According to the agency’s report, the pharmacy began shipping vials from the August lot to customers on Aug. 17.
That was nearly two weeks before the pharmacy received test results from an outside laboratory confirming the sterility of the drug. When FDA scientists went back and tested the same lot this month, they found contamination in 50 vials.
Outside experts said the report paints a picture of a dysfunctional operation.
“The entire pharmacy was an incubator of bacteria and fungus,” said Sarah Sellers, a former FDA officer who left the agency in 2008 after unsuccessfully pushing it to increase regulation of compounding pharmacies. She now consults for drug manufacturers.
“The pharmacy knew this through monitoring results, and chose to do nothing,” she said.
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