WASHINGTON (AP) – Federal health inspectors found numerous potential sources of contamination, including leaky ceilings and insects, at a drug-making facility that has the same founders as the specialty pharmacy linked to a deadly meningitis outbreak.
The Food and Drug Administration on Monday released the results of a monthlong inspection of Ameridose, a Westborough, Mass.-based company that makes injectable drugs. The agency’s report, posted online, lists a host of problems at the plant, ranging from manufacturing to sterility to quality control.
Inspectors said they found insects within 10 feet of a supposedly sterile area where drugs were manufactured. In another case, inspectors reported a bird flying into a room where drugs are stored.
Elsewhere, the report cites leaks and cracks in the ceiling and walls of a clean room used to manufacture sterile drugs. The same room contained “thick residues that were orange, brown, and green” on equipment used for sterilization.