Form FDA 483

6 Features to Look for in FDA 483s

A challenge with interpreting 483s that are issued to firms other than your own is that 483s don’t provide the context for what occurred during the inspection and how the issues were identified. Thus, to evaluate the seriousness of a 483 and the potential for additional enforcement action, I ask the following questions.

Posted FDA 483 Violations | Week of 9/16/18

It's 483 study time, and our GMP expert has extracted the key points in this week's featured 483 posted by the FDA. Violations ranged from failing to provide scientific reasons for invalidating OOS results to failing to prevent colored residues on equipment.