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A Few Clouds In Sunny US FDA Review Of FY21 Drug Quality: Recalls, Investigations, Offshoring

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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