Introduction
The Office of Compliance (OC), in FDA's Center for Drug Evaluation and Research (CDER), works to ensure that drug manufacturers produce drug products in compliance with regulations and that adhere to good manufacturing practices (GMPs) as defined by FDA regulations. This work is accomplished in large part through the development of compliance programs used by FDA field offices during inspections and by providing guidance to industry on meeting FDA's expectations and regulatory requirements.
From a public health perspective, OC makes sure a U.S. manufactured drug product is uniform and a person who uses the product is getting what was prescribed. From a regulatory perspective, OC works to ensure the purity, strength and quality of drug products. The office reviews, advises, monitors and drafts responses to regulatory actions submitted to FDA headquarters by FDA field offices.
