JANIS GRAHAM JACK, District Judge:
This is an enforcement action brought by the United States against Sage Pharmaceuticals, Inc., a manufacturer of prescription and over-the-counter drugs, and its president, Jivn Ren Chen (collectively, Sage). The United States sought to enjoin the distribution of adulterated drugs and unapproved new drugs in violation of the Federal Food, Drug, and Cosmetic Act (FDCA).
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