Strengthening FDA Inspection Efforts: A Look at the GAO Report
The U.S. Food and Drug Administration (FDA) shoulders the critical responsibility of safeguarding the safety of approximately 80% of the U.S. food supply, a daunting task given the scale of food production, importation, and consumption. Despite progress, challenges persist, as outlined in the January 2025 report from the U.S. Government Accountability Office (GAO), titled “Food Safety: FDA Should Strengthen Inspection Efforts to Protect the U.S. Food Supply” (GAO-25-107571). This report sheds light on the FDA’s inspection processes, its challenges, and its areas for improvement to ensure the safety of both domestic and imported food.
The report highlights the FDA’s reliance on the Food Safety Modernization Act (FSMA) of 2011, which mandates a risk-based approach to food safety inspections. Domestic facilities are categorized as high-risk or non-high-risk based on statutory factors, including compliance history and known safety risks of the food produced. High-risk facilities are inspected more frequently, with FSMA requiring inspections every three years, while non-high-risk facilities are inspected every five years. For foreign facilities, the FDA uses a similar risk-based framework, though they lack explicit risk categorization. The GAO emphasizes that foreign inspections are critical, as imported food constitutes a significant portion of the U.S. diet.
One striking finding is that the FDA has consistently fallen short of FSMA’s mandated targets for domestic inspections since fiscal year 2018. Similarly, it has conducted only a fraction of the annual 19,200 foreign inspections mandated by FSMA, averaging just 917 inspections per year. Workforce capacity challenges play a significant role in this shortfall. As of 2024, the FDA had 432 investigators, about 90% of its capacity, and nearly one-quarter of them were eligible for retirement. Moreover, it takes approximately two years to fully train new investigators, which exacerbates staffing shortages. These challenges are compounded by the FDA’s need to prioritize resources for emergencies, such as foodborne illness outbreaks.
The GAO report also highlights the inefficiencies associated with attempted domestic inspections, which account for nearly one-third of the FDA’s inspection attempts since 2018. These failed attempts, often due to facilities being closed or out of business, drain resources that could be allocated to more productive activities. For foreign inspections, logistical issues such as travel planning, visa acquisition, and language barriers further complicate the FDA’s ability to meet its targets.
Efforts to address these challenges include the FDA’s reorganization of its Human Foods Program, aimed at improving resource allocation and prioritization. The FDA has also initiated remote regulatory assessments during the COVID-19 pandemic to partially offset the inability to conduct in-person inspections. While these efforts have value, the GAO underscores that remote assessments do not count toward FSMA targets and should not replace on-site inspections.
The GAO recommends several actions to enhance FDA’s inspection capabilities. First, the FDA should determine the appropriate size and workload of its foreign investigator cadre and establish realistic annual inspection targets. The FDA’s current annual foreign inspection target of 19,200 is deemed unachievable given existing resources. The GAO suggests that Congress direct the FDA to conduct an analysis to establish a more feasible target and communicate these findings. Additionally, the FDA should implement procedures to minimize attempted domestic inspections and establish a formal performance management process to measure progress and inform decision-making.
The report also points to the importance of congressional support in updating FSMA’s targets for foreign inspections based on realistic workforce and resource constraints. Without such updates, the FDA will continue to struggle with unrealistic goals, hampering its ability to ensure the safety of imported food.
In conclusion, while the FDA has made strides in modernizing its food safety oversight, significant gaps remain in its ability to meet inspection targets and optimize resource use. Addressing these challenges will require a collaborative effort between the FDA and Congress to redefine inspection targets, invest in workforce development, and enhance performance management. The stakes are high, as foodborne illnesses continue to pose a significant public health threat, impacting millions of Americans annually. By strengthening its inspection framework, the FDA can better protect the nation’s food supply and public health.
Disclaimer: This blog post summarizes information from the GAO report GAO-25-107571. It is intended for informational purposes only and does not guarantee accuracy or provide legal advice. For detailed insights and recommendations, consult the original GAO report.
