World of Compliance Module

Surveillance

The compliance inspection program includes both a surveillance and a "for cause," in addition to a pre-approval, component. As part of the surveillance program, OC provides information to FDA field offices on the types of inspections of manufacturing facilities that should be performed on an annual basis. The selection of these sites is determined through a risk-based selection model that uses criteria identified as raising the public health risk from the products made by different manufacturers and firms. FDA field office investigators do inspections. If it appears that a warning letter or other legal action is indicated, a copy of the report from the inspection (FDA-483) is sent to the FDA district compliance branch.