FDA Inspection Decision Scenario
Who Authorized the Material Rejection Decision?
What FDA investigators are actually asking
FDA Investigator Question
"Who made the decision to reject this incoming material, and what was the regulatory basis for that determination?"
Inspector's Line of Inquiry
When investigators ask this question, they typically follow with:
- Who evaluated the test results and specification failures before the rejection was authorized?
- What specification criteria governed the rejection determination?
- What regulatory standard was applied to the acceptability assessment?
- What evidence would have allowed conditional acceptance or retest?
- When was the rejection formally 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 incoming material records. A lot was rejected. The rejection is documented. The investigator asks who made the formal rejection authorization.
Authorization Gap
The receiving record documents the test results that triggered rejection. It does not document who evaluated the evidence and made the formal authorization that the material was unacceptable for use. 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 rejection authorization
- Specification or regulatory standard applied to the rejection determination
- Evidence reviewed before the rejection was authorized
- Authorization timestamp for the rejection decision
- Rationale for why the material failed to meet the acceptance threshold
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.
Start the Authorization Assessment →Free · No account required · Results in under 5 minutes
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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