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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Hai Nam Co., Ltd. 6/18/12


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

Public Health Service
Food and Drug Administration
College Park, MD 20740 


June 18, 2012
Mr. Nguyen Thi Thu Sac, President
Hai Nam Co., Ltd.
55 Pham Ngoc Thach Street, District 3
Ho Chi Minh City, Vietnam
Reference No. 311300
Dear Mr. Nguyen Thi Thu Sac:
This letter is in response to the information your firm provided on April 12, 2012, in response to our letter to your firm dated March 9, 2012. Our review of your HACCP plan and associated records found that you had serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations, Part 123 (21 CFR 123). 
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 scombrotoxin (histamine) forming fish are adulterated, in that they have been prepared, packed, or held under 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 and Controls Guidance (the Hazards Guide) through links in FDA's home page at www.fda.gov.
Based on the information provided in your April 12th correspondence, we note the following serious deviations:

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 revised HACCP plan for mahi-mahi, which is identified as “HACCP Plan Form” received April 12, 2012, is not adequate to control histamine formation. Specifically:

    1. At the “Receiving Raw Material” critical control point, your firm’s revised HACCP plan does not include critical limits associated with the handling practices onboard the harvest vessels to control histamine formation.  FDA recommends in order to ensure that the fish were properly handled during harvesting and storage onboard the vessels that firms include either a histamine testing strategy or obtain harvest vessel records. In addition, FDA recommends that firms take internal temperatures of a representative number of fish at off-loading, to ensure proper temperature controls during storage onboard the vessels.  
    1. At the “Receiving Raw Material” critical control point, your firm’s revised HACCP plan does not include adequate critical limits associated with products that have been transported up to (b)(4) from the wharf, in transit to your facility.  Your HACCP plan references temperatures at receipt as (b)(4) This appears to be a monitoring procedure associated with receipt of the fish at your facility (b)(4) FDA does not recommend taking a one time temperature for products that have been in transit for extended time periods (i.e., in transit longer than about four (4) hours), as this does not assure that the fish was maintained at an appropriate temperature during transit. Your firm should monitor the presence of adequate ice surrounding the products or obtain records demonstrating that the temperatures were continuously monitored during transit to your facility.
    1. At the “Filleting” and “Processing” critical control points, your firm does not list adequate critical limits to control histamine formation. FDA recommends limiting cumulative exposure times during unrefrigerated processing steps to 4 hours when temperatures in the processing area exceed 21°C (70°F) or washing water exceeds 21°C (70°F). 

2. Because you chose to include a corrective action in your revised HACCP plan, your described corrective actions must be appropriate, to comply with 21 CFR 123.7(b). However, your corrective action plans for mahi-mahi to control histamine formation are not appropriate at the:

    1. “Receiving Raw Material,” “Filleting,” and “Processing” critical control points. These critical control points state that you will perform histamine testing when the sensory evaluation fails, in that the sensory analysis shows (b)(4) decomposition in the lot (b)(4)   However, the plan does not specify the number of fish in the histamine sample. FDA recommends when histamine testing is performed as a corrective action, that a minimum of 60 fish be collected from throughout each affected lot and that firms destroy the entire lot or divert it to a non-food use when any fish is found with histamine greater than or equal to 50 ppm. 
    1. “Filleting” and “Processing” critical control points. The corrective actions do not address the cause of the deviation to prevent its reoccurrence.
    1.  “Receiving Raw Material” critical control point.  Your plan states that you will perform sensory evaluation; however, the plan does not specify that the entire lot will be evaluated. 
3. You must have a HACCP plan that, at a minimum, lists the food safety hazards that are reasonably likely to occur, to comply with 21 CFR 123.6(c)(1). A food safety hazard is defined in 21 CFR 123.3(f) as, “any biological, chemical, or physical property that may cause a food to be unsafe for human consumption.” However, your firm’s revised HACCP plan for mahi-mahi does not list the food safety hazards of undeclared allergens.
4. You must have a HACCP plan that, at a minimum, lists the critical control points, to comply with 21 CFR 123.6(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 result be prevented, eliminated, or reduced to acceptable levels.”  However, your firm’s revised HACCP plan does not list critical control points of temporary storage, butchering, washing 1 & 2, skinning, removal of bloodline, and sizing, which are identified in your “Hazard Analysis Worksheet,” received April 12, 2012, for controlling the food safety hazard of histamine formation.  Because histamine formation is cumulative, your firm needs to assess all processing steps when the fish are unrefrigerated, to ensure that cumulatively each does not expose the fish to time and temperature abuse conducive to excessive histamine formation.
For additional information regarding the hazards and controls discussed above, please refer to the 4th Edition of the Fish and Fisheries Products Hazards and Controls Guidance: Fourth Edition, which can be found on FDA’s web site at:
You should respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific things you are doing to correct these violations. Your response should include documentation, such as a copy of any revised HACCP plans and at least five (5) product days worth of monitoring records to demonstrate that you have implemented the revised plan, any verification records, and other useful information that would assist us in evaluating your corrections. If you cannot complete all corrections before the 15 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. This procedure is generally based on past history or other information, such as an inspection of a facility or HACCP plan review, indicating that the factory producing the product or the product itself may not be in compliance with FDA’s laws and regulations. DWPE information is conveyed in FDA’s Import Alerts. 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 regulation, and other applicable regulations.  You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations.
Please send your reply to Food and Drug Administration, Attention:  Maria Lau, Office of Compliance, Division of Enforcement, Food Adulteration Assessment 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 Maria Lau by phone at (240) 402-2271 or via email at maria.lau@fda.hhs.gov.
Michael W. Roosevelt  
Acting Director
Office of Compliance
Center for Food Safety and Applied Nutrition