Delaware MPJE Practice Exam

Form FDA 482 is primarily utilized as a Notice of Inspection. When the U.S. Food and Drug Administration (FDA) intends to conduct an inspection of a facility, whether it is a pharmaceutical manufacturer, a compounding pharmacy, or another relevant entity, the FDA inspector presents this form to officially notify the facility of the inspection.

This form serves critical functions, including outlining the authority under which the inspection is being conducted and detailing the regulatory framework that governs the FDA's inspection processes. Through this notification, the facility becomes aware that an inspection is taking place, which allows for the necessary preparation and facilitates compliance with FDA regulations.

Understanding the purpose of Form FDA 482 is essential for recognizing how the inspection process is initiated and the types of interactions that regulated businesses have with the FDA, which ultimately supports the safety and efficacy of drugs on the market.