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FDA finds contamination issues at Ameridose

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.

"There is no documented evidence that your firm implemented permanent corrective actions to prevent these sterility events from recurring," investigators wrote.

Late last month, the company agreed to recall all of its products under pressure from FDA regulators. FDA officials previously said they have not connected any Ameridose drugs to infection or illness, but they have concerns about the products' sterility.

Regulators report that Ameridose also failed to investigate potentially serious side effects reported with drugs. One complaint involving the company's painkiller fentanly states the "patient was over-sedated, unresponsive." A complaint for oxytocin, which is used to induce labor in pregnant women, states that the "patient had shortness of breath, the throat was closing, and coughing."

Ameridose and NECC were founded by brothers-in-law Barry Cadden and Greg Conigliaro. Ameridose says it is a separate entity with distinct management. Since the outbreak, Cadden, the lead pharmacist at NECC, resigned his post as director at Ameridose. He is scheduled to testify before Congress at a hearing Wednesday examining the outbreak.

Last week Ameridose laid off nearly all of its 650 employees and 140 employees at its marketing and support arm, Medical Sales Management, due to the company's extended shutdown.
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