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Compliance Corner: How To Survive An FDA ‘Desk Audit’ During The COVID-19 Crisis

 
• By Shawn M. Schmitt

A former US FDA investigations branch director explains how a paper-based “desk audit” would be performed by the agency in lieu of an on-site quality systems inspection. Last month the FDA hit the pause button on in-person inspections as the coronavirus pandemic rolls on.

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Last month the US Food and Drug Administration hit the pause button on on-site quality systems inspections as the COVID-19 pandemic rolls on. One tool the agency has in its compliance arsenal, however, are so-called “desk audits” that it can conduct in lieu of an in-person inspection.

Below, Ricki Chase – compliance practice director for Lachman Consultant Services and a former FDA investigations branch director – explains how a desk audit would unfold.

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