A contract testing laboratory run by Miami University was scolded by the Food and Drug Administration for failing to ensure that drugs are appropriately tested and preventing data from being changed or omitted.
In an April 20 warning letter, the agency noted the Department of Chemistry and Biochemistry failed to follow good manufacturing practices as it went about testing the raw material used to make heparin, which is relied on to prevent and treat blood clots. The letter, which was posted to the FDA website this week, followed an inspection conducted by the agency last November.
The agency noted that a customer ran an audit and determined that a student analyst had “falsified” data and entered arbitrary values. Moreover, the department was lax in monitoring access to data. The department maintained that such an episode never occurred before and that the “data manipulation” was not done specifically to ensure results met requirements.
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