GAO finds persistent challenges in FDA’s ability to hire and retain inspectors

The US Food and Drug Administration (FDA) needs a better long-term plan for attracting and retaining inspectors besides offering better pay to address high staff turnover and rebuild its ability to complete foreign and domestic inspections, according to new report by the US Government Accountability Office (GAO).

For the report, GAO interviewed FDA officials about their efforts to maintain a staffing sufficient pool as well as their experiences conducting in-person inspections. The audit was conducted from April 2023 to November 2024.

FDA conducted 621 foreign and 444 domestic inspections in fiscal year (FY) 2023, which was 36% lower than in FY 2019, according to the report FDA attributed the decrease to “reduced investigator capacity.”

The number of vacancies on the inspection staff continues to grow, going from 25 vacancies in November 2021 to 55 in fiscal year (FY) 2022 to 73 in 2023. In FY 2024, partial data shows that 51 jobs remained unfilled, GAO wrote in the report, which was required under the Consolidated Appropriations Act of 2023.

According to FDA, these vacancies, along with the resulting large number of relatively inexperienced investigators, have limited the number of drug inspections they can complete. These finding generally echo an earlier report, which found that the ability to hire and train investigators is contributing to a decline in foreign inspections, (RELATED: FDA’s inspection backlog: GAO raises concerns as delays mount, Regulatory Focus 9 March 2021).

GAO said that despite FDA’s identifying some of the root causes of investigator attrition and having some strategies underway to address them, the agency needs to do more.

For example, FDA’s Office of Regulatory Affairs (ORA), now called the Office of Inspections and Investigations (OII), is now paying investigators more. FDA has expanded the use of Title 21 hiring authorities to cover all investigators, “which allows them to offer a higher maximum salary than is available under the traditional General Schedule pay system.”

GAO notes that “changing internal and external factors” since the pandemic have further exacerbated issues of travel, workload, and work-life balance. For example, FDA’s increased use of inspection reports from European regulators has reduced the need to conduct inspections in Europe. As a result, a larger proportion of foreign trips are to India and China which increases travel time and “hardship” for investigators.

In addition, officials noted that since the pandemic many non-investigator jobs offer telework or remote work opportunities, which may offer better work-life balance.

GAO said that “FDA has not yet developed action plans to fully address travel, workload, and work-life balance because potential solutions may not allow FDA to meet its inspection needs. However, the continued loss of experienced investigators is already affecting FDA’s ability to meet inspection goals. Therefore, developing and implementing action plans to address these remaining root causes will help FDA maintain the experienced workforce it needs to oversee global drug manufacturing. “

GAO report

GAO finds persistent challenges in FDA’s ability to hire and retain inspectors

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