FDA inspections reveal roots of fungal meningitis outbreak

Investigation of NECC, Ameridose facilities uncovers unsanitary practices, contaminated vials

With hundreds of fungal meningitis infections and dozens of deaths caused by contaminated methylprednisolone manufactured at the New England Compounding Center (NECC), patients and health professionals alike are wondering how this could have happened. Recently released reports documenting FDA’s inspections of NECC and allied company Ameridose have shed some light on the question.

FDA conducted an inspection of the NECC facility over 7 days in October, releasing its report last month. The agency’s inspectors reported observing “what appeared to be greenish black foreign matter” in about 83 vials out of a bin containing 321 vials of methylprednisolone from one of the lots shipped to patients in August and September and later recalled in response to the fungal meningitis outbreak. An additional 17 vials were observed to contain “white filamentous material.”

The FDA inspectors also attempted to confirm NECC’s claim of sterility in this lot. NECC had reported a sterile test result from a vial of bulk-formulated methylprednisolone from the lot in August. The agency collected 50 vials of methylprednisolone 80 mg/mL and confirmed the presence of viable microbial growth in every one. “Fungal morphological features” were also observed in one vial.

Through its inspection, FDA also found that NECC shuts off their clean room air conditioning systems at night. Inspectors noted numerous discolorations and residues on various devices and surfaces in the NECC facility, including autoclaves, hoods, walls, and floors.

Over 10 days in October and an additional 4 days in November, FDA also inspected the facilities of Ameridose, which shares ownership with NECC. All of Ameridose’s products were recalled on October 31.

According to inspectors, the Ameridose facility featured walls that were “cracked, corroded, and covered with what appeared to be adhesive material”; multiple hoods for sterile drug preparation with “thick residues that were orange, brown, and green in coloration”; and insects and birds in areas where sterile products were packaged and stored.

Reports from inspections of both facilities are available online at http://apha.us/TeuB9W and http://apha.us/RRKDFp.

The outbreak of fungal meningitis has claimed 34 lives, according to CDC reports. In addition, 478 cases of fungal meningitis, as well as 12 peripheral joint infections, caused by contaminated injections have been confirmed by the agency.