Zen Enterprises LLC

CLOSEOUT LETTER Zen Enterprises LLC MARCS-CMS 678407 — September 11, 2024 More Warning Letters Warning Letters About Warning and Close-Out Letters Product: Drugs Recipient: Recipient Name David Makima Zen Enterprises LLC 9061 W. Sahara Ste 105 Las Vegas , NV 98117-5797 United States Registration@fdaimports.com Issuing Office: Center for Drug Evaluation and Research | CDER United States Secondary Issuing Offices United States Dear Mr. Makima: The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter # 2644. Based on our evaluation, you have discontinued Zen Sports Balm, NDC 73048-000, Zen Hemp Balm, NDC 73048-001, Zen Hand Sanitizer, NDC 73048-002, and Sycuan Casino Resort Hand Sanitizer, NDC 73048-003 by adding end marketing dates to each listing data, thus this warning letter is closed. Future FDA regulatory activities will further assess the adequacy and sustainability of these corrections. This letter does not relieve you or your firm from the responsibility of taking all necessary steps to assure sustained compliance with the Federal Food, Drug, and Cosmetic Act and its implementing regulations or with other relevant legal authority. If this product is reintroduced in U.S. commercial distribution, FDA expects that all previous errors are corrected. The Agency expects you and your firm to maintain compliance and to continue to monitor your state of compliance. This letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means. Sincerely, /S/ Tina Smith, M.S. Captain, U.S. Public Health Service Director Office of Unapproved Drugs & Labeling Compliance Office of Compliance Center for Drug Evaluation and Research U.S. Food and Drug Administration Content current as of: 09/17/2024 Regulated Product(s) Drugs