The Very Bad 483 Report From New England Compounding
October 30th, 2012 // 5:00 pm @ jmpickett
The compounding pharmacy in Massachusetts that has been at the center of an alarming meningitis outbreak had ‘greenish-black foreign matter’ on sterilization equipment and regularly turned off air conditioning each night, despite the need to control temperature in the so-called clean rooms where medications were made and stored, according to the FDA [PLEASE SEE EDITOR’S NOTE*].
The details were among dozens of findings that were contained in a so-called 483 inspection report released late last week by the agency, which has been widely criticized for not taking action against the New England Compounding Center sooner, despite having issued a 2006 warning letter and lingering debate over the extent of its regulatory authority.
Last week, Public Citizen called for the FDA to be investigated (see this), arguing that the agency could – and should – have pursued an enforcement action against the NECC over its practices. And Congress is expected to hold hearings next year.
Unlike the conventional notion of a compounding pharmacy, the NECC had for years been making and distributing large amounts of medications that were sold to hundreds of hospitals and physicians across the country. Its operations, some argue, constituted the sort of large-scale production that would have allowed the FDA to exercise oversight.
Responding to the controversy and what has become one of the worst scandals over domestic drug production in many years – so far, 25 people have died – the FDA inspected the NECC facility in Framingham, Massachusetts, several times over the past month and found mold and bacteria in dozens of places in a pair of clean rooms.
Significantly, FDA inspectors found that 83 of 321 vials from one lot linked to the meningitis outbreak contained “greenish black foreign matter†and another 17 vials had “white filamentous material,†the report stated. The NECC tested one sample from the lot, which was sterile, but the FDA tested 50 vials from the same lot and found microbial growth.
Meanwhile, the inspectors also found a boiler located within 30 feet of the entrance to a prep room that was leaking water into puddles, and wet floor surfaces were soiled with black debris. And there was mold and bacteria on windowsills, sink benches and in mask and glove bins; “reddish-brown and cloudy substances†on a metal ledge; and “dark, hair-like discoloration†a gasket and crevices in one room.
Yet, the NECC did not investigate any location where levels exceeded “action limits†and “no documented corrective actions were taken to remove microbial contamination from the facility,†according to the report. “Think of a plant just growing out of control,†Steven Lynn, director of the FDA Office of Manufacturing and Product Quality, during a teleconference with the media.
The inspection report also noted that NECC is located near a recycling plant. In fact, both share the same address and one of the owners of the compounding pharmacy, Greg Conigliaro, runs the recycler, Conigliaro Industries. The report mentioned rooftop units for NECC air-conditioning system were located about 100 feet away from where trucks and excavators move mattresses and plastics.
