This is a ready-to-use checklist for the inspection that arrives without a visit: an FDA records request under Section 704(a)(4) of the Federal Food, Drug, and Cosmetic Act, or a remote regulatory assessment (RRA).
The records you send become the record of the examination, produced on a deadline, with no chance to explain in the room, so retrieval speed, completeness, and a proper true copy carry the whole event.
Work each item and mark Pass / Fail / NA. Replace every <<FILL: ...>> placeholder and route it through your normal document control. A filled specimen follows. The background is in inspection readiness; confirm each cited authority against the current source before you rely on it.
Context header
| Field | Entry |
|---|---|
| Request reference | <<FILL: internal tracking ID>> |
| Type | 704(a)(4) mandatory records request / Mandatory RRA / Voluntary RRA |
| Date received | <<FILL>> |
| Stated deadline | <<FILL>> |
| Requesting office | <<FILL: FDA office / investigator>> |
| Owner (coordinator) | <<FILL: role/name>> |
1. Intake and logging
| # | Item | Pass / Fail / NA |
|---|---|---|
| 1.1 | Request logged the day it arrived: date received, deadline, requesting office, and exact scope captured verbatim. | |
| 1.2 | Type confirmed: mandatory (704(a)(4) or mandatory RRA) versus voluntary RRA, and the consequence of each understood. | |
| 1.3 | A single coordinator and a named backup are assigned to own the response. | |
| 1.4 | Senior quality management and, where used, regulatory/legal are informed the same day. |
2. Scope confirmation
| # | Item | Pass / Fail / NA |
|---|---|---|
| 2.1 | Every requested record, system, lot, date range, and format is identified and mapped to where it lives. | |
| 2.2 | Any ambiguity in the request is clarified with the requesting office in writing before assembly begins. | |
| 2.3 | The boundary is documented: what is in scope, and what is out of scope with a recorded reason. | |
| 2.4 | For a voluntary RRA, a decision to participate or decline is made and documented, recognizing that declining may prompt an on-site inspection. |
3. Assembly under document control
| # | Item | Pass / Fail / NA |
|---|---|---|
| 3.1 | Each record is the correct, current version, retrieved from the controlled source. | |
| 3.2 | Copies provided are true/certified copies, with the certification recorded. | |
| 3.3 | Associated metadata and audit trails are included where the record’s meaning depends on them. | |
| 3.4 | Nothing is altered, backdated, completed, or “tidied” to send it; a gap found is handled as a deficiency, not edited away. | |
| 3.5 | Genuinely confidential commercial information is marked appropriately, without withholding a record the agency is entitled to. |
4. Quality review before production
| # | Item | Pass / Fail / NA |
|---|---|---|
| 4.1 | QA reviews the assembled package for completeness against the request scope. | |
| 4.2 | QA reviews for accuracy and internal consistency (dates, signatures, cross-references reconcile). | |
| 4.3 | The package is exactly responsive: the records requested, and not a pile of unrequested extras that widen exposure. | |
| 4.4 | Sign-off recorded that the package is complete, accurate, and ready to produce. |
5. Production and retention
| # | Item | Pass / Fail / NA |
|---|---|---|
| 5.1 | The package is produced by the stated deadline, through the channel the request specified. | |
| 5.2 | If more time is genuinely needed, a documented request for an extension is made before the deadline, not after. | |
| 5.3 | An exact copy of precisely what was sent, and the date/time sent, is retained (the equivalent of the on-site request log). | |
| 5.4 | Any follow-up questions or supplemental requests are logged and handled through this same checklist. |
6. Acceptance criteria
The response is defensible when: the request was logged and scoped on arrival; the package is complete, accurate, and made of true copies with audit trails where needed; QA reviewed before anything left the building; nothing was altered to send it; the response met the deadline (or a timely, documented extension was agreed); and an exact copy of what was sent is retained. If you cannot later reconstruct precisely what the agency received, the response was not controlled.
7. References
Section 704(a)(4) of the Federal Food, Drug, and Cosmetic Act (records or other information in advance of or in lieu of an inspection), added for drugs by FDASIA (2012) and extended to devices and bioresearch monitoring by FDORA (2022). FDA guidance, Conducting Remote Regulatory Assessments, Questions and Answers (finalized 26 June 2025). 21 CFR Part 11 (electronic records and signatures); 21 CFR 211.180 and 211.194 (records). FDA guidance, Data Integrity and Compliance With Drug CGMP (2018).
Confirm the current version and clause numbers of each reference before issue.
8. Filled specimen
An illustrative completed intake and production summary. The company, systems, and numbers are illustrative; replace them with your own.
| Field | Entry |
|---|---|
| Request reference | RR-2026-004 |
| Type | 704(a)(4) mandatory records request |
| Date received | 03 August 2026 |
| Stated deadline | 17 August 2026 |
| Scope | Batch records and CDS audit trails for lots 26-0611, 26-0624; last EM trend report for the fill suite |
| Ambiguity clarified | Confirmed “audit trails” meant the run-level CDS trails, in writing, 04 August |
| Assembled | 2 batch records, 2 CDS trail exports (certified copies), 1 EM trend report, rev current |
| QA review | Complete and accurate; sign-off S. Rao, 12 August |
| Produced | 13 August, via the secure portal specified; deadline met with margin |
| Retained | Exact copy of the sent package + transmittal timestamp filed under RR-2026-004 |
In this example the firm logged and scoped the request on arrival, clarified an ambiguity in writing before assembling, produced certified copies with the audit trails included, had QA review the package before it left, met the deadline with margin, and kept an exact copy of what was sent. That is a records request handled as the mandatory examination it is.
9. Common mistakes this checklist prevents
- Treating a records request as lower stakes than a visit and missing the deadline.
- Sending an incomplete set on the assumption that a follow-up conversation will fix it.
- Producing records without QA review, so an inconsistency reaches the agency uncorrected.
- Not keeping an exact copy of what was sent, so the examination cannot be reconstructed later.
- Declining a voluntary RRA without realizing it can convert to an on-site inspection on short notice.
- Editing or completing a record to close a gap the assembly exposed, converting a deficiency into a data integrity finding.
10. How to adapt this checklist
- Set your tracking scheme, coordinator role, and escalation contacts.
- Point the cross-references to your real document-control, true-copy, and deviation procedures.
- Pre-map where each common record type lives, so scope-to-location mapping in section 2 is fast under a deadline.
- Confirm the statutory basis and guidance status in section 7 against the current source before issue.