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Denison Pharmaceuticals was cited for significant Current Good Manufacturing Practice (CGMP) violations in the production of finished pharmaceutical drugs, including homeopathic products marketed for infants and young children such as "Colic Calm," "Colic Calm +," and "Nauzene Kids." The company failed to thoroughly investigate unexplained discrepancies or batch failures that did not meet specifications, rendering the drug products adulterated and in violation of federal regulations. Additionally, the FDA determined that these homeopathic products were unapproved new drugs being distributed in interstate commerce without proper authorization. The enforcement action was particularly significant given the combination of quality control failures and the vulnerable population—infants and young children—for whom these products were labeled.