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Synergy Animal Products, Inc. was cited for marketing five unapproved animal drug products—Ex-Cell Countdown 7000, Natural Cow Herbal Support, Ex-Cell Somaticare, Superior Cow Cream, and Super Cow Udder Mint—intended to treat, prevent, or mitigate disease in cattle without FDA approval. The company's violations included failing to register as a drug manufacturer, failing to list its drugs with the FDA, distributing misbranded drugs lacking adequate directions for use, and non-compliance with Current Good Manufacturing Practice (CGMP) regulations. These violations were identified during an FDA inspection conducted September 5-10, 2024, and confirmed through review of the company's website and product labeling.