GAO: FDA Should Strengthen Inspection Efforts to Protect the U.S. Food Supply

The Food and Drug Administration (FDA) conducted thousands of routine surveillance food safety inspections of domestic and foreign food facilities from fiscal year 2018 through fiscal year 2023 (see fig.). According to GAO’s analysis of FDA data, FDA conducted an average of 8,353 domestic inspections per year and an average of 917 foreign inspections per year.

FDA has not met its domestic and foreign inspection targets since fiscal year 2018. The FDA Food Safety Modernization Act (FSMA) directs FDA to inspect each high-risk domestic food facility at least once every 3 years and each non-high-risk facility at least once every 5 years. GAO’s analysis of FDA data shows that FDA nearly met its mandated targets for both high-risk and non-high-risk domestic facilities in fiscal years 2018 and 2019, but faced significant challenges in meeting mandated targets beginning in fiscal year 2020—largely due to the COVID-19 pandemic. For example, according to FDA data, FDA did not inspect about 7 percent of high-risk domestic facilities due for inspection during fiscal year 2019. In contrast, the data show that in fiscal years 2020 and 2021, the percentage increased to 40 percent and 49 percent, respectively.

For foreign facility inspections, FDA conducted far fewer than the annual target of 19,200 inspections identified by FSMA, according to FDA data. For example, the highest annual number FDA completed was in fiscal year 2019 when FDA inspected 1,727 foreign facilities—about 9 percent of the annual target. FDA considers the existing target to be unrealistic and unachievable. However, FDA has not identified an appropriate annual target and communicated this information to Congress, as we recommended in January 2015.

FDA officials identified limited workforce capacity as FDA’s primary challenge to meeting inspection targets. FDA’s investigator cadre has remained understaffed for years. For example, in July 2024, FDA had a total of 432 investigators—90 percent of the full-time equivalent ceiling—for conducting both domestic and foreign inspections, according to FDA officials. Taking steps to determine the appropriate size of its foreign investigator cadre would help FDA better plan its foreign inspection efforts and, in turn, better ensure the safety of imported food for U.S. consumers.

FDA has not identified and implemented additional procedures for minimizing incidences where investigators attempt but are unable to complete an inspection. Doing so would better ensure the efficient use of FDA’s resources. FDA also does not yet have a formal performance management process focused on its food safety inspection efforts. Developing and implementing such a process would provide FDA with greater assurance the agency is achieving its goals. For example, FDA could develop goals and measures for use in assessing agency progress in recruiting and retaining investigators. Systematically collecting such performance information and using it to assess progress and inform decision-making would assist FDA in its efforts to safeguard the U.S. food supply and protect the Americans who rely on it.

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Republished with permission from Bill Marler and Marler Clark. Copyright (c) Marler Clark LLP, PS. All rights reserved.