Government Accountability Office finds problems with FDA inspection rates

In response to a report from the Government Accountability Office, the FDA says the biggest stumbling block to conducting inspections of food facilities is understaffing.

The Food and Drug Administration hasn’t met targets for inspections of domestic and foreign food facilities since 2018, according to the Government Accountability Office (GAO). The FDA is responsible for 80 percent of the U.S. food supply, including domestic and imported food.

The FDA conducted thousands of routine surveillance food safety inspections of domestic and foreign food facilities from fiscal year 2018 through fiscal year 2023. 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’s inspections are a proactive tool aimed at preventing food safety problems rather than reacting to outbreaks after they happen,” according to the GAO report.

The Food Safety Modernization Act directs the FDA to inspect each high-risk domestic food facility at least once every three years and non–high-risk facilities every five 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,” the report said. 

“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 shows that in fiscal years 2020 and 2021, the percentage increased to 40 percent and 49 percent, respectively.”

The annual target for FDA inspections is 19,200, according to the report. The most annual inspections of foreign food facilities occurred in 2019, with 1,727 inspections, or 9 percent of the annual target. 

“FDA considers the existing target to be unrealistic and unachievable,” the GAO wrote. “However, FDA has not identified an appropriate annual target and communicated this information to Congress, as we recommended in January 2015.”

FDA officials have said that inspector understaffing is its greatest barrier to meeting inspection targets. 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,” the GAO said in its report.

For the most part, the FDA agreed with the GAO report. Two specific recommendations that the agency agreed with were that: 

• Congress direct the FDA to determine the annual number of foreign food facility inspections needed to ensure the safety of imported food and communicate this information back to Congress, which should use the data to update the FDA’s annual foreign inspection target.
• The FDA determine the appropriate size and workload of its foreign investigators, identify and implement more procedures to minimize the number of attempted inspections of domestic food facilities, and develop and implement a formal performance-management process focused on food safety inspections. 

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