Definition

The form FDA uses to document inspectional observations of conditions that may constitute violations of regulations.

Example

Form 483 observation: 'Written procedures for handling adverse drug experiences are not followed. Specifically, 12 of 50 reviewed expedited reports were submitted late.'

Regulatory source

FDA Compliance

Common mistakes

Not providing timely and comprehensive response to 483 observations.

Inspector question

Describe your process for responding to FDA Form 483 observations.

Related terms