In response to the COVID-19 outbreak, the FDA has postponed most inspections of overseas facilities until April for the time being.
The FDA made this decision based on the Level 4 alert issued by the U.S. government. The alert prohibits government employees from traveling overseas and restricts access to foreign visitors by certain countries. FDA is confident of its ability to maintain oversight of international manufacturers and imported products using alternative tools and methods.
As an interim measure, FDA is employing additional tools to ensure the safety of products imported into the U.S., including denial of entry of unsafe products into the U.S., physical examinations and/or sampling of products at the border, reviewing a company’s prior compliance history, using information from foreign governments as part of mutual recognition and confidentiality agreements, and requesting records before or instead of on-site inspections. The FDA has already applied this system to manufacturers of FDA regulated products in China at the onset of the outbreak.
Because of this dynamic situation, FDA will continue to evaluate and calibrate its approach as needed to help advance the federal response to COVID-19.