---
title: "FDA QSR Forcing Questions"
type: skill
id: "rezvani-skills/regulatory-compliance/fda-qsr-audit-prep"
category: "Legal & compliance"
publisher: "Alireza Rezvani"
license: "MIT"
source: "https://github.com/alirezarezvani/claude-skills/tree/c85b17e"
canonical: "https://labs.pho.chat/en/skills/rezvani-skills/regulatory-compliance/fda-qsr-audit-prep"
open_in_pho: "https://pho.chat/customize?item=rezvani-skills%2Fregulatory-compliance%2Ffda-qsr-audit-prep&utm_source=labs&utm_medium=skill-page&utm_campaign=skills-library"
---

# FDA QSR Forcing Questions

Use before an FDA inspection, QMSR internal audit or Form 483 response.

Source: Alireza Rezvani (MIT), copied at a pinned commit. Free to use. Part of the Phở Skills library (https://labs.pho.chat/en/skills).
Skill set: Regulatory & compliance audits (https://labs.pho.chat/en/skills/rezvani-skills/regulatory-compliance.md).

## What it covers
- When to Run
- The Six QSR Questions
  - 1. Show me the complaint files from the last quarter — and the corresponding MDR reports.
  - 2. When was process validation (IQ/OQ/PQ) last revalidated per 21 CFR 820.75?
  - 3. Show me the DHRs for products commercially distributed in last 2 years.
  - 4. Show me CAPAs from the last 6 months with effectiveness verification.
  - 5. Show me labeling (21 CFR 801) review for the most recent product launch.
  - 6. If a Form 483 was issued in the last 3 years, show me the closure status.
- Workflow
- Output Format
- Routing
- Related

## Other skills in this set
- [ISO 13485 QMS Forcing Questions](https://labs.pho.chat/en/skills/rezvani-skills/regulatory-compliance/iso13485-audit-prep.md): Use before an ISO 13485 internal audit or DHF closure.
- [ISO 27001 ISMS Audit Forcing Questions](https://labs.pho.chat/en/skills/rezvani-skills/regulatory-compliance/iso27001-audit-prep.md): Use before an ISO 27001 internal, surveillance or stage 1 audit.
- [SOC 2 Type II Forcing Questions](https://labs.pho.chat/en/skills/rezvani-skills/regulatory-compliance/soc2-audit-prep.md): Use before or during a SOC 2 Type II observation period.
- [GDPR DPO Forcing Questions](https://labs.pho.chat/en/skills/rezvani-skills/regulatory-compliance/gdpr-audit-prep.md): Use before a GDPR review, post-breach audit or DPA investigation.
- [EU AI Act Forcing Questions](https://labs.pho.chat/en/skills/rezvani-skills/regulatory-compliance/ai-act-readiness.md): EU AI Act readiness for an AI system. Use when launching AI in the EU, at AI intake.
- [AIMS ISO 42001 Forcing Questions](https://labs.pho.chat/en/skills/rezvani-skills/regulatory-compliance/aims-audit.md): ISO 42001 AI readiness check. Use before a stage 1 or internal audit.
- [Compliance Officer Forcing Questions](https://labs.pho.chat/en/skills/rezvani-skills/regulatory-compliance/compliance-readiness.md): Use before adding a framework or planning the annual audit calendar.

## Use it
- In Phở: open https://pho.chat/customize?item=rezvani-skills%2Fregulatory-compliance%2Ffda-qsr-audit-prep&utm_source=labs&utm_medium=skill-page&utm_campaign=skills-library and press Try, or add it so Phở loads it whenever a request matches. Phở works with your own API key (OpenAI, Anthropic, Google and others).
- Full instructions (original SKILL.md, unchanged): https://labs.pho.chat/skills/raw/rezvani-skills/regulatory-compliance/skills/fda-qsr-audit-prep/SKILL.md
- Original files: https://github.com/alirezarezvani/claude-skills/tree/c85b17e (MIT).
- Full machine-readable index: https://labs.pho.chat/skills.json