STAT+: FDA warns Miami University contract testing lab over falsified data, poor quality control

A contract testing laboratory run by Miami University was scolded by the U.S. 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 used 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.

Continue to STAT+ to read the full story…