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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Jieyang Rex Foods Co., Ltd 06-Sep-02

Department of Health and Human Services' logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration


Washington, DC

SEP 6, 2002


Mr. Li Wing Kai, General Manager
Jieyang Rex Foods Co., Ltd.
Jiedong Economic Development District
Jieyang City, Guangdong, China 5P5500

Dear Mr. Kai:

The United States Food and Drug Administration ("FDA") conducted an inspection of your firm on May 17-18, 2002, to determine your compliance with the United States Food and Drug Administration's (FDA's) Seafood Processing Regulations found in Part 123 of Title 21 of the Code of Federal Regulations (21 CFR 123) and the Good Manufacturing Practices requirements for foods (21 CFR 110).

The seafood processing regulations, which became effective on December 18, 1997, require that you, as a processor of seafood products destined to U.S. consumers, implement a preventive system of food safety controls known as Hazard Analysis Critical Control Point (HACCP). HACCP essentially involves: (1) identifying food safety hazards that, in the absence of controls, are reasonably likely to occur in your product; and (2) having controls at "critical control points" in the processing operation to eliminate or minimize the likelihood
that the identified hazards will occur.

During the inspection, we noted the following deviation that we would again like to bring to your attention:

You must have a HACCP plan that lists the critical limits that must be met, in accordance with 21 CFR 123.6(c)(3). However, your firm's HACCP plan for canned tuna lists critical limits at the critical control point that are inadequate to control histamine. Based on the fact that you receive fresh and frozen tuna from other suppliers, your firm is defined as a secondary processor of histamine producing fish. The FDA Fish & Fishery Products Hazards & Control Guide, 3rd Edition recommends that secondary processors of histamine producing fish list one of the following critical limits at the receiving critical control point to control histamine:

a) The presence of adequate ice or other refrigerants surrounding the fish at the time of receiving.

b) Internal temperature of 40 degrees F or less at time of receiving.

We noted that your firm is already monitoring both of these correct critical limits at the receiving critical control point, but has not listed them in your HACCP plan. Your plan must be modified to include the critical limits currently monitored to be in compliance with the regulations.

Please advise me at the following address when you have modified your plan accordingly:

Food and Drug Administration
Attention: Brian S. Landesberg, Consumer Safety Officer
Office of Field Programs, Division of Enforcement and Programs
Imports Branch, HFS-606
5100 Paint Branch Parkway
College Park, Md. 20740

If you have questions regarding any issue in this letter, please contact me at (301) 436-1622.



Brian S. Landesberg
Consumer Safety Officer
Import Branch
Division of Enforcement and Programs
Office of Field Programs
Center for Food Safety
And Applied Nutrition