FDA uncovers contamination issues at facility

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.

FDA inspectors also said the company did not investigate at least 53 incidents of bacterial contamination that arose during testing of stock drug solution.

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

Ameridose agreed to shut down for inspection in October after tainted steroids from its sister company, the New England Compounding Center, were linked to a fungal meningitis outbreak that has spread to 19 states and caused 32 deaths. Ameridose operates two facilities in Westborough and provides medication in pre-filled oral syringes to hospitals nationwide. Its drugs range from painkillers to blood thinners to pregnancy drugs.

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.

Inspectors visiting the company’s plant also questioned whether some of Ameridose’s drugs work properly.

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