US FDA postpones foreign inspections over coronavirus outbreak

The US FDA is postponing most foreign inspections through April, effective immediately. Inspections outside the US deemed mission-critical will still be considered on a case-by-case basis.

The FDA based this decision on a number of factors, including State Department Level 4 travel advisories in which travel is prohibited for US government employees, centres 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 importance of the health and safety of our employees. Another critical factor in taking this action is the confidence that US FDA have in our ability to maintain oversight over international manufacturers and imported products using alternative tools and methods.

According to a note in the US FDA website by Stephen M Hahn, Commissioner of Food and Drugs – Food and Drug Administration, the situation will be monitored very closely and will try to mitigate potential impacts from this outbreak in lockstep with the whole of the federal government. The foreign inspections will be resumed as soon as feasible.

As an interim measure, additional tools will be employed to ensure the safety of products imported to the US, which have proved effective in the past. These include denying entry of unsafe products into the US, 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.

The FDA will continue working with US Customs and Border Protection to target products intended for importation into the US that violate applicable legal requirements for FDA-regulated products, which may come from a variety of sources, such as first-time importers unfamiliar with regulatory requirements or repeat offenders trying to skirt the law. The FDA has the ability through its risk-based import screening tool (PREDICT) to focus on examinations and sample collections based on heightened concerns of specific products being entered into US commerce. The PREDICT screening continues to adjust risk scores as necessary throughout the COVID-19 outbreak.

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