FDA Inspections and Enforcement
Mock FDA Inspection
The best time to learn that your back room can't produce a supplier file is during practice. In a mock FDA inspection, an advisor plays the investigator in the FDA Inspection Simulator, and every observation becomes a finding you can fix before an investigator arrives.
What You Receive
- 01Practice Observation List
- 02Simulated Outcome
- 03Document Request Record
- 04Interview Scorecards
- 05Findings in Your Action Plan
Every finding is reviewed and approved by a qualified QMS advisor before it reaches you.
What It Is
A mock inspection tests what a document review can't: whether your team can run an inspection under pressure. The advisor acts as the investigator, scopes the exercise by CP 7382.850 areas, issues document requests with response clocks and interviews your subject matter experts. Your back room produces documents from the library while the front room manages the conversation.
Interviews are scored for answer discipline: answering the question that was asked, showing evidence rather than describing it from memory, staying within one's own process, and saying 'I'll check' instead of guessing. Those habits matter as much as the records, and they're hard to build without practice.
At closeout, the advisor reveals practice observations in a 483-style list along with a simulated NAI, VAI or OAI outcome. The exercise is clearly marked as practice and is never an FDA document. Each observation converts into a finding in your action plan, with an owner, a due date and the evidence that closes it.
When You Need It
- Your inspection SOP and room roles have never been exercised end to end.
- New subject matter experts are likely to be interviewed and have never faced an investigator.
- You've finished readiness work and want to test it under realistic conditions.
- A prior inspection exposed slow or incomplete document retrieval.
- Leadership wants a realistic picture of how an inspection would unfold before an investigator shows up.
What We Do
- 01
Scope the Exercise
We choose the CP 7382.850 areas, products and processes to cover, usually weighted toward your highest-risk areas or prior findings.
- 02
Open the Inspection
The advisor arrives as the investigator, your front room runs its opening procedure, and the exercise starts from your risk management documentation.
- 03
Issue Document Requests on the Clock
Requests arrive with response clocks running. The back room retrieves, reviews and produces documents from the library, and the simulator records how each request was handled.
- 04
Interview Subject Matter Experts
The advisor questions process owners on areas such as complaints, CAPA, design changes and supplier controls, scoring each interview for answer discipline.
- 05
Close Out With Practice Observations
The advisor presents practice observations in a 483-style list with a simulated NAI, VAI or OAI outcome, then debriefs the team on what worked and what didn't.
- 06
Convert Observations to Findings
Each observation becomes a finding in your action plan, so the fixes are tracked through to accepted evidence.
Deliverables
Practice Observation List
A 483-style list of practice observations from closeout, clearly marked as a practice exercise and not an FDA document.
Simulated Outcome
A simulated NAI, VAI or OAI classification with the advisor's reasoning.
Document Request Record
Every request, how quickly it was answered, and whether what was produced actually answered it.
Interview Scorecards
Answer discipline scores and coaching notes for each interview.
Findings in Your Action Plan
Observations converted into tracked findings with owners, due dates and evidence requirements.
How the Platform Helps
FDA Inspection Simulator
Scoped by CP 7382.850 areas, with document requests, response clocks, scored interviews and a simulated outcome in one place.
Back Room Works From the Library
Your team produces documents from the same library it would use in a real inspection, so retrieval practice is real practice.
Observations Become Findings
Practice observations flow into the action plan, so nothing from the debrief gets lost in a slide deck.
Audits and Inspections It Prepares You For
Mock Audit and Mock Inspection
A realistic practice inspection, with an advisor playing the FDA investigator, before the real one arrives.
FDA Baseline Surveillance Inspection
FDA's comprehensive surveillance inspection of your quality system under Compliance Program 7382.850.
FDA For-Cause Inspection
An FDA inspection prompted by specific information, such as complaints, MDRs or recalls, and focused on it.
FDA Non-Baseline Surveillance Inspection
A focused FDA surveillance inspection that goes deep on selected QMS areas under Compliance Program 7382.850.
FDA PMA Pre-Approval Inspection
An FDA inspection tied to a PMA application that checks your quality system and its match to the submission.
FDA Foreign Facility Inspection
FDA inspection of a manufacturer outside the US that makes devices for the US market.
Standards and Regulations in Scope
Questions About This Service
Is anything produced in the mock inspection an FDA document?
No. The simulator and everything it produces are practice materials. The 483-style list and the simulated NAI, VAI or OAI outcome exist to help your team prepare and carry no regulatory status.
Who plays the investigator?
A QMS advisor plays the investigator, scoping the exercise by CP 7382.850 areas and questioning your team the way an inspection would. Your own staff run the front room and back room, just as they would for a real inspection.
Does a good mock result predict a real inspection?
No. A real inspection is shaped by the investigator, your products and the issues in front of them, and the outcome is FDA's decision. A mock inspection shows where your team and records are weak so you can work on those areas first.
Should we do readiness work first?
Usually, yes. A mock inspection is most useful once major documentation gaps are closed, because it tests execution. If you run one early, expect many observations to point back to gaps a readiness assessment would also have found.
Can we run more than one?
Yes. Some firms run a second exercise after remediation, focused on the areas that drew observations the first time, to confirm the fixes hold up under questioning.
Request an Assessment
Discuss Mock FDA Inspection With an Advisor
Tell us about your devices, your documents and your timeline, and an advisor will scope the work with you. Please don't send confidential documents yet: secure upload is set up after onboarding.
