International Marine Products, Inc. 17-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: 2953567

January 17, 2002

WARNING LETTER

Minoru Yokoshima, President

International Marine Products, Inc.

500 E. 7^th Street

Los Angeles, CA 90014

Dear Mr. Yokoshima:

On August 29, 2001, we inspected your seafood processing facility, located at 1741

South Mojave Road, Las Vegas, Nevada, and 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 tuna, mackerel, and yellowtail 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. See attached handout on how you can obtain a copy of the Fish &

Fisheries Products Hazards & Controls Guidance, 3d edition, June 2001.

The deviations were as follows:

1. You must have a written HACCP plan that lists the food safety hazards that are

reasonably likely to occur, to comply with 21 CFR 123.6(c)(l). However, your

firm? s HACCP plan for mackerel and yellowtail does not list the food safety

hazard of histamine formation due to time/temperature abuse.

2. You must have a HACCP plan that lists the critical limits that must be met, to

comply with 21 CFR 123.6(c)(3). However, your firm?s HACCP plan for tuna

lists a critical limit, ? Tuna must be 4OoF or less," at the receiving critical control

point, that is not adequate to control the food safety hazard of histamine

formation. Because you purchase histamine forming fish from other processors,

you are responsible for ensuring that the fish you receive are handled in a safe

manner during transport. This can be accomplished by maintaining transportation

records for all lots showing that the fish have been held at 40?F or less throughout

transit or checking the adequacy of the cooling medium in a representative number of boxes [the cooling medium must completely surround the product]. This requirement applies to all histamine forming fish, including mackerel and yellowtail.

3. You must have a HACCP plan which lists the procedures, and frequency thereof,

that will be used to monitor each of the critical control points to ensure compliance with the critical limits, to comply with 21 CFR 123.6(c)(4). However, your procedure for monitoring refrigerated storage for tuna and for mackerel and yellowtail is inadequate in that the temperature is not monitored continuously. You may either monitor the adequacy of ice or cooling media twice a day or monitor the temperature of the storage chamber continuously by means of a temperature data recorder or by using an alarm system.

4. Since you chose to include corrective actions in your HACCP plan, your described corrective actions must be appropriate, to comply with 21 CFR 123.7(b). However, your corrective action plans for tuna, mackerel and yellowtail at the receiving and refrigerated storage critical control points to control pathogens/histamines are not adequate if the temperature of the fish is found to be between 40 degrees F and 45 degrees F. Further cooling of the fish at refrigerated temperatures does not prevent adulterated product from entering commerce. You need to evaluate the total exposure time of the fish to elevated temperatures as well as address the cause of the process deviation. Please refer to the FDA Fish & Fisheries Products Hazards & Controls Guidance.

We observed similar HACCP deviations during the previous FDA inspection of your

facility on June 9 and 10,1998. We reported the deviations to you, by correspondence

from this office, on August 5,1998. Your firm responded on August 27,1998. We

found a few deficiencies in your response and responded back to you on November 2,

1998. Your subsequent response on November 16,1998 and revised HACCP plans were

satisfactory as we indicated in our letter of December 7, 1998.

At the conclusion of the inspection, the deviations were listed on Form FDA 483

(Inspectional Observations) and discussed with Mr. Ken Murao, Branch 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. 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.

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 these deviations. You

may wish to include in your response documentation such as copies of the HACCP plans,

temperature monitoring records, or other useful information 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.

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 (21 CFR Part 110). You also have a responsibility to use

procedures to prevent further violations of the Federal Food, Drug, and Cosmetic Act and

all applicable regulations.

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