Inspection readiness ·

The inspector already knows where to look.

Twenty observation themes that keep appearing on FDA Form 483s, each with what it actually says, why it keeps recurring, the evidence that answers it, and the questions an inspector uses to get there. Score your readiness, then drill your team on the questions before someone else does.

observation themes
mock inspector questions
evidence items listed
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Observation themes

Readiness score

How to answer

Pricing

The themes, the evidence lists, the mock questions and the readiness scorer are free and stay free. What costs money is the part you cannot get from a checklist: what the inspector is actually testing, and how the question grows when your first answer is weak.

Free
$0
  • All 20 observation themes
  • 80 mock inspector questions
  • Evidence list for every theme
  • Readiness scorer across 7 areas
  • Works offline, nothing transmitted
War-room edition
$99 one-time
  • What the inspector is really testing — per theme
  • 60 follow-up questions with the answer that triggers each
  • 60 answers that make it worse, and why
  • The shape of an answer that closes the thread
  • The five-level escalation ladder
  • Hostile-review prompt for your written response
Get the war-room edition

Straight answers

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