The US Food and Drug Administration is currently not able to conduct routine inspections on drugs, medical supplies or household goods from China due the US State Department’s travel advisory for China over the coronavirus outbreak, the agency said in a statement.
Inspections are just one tool the FDA uses to make sure products are safe, and the lack of inspections is “not hindering our efforts to monitor medical products and food safety,” officials said. The agency monitors products through import screening, sampling and import alerts and it works with US Customs and Border Protection to look for products that violate legal requirements. Some 60% of FDA-regulated products imported from China are medical devices, the agency said, and 20% are housewares, such as food packaging.
In response to the outbreak, the FDA said it will also use, where appropriate, the agency’s authority to request records from firms “in advance or in lieu of” drug surveillance inspections in China. Paper records will help prioritize what inspections should happen first during what could become a back log in on-the-ground inspections, depending on how long the travel restrictions continue, the agency said.
The FDA reiterated that there is no evidence that the virus can be transmitted through imported goods, but added that this is a “dynamic” situation and the agency will continue to assess it and update guidance as needed.
The FDA promised it is working around the clock to monitor and mitigate any coronavirus-related issues in a collaborative effort with other agencies.