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The Impact of the COVID-19 Pandemic on FDA's Domestic Food Facility Inspections

Food facility inspections are one of the Food and Drug Administration's (FDA's) most effective preventive tools for protecting public health. The Food Safety Modernization Act (FSMA) requires FDA to inspect domestic food facilities at regular intervals, based on risk. Domestic food facilities designated as high-risk are required to be inspected every 3 years, whereas non-high-risk facilities are required to be inspected every 5 years. The COVID-19 pandemic curtailed FDA's ability to conduct required food facility inspections in 2020 and 2021 as scheduled, impacting its ability to meet FSMA mandates. This review will look at the impact of COVID-19 on FDA's domestic food facility inspections, the extent to which FDA has completed food facility inspections within required timeframes, and how FDA has addressed the backlog created by the COVID-19 pandemic. Even prior to the pandemic, OIG found that FDA faced challenges in meeting its required inspection timeframes and that FDA did not always conduct timely followup of violations identified. This review will also determine the extent to which FDA identified significant violations, and whether FDA conducted followup inspections to see if these significant violations were corrected.

Announced or Revised Agency Title Component Report Number(s) Expected Issue Date (FY)
June 2023 Food and Drug Administration The Impact of the COVID-19 Pandemic on FDA's Domestic Food Facility Inspections Office of Evaluation and Inspections OEI-02-23-00300 2024