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CLOSEOUT LETTER

Smartpowders Feb 05, 2016

Smartpowders - Close Out Letter 2/5/16


Smartpowders

  

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


Craig M. Spierer, Attorney
Harris Beach PLLC
333 Earle Ovington Blvd, Suite 901
Uniondale, New York 11553

Dear Mr. Spierer:

The Food and Drug Administration has completed an evaluation of your client’s corrective actions in response to our Warning Letter Re: 470577 issued August 27, 2015. Based on our evaluation, it appears that your client has 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 your client 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 your client to maintain compliance and will continue to monitor their 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: Michael McCandless
     SPN, LLC dba Smartpowders
     1130 Cherry Lane
     Graham, NC 27253