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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Campbell Soup Supply Co. LLC 12-Mar-02

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration

San Francisco District

1431 Harbor Bay Parkway

Alameda, CA 94502-7076

Telephone: 510-337-6700

VIA FEDERAL EXPRESS

Our Reference: 2910322

March 12, 2002

WARNING LETTER

Raymond P. Oldach, VP of Manufacturing and Plant Manager

Campbell Soup Supply Co. LLC

6200 Franklin Blvd.

Sacramento, CA 95824-3499

Dear Mr. Oldach,

U.S. Food and Drug Administration (FDA) collected samples of the product, Prego®

brand THREE CHEESE PASTA SAUCE, NET WT. 28 OZ (1 LB 12 02)(794g), for

laboratory analyses on September 10, 200l. The samples were collected from your

facility located at 6200 Franklin Blvd., Sacramento, CA. A copy of the product label is

enclosed for your ready reference.

FDA analysis revealed sub-potency in the nutrient, Vitamin C, compared to the amount

declared on the label. FDA laboratory results are, as follows:

Nutrient

Analysis

Declared

Found

% of Declared

Vitamin C

Original

25% DV*

5.47 DV

21.9

Vitamin C

Check

25% DV

8.33 DV

33.3

*DV: Daily Value

The product is misbranded within the meaning of section 403(a)( 1) of the Act in that the

label is false and misleading.

The above violation is not meant to be an all-inclusive list of deficiencies on your label.

Other label violations can subject the product to legal action. It is your responsibility to

assure that all of your products are labeled in compliance with all applicable statutes and

regulations enforced by FDA.

You should take prompt measures to correct the violations. Failure to promptly correct

T these violations may result in regulatory action without further notice. Such action

includes seizure and/or injunction.

You should notify this office in writing, within 15 working days of receipt of this letter,

of the specific steps you have taken to correct the noted violations. If corrective action

cannot be completed within 15 days, state the reasons for the delay and the time at which

the corrections will be completed.

Your reply should be directed to Ms. Harumi Kishida, Compliance Officer, U.S. Food

and Drug Administration, 1431 Harbor Bay Parkway, Alameda, California 94502-7070.

Sincerely,

Dermis K. Linsley

District Director

San Francisco District