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Understanding the Preapproval Inspection Experience: Expect a Team
July 30, 2008
When pharmaceutical or device manufacturers apply for premarket approval of a new product, the FDA must conduct a preapproval inspection. During the inspection, field officers from the agency’s Office of Compliance must inspect sites to ensure that the active drug substance and final drug product manufacturers, as well as the testing and packaging facilities, operate in compliance with current good manufacturing practice (GMP) guidelines.