The Food and Drug Administration has extended the previously announced temporary changes to its inspectional activities to ensure the safety of its employees and those of the firms it regulates.
The reduction of inspections comes “as the agency further adapts to the evolving COVID-19 pandemic and the spread of the omicron variant.”
The agency continues to conduct both foreign and domestic mission-critical inspections, as well as provide oversight of foods, drugs, medical products and tobacco leveraging a variety of tools. Those tools include using remote assessments and import operations surveillance.
The FDA is extending its “pause” on domestic surveillance inspections through Feb. 4 with the goal of restarting these activities as soon as safely possible, according to a statement from the agency.
The agency will proceed with previously planned foreign surveillance inspections that have received country clearance and are within the Center for Disease Control and Prevention’s Level 1 or Level 2 COVID-19 travel recommendation; otherwise, the inspection will be rescheduled.
The FDA’s goal is to return to a regular rate for foreign surveillance inspections in April.
The agency also is continuing remote foreign supplier verification program activities for human and animal foods.
State inspections under FDA contract and cooperative agreements have the discretion to make inspection decisions based on their local information.
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