FDA Inspection Decision Scenario
Who Authorized the OOS Investigation Conclusion?
What FDA investigators are actually asking
FDA Investigator Question
"Who made the final determination that this OOS result was assignable, and what was the basis?"
Inspector's Line of Inquiry
When investigators ask this question, they typically follow with:
- Who reviewed the Phase I and Phase II investigation findings before the conclusion was made?
- What evidence supported the assignable cause determination?
- What regulatory standard was applied to the invalidation decision?
- What would have prevented the OOS result from being assignable?
- When was the final determination authorized, and who is named as the decision owner?
Can your team answer this question in under five minutes? The Authorization Assessment identifies where your decision trail breaks before an investigator does.
Find Your Gaps →The authorization gap this scenario reveals
The investigator is reviewing a closed OOS investigation. Phase I and Phase II investigations are documented. The investigator asks who authorized the final conclusion.
Authorization Gap
The OOS record documents the investigation steps. It does not document who made the formal determination that the result was assignable — or that the conclusion was an authorization event at all. This is the authorization gap: the decision was made, but it was never documented as an authorization event — with a named decision owner, the evidence reviewed, the regulatory standard applied, and a timestamped record of when the authorization occurred.
Why does this gap exist across so many compliance programs? The Decision Authorization Model explains the structural difference between what documentation systems produce and what inspectors evaluate.
Understand the Model →What evidence the investigator expects
- Named decision owner for the OOS conclusion authorization
- Evidence reviewed before the final determination was made
- Regulatory standard applied to the assignable cause determination
- Authorization timestamp for the conclusion decision
- Rationale linking the investigation findings to the final disposition
Organizations operating with authorization infrastructure produce this record at the moment the decision is made.
See how authorization capability scales across organizations →Inspection Case File
See exactly what this authorization gap looks like — and what closes it.
The case file reconstructs this scenario in full: the investigator's question, the record that existed, the authorization evidence that was missing, and the Decision Defense Record that resolves it.
Inspection Case File
Close this authorization gap
before inspection.
The case file documents this exact scenario — the investigator's question, the missing authorization trail, and the Decision Defense Record that produces the evidence inspectors expect.
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Not sure where all your gaps are? Take the free Authorization Assessment →