Published October 26, 2012
Health officials and doctors have tracked down most of the 14,000 people potentially at risk for fungal meningitis, blamed for the deaths of 25 people and sickening 338 — but the outbreak is still posing challenges.
In addition to the new numbers released by the Centers for Disease Control and Prevention (CDC), the Food and Drug Administration released Friday a copy of the Form 483, which was issued to the New England Compounding Center (NECC).
The agency issues a Form 483 at the end of an inspection when investigators believe they may have observed conditions or practices in violation of the Federal Food, Drug, and Cosmetic Act, or other related regulations.
In the report, the agency confirmed contaminated products and listed a number of observations in reference to one of the compounding pharmacies ‘clean rooms' – a sterile space where medications are processed and filled into their final containers.
Investigators said they found bacteria and mold on clean room surfaces. They also found that the NECC had been turning off the air conditioner in the clean room overnight, which is apparently contrary to standard climate control procedures for this type of sensitive area.
Facilities are supposed to maintain strict control of humidity, temperature and cleaning in these rooms.
"One observation was the air conditioning in clean room number one was turned off from 8 p.m. to 5:30 a.m. nightly," said Steven Lynn, director of the FDA's Office of Manufacturing and Product Quality. "Next, the investigators reported that the firm's own environmental monitoring revealed bacteria and mold in multiple locations, including surfaces in their clean rooms, between January and September 2012."
Investigators didn't need a microscope to see contamination inside sealed vials of medication of the steroid methylprednisolone acetate, according to the report.
"It had a greenish-black foreign material and a white filamentous material inside," Lynn said."Microscopic examination of these vials showed the presence of fungus."
Lynn added that investigators also observed leaking boilers and standing water approximately 30 feet from the entrance to the preparation room.
"This room is used to prepare equipment to make the injectable drugs in the clean room," he said.
FDA officials cautioned that a Form 483 does not have legal force, nor is it a final FDA determination of violations. They added their investigation of the NECC is still ongoing.
Massachusetts health regulators said earlier this week that they had turned up evidence of problematic procedures, record-keeping and work conditions inside the pharmacy facility.
Reuters and Fox News' Jonathan Serrie contributed to this article.