Track I Inspection
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A Track I Inspection is a limitted inspection of a manufacturrs quality system performed by the FDA every two years.
Routine inspections generally include a review of the following firm activities:
- Submissions and changes to cleared 510(k)'s
- Complaint handling processes
- Medical Device Reporting
- Device Tracking
- Failure investigations
- In-process and finished device testing
- Change Control Procedures
- Process Validation
- Component Control
- Planned and periodic audits
- Recalls
- Corrective and preventive actions
- Written procedures
