This is a ready-to-use readiness checklist for FDA’s one-day inspectional assessment pilot. Replace every <<FILL: ...>> placeholder with your specifics and route it through your normal document control. A filled specimen follows. Confirm the pilot’s current scope and status against FDA’s own announcements before relying on this as written, since a pilot program’s criteria can change.
Document control header
| Field | Entry |
|---|---|
| Document title | One-Day FDA Inspectional Assessment Readiness Checklist |
| Document number | <<FILL: CHK-ID, e.g. QA-CHK-073>> |
| Version | <<FILL: version>> |
| Effective date | <<FILL: effective date>> |
| Site | <<FILL: facility name>> |
| Completed by | <<FILL: name, role>> |
1. Why this checklist is different from a standard PAI or system-level readiness check
A one-day assessment compresses the same scrutiny a multi-day inspection applies into a single visit, with no overnight runway to assemble a record the team did not already have staged. The gap this checklist closes is not depth of control, it is speed of production: everything below has to be retrievable within the visit, not within a day or two after it.
2. Standing readiness: confirm before any notice is possible
Because facilities are selected on risk-based criteria without the lead time a PAI often carries, treat every item below as always-on, not something assembled after notice.
| # | Item | Status | Evidence location | Action ref |
|---|---|---|---|---|
| 1 | A named front room team (coordinator, at least one scribe, SME contact list by system) is current and can convene within <<FILL: e.g. 1 hour>> of notice | <<FILL>> | <<FILL>> | <<FILL>> |
| 2 | Validation state summaries for all GxP systems are current and centrally indexed, not scattered across owners | <<FILL>> | <<FILL>> | <<FILL>> |
| 3 | Access lists with role justification are current for every validated system | <<FILL>> | <<FILL>> | <<FILL>> |
| 4 | The last periodic audit trail review for each high-criticality system is complete and signed | <<FILL>> | <<FILL>> | <<FILL>> |
| 5 | Open deviations and OOS records are current in status, with no aged-but-silent backlog | <<FILL>> | <<FILL>> | <<FILL>> |
| 6 | Training records for staff likely to be interviewed are current, with no lapsed qualifications | <<FILL>> | <<FILL>> | <<FILL>> |
| 7 | A document request log template and two-copy document control practice are ready to deploy immediately, not set up after the investigator arrives | <<FILL>> | <<FILL>> | <<FILL>> |
3. Coverage across the six-system model
Because a one-day visit may sample any of the six systems with no indication in advance of which one, confirm baseline readiness across all of them, not only the system most recently inspected.
| System | Last internal self-check date | Any known open gap | Action ref |
|---|---|---|---|
| Quality system | <<FILL>> | <<FILL>> | <<FILL>> |
| Facilities and equipment | <<FILL>> | <<FILL>> | <<FILL>> |
| Materials | <<FILL>> | <<FILL>> | <<FILL>> |
| Production | <<FILL>> | <<FILL>> | <<FILL>> |
| Packaging and labeling | <<FILL>> | <<FILL>> | <<FILL>> |
| Laboratory controls | <<FILL>> | <<FILL>> | <<FILL>> |
4. The day itself: go/no-go confirmations within the first hour
| # | Item | Confirmed |
|---|---|---|
| 1 | Investigator credentials and Form FDA 482 reviewed and logged, scope confirmed verbatim | <<FILL: Y/N>> |
| 2 | Front room and back room roles activated per the standing list in Section 2 | <<FILL: Y/N>> |
| 3 | Leadership notified and available for the daily huddle expectation, compressed to same-day given the single-day format | <<FILL: Y/N>> |
| 4 | Document request log opened and in use from the first request | <<FILL: Y/N>> |
| 5 | Scribe assigned and present for every interaction from the opening meeting onward | <<FILL: Y/N>> |
5. Acceptance criteria
- Every item in Section 2 is confirmed current as a standing state, not assembled in response to this checklist.
- No system in Section 3 shows an open gap without a logged action reference and owner.
- The Section 4 confirmations can all be completed within the stated time of the opening meeting, demonstrating the team can mobilize without a multi-day runway.
6. Escalation
If any Section 2 item is not current when this checklist is run as a standing self-audit (not during a live assessment), escalate to the inspection readiness lead and site quality head immediately and open a tracked action; do not wait for the next scheduled review cycle, since a one-day assessment can arrive with materially less notice than a routine surveillance inspection.
Filled specimen
A drug product manufacturing site runs this checklist as a quarterly standing self-audit, not in response to any notice.
| # | Item | Status | Evidence location | Action ref |
|---|---|---|---|---|
| 1 | Front room team current, can convene within 1 hour | Confirmed, roster last updated 3 weeks ago | Inspection readiness SharePoint, roster tab | N/A |
| 4 | Audit trail reviews for high-criticality systems current and signed | Confirmed for 7 of 8 systems; HPLC-11 review 4 days overdue | QMS periodic review tracker | CAPA-2026-0511 opened same day |
| 5 | Deviations and OOS current, no silent backlog | One deviation open 38 days against a 30-day target, justified extension on file and approved | Deviation log | No action beyond the approved extension |
Six-system coverage: all six systems show a self-check within the last quarter; packaging and labeling flagged a minor gap (a label reconciliation SOP revision pending final approval), tracked under CC-2026-0298, not yet a live finding.
The quarterly run surfaced one genuinely overdue item (the HPLC-11 audit trail review) before any inspection notice, which is exactly the point: the gap was found and a CAPA opened from the site’s own standing check, not from an investigator’s question.
Common inspection findings this checklist prevents
- A site treats “readiness” as something built after notice of an inspection, which a one-day assessment’s compressed timeline does not allow time for.
- A validated system’s audit trail review lapses quietly because no standing, dated self-check surfaces it before an investigator asks.
- The front room team is identified on paper but has never actually convened, so the one-day assessment’s opening hour is lost to logistics rather than substance.
How to adapt this checklist
- Run this as a recurring standing self-audit (for example quarterly), not only after a facility learns it may be a pilot candidate; the pilot’s selection criteria do not guarantee advance notice.
- Tailor Section 3’s system list if your site’s compliance program model differs from the six-system structure.
- Confirm the pilot’s current scope, selection criteria, and status directly against FDA’s own published materials before treating any detail here as settled, since a pilot program can be modified or discontinued.