CLOSEOUT LETTER
Gaea Products S.A.
- Recipient:
- Gaea Products S.A.
United States
- Issuing Office:
United States
| Public Health Service Food and Drug Administration |
| Washington, DC |
Department of Health and Human ServicesAugust 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