Inspections, Compliance, Enforcement, and Criminal Investigations

Healing Noni Co., LLC - Close Out Letter 3/2/18

 

  

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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

Page Last Updated: 03/26/2018
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