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FDA halts overseas inspections over coronavirus concerns

Published on 11/03/20 at 11:42am

The FDA has responded to the ongoing COVID-19 coronavirus outbreak by announcing that it will halt all inspections of overseas facilities until further notice.

“After careful consideration, the FDA is postponing most foreign inspections through April, effective immediately. Inspections outside the US deemed mission-critical will still be considered on a case-by-case basis,” the agency announced via a release on its website.

The FDA said it considered a range of factors when making the decision, including travel recommendations coming out of the Centers for Disease Control and Prevention, guidance from the Office of Personnel Management, and the State Department Level 4 advice ruling out travel for employees of the US Government.

It also offered the assurance that it was considerate of how the decision will impact other FDA operations such as regulatory reviews, but it was confident in its ability to use alternative methods to maintain its oversight in sync with the federal government.

To this end, the FDA said it would employ previously successful strategies such as physical sampling of products at the border as well as reviewing compliance history of manufacturers and supplementary data from foreign governments, potentially denying the import of suspected non-compliant products.

The agency said it aims to recommence these foreign inspections as soon as it becomes feasible to do so.

Matt Fellows

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