WARNING LETTER
Kyokuyo Global Seafoods Co. LTD.
MARCS-CMS 688294 —
August 30, 2024
Delivery Method:
Via Express Delivery and Electronic Mail
Product:
Food & Beverages
Recipient:
Recipient Name
Mr. Taisuke Kunimune
Recipient Title
President
Kyokuyo Global Seafoods Co. LTD.
55/237 Moo.6 Tasai
Mueang
Samut Sakhon
74000
Thailand
Taisuke_Kunimune@kgsf.co.th
Issuing Office:
Center for Food Safety and Applied Nutrition
United States
WARNING LETTER
Reference # 688294
Dear Mr. Taisuke Kunimune,
The United States Food and Drug Administration (FDA) conducted an inspection of your seafood processing facility, Kyokuyo Global Seafoods Co. LTD., located at 55/237 Moo.6 Tasai, Mueang Samut Sakhon Samut Sakhon, Thailand 74000, on January 19, 2024, through January 22, 2024. During that inspection, we found that you had serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations (21 CFR Part 123). At the conclusion of the inspection, the FDA investigator issued an FDA 483, Inspectional Observations, listing the observations made at your firm. We acknowledge receipt of your response via email on February 8, 2024, which included a cover letter outlining your corrective actions and revised HACCP plans. However, our evaluation of your response revealed it 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 (RTE) raw and cooked mackerel and frozen red shrimp 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 & Controls Guidance (the Hazards Guide) through links in FDA's home page at www.fda.gov.
Your significant deviations are as follows:
1. You must conduct or have conducted 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 plans for Frozen “Shimi Saba Slice” and Frozen “Raw Mackerel Kirimi (for cooked fish)” with effective dates of “05/02/2024” do not list the food safety hazard of
Staphylococcus aureus (S. aureus)
growth and toxin formation.
S. aureus
is a reasonably likely hazard for frozen mackerel products processed by your firm at ambient temperatures ranging from
(b)(4)
°C (
(b)(4)
° F). Either exposure times and/or ambient temperatures should be controlled to prevent
S. aureus
toxin formation. For example, when ambient temperatures exceed
(b)(4)
°C, but remain below
(b)(4)
°F, temperatures should be monitored. If ambient temperatures have the possibility of exceeding
(b)(4)
°F, then cumulative exposure times should be limited to
(b)(4)
hours.
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” (CCP) 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 revised HACCP for Frozen “Shimi Saba Slice” HACCP plan effective date “05/02/2024”, does not list a CCP for overnight refrigerated thawing of RTE frozen mackerel products to control the possible hazard of histamine formation and pathogen growth. Further, at your “
(b)(4)
” step, the raw fillets and vinegar are placed into a bag that is vacuum sealed and stored overnight in refrigerated storage. This introduces the hazard of
Clostridium botulinum (C. botulinum)
, in addition to histamine formation. FDA recommends temperature controls be in place to control these hazards including that storage temperatures remain below 3.3°C (38°F) until the fish flesh reaches a pH of 5.0 to prevent the hazard of
C. botulinum
growth and toxin formation.
3. Because you chose to include corrective action plan in your HACCP plans, your described corrective actions must be appropriate, to comply with 21 CFR 123.7(b). However, your corrective action plans for your raw and cooked mackerel products including your “Frozen Raw Mackerel Kirimi Fillet”, “Frozen Cooked Mackerel Fillet/Portion with Seasoning Sauce”, “Frozen Shimi Mackerel Slice” and “frozen red shrimp” are not appropriate at the packing and labeling steps. Specifically, the corrective actions identified for the allergen hazard, does not cover potentially affected products and how the cause of the deviation will be addressed.
You should respond in writing within 15 working days from your receipt of this letter. Your response should outline the specific things you are doing 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 consecutive days of completed monitoring records (i.e., complete sets of monitoring records for five production date codes of products) to demonstrate implementation of the plan, 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 seafood HACCP regulation. 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 believe that your product is not in violation of the Act, include your reasoning and any supporting information for our consideration.
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. This alert can be found on FDA’s web site at: Import Alert 16-120 (fda.gov).
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 (21 CFR Part 123) and the current Good Manufacturing Practice Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation (CGMP & PC rule), Title 21, Code of Federal Regulations, Part 117 (21 CFR Part 117 Subpart B). You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations.
Please send your reply to the Food and Drug Administration, Attention: Lisa Thursam, Compliance Officer, Office of Compliance, Division of Enforcement, Food Adulteration and Assessment Branch (HFS- 607), 5001 Campus Drive, College Park, MD 20740 U.S.A. If you have any questions regarding any issues in this letter, please contact Lisa Thursam via email at: lisa.thursam@fda.hhs.gov. Please include reference #688294 on any submissions and within the subject line of any email correspondence to the agency.
Sincerely,
/S/
Ann M. Oxenham, J.D.
Director, Office of Compliance
Center for Food Safety and Applied Nutrition
Content current as of:
11/26/2024
Regulated Product(s)
Food & Beverages