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Zen Enterprises LLC was warned for failing to properly register and list four drug products (Zen Sports Balm, Zen Hemp Balm, Zen Hand Sanitizer, and Sycuan Casino Resort Hand Sanitizer) in violation of section 510(j) of the Federal Food Drug and Cosmetic Act. The company's drug listing submissions did not include required facility information—specifically, the name and Unique Facility Identifier of all establishments where manufacturing was performed, including the referenced manufacturer Dr. Sankunni's Ayurvedic Research Foundation Private Ltd. These incomplete listings rendered the drugs misbranded and prohibited from interstate commerce under section 301(a) of the FD&C Act.