In response to the COVID-19 coronavirus outbreak, the U.S. Food and Drug Administration (FDA) said Tuesday it is suspending most inspections of overseas manufacturers that import food, pharmaceuticals and medical devices to the United States through April.
The federal agency, which had previously suspended inspections in China, said the postponements include routine surveillance inspections of operations that make products regulated by the FDA.
However, the agency said it will evaluate “for cause” inspections, which are prompted by the need to investigate specific problems, on a case-by-case basis.
The FDA said its decision is based on federal travel advisories, Centers for Disease Control and Prevention travel recommendations and restrictions imposed on foreign visitors by certain countries.
FDA Commissioner Stephen Hahn said in a statement: “When we are temporarily not able to physically inspect foreign produced FDA-regulated products or manufacturers, as an interim measure we employ additional tools to ensure the safety of products imported to the U.S., which have proved effective in the past. These include denying entry of unsafe products into the U.S., physical examinations and/or product sampling at our borders, reviewing a firm’s previous compliance history, using information sharing from foreign governments as part of mutual recognition and confidentiality agreements and requesting records “in advance of or in lieu of” on-site drug inspections.”