FDA 483s: Inspectional Observations

This course is designed to familiarize FDA staff with the important aspects of the FDA 483. Topics in this course include: FDA 483, Objectionable Conditions, Reportable Conditions, Essentials, and Annotation. After completing this course, you will recognize the purpose of issuing an FDA 483. You will be able to identify what kinds of inspectional observations are included on an FDA 483, when that form is issued to the inspected firm, and how to annotate it during the discussion with management.

After this course learners will be able to recognize the purpose of issuing an fda 483. identify what kinds of inspectional observations are included on an fda 483, when it is issued to the inspected firm, and how to annotate it during the discussion with management.