Omicron Causes Delays In FDA’s Onsite Facility Inspections

The rapidly spreading Omicron variant of COVID-19 pushed FDA to temporarily suspend non-critical onsite facility inspections and focus only on in-person, domestic, mission-critical work while relying on remote tools to continue monitoring other facilities. The agency on Dec. 29 decided to postpone certain onsite inspection activities, including prioritized surveillance foreign inspections planned for February 2022, to protect both FDA and facility employees from the COVID-19 surge. FDA will continue to conduct both domestic and foreign mission-critical inspections through Jan. 19...