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FDA investigator asking questions during compliance inspection

Inspection Defense

Everything was documented. Then the inspector asked who authorized the decision. That record did not exist.

You had the documentation. You did not have the authorization record. You approved it. ComplianceWorxs is the record that answers the question.

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Based on patterns observed across FDA and EU GMP inspections.

Where authorization fails under inspection

✗ Decision made, but no recorded rationale
✗ Evidence exists, but not tied to the decision
✗ Signature present, but no authorization logic
Resolve this before inspection →

If inspection started right now — which decision would be questioned first?

Investigators do not review everything. They isolate one decision and go deep.

CAPA Closure Effectiveness decisions are frequently challenged Batch Release Release authorization is a primary inspection target Deviation Resolution Root cause conclusions are often re-evaluated Change Control Risk assessments are challenged after downstream issues Validation Approval Approval decisions must be justified against protocol evidence Data Integrity Data decisions are scrutinized for traceability and control

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When the FDA inspector asks who authorized this and why, ComplianceWorxs is the record that answers.

See how the authorization structure works →

Inspection Scenario

Your CAPA is closed. Your records are complete. An investigator asks one more question.

During a routine FDA inspection, an investigator pulls a CAPA closed fourteen months ago. The effectiveness check is marked complete. All corrective actions are documented.

Then the investigator asks the question your quality system was not designed to answer.

The issue was not the CAPA. It was the absence of a defensible authorization record.

FDA Inspection — CAPA Effectiveness Review

“Who made the determination that this CAPA was effective — and what evidence did they review before authorizing the closure?”

Record That Does Not Exist

✗Who evaluated the effectiveness evidence
✗What standard governed the determination
✗Who formally authorized the closure decision

Inspection Case Files

See the authorization gap documented in full.

Each case file reconstructs a real inspection moment — the investigator's question, the record that existed, the authorization evidence that was missing, and what a complete authorization record looks like.

Case File #01

Inspection Case File

Batch Release Authorization

FDA Inspection Question

"Who authorized the batch release decision, and what evidence was evaluated before approval?"

How the authorization record works → See the inspection record
Case File #02

Inspection Case File

CAPA Effectiveness Authorization

FDA Inspection Question

"Who decided this CAPA was effective, and under which regulatory standard was that determination made?"

How the authorization record works → See the inspection record
Case File #03

Inspection Case File

Change Control Authorization

FDA Inspection Question

"What risk was evaluated before this change was approved, and who authorized the determination?"

How the authorization record works → See the inspection record

You've reviewed the problem. Now check if it exists in your system.

Answer 5 questions. Identify whether your release decisions can be defended under inspection.

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