Inspections, Compliance, Enforcement, and Criminal Investigations
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
