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Warning Letters Special Report: What Worried The FDA Most About Pharmaceutical Supply Chains

Executive Summary

One in five drug GMP warning letters FDA issued in 2022 raised supply chain concerns. Active pharmaceutical ingredient distribution became major focal point as agency checked opioid and alcohol-based hand sanitizer supply chains. Year also featured a pair of warning letters to excipient firms, one a Mexican glycerin supplier and the other a unit of DuPont.

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