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Zen Enterprises LLC was cited 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 FD&C Act. The company's eDRLS listing submissions did not include required manufacturing establishment information, including the name and Unique Facility Identifier for all establishments where manufacturing was performed. These omissions rendered the products misbranded drugs, making their introduction into interstate commerce a prohibited act under section 301(a) of the FD&C Act.