May 4, 2022
FDA’s warning letter to university is worth noting
If you just read the news story, this seems like a not-interesting-to-compounders FDA warning letter — in this case to Miami University of Ohio for “falsifying data.”
But if you read the actual letter, you get a much fuller picture of why MU was scolded for its heparin testing: Test results in an ‘uncontrolled’ folder on the computer. No software audit trail. “All users shared one master login.”
While the biggest problem seems to be “falsified data” — apparently a lazy user who didn’t feel like re-running an analysis — the various issues FDA highlights are worth noting because they’re easy traps to fall into: “Oh, just use my login….”
