FDA Updates Plan For Mfg Inspections In China In Wake Of Coronavirus Outbreak

The US Food and Drug Administration (FDA) is providing updated and more detailed information about the status of FDA inspections in China and the agency’s oversight of imported products from China, which have been impacted by the novel coronavirus (COVID-19) outbreak. Earlier this month, the FDA outlined its supply-chain surveillance plan in the wake of the coronavirus (COVID-19) outbreak in China, including the steps the agency is taking to mitigate potential shortages and supply disruptions of products from China and how the agency is handling inspections of manufacturing facilities in China.

“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,” said FDA Commissioner Stephen M. Hahn and FDA Associate Commissioner for Regulatory Affairs Judith A. McMeekin in a joint statement issued February 25, 2020. “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. The FDA is not currently conducting inspections in China in response to the US Department of State’s Travel Advisory to not travel to China due to the novel coronavirus outbreak. We will continue to closely monitor the situation in China so that, when the travel advisory is changed, we will be prepared to resume routine inspections as soon as feasible.”

The FDA says it is using other tools to help complement its inspections, including import screening, examinations, sampling, and import alerts, relying on a firm’s previous compliance history, and using information from foreign governments as part of mutual recognition agreements.

In response to the COVID-19 outbreak, the FDA says it will use, where appropriate, its authority to request records from firms “in advance or in lieu of” drug-surveillance inspections in China. The Federal Food, Drug, and Cosmetic Act, as amended by the FDA Safety and Innovation Act (FDASIA) of 2012, gives the FDA authority to request records “in advance of or in lieu of” on-site drug inspections. Congress enacted this provision to improve the effectiveness and efficiency of inspections, given the increasing globalization of drug production. Along with other FDASIA provisions, this inspection-record request authority was viewed as a way to “level the playing field” between foreign and domestic drug inspections by allowing the FDA to review records ahead of time and take a more risk-based approach to conducting both domestic and foreign inspections.

“These records will help the agency when we resume drug inspections in China. By applying the use of paper records in our risk-based inspection framework, we can prioritize our early inspections on those deemed most needed, based on the records,” according to FDA’s February 25 statement. “By doing so, we hope to rapidly assess what could become a backlog number of on-the-ground surveillance inspections this fiscal year if travel restrictions persist.”

In addition to records requests, the FDA says it will continue working with US Customs and Border Protection to target products intended for importation into the US that violate applicable legal requirements for FDA-regulated products, which may come from a variety of sources, such as first-time importers unfamiliar with regulatory requirements or repeat offenders. The FDA has the ability, through its risk-based import screening tool (PREDICT), to focus its examinations and sample collections based on heightened concerns of specific products being entered into US commerce. The agency says the PREDICT screening continues to adjust risk scores as necessary throughout the COVID-19 outbreak. “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,” said the FDA in its statement. “We can refuse admission of products that fail sample testing or may violate other applicable legal requirements.”

The FDA said in its statement that there is no evidence to support transmission of COVID-19 associated with imported goods and that there have not been any cases of COVID-19 in the US associated with imported goods.