October 26, 2012 — According to a public report, inspectors from the U.S. Food and Drug Administration (FDA) have found visible mold in medicine from New England Compounding Center (NECC). The compounding pharmacy has been linked to a nationwide outbreak of fungal meningitis and joint infections, which have sickened more than 300 people and caused at least 25 deaths.
The “greenish black foreign matter” was found in approximately 83 vials in a bin containing 321 vials of methylprednisolone acetate, an injectable steroid shot used to treat back pain. Another 17 vials from the same lot contained “white filamentous material.”
The FDA also found viable microbial growth in 50/50 vials tested for sterility in one lot of methylprednisolone acetate. However, the NECC sterility report for that lot found that the sample was sterile.
Employees for NECC reported that the air-conditioning system for the clean room was shut off every night from 8:00 pm to 5:30 am. Without air-conditioning at night, the temperature and humidity of the clean room is not controlled, which could allow bacteria and molds to grow. It could also allow negative-air flow into the clean room from outside, potentially introducing contaminants into the room.
The FDA report listed dozens of locations where mold, bacteria, and hairs were discovered in the facility — including dark particulate matter, white filamentous substances, yellow reside, greenish residue, reddish-brown and cloudy substances, and a hair-like discoloration. A boiler installed within 30 feet of a prep room was leaking water into puddles, and wet floors around the boiler were visibly soiled with “thick white debris and thick, black granular matter.”
The report also described several problems with the company’s autoclave, which is a machine that uses steam and high pressure to sterilize equipment. On the autoclave used in the final sterilization step for methylprednisolone acetate and triamcinolone, there was condensation and tarnished discoloration. On the autoclave used to sterilize equipment, the investigators found “greenish yellow discoloration lining the interior surface.”
Another issue was the pharmacy’s location adjacent to a recycling facility that handles materials including mattresses and plastics. Large equipment such as excavators and freight trucks were producing airborne dust particles approximately 100 feet from the pharmacy’s rooftop HVAC system.