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FDA Pauses Facility Inspections Citing Omicron Variant

FDA will continue conducting mission-critical foreign inspections

Photo | Pixabay
Photo | Pixabay

On December 29, the Food and Drug Administration implemented temporary changes to its inspectional activities to ensure the safety of its employees and those of the firms it regulates as the agency further adapts to the evolving COVID-19 pandemic and the spread of the omicron variant.

Through January 19, the agency intends to continue mission-critical work but has temporarily postponed certain inspectional activities with the hopes of restarting these activities as soon as possible.

The FDA will continue conducting mission-critical foreign inspections and will reassess plans as needed based on its monitoring foreign travel conditions. The agency also is postponing the planning of prioritized surveillance foreign inspection assignments that were scheduled to begin in February 2022.

The FDA is also continuing to conduct mission-critical domestic inspections. State inspections under FDA contract have the discretion to make inspection decisions based on their local information.

The agency is continuing remote foreign supplier verification program activities for human and animal foods, as well as leveraging other remote tools to maintain oversight of foods, drugs, medical products and tobacco.

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