FDA temporarily postpones all domestic routine facility inspections in response to COVID-19 pandemic

On 18 March 2020, in addition to a series of responses to combat the COVID-19 pandemic, the U.S. Food and Drug Administration (FDA) announced that it is temporarily postponing all domestic routine surveillance facility inspections. The agency did not indicate how long this temporary postponement is projected to be in place.

FDA is evaluating additional ways to conduct inspectional work, such as records-based inspections.

On 18 March 2020 FDA announced that it is temporarily postponing all domestic routine surveillance facility inspections for the health and well-being of FDA investigators and because of industry concerns with visitors at their facilities. The agency did not indicate how long this temporary postponement is projected to be in place.

This postponement affects domestic routine surveillance facility inspections. All domestic for-cause inspection assignments will be evaluated and will proceed if deemed mission-critical.

On 10 March 2020 the agency had announced the postponement of most foreign inspections through April 2020.  Mission-critical inspections outside of the United States also are being evaluated on a case-by-case basis.

FDA’s announcement noted that the agency will continue to leverage all available authorities to continue to ensure the integrity of the products it regulates.  This includes, among other things, evaluating records in lieu of conducting an onsite inspection.

As this situation evolves we will continue to monitor FDA’s stance on domestic and foreign inspections, and the agency’s response to the COVID-19 outbreak more broadly.  Please contact us if you have any questions.

 

Authored by Michael S. Heyl, Jim Johnson, Jodi K. Scott, Seth Olson, Daniel Roberts

Contacts
Ted Wilson
Partner
Washington D.C.
Michael Heyl
Partner
Washington, D.C.
Jodi Scott
Partner
Denver

 

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