COVID-19 Update: FDA Foreign Inspections

The FDA has provided an update on the status of U.S. FDA inspections outside of the U.S. in response to the COVID-19 outbreak. The FDA is postponing most foreign inspections through April, effective immediately. Inspections outside the U.S. deemed mission-critical will still be considered on a case-by-case basis.

The FDA based this decision on State Department Level four travel advisories in which travel is prohibited for U.S. government employees, CDC and Prevention travel recommendations, access restrictions being imposed on foreign visitors by certain countries, and guidance from the Office of Personnel Management. According to the FDA, it remains confident in its ability to maintain oversight over international manufacturers and imported products using alternative tools and methods.

When not able to physically inspect foreign produced FDA-regulated products or manufacturers, additional tools are employed to ensure the safety of products imported to the U.S. including: 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. The FDA began exercising this authority when it postponed on-the-ground inspections of manufacturers of FDA-regulated products in China earlier in the outbreak.

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, 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 a risk-based import screening tool (PREDICT) to focus examinations and sample collections based on heightened concerns of specific products being entered into U.S. commerce. The PREDICT screening continues to adjust risk scores as necessary throughout the COVID-19 outbreak.

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