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  5. Kalloni S.A. - Close Out Letter 5/19/17
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CLOSEOUT LETTER

Kalloni S.A. May 19, 2017

Kalloni S.A. - Close Out Letter 5/19/17


Kalloni S.A.

 

  

Black HHS-Blue FDA Logo

 

 

 
5001 Campus Drive
College Park, MD 20740 

May 19, 2017

Ignatios Petropoulos, CEO
Kalloni S.A.
P.O. Box 312, Kimmeria
Xanthi, Greece 67100

Dear Mr. Petropoulos:

The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter #460487, issued July 1, 2015. 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/

Maria G. Corpuz
Division of Enforcement
Office of Compliance
Center for Food Safety and Applied Nutrition