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  5. Gaea Products S.A. - Close Out Letter 8/12/15
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CLOSEOUT LETTER

Gaea Products S.A.


Gaea Products S.A.

  

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

Public Health Service
Food and Drug Administration
 Washington, DC 

August 12, 2015

Mr. Aris Kefalogiannis, CEO
GAEA Products S.A.
48 Street Armatolon & Kelfton
11471 Athens, Greece

Dear Mr. Kefalogiannis:

The Food and Drug Administration (FDA) has completed an evaluation of your firm's corrective actions in response to our Warning Letter #454758, issued April 16, 2015. Based on our evaluation of your 7/30/15 response, it appears that your Santorini sauce is an acid food not covered by the acidified food regulations (21 CFR 108 and 114). Accordingly, the deviations listed in the Warning Letter do not apply to your Santorini Sauce. Future FDA inspections and regulatory activities will further assess your firm 's compliance with applicable regulations.
 

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/

Donald W. Greaves
Compliance Officer
Office of Compliance
Center for Food Safety
    and Applied Nutrition