Complete Response Letters In Lieu Of Inspections: What To Expect During COVID-19
If agency has concerns about facilities it cannot inspect, it will generally issue complete responses, Q&A guidance says.
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Agency revises pandemic inspection guidance to explain CRL ‘non-deficiency’ inspection comments and update industry on remote interactive evaluations and post-COVID-19 inspection priorities.
Time taken for interagency alignment, lessons learned from foreign counterparts will increase use of remote video tours, say FDA officials..