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.
This program aired on October 26, 2012. The audio for this program is not available.