‘What, Me Worry?’: Experts Say They’re Not Concerned About FDA Restarting Domestic Inspections Amidst COVID-19
In a few days the US FDA will fire up its domestic inspectorate for the first time since March. But is it a good idea? Three industry experts said during a Food and Drug Law Institute webinar that they’re not particularly worried.
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US FDA commissioner Stephen Hahn said on 10 July that the agency has a plan to send investigators back into the field in 10 days. Whether or not a company is inspected, however, will depend on local COVID-19 conditions.
A newly finalized FDA guidance on device firm inspection procedures recommends a five-day advance warning, three- to six-day inspections and lots of verbal communication throughout the process.
Expect Surge In Recalls, Enforcement Actions When FDA’s Soft Touch Ends, Inspections Resume, Experts Warn
Two industry experts say device makers that became complacent during the coronavirus public health emergency will be in for a rude awakening when the US FDA retightens its regulatory grip after the worst of the pandemic fades. Aside from a probable uptick in enforcement actions, there will likely be a wave of product recalls in part because the agency passed out emergency use authorizations like Tic Tacs and paused routine surveillance inspections in March.