Definition

Observation or deficiency raised during a regulatory PV inspection; may be critical, major, or minor. Requires CAPA and follow-up.

Example

Finding: Inadequate training records for case processors.

Regulatory source

EMA GVP Module I, FDA inspection procedures

Common mistakes

Disputing findings without evidence or not closing CAPAs on time.

Inspector question

Describe a recent inspection finding and how you addressed it.

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