FDA Inspections of Domestic Food Facilites

Each year, more than 300,000 Americans are hospitalized and 5,000 die after consuming contaminated foods and beverages. In order to protect the public health, the Food and Drug Administration (FDA) inspects food facilities to ensure food safety and compliance with applicable laws and regulations. Recent high-profile outbreaks of foodborne illness — such as the salmonella outbreak caused by insanitary conditions at a peanut processing plant in Georgia — have raised serious questions about FDA's inspections process and the agency's ability to protect the nation's food supply. In addition, many food safety experts believe that that the number of food facility inspections has been declining, even as the number of food facilities regulated by FDA is increasing. The Office of Inspector General of the US Department of Health and Human Services recently concluded a review which assesses the extent to which FDA: (1) conducts inspections of domestic food facilities; (2) identifies violations in food facilities and takes action against those food facilities; and (3) ensures that violations are corrected. We based this study on FDA's food facility inspection data, documentation on facility violations and followup activities, and structured interviews with FDA staff. Our review will identify trends and vulnerabilities within FDA's inspections process and will make a number of recommendations designed to improve FDA's inspections process. We anticipate that this report will be finalized in March of 2010.