FDA has provided an update on the status of its inspections outside of the US in response to the COVID-19 outbreak and announced that it is postponing most foreign inspections through April, effective immediately.
The Food and Drug Administration (FDA) said Tuesday that it is postponing most inspections of foreign manufacturers of pharmaceutical products, medical devices and food imported into the United States. Inspections outside the U.S. deemed mission-critical will still be considered on a case-by-case basis. The agency already had suspended most inspections in China.
The postponement is likely to increase concerns about the US reliance on drugs and ingredients made abroad and about possible shortages due to the novel coronavirus, according to the Washington Post. Not only are many medications used in the United States manufactured overseas, but critical ingredients — and the chemicals used to make them — also are overwhelmingly made in China and other countries.
May impact other FDA responsibilities
The FDA based this decision on a number of factors, including State Department Level 4 travel advisories in which travel is prohibited for U.S. government employees, Centers for Disease Control and Prevention travel recommendations, access restrictions being imposed on foreign visitors by certain countries, guidance from the Office of Personnel Management and the importance of the health and safety of its employees.
Another critical factor in taking this action is the confidence they have in their ability to maintain oversight over international manufacturers and imported products using alternative tools and methods.
“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,” they write in the statement.
“When we are temporarily not able to physically inspect foreign produced FDA-regulated products or manufacturers, as an interim measure we employ additional tools to ensure the safety of products imported to the U.S., which have proved effective in the past. These include denying entry of unsafe products into the U.S., physical examinations and/or product sampling at our borders, reviewing a firm’s previous compliance history, using information sharing from foreign governments as part of mutual recognition and confidentiality agreements and requesting records “in advance of or in lieu of” on-site drug inspections. 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.”