In a report released Monday afternoon, federal inspectors detailed 15 problems found at major hospital drug supplier Ameridose LLC, ranging from insufficient testing of the sterility and potency of the drugs it made to the presence of vermin in an area where sterile products were packaged and stored.
Inspectors also wrote that the company did not adequately investigate instances when solutions used to manufacture drugs were determined to be potentially contaminated with microbes, the report said.
Ameridose, based in Westborough, is a sister company of New England Compounding Center, where contaminated batches of an injectable steroid have been linked to fungal infections that have sickened more than 400 people and killed 32. Ameridose agreed to recall all of its more than 2,000 products last month after the US Food and Drug Administration said it had not found “adequate assurance of sterility” during an inspection.
The 20-page report made public Monday describes the shortcomings identified during 14 days of investigation in October and November. They include concerns that the company failed to properly test batches of drugs, and problems with the validity of certain procedures used in sterility testing.
FDA spokeswoman Sarah Clark-Lynn said she could not comment on how serious the findings are, and noted that no infections have been linked to Ameridose products.
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