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CLOSEOUT LETTER

PureBulk 05/02/2016

PureBulk - Close Out Letter 2/5/16


PureBulk

  

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

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

February 5, 2016


Timothy McNulty
Alden E. Hamlin
Purebulk, Inc.
1640 Austin Road
Roseburg, OR 97471

Dear Mr. McNulty and Mr. Hamlin:

The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter Re: 470586 issued August 27, 2015. Based on our evaluation, it appears that you have addressed the violation(s) 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