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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Toma Tek 25-Jan-02

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

CERTIFIED MAIL

RETURN RECEIPT REQUESTED

Our Reference: 2939590

January 25, 2002

WARNING LETTER

L. Neal Jones, President/Owner

Toma Tek

16th and Simpson Streets

P.O. Box 30

Vancouver, WA 98666

Dear Mr. Jones:

The U S. Food and Drug Administration (FDA) conducted an inspection of your facility

located at 2502 "N" Street, Firebaugh, CA on April 2 and 4, 2001. A review of the labels

of your Old California brand tomato products reveals that the products are misbranded

within the meaning of Section 403(a)( 1) of the Federal Food, Drug, and Cosmetic Act

(the Act) because their labeling is false or misleading.

Your Old California brand tomato products are misbranded because the phrase "FRESH

FROM THE FIELD," as it appears on the label implies that the finished product is

"fresh," when, in fact, It has been thermally processed. We would not object to the use of

the term "fresh" in the context of a statement such as "packed from" or "made with" fresh

from the field tomatoes, provided that the tomatoes were indeed fresh as defined in Title

21, Code of Federal Regulations, Part 101.95 (21 CFR 101.95) when they were added to

the product.

The inspection also found that you have failed to provide the FDA information on the

scheduled processes for your acidified product, Comer Bakery brand Marinara Sauce, as

required by 21 CFR 108,25(c)(2). Accordingly, records are not maintained of the

examination of raw materials and packaging materials for this product to verify compliance with FDA regulations and guidelines or action levels, as required by 21 CFR

114.100(a).

At the conclusion of the inspection, some of the above deviations were listed on Form

FDA 483 (Inspectional Observations) and discussed with John Cranfield, Plant Manager.

A copy of this form is enclosed for your ready reference. This list is not meant to be an

all-inclusive list of violations. As a manufacturer of food products, you are responsible

for assuring that your overall operation and the products you manufacture and distribute

are in FDA compliance with all applicable regulations.

You should take prompt action to correct these violations. Failure to promptly correct

these violations may result in regulatory action without further notice, such as 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, 143 1 Harbor Bay Parkway, Alameda 94502-7070. If you have

any questions concerning the violations noted, then please contact Ms. Kishida at (510)

337-6824.

Sincerely,

Dennis K. Linsley

District Director

San Francisco District