FDA Inspections Halted in China, but No Direct Public Health Risk From Imports, Agency Says

Imports do not pose a higher public health risk as a result of the ongoing COVID-19 (coronavirus) outbreak, the Food and Drug Administration said in a Feb. 24 statement. “There is no evidence to support transmission of COVID-19 associated with imported goods and there have not been any cases of COVID-19 in the United States associated with imported goods,” FDA said, though it noted that “this remains a dynamic situation and we will continue to assess, and update guidance as needed.”

But the outbreak is affecting FDA’s activities in other ways, and the agency is adjusting its import screening accordingly, it said. A State Department travel advisory warning against travel to China is preventing FDA from conducting inspections of facilities in the country, FDA said. As a result, FDA is leaning on its authority to request records “’in advance or in lieu of’ drug surveillance inspections in China.” FDA will then use these records to prioritize inspections when it begins to tackle the expected backlog once the travel advisory is lifted, it said.

“While we are not able to conduct inspections in China right now, this is not hindering our efforts to monitor medical products and food safety,” FDA said. “We have additional tools we are utilizing to monitor the safety of products from China, and in the meantime, we continue monitoring the global drug supply chain by prioritizing risk-based inspections in other parts of the world.”

FDA is also adjusting its “PREDICT” risk-based import screening tool, which “continues to adjust risk scores as necessary throughout the COVID-19 outbreak,” the agency said. “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,” FDA said.

FDA will also “continue to aggressively monitor the market” for products with fraudulent COVID-19 prevention and treatment claims, it said. “The FDA can and will use every authority at our disposal to protect consumers from bad actors who would take advantage of a crisis to deceive the public, including pursuing warning letters, seizures, or injunctions against products on the market that are not in compliance with the law, or against firms or individuals who violate the law,” FDA said.