FDA finds contamination concerns at Ameridose
WASHINGTON (AP) – Federal health inspectors have found more than a dozen sterility problems, including insects, at a drugmaking facility with the same founders as the specialty pharmacy linked to a deadly meningitis outbreak.
The Food and Drug Administration has released the results of a monthlong inspection of Ameridose, a Westborough, Mass.-based company that makes a variety of injectable drugs.
Inspectors say they found insects within 10 feet of a supposedly sterile area where drugs are manufactured. In another case, inspectors reported a bird flying into a room where drugs are stored.
Ameridose agreed to shut down for inspection in October after tainted steroids from its sister company, the New England Compounding Center, were linked to a fungal meningitis outbreak that’s spread to 19 states and caused 32 deaths.