Per US FDA, Corrective and Preventive Action is defined as a sub-system to collect information, analyze data, identify and investigate product and quality problems, and take appropriate and effective corrective and/or preventive action to avoid recurrence. Verifying or validating corrective and preventive actions, communicating corrective and preventive action activities to responsible people, providing relevant information for management review, and documenting these activities are essential in dealing effectively with product and quality problems, preventing their recurrence, and preventing or minimizing device failures.
How does FDA Train its Inspectors?
