Definition

An inspection triggered by a specific concern, such as suspected fraud, serious adverse events, data integrity issues, or recall. Can be unannounced.

Example

A spike in product complaints or a whistle-blower allegation may trigger a for-cause inspection at a site.

Regulatory source

FDA Compliance Program, EMA inspection procedures

Common mistakes

Not having a rapid response plan. Destroying or altering documents when an inspection is announced.

Inspector question

What is your procedure when you receive an inspection notice or when inspectors arrive unannounced?

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