The Regulatory Intelligence Library.

The OAI rate is the share of an investigator’s inspections with a published FDA classification that ended Official Action Indicated. It is calculated from FDA’s own published classifications and describes historical inspection outcomes only.

It is not a rating, ranking, score or measure of an investigator’s performance, and it does not predict the outcome of any future inspection. Outcomes mainly reflect the compliance state of the sites inspected, the reason for the inspection (for example, OAI follow-ups) and the product mix, and the classification is FDA’s decision, not the investigator’s alone. Inspections still pending classification, or whose classification has not been published, are excluded, so the rate can rest on a small number of inspections. Investigators are not compared or ordered against each other in our reports.