Manufacturing site deficiencies are not behind every recent complete response letter that mentions pandemic site inspection travel delays, the US Food and Drug Administration stresses in a 17 May revision to its August 2020 question-and-answer guidance on inspections during the COVID-19 public health emergency.
US FDA Cautions Against Blaming CRLs On Inspection Delays
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.
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