"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 FDA's Office of Manufacturing and Product Quality, said during the briefing.
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.
Over the weekend, Massachusetts officials closed a second compounding pharmacy after inspection revealed conditions that might threaten the sterility of its products.
According to The New York Times, Waltham, Mass.-based Infusion Resource voluntarily surrendered its license over the weekend after inspectors found "significant issues with the environment in which medications were being compounded," Dr. Madeleine Biondolillo, director of the Bureau of Health Care Safety and Quality at the Massachusetts Public Health Department, said at a press briefing.
While she did not release details of what the inspection found, Biondolillo did say that patients had been receiving intravenous medications at the pharmacy, violating state law.
Massachusetts officials said last Tuesday that they had begun a criminal investigation into New England Compounding Center. They added that the company functioned as a drug manufacturer, producing drugs for broad use, rather than filling individual prescriptions for individual doctors, in violation of its state license, CBS News reported.
According to published reports, state records show that the New England Compounding Center was plagued by problems as far back as 2006. Those records, obtained by the Associated Press under a public documents request, show
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