Chinese inspections not impacted despite COVID-19 outbreak, FDA says

One of the greatest concerns pushed by U.S. lawmakers since the outbreak of the novel coronavirus — COVID-19 — has been the potential impacts on products coming from China, but this week, the Food and Drug Administration (FDA) insisted its inspections have not been hindered, nor has the virus spread in this manner.

In a statement, FDA Commissioner of Food and Drugs Stephen Hahn and Associate Commissioner for Regulatory Affairs Judith McMeekin noted that the administration’s physical inspections in China have indeed been rendered nonexistent by the viral outbreak. That said, they concluded that this has not hindered the organization’s ability to monitor either medical products or food safety, owing to a broad range of tools in play, including the authority to request records from firms in advance or in place of drug surveillance inspections in China.

“We already use other tools to help complement our inspections, including import screening, examinations, sampling, and import alerts, relying on a firm’s previous compliance history, and we use information from foreign governments as part of mutual recognition agreements,” Hahn and McMeekin said. “Thus, at this time, we can rely on these other tools to give us comprehensive oversight of FDA-regulated products entering this country. This is all part of our agency’s risk-based approach to ensuring quality, as well as compliance with applicable FDA requirements.”

The FDA continues to monitor the global drug supply chain as well, prioritizing risk-based inspections in non-affected parts of the world. Admittedly, the pair noted that the FDA could face a backlog number of on-the-ground surveillance inspections if travel restrictions persist, but that paper records could help prioritize early inspections on those products deemed most needed.

At this time, more than 60 percent of FDA-regulated products imported from China are medical devices, while another 20 percent are housewares.

Beyond this, the FDA plans to continue work with U.S. Customs and Border Protection to target imports that violate legal requirements for FDA-regulated products. They will proceed with a risk-based import screening tool to focus examinations and sample collections on specific products.

The officials stated that COVID-19 has led to no increased health risk for American consumers via imported products. While some firms have attempted to capitalize on the outbreak fraudulently, the FDA has moved to penalize them and shield the public.