What Not To Do When An FDA Inspector Comes Knocking At Your Door
This article was originally published in The Pink Sheet Daily
FDA tweaks final guidance on what constitutes interference with FDA inspections to include examples of ‘reasonable’ explanations for sponsor delays; industry had requested many other changes.
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With inspectorate grounded by COVID-19, agency cannot clear remediated facilities or approve related applications – unless industry has a better idea.
Agency should clarify how quickly it expects requested documents to be produced before a company is determined to have delayed an inspection, attorneys say during a FDLI meeting discussion of how a 2012 law enabling the agency to put a foreign facility on import alert for delaying, limiting, or refusing an inspection has played out.
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