FDA postpones some inspectional activities amid omicron surge

Friday, January 7, 2022

Source: Medical Design & Outsourcing

The FDA announced earlier this week that it made some temporary changes to its inspectional activities due to COVID-19.

With the omicron variant of the virus causing surges across the world, the FDA implemented the changes in the U.S. on Dec. 29, 2021, to ensure the safety of its employees and the firms it regulates, according to a news release.

Through Jan. 19, 2022, the FDA plans to continue mission-critical work while postponing certain inspectional activities with the aim to restart those activities as soon as possible. Mission-critical foreign inspections will continue with plans reassessed as needed based on monitoring foreign travel conditions, the agency said.

FDA also confirmed it is postponing the planning of prioritized surveillance foreign inspection assignments scheduled to begin in February 2022. Mission-critical domestic inspections will continue, while state inspections under FDA contract have the discretion to make inspection decisions based on their local information.

The agency continues to conduct remote foreign supplier verification activities for human and animal foods and is leveraging other remote tools to oversee foods, drugs, medical products and tobacco.

View All News »