Recipient:

Recipient Name

David Makima

Zen Enterprises LLC

9061 W. Sahara Ste 105
Las Vegas, NV 98117-5797
United States

[email protected] Issuing Office: Center for Drug Evaluation and Research | CDER

United States

Secondary Issuing Offices

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