Definition

A regulatory inspection triggered by specific concerns, such as safety issues, compliance complaints, or signals of potential violations.

Example

A for-cause inspection is initiated after multiple late expedited reports are detected in regulatory databases, suggesting systemic compliance issues.

Regulatory source

EU GVP Module III, FDA Compliance

Common mistakes

Not treating for-cause inspections with appropriate urgency or failing to understand the triggering concern.

Inspector question

What circumstances might trigger a for-cause inspection of your operations?

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