What does official action indicated (OAI) mean?

The U.S. Food and Drug Administration (FDA) classifies inspection outcomes as no action indicated (NAI), voluntary action indicated (VAI), or official action indicated (OAI). OAI means the findings may warrant regulatory or administrative action.

OAI does not by itself mean a facility was penalized. Review the inspection scope, cited findings, company response, and later follow-up before qualification.