What The FDA’s Inspections Q&A Guidance Really Means: It’s Time To Offer Virtual Inspections
Compliance experts see possibilities in offering video tours as the FDA offers “holistic” approach to assessing sites during pandemic.
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FDA’s remote assessment using documents Natural Beauty Care Pty provided led to a warning and an import alert. Melbourne area contract manufacturer responded to FDA request in April 2020, soon after agency stopped international inspections due to the coronavirus pandemic.
Time taken for interagency alignment, lessons learned from foreign counterparts will increase use of remote video tours, say FDA officials..
Guidance discusses what are generically called virtual inspections, but which the agency terms “remote interactive evaluations.” As site inspections remain constrained by the pandemic, remote interactive evaluations “should help FDA operate within normal timeframes,” the document says.