Coronavirus (COVID-19) Update: FDA prepares for resumption of domestic inspections with new risk assessment system

Opening Up America Again | The White House



https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-prepares-resumption-domestic-inspections-new-risk-assessment-system?utm_campaign=071020_PR_FDA%20prepares%20for%20resumption%20of%20domestic%20inspections%20with%20new%20risk%20assessment%20system&utm_medium=email&utm_source=Eloqua

Coronavirus (COVID-19) Update: FDA prepares for resumption of domestic inspections with new risk assessment system

The following is attributed to FDA Commissioner Stephen M. Hahn, M.D.

The U.S. Food and Drug Administration has been thoughtfully and deliberately determining the safest and most appropriate time to resume prioritized domestic inspections of FDA-regulated facilities and other associated activities since we first announced postponement in March. The White House Guidelines for Opening Up America Again are providing us a roadmap for optimizing operations and new work arrangements, as well as the Centers for Disease Control and Prevention (CDC) guidance for protecting workplace exposures to COVID-19 in non-healthcare settings. Despite pausing on-site surveillance inspections in the U.S. in March, our investigators have conducted mission critical inspections and other activities to ensure FDA-regulated industries are meeting applicable FDA requirements, including conducting mission critical inspections. We have had great success by using a number of tools as part of the agency’s risk-based approach to ...

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