FDA Inspections
FDA Baseline Surveillance Inspection
A baseline inspection is FDA's comprehensive look at your quality management system. Since February 2, 2026 it runs under Compliance Program 7382.850 and the QMSR, so the investigator starts from your risk management documentation and follows it into every part of the system.
At a Glance
- Conducted by
- FDA investigators
- Notice
- Usually pre-announced about five days ahead; begins with Form 482
- Framework
- Compliance Program 7382.850 and the QMSR (21 CFR Part 820)
- Scope
- Broad coverage of the six QMS areas plus MDR, corrections and removals, tracking and UDI
- Possible outcome
- Observations on Form 483; NAI, VAI or OAI classification
What It Is
Baseline inspections are the comprehensive form of FDA's routine surveillance of device manufacturers. Rather than chasing a single issue, the investigator samples broadly across the quality management system to form a picture of how well it works as a whole.
Under Compliance Program 7382.850, which replaced QSIT on February 2, 2026, the inspection is risk-based. It starts from your risk management documentation and uses what it finds there to decide which records, processes and products to pull. Coverage is organized around six QMS areas (Change Control; Design and Development; Management Oversight; Measurement, Analysis, and Improvement; Outsourcing and Purchasing; Production and Service Provision) plus four other FDA requirements: Medical Device Reporting, Corrections and Removals, Tracking, and UDI.
Because the QMSR incorporates ISO 13485:2016 by reference, the investigator is checking your system against ISO 13485 requirements plus FDA-specific additions such as 820.35 (records, including complaint and servicing records and UDI) and 820.45 (labeling and packaging controls). Internal audit, management review and supplier audit records are now open to inspection as well.
Who Conducts It
FDA investigators conduct the inspection. For a domestic firm, FDA generally calls ahead, usually at least five calendar days before, and the inspection opens when the investigator presents credentials and a Form 482 Notice of Inspection to the person in charge at the site.
On your side, the people who matter are the head of quality or management representative who hosts, a scribe who logs every request and answer, a back room that retrieves and checks records, and the process owners who will be interviewed.
What Triggers It
- FDA's routine, risk-based surveillance of registered device manufacturers
- Your establishment is registered with FDA and makes devices for the US market
- Your first inspection under the QMSR, where records written for the old Part 820 structure are read against ISO 13485 terms
- Substantial changes since your last inspection (new products, processes or facilities) that make broad readiness essential
What They Look At
Risk Management as the Starting Point
Investigators read your risk management file first and use it to choose what to sample. Weak links between hazards, risk controls, design outputs and production controls show up early.
Management Oversight
Quality policy and objectives, management review inputs and outputs, resources, and whether leadership acts on what the system reports. Management review records are open to inspection under the QMSR.
Design and Development
Design inputs and outputs, verification and validation, design transfer and design changes, traced back to the risks they control.
Change Control
How changes to design, processes, suppliers and documents are evaluated, approved, validated where needed and communicated, including changes made since your last inspection.
Production and Service Provision
Process controls and validation, equipment, work environment, identification and traceability, labeling and packaging controls under 820.45, and servicing.
Outsourcing and Purchasing
Supplier selection and evaluation, purchasing controls, quality agreements and monitoring of outsourced processes. Supplier audit records can be requested.
Measurement, Analysis, and Improvement
Complaint handling, nonconforming product, CAPA, internal audit and data analysis, and the records that link them together.
MDR, Corrections and Removals, Tracking and UDI
Reportability decisions on complaints, Part 806 reports and records, device tracking where it applies, and UDI data on labels and in records.
How to Prepare
- 01
Start With Your Risk Management File
Read it the way an investigator will. Check that it's current, that it links to design outputs, production controls and postmarket data, and that someone can walk through it confidently.
- 02
Map Records to the Six QMS Areas
Build an index that puts procedures and recent evidence for each area, and for the four other FDA requirements, within easy reach of the back room.
- 03
Clean Up Open CAPAs and Complaints
Old open items with no progress notes read as a system that isn't working. Update them, close them with effectiveness evidence, or document why they remain open.
- 04
Read Your Internal Audit and Management Review Records
Assume FDA will read them now that the 820.180(c) exception is gone. Check that findings were followed through and that the records say what actually happened.
- 05
Set Up the Front Room and Back Room
Name the host, scribe, runners and subject-matter experts. Agree how requests are logged, reviewed before release and tracked to delivery.
- 06
Rehearse Interviews
Practice short, accurate answers with the people who own each process, including what to say when they don't know.
Common Pitfalls
- Treating the inspection like a QSIT walkthrough. Under CP 7382.850 the risk file drives sampling, so a stale risk file steers investigators toward your weakest areas.
- Procedures still written around the old Part 820 section structure, with no mapping to ISO 13485 terms or the FDA-specific additions.
- Internal audit reports written on the assumption FDA would never see them, with candid findings and no follow-through.
- Releasing documents without a quick quality check, so drafts, superseded versions or unrelated records reach the investigator.
- Complaints never evaluated for MDR reportability, or evaluated without a documented rationale.
- Subject-matter experts who volunteer opinions or guess instead of answering the question asked.
How QMSAdvisor Helps
- An AI-assisted gap analysis over the documents you already have, organized by the six CP 7382.850 QMS areas and the four other FDA requirements, with every finding reviewed by an advisor.
- Advisor-reviewed findings tied to their source document and location, with severity, owner, due date and a clear list of what evidence to submit.
- An action plan sorted by severity, so the risk file, CAPA backlog and complaint files get attention first.
- A full-scope session in the FDA Inspection Simulator, with document request clocks and interview scoring, before the real investigator arrives.
FDA Inspection Readiness (CP 7382.850)
FDA device inspection preparation built around Compliance Program 7382.850 and its risk-based approach.
Mock FDA Inspection
A practice FDA inspection in our Inspection Simulator, with an advisor playing the investigator.
QMSR Transition
Bringing a QSR-era or ISO 13485 quality system in line with FDA's QMSR, which is now in effect.
AI-Assisted QMS Gap Assessment
An AI-assisted first pass over the QMS documents you already have, with every result reviewed by an advisor.
Standards and Regulations Involved
Questions About the FDA Baseline Surveillance Inspection
How is a baseline inspection different from a non-baseline one?
A baseline inspection samples broadly across the quality system, while a non-baseline surveillance inspection is more focused. Both run under Compliance Program 7382.850 and both start from your risk management documentation. FDA decides the type, so prepare every area rather than guessing.
Will FDA tell us in advance?
FDA generally pre-announces routine device inspections by phone, usually at least five calendar days ahead, and the investigator presents a Form 482 Notice of Inspection on arrival. For-cause inspections may come with no notice. Five days isn't long, so plan as if you'll have less: records indexed, roles assigned and an inspection procedure people have actually practiced.
Does FDA still use QSIT?
No. FDA stopped using QSIT on February 2, 2026, when the QMSR took effect. Device QMS inspections now follow Compliance Program 7382.850, organized around six QMS areas plus four other FDA requirements.
Can the investigator read our internal audit reports?
Yes. Under the QMSR, internal audit, management review and supplier audit records are open to FDA inspection because the former 820.180(c) exception was removed. Write them, and close out their findings, with that in mind.
What happens at the end of the inspection?
The investigator holds a closeout meeting and, if there are observations, issues a Form 483. FDA later classifies the inspection as NAI, VAI or OAI. For a written 483 response to be considered, it should reach FDA within 15 business days after the inspection closes.
Related Audits and Inspections
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.
Mock Audit and Mock Inspection
A realistic practice inspection, with an advisor playing the FDA investigator, before the real one arrives.
Request an Assessment
Prepare for Your FDA Baseline Surveillance Inspection With an Advisor
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