Last December, a little-known compounding pharmacy recalled all of its products due to “process issues that could lead to a lack of sterility,” according to a statement issued at the time by the U.S. Food and Drug Administration.
Now, the extent of those problems has been made clear after the agency posted a 28-page report by its inspectors, who last fall found a plethora of filthy conditions at a facility run by Edge Pharma, which compounds numerous medicines for hospitals, surgery centers, and clinics for more than a dozen different therapeutic areas including urology, ophthalmology, and neurology.
The unsanitary conditions included ants and spiders around cleanrooms and bins of finished medicines, mold spores in cleanrooms, unknown residue stains on an air return duct above a cleanroom, and an unknown grime on the floors in front of the doors leading to cleanrooms, where the substance could be tracked into sterile areas by employees.
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