FDA postponing overseas inspections

March 12, 2020

As a result of the ongoing COVID-19 outbreak, the Food and Drug Administration (FDA) is postponing most foreign inspections through April. Inspections outside the U.S. deemed mission-critical will still be considered on a case-by-case basis.

The FDA based the decision on a number of factors, including State Department Level 4 travel advisories, Centers for Disease Control and Prevention (CDC) travel recommendations, access restrictions being imposed on foreign visitors by some countries, and guidance from the Office of Personnel Management.

The FDA had previously postponed on-the-ground inspections in China.

When the FDA cannot physically inspect produced FDA-regulated products or manufacturers, it plans to rely on other measures, such as denying entry of unsafe products into the U.S., physical examinations or product sampling at U.S. borders, reviewing a firm’s previous compliance history, and using information sharing from foreign governments.

Using a risk-based import screening tool, the FDA plans to focus its examinations and sample collections at U.S. borders on products for which the agency has” heightened concerns,” according to a statement from Stephen M. Hahn, commissioner of the FDA.

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