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FDA Exploring Use Of Video – ‘Live Or Recorded’ – To Support Virtual Inspections During Pandemic

The agency using video during inspection of a device firm could prove dicey given industry’s general aversion to investigators taking photographs

 
• By Shawn M. Schmitt

The US FDA is assessing via a pilot program whether the use of video is helpful when investigators perform remote facility inspections. Meanwhile, the agency’s device center is “working on alternative approaches for assessing a firm’s quality management system,” an FDA official says.

Close-up view on black video camera lens.

For several months the US Food and Drug Administration has been exploring new ways to ensure manufacturer compliance during the COVID-19 pandemic. To that end, the agency is assessing via a pilot program whether the use of video is helpful in supporting virtual facility inspections.

“One of the things you always hear is, you never let a good crisis go to waste

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