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The agency is postponing the inspection of most foreign facilities through April 2020.
FDA provided an update on the inspection of foreign facilities during the COVID-19 outbreak. The agency is postponing most of its foreign inspections through April 2020 and will be considering mission-critical inspections outside the United States on a case-by-case basis. FDA Commissioner Stephen M. Hahn M.D. said in a statement that he is confident FDA can maintain oversight over international manufacturers using alternative methods. The decision was based on US State Department Level 4 travel advisories, which prohibit travel of US government employees; recommendations from the Centers for Disease Control; restrictions imposed by other countries; and guidance from the Office of Personnel Management.
“We are aware of how this action may impact other FDA responsibilities, including product application reviews. We will be vigilant and monitor the situation very closely and will try to mitigate potential impacts from this outbreak in lockstep with the whole of the federal government. We stand ready to resume foreign inspections as soon as feasible,” Hahn said in the statement.
FDA will be using alternative methods that include denying entry of unsafe products into the country; physical examinations and product sampling at US borders; reviewing the compliance history of foreign companies; and information obtained through mutual recognition and confidentiality agreements with other countries. “For example, we began exercising this authority when we postponed on-the-ground inspections of manufacturers of FDA-regulated products in China earlier in the outbreak. This is all part of the FDA’s multi-pronged and risk-based approach to ensuring quality, as well as compliance, with applicable federal laws and regulations,” Hahn stated.
The agency will be working with US Customs and Border Protection to monitor imported FDA-regulated products and will be using its risk-based import screening tool (PREDICT) to focus product examinations and sample collections. “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. We can refuse admission of products that fail sample testing or may violate other applicable legal requirements,” said Hahn.