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WARNING LETTER

Seiki Co., Ltd. MARCS-CMS 523744 —

Recipient:
Recipient Name
Mr. Kenji Kuroiwa
Seiki Co., Ltd.

7922-3 Kiire Maenohama-Cho
Kagoshima City, Kagoshima Prefecture,
891-0205
Japan

Issuing Office:
Center for Food Safety and Applied Nutrition

United States

 

   

Black HHS-Blue FDA Logo

 

 
 
500 Campus Drive
College Park, MD  20740

 

June 1, 2017
WARNING LETTER
 
 
 
VIA EXPRESS DELIVERY
 
Mr. Kenji Kuroiwa
President                                                                                                                                                                 
Seiki Co., Ltd.
7922-3 Kiire Maenohama-Cho
Kagoshima City, Kagoshima Prefecture
Japan 891-0205
 
Reference # 523744
 
Dear Mr. Kuroiwa:
 
On December 19, 2016, a representative of the United States Food and Drug Administration (FDA) conducted an inspection of fish and fishery products importer located in the United States, Frontier Japan, Inc., located in New York, New York. The inspection was conducted in order to assess the 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 fish and fishery products from your processing facility. During the inspection of the importer, we collected copies of your HACCP plans entitled “Frozen Aquacultured Yellowtail Product Group (Fillet • Loin/Smoked)” and “Refrigerated Aquacultured Yellowtail (Fillet)”, both dated June 2, 2014.
 
Our evaluation of these HACCP plans (copies attached) revealed serious deviations from the requirements of the seafood 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 refrigerated and frozen vacuum packaged aquaculture yellowtail fillet 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 4th Edition of the Hazards Guide can be found on our web site at: http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/Seafood/FishandFisheriesProductsHazardsandControlsGuide/default.htm
 
We found the following significant 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, your HACCP plan for “Frozen Aquacultured Yellowtail Product Group (Fillet • Loin/Smoked)”, dated June 2, 2014, does not list the food safety hazard of Clostridium botulinum (C. botulinum) toxin formation.
 
Specifically, (b)(4). Since air is replaced by smoke at this step, it creates an anaerobic condition at this processing step conducive to C. botulinum growth and toxin formation. Moreover, the seafood HACCP regulation requires that firms control all reasonably likely hazards through implementation of their written HACCP plan, in lieu of implementation of SOPs. As such your firm needs to identify the hazard of C. botulinum growth and toxin formation in your written HACCP plan, with a critical control point to control the hazard and adequate corresponding critical limits (e.g., ambient temperature of 3.3°C or below), monitoring procedures (e.g., continuous temperature monitoring), recordkeeping (e.g., continuous temperature recording), etc. at this Smoke/Cool step.
 
Additionally, your frozen aquacultured yellowtail is vacuum packaged, which generally reduces the amount of oxygen in a package.  The food safety hazard of C. botulinum toxin formation is associated with packaged products which may create an anaerobic environment in which C. botulinum can proliferate and produce toxin during thawing of the packaged product. FDA recommends the packages of frozen vacuum packaged fish include handling instructions to state “Keep Frozen; Thaw Under Refrigeration Before Use” or similar language.
 
2.    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 HACCP plans for “Frozen Aquacultured Yellowtail Product Group (Fillet • Loin/Smoked)” and “Refrigerated Aquacultured Yellowtail (Fillet)”, both dated June 2, 2014, do not list the following critical control points to control the identified food safety hazards:
 
a.  Unrefrigerated processing to control the food safety hazard of scombrotoxin (histamine) formation.  Specifically, (b)(4) in your firm’s HACCP plan for “Frozen Aquacultured Yellowtail Product Group (Fillet • Loin/Smoked)”.  In addition, (b)(4) in your firm’s HACCP plan for “Refrigerated Aquacultured Yellowtail (Fillet)”.  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 from when the first fish in a marked batch is removed from ice or refrigerated storage until the last finished product from the marked batch is placed in the freezer or refrigerated storage.  Your firm may choose to combine these unrefrigerated 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.  Refrigerated storage to control the food safety hazards of scombroxin (histamine) formation and C. botulinum toxin formation.  Since your refrigerated, vacuum packed aquacultured yellow tail is stored refrigerated, FDA recommends that you include these storage periods as critical control points to ensure that proper time and temperature controls are maintained to control the food safety hazards.  Furthermore, you should ensure that the product is held at a cooler temperature of 38°F (3.3°C) or below to control C. botulinum in the reduced oxygen packaged products.
 
c.  Application and activation of the TTIs to control the food safety hazard of C. botulinum toxin formation. FDA recommends establishing controls to ensure that each consumer package has an activated TTI applied to the package.
 
3.    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 HACCP plans for “Frozen Aquacultured Yellowtail Product Group (Fillet • Loin/Smoked)” and “Refrigerated Aquacultured Yellowtail (Fillet)”, both dated June 2, 2014, list critical limits that are not adequate to control the identified food safety hazards:
 
a.  Your critical limits listed at the “Receipt of yellowtail” critical control point for both your frozen and refrigerated yellowtail products are not adequate to control histamine.  To adequately control the food safety hazard of scombrotoxin (histamine) formation that is reasonably likely to occur onboard the harvest vessel, FDA recommends you include critical limits for the following:
 
i.  Harvest vessel records or Histamine testing;
ii.  Sensory examination; and
iii.  Internal temperature measurements at the time of off-loading from the harvest vessel by the processor.
 
Additionally, to adequately control the food safety hazard of scombrotoxin (histamine) formation that is reasonably likely to occur during transit from the harvest vessel to the processing plant, FDA recommends you include the following critical limit or critical limit combinations at the “Receipt of yellowtail” critical control point:
 
i.  For fish delivered refrigerated (not frozen):
  • All lots received are accompanied by transportation records that show that the fish were held at or below an ambient or internal temperature of 40°F (4.4°C) throughout transit; or
ii.  For fish delivered under ice:
  • Fish are completely surrounded by ice at the time of delivery; or
iii.  For fish delivered under ice on an open-bed truck:
  • Fish are stored completely surrounded by ice, and
  • The internal temperature of the fish at the time of delivery is 40°F (4.4°C) or below; or
iv.  For fish delivered under chemical cooling media such as gel packs:
  • There is an adequate quantity of cooling media that remain frozen to have maintained product at an internal temperature of 40°F (4.4°C) or below throughout transit, and
  • The internal temperature of the fish at the time of delivery is 40°F (4.4°C) or below; or
v.  For fish delivered refrigerated (not frozen) with a transit time (including all time outside a controlled temperature environment) of 4 hours or less:
  • Time of transit does not exceed 4 hours, and
  • Internal temperature of the fish at the time of delivery does not exceed 40°F (4.4°C). 
b.  Your critical limit at the “Receipt of TTI” critical control point for your refrigerated yellowtail product is not adequate to control production of botulinum toxin.  In addition to “Do not use until approval by a certificate returned by Vitsab is obtained”, FDA recommends your critical limit consists of the following:
 
i.  Ensure TTI is suitable for use.  Specifically, it should be designed to perform properly under the conditions that it will be used.  Additionally, it should be designed to produce an alert indicator at a combination of time and temperature exposures that will prevent the formation of non-proteolytic C. botulinum toxin formation.
 
ii.  Where transportation temperature could affect the functionality of the TTI, all lots of TTIs are accompanied by transportation records that show that they were held at conditions that do not result in loss of functionality throughout transit.
 
c.  Your critical limits at the “Remove Head and Guts” and “Wipe” critical control points for your refrigerated yellowtail product are not adequate to control histamine.  Specifically, (b)(4), FDA recommends that fish are not exposed to ambient temperatures above 40°F (4.4°C) for more than 8 hours, cumulatively, as long as no portion of that time is at temperatures above 70°F (21.1°C).  Furthermore, you should monitor both the ambient temperatures during the exposure periods and length of time the scombrotoxin-forming fish are exposed to unrefrigerated conditions (i.e., above 40°F (4.4°C)) from when the first fish in a marked batch is remove from ice or refrigerated storage until the last finished product from the marked batch is placed in refrigerated storage, at least every 2 hours.
 
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 HACCP plans for “Frozen Aquacultured Yellowtail Product Group (Fillet • Loin/Smoked)” and “Refrigerated Aquacultured Yellowtail (Fillet)”, both dated June 2, 2014, list a monitoring procedure/frequency at the “Receipt of yellowtail” critical control point that is not adequate to control scombrotoxin (histamine) formation.  Specifically, (b)(4).  FDA recommends when receiving 10 tons or more of fish, measure a minimum of one fish per ton, and when receiving less than 10 tons of fish, measure a minimum of one fish per 1,000 pounds.  In addition, FDA recommends that you measure a minimum of 12 fish regardless of the weight of the batch, unless there are fewer than 12 fish in the lot, in which case we recommend that you measure all of the fish.
 
5.    Because you chose to include a corrective action plan in your HACCP plan, your described corrective action must be appropriate, to comply with 21 CFR 123.7(b). However, your corrective action plans for “Frozen Aquacultured Yellowtail Product Group (Fillet • Loin/Smoked)” and “Refrigerated Aquacultured Yellowtail (Fillet)”, both dated June 2, 2014, at the following critical control points are not appropriate.
 
a.  Your corrective action plan at the “Receipt of yellowtail” critical control point for internal temperature is not appropriate to address the deviation.  FDA recommends that when the internal temperature critical limit has not been met, you chill and hold the affected lot until histamine analysis is performed on a minimum of 60 fish representatively collected from throughout the lot or the entire lot for lots smaller than 60 fish, you should reject the lot if any fish are found with histamine greater than or equal to 50 ppm; or you may choose to just reject the lot.  Additionally, discontinue use of the supplier until evidence is obtained that the identified harvesting and onboard practices have been improved.
 
b.  Your corrective action plans for the “Receipt of TTI” and “Storage of TTI” critical control points for refrigerated yellowtail product do not adequately address how you will ensure that adulterated product does not enter commerce when a deviation from the critical limits occurs.  If you are unable to obtain approval by a certificate, FDA recommends that you reject or return the shipment.  If the storage temperature rises to a temperature that affects the functionality of the TTI, FDA recommends you destroy the lot of TTIs.  In addition, your corrective action plan does not address deviations from your critical limit for TTI use-by-date.
 
c.  Your corrective action plans for the “Remove head and Guts” and “Wipe” critical control points for refrigerated product are not appropriate to address the deviation.  FDA recommends you chill and hold the affected lot until histamine analysis is performed on a minimum of 60 fish representatively collected from throughout the affected lot and if any fish are found with histamine greater than or equal to 50 ppm, you should destroy the product or divert the product to a non-food use; or you may choose to just destroy the product or divert the product to a non-food use.
 
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 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
 
We have the following comments concerning your HACCP plan for “Refrigerated Aquacultured Yellowtail (Fillet)”, dated June 2, 2014:
  • Your critical limit at the “TTI Activation Test” critical control point to control C. botulinum toxin formation states "(b)(4)”, however, you do not indicate what determines if the (b)(4), for example if the TTI produces an alert indicator, such as a color change of the device when exposed to time and temperature abuse.
  • Your monitoring frequency at the “Storage of TTI” critical control point is not adequate to control C. botulinum toxin formation. Specifically, monitoring the temperature of the freezer once per day is not sufficient to ensure control. FDA recommends using a continuous temperature-recording device (e.g., a recording thermometer) with continuous monitoring by the device itself and a visual check of the recorded data at least once per day.
  • The method of storage and distribution listed in the heading of your HACCP plan of “(b)(4)” is not adequate.  Refrigerated vacuum and reduced oxygen packaged fresh fish must be continuously maintained at temperatures of 3.3°C or below to prevent the hazard of C. botulinum growth and toxin formation during all subsequent distribution until the individual packages are opened.
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, 5001 Campus Drive, 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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