Definition

An observation of non-compliance or deficiency identified during a regulatory inspection, categorized by severity (critical, major, minor).

Example

A major finding: 'The company failed to submit 5 expedited reports within required timeframes during the inspection period, with delays ranging from 2-10 days.'

Regulatory source

EU GVP Module III, EMA Inspection Procedures

Common mistakes

Disputing findings without valid justification, or providing inadequate response and CAPA.

Inspector question

If I identify a finding during this inspection, what is your process for responding?

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