FDA: ‘Greenish Black’ Matter In Steroid Vials, Mold In NECC ‘Clean Rooms’
BOSTON — Federal inspectors found “greenish black” matter in 83 vials returned to the Framingham pharmacy linked to the nationwide meningitis outbreak — vials from the same batch of steroids that have now killed 25 people in 18 states.
The FDA’s observations build on findings from state inspectors released Tuesday. The raw materials used to mix steroids were not sterile and inspectors say New England Compounding Center had no required proof that its sterilizing procedures were effective.
In addition, the FDA found mold and bacteria on surfaces and in air samples of two so-called “clean rooms” where NECC pharmacists produced numerous drugs.
The FDA’s report (PDF) mentions that NECC turned off its air conditioning overnight and that the rooftop units of that system are about 100 feet from a recycling facility that produces a lot of dust.
But the report does not reach any conclusion about the source of fungus in tainted steroids that continues to make patients sick.
Update at 5:30 p.m.: The New England Compounding Center has released this statement:
We received the Food and Drug Administration’s Form 483 earlier today. We will review this report and will continue our cooperation with the FDA. We will follow the existing regulatory process and provide our comments to the FDA after we have had adequate time for a complete review of the report.