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Challenges Remain in FDA's Inspections of Domestic Food Facilities


Each year roughly 48 million people in the United States get sick, 128,000 are hospitalized, and 3,000 die of foodborne diseases. To protect against foodborne illnesses, FDA inspects food facilities to ensure both food safety and compliance with regulations. Congress passed the Food Safety Modernization Act (FSMA), which enabled FDA to focus more on preventing food safety problems rather than reacting to them after the fact. FSMA requires FDA to inspect domestic food facilities within certain timeframes.


We analyzed data from four sources: (1) information about facilities that FDA designated high risk and non-high risk pursuant to FSMA, and whether these facilities were inspected as required; (2) FDA's food facility inventory and inspection data from 2010 to 2015; (3) information about FDA's advisory and enforcement actions, such as warning letters and seizures, taken in response to significant inspection violations, as well as whether followup inspections were conducted for these violations, and; (4) structured interviews with FDA officials.


FDA is on track to meet the domestic food facility inspection timeframes for the initial cycles mandated by FSMA; however, challenges remain as FSMA requires FDA to conduct future inspections in timeframes that are 2 years shorter than the timeframes for the initial cycles. Also, inaccuracies in FDA's domestic food facility data result in FDA attempting to inspect numerous facilities that are either out of business or otherwise not in operation at the time of the visit. Although FDA is on track to meet the FSMA inspection mandates during the initial cycles, this did not result in a greater number of facilities being inspected. In fact, the overall number of food facilities FDA inspected decreased over time. In addition, FDA did not always take action when it uncovered significant inspection violations-those found during inspections classified as "Official Action Indicated" (OAI). When it did take action, it commonly relied on facilities to voluntarily correct the violations. Also, it rarely took advantage of the new administrative tools provided by FSMA. Moreover, FDA's actions were not always timely nor did they always result in the correction of these violations. Further, FDA consistently failed to conduct timely followup inspections to ensure that facilities corrected significant inspection violations.


We recommend that FDA (1) improve how it handles attempted inspections to ensure better use of resources, (2) take appropriate action against all facilities with significant inspection violations, (3) improve the timeliness of its actions so that facilities do not continue to operate under harmful conditions, and (4) conduct timely followup inspections to ensure that significant inspection violations are corrected. FDA concurred with all four recommendations.