FDA Inspection Decision Scenario

Who Authorized the Complaint Investigation Closure?

“Who made the determination that this complaint investigation was complete and that no further action was required?”

21 CFR 211.198 · 21 CFR 820.198

Why this becomes difficult to defend

The decision exists. The basis for it may not be retrievable as one record.

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.

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.

What must be retrievable

The reviewer needs more than the final outcome.

  • 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
  • Reasoning for why the complaint did not require further action or reporting

Relevant proof

See how the record connects evidence, judgment, risk, and authorization.

A completed ComplianceWorxs record shows the reasoning layer that is usually hardest to reconstruct after the decision has been made.

EvidenceWhat was known JudgmentHow it was evaluated RiskWhat was weighed AuthorizationWho decided and why

When this is your active decision

Preserve the reasoning before the context disappears.

Use the completed proof first. When the decision is consequential enough to preserve, create an Inspection Response Record for the actual decision.