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FDA Inspection Intelligence

FDA Inspection Questions QA Directors
Are Asked Most Often

Real questions investigators ask during pharmaceutical and biotechnology inspections — and what records they expect to see.

How investigators use these questions

During an inspection, investigators rarely challenge the existence of records.

They challenge the decisions behind those records.

The questions below reflect the sequence investigators use to determine:

  • who made the decision
  • what evidence was reviewed at the moment of authorization
  • which regulatory standard applied to the determination
  • whether the decision was defensible as documented

Common inspection triggers

Batch release decisions
CAPA closure determinations
Change control impact assessments
Deviation root cause conclusions
Validation approval decisions

Product Disposition Decisions

Batch Release and Product Disposition

  • Who authorized the release of this batch?
  • Which deviations or exceptions were evaluated before release was approved?
  • What evidence confirmed all specifications were met before disposition?
  • Who made the final disposition determination?
→ Inspection scenario: Who Authorized This Batch Release?

Investigation Closure Decisions

CAPA and Investigation Closure

  • Who determined this CAPA was effective?
  • What evidence demonstrated the corrective action eliminated the root cause?
  • Who authorized the closure of this investigation?
  • What criteria were used to conclude the issue was resolved?
→ Inspection scenario: Who Authorized This CAPA Closure?

Regulatory Impact Decisions

Change Control and Regulatory Impact

  • Who determined the regulatory impact classification for this change?
  • What evidence supported the decision that this change was minor?
  • Who authorized the implementation of this change?
  • What regulatory standard governed the impact determination?
→ Inspection scenario: Who Approved This Change Control?

Could your team answer these questions during an inspection?

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Validation and Qualification Decisions

Validation and Qualification Decisions

  • Who approved this validation protocol?
  • What evidence demonstrated the system met acceptance criteria?
  • Who authorized the validation conclusion?
  • What would have caused the validation to fail?
→ Inspection scenario: Who Authorized the Process Validation Conclusion?

Deviation and Root Cause Investigations

Deviation and Root Cause Investigations

  • Who determined the root cause of this deviation?
  • What evidence supports that determination?
  • Who authorized the corrective action plan?
  • What alternative root causes were considered?
→ Inspection scenario: Who Authorized the Root Cause Determination?

Inspection Reality

These questions are rarely theoretical.

Investigators ask them when they identify a decision that must be explained.

If the authorization record does not exist at that moment, the decision becomes difficult to defend — even if the decision itself was correct.

Decision Authorization Model

Compliance records document events.

Inspectors evaluate the decisions behind those events.

The difference between the two is the authorization record.

Understand the Decision Authorization Model

Frequently asked questions

What questions do FDA inspectors ask during inspections? +
FDA investigators typically probe the decisions behind records, not just their existence. The most common questions establish who made a specific compliance decision, what evidence they reviewed, and which regulatory standard governed their determination.
What records must be available during an FDA inspection? +
Investigators expect authorization records that document not just what was done, but who made the decision to do it. Batch records, CAPA files, change controls, and deviation investigations must each contain a traceable authorization trail — a named decision owner, evidence reviewed, regulatory standard applied, and timestamp.
How do investigators evaluate batch release decisions? +
Investigators look beyond test results. They evaluate whether a named individual formally authorized the release decision, what evidence was reviewed at the moment of authorization, and whether the regulatory standard governing the disposition judgment is documented in the record.
What evidence supports CAPA closure decisions? +
A defensible CAPA closure requires documentation that a named individual reviewed effectiveness evidence, applied a defined regulatory standard, and formally authorized the closure as a discrete authorization event — not just that corrective action steps were completed.

These questions correspond to scenarios in the Inspection Scenario Library →

When investigators cannot get a satisfactory answer, they issue an observation. See how these questions become findings: Common FDA Form 483 Observations →

Authorization Assessment

Could your team answer these questions
during an inspection?

Most organizations can reconstruct the answer.
Investigators expect the answer to already exist in the record.

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