Compliance Corner: How To Survive An FDA ‘Desk Audit’ During The COVID-19 Crisis
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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In a 23 June blog post, FDA head Stephen Hahn issued a statement praising agency staff for continuing to meet their statutory obligations under MDUFA V considering the added difficulties of working through the coronavirus pandemic. While noting the agency is being creative in how it works in its new COVID-19 reality, he cautioned the FDA may not be able to meet those deadlines in the future if things continue as they are. Hahn also in his blog post addressed in-person inspections of manufacturing facilities.
The US FDA is collaborating with the Centers for Disease Control and Prevention to determine the best way for agency investigators to perform on-site inspections again, using the White House's "Guidelines for Opening Up America Again" for guidance. Routine surveillance audits were paused in the US and abroad back in March.
Yes, Gottlieb’s in there twice; things get complicated when an agency starts to lose credibility.