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  1. Warning Letters

CLOSEOUT LETTER

Natures One Inc.


Natures One Inc.

  

Department of Health and Human Services' logoDepartment of Health and Human Services

Public Health Service
 Food and Drug Administration
College Park, MD 20740

February 3, 2016


Jay Highman
CEO & President
Nature's One, Inc.
8754 Cotter Street
Lewis Center, OH 43035

 

Re: 335738
 


Dear Mr. Highman:

The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter issued September 26, 2012. 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/

Carrie Lawlor
Acting Branch Chief
Labeling and Dietary Supplement
        Compliance Branch
Division of Enforcement
Office of Compliance
Center for Food Safety
        and Applied Nutrition


cc: FDA Cincinnati District Office
cc: John F. Lemker, Counsel for Nature's One
     The Wood Burditt Group LLC
     10 E. Scranton A venue, Suite 201
     Lake Bluff, IL 60044