Healing Noni Co., LLC

CLOSEOUT LETTER Healing Noni Co., LLC MARCS-CMS 492662 — March 02, 2018 More Warning Letters Warning Letters About Warning and Close-Out Letters Recipient: Healing Noni Co., LLC United States Issuing Office: United States Office of Human and Animal Foods Division West 5 San Francisco District Office 1431 Harbor Bay Parkway, Alameda, CA 94502 Telephone: 510-337-6700 UNITED PARCEL SERVICE SIGNATURE REQUIRED March 2, 2018 Michael D. Harvey, Owner Healing Noni Co. L.L.C. 13-1399 Kamaili Rd. Pahoa, HI 96778 P.O. Box 5884 Hilo, HI 96720 RE: WL #492662 Close-Out Letter Dear Mr. Harvey: The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter [WL#492662 issued August 26, 2016]. Based on our evaluation, it appears that you have addressed the violations contained in this Warning Letter. Future FDA inspections and 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. The Agency expects you and your firm to maintain compliance and will 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/ Darla Bracy, District Director Office of Human and Animal Food Division 5 West Content current as of: 03/26/2018