An FDA inspection of a medical device company’s quality management system (QMS) means heightened scrutiny and potential compliance issues. The best way to prepare is to maintain an efficient QMS on a daily basis, rather than rushing to clean things up at the last minute.
Since February 2026, medical device manufacturers have had to prepare for FDA inspections under the updated FDA regulation 21 CFR Part 820, now known as the Quality Management System Regulation (QMSR).
This post explains how to prepare for an FDA inspection of your QMS in practice and what to expect during and after an inspection. You’ll learn what is meant by inspection-readiness, explore what changed under QMSR, and discover 7 tips on how to prepare for FDA inspections of your QMS.
What is FDA inspection readiness?
Being inspection-ready means your company is prepared to face an FDA visit today and able to show that its QMS meets the requirements set out by the QMSR regulation. Having the right procedures in place is only part of this; staff need to understand their responsibilities, while the QMS records need to show how the company deals with problems.
Mock inspections are useful to show where the process breaks down. Choose a recent issue and ask someone to find the records without advance notice. If they lose the trail, you know where work is needed. Running this exercise regularly leaves time to fix the problem before an FDA inspection takes place.
What has changed with FDA inspections under QMSR?
QMSR took effect on February 2, 2026. One of its main changes was to bring ISO 13485:2016 into 21 CFR Part 820. For manufacturers already working to the international standard, much of the new US system may therefore look familiar. However, FDA-specific rules remain.
QMSR organizes the inspection process around six connected QMS areas:
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Change control
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Design and development
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Management oversight
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Measurement, analysis and improvement
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Outsourcing and purchasing
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Production and service provision
The FDA may look beyond the six core QMS domains during an inspection. Depending on the device and reason for the visit, this could include Medical Device Reporting or any corrections and removals. The FDA may review device tracking separately, along with Unique Device Identification.
If an issue occurred in the past, the investigator may follow it into other parts of the QMS to understand how the company corrected and managed the issue throughout the device’s lifecycle.
What should you expect during an FDA inspection?
Not every FDA inspection follows the same format or scope; it depends on the reason for the inspection, as well as the company's history and any risks related to its devices.
The FDA uses two inspection models:
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Model 1 is generally used when there is previous FDA inspection or Medical Device Single Audit Program (MDSAP) audit history. It can also focus on a particular complaint or concern.
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Model 2 is used for a baseline inspection where there is no previous FDA or MDSAP history. It may also be used for certain Premarket Approval inspections.
For a domestic inspection, the investigator presents their credentials and issues an official Notice of Inspection, known as Form FDA 482. The visit will normally include an opening meeting, a tour of the facility, employee interviews, document review, and a closing meeting.
The investigator will check that the daily work carried out by staff corresponds to the written procedures and records. During the closing meeting, the investigator will present any concerning findings for discussion, which may be recorded using Form FDA 483.
Records FDA can review under QMSR
Following the introduction of QMSR, an FDA investigator can now ask to see management reviews, quality audit reports, and supplier audit reports. These must therefore also be maintained to the same standard as the rest of the QMS. Records created prior to February 2, 2026 may also be reviewed, so legacy information must remain accessible.
How to prepare for an FDA inspection
Since FDA inspections can often come unannounced, it’s a good idea to always be prepared.
Review your compliance history
Review previous Form FDA 483 observations, warning letters, Medical Device Reports, complaints, and recalls. Confirm that planned actions were completed, addressed the full scope of the problem, and proved effective.
Keep records current
Complete records when the work occurs. Confirm that staff use approved procedures, obsolete versions cannot be used accidentally, and archived records remain retrievable. Include internal audits, supplier audits, and management reviews in this check.
Ensure staff know their role
Employees should be able to explain their responsibilities, training, procedures, records, and what they would do if they found a problem. Prepare them for the process, but do not give them scripts. They should answer from their own knowledge and seek clarification when necessary.
Test traceability and transparency
Tracking a past complaint or quality issue from start to finish can highlight any gaps in QMS procedures. An investigator should be able to see what happened, who dealt with it, and any actions that were taken to resolve it through detailed records. If any of this information is in an older system, check that the required employees still have access.
Plan for logistics and other practical arrangements
Decide in advance who will lead the inspection and stay with the investigator. Other staff can take notes or handle document requests, with specialists available when needed. If space allows, provide the investigator with a separate room from the team preparing responses. Make sure that reception and security also have a clear point of contact.
Test document retrieval
Give staff a few sample records to find. Check that they return the correct version and that nothing is missing. Include management and audit records in this exercise. Once the inspection begins, keep a log of each request, making sure to record the document supplied and its version number as well as the time it was handed over.
Ensure internal audits are as useful as possible
Use an internal audit to look at the facility through the eyes of an investigator, checking equipment status and product storage, and paying particular attention to outdated documents, notices or other materials and the procedures available to staff.
Remove any outdated notices to avoid confusion during a tour, along with other loose documentation. Agree in advance with your team how they should respond if an investigator asks to photograph a work area. When an audit identifies a problem, records need to show what happened next and whether the response was successful.
What to do during an FDA inspection
During an FDA inspection, staff should listen to what is being asked before responding based on their own knowledge. Some questions may need checking, in which case staff can refer to the procedure or bring in the person responsible for that area, but no one should guess an answer.
Each document given to the investigator needs to be logged, together with any concerns raised by the inspector. Update the log with agreed follow-up actions once the investigator leaves, so that your team knows what still needs to happen next.
What happens after an FDA inspection?
Review any Form FDA 483 observations while the visit is still fresh, using the closing discussion to understand why a problem occurred and whether it may extend elsewhere. An immediate correction may address what the investigator saw, but you should still perform a root cause analysis and Corrective and Preventive Actions (CAPA) to ensure an effective resolution and prevent recurrence.
The FDA encourages a written response to a Form FDA 483 within 15 business days. In your response, explain what has been done for each observation and, where work remains, state who is responsible and when it will be finished.
The FDA also classifies the inspection afterward. “No Action Indicated” means no further action is needed. “Voluntary Action Indicated” leaves the company to correct the identified problems on its own without any further oversight. “Official Action Indicated” means the FDA may proceed into formal action, which is far more serious.
How a digital QMS maintains continuous inspection readiness
The main benefit of an electronic system is that it automatically maintains a secure, auditable system where related records can be kept together, version control is easily traceable, and accountability is well documented.
If a complaint leads to a CAPA or change control, the team can follow that link. Training records and audit findings may provide further context, while the audit trail will also show when a record changed and who approved it.
The system still needs appropriate controls and must also meet the relevant 21 CFR Part 11 requirements. An eQMS can help a company make better use of its records, prompt users when they need to take action, alert management when procedures are not being followed, and make compliance more efficient, but it cannot recreate missing documentation or data.
Conclusion
Inspection readiness is easier when records are kept up to date as the work happens. If records are stored across different locations, piecing them together during an inspection can take time, which can be compounded if staff also need to confirm they have the latest approved procedures.
Scilife Smart QMS brings controlled documents and their supporting records into one place. Medical device manufacturers can use an eQMS to:
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Link quality issues and CAPAs to relevant audit findings and training documents
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Keep approved procedures available and records up to date
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Follow a quality issue into its investigation and see what action was taken
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Locate an approval history or audit trail without searching through other systems
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Collate all evidence when an investigator asks for it
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Ensure FDA inspection readiness is continuous across teams and sites
Keeping up with this work throughout the year gives your team time to address problems before they become inspection findings. When an FDA investigator arrives, there is less unfinished work to catch up o
