FDA suspends foreign food and drug inspections over coronavirus outbreak

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The outside of the Food and Drug Administration headquarters is seen in White Oak, Md., on Monday, November 9, 2015.

Al Drago | CQ Roll Call | Getty Images

The U.S. Food and Drug Administration will suspend most foreign inspections for food, drug and medical devices outside the country through April as the coronavirus outbreak spreads across America, the agency announced Tuesday. 

“We are aware of how this action may impact other FDA responsibilities, including product application reviews,” FDA Commissioner Stephen Hahn said in a statement. “We will be vigilant and monitor the situation very closely and will try to mitigate potential impacts from this outbreak in lockstep with the whole of the federal government.” 

Hahn said the decision was based on a number of factors, including the State Department’s multiple advisories that prohibit U.S. government employees from traveling, as well as travel restrictions imposed on foreign visitors by other countries. 

However, inspections outside the U.S. deemed “mission-critical” will be considered on a case-by-case basis, the FDA said. 

The agency previously halted physical inspections in China at the beginning of February where the coronavirus outbreak originated. However, the agency has maintained since then that it has a number of ways to continue conducting inspections. 

That includes physical examinations and product sampling at the border, reviewing a firm’s previous compliance history and using information provided by foreign governments or companies in advance or in lieu of drug surveillance inspections. 

The FDA announced in late February that the pharmaceutical industry reported the first shortage of a drug due to the COVID-19 outbreak. The agency has been warning consumers that halted production from China could impact the medical supply chain, causing disruptions to the prescription drugs or cause shortages of critical medical products in the country.

As of Tuesday, there were more than 118,000 confirmed cases of coronavirus and at least 4,262 deaths, according to Johns Hopkins University. In the U.S., the virus infected at least 800 and killed 28.

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