COVID-19: US FDA Focuses on Safety of Regulated Products While Scaling Back Domestic Inspections

Protecting the health and safety of our staff and their families is of paramount concern to the U.S. Food and Drug Administration. As a nation we must do everything we can to help slow the spread of the virus and help flatten the curve of the COVID-19 pandemic. Now more than ever, the American people are depending on us. We must ensure our workforce remains healthy to carry out the FDA’s critical public health mission to keep Americans safe.

In keeping with the White House Coronavirus Task Force and cross-government guidance, this week we directed all eligible FDA employees to begin teleworking. While this does not apply to those carrying out non-portable activities, such as certain lab activities or the monitoring of imported products, we will continue to adjust our approach to a number of activities, including facility inspections for all FDA-regulated products such as food, animal feed, drugs, biological products, devices and tobacco.

Earlier this month, we announced that we are postponing most foreign facility inspections through April and that inspections outside the U.S. deemed mission-critical will be considered on a case-by-case basis as this outbreak continues to unfold.

Today, we’re announcing that for the health and well-being of our staff and those who conduct inspections for the agency under contract at the state level, and because of industry concerns about visitors, we have temporarily postponed all domestic routine surveillance facility inspections. These are facility inspections the FDA traditionally conducts every few years based on a risk analysis. Importantly, all domestic for-cause inspection assignments will be evaluated and will proceed if mission-critical. We will continue to respond to natural disasters, outbreaks and other public health emergencies involving FDA-regulated products.

I want to assure the American public that we have full confidence in the safety and quality of the products we all use every day and that the FDA will continue to leverage all available authorities to continue to ensure the integrity of the products we regulate.

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