Inspections, Compliance, Enforcement, and Criminal Investigations
Del Monte Foods, Inc. 29-Jun-01
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
San Francisco District
1431 Harbor Bay Parkway
Alameda, CA 94502-7070
Telephone: 510-337-6700
VIA FEDERAL EXPRESS
Our Reference: 2910485
June 29, 2001
WARNING LETTER
Richard G. Wolford, President & Chief Executive Officer
Del Monte Foods, Inc
One Market Plaza
San Francisco, CA 94105
Dear Mr. Wolford:
The U.S. Food and Drug Administration (FDA) collected samples of the product, "SNAP. E. TOM TOMATO & CHILE COCKTAIL," 11.5 FL. OZ., for laboratory analyses on December 22, 2000. The samples were collected from your contract manufacturer [redacted], [redacted]. A copy of the product label is enclosed or 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 |
%Declared |
|
Original |
40% DV |
4.63 DV* |
11.6 |
|
|
Vitamin C |
Check |
40% DV |
5.97% DV |
14.9 |
* DV: Daily Value
The product is adulterated within the meaning of section 402(b)(1) of the Federal Food, Drug, and Cosmetic Act in that a valuable constituent has been in part omitted. 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 violations are 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 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 connective 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 94502-7070.
Sincerely,
/s/
Dennis K. Linsley
District Director
San Francisco District
