Camtrade Enterprises, Inc. 17-Dec-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

416504630259

VIA FEDERAL EXPRESS

December 17, 2001

Our Reference: 2951445

WARNING LETTER

Aliled Y. Kwong, President

Camtrade Enterprises, Inc.

23520 Foley Street, Unit F

Hayward, California 94545

Dear Mr. Kwong:

We inspected your seafood firm on September 20-24 and October 3, 2001. We

conducted this inspection to determine your compliance with FDA?s seafood

processing regulations, 21 Code of Federal Regulations (21 CFR 123) and the Good

Manufacturing Practice (GMP) requirements for foods (21 CFR 110).

We found that your firm has serious HACCP deviations. These deviations cause your

Fish Sauce, Smoked Round Scad, and Salted Shrimp Fry 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. We listed the HACCP deficiencies on a Form FDA 483 and discussed them with Mrs. Lourdes C. Kwong, General Manager, at the conclusion of the inspection. We are enclosing a copy of the FDA 483 for your reference. Your serious HACCP deviations were as follows:

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

products you import are processed in accordance with the seafood HACCP regulation, to comply with 21 CFR 123. 12(a)(2)(ii). However, your firm?s performance of affirmative step Option D under 21 CFR 123. 12(a)(2)(ii) of maintaining on file a copy, in English, of the foreign processor?s HACCP plans for Smoke Round Sauce, and Salted Shrimp Fry manufactured by [redacted] is inadequate. Specifically,

(a) You did not obtain written guarantees from your supplier pledging that the

imported fishery products were processed in accordance with the Seafood

HACCP regulations.

(b) The HACCP plan for Smoked Salted Round Scad in vacuum packaging

does not address the food safety hazard of Clostridium botulinum. Since

the Frozen Smoked Salted Round Scad you receive does not have a label

that includes a warning that the product must be kept and thawed under

refrigerated conditions, the hazard of Clostridium botulinum must be

included in the processor?s HACCP plan.

2. You must adequately monitor sanitation conditions and practices at your facility,

to comply with 21 CFR 123.11(b). However, your firm did not monitor the

exclusion o f pests from your facility with sufficient frequency to ensure control as

evidenced by the presence of rodent pellets under pallets throughout the premises.

We observed similar insanitary conditions during the previous inspections of your

facility in September 1998 and January 2000. We discussed this GMP deviation with

Mrs. Kwong at the conclusion of both inspections, and also reported it by

correspondence to you from this office on October 13, 1998. We are concerned that

you have not made any effort to correct this problem.

You must immediately take appropriate steps to correct the deviations at your facility.

We may initiate regulatory action without further notice if you do not correct them.

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

firm horn operating. In addition, we may detain your imported seafood products

without examination.

The above-identified deviations are not intended to be an all inclusive list of deficiencies at your facility. It is your responsibility to ensure that all seafood products processed and distributed by your firm are in compliance with the Act and all requirements of the federal regulations.

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

Your response should outline the specific steps you have taken to correct these

violations, including an explanation of each step taken to prevent their reoccurrence.

Your response should include copies of any available documentation demonstrating

that corrections have been made. If you cannot complete all the corrections before

you respond, we expect that you will explain the reason for your delay and state when

you will correct any remaining deficiencies.

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

Figueroa, Compliance officer, 1431 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