FDA Inspection Decision Scenario
Who Authorized the Complaint Investigation Closure?
What FDA investigators are actually asking
FDA Investigator Question
"Who made the determination that this complaint investigation was complete and that no further action was required?"
Inspector's Line of Inquiry
When investigators ask this question, they typically follow with:
- Who reviewed the investigation findings before the closure decision was authorized?
- What MDR or reportability analysis was conducted and who made that determination?
- What regulatory standard governed the decision that no further action was required?
- What findings would have required a reportable event determination?
- When was the complaint closure 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 complaint file. The complaint was received, investigated, and closed. The investigator asks who authorized the closure — not who documented it.
Authorization Gap
The complaint record documents the investigation steps and conclusions. It does not document who made the formal authorization that the investigation was sufficient and that no reportable event had occurred. 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 complaint closure authorization
- MDR/reportability determination and who made it
- Regulatory standard applied to the closure decision
- Authorization timestamp for the investigation closure
- Rationale for why the complaint did not require further action or reporting
Organizations operating with authorization infrastructure produce this record at the moment the decision is made.
See how authorization capability scales across organizations →These gaps are not documentation failures. They are authorization failures. The Authorization Assessment maps exactly where your decision trail is missing these elements.
Start the Assessment →Authorization Assessment
Which of your decisions
have an authorization gap?
The Authorization Assessment identifies where your compliance decisions are undocumented as authorization events — the exact gap inspectors expose in scenarios like this one.
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Inspection Case Files document the authorization gap in detail — showing exactly what a Decision Defense Record resolves and what inspectors expect to see.
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