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 specialistra-qm-team/qms-audit-expert— internal/external QMS auditsra-qm-team/audit-prep/compliance-readiness— multi-framework readiness