The FDA has released a preliminary report of its investigation of the compounding pharmacy facility owned by New England Compounding Center (NECC), the company whose methylprednisolone acetate has been linked to over 300 cases of fungal meningitis and over 20 deaths. Last week, the FDA confirmed that it found a fungus that has sickened outbreak victims, Exserohilum rostratum, in vials of one of three lots of NECC methylprednisolone acetate implicated in the outbreak.
As part of its investigation of the NECC facility, FDA obtained documents showing that since January of this year, NECC employees have documented findings of mold and bacteria in rooms that were supposed to be sterile environments, including the main “Clean Room”, the “Gown Room”, and the “Prep Room”. The FDA found “no evidence that any corrective actions were taken to prevent contamination of the sterile drug products,” according to the preliminary report.
Attorney Fred Pritzker is representing over 40 patients in several states who were injected with the NECC methylprednisolone acetate implicated in the fungal meningitis outbreak. “New England Compounding Center appears to be a company that disregarded patient safety,” said Pritzker. “The result is the tragic loss of over 20 lives, hundreds of people severely sickened and thousands of patients who have had to have painful spinal taps to determine if they have meningitis.” Pritzker is providing free consultations to all patients who were administered NECC drugs. He filed one of the first meningitis outbreak lawsuits against NECC and is preparing to file several more.
The FDA found a host of other problems at the NECC compounding facility in Framingham, MA. In the facility’s Clean Rooms, FDA inspectors found greenish yellow discoloration in one autoclave, tarnished discoloration and condensation inside another and dark particulate and white filamentous substances behind another autoclave. Autoclaves are used for steam sterilization. Greenish residue and yellowish residue were found on equipment used to weigh active ingredients and other raw materials utilized in the formulation of sterile drug preparations. In addition, inspectors found reddish-brown cloudy substances and dark, hair-like discoloration on metal surfaces used to formulate and fill sterile preparations, including methylprednisolone acetate.
In the Prep Room, some sterilization equipment was tarnished and discolored, a boiler was leaking water into puddles and web floor surfaces around the boiler that appeared to be soiled with thick white debris and thick black granular material.