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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Dangjin Food Inc.

  

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

Public Health Service
Food and Drug Administration
 College Park, MD

 

                                                                                                                   
Warning Letter
I.D. # 157872
 
 
VIA OVERNIGHT MAIL
 
Dangjin Food, Inc.
32 Choil-Dong,
Hanam City, Kr-41
Republic of Korea
 
Dear Sir/Madame:
 
This in response to a request by the United States Food and Drug Administration for a copy of your firm’s HACCP plans for your boiled, dried anchovies and dried Pollock. The request was made following detention of these products, when they were offered for entry into the United States. We have reviewed the HACCP plans and our evaluation revealed serious deviations from the requirements of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations, Part 123 (21 CFR Part 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 boiled, dried anchovies and the dried Pollock 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 and Controls Guidance: 3rd Edition (the Hazard Guide) through links in FDA’s home page at www.fda.gov.
 
We note the following deviations:
  1. You must conduct or have conducted for you a hazard analysis for each kind of fish and fishery product that you produce 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 food safety hazards that are reasonably likely to occur, to comply with 21 CFR 123.6 (a) and (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,
    1. your firm’s HACCP plan for boiled, dried anchovies does not list the food safety hazards of histamine and pathogen growth, including Clostridium botulinum growth and toxin formation.   Specifically, your HACCP plan for your boiled, dried anchovies only references metals as a reasonably likely hazard. However, anchovies are a scombroid species susceptible to scombrotoxin (histamine) development as a result of time and temperature abuse. Your Process Flow Diagram and Hazard Analysis Worksheet list steps that may, as a result of time and temperature abuse, result in excessive histamine development.   These may include steps such as thawing and would also include any additional extended storage periods, between thawing and boiling. 
In addition, because the anchovies are uneviscerated, they pose the hazard of Clostridium botulinum growth and toxin formation.   Processors of small fish (less than 5 inches in length) such as anchovies must ensure that the fish are appropriately handled and processed in a manner that controls the potential of Clostridium botulinum growth and toxin formation. 
 
Additionally, because your products are not labeled to be held refrigerated or frozen, they are considered shelf stable. Consequently, your finished products need to achieve either a water-phase salt level of at least 10 percent, or a water activity below 0.85.  
 
Additionally, these types of dried products are usually intended to be marketed as shelf stable.  Photographs of your cartons do not appear to include any instructions for maintaining the products under refrigeration or held frozen. As a dried product intended to be shelf stable, the finished products must achieve a water activity of 0.85 or below to control pathogen growth.   
 
Moreover, we note from the photos that the anchovies are placed in unlined cardboard containers for shipping and distribution. Unlined cardboard is not sufficient to prevent rehydration of the product.
    1. your firm’s HACCP plan for dried Pollock does not list the food safety of pathogen growth. However, your Hazard Analysis for this product lists several processing steps such as thawing, boiling and two drying steps. Pathogen survival following the boiling step is referenced in the hazard analysis, as well as pathogen cross contamination following each drying step. Pahtogen growth and potential toxin formation are reasonably likely hazards for a product such as your dried Pollock. For example, Staphylococcus aureus toxin formation maybe result due to time and temperature abuse following the boiling step. 
Additionally, as mentioned above, this type of dried product is also usually intended to be marketed as shelf stable. As a dried product intended to be shelf stable (i.e., without refrigeration or frozen), the finished products must achieve a water activity of 0.85 or below to control pathogen growth.
 
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. 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 other useful information that would assist us in evaluating your corrections. If you cannot complete all corrections before the 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. 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 the Good Manufacturing Practice regulation (21 CFR 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 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@hhs.fda.gov 
 
 
Sincerely,
/s/
William A. Correll
Acting Director
Office of Compliance
Center for Food Safety and Applied Nutrition