FDA Inspection Decision Scenario
Who Authorized the Deviation Disposition?
What FDA investigators are actually asking
FDA Investigator Question
"Who made the disposition decision for this deviation, and what evidence did they review?"
Inspector's Line of Inquiry
When investigators ask this question, they typically follow with:
- Who evaluated the regulatory significance of this deviation before disposition?
- What product quality impact analysis was reviewed before the disposition decision?
- What regulatory standard governed the acceptability determination?
- What evidence would have changed the disposition outcome?
- When was the disposition authorization made, and is the decision owner named?
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 deviation. The deviation was documented. The product was released. The investigator asks who authorized the disposition.
Authorization Gap
The deviation record shows the event was captured and closed. It does not show who evaluated the regulatory significance of the deviation and made the formal disposition authorization. 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 individual accountable for the disposition authorization
- Regulatory impact analysis supporting the disposition
- Evidence reviewed at the moment of the disposition decision
- Timestamp of the authorization event
- Rationale for why the deviation did not affect product quality or compliance
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.
Get the Case File →$149 · Immediate access · No account required
Not sure where all your gaps are? Take the free Authorization Assessment →