FDA reports shocking findings at facility implicated in fungal meningitis cases
As the number of cases and deaths from contaminated steroid vials produced by the New England Compounding Center (NECC) continue to mount, the Food and Drug Administration (FDA) released a disturbing report regarding the sanitation of the NECC clean rooms. To date, 338 people have been sickened and 25 have died after receiving a methylprednisolone acetate injection prepared by NECC.
In addition to the new tallies released by the Centers for Disease Control and Prevention (CDC), the FDA released a copy of the Form 483, which was issued to the NECC. The FDA 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 inspectors confirmed contaminated products and listed a number of observations in reference to one of the compounding pharmacies clean rooms. Clean rooms are sterile areas where medications are processed and filled into their final containers under strict hygienic guidelines.
The investigators reported that they found bacteria and mold on clean room surfaces. In addition, they found out that the compounding center been turning off the air conditioner in the clean room overnight, which is contrary to standard climate control procedures for this type of sensitive area. In addition to scrupulous cleanliness, clean rooms should maintain strict control of humidity and temperature. “One observation was the air conditioning in clean room number one was turned off from 8 p.m. to 5:30 a.m. nightly,” noted Steven Lynn, director of the FDA's Office of Manufacturing and Product Quality. He added, “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.”
A microscope was not needed for the investigators to spot the contamination inside sealed steroid vials. Lynn noted, “It had a greenish-black foreign material and a white filamentous material inside. Microscopic examination of these vials showed the presence of fungus.” He added that investigators also observed leaking boilers and standing water approximately 30 feet from the entrance to the preparation room. He explained, “This room is used to prepare equipment to make the injectable drugs in the clean room.”
FDA officials cautioned that a Form 483 does not have legal force; furthermore, it is not a final FDA determination of violations. They added the investigation of NECC is still ongoing. Earlier this week, Massachusetts health regulators said that they had turned up evidence of problematic procedures, record-keeping and work conditions inside the facility.