FDA pauses international inspections due to COVID-19

By AuntMinnie.com staff writers

March 10, 2020 -- The U.S. Food and Drug Administration (FDA) said it is postponing all inspections outside of the U.S. through April due to the outbreak of the novel coronavirus disease (COVID-19).

However, the FDA said it would still consider on a case-by-case basis inspections outside the U.S. that are deemed mission-critical, according to a statement by FDA Commissioner Dr. Stephen Hahn. The FDA is also confident in its ability to maintain oversight over international manufacturers and imported products using alternative tools and methods.

The FDA is aware of how this action will affect other FDA responsibilities, such as product application reviews, Hahn said.

"We will be vigilant and monitor the situation very closely and will try to mitigate potential impacts from this outbreak in lockstep with the whole of the federal government," Hahn said. "We stand ready to resume foreign inspections as soon as feasible."


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