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Re: BarrellofHay post# 2955

Thursday, 10/22/2020 10:40:14 AM

Thursday, October 22, 2020 10:40:14 AM

Post# of 3283
they were prepared to perform the inspection virtually, but the FDA has not done a virtual inspection anywhere that I know of.

From this article published today.
https://www.parexel.com/news-events-resources/blog/early-demise-fda-exaggerated-highlights-fdli-annual-meeting

The agency is using its statutory authorities under Section 704 of the FDCA (Section 706 of FDASIA) requesting information in advance of inspections to prioritize and triage the backlog of manufacturing inspections for drugs. So far, FDA has conducted approximately 200 mission critical inspections during the pandemic.
There is a process underway to examine the utility of remote or “virtual” inspections and work is being done to create work procedures for remote inspections.