FDA postpones overseas inspections through April as COVID-19 cases increase11 Mar 2020
The US Food and Drug Administration has postponed “most foreign inspections” through April in response to the COVID-19 outbreak, the US drug regulator said late Tuesday.
Inspections outside the US deemed mission-critical will be considered on a case-by-case basis, the FDA said.
The regulator had already suspended on-the-ground inspections in China, the source of the outbreak, but the new restrictions will include India, a key supplier of active pharmaceutical ingredients (APIs) and generic medicines.
As of March 11, the number of reported COVID-19 cases in the US had increased to 1,037.
The FDA said the decision had been based on several factors, including state department travel restrictions on US government employees and access restrictions imposed on foreign visitors by certain countries.
“Another critical factor in taking this action is the confidence we have in our ability to maintain oversight over international manufacturers and imported products using alternative tools and methods,” the FDA said in a statement.
It said these tools include denying entry of unsafe products into the US, physical examinations and product sampling at the country’s 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.
At the end of February, the FDA reported the first case of a pharmaceutical drug shortage directly related to COVID-19 but did not name the medicine.
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