FDA pauses facility inspections due to omicron variant

The U.S. FDA has put certain inspectional activities on hold through Jan. 19 in response to the rapid spread of the omicron variant of COVID-19. The FDA announced the pause on Dec. 29, but said they plan to continue “mission-critical inspections,” including those taking place abroad, as the agency continues monitoring conditions.

According to the FDA, changes were implemented to ensure the “safety of its employees and those of the firms it regulates.” The agency will continue using remote and other alternative tools for oversight of food, drugs, medical products and tobacco as they have done throughout the pandemic after previous pauses.

The “Resiliency Roadmap for FDA Inspectional Oversight,” published by the FDA on May 5, 2021 outlines which inspections are considered mission-critical. Some of the qualifications include facilities manufacturing human and animal food, human and animal medical products and tobacco, and facilities whose product is related to FDA’s COVID-19 response.

The Roadmap was created to address the backlogs caused by initial disruptions in facility inspections at the start of the pandemic. A report released by the Government Accountability Office in January 2021 found the FDA was facing a major backlog of facility inspections. According to the GAO, the total number of inspections of foreign and domestic facilities was 56% lower in 2020 than in 2018 and 2019. The FDA conducted only 52 domestic inspections between March and October 1, 2020 compared to about 400 inspections in the same time period in each of the two years prior.

The FDA has struggled with inspection backlogs, and concerns about delays in drug applications and approvals are increasing.

The agency hopes to restart inspection activities “as soon as possible.”