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CLOSEOUT LETTER

Philemon Pty Ltd Jun 18, 2014

Philemon Pty Ltd - Close Out Letter 6/18/14


Philemon Pty Ltd

  

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

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

June 18, 2014

Mr. John Stanger
Technical Manager
Waterwheel Premium Foods Pty Limited
Gateway Corporate Park
Unit 6, 11 David Street
Dandenong, Victoria 3175, Australia

Dear Mr. Stanger:

The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter issued July 26, 2013. 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 finn 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/

Latasha A. Robinson
Branch Chief
Labeling and Dietary Supplement
Compliance Branch
Division of Enforcement
Office of Compliance
Center for Food Safety
     and Applied Nutrition