ISO 13485 · Expert · 15 min lesson
Mock FDA inspection and inspection-readiness audit
FDA QMSR (21 CFR Part 820), ISO 13485:2016 clauses 4.2.4, 7.3.10, 8.2.2 and 8.5.2, section 704 of the FD&C Act, 21 CFR Part 11
What you will learn
- Plan a mock inspection with a front room and a back room, a request log and a daily debrief.
- Audit complaint, CAPA, design control and production records the way an investigator asks for them under the QMSR.
- Handle document requests and responses, including electronic records under 21 CFR Part 11, and write up readiness gaps.
Key takeaways
- Since 2 February 2026 the QMSR incorporates ISO 13485:2016 into 21 CFR Part 820, so a mock inspection tests ISO 13485 clauses with the FDA's reading of them.
- A mock inspection copies the real one: a front room that meets the investigator, a back room that finds records, a request log and a daily debrief.
- Complaint, CAPA, design and production records are tested by pulling a record and following it end to end, including the medical device reporting decision.
- Answer only what is asked, with the record asked for, and log every request with its time of receipt and time of delivery.
- Readiness gaps are graded and fixed before the real visit, and the closing meeting is rehearsed too.
Free practice question
Verdane's host brings the investigator the complaint list from the shared drive. The back room later finds that the spreadsheet in complaints holds four more entries.
What should the mock lead record?
Nothing, because the investigator accepted the first list.
Not quite. Acceptance does not remove the control gap under clause 4.2.5 that the mock exists to find.
Two sources of the complaint list disagree, so the controlled list is not defined; the firm must name one record of complaints.
Correct. Clause 8.2.2 and clause 4.2.5 expect controlled records, and two diverging lists undermine them.
A finding against the complaint handler for typing speed.
Not quite. Typing speed is irrelevant; the gap is an undefined controlled record under clause 4.2.5.
A positive point, because two lists give redundancy.
Not quite. Two disagreeing lists create doubt about completeness, which section 820.35 and clause 4.2.5 aim to prevent.
Key terms
- QMSR: The amended 21 CFR Part 820, effective 2 February 2026, which incorporates ISO 13485:2016 by reference.
- front room: The place where the investigator sits with the host, scribe and subject experts, and where all answers are given.
- back room: The support team that finds, checks and copies records before they are handed to the front room.
- Form FDA 483: The list of inspectional observations given to management at the end of an inspection.
- medical device file: The ISO 13485 clause 4.2.3 file per device type or family that replaces the old device master record idea.
- audit trail: A secure, time stamped record of who created, changed or deleted an electronic record, expected by 21 CFR Part 11.
Official sources
- FDA - Quality Management System Regulation (QMSR) overview
- eCFR - 21 CFR Part 820, Quality Management System Regulation
- eCFR - 21 CFR Part 11, Electronic Records; Electronic Signatures
- FDA - QMSR frequently asked questions
Go further
The full lesson has narrated slides, more scenario questions with explained answers and a simulation.
Open the AcademyWatch on YouTubeIllustrative example. Educational only, not legal advice.