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US FDA Looks To Resume Unannounced Inspections In India And China

Executive Summary

After lapsing due to COVID-19, an unannounced foreign inspection pilot program is on track to resume in 2022, “despite challenges and constraints of travel.”

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Inspection subsection would penalize high-quality sites in low-quality foreign regions with greater inspection frequency, while adding more surprise inspections and requiring greater internal FDA coordination to prevent quality issues from causing drug shortages.

House User Fee Bill’s Inspections Provisions Would Add Layers Of Scrutiny Abroad

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