WARNING LETTER
Nara Company Ltd.
MARCS-CMS 651234 —
February 07, 2023
Delivery Method:
Via Express Delivery
Product:
Food & Beverages
Recipient:
Recipient Name
Mr. Daisuke Nara
Recipient Title
Executive Director
Nara Company Ltd.
482-1 Nishikata
Ibusuki
,
Kagoshima
891-0311
Japan
Issuing Office:
Center for Food Safety and Applied Nutrition (CFSAN)
United States
February 07, 2023
WARNING LETTER
Reference #651234
Dear Mr. Daisuke Nara:
The United States Food and Drug Administration (FDA) conducted a Foreign Regulatory Assessment (FRRA) of your seafood processing facility, Nara Company Ltd., 775 Nishikata, Ibusuki, Kagoshima, Japan 891-0311 on September 7, 2022. 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 October 7, 2022. Your response included a revised HACCP plan for “Frozen aquaculture fish, CO processed product group for General Use” dated September 19, 2022, and other HACCP related documents. 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 fish fillet 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 & 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 does not list the food safety hazards of pathogenic bacteria growth and toxin formation, and metal inclusion. The seafood HACCP regulation requires that all reasonably likely food safety hazards be identified and that controls be in place through an adequate HACCP plan.
2. You must have a HACCP Plan that, at minimum, lists the critical limits that must be met, to comply with 21 CFR 123.3(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 dated September 19, 2022, for your seafood products, lists critical limits that are not adequate to control the identified food safety hazards. Specifically,
Your critical limits of
(b)(4)
at the “
(b)(4)
” critical control point are not adequate to control the hazard of unapproved aquaculture drugs. While FDA has approved the use of oxytetracycline on specific finfish and crustaceans, buri (
Seriola quinqueradiata
) is not one of the approved finfish.
Your critical limit of “
(b)(4)
” at the “
(b)(4)
” critical control point is not adequate to control the hazard of scombrotoxin (histamine) formation that is reasonably to occur during harvest, onboard the harvest vessel, and transit of the fish to the processing facility. To adequately control the food safety hazard of histamine, in addition to your critical limit for water tank temperature. FDA recommends that you include critical limits for:
i. Harvest vessel records or Histamine testing; and
ii. Sensory examination; and
iii. Internal temperature measurements; and
iv. Transit control.
Your critical limits of “
(b)(4)
” to control the food safety hazard of
Clostridium botulinum
and “
(b)(4)
” at the “
(b)(4)
” critical control point to control the food safety hazard of undeclared allergens are inadequate. In addition to checking the incoming labeling for these declarations, your HACCP plan should include critical limits to ensure that the labels are properly applied to each package of finished product which is typically performed at the
(b)(4)
step.
You should respond in writing within fifteen (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 (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. This alert can be found on FDA’s web site at:
http://www.accessdata.fda.gov/cms_ia/importalert_25.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 (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: Giselle Jordan, 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 Giselle Jordan via email at: giselle.jordan@fda.hhs.gov. Please include reference #651234 on any submissions and within the subject line of any email correspondence to the agency.
Sincerely,
/S/
Ann M. Oxenham
Director
Office of Compliance
Center for Food Safety and Applied Nutrition
Content current as of:
03/28/2023
Regulated Product(s)
Food & Beverages