FDA postpones foreign inspections due to coronavirus

March 10, 2020

The U.S. Food and Drug Administration is postponing most foreign inspections through April, effective immediately, in response to the COVID-19 outbreak. Inspections outside the U.S. deemed mission-critical will still be considered on a case-by-case basis.

According to the FDA, the decision was based on various factors, including State Department Level 4 travel advisories in which travel is prohibited for U.S. government employees, Centers for Disease Control and Prevention travel recommendations, access restrictions being imposed on foreign visitors by certain countries, guidance from the Office of Personnel Management and the health and safety of its employees. The FDA says it is confident in its ability to maintain oversight over international manufacturers and imported products using alternative tools and methods.

Because it cannot physically inspect foreign produced FDA-regulated products or manufacturers, it will employ additional tools to ensure the safety of imported products in the interim. This includes physical examinations and/or product sampling at borders, reviewing a firm’s previous compliance history, using information sharing from foreign governments and requesting records in advance of on-site drug inspections.

The FDA will continue working with U.S. Customs and Border Protection to target products intended for importation into the U.S. that violate applicable legal requirements for FDA-regulated products.

Read the full FDA statement