Draft Guidance: Clean ISO Audit Report May Permit Delayed FDA Inspections
This article was originally published in The Gray Sheet
Executive Summary
Device companies may be able to put off an FDA facility inspection if the plant has recently satisfied international quality system standards, according to a 1draft guidance released by the agency May 20
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Device makers generally support FDA's plan for accepting voluntary international audit reports as a means for possibly delaying an FDA inspection, but firms say more details need to be spelled out before many will agree to participate
Good Deal? Firms Seek Details On FDA ISO Audit Report Submission Program
Device makers generally support FDA's plan for accepting voluntary international audit reports as a means for possibly delaying an FDA inspection, but firms say more details need to be spelled out before many will agree to participate