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Private Third-Party Audits Could Enhance FDA’s Manufacturing Risk Analysis

This article was originally published in The Tan Sheet

Executive Summary

Private and third-party audits could direct FDA to problematic facilities while easing some inspection burden on firms that already comply, but not replace FDA’s typical inspection duties.

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Collaboration On Foreign Inspections Helps FDA Improve Resource Allocations

FDA better allocated resources for foreign inspections based on information European and Australian authorities shared in a two-year pilot program, including conducting good manufacturing practices inspections that met the needs of multiple agencies.

Collaboration On Foreign Inspections Helps FDA Improve Resource Allocations

FDA better allocated resources for foreign inspections based on information European and Australian authorities shared in a two-year pilot program, including conducting good manufacturing practices inspections that met the needs of multiple agencies.

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