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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Vinh Sam Enterprise 29-Jan-08

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

Public Health Service
Food and Drug Administration


Washington, DC

Warning Letter

January 29, 2008


Do Dan Vinh
Vinh Sam Enterprise
An Phu Industrial Zone
Tuy Hoa City
Phu Yen Province

Dear Mr. Dan Vinh:

On September 4th through 10th, 2007, a representative of the United States Food and Drug Administration (FDA) conducted an inspection of a fish and fishery products importer located in the United States; Nu-Wave Seafood Consultants, LLC in Barnegat Light, New Jersey to assess that importer's compliance with the United States' Seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations, Part 123 (21 CFR Part 123), referred to as the seafood HACCP regulation. That importer was found to be importing various fish and fishery products from your processing facility. During the inspection of that importer, we collected a copy of your firm's HACCP plan for "Fresh Chilled Fish Products" that includes scombroid (histamine) forming species of fish such as Yellow Fin Tuna and Mahi Mahi and species of fish susceptible to natural toxins such as grouper. Our evaluation of that HACCP plan (copy attached) revealed that this plan demonstrates serious deviations from the requirements of the seafood HACCP regulation.

In accordance with 21 CFR 123.6(g), failure of a processor to have and implement a HACCP plan that complies with this section, or otherwise operate in accordance with the requirements of 21 CFR Part 123, renders the fishery products adulterated within the meaning of section 402(a)(4) of the U.S. Federal Food, Drug and Cosmetic Act (the Act), [21 USC § 342(a)(4)]. Accordingly, your firm's scombroid (histamine) forming species of fish such as Yellow Fin Tuna and Mahi Mahi and your fish susceptible to natural toxins such as grouper are adulterated within the meaning of the Act, in that the products have been prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth, or whereby they may have been rendered injurious to health. You may find the Act, the seafood HACCP regulation and FDA's Fish and Fisheries Products Hazards and Controls Guidance: 3rd Edition (the Hazard Guide) through links in FDA's home page at www.fda.gov.

We note the following violations in your Seafood HACCP plan:

1. You must have a HACCP plan that, at a minimum, lists the critical limits that must be met, to comply with 21 CFR 123.6(c)(3). A critical limit is defined in 21 CFR 123.3(c) as "the maximum or minimum value to which a physical, biological, or chemical parameter must be controlled at a critical control point to prevent, eliminate, or reduce to an acceptable level the occurrence of the identified food safety hazard."

However, your firm's HACCP plan for "Fresh Chilled Fish Products" including scombroid (histamine) forming species of fish such as Yellow Fin Tuna and Mahi Mahi does not list a critical limit to control the hazard of histamine development at the "Receiving of raw material" critical control point. Your hazard analysis indicates that you act as both a primary processor receiving fish directly from the boats, and as a secondary processor receiving fish from previous processors.

Primary processing - Histamine formation is expected to begin upon death because the defense mechanisms of the fish no longer inhibit the histamine forming bacteria. Histamine formation will continue from the time of death if the fish are not properly handled on-board the vessels. Consequently, we recommend that when you receive fish directly from the harvest vessels, you include a critical control point for receipt of the fish to address handling practices onboard the harvest vessels. As a control strategy, we suggest either:

    i. obtaining and reviewing harvest vessel records at receipt;
    ii. conducting histamine testing at receipt.

In both cases, we also suggest in order to ensure no more than 2.5% decomposition in each incoming lot (as listed in your plan), that you perform sensory examination on a minimum of 118 fish per lot or the entire lot if the lot contains less than 118 fish.

Secondary processing - As a secondary processor receiving fish from a previous processor (i.e., from a primary processor or from a processor who stored the products), we recommend that you amend your receiving critical control point to ensure that the fish you receive were properly chilled during transit to your facility. Your analysis indicates that transit times are as long as ten hours. Monitoring "Temperature of the fish" at receipt as listed in your plan does not ensure that proper temperatures were maintained during the entire ten hour time period. We recommend that you only accept fish with a record demonstrating continuous temperature monitoring during the entire transit period, for example, by obtaining a record that will provide a continuous readout of the transit temperatures. Alternatively, we recommend monitoring for the presence of adequate ice or cooling media upon receiving fish (i.e., for fish received on ice or with cooling media).

• Your HACCP plan for "Fresh Chilled Fish Products" including grouper and other fish susceptible to natural toxins (e.g., ciguatera) does not list an adequate critical limit at the receiving critical control point to control the food safety hazard of ciguatera food poisoning (CFP). Monitoring the size of a fish as listed in your plan: "Screening size of each individual < at 2.0 kgs" is not a reliable method of determining the presence of unsafe ciguatoxin levels. FDA recommends monitoring the location where the fish are harvested to exclude potentially ciguatoxic fish.

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 "Fresh Chilled Fish Products" including scombroid (histamine) forming species of fish such as Yellow Fin Tuna and Mahi Mahi lists monitoring of "Once per hours" at the "RM storing cooler" and "Product Cooler" critical control points to control histamine development. That is not an adequate monitoring frequency because it does not indicate a clear frequency. We suggest the use of equipment that can provide a record with continuous monitoring of the storage temperatures based on a 24 hour a day/7 day a week cycle. We also recommend a daily check of the equipment and a daily check of the temperatures.

In addition, please be sure when amending your plan to address adequate controls for each hazard with appropriate critical control points that you review your entire HACCP plan to include appropriate corresponding critical limits, monitoring records, and corrective actions.

For more information related to the hazard of scombrotoxin (histamine) formation, please refer to the Fish and Fisheries Products Hazards and Controls Guidance: Third Edition, Chapter 7, found at: www.cfsan.fda.gov/~comm/haccp4.html. For additional information related to the hazard of natural toxins, please refer to Chapter 6 of the Guide.

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 plan, 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 [21 CFR Part 123] 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 Food and Drug Administration, Attention: Mildred Benjamin, Consumer Safety Officer, Office of Compliance, Division of Enforcement, Manufacturing and Storage Adulteration Branch (HFS-607), 5100 Paint Branch Parkway, College Park, MD 20740 U.S.A. If you have any questions regarding this letter, you may contact Ms. Benjamin by phone at (301) 436-1424 or via email at Mildred.Benjamin@fda.hhs.gov



Joseph R. Baca
Office of Compliance
Center for Food Safety and Applied Nutrition


Mr. Curt Blinsinger, Managing Member
Nu-Wave Consultants
1801 Bayview Avenue
P.O. Box 875
Barnegat Light, New Jersey 08006