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
bag
fda_public
created
Sun, 24 Jun 2012 14:48:05 GMT
creator
dirkjan
modified
Sun, 24 Jun 2012 14:48:05 GMT
modifier
dirkjan
tags
FDA
Term
creator
dirkjan