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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Le Gourmet Lorrain, Inc. 25-Jul-05

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) 779-5707


Certified Mail
Return Receipt Requested

July 25, 2005

Mr. Alain J . Franques, President/Owner
Le Gourmet Lorrain, Inc.
5586 Tuxedo Road
Tuxedo Industrial Park
Tuxedo, Maryland 20781

Dear Mr. Franques:

The Food and Drug Administration (FDA) inspected your firm located at 5586 Tuxedo Road, Tuxedo, Maryland on March 3rd and 9th, 2005 . During the inspection, physical samples and labeling for your packaged products "VEGETABLE MOUSSE EN CROUTE" and "MOUSSE DE SAUMON EN CROUTE" were collected. Review of the labeling for these products found violations of section 403 of the Federal Food, Drug, and Cosmetic Act (the Act) [21 United States Code (U.S.C.) 343] and Title 21, Code of Federal Regulations , Part 101- Food Labeling (21 CFR Part 101). You can find the Act and the food labeling regulations through links on FDA's web page at www.fda.gov.

These products are misbranded within the meaning of section 403(e)(2) of the Act [21 U.S.C. 343(e)(2)] in that they are in package form and their labeling fails to bear a statement of the net quantity of contents.

The above violation addresses a particular labeling requirement and is not meant to be an all inclusive list of deficiencies. It is your responsibility to assure that all of your products are in compliance with the Act and all applicable regulations enforced by FDA.

Please notify this office in writing, within 30 working days of receipt of this letter, of the specific steps you have taken to correct the noted violation and to prevent its recurrence. Your response should outline the specific things that you are doing to correct this deviation. You should include in your response copies of revised labels for your products, if applicable . If you cannot correct this violation before you respond, please explain the reason for your delay.

Your response should be sent to the Food and Drug Administration, Attention: Elizabeth A. Laudig, Compliance Officer, 6000 Metro Drive, Suite 101, Baltimore, MD 21215. If you have any questions regarding this letter, please contact Ms. Laudig at (410) 779-5441.

Sincerely,
/s/

Edwin Rivera Martinez
Acting District Director
Baltimore District Office