GAO Releases a Critical Assessment of FDA’s Ability to Inspect

Jan. 10, 2025

The agency is not inspecting 49% of high-risk domestic facilities, 74% of low-risk ones and 95% of the foreign facilities it’s been charged with regulating, according to the Government Accountability Office’s report to Congress.

Dave Fusaro

The U.S. Government Accountability Office (GAO) on Jan. 8 released a lengthy and critical assessment of the FDA’s efforts to safeguard the country’s food supply, focusing on the agency’s inability to meet targets for domestic and foreign facility inspections. Manpower shortages were the main culprit.

The title of the report is a good summary: “Food Safety: FDA Should Strengthen Inspection Efforts to Protect the U.S. Food Supply.”

“FDA has not met FSMA’s [the 2011 Food Safety Modernization Act] mandated targets for domestic food facility inspections since fiscal year 2018 [the first year the agency started tracking its performance]. In addition, FDA has consistently fallen short of meeting its annual targets for foreign food facility inspections,” the report says in its “key takeways.”

Not even close. Citing FDA’s own data, the report says FDA did not inspect or attempt to inspect about 7% of high-risk domestic food facilities in fiscal year 2019. That percentage rose to 40% and 49% in 2020 and 2021, respectively.

The shortfall was even greater for non-high-risk facilities. From fiscal year 2020 through fiscal year 2021, the percentage of non-high-risk facilities that FDA did not inspect by their required dates increased from about 38% to nearly 74%.

Wait, it gets worse. “The data show that FDA conducted an average of 917 foreign food safety inspections each year — about 5% of its target of 19,200 inspections,” the report states.

To be fair, 2020-2022 was the Covid pandemic, when a lot of in-person visits for all of us didn't happen.

GAO does acknowledge the enormity of FDA’s job. At the end of fiscal year 2023, there were about 75,000 domestic food facilities that were subject to FDA inspection, including more than 17,000 high-risk facilities (about 23%). Plus those 19,200 foreign locations.

FSMA directs FDA to inspect each domestic high-risk food facility at least once every three years and each non-high risk food facility at least once every five years.

Those inspections are expensive and time-consuming. “A routine domestic inspection typically takes from 1 to 4 days to complete depending on the facility’s size, the type of food at the facility, and the investigator’s familiarity with the facility,” according to the report. “FDA officials stated that, as of August 2024, the average cost of inspecting a domestic high risk facility was about $28,600 while the average cost of inspecting a domestic non-high-risk facility was about $14,900.

“Further, FDA officials told us that, on average, each foreign inspection typically takes from 2 to 5 days to complete and costs about $38,700.”

And while the report notes some of the agency’s critical workforce issues, “FDA has taken steps to address significant and long-standing workforce capacity challenges but has not determined the appropriate size or workload of its foreign investigator cadre.”

GAO is an independent, nonpartisan watchdog that provides auditing, evaluative and investigative services for the U.S. Congress, “ensuring accountability, integrity, and reliability in the federal government.” Congress is the recipient of this report.

The GAO report will recommend, “Congress should consider directing FDA to conduct an analysis to determine the annual number of foreign food facility inspections sufficient to ensure the safety of imported food and communicate this number and FDA’s underlying analysis to Congress. [Then] Congress should consider updating the annual target for the number of foreign food facility inspections.”

And there were three recommendations to the leadership of FDA:

The Commissioner of FDA should take steps to determine the appropriate size and workload of its foreign investigator cadre for the purpose of meeting FDA’s foreign inspection goals and ensuring FDA’s ability to safeguard imported food.
The Commissioner of FDA should identify and implement additional procedures to minimize incidences of attempted [but unsuccessful] inspections of domestic food facilities.
The Commissioner of FDA should develop and implement a performance management process that includes defining the desired results of FDA’s food safety inspection efforts, collecting performance information on these efforts, and using this information to assess performance, inform FDA decision-making and communicate to Congress and the public about results. Specific elements of this process could include, but not be limited to, data and information on FDA’s progress in recruiting and retaining food safety investigators and in minimizing incidences of attempted inspections.”

Again, the full report is here (https://www.gao.gov/assets/gao-25-107571.pdf).

About the Author

Dave Fusaro | Editor in Chief

Dave Fusaro has served as editor in chief of Food Processing magazine since 2003. Dave has 30 years experience in food & beverage industry journalism and has won several national ASBPE writing awards for his Food Processing stories. Dave has been interviewed on CNN, quoted in national newspapers and he authored a 200-page market research report on the milk industry. Formerly an award-winning newspaper reporter who specialized in business writing, he holds a BA in journalism from Marquette University. Prior to joining Food Processing, Dave was Editor-In-Chief of Dairy Foods and was Managing Editor of Prepared Foods.