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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Enforcement Actions

Tabatchnick Fine Foods, Inc 07-Sep-04

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

Public Health Service
Food and Drug Administration

 

Central Region
New Jersey District
Waterview Corporate Center
10 Waterview Blvd., 3rd Floor
Parsippany, NJ 07054



WARNING LETTER


Telephone (973) 526-6004

September 7, 2004

CERTIFIED MAIL
RETURN RECEIPT REQUESTED

Barry Tabatchnick
President & CEO
Tabatchnick Fine Foods, Inc,
1230 Hamilton Street
Somerset, New Jersey 08873

File No.: 04-NWJ-17

Dear Mr. Tabatchnick:

On April 28, 2004, an Investigator from the New Jersey District Office of the Food and Drug Administration (FDA) collected a sample of your product, Balsamic Tomato and Rice Soup, expiration date of March 29, 2007. The sample was collected to determine compliance with the Federal Food, Drug and Cosmetic Act (the Act) and FDA's food labeling requirements (21 CRt part 101- Food Labeling). You can find the Act and regulations on FDA's Internet web site at www.fda.gov.

FDA analyzed a sample of your soup product to determine whether the Information in the Nutrition Facts panel accurately reflects the nutrient content of the product. Your label states that your product contains 50% of the RDI (Reference Daily Intake) of Vitamin C. The analyzed content of Vitamin C In your soup product was 29.496 (original analysis) and 24.696 (check analysis) of the amount of Vitamin C declared on the label.

Your product is misbranded under section 403(a}(i) In that the label Is false or misleading because the amount of Vitamin C present Is less than 80 percent of the amount declared (see CFR 101.9(gx4)(ii)). You should take prompt action to correct the deviation. Failure to promptly correct this deviation my result in regulatory action without further notice, such as seizure of your product.

You should notify this office in writing within 15 working days of receipt of this letter, of any corrective actions, Including an explanation of each step being taken to prevent the recurrence of similar conditions. If corrective action cannot be completed within 15 working days, state the reason for the delay.

Your reply should be sent to the Food and Drug Administration, New Jersey District Office, 10 Waterview Boulevard, 3rd Floor, Parsippany, New Jersey 07054, attention: Andrew Ciaccia, Compliance Officer.

Very truly yours,

/s/
Ray Abrahams for Douglas I. Ellsworth
District Director
New Jersey District Office