WARNING LETTER
Fukusui Shoji Ltd.
MARCS-CMS 659726 —
June 27, 2023
Delivery Method:
Via Express Delivery
Product:
Food & Beverages
Recipient:
Recipient Name
Nagasawa Satoshi
Recipient Title
CEO
Fukusui Shoji Ltd.
3 Chome 11-3 605
Nagahama; Chuo
Fukuoka
,
Fukuoka
810-0072
Japan
Issuing Office:
Center for Food Safety and Applied Nutrition
United States
June 27, 2023
WARNING LETTER
Reference # 659726
Dear Mr. Satoshi:
The United States Food and Drug Administration (FDA) conducted an inspection of your seafood processing facility, Fukusui Shoji Ltd., located at 3 Chome 14-1 C, Nagahama, Chuo, Fukuoka, Fukuoka Japan on February 8-9, 2023. 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, 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 received your responses via email on April 7 and 8, 2023. Your responses included a written statement and revised HACCP plan for group C fresh fish. However, our evaluation of your responses revealed that you continue to have serious concerns with your HACCP program, 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 fresh fish products 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.
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 “Fresh Fish Group C”, issued on February 16, 2023, does not identify the food safety hazard of
Clostridium botulinum (C. botulinum)
growth and toxin formation. You place the fish in plastic bags, then the bag is
(b)(4)
at the opening and placed into a
(b)(4)
cooler filled with ice for shipment to the U.S.
C. botulinum
growth and toxin formation is reasonably likely to occur in your packaged products as
(b)(4)
bags can create an anaerobic condition conducive to growth and toxin formation when mishandled, particularly when products are refrigerated (i.e., not frozen).
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 HACCP plan for “Fresh Fish Group C”, issued on February 16, 2023, list critical limits at the “
(b)(4)
” critical control point that are not adequate to control scombrotoxin (histamine) formation. Specifically, your critical limit of “
(b)(4)
.”
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 HACCP plan for “Fresh Fish Group C”, issued on February 16, 2023, lists monitoring procedures that are not adequate to control scombrotoxin (histamine) formation.
a. Your monitoring procedure of “
(b)(4)
” at the “
(b)(4)
” critical control point is not adequate. Your critical limit lists that the fish are “
(b)(4)
,” however it does not list a critical limit for the internal temperatures being monitored. The listed monitoring procedures cannot demonstrate that the lots received comply with your critical limits. A more appropriate monitoring procedure would include visually observing that the fish are completely surrounded by ice in a representative number of containers.
b. Your monitoring procedure for monitoring the temperature of the fish and ice water using a thermometer “
(b)(4)
” of fish at the “
(b)(4)
” critical control point is not adequate. FDA recommends you identify when you will monitor
(b)(4)
temperatures. For example, monitoring the start and ending time of
(b)(4)
and the temperature of the
(b)(4)
water at the start of
(b)(4)
and the end of
(b)(4)
.
4. Because you chose to include a corrective action plan in your HACCP plan, your described corrective actions must be appropriate, to comply with 21 CFR 123.7(b). However, your corrective action plans for “Fresh Fish Group C” at all the listed critical control points in your HACCP plan do not address the cause of the deviation to prevent reoccurrence of the deviation.
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., complete sets of monitoring records for the production of 5 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. 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 Current Good Manufacturing Practice regulation (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 U.S. Food and Drug Administration, Attention: Sheena Phillips, Compliance Officer, Office of Compliance, Division of Enforcement, Food Adulteration and Assessment Branch (HFS-607), 5001 Campus Drive, College Park, Maryland 20740 U.S.A. If you have any questions regarding this letter, you may contact Ms. Phillips via email at Sheena.Phillips@fda.hhs.gov. Please reference CMS # 659726 on any documents or records you provide to us and/or within the subject line of any email correspondence you send to us.
Sincerely,
/S/
Ann M. Oxenham
Director
Office of Compliance
Center for Food Safety and Applied Nutrition
Content current as of:
07/11/2023
Regulated Product(s)
Food & Beverages