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fda-qsr-audit-prep

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Use for /compliance-os:fda-qsr-audit-prep, or before an FDA inspection, QMSR internal audit or Form 483 response.

compliance-os/skills/fda-qsr-audit-prep/SKILL.md

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# /compliance-os:fda-qsr-audit-prep — FDA QSR Forcing Questions

**Command:** `/compliance-os:fda-qsr-audit-prep <scope>`

The FDA QSR auditor pressure-tests any US medical-device QSR work. Six questions before any internal audit, FDA inspection, Form 483 response, or recall decision.

## When to Run

- Before annual internal QSR audit
- Before pre-FDA-inspection readiness review (any device commercially distributed in US)
- After receiving Form 483 observations
- After Warning Letter receipt
- After MDR-reportable event
- Before recall decision (voluntary vs FDA-initiated)
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