AS PART OF THE Food and Drug Administration (FDA) Bioresearch Monitoring Program, the FDA routinely conducts clinical study- oriented inspections of high enrollment clinical sites used in support of New Drug applications. These inspections are designed to validate clinical studies on which drug approval maybe based and to assure that the rights and welfare of the human subjects in those studies are protected. The first notice of the FDA’s concern is usually the FDA483 issued during the inspection. A lack of an adequate response to the 483 could result in the issuance of a Warning Letter.

A WARNING LETTER is a serious notice to an investigator and demands development of effective corrective actions, with the threat of legal penalties if the actions are not impending. Serious repeat violators may be banned by the FDA from performing clinical research on FDA-regulated products. Additionally, the data from any clinical investigator’s site could be rejected from consideration in the FDA submission it is intended to support.