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.
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 bacteria in the clean room, Lynn said.
"In addition, the investigators observed a dark, hair-like discoloration in a transition room that connects directly to a room used to formulate and fill the injectable products," Lynn said.
Massachusetts officials said 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, showed there was evidence of inadequate contamination control and no written standard operating procedures for using equipment, among other problems, at the facility.
New England Compounding Center and Infusion Resource are both compounding pharmacies. These pharmacies combine, mix or alter ingredients to create drugs to meet the specific needs of individual
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