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CDRH QSIT Team Considers Third-Party Audit Option To Level 1 Inspections

This article was originally published in The Gray Sheet

Executive Summary

Firms with a good compliance history may be eligible to submit third-party auditing certifications in lieu of biennial FDA inspections, according to a proposal being drafted for consideration by the Center for Devices and Radiological Health's quality systems inspection technique (QSIT) reengineering team.

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