FDA Inspection Decision Scenario

Who Authorized the Material Rejection Decision?

“Who made the decision to reject this incoming material, and what was the regulatory basis for that determination?”

21 CFR 211.84 · 21 CFR 211.122

Why this becomes difficult to defend

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

The investigator is reviewing incoming material records. A lot was rejected. The rejection is documented. The investigator asks who made the formal rejection authorization.

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.

What must be retrievable

The reviewer needs more than the final outcome.

  • 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
  • Reasoning for why the material failed to meet the acceptance threshold

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.