Postponing foreign inspection will likely delay product application reviews that require facility inspections.
FDA announced on March 10, 2020, that the agency is postponing most foreign inspections through April, effective immediately. FDA will consider whether to conduct inspections outside the U.S. deemed mission-critical on a case-by-case basis.
Postponing foreign inspection will likely delay product application reviews that require facility inspections. FDA has committed to trying to mitigate any potential impact that the COVID-19 outbreak and suspension of foreign inspections may have regarding FDA action on product applications. The extent of that impact will likely depend on how soon foreign inspections can resume and the resources, including personnel, available to FDA once they resume.
Stopping foreign inspections also affects FDA’s ability to physically inspect foreign manufacturing facilities for FDA-regulated products. FDA announced interim measures it intends to use during the time the agency is unable to travel for inspection of foreign facilities:
- Denying entry of unsafe products into the U.S. without physical inspection (import alerts);
- Physical examination/product sampling at the point of entry at the U.S. border;
- Reviewing a firm’s previous compliance history;
- Information sharing with foreign governments/regulatory agencies through mutual recognition and confidentiality agreements; and
- Requesting records in advance or in lieu of on-site inspections.
FDA had previously implemented these interim measures with respect to manufacturers of FDA-regulated products in China. With the temporary suspension of foreign inspections, FDA is now implementing these interim measures more broadly. FDA has a multipronged, risk-based approach to ensuring product quality and regulatory compliance. The agency uses a risk-based import screening tool known as “PREDICT” to focus the agencies efforts on products entering the U.S. for which the agency has heightened concerns.
To fulfill its responsibility to protect the public health, FDA will continue to ensure the quality of safety of medical products sold in the United States. If FDA has questions about the quality of a regulated product or the conditions under which the product is manufactured, FDA will not allow the product to remain on the market. For a manufacturer seeking to answer any concerns FDA may raise, an on-site inspection is often the best way to promptly address FDA’s questions or concerns. The temporary suspension of foreign inspections may make it more difficult for companies with foreign facilities to fully satisfy FDA as quickly as it could through an on-site inspection, thereby increasing the likelihood of potential consequences of FDA’s unaddressed concerns.
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The Duane Morris COVID-19 Strategy Team is advising clients on all aspects of the legal implications of COVID-19 including contractual, employment, insurance and healthcare issues.
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