Trends and Perspectives

The mission of the Office of Inspector General (OIG), as mandated by Public Law 95-452, is to protect the integrity of the Department of Health and Human Services programs as well as the health and welfare of beneficiaries served by them. This statutory mission is carried out through a nationwide program of audits, investigations, inspections, sanctions, and fraud alerts. The Inspector General informs the Secretary of program and management problems and recommends legislative, regulatory, and operational approaches to correct them. The Office of Evaluation and Inspections (OEI) is one of several components of the Office of Inspector General. It conducts short-term management and program evaluations (called inspections) that focus on issues of concern to the Department, the Congress, and the public. The inspection reports provide findings and recommendations on the efficiency, vulnerability, and effectiveness of departmental programs. PURPOSE To determine (1) why the number of Food and Drug Administration (FDA) warning letters has decreased in recent years, (2) what accounts for variations in district office warning letters, and (3) how firms view the warning letter process. BACKGROUND The FDA is the Federal agency charged with enforcing the Federal Food, Drug, and Cosmetic Act and related laws. At the headquarters level, FDA primarily is comprised of five centers and the Office of Regulatory Affairs. The Office of Regulatory Affairs coordinates compliance activities and oversees FDA's 5 regional offices, 20 district offices, and 130 resident posts. The FDA's district offices and resident posts conduct almost all inspections of the firms that FDA regulates. When investigators find objectionable conditions, they are required to provide the firm with their findings using form FDA-483. If violations uncovered during an inspection meet a threshold of " regulatory significance, " FDA also may issue a warning letter. Both FDA centers and district offices issue warning letters, depending on the type of firm and violation. Some warning letters issued by the district office require headquarters review and approval. The warning letter generally represents FDA's first official notification that it has found one or more products, practices, processes, or other activities that are in violation of the Food, Drug, and Cosmetic Act. The warning letter affords firms the opportunity to voluntarily correct violations prior to the initiation of formal enforcement action. District offices issue approximately 80 percent of all warning letters. The number of warning letters issued varies greatly, and concerns have been raised about this variation as well …