Regulatory Affairs Certification (RAC) Practice Exam

Which of the following is NOT true for an FDA inspection of a manufacturing facility?

1. A notice of inspection FDA 482 form is presented to the facility upon arrival

2. The FDA investigator provides inspectional report with the FDA 483 form

3. The FDA investigator provides an FDA 484 form to describe samples taken during the inspection

4. The credentials of the FDA investigator can be photocopied for filing at the facility

The correct answer is: The FDA investigator provides inspectional report with the FDA 483 form

The assertion that an FDA investigator provides an inspectional report with the FDA 483 form is not accurate because the FDA 483 is not considered a final inspection report. Instead, the FDA 483 form is issued when an investigator observes conditions that may constitute violations of the Food Drug and Cosmetic Act during an inspection. This document serves to communicate concerns or observations directly to the facility but does not provide a comprehensive report of the entire inspection process or outcomes. In standard FDA practices, the notice of inspection (FDA 482 form) is indeed presented upon arrival, indicating the purpose and scope of the inspection. The FDA 484 form is used to document samples collected during an inspection, ensuring that there is a clear record of which items were taken and their associated details. Additionally, the ability to photocopy the credentials of the FDA investigator is a standard practice that allows the facility to maintain documentation of the official inspector for compliance purposes and future reference. This distinction regarding the purpose and function of the FDA 483 form emphasizes its role as an initial notification of issues rather than a conclusive report on compliance. Thus, the misunderstanding lies in interpreting the nature of what the FDA 483 represents within the context of an FDA inspection.