WASHINGTON — The Food and Drug Administration (FDA) has fallen short of its facility inspection targets, according to the Food Safety: FDA Should Strengthen Inspection Efforts to Protect the US Food Supply report recently published by the US Government Accountability Office (GAO).

Using data recorded between fiscal year 2018 and fiscal year 2023, the GAO examined how well the FDA has safeguarded the United States’ food supply, issuing determinations as to whether the agency is meeting annual domestic and foreign food inspection targets set by the Food Safety Modernization Act (FSMA).

The report stated that 75,000 domestic food facilities were subject to FDA inspection under FSMA at the end of fiscal year 2023, with more than 17,000 of those facilities being high risk and nearly 58,000 being non-high risk.

The GAO said the FDA failed to meet its domestic targets, inspecting each high-risk facility at least once every three years and each non-high-risk facility at least once every five years, since fiscal year 2018.

“According to FDA data, in fiscal year 2019 FDA did not inspect — or attempt to inspect — about 7% of high-risk domestic food facilities by their cover-by date, as required by FSMA,” the report said. “However, the data show that in fiscal years 2020 and 2021, this percentage increased to 40% and 49%, respectively. According to FDA data, an even greater increase occurred for non-high-risk facilities. For example, from fiscal year 2020 through fiscal year 2021, the percentage of non-high-risk facilities that FDA did not inspect by their cover-by dates increased from about 38% to nearly 74%.”

Meanwhile, the FMSA requires the FDA to inspect 19,200 foreign food facilities per year. The GAO report determined the FDA did not meet its foreign inspection targets between fiscal year 2018 and fiscal year 2023.

“According to our analysis of FDA data, the number of foreign inspections FDA conducted annually from fiscal year 2018 through fiscal year 2023, the most recent year with complete data, represents a fraction of its target,” the report said. “Specifically, 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 for this period.”

The GAO also created a list of the top five types of foods inspected by the FDA between fiscal year 2018 and fiscal year 2023, divided by domestic inspections and foreign inspections. Bakery products were ranked No. 2 in domestic inspections (behind seafood products) and No. 5 in foreign inspections (behind seafood, fruit, vegetable and cheese).

The FDA said it has undertaken several measures to correct these errors, such as increasing staffing levels and retaining qualified investigators, but the GAO noted in the report that it does not believe these measures are sufficient. Despite the FDA claiming that 19,200 foreign inspections a year is not a realistic goal, it could not determine the appropriate number of investigators for foreign inspections, the report said.

“FDA officials were not able to tell us whether 20 investigators is an appropriate size for its foreign cadre, or whether the current workload ratio between the foreign and domestic cadres is optimal for conducting the highest possible number of annual foreign inspections,” the report said.

Furthermore, the GAO said the FDA did not sufficiently address performance concerns. While the FDA claimed to use a three- and five-year mandate for inspecting domestic facilities and developing an annual target for these inspections, it did not create a similar target for foreign inspections.

“FDA officials stated they have taken steps in recent years to identify the number of foreign inspections the agency can realistically conduct each year as part of its annual planning process,” the report said. “For example, FDA projected it would be able to conduct 1,008 total foreign inspections in fiscal year 2024 based on its existing capacity and resources. While useful for FDA’s planning purposes, this process focuses on the number of inspections FDA has the capacity to conduct rather than, more importantly, the number FDA should be conducting to best ensure the safety of imported food.”

In the report, the GAO recommended that Congress should direct the FDA to conduct an analysis to determine an annual foreign inspection target.

“Congress should consider, upon receiving the relevant information and analysis from FDA, updating the annual target for the number of foreign food facility inspections FDA should conduct to ensure the safety of imported food,” the report said.

The GOA also gave the FDA three recommendations: determine the appropriate size and workload of its foreign investigation team, conduct analysis to determine the right number of foreign inspections to be conducted per year, and develop a performance management process for assessing its own inspection efforts.

“FDA has a critical mission to ensure the safety of the food that Americans consume,” the report said. “Food safety inspections are an essential proactive tool in meeting this mission. FDA has taken steps to ensure its inspections effectively safeguard the US food supply, including prioritizing high-risk food facilities for inspection and reorganizing its Human Foods Program to better support agency personnel responsible for conducting inspections. However, FDA has not determined the appropriate size or workload of its current foreign investigator cadre, which inhibits FDA’s ability to plan its overall foreign inspections.”