FDA suspends China inspections in light of COVID-19 outbreak

By Hank Schultz

- Last updated on GMT

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Related tags Regulation coronavirus

The United States Food and Drug Administration has suspended all inspections of facilities in China in keeping with a State Department travel advisory, the agency announced on Friday.

Foreign inspections in other areas are continuing, the agency said, including trips to facilities in other parts of East Asia. FDA inspects overseas facilities that manufacture drugs, medical devices, dietary supplements and foods.

“FDA inspections are used as part of our commitment to the supply chain and are currently continuing as normal except in China consistent with the State Department Travel warning. Any travel to China which is deemed to be mission-critical is being assessed on a case-by-case basis in close coordination with HHS and the State Department. We will revisit this approach and adjust as necessary as this outbreak continues to unfold,”​ FDA Commissioner Steven M. Hahn, MD, said in a statement issued Friday.

Travel coordinators facilitate implementation of restrictions

Larisa Pavlick, vice president of regulatory and compliance  for the United Natural Products Alliance spent a number of years as an FDA inspector working out of the Denver office.  Pavlick, who conducted foreign as well as domestic inspections, said the coordination of any travel restrictions were handled by federal bureaucrats who acted more or less as travel agents for federal employees.

“We had travel coordinators who arranged all of your international travel, where you stayed and how you got from location to location.  They followed all of the CDC travel advisories. And if you needed any immunizations they’d send you to the travel doctor,” ​Pavlick told NutraIngredients-USA.

At one point during her tenure during the 2009 swine flu epidemic Pavlick said the agency had issued employees an “H1N1 kit” that included personal protective gear such as googles, gloves and a Tyvek suit.  She said she was never in a situation where she needed to use it.

‘Layered’ approach to safety

Hahn said the agency conducts about 500 inspections a year in China.  He said the inspections scheduled for February have either been rescheduled or the agency was able to use other information to make decisions about the products coming form those facilities. For March the majority of routine surveillance inspections were for medical products, he said.

Hahn emphasized the ‘layered’ approach that FDA takes toward the safety of imported products, of which foreign inspections are only one part.

“While the outbreak is impacting our ability to conduct inspections in China, it's important to underscore that the FDA's regular risk-based process of surveillance testing of imported products, including those from China, which is based on a number of factors, continues. Fortunately, at this time, we are not seeing the impacts of this outbreak resulting in an increased risk for American consumers from imported products,”​ he said.

Reining in fraudulent claims

Hahn also said the agency is moving quickly to make sure unscrupulous marketers don’t take advantage of the public health scare.

“We have established a cross-agency task force dedicated to closely monitoring for fraudulent products and false product claims related to COVID-19 and we have already reached out to major retailers to ask for their help in monitoring their online marketplaces for fraudulent products with coronavirus and other pathogen claims. Products sold are subject to FDA investigation and potential enforcement action if they claim to prevent, treat, or cure COVID-19 and have not been evaluated by the agency for that intended use. The task force has already worked with retailers to remove more than a dozen of these types of product listings online,”​ he said.

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