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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Enforcement Actions

Nor-Cal Seafood, Inc. 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

VIA FEDERAL EXPRESS

Our Reference: 2953656

January 25, 2002

WARNING LETTER

Kevin K. Lee, President

Nor-Cal Seafood, Inc.

2810 E. 7th Street

Oakland, California 94601

Dear Mr. Lee:

On August 31 and November 1 and 5, 2001, we inspected your seafood processing

facility, located at 2510 E. 7th Street, Oakland, California. We found that you have

serious deviations from the seafood HACCP regulations in Title 21, Code of Federal

Regulations, Part 123 (21 CFR 123). These deviations cause your mud fish, largemouth

bass, white eel, red snapper, Atlantic lobster, Mandarin fish, and mackerel to be

adulterated within the meaning of Section 402(a)(4) of the Federal Food, Drug, and

Cosmetic Act (the Act), in that the fish have been prepared, packed, and held under

insanitary conditions whereby they may be rendered injurious to health. You may find

the Act and the seafood HACCP regulations through links in FDA? s home page at

www.fda.gov. We have attached a copy of 21 CFR 123, Fish and Fishery Products, for

your ready reference.

Your serious HACCP deviations are as follows:

1. You must have product specifications that are designed to ensure that the fish and

fishery products you import are not injurious to health to comply with 21 CFR

123.12(a)(2)(i). However, your firm does duct specifications for mackerel and Mandarin fish imported from [redacted]

2. You must implement an affirmative step which ensures that the fish and fishery

products you import are processed in accordance with the seafood HACCP

regulations to comply with 21 CFR 123,12(a)(2)(ii). However, your firm did not

perform an affirmative step for:

a mud fish, largemouth bass, and white eel shipped by [redacted] and

red snapper, Atlantic Lobster, Madarin fish, and mackerel shipped by [redacted]

At the conclusion of the October/November 2001 inspection, the deviations were listed

on Form FDA 483 and discussed with you. A copy of this form is enclosed for your

ready reference, This list is not meant to be an all-inclusive list of violations, You are

responsible for ensuring that your processing facility operates in compliance with the

Act, the seafood HACCP regulations, and the Good Manufacturing Practice regulations

(21 CFR 110).

We may take further action if you do not promptly correct these violations. For instance,

we may take further action to seize your products and/or enjoin your firm from operating.

Furthermore, your firm and the foreign processor(s) may be placed on import alert, and

future shipments of the product(s) may be subject to detention without physical

examination.

Please respond in writing within fifteen (15) working days of receipt of this letter. Your

response should outline the specific things you are doing to correct the deviation. You

may wish to include in your response documentation that would assist us in evaluating

your corrections. If you cannot complete all corrections before you respond, we expect

that you will explain the reason for your delay, and state when you will correct any

remaining deviations.

Your response should be directed to: Ms. Harumi Kishida, Compliance Officer, U.S.

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

If you have any questions regarding any issue in this letter, please contact Ms. Kishida at

(510) 337-6824.

Sincerely,

Dennis K. Linsley

District Director

San Francisco District