at NECC's Framingham, Mass., facility. Among the agency's observations:
- Vials of preservative-free methylprednisolone acetate contained "greenish black foreign matter" or "filamentous material."
- Formula worksheets stated that raw materials were sterile but the pharmacy director "stated that the firm uses non-sterile active pharmaceutical ingredients and raw materials, with the exception of sterile water for injection, to formulate injectable suspensions."
- The interior chamber of an autoclave used for the steam sterilization of formulated bulk drug suspensions the final sterilization step for formulations such as preservative-free methylprednisolone and triamcinolone appeared to be tarnished and discolored.
- "Greenish yellow discoloration" lined the interior surface of the viewing lens of another autoclave, used for sterilizing components and equipment used in formulating sterile drug products.
- Yellow residue lined the rear return of a weigh station hood, where active ingredients and other raw materials were measured, and greenish residue was found on another.
- A boiler within 30 feet of the entrance to the prep room was leaking water into puddles, and the floor "appeared to be soiled with thick white debris and thick black, granular material."
Thirty people have died and 419 have been sickened so far in the fungal meningitis outbreak.
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