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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Hai Soon Leong Sdn Bhd 11/7/2008


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

Public Health Service
Food and Drug Administration
 College Park, MD



November 07, 2008

Koh Keng Kok, Managing Director
Hai Soon Leong Sdn Bhd
No 23, Jalan Taming 5
Balakong, 43300 Sri Kembangan
Selangor, Malaysia

Dear Mr. Kok:

We inspected your seafood processing facility, located at No 23, Jalan Taming 5, Balakong, 43300 Sri Kembangan, Selangor, Malaysia on June 2 and 3, 2008. We found that you have serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations, Part 123, and the Current Good Manufacturing Practice regulation for foods, Title 21, Code of Federal Regulations, Part 110 (21 CFR 123 & 110). In accordance with 21 CFR 123.6(g), failure of a processor of fish or fishery products to have and implement a HACCP plan that complies with this section or otherwise operate in accordance with the requirements of Part 123, renders the fish or fishery products adulterated within the meaning of Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 342(a)(4). Accordingly, your salted seafood products are adulterated, in that they have been prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health. You may find the Act, the seafood HACCP regulation and the Fish and Fisheries Products Hazards & Controls Guidance through links in FDA's home page at www.fda.gov.

Your firm provided a response to the observations of concern listed on the FDA Form 483 that was issued to your firm at the conclusion of the inspection. This response, dated June 24, 2008, included a summary of the corrections and a revised HACCP plan for your salted fish. We have evaluated that response and the continuing violations are as follows:

1. You must conduct a hazard analysis to determine whether there are food safety hazards that are reasonably likely to occur and have a HACCP plan that, at a minimum, lists the critical control points, to comply with 21 CFR 123.6(a) and (c)(2). A critical control point is defined in 21 CFR 123.3(b) as a "point, step, or procedure in a food process at which control can be applied and a food safety hazard can as a result be prevented, eliminated, or reduced to acceptable levels." However, your firm’s HACCP plan for salted fish does not list the following critical control points to control the food safety hazard of pathogen growth and toxin formation:

• Rinsing/Soaking Operation; and
• Oven Drying

2. You must have a HACCP plan that, at a minimum, lists monitoring procedures and their frequency for each critical control point, to comply with 21 CFR 123.6 (c)(4). However, your firm’s HACCP plan for salted fish lists a monitoring procedures/frequency at the "Defrosting" critical control point that is not adequate to control pathogen growth.

Since your firm defrosts product for up to two days under refrigeration in a cold room, the HACCP plan monitoring procedure of checking the temperature at the “Start, middle and end of production” is inadequate. This monitoring schedule at best provides your firm with assurances of temperature control only every 24 hours for the 48 hour duration of this step. FDA recommends that you adopt a monitoring procedure/frequency capable of continuously monitoring temperatures on a 24 hour a day, 7 days a week basis.

The listed monitoring procedures/frequency for water bath defrosting appears to be satisfactory, since the time period is limited to two hours and the frequency provides monitoring every hour for the two hour duration. However, for both of these defrosting methods, the monitoring procedures or the critical limit should identify “what” is measured (e.g., the fish temperature, the cold room air temperature, or the water bath temperature). Please be advised that FDA would recommend that your firm monitor the cold room air temperatures and the water bath temperatures, in lieu of fish temperatures.

3. Because you chose to include a corrective action plan 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 salted fish at the Defrosting and Salting critical control points to control pathogen growth are not appropriate.

Corrective action plans are to be developed as procedures to be followed in response to deviations from the critical limits, not as an additional means of meeting the critical limits or as a duplicate of the critical limit.

With respect to the "Defrosting" critical control point, the corrective action listed includes “rejection” as a potential action. The correction, however, does not explain what rejection will entail (e.g., diversion for waste disposal or pet food manufacturing). Also, the corrective action states that the “cause of the problem” is to be determined, but does not ensure that the cause is corrected.

Regarding the "Salting" critical control point, your corrective action “add salt” to achieve the critical limit of salt percentage in the fish is concerning because it has very limited application for a very brief time and can only be implemented during the actual salting operation or shortly thereafter. Inadequately salted product may cause the fish to support pathogen growth and scombrotoxin formation. Consequently,determining that the deviation occurred days or weeks following the actual salting process may not mitigate pathogens and/or histamine that may have already formed in the interim time period (i.e., that time between the original/initial salting and discovery that the salting process was inadequate). In addition, neither of the corrective action procedures listed at the “Salting” critical control point are designed to ensure that the cause of the critical limit deviation will be corrected.

For more information related to the hazard of pathogens and histamine, please refer to the Fish and Fisheries Products Hazards and Controls Guidance: Third Edition, found at:www.cfsan.fda.gov/~comm/haccp4.html.

You should respond in writing within thirty (30) working days from your receipt of this letter. Your response should outline the specific things you are doing to correct these violations. You should include in your response documentation such as a copy of any revised HACCP plans, at least five (5) product days worth of monitoring records to demonstrate that you have implemented the revised plans, any verification records, and any other useful information that would assist us in evaluating your corrections. If you cannot complete all corrections within thirty (30) days, you should explain the reason for your delay and state when you will correct any remaining violations.

If you do not respond or if we find your response inadequate, we may take further action. For instance, we may take further action to refuse admission of your imported fish or fishery products under Section 801(a) of the Act (21 U.S.C. §381(a)), including placing them on detention without physical examination (DWPE). FDA’s DWPE is an administrative procedure whereby products offered for import into the United States may be detained without physical examination upon entry. DWPE information may be conveyed in FDA’s Import Alerts. For your information, an example of an Import Alert that conveys information specific to foreign firms that are not in compliance with the seafood HACCP regulation is Import Alert #16-120. This alert can be found on FDA’s web site at: http://www.fda.gov/ora/fiars/ora_import_ia16120.html.

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 current Good Manufacturing Practice regulations (21 CFR Part 110). You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations.

Please send your reply to the U.S. Food and Drug Administration, Attention: Frank C.L. Sikorsky, Consumer Safety Officer, Office of Compliance, Division of Enforcement, Manufacturing and Storage Adulteration Branch (HFS-607), Harvey W. Wiley Building (CPK1), 5100 Paint Branch Parkway, College Park, MD 20740 U.S.A. If you have questions regarding any issues in this letter, please contact Frank C.L. Sikorsky at (301) 436-1623.




Roberta Wagner
Office of Compliance
Center for Food Safety and Applied Nutrition