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  5. Celtrock Holdings Limited - 07/12/2017
  1. Warning Letters

CLOSEOUT LETTER

Celtrock Holdings Limited

Recipient:
Celtrock Holdings Limited

United States

Issuing Office:

United States

 

  

Black HHS-Blue FDA Logo

 

 

 
5001 Campus Drive
College Park, MD 20740 

July 20, 2017
 

VIA EXPRESS MAIL
 

James Zavir
Celtrock Holdings Limited
P. O. Box 13968
Suva
Fiji
 

The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions following issuance of our Warning Letter #394238, issued June 21, 2013. Based on our evaluation, it appears you have addressed the violations contained in the 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/

Mildred P. Benjamin
Branch Chief
Division of Enforcement
Office of Compliance
Center for Food Safety and Applied Nutrition

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