Water dripping from leaks, bugs, and a flying bird are just a few of the troubling things discovered in an FDA inspection of Ameridose’s sterile drug manufacturing facility, which has been shut down since October 10 after its sister company, the New England Compounding Center (NECC), was implicated in the meningistis outbreak that has since killed 32 people. (Read our explainer to get up to speed on the outbreak.) Ameridose and NECC are both owned by the members of the Conigliaro familiy of Massachusetts.
Investigations in the wake of the meningistis outbreak revealed sterility problems at the NECC facility that made the tainted steroid injections. As scrutiny turned to its larger sister company, Ameridose followed NECC in shutting down production and recalling all of its products.
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.
Here is the full report of the FDA inspection.