BC-US--Meningitis Outbreak,3rd Ld-Writethru

FDA closer to meningitis source

Published: Tuesday, Nov. 13, 2012 1:15 a.m. CDT

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.

 

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