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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Euro Gourmet, Inc. Close out Letter 4/28/11

   

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

 Public Health Service
Food and Drug Administration
 

Baltimore District Office
Central Region
6000 Metro Drive, Suite 101
Baltimore, MD 21215
Telephone: (410) 779-5454
Fax: (410) 779-5703 

FEI: 3003700093


April 28, 2011


VIA CERTIFIED MAIL
RETURN RECEIPT REQUESTED


Mr. Francesco Marra, President and CEO
Euro Gourmet, Inc.
10312 Southard Drive
Beltsville, MD 20705-2107


Dear Mr. Marra:


The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter 109809 dated July 21, 2010. Based on our evaluation, it appears that you have adequately 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 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/
Randy Pack
Compliance Branch Director
Baltimore District

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