FDA halts most foreign inspections through April due to coronavirus

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FDA halts most foreign inspections through April due to coronavirus

The U.S. Food and Drug Administration says that it is halting most foreign inspections through April due to the coronavirus outbreak.

Inspections outside the U.S. deemed mission-critical will still be considered on a case-by-case basis, it said.

The FDA based this decision on a number of factors, including State Department Level 4 travel advisories in which travel is prohibited for U.S. government employees.

Another critical factor is the confidence it has in its ability to maintain oversight over international manufacturers and imported products using alternative tools and methods.

"We are aware of how this action may impact other FDA responsibilities, including product application reviews," the FDA said.

"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. We stand ready to resume foreign inspections as soon as feasible."

It explained that when it is temporarily not able to physically inspect foreign produced FDA-regulated products or manufacturers, as an interim measure it employs "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 the U.S. border, 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.

It added that it will continue working with U.S. Customs and Border Protection to target products that do not comply with regulations. 

"The FDA has the ability through our risk-based import screening tool (PREDICT) to focus our examinations and sample collections based on heightened concerns of specific products being entered into U.S. commerce," it said.

"The PREDICT screening continues to adjust risk scores as necessary throughout the COVID-19 outbreak.

"We are keeping a close eye out for indications of port shopping or cargo diversion and will continue our oversight of shipments through potentially higher-risk venues such as International Mail Facilities. We can refuse admission of products that fail sample testing or may violate other applicable legal requirements."

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