The FDA's inspection report, released last Monday, describes thick brown, orange, and green residues on equipment used to make sterile drugs. Insects and even a bird were found hanging around in storage rooms. Despite leaks dripping into the clean room, the inspectors noted, "we observed totes placed in the location of the penetrating leaks containing water. There was no documented evidence that the leaks were permanently corrected."
In addition, the FDA says Ameridose failed to investigate doctor and nurse complaints that suggested their products did not work correctly. A separate FDA investigation four years earlier had also found quality control issues at Ameridose. In 2008, the company had to recall a misformulated painkiller that was too potent.
Unsurprisingly, the meningistis outbreak hasn't been too good for business. Ameridose laid off 650 workers, the Boston Globe reported last week, and another 140 workers at its affiliated marketing company, Medical Sales Management, were also let go.
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