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    FDA warning letters in 2020 reveal concerns around purity, investigations, and data integrity

    Warning letters issued by the US Food and Drug Administration (FDA) provide important context for regulatory intelligence professionals in the pharmaceutical manufacturing space. In this article, the authors review 2020 warning letters related to good manufacturing practices (GMP) and provide examples of common citations that point to larger trends in FDA enforcement. Among the warning letters, citations frequently pointed to inadequate qualification of supplier certificat...