ABSTRACT
A preapproval inspection is a visit by regulatory authority inspectors (generally from the District officer of FDA) to review the compliance, in terms of adequacy and accuracy of the information included in a regulatory submission (Compliance Program Guidance Manual, Program 7346.832). The preapproval inspection program has evolved over the years in response to the fraudulent submissions to the U.S. Food and Drug Administration (FDA) by the the generic drug industry.
