Birds, Insects, and More Identified at Ameridose by FDA Inspectors
By now, you’ve likely heard about the fungal meningitis outbreak that has affected hundreds of people across the country and led to the shutdown of the New England Compounding Center responsible for distributing the contaminated steroid injections. But somewhat overshadowed by all of that are the repercussions that the whole situation has had on other facilities.
Ameridose, a Westborough, Massachusetts-based affiliate of the NECC, was recently the target of FDA scrutiny, and inspectors have just released their findings upon investigation of the Ameridose facility. Among their findings were the identification of a bird and a number of insects in an area where sterile products were meant to be stored.
Those weren’t the only issues potentially compromising the sterility of products from Ameridose. Investigators were also able to identify metal surfaces that suffered from brown spots and wall corrosion in an area meant for the preparation of sterile drugs. Water leaks had also taken place, and the FDA found no evidence to suggest an assessment of the leak was carried out or a permanent solution had.
The FDA also says that complaints that came in to the company were not adequately looked into and that classification was such that responses from patients were not designated as adverse events.
With 32 people having lost their lives to the meningitis outbreak, one would hope that these failings do not signify further potential health risks. Consumers should speak with a doctor should they ever feel like they’ve been adversely affected by a drug from any facility.