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Management Responsibility for GMP Oversight and Control

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Do you know where your daily operation stands at any given moment?

Historically, the Food and Drug Administration (FDA) has cited the Supreme Court decisions of United States v. Dotterweich (1943) and United States v. Park (1975) as Federal Food, Drug, and Cosmetic Act (FDCA) legal cases that establish that the manager of a corporation can be prosecuted under the Federal FDCA, even if there is no affirmation of wrongdoing on the part of the manager individually.

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