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WARNING LETTER

Yamahide Shokuhin, Inc. MARCS-CMS 445114 — Dec 30, 2014

Yamahide Shokuhin, Inc. - 445114 - 12/30/2014


Recipient:
Yamahide Shokuhin, Inc.


United States

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 20740 

 

December 30, 2014
WARNING LETTER
 
VIA EXPRESS DELIVERY
 
Kyosuke Muraoka
President
Yamahide Shokuhin, Inc.
29 Tomoe, Bessho-cho
Miki-shi, JP-28 673-0443
Japan
 
Reference No. # 445114
 
 
Dear Mr. Muraoka:
 
In response to deviations from the United States Food and Drug Administration’s seafood Hazard Analysis and Critical Control Point (HACCP) regulation, 21 CFR Part 123, found during an inspection that we conducted at your seafood processing facility, Yamahide Shokuhin, Inc. located at 29 Tomoe, Bessho-cho, Miki-shi, Japan, on March 27-28, 2014, your firm provided information and documentation via emails on April 11, 2014, July 28, 2014, and October 29, 2014, to address those deviations.
 
The documentation you provided included your revised HACCP plan (i.e., English version) dated July 25, 2014. In addition, you provided information on your manufacturing process via email on October 29, 2014. Our evaluation of your revised HACCP plan and the information you provided on your manufacturing process, revealed continuing concerns with your firm’s operations 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 dried shaved bonito (dried bonito flakes) 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 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 (English version) for dried shaved bonito (dried bonito flakes) dated July 25, 2014, does not list critical control points for:
 
a.    Processing steps conducted under unrefrigerated conditions to control the food safety hazard of scombrotoxin (histamine) formation. Specifically, your flow chart, dated July 25, 2014, lists several unrefrigerated processing steps following removal of the fish (b)(4). Although your fish is received fully dried, the fish is exposed to both moisture and temperatures above (b)(4) following removal from the freezer. These combined handling practices pose a risk for scombrotoxin (histamine) formation as a result of time and temperature abuse particularly after rehydration. Therefore, FDA recommends you include controls for time of exposure to temperatures above 4.4°C (40°F) during unrefrigerated processing to control scombrotoxin (histamine) formation, starting when the product is removed from material storage at “Retrieval / Shipping (3)” and particularly after any exposures to moisture that lead to rehydration, until the time you finish drying the product at the “Elevator (Far infrared heater) (13)” step. While your firm may choose to combine the processing steps into one critical control point, when doing so your firm needs to include adequate corresponding monitoring procedures, recordkeeping, etc. to address all exposure times at unrefrigerated temperatures.
 
b.    Processing to control the food safety hazard of pathogenic bacteria growth and toxin formation, including Staphylococcus aureus. Specifically, your firm has identified general pathogens and Staphylococcus aureus at various critical control points in your HACCP plan and your flow chart dated July 25, 2014, lists several unrefrigerated processing steps (b)(4), and your cooked product comes into contact with equipment that was not heat treated along with the product, prior to final drying to control water activity of the fish. These conditions may pose a risk for pathogen growth, including Staphylococcus aureus growth and toxin formation. Therefore, FDA recommends you include controls for time of exposure to internal temperatures above 10°C (50°F) but below 52.7°C (135°F) during unrefrigerated processing,  starting at the time when the cooked product comes into contact with equipment that was not heat treated along with the product, specifically after the “Extreme infrared radiation heating (sterilization) (8)” critical control point until the time you finish drying the product at the “Elevator (Far infrared heater) (13)” step.As mentioned above, you should ensure to include adequate corresponding monitoring procedures, recordkeeping, etc. to address all exposure times at unrefrigerated temperatures.
 
c.    Container integrity testing during the automatic packing step to control the food safety hazards of scombrotoxin (histamine) formation and pathogenic bacteria growth and toxin formation, including Staphylococcus aureus. To ensure your dried shaved bonito (dried bonito flakes) packed in vacuum reduced oxygen packaging is not exposed to moistureduring storage and distribution, which may bring the water activity above your listed critical limit of (b)(4), you should include controls to ensure finished product packaging closures are free of gross defects.Therefore, 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).
 
2.    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 (English version) for dried shaved bonito (dried bonito flakes) dated July 25, 2014, lists critical limits at the (b)(4). Specifically, your critical limits list “Set heating temperature (b)(4).” However, based on the type of cooking equipment observed to be used at your facility and because you are monitoring the setting on this equipment, FDA recommends your critical limits for cooking include all of the following:
 
a.    length of the cook cycle (speed of the belt for a continuous cooker);
 
b.    actual temperature used for cooking (rather than settings for the cooking equipment); and
 
c.    any other critical factors established by a scientific study that affect the rate of heating of the product.
 
In addition, you should use a continuous temperature-recording device to monitor the cooking temperature, and a stopwatch or tachometer to monitor the speed of the belt or a stopwatch to monitor the time necessary for a test unit or belt marking to pass through the equipment. 
 
3.    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 in English for dried shaved bonito (dried bonito flakes) dated July 25, 2014, lists a monitoring procedure/ frequency at the “Elevator / Far Infrared Heater (13)” critical control point that is not adequate to control the identified hazards of pathogenic bacteria growth and toxin formation, including Staphylococcus aureus. Specifically, your monitoring procedure states you monitor water activity using the (b)(4). However, FDA recommends monitoring water activity of the finished product by collecting a representative sample of the finished product and conducting water activity analysis for each lot.
 
You should respond in writing within fifteen (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
Director
Office of Compliance
Center for Food Safety
    and Applied Nutrition

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