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'Greenish-Black' Contaminant in Vials of Steroid Behind Meningitis Outbreak: FDA
Date:10/28/2012

By Steven Reinberg and Margaret Steele
HealthDay Reporters

FRIDAY, Oct. 26 (HealthDay News) -- Federal investigators who toured the plant at the center of the ongoing meningitis outbreak found foreign, "greenish-black" material in some vials of the injectable steroid suspected as the cause of the illnesses, U.S. health officials said Friday.

The contaminated product was one of a host of potential violations discovered during a recent inspection of the New England Compounding Center's plant in Framingham, Mass., officials said.

"The investigators observed approximately 100 vials of the steroid drug, which purports to be a sterile injectable drug, that had a greenish-black foreign material and a white filamentous [containing filaments] material inside," Steven Lynn, director of the U.S. Food and Drug Administration's Office of Manufacturing and Product Quality, said during a news conference Friday afternoon.

As of Friday, the U.S. Centers for Disease Control and Prevention said that 25 people have now died and 338 people in 18 states have been sickened in the nationwide fungal meningitis outbreak.

Vials from the lot Lynn described were shipped by the company to customers this year, he said. The FDA tested 50 of these vials and all were contaminated with fungus, he added.

In addition, the company couldn't demonstrate that the equipment used to sterilize these products was actually able to sterilize them, Lynn said.

The FDA also found the company was not able to keep its "clean room" clean, Lynn said. "A clean room is a space designed to maintain a controlled environment with low levels of airborne particles and surface contamination," he explained.

According to the report, the company failed to keep the air conditioner in the clean room running at night, which is standard practice to maintain the room's humidity and temperature control. In the past, the company itself had found mold and b
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