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Imported from borghei/claude-skills (ra-qm-team/audit-prep/fda-qsr-audit-prep/SKILL.md). Install upstream with npx skills add borghei/claude-skills --skill fda-qsr-audit-prep. Copyright stays with the author (MIT + Commons Clause).

FDA QSR / QMSR Audit Prep

Name: fda-qsr-audit-prep
Author: borghei

Operational playbook for FDA inspection preparation under Quality System Regulation (21 CFR 820) and the transitioning Quality Management System Regulation (QMSR, fully effective 2026, harmonizing with ISO 13485:2016).

When to use this skill vs. fda-consultant-specialist:

This skill: FDA inspection imminent OR 483/Warning Letter received; need sprint
fda-consultant-specialist: building / maintaining QMS; multi-quarter

When to use this skill

Situation	Skill applies
FDA inspection announced (or unannounced visit imminent)	Yes — start immediately
Form 483 observation received	Yes — `scripts/qsr_readiness_score.py` to assess + plan response
Warning Letter received	Yes — plus engage outside FDA counsel
Annual readiness assessment	Yes — periodic sprint
Building QMS from scratch	Use `ra-qm-team/fda-consultant-specialist`
Medical device submission (510k / PMA)	Use `ra-qm-team/fda-consultant-specialist`

The audit-prep sprint at a glance

2-week sprint (announced inspection, mature QMS)

Week 1: Inventory, walkthrough rehearsal, gap remediation
Week 2: Inspection week (front room + back room operation)

8-week sprint (gaps identified, scheduled inspection)

Weeks 1-2: Readiness assessment + 483 / WL prior issue review
Weeks 3-6: Gap remediation (DHF, CAPA, complaint records, etc.)
Weeks 7-8: Mock inspection + final remediation + inspection prep

Reactive: 483 / Warning Letter response

- 483: 15 business days to respond (then ongoing)
- Warning Letter: 15 business days to respond (then full corrective action plan)
- Approach: Acknowledge + investigate root cause + corrective action plan + commitment + evidence

QSR / QMSR key audit areas

21 CFR 820 Subpart	Topic	Audit focus
Subpart B	Quality system	Management responsibility, quality policy, planning
Subpart C	Design controls	Design history file (DHF), design reviews, V&V
Subpart D	Document controls	Document approval, change control, distribution
Subpart E	Purchasing controls	Supplier qualification, agreements, evaluations
Subpart F	Identification and traceability	Product ID, lot/batch traceability
Subpart G	Production and process controls	Process validation, environmental controls, equipment maintenance
Subpart H	Acceptance activities	Receiving, in-process, finished device acceptance
Subpart I	Nonconforming product	Identification, segregation, disposition
Subpart J	Corrective and preventive action (CAPA)	CAPA process, root cause analysis, effectiveness verification
Subpart K	Labeling and packaging	Label inspection, packaging validation
Subpart L	Handling, storage, distribution	Procedures, shelf-life, distribution records
Subpart M	Records	Device Master Record (DMR), Device History Record (DHR), QSR records
Subpart N	Servicing	Servicing procedures, complaint review
Subpart O	Statistical techniques	Sampling, statistical methods

QMSR transition (effective Feb 2026): Harmonizes 21 CFR 820 with ISO 13485:2016. Adds requirements for risk management (ISO 14971), software lifecycle (IEC 62304), usability (IEC 62366).

Clarify First

Before running the audit-prep, confirm these inputs. If any is unknown or vague, ASK — do not assume:

Trigger — announced inspection, Form 483 received, Warning Letter, or annual readiness (chooses between the sprint track and the reactive 15-day response track, and sets deadlines)
Framework — legacy QSR (21 CFR 820) vs QMSR (ISO 13485-harmonized, effective Feb 2026) (changes which requirements and subparts apply)
QMS maturity and known issues — mature vs gaps, plus prior 483/WL findings (picks the 2-week vs 8-week sprint)

Stop rule: ask only the 2-3 that most change the output. If the user says "just draft it," proceed and list your assumptions at the top of the readiness assessment.

Quick start

Run readiness score: python3 scripts/qsr_readiness_score.py --config qsr-controls.yaml
Check DHF completeness for in-scope devices: python3 scripts/dhf_completeness_checker.py --dhf device-dhf.yaml
Pick sprint length based on score + known issues
Execute sprint per references/fda-qsr-pre-inspection-checklist.md

Common FDA inspection findings (highest 483 / Warning Letter trigger)

CAPA failures — root cause not addressed, ineffective corrective action
Complaint handling — complaints not investigated, MDR (Medical Device Reporting) missed
Design controls (Subpart C) — DHF incomplete, V&V gaps, no design reviews
Process validation — processes not validated, validation stale
Supplier controls — suppliers not qualified, agreements missing, evaluations skipped
Document control — old procedures in use, no document approval evidence
Management responsibility — no management review, no quality policy, no objectives
Records (DHR) — incomplete records, missing lot traceability

See references/483-warning-letter-prevention.md for prevention patterns + response templates.

Inspection-week operations

Front room (where inspector works)

Designated front room (conference room, not someone's office)
Front-room lead (often Quality Manager) accompanies inspector all day
All requests routed through front-room lead
Inspector requests evidence; front-room asks back-room

Back room (where requests are fulfilled)

Cross-functional team available
Document retrieval, witness preparation, technical questions answered
Inspector requests evidence; back-room delivers (filtered through front-room lead)

Daily debrief

End of each inspection day: review what was inspected, observations, next-day topics
Prepare overnight any evidence needed for next day

After inspection

Form 483 review (if issued): consult with QA Lead + outside counsel
15 business days to respond
Full corrective action plan
Ongoing engagement with FDA office

Tooling

Script	Purpose
`scripts/qsr_readiness_score.py`	Score current QSR/QMSR state per subpart
`scripts/dhf_completeness_checker.py`	Validate Design History File completeness per device

References

fda-qsr-pre-inspection-checklist.md — full pre-inspection punch list per subpart
483-warning-letter-prevention.md — common triggers + prevention + response patterns

Related skills

ra-qm-team/fda-consultant-specialist — deep FDA program (510k, PMA, QMSR build)
ra-qm-team/quality-manager-qms-iso13485 — ISO 13485 QMS (QMSR harmonized)
ra-qm-team/risk-management-specialist — ISO 14971 (required for QMSR)
ra-qm-team/capa-officer — CAPA process specialist
ra-qm-team/qms-audit-expert — internal/external QMS audits
ra-qm-team/audit-prep/compliance-readiness — multi-framework readiness

Use it

Copy one of these into your project. Installing also returns the manifest and these snippets.

yaml

targets:
  - https://api.opensmartroute.ai/api/v1/registry/borghei-claude-skills-fda-qsr-audit-prep/manifest   # or paste the manifest below

Manifest

An Open Capability Manifest: the router reads it to know what this does, what it costs and when to pick it.

borghei-claude-skills-fda-qsr-audit-prep.ocm.jsonjson

{
  "ocm": "1",
  "id": "borghei-claude-skills-fda-qsr-audit-prep",
  "kind": "skill",
  "name": "fda-qsr-audit-prep",
  "description": "FDA Quality System Regulation (21 CFR 820 / QMSR) audit-prep playbook for medical devices. Use when an FDA inspection is announced, when preparing for the new QMSR (2026), or when a 483 / Warning Letter response is needed.",
  "publisher": "borghei",
  "version": "1.0.0",
  "capabilities": {
    "domains": [
      "legal",
      "math"
    ],
    "tags": [
      "skill-md",
      "fda",
      "qsr",
      "qmsr",
      "21-cfr-820",
      "medical-devices",
      "audit-prep",
      "483-response",
      "warning-letter",
      "skills-sh"
    ],
    "languages": [
      "en"
    ]
  },
  "quality_prior": 0.6,
  "examples": [
    "FDA Quality System Regulation (21 CFR 820 / QMSR) audit-prep playbook for medical devices. Use when an FDA inspection is announced, when preparing for the new QMSR (2026), or when a 483 / Warning Letter response is needed."
  ],
  "primary": false,
  "metadata": {
    "source": {
      "provider": "skills.sh",
      "repository": "https://github.com/borghei/claude-skills",
      "path": "ra-qm-team/audit-prep/fda-qsr-audit-prep/SKILL.md",
      "ref": "HEAD",
      "url": "https://github.com/borghei/claude-skills/blob/HEAD/ra-qm-team/audit-prep/fda-qsr-audit-prep/SKILL.md",
      "key": "borghei/claude-skills/ra-qm-team/audit-prep/fda-qsr-audit-prep/SKILL.md"
    },
    "license": "MIT + Commons Clause"
  },
  "instructions": "# FDA QSR / QMSR Audit Prep\n\nOperational playbook for FDA inspection preparation under Quality System Regulation (21 CFR 820) and the transitioning Quality Management System Regulation (QMSR, fully effective 2026, harmonizing with ISO 13485:2016).\n\nWhen to use this skill vs. fda-consultant-specialist:\n- **This skill**: FDA inspection imminent OR 483/Warning Letter received; need sprint\n- **fda-consultant-specialist**: building / maintaining QMS; multi-quarter\n\n---\n\n## When to use this skill\n\n| Situation | Skill applies |\n|-----------|---------------|\n| FDA inspection announced (or unannounced ",
  "cost": {
    "context_tokens": 1817
  }
}

Fetch it by URL: GET /api/v1/registry/borghei-claude-skills-fda-qsr-audit-prep/manifest?version=1.0.0

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