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.
1. Intake and logging
2. Scope confirmation
3. Assembly under document control
4. Quality review before production
5. Production and retention
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.
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.
