The Food and Drug Administration (FDA) is not currently conducting inspections of food, drugs or medical devices produced in China as a result of the coronavirus outbreak in that country, FDA Commissioner Stephen M. Hahn said in a statement.
He also said the agency is actively monitoring the U.S. medical product supply chain for shortages that may occur because of the coronavirus outbreak. If the FDA detects a shortage or disruption of a medical product, the agency will use all tools at its disposable, such as expediting review of alternate supplies, to prevent shortages, Hahn said.
As far as on-the-ground inspections in China scheduled for February, the FDA has either postponed them or is using other sources of information to decide whether to let FDA-regulated products into the United States.
Of the inspections scheduled for February in China, approximately 90 percent were routine surveillance inspections, while 10 percent were for-cause inspections, which are considered more serious because the FDA schedules them in response to a specific problem or concern.
The agency typically conducts 500 inspections annually in China for drugs, food and medical devices.
“We will continue to closely monitor the situation in China so that as the situation improves, we will be prepared to resume routine inspections as soon as feasible,” Hahn said, adding that routine surveillance inspections scheduled for March, most of which are for medical products, also are likely to be postponed.
In the statement, Hahn also noted that inspections are not the only regulatory tool that the FDA uses ensure the safety of imported food, drugs and medical products. Other tools include import alerts, increased import sampling and screening, and requesting records (in lieu or in advance of an inspection).
“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,” Hahn said.
In addition, all imported shipments of FDA-regulated products, including those from China, are reviewed by the FDA and must comply with the same standards as domestic products before they are released for sale in the United States. “At this time, the FDA continues to review products imported from China using our routine process and has not determined that additional measures are needed to protect public health,” Hahn said in the statement.
