COVID-19: FDA Expands Overseas Inspections Freeze Through April
Industry experts advise companies to prepare for paper-based inspection in light of the US FDA's suspended overseas inspections in response to the COVID-19 crisis.
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‘Have Some Level Of Fear’: How Scrapped FDA Inspections, Hastily Made Ventilators Could Portend Product Problems
Two former US FDA officials tell Medtech Insight they’re concerned about product problems down the line as automobile manufacturers make critically needed medical ventilators amid the COVID-19 crisis, and as device makers quickly scale up manufacturing on items like masks and gowns. Compounding problems is the agency’s decision to stop conducting quality systems inspections domestically and abroad.
COVID-19: US FDA’s Hahn Slams The Brakes On Domestic Inspections ‘For The Health And Well-Being Of Our Staff’
A little more than a month after it put the kibosh on conducting facility inspections in China, the agency announced late on 18 March that it was suspending routine surveillance audits in the US, too.