WASHINGTON — The US Food and Drug Administration has provided several updates to its regulatory guidelines in regard to the coronavirus (COVID-19) outbreak in the United States, including a scaling back of in-person domestic and foreign inspections for Food Safety Modernization Act (FSMA) audits.
On-site verification inspections related to the FSMA rules for animal food and Foreign Supplier Verification Programs (FSVP) will be put on hold due to travel restrictions and health advisories. The FDA stated that other methods of verification, including sampling and testing, will continue in a way that minimizes potential safety hazards while still ensuring product is safe for consumers.
These audits are expected to continue “within a reasonable period of time,” the agency stated.
In-person verifications for foreign products entering the US have also been pulled back, which could result in a delay in product application reviews.
FDA Commissioner Stephen M. Hahn, M.D., said, “After careful consideration, the 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.”
In lieu of physically inspecting foreign products, Hahn said the FDA will employ other methods, such as barring the entry of unsafe products, product sampling at US borders, referring to a company’s compliance history and using information from other governments to determine product safety.
“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,” Hahn said.
Hahn noted that the agency is following State Department Level 4 travel advisories, which bars travel by US government employees, recommendations from the Centers for Disease Control and Prevention (CDC), and restrictions for foreign visitors from certain countries.
“As this remains a dynamic situation, we will continue to assess and calibrate our approach as needed to help advance federal response efforts in the fight against this outbreak,” Hahn added.
The agency has allowed all eligible staff to begin working from home this week, which does not include those working in labs or monitoring imported products, Hahn said.
Domestic routine surveillance facility inspections have also been postponed, Hahn said in his most recent update published March 18. The agency will still respond to natural disasters, other outbreaks and public health emergencies involving regulated products, and will evaluate critical inspections on a case-by-case basis.
“I want to assure the American public that we have full confidence in the safety and quality of the products we all use every day and that the FDA will continue to leverage all available authorities to continue to ensure the integrity of the products we regulate,” Hahn concluded.
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