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FDA finds potentially dangerous drug issues at Floriday specialty pharmacy

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By The Washington Post

Published: Thursday, April 11, 2013, 10:00 p.m.

Months after tainted steroid shots made by a Massachusetts specialty pharmacy triggered the worst drug disaster in decades, federal inspectors have found dozens of potentially dangerous safety problems at about 30 other specialty pharmacies, known as compounders.

Among the lapses discovered by Food and Drug Administration inspectors were “black particles of unknown origin” in seven vials of a sterile injectable steroid at a Florida company. Elsewhere, they found rust and mold in “clean rooms,” inadequate microbial testing, even tears in gloves worn by technicians — all practices that create the risk of possible deadly contamination.

An FDA spokesman said the investigation of the Florida pharmacy is ongoing and that officials do not know what the black particles are.

The inspections, which were conducted between February and April, marked the first time that the FDA targeted compounders since inspectors found filthy conditions at the Massachusetts pharmacy at the heart of the fungal meningitis outbreak. The “priority inspections” were aimed at compounders who make high-risk sterile products, a key segment of the multibillion-dollar compounding industry that has fallen between the regulatory cracks.

Last fall, the FDA found “greenish black foreign matter” in vials of steroid shots at NECC that was later determined to be a culprit in the outbreak that has killed 53 people and sickened 680 others.

FDA officials say the problems highlight continuing sterility failures at compounding pharmacies despite months of stepped-up scrutiny from state and federal regulators and consumer groups.

 

 
 


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