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Inspection readiness/US
What happens at an FDA inspection after clearance?
A founder-friendly guide to post-clearance inspection questions, quality system evidence, complaint files, and review preparation.
Direct answer
Clearance is not the end of the operating burden. After market entry, FDA inspection questions may reach design controls, production controls, complaint handling, corrective and preventive action, labeling, servicing, medical device reporting, and records.
A useful first step is to build a review map that shows where each record lives, who owns it, and what public or customer signal would trigger review.
Use this if
Reader
A founder or operator preparing for post-clearance operational responsibility
Trigger
The team is moving from clearance planning into selling, supporting, and maintaining records
Blocked decision
What quality and post-market evidence should be review-ready
Useful output
A practical post-clearance inspection-readiness map
Do these first
- List the records that support design, production, complaint, and post-market decisions.
- Map who owns each record and when it is reviewed.
- Connect complaint and support data to risk and corrective-action review.
- Prepare a plain-language inspection briefing for founders and operators.
What to collect before you ask for help
- Design history file, device master record, and labeling controls.
- Complaint, service, support, and return records.
- Risk management and corrective-action records.
- Training records and supplier controls.
Common mistakes
- Thinking clearance means inspection readiness is optional.
- Leaving complaint and support knowledge outside the quality review loop.
- Treating inspection prep as a document scramble instead of an operating system.
Public sources to start with