FDA Inspection Simulator
Rehearse an FDA Inspection Before the Real One
Your advisor plays the investigator. Document requests run on the clock, your back room produces from your own library, interviews are scored for answer discipline, and practice observations are listed at closeout in a 483-style list.
A practice exercise run by your advisor. Never an FDA document, and never presented as one.
Document requests
| ID | Request | Clock | Status |
|---|---|---|---|
| R-07 | Three closed CAPA records with effectiveness checksMeasurement, Analysis, and Improvement | 00:42:10 | In back room |
| R-06 | Quality agreement for sterilization supplierOutsourcing and Purchasing | 00:18:55 | Produced |
| R-05 | Process validation for the sealing processProduction and Service Provision | 01:05:30 | Returned: not adequate |
| R-04 | Minutes of the two most recent management reviewsManagement Oversight | 00:12:04 | Accepted |
| R-03 | Change log for the inspection periodChange Control | 00:09:41 | Accepted |
Why Rehearse
Inspections Test How You Produce Records, Not Just Whether They Exist
FDA usually gives about five days' notice of a routine inspection, and none for a for-cause one. Then the investigator presents a Form 482 Notice of Inspection, and from that moment, how quickly and cleanly your team finds the right record, checks it and hands it over shapes the whole inspection. So does how process owners answer questions.
Since February 2, 2026, FDA inspects device manufacturers under the Quality Management System Regulation and Compliance Program 7382.850. Inspections are risk-based, start from your risk management documentation, and can now include your internal audit, management review and supplier audit records.
Most quality software helps you store and approve documents. Most tools don't let you practice producing them under time pressure, with someone pushing back. The simulator does.
6
QMS areas from CP 7382.850
4
Other applicable FDA requirements
41
Preloaded document requests
23
Preloaded interview questions
How a Session Runs
From Opening Meeting to Closeout
A session follows the shape of a real inspection, so the habits your team builds carry over.
- 01
Scope the Exercise
Choose the inspection type to rehearse, the products and sites in play, and which compliance areas to cover. As in a real inspection, the exercise starts from your risk management documentation.
- 02
Open the Inspection
The advisor opens with a simulated notice of inspection and an opening meeting, so your front room and back room practice the first hour, which sets the tone.
- 03
Issue Document Requests
The advisor issues requests drawn from the preloaded library for each area, or writes new ones. Each request starts a response clock that everyone can see.
- 04
Produce From the Back Room
Your back room finds the document in your QMSAdvisor library, reviews it and produces it to the investigator. Nothing leaves without a second look.
- 05
Accept or Return
The advisor accepts each production or returns it as not adequate, with a reason, exactly the friction a real investigator creates.
- 06
Interview Process Owners
Management and process owners answer interview questions. The advisor scores each answer for discipline and notes where the answer and the records disagree.
- 07
Close Out
Practice observations, held back during the drill so the team works without hints, are listed together in a 483-style list, with a simulated NAI, VAI or OAI outcome and the scorecard.
- 08
Turn Observations Into Work
Each practice observation converts to a finding in your action plan with an owner, a due date and an evidence checklist.
Scope
Scoped by the Areas in CP 7382.850
Every compliance area comes with preloaded document requests and interview questions. They are our practice material, written in the style an investigator might use, not text quoted from FDA. Your advisor adds requests specific to your products and history.
Six QMS Areas
01Management OversightHow top management directs, resources and reviews the quality system.
Document requests
- Quality policy, quality objectives and how progress against them is measured
- Organization chart with quality responsibilities and authorities
- Minutes and outputs of the two most recent management reviews
- Internal audit schedule and the reports issued in the last cycle
- Quality manual or equivalent description of the QMS scope
Interview questions
- Walk me through your last management review. What inputs were reviewed and what actions came out of it?
- How do you know your quality objectives are being met?
- Who has the authority to stop a shipment, and when was that authority last used?
02Design and DevelopmentPlanning, inputs, outputs, verification, validation, transfer and design changes.
Document requests
- List of design projects active or completed in the inspection period
- Design and development plan for a selected product
- Traceability from design inputs to outputs, verification and validation
- Design review records, including attendees and independent reviewer
- Design transfer records and the risk management file for the same product
Interview questions
- How did you decide that design validation covered the intended users and use environments?
- Show me where a hazard in the risk file is linked to a verified control.
- Who signs off design transfer, and what do they check before they sign?
03Change ControlHow changes to product, process and the QMS are assessed, approved and verified.
Document requests
- Change control procedure and the change log for the inspection period
- Three change records, including the risk assessment for each
- Verification or validation performed before each change was implemented
- The documented assessment of whether a change needed a new submission
Interview questions
- Pick a recent change. How did you decide whether it needed revalidation?
- How do you make sure a change to a supplier's process reaches your change control?
- Who decides whether a change affects a regulatory submission?
04Measurement, Analysis, and ImprovementComplaints, nonconformances, CAPA, data analysis and internal audit.
Document requests
- Complaint log for the inspection period and five complaint files
- CAPA log and three closed CAPA records with effectiveness checks
- Nonconforming product reports and their dispositions
- Trend analysis of quality data and the actions it led to
- Internal audit reports and the follow-up on their findings
Interview questions
- How do you decide whether a complaint needs an investigation?
- Show me how you verified that this corrective action was effective.
- What quality data do you trend, and who looks at it?
05Outsourcing and PurchasingSupplier selection, controls over outsourced processes and purchased product.
Document requests
- Approved supplier list with the risk basis for each supplier's controls
- Supplier evaluation and selection records for critical suppliers
- Quality agreements for outsourced processes
- Supplier audit reports and supplier corrective action requests
- Incoming acceptance records for a recent lot of a critical component
Interview questions
- How did you decide how much control to apply to this supplier?
- What happens when a critical supplier changes its process?
- When did you last audit this supplier, and what did you find?
06Production and Service ProvisionProduction and process controls, validation, labeling, packaging and servicing.
Document requests
- Production records for a recently released lot
- Process validation for a special process, with revalidation criteria
- Equipment maintenance and calibration records for the line
- Environmental monitoring records where the product requires them
- Labeling and packaging inspection and release records
- Servicing records and how they feed complaint handling
Interview questions
- Walk me through how this lot was released. Who checked what?
- How do you know this validated process is still in a validated state?
- How do you prevent the wrong label from reaching the line?
Four Other Applicable FDA Requirements
07Medical Device ReportingIdentifying, evaluating and reporting reportable events.
Document requests
- MDR procedure
- Complaints evaluated for reportability, with the decision and rationale
- MDR reports submitted in the inspection period
Interview questions
- Who decides whether a complaint is reportable, and how is that decision documented?
- Show me a complaint you decided was not reportable and why.
08Corrections and RemovalsField actions, their reporting and the records behind them.
Document requests
- Procedure for corrections and removals
- Records of field actions in the inspection period
- Reports submitted, or the documented reason a report was not required
Interview questions
- When did you last correct or remove product in the field, and how did you decide whether to report it?
09TrackingTracking of devices where FDA has ordered it.
Document requests
- Whether any of your devices are subject to tracking, and the procedure if so
- Tracking records and the results of any audit of the tracking system
Interview questions
- If a tracked device had to be located today, how would you find it?
10Unique Device IdentificationUDI on labels and in records, and the data submitted for each device.
Document requests
- Labels showing the UDI for a selected device
- Device identifier data submitted for that device
- How UDI is captured in production, distribution and complaint records
Interview questions
- How do you make sure the UDI on the label matches the data you submitted?
Interviews
Interviews Scored for Answer Discipline
Good answers are short, true and backed by a record. Your advisor scores every interview answer against five habits and notes where an answer and a procedure disagree.
- 01
Answer What Was Asked
A direct answer to the question, then stop. Volunteering adjacent topics widens the inspection.
- 02
Point to the Record
Name the procedure or record that shows it, and let the back room produce it.
- 03
Don't Speculate
If you don't know, say so and commit to finding out. A guess becomes a statement.
- 04
Stay in Your Role
Speak for the processes you own. Hand off cleanly when the question belongs to someone else.
- 05
Match the Documents
What you say should agree with what the procedure says. Gaps between the two are a common source of observations.
Closeout
Practice Observations, a Simulated Outcome and a Scorecard
Real FDA investigators usually discuss observations as they go, then list them on a Form 483 at closeout. The simulator holds practice observations back until closeout so your team works without hints, then lists them together in a 483-style list. The exercise ends with a simulated classification on FDA's scale: NAI (No Action Indicated), VAI (Voluntary Action Indicated) or OAI (Official Action Indicated).
The simulated outcome is not a prediction. It shows your team where this exercise would have landed, so the stakes are concrete.
- On-time responses
- Share of document requests produced within their response clock.
- Median response time
- Typical time from request to production, across all requests.
- Slowest request
- The request that took longest to produce, and why.
- Outstanding
- Requests still open or returned as not adequate at closeout.
- Interview score
- Answer discipline across all interviews, scored by the advisor.
Primary Sources
On-time responses
18 of 22
Median response
24 min
Slowest request
R-05, 1 h 52 m
Outstanding
2
Interview score
3.6 / 5
Practice observations
Simulated outcome VAI- 01Process validation for the pouch sealing process did not define revalidation criteria.Convert to finding
- 02Complaint records did not document the reportability decision for two complaints reviewed.Convert to finding
- 03Supplier controls for the contract sterilizer were not based on a documented risk assessment.Convert to finding
After the Exercise
Every Observation Becomes a Finding
A rehearsal is only worth what it changes. Each practice observation converts into a finding in your action plan, and from there it follows the same advisor-reviewed path as any other gap.
Convert
The advisor converts a practice observation into a finding with severity, gap type and the requirement behind it.
Assign
The finding gets an owner, a due date and a checklist of what to submit to close it.
Close With Evidence
Your team submits evidence, and the advisor accepts it or returns it with a note. Every step is in the activity history.
What the Simulator Is Not
- It is not an FDA inspection, and nothing it produces is an FDA document.
- The practice observations are not Form 483 observations.
- The simulated NAI, VAI or OAI outcome is not a prediction of a real classification.
- It does not guarantee any inspection outcome. QMSAdvisor is not affiliated with the FDA.
Questions
Questions About the Simulator
Is the simulator an FDA tool or an FDA document?
No. It is a practice exercise run by your QMSAdvisor advisor. The practice observations and the simulated classification are training material, not FDA findings, and they are never presented as anything else.
Who plays the investigator?
Your advisor. They scope the exercise, issue the document requests, decide whether each production is adequate, run the interviews and write the practice observations.
Does the simulated outcome predict our real inspection?
No. It shows where the exercise would have landed on FDA's NAI, VAI and OAI scale given what the advisor saw, so your team can see the stakes. A real classification is FDA's decision, based on a real inspection.
Do we need to have our documents in QMSAdvisor first?
Yes. The back room produces documents from your QMSAdvisor library, which is how the response clock and the scorecard work. Your documents stay as they are; they're uploaded, not migrated.
Can we run it for a single area, like CAPA or supplier controls?
Yes. The exercise is scoped by compliance area, so you can rehearse one area in depth or run a full inspection across all of them.
What happens to the practice observations?
Each one can be converted into a finding in your action plan, with an owner, a due date and an evidence checklist, so the rehearsal turns straight into remediation work your advisor tracks to closure.
Mock FDA Inspection
Book a Mock Inspection With Your Advisor
Tell us which inspection you expect and when, and an advisor will scope a mock inspection around your products and history. Please don't send confidential documents yet: secure upload is set up after onboarding.
