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  5. D & N Foods Processing Co., LTD. - 439137 - 10/16/2014
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WARNING LETTER

D & N Foods Processing Co., LTD. MARCS-CMS 439137 — 16/10/2014

D & N Foods Processing Co., LTD. - 439137 - 10/16/2014


Recipient:
Recipient Name
Shinichi Tamura
D & N Foods Processing Co., LTD.

62 Yet Kieu St.

Danang City
Vietnam

Issuing Office:
Center for Food Safety and Applied Nutrition

United States


  

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

Public Health Service
Food and Drug Administration
 5100 Paint Branch Parkway
College Park, MD 20742

 

October 16, 2014
 
WARNING LETTER
 
VIA EXPRESS DELIVERY
 
Shinichi Tamura
Director/President
D & N Foods Processing Co., LTD.
62 Yet Kieu St.
Danang City, Vietnam
 
Reference No. # 439137
 
Dear Mr. Tamura:
 
We inspected your seafood processing facility D & N Foods Processing Co., LTD., locatedat 62 Yet Kieu St., Danang City, Vietnam,on April 7-8, 2014.  During that inspection, we found 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).  At the conclusion of the inspection, the FDA investigator issued an FDA-483, Inspectional Observations, listing the deviations found at your firm.  
 
We acknowledge receipt of your response sent via email on July 15, 2014. Your response included various documents, including a written statement of corrections and other supporting documents. Additionally, you provided your revised HACCP plan via email on July 19, 2014. However, review of the documentation revealed that the response was not adequate, as further described in this letter.
 
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 ready-to-eat frozen vacuum packaged fried fish cake, fish cake, and imitation crab meat 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 4th Edition of the Fish and Fisheries Products Hazards and Controls Guidance (the Hazards Guide) through links in FDA's home page at www.fda.gov. The Hazards Guide, which provides our recommendations regarding identification and control of food safety hazards reasonably likely to occur for your fish and fishery products, can be found on our web site at: http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/Seafood/FishandFisheriesProductsHazardsandControlsGuide/default.htm
 
Your significant deviations are as follows:
  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, your firm’s revised HACCP plan for fried fish cake, fish cake, and imitation crab meat provided with your July 19, 2014, response does not list the food safety hazard of undeclared food allergens. 
Once identified as a hazard, your firm should include a critical control point addressing undeclared allergens. One way to control for undeclared allergens is to include a critical control point for review of the labels for each type of product to ensure that all allergenic ingredients are accurately listed and correspond to that specific product. 
  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 revised HACCP plan for fried fish cake, fish cake, and imitation crab meat provided with your July 19, 2014, response does not list the following critical control points for controlling pathogenic bacteria growth and toxin formation:
    1. Cooling following the pasteurization (“sterilizing”) step to control post-pasteurization recontamination.  We acknowledge that your response includes the statement “product is to cool down by cold air with temperature 0-5oC.”  However, this is not adequate and, moreover, there is no reference to cooling in your HACCP plan.  Pathogenic spores could survive the cooking process, and could grow and produce toxin in the product during cooling; therefore, FDA recommends critical limits to ensure that the product is cooled from 135°F (57.2°C) to 70°F (21.1°C) within 2 hours, and that the product is further cooled from 135°F (57.2°C) to 40°F (4.4°C) within an additional 4 hours. 
    1. Container integrity testing following the pasteurization (i.e., “sterilization”) processing step. Our investigator observed the product being vacuum sealed in a plastic bag prior to pasteurization. Consequently, your HACCP plan should include controls to prevent the reintroduction of pathogenic bacteria after the pasteurization (“sterilizing”) processing step through inadequate packaging seals. FDA recommends that you control container integrity through visual examination of the plastic bags for gross closure defects, and a detailed examination of your plastic bags (i.e., burst, vacuum, or bubble testing).
  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 fried fish cake, fish cake, and imitation crab meat provided with your July 19, 2014, response lists critical limits that are not adequate to control pathogen survival, including Listeria monocytogenes growth.
Your critical limit at the “Sterilizing” critical control point includes the minimum time and minimum temperature of the pasteurization process; however, to fully control the hazard of Listeria monocytogenes, FDA recommends the critical limit for cooking include all of the following, for each product:
a.    length of pasteurization cycle (e.g. speed of the belt for a continuous cooker)
b.    temperature of steam or water used for cooking
c.    minimum initial temperature of the product
d.    container size (e.g. pouch thickness)
e.    product formulation.
 
4.     You must have a HACCP plan that, at a minimum, lists monitoring procedures and their frequencies for each critical control point to comply with 21 CFR 123.6(c)(4). However, your firm’s revised HACCP plan for fried fish cake, fish cake, and imitation crab meat provided with your July 19, 2014, response lists a monitoring procedure/frequency at the “Sterilizing” critical control point that is not adequate to control pathogenic bacteria growth. Your monitoring procedure states that you monitor steam temperature using a thermometer and a stop watch, every 30 minutes. FDA recommends using a continuous temperature-recording device to measure the temperature of the cooking equipment at the cold spot of the equipment, and a visual observation of temperature at least once per day.
You should respond in writing within 15 working days from your receipt of this letter. Your response should outline the specific steps you are taking to correct these deviations. More specifically, your response should include documentation reflecting the changes you made, such as a copy of your revised HACCP plan or plans, five (5) consecutive days of completed monitoring records (i.e., records for the production of 5 production date codes of the products) to demonstrate implementation of the plan or plans, and any additional information that you wish to supply that provides assurance of your intent to fully comply now and in the future with the applicable laws and regulations. Submission of the information in English will assist in our review.  If you cannot complete all corrections within 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. 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. You may view this alert at: http://www.accessdata.fda.gov/cms_ia/ialist.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 and all applicable regulations, including 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.
 
Additionally, Section 743 of the Act (21 U.S.C. § 379j-31) authorizes FDA to assess and collect fees to cover FDA’s costs for certain activities, including re-inspection-related costs. A re-inspection is one or more inspections conducted subsequent to an inspection that identified noncompliance materially related to a food safety requirement of the Act, specifically to determine whether compliance has been achieved. Re-inspection-related costs means all expenses, including administrative expenses, incurred in connection with FDA’s arranging, conducting, and evaluating the results of the re-inspection and assessing and collecting the re-inspection fees (21 U.S.C. § 379j-31(a)(2)(B)). For a foreign facility, FDA will assess and collect fees for re-inspection-related costs from the U.S. Agent for the foreign facility. The inspection noted in this letter identified noncompliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any re-inspection-related costs. Please consider providing a copy of this letter to your U.S. Agent.
 
Please send your reply to Food and Drug Administration, Attention:  Sheena Crutchfield, Compliance Officer, Food Adulteration Assessment Branch (HFS-607), Division of Enforcement, Office of Compliance, 5100 Paint Branch Parkway, College Park, MD 20740 U.S.A. If you have any questions regarding this letter, you may contact Ms. Crutchfield via email at sheena.crutchfield@fda.hhs.gov.
 
Sincerely,
/S/
William A. Correll, Jr.
Director
Office of Compliance
Center for Food Safety
    and Applied Nutrition

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