FDA lifts domestic inspection pause as omicron numbers begin to wane

The FDA said it will resume domestic inspections today, lifting the pause it put into place late last year as the omicron variant of COVID-19 was sweeping across the U.S.

The pause, which started Dec. 29, applied to certain inspection activities as the regulatory agency kept watch over the COVID-19 pandemic in order to make sure its employees and the firms it regulates were kept safe. The FDA continued to perform mission-critical inspections in the U.S. and abroad during the pause that was set to end Friday, it said.

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“In addition to the resumption of planning and conducting domestic surveillance inspections on Feb. 7, the FDA continues to conduct both foreign and domestic mission-critical inspections, as well as provide effective oversight of foods, drugs, medical products and tobacco leveraging a variety of tools, including remote assessments,” the agency said in a statement posted on its website.

Additionally, the agency reiterated it will move forward with previously planned foreign inspections that have country clearance and fall within the Centers for Disease Control and Prevention's Level 1 or Level 2 COVID-19 travel recommendations. The FDA is planning more foreign inspections starting in April as part of its goal for restarting prioritized inspections overseas.

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The agency had been looking to overhaul its foreign oversight inspections prior to the surge in the omicron variant, with a previous goal of restarting them in February.