What does Form FDA 483 indicate?

Form FDA 483 is an official document issued by the Food and Drug Administration (FDA) during an inspection of a facility. It reports any observations made by the FDA officials regarding violations of the Federal Food, Drug, and Cosmetic Act and related regulations. The purpose of the form is to bring these observations to the attention of the appropriate individuals so they can take corrective actions.

When the form lists the inspectional observations, it serves as a warning to the inspected entity that certain practices may need to be addressed to achieve compliance with regulatory requirements. Thus, the correct answer identifies the primary function of Form FDA 483, which focuses on documenting the inspector's findings regarding compliance during an inspection. This follows a standard procedure in which manufacturers and other entities can respond to and rectify the identified issues before any further action, such as warning letters or sanctions, is taken by the FDA.