FDA’s Food Safety Inspections Struggle Amid Staffing Shortfall

The FDA has failed to meet its mandated targets for domestic and foreign food safety inspections since fiscal 2018, the US Government Accountability Office said in a report Wednesday.

Thousands of routine food safety inspections of domestic and foreign food facilities were conducted by the Food and Drug Administration from fiscal 2018 through fiscal 2023, but the agency has fallen short in inspection targets to ensure the safety of nearly 80% of the nation’s food supply, according to the federal watchdog’s report.

The Food Safety Modernization Act identifies an annual target of 19,200 foreign facility inspections conducted by the FDA. However, FDA data show the agency has conducted far fewer.

From fiscal 2018 through fiscal 2023, the agency conducted an average of 917 foreign inspections per year and 8,353 domestic inspections per year.

The highest annual number of foreign facility inspections the FDA completed was in fiscal 2019 when the agency inspected 1,727, which is about 9% of the annual target.

The law also directs the agency to inspect each high-risk domestic food facility at least once every three years and each non-high-risk facility at least once every five years.

The report found the agency did not inspect—or attempt to inspect—about 7% of high-risk domestic facilities due for inspection during fiscal year 2019. That increased to 40% and 49% in fiscal years 2020 and 2021.

FDA officials told the GAO that they struggle with a limited workforce capacity because the agency’s investigator cadre has remained understaffed for years.

The agency also said it considers existing foreign inspection targets to be “unrealistic and unachievable.”

Challenges of meeting the mandated targets began in fiscal 2019 due to a 35-day government shutdown and in fiscal 2020 due to the Covid-19 pandemic.

The watchdog office recommends Congress consider directing the FDA to determine the annual number of foreign food facility inspections needed. Once received, lawmakers should consider updating the FDA’s foreign inspection annual target, according to the report.

The GAO also recommends that the FDA determine the appropriate size and workload of its foreign investigator cadre; identify and implement additional procedures to minimize incidences of attempted inspections of domestic food facilities; and develop and implement a formal performance management process on food safety inspection efforts.

Attempted inspections occur when FDA investigators attempt to conduct an inspection of a food facility, but the inspection cannot be completed.

The FDA agreed with the recommendations.

“FDA’s foreign inspection goals are determined by available foreign investigator cadre resources,” the agency said in a letter to the GAO. “FDA will consider the appropriate size and workload of its foreign investigator cadre in light of the full range of regulatory oversight activities aimed at ensuring the safety of imported foods.”