The FDA continues to face significant staffing shortages in its drug inspection workforce, according to a new report from the Government Accountability Office.
Despite some progress in resuming in-person inspections after COVID-19 disruptions, the report showed that the FDA is struggling to keep pace with the growing demand for oversight, particularly in foreign drug manufacturing.
The GAO's findings highlight that while the FDA conducted 621 foreign and 444 domestic inspections in fiscal 2023, the total number of inspections was still 36% lower than pre-pandemic levels in 2019. The agency attributes the shortfall to reduced investigator capacity, exacerbated by high attrition rates within its inspection workforce.
As of May 2024, the FDA had not yet fully addressed the root cause of the investigator turnover. However, FDA officials acknowledged that the lack of experienced inspectors is limiting the agency's ability to meet inspection goals.
To address the issue, the GAO recommended that the FDA collaborate with other stakeholders to develop comprehensive action plans to address the root causes of investigator attrition.
While the FDA agreed with the recommendation, continued vacancies and high turnover may delay the agency's ability to restore full oversight capacity, the report said.