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  5. Total Nutrition Inc - 525508 - 07/24/2018
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CLOSEOUT LETTER

Total Nutrition Inc MARCS-CMS 525508 —

Recipient:
Total Nutrition Inc

United States

Issuing Office:

United States

 

   

Black HHS-Blue FDA Logo

 

 
 
Office of Human and Animal Food Operations East
Division 1
 

VIA UNITED PARCEL SERVICE
SIGNATURE REQUIRED

July 24, 2018

Mr. Jay M. Silverman, President
Total Nutrition, Inc.
75 Bi-County Boulevard
Farmingdale, NY 11735

Dear Mr. Silverman:

The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter CMS# 525508, issued on August 16, 2017. 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/
CDR Catherine Beer
Director, Compliance Branch
Office of Human and Animal Food Operations East Division 1

 
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