Agent skill · research science · alirezarezvani
fda-qsr-audit-prep
Use for /compliance-os:fda-qsr-audit-prep, or before an FDA inspection, QMSR internal audit or Form 483 response.
Why this skill is useful
Adds 4 executable scripts for FDA compliance checks and submission tracking that are not publicly documented.
What it needs
Requires python installed locally. About 3k tokens when loaded. Last updated 2026-08-05. 23,939 stars on the source repository.
What this skill does
/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) Before submitting 510(k) / PMA (where QSR posture affects approval timeline) The Six QSR Questions 1. Show me the complaint files from the last quarter — and the corresponding MDR reports. 21 CFR 820.198 + 21 CFR 803 — most-cited FDA inspection area. Complaint log complete: who / what / when / device / batch Investigation closure within reasonable timeline MDR-reporting decision tree applied: death OR serious injury OR malfunction-that-could-cause = MDR 30-day timeline for most MDR reports; 5 days for certain serious events Complaint trending input to management review 2. When was process validation (IQ/OQ/PQ) last revalidated per 21 CFR 820.75? Cross-walks ISO 13485 Clause 7.5.6 (substantially harmonized post-Feb 2026). Initial validation at process introduction Revalidation triggers: process / equipment / material change OR periodic schedule Statistical techniques per 21 CFR 820.250 where applicable Cross-check with cs-cqm-iso13485 for ISO 13485 alignment 3. Show me the DHRs for products commercially distributed in last 2 years. 21 CFR 820.180 — 2-year retention from commercial distribution; check sampling for completeness. …
How to use it
Reference it in AdaL, Claude Code, Cursor or any coding agent — nothing to install:
@skills alirezarezvani/fda-qsr-audit-prep--89f8cd