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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. license: MIT + Commons Clause metadata: version: 1.0.0 author: borghei category: compliance domain: ra-qm-team updated: 2026-05-27 tags: [fda, qsr, qmsr, 21-cfr-820, medical-devices, audit-prep, 483-response, warning-letter]

FDA QSR / QMSR Audit Prep

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

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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

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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

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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).

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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

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

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

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

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

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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

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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

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References

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

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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