Audits and Inspections
Every Audit and Inspection a Device Maker Faces
FDA inspections, certification and regulatory audits, and the customer, supplier and internal audits in between. For each one: what it is, who conducts it, what triggers it, what gets examined and how to prepare.
How FDA Inspects Now
QMSR and Compliance Program 7382.850
On February 2, 2026, FDA stopped using QSIT. Device QMS inspections now follow Compliance Program 7382.850, "Inspection of Medical Device Manufacturers". Inspections are risk-based and start from your risk management documentation. Inspection types include baseline, non-baseline surveillance, compliance follow-up, for-cause, and PMA pre-approval and postmarket inspections.
Routine domestic inspections are usually pre-announced about five days ahead, and for-cause inspections may not be. Either way, the inspection opens with a Form 482 Notice of Inspection. Observations are listed on a Form 483 at closeout, and FDA later classifies the inspection as NAI, VAI or OAI.
Areas in CP 7382.850
Six QMS areas
- 01Management Oversight
- 02Design and Development
- 03Change Control
- 04Measurement, Analysis, and Improvement
- 05Outsourcing and Purchasing
- 06Production and Service Provision
Four other applicable FDA requirements
- 07Medical Device Reporting
- 08Corrections and Removals
- 09Tracking
- 10Unique Device Identification
FDA Inspections
| Audit or Inspection | Conducted By | In Brief |
|---|---|---|
| FDA Baseline Surveillance Inspection | FDA investigators | FDA's comprehensive surveillance inspection of your quality system under Compliance Program 7382.850. |
| FDA Non-Baseline Surveillance Inspection | FDA investigators | A focused FDA surveillance inspection that goes deep on selected QMS areas under Compliance Program 7382.850. |
| FDA For-Cause Inspection | FDA investigators | An FDA inspection prompted by specific information, such as complaints, MDRs or recalls, and focused on it. |
| FDA Compliance Follow-Up Inspection | FDA investigators | An FDA inspection verifying that corrective actions promised after earlier findings are done and working. |
| FDA PMA Pre-Approval Inspection | FDA investigators | An FDA inspection tied to a PMA application that checks your quality system and its match to the submission. |
| FDA BIMO (Clinical Investigation) Inspection | FDA investigators under the Bioresearch Monitoring program | FDA inspection of a clinical investigation's sponsor, monitors, investigators or IRB under 21 CFR Part 812. |
| FDA Foreign Facility Inspection | FDA investigators | FDA inspection of a manufacturer outside the US that makes devices for the US market. |
Certification and Regulatory Audits
| Audit or Inspection | Conducted By | In Brief |
|---|---|---|
| ISO 13485 Certification Audit (Stage 1 and Stage 2) | A certification body you engage | The Stage 1 and Stage 2 audits a certification body runs before granting ISO 13485 certification. |
| ISO 13485 Surveillance Audit | Your certification body | The periodic audits, at least annually, that support continued ISO 13485 certification between renewals. |
| ISO 13485 Recertification Audit | Your certification body | The pre-expiry audit that reviews the whole ISO 13485 system and how it performed over the three-year cycle. |
| MDSAP Audit | An auditing organization recognized under MDSAP | One audit by a recognized auditing organization that covers several participating regulators, including FDA. |
| EU Notified Body Audit (Including Unannounced Audits) | A notified body designated under the EU MDR or IVDR | Conformity assessment, surveillance and unannounced audits by an EU notified body under the MDR or IVDR. |
Customer, Supplier and Internal Audits
| Audit or Inspection | Conducted By | In Brief |
|---|---|---|
| Customer Audit | Your customer's quality or supplier quality team, or a third party acting for them | A customer's audit of your quality system, often a device maker auditing a supplier or contract manufacturer. |
| Supplier Audit | The manufacturer's supplier quality or quality team, or a qualified third party acting for it | Audits you perform of your own suppliers and contract manufacturers as part of purchasing controls. |
| Internal Audit | Your own trained auditors, or an independent auditor acting for you | Audits your own team runs of your quality system, now open to FDA inspection under the QMSR. |
| Mock Audit and Mock Inspection | A QMSAdvisor advisor playing the investigator | 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. |
Next Step
Tell Us What's Coming and When
An inspection date, a certification audit or a customer audit: an advisor will scope readiness work around it. Please don't send confidential documents yet: secure upload is set up after onboarding.
