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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FDA Presses Domestic Manufacturers To Engage In Remote Regulatory Assessments In Lieu Of Inspections
A US FDA official says the agency’s taking steps to plan for post-pandemic on-site inspections that could look slightly different than typical agency audits pre-COVID-19. But in the interim, some companies are being asked to participate in voluntary Remote Regulatory Assessments.
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.