FDA Inspections and Enforcement
FDA Inspection Readiness (CP 7382.850)
Since February 2, 2026, FDA inspects device manufacturers under Compliance Program 7382.850 rather than QSIT. We prepare your system, your records and your people for an inspection organized around that program, starting where investigators now start: your risk management documentation.
What You Receive
- 01Readiness Status by CP 7382.850 Area
- 02Inspection SOP and Room Roles
- 03Document Request Process
- 04Advisor-Reviewed Findings and Action Plan
Every finding is reviewed and approved by a qualified QMS advisor before it reaches you.
What It Is
Compliance Program 7382.850, Inspection of Medical Device Manufacturers, groups requirements into six QMS areas: Change Control; Design and Development; Management Oversight; Measurement, Analysis, and Improvement; Outsourcing and Purchasing; and Production and Service Provision. It adds four other applicable FDA requirements: Medical Device Reporting, Corrections and Removals, Tracking, and UDI. Inspections are risk-based, and they start from your risk management documentation.
That changes how you prepare. If your risk files are disconnected from your complaints, nonconformances and design changes, an investigator will see it quickly and the inspection will follow the gap. Readiness means risk decisions that trace into the processes they should drive, and records behind them that your team can produce promptly and explain calmly.
QMSR also opened records that used to be shielded. Internal audit, management review and supplier audit records are now open to FDA inspection, because the former 820.180(c) exception was removed. Many firms wrote those records assuming no investigator would read them. We review them with that new reader in mind.
When You Need It
- You're due for a routine surveillance inspection and haven't been inspected since QMSR took effect.
- Complaints, MDRs, corrections or removals could prompt a for-cause inspection.
- A prior inspection ended with observations and a compliance follow-up inspection is likely.
- Your inspection SOP and front room and back room roles were never tested, or no longer match your organization.
- Your internal audit and management review records were written before FDA could inspect them.
What We Do
- 01
Start From Your Risk Management Files
We review your risk management documentation the way an investigator would, then trace risk decisions into complaints, nonconformances, CAPA, design changes and production controls.
- 02
Assess the Six QMS Areas and Other Requirements
Each of the six CP 7382.850 areas and the four other FDA requirements gets a readiness status, backed by advisor-reviewed findings from your documents and sampled records.
- 03
Build the Inspection Playbook
We write or revise your inspection SOP: who greets the investigator and receives the Form 482, who leads the front room, how the back room retrieves, reviews and logs documents, and how each request is tracked to delivery.
- 04
Prepare Records Now Open to FDA
We review internal audit, management review and supplier audit records for accuracy, clarity and follow-through, since FDA can now ask to see them.
- 05
Coach the People Who Will Be Questioned
Subject matter experts practice answering the question asked, showing evidence rather than describing it from memory, and saying when they need to check.
- 06
Close Gaps Before an Investigator Arrives
Findings go into the action plan by severity, and the advisor reviews evidence as owners close them.
Deliverables
Readiness Status by CP 7382.850 Area
A view across the six QMS areas and the four other FDA requirements, showing where you're ready and where work remains.
Inspection SOP and Room Roles
A practical procedure covering arrival and the Form 482, front room and back room roles, document request handling and daily wrap-ups.
Document Request Process
A defined path for every request: logged, retrieved from the controlled source, reviewed before release and tracked to delivery.
Advisor-Reviewed Findings and Action Plan
Every gap with severity, owner, due date and the evidence that closes it.
How the Platform Helps
Document Library for the Back Room
Your documents already sit in one library with original files preserved, so the back room retrieves controlled copies instead of searching shared drives.
Action Plan by Severity
Readiness gaps are sorted by severity with owners and due dates, so the most significant work gets done first.
Practice in the FDA Inspection Simulator
When you're ready, the simulator runs a practice inspection scoped by CP 7382.850 areas, and its observations convert to findings in the same action plan.
Audits and Inspections It Prepares You For
FDA Baseline Surveillance Inspection
FDA's comprehensive surveillance inspection of your quality system under Compliance Program 7382.850.
FDA Non-Baseline Surveillance Inspection
A focused FDA surveillance inspection that goes deep on selected QMS areas 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 Compliance Follow-Up Inspection
An FDA inspection verifying that corrective actions promised after earlier findings are done and working.
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.
Supplier Audit
Audits you perform of your own suppliers and contract manufacturers as part of purchasing controls.
Mock Audit and Mock Inspection
A realistic practice inspection, with an advisor playing the FDA investigator, before the real one arrives.
Remote and Hybrid Audits
Audits and regulatory assessments run partly or fully through video, screen sharing and electronic records.
Standards and Regulations in Scope
Questions About This Service
Is QSIT still used?
No. On February 2, 2026 FDA stopped using QSIT for device QMS inspections. Inspections now follow Compliance Program 7382.850, which organizes requirements into six QMS areas plus four other applicable FDA requirements.
Why does the inspection start with risk management?
CP 7382.850 takes a risk-based approach, and inspections start from the firm's risk management documentation. Weak or disconnected risk files tend to steer attention toward the areas you're least prepared to defend.
Can FDA see our internal audit reports now?
Yes. Under QMSR, internal audit, management review and supplier audit records are open to FDA inspection, because the former 820.180(c) exception was removed. It's worth reviewing those records for accuracy and follow-through before an investigator does.
Do inspections come with advance notice?
Usually a little. FDA generally pre-announces routine device inspections by phone, usually at least five calendar days ahead, while for-cause inspections may come with no notice. The investigator presents a Form 482 (Notice of Inspection) on arrival. That's why the inspection SOP, room roles and document retrieval need to work on short notice.
Which inspection types does this cover?
Baseline and non-baseline surveillance inspections, for-cause inspections and compliance follow-up inspections. PMA pre-approval and BIMO inspections have a different focus, and we cover them as separate services.
Who decides how the inspection is classified?
FDA does. Inspections are classified NAI (No Action Indicated), VAI (Voluntary Action Indicated) or OAI (Official Action Indicated). Preparation helps you address weaknesses beforehand and handle the inspection well, but it can't determine the result.
Request an Assessment
Discuss FDA Inspection Readiness (CP 7382.850) 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.
