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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Lafayette Fine Foods Inc 14-Feb-02

DEPARTMENT OF HEALTH & HUMAN SERVICE

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

February 14, 2002

Our Reference: 2954019

WARNING LETTER

Jerry S. Ivers, President

Lafayette Fine Foods, Inc.

Dba Lafayette Caviar & Fine Foods

2504 Third Street

San Francisco, California 94107

Dear Mr. Ivers:

We inspected your seafood processing facility, located at the above address, on

August 9, 200l. We conducted this inspection to determine your compliance with

FDA?s seafood processing regulations Title 2 1, Code of Federal Regulations, Part 123

(21 CFR 123) and the Good Manufacturing Practice requirements for foods (21 CFR

110).

We found that your firm has a serious HACCP deviation. This deviation causes your

refrigerated, ready-to-eat Caviar 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 or held under insanitary conditions whereby they may be

rendered injurious to health. Your serious HACCP deviation is as follows:

You must have a HACCP plan that lists the food safety hazards that are reasonably likely to occur, to comply with 21 CFR Part 123.6(c)( 1). However, your firm?s HACCP plan for caviar does not list the food safety hazards associated with pathogen growth and toxin formation at the various critical control points listed in your plan. Specifically, caviar packed in reduced oxygen containers is at risk for Clostridium botulinum growth and toxin formation. We recommend that you refer to Chapter 13 of the Fish and Fisheries Products Hazards and Contra Guide information relating to control strategies for Clostridium botulinum. We also recommend you refer to Chapter 12 for information on possible food safety hazards resulting from pathogen growth other than Clostridium botulinum.

The above deviation was pointed out to you during our presentation of the FDA 483

Inspectional Observations, at the close of the inspection. You told our investigator

that you would make the corrections. If you have not made-the corrections, we

expect that you will quickly correct the violation addressed in this letter. We may

initiate regulatory action without further notice if you do not correct the violation.

For instance, we may take further action to seize your products and/or enjoin your

firm from operating.

Please respond in writing within fifteen working days from 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 such as your

revised HACCP plan and copies of completed monitoring records, or other useful

information that would assist us in evaluating your correction.

This letter may not list all the deviations at your facility. You are responsible for

ensuring that your processing plant operates in compliance with the Act, the seafood

HACCP regulations and the Good Manufacturing Practice regulations. You also

have a responsibility to use procedures to prevent further violations of the Federal

Food, Drug, and Cosmetic Act and all applicable regulations.

Please send your reply to the Food and Drug Administration, Attention: Erlinda N.

Figueroa, Compliance Officer, 143 1 Harbor Bay Parkway, Alameda, California

94502-7070. If you have questions regarding any issue in this letter, please contact

Ms. Figueroa at (510) 337-6795.

Sincerely,

Dennis K. Linsley

District Director

San Francisco District