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OTC Monograph Purity Concern Among Problems Noted In US FDA FY21 Drug Quality Review

Data Point To More Recalls As Inspections Increase, Problems With Firms' Investigations

Executive Summary

Manufacturing sites drew high marks in FY21, especially for essential medicines and complex drugs. But inspection resumption means more recalls are coming, and inspection protocols indicate problems with investigations. Meanwhile, site data suggest post-pandemic supply chain is growing even more dispersed, particularly for essential medicines, despite government onshoring initiatives.

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