WARNING LETTER
Ogura Shokuhin Co. Ltd.
MARCS-CMS 676941 —
May 01, 2024
Delivery Method:
Via Express Delivery and Electronic Mail
Product:
Food & Beverages
Recipient:
Recipient Name
Mr. Tomohiko Sugiyama
Recipient Title
Factory Manager
Ogura Shokuhin Co. Ltd.
821-1 Yuiterao, Shimizu Ward
Shizuoka Prefecture
Shizuoka City
,
421-3112
Japan
Tomohiko_sugiyama@ogurashokuhin.co.jp
Issuing Office:
Center for Food Safety and Applied Nutrition
United States
WARNING LETTER
Reference # 676941
Dear Mr. Sugiyama:
The United States Food and Drug Administration (FDA) conducted a Foreign Remote Regulatory Assessment (FRRA) of your seafood processing facility, located at 821-1 Yuiterao, Shimizu Ward, Shizuoka City, Shizuoka Prefecture 421-3112, Japan, on November 12-16, 2023. During the assessment, 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 Part 123). At the conclusion of the assessment, the FDA investigator issued a Remote Regulatory Assessment Observations Form. To date, we have not received any written corrective actions for FDA evaluation.
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 21 CFR 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. § 324(a)(4)). Accordingly, your seafood products, including but not limited to dried Sardines and seasoned fish flakes and powder, are adulterated under section 402(a)(4) of the Act, 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 4rth 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.
In addition, we have reviewed your product labels that were collected during the Remote Regulatory Assessment and found significant violations of the food and color additive regulations for foods, sections 21 CFR Parts 101, 74, and 82. These violations cause your products to be adulterated within the meaning of section 402 of the Act [21 U.S.C. § 342], and misbranded within the meaning of section 403 [21 U.S.C. § 343].
Your significant deviations are as follows:
You must conduct, or have one 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 you must have and implement a written HACCP plan to control any food safety hazards that are reasonably likely to occur to comply with 21 CFR 123.6 (a), and (b). Your firm receives dried frozen fish products of unknown water activity that are not packaged to prevent rehydration. Additionally, your firm conducts additional processing (e.g.,
(b)(4)
) that could allow for rehydration and uses oxygen absorbers in the packaging to create a reduced oxygen environment without controls for pathogens such as knowing the finished product water activity to ensure food safety. Furthermore, your product labeling does not include any storage instructions indicating that the product is intended to be shelf stable. However, your firm does not have a HACCP plan for your dried reduced oxygen packaged (ROP) shelf-stable uneviscerated sardines, and dried ROP seasoned fish flakes and powder to control the food safety hazards of pathogen growth and toxin formation including
Clostridium botulinum
and undeclared allergens.
Specifically, in 2023, your firm manufactured four ready-to-eat, shelf-stable fish products that were packed in reduced oxygen packaging (ROP). The products were exported to the United States by a trader in Tokyo. Your firm has not conducted a hazard analysis or written a HACCP plan for any of the products. The labels that you applied to the fish products were provided by the trader in Japanese and English as follows:
349-450006 Niboshi Taberu Kozakana Dried Sardine Ingredients: Sardine, Vitamin E 45g/1.59oz.
349-450010 Shirisu Chirimen Dried Prepared Sardine Ingredients: Sardine, Salt 30g/1.0oz.
349-450016 Denbu Sakura Seasoned Fish Flake Ingredients: Alaska Pollack Flake, Sugar 30g/1.0oz.
349-450020 Denbu Sakura Seasoned Alaska Pollack Powder Ingredients: Sugar, Salted Alaska Pollack, Coloring (Cochineal).
Adulterated food
Your Denbu Sakura Seasoned Fish Flake (product 349-450016) product contains the artificial color red 106 that imparts color to the product(s) and therefore meets the definition of a color additive. Red 106 (C.I 45100, Xylene Red B) is not listed for use as a color additive in foods or any other FDA-regulated product. Therefore, your Denbu Sakura Seasoned Fish Flake product is adulterated within the meaning of section 402(c) of the Federal Food, Drug, and Cosmetic Act because it appears to contain a color additive which is unsafe within the meaning of section 721(a) of the Act. Red 106 is a non-permitted color additive. Of note, the artificial Red 106 color was not declared on the finished product label but we were provided the manufacturer’s specification sheet for artificial color red 106 at the time of inspection.
Misbranded food
Your Seasoned Alaska Pollock Powder product is misbranded within the meaning of sections 403(a)(1) and 403(b) because the product label is false or misleading, and the product is offered for sale under the name of another food. Based on the evidence provided, the product is manufactured with “Cod” yet labeled as “Seasoned Alaska Pollock Powder” and in the ingredient statement as containing “Salted Alaska Pollock,” potentially leading to consumer confusion. Of note, see Compliance Policy Guide Sec. 540.750 - Common or Usual Names for Seafood in Interstate Commerce” as an additional reference.
Your Seasoned Alaska Pollock Powder product is misbranded within the meaning of section 403(w) because the label fails to declare the individual major food allergen, as required by section 403(w) of the Act. Specifically, the product fails to declare the common or usual name of the fish ingredient in the ingredient statement and or “
(b)(4)
” statement. As previous mentioned this product is manufactured with “Cod”, however it is labeled as “Alaskan Pollock”.
Your Dried Sardine and Dried Prepared Sardine products are misbranded within the meaning of section 403(q)(1)(A) of the Act [21 U.S.C. § 343 (q)(1)(A)], because the serving size declared on the label is not based on the appropriate Reference Amounts Customarily Consumed Per Eating Occasion (RACC) as required by 21 CFR 101.9(b)(2) and CFR 101.12(b) Table 2. Based on the statements of identity, these products are dried snacks, therefore, the appropriate RACC for these products would fall under “dried, e.g., jerky” product category with a reference amount of 30g (Label statement: “_piece(s) (_g) for discrete pieces…”). The products’ labels declare “serving size 10g (0.35)”. Therefore, all the nutrient information is incorrectly declared. For additional guidance, refer to the FDA's guidance on reference amounts customarily consumed, available at Guidance: RACC List of Products. We also note that the serving sizes for both products are not expressed in a common household measure as required by 21 CFR 101.9(b)(5) and 101.9(b)(7).
Your Seasoned Alaska Pollock Powder product is also misbranded within the meaning of section 403(q)(1)(A) of the Act [21 U.S.C. § 343 (q)(1)(A)], for failing to declare the nutrition information in accordance with 21 CFR 101.9. Specifically, the serving size is not expressed in a common household measure as required by 21 CFR 101.9(b)(5) and 101.9(b)(7).
Your Seasoned Alaska Pollock Powder product is misbranded within the meaning of section 403(i)(1) because Seasoned Alaska Pollock Powder product is not an appropriate name for a product that is
(b)(4)
% sugar colored with cochineal and
(b)(4)
% cod flakes. Under section 21 CFR 101.3(b), the statement of identity is the name specified by law or regulation; or, in the absence thereof, the common or usual name of the food; or, in the absence thereof, an appropriately descriptive term.
Your Seasoned Alaska Pollock Powder product is misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that the product label fails to declare the common or usual name of each ingredient used as required by section 21 CFR 101.4, for example, the product label lists Alaska Pollock in the ingredients statement, but Denbu is made from Cod. Further, the Seasoned Alaska Pollock Powder is produced using "salted Cod fillets” and the product specification sheet consistently identifies "Cod" as the primary ingredient. We also point out that the ingredient label declares “salted Alaska pollock” which is a multicomponent ingredient; however, the sub ingredients are not declared in accordance with section 21 CFR 101.4(b).
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 for each of your fish and fishery products, such as a detailed step by step description of the food processing (e.g., flow diagram), a copy of your written hazard analysis and HACCP plan, 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 such as your dried ROP seasoned fish flakes and powder 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. For assistance with creating your HACCP plan see Chapter 2 of the Hazards Guide.
Labeling comments
For your Seasoned Alaska Pollock Powder, the street address is not declared as required by section 21 CFR 101.5(d). We note that the street address may be omitted if it is shown in a current city directory or telephone directory.
The labels for your Dried Sardine (349-450006) product lists vitamin E in the ingredients statement, but vitamin E is not added to the product, which was confirmed by the plant manager.
The correct symbol for grams in the net quantity of contents declaration is 'g,' not 'GR,' as per FDA guidance on metric declarations for quantity of contents on product labels at: CPGSec.140.500 Metric Declarations of Quantity of Contents. Note that this comment applies to allproduct labels during this inspection.
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 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.
You should direct your written reply to Nicholas Long, Food and Drug Administration, Center for Food Safety and Applied Nutrition, 5001 Campus Drive, Office of Compliance (HFS-608), Division of Enforcement, College Park, Maryland 20740-3835. If you have any questions regarding this letter, you may contact Nicholas Long via email at Nicholas.Long@fda.hhs.gov. Please reference CMS #676941 on any submissions and on the subject line of any emails to us.
Sincerely,
/S/
Ann Oxenham
Director
Office of Compliance
Center for Food Safety and Applied Nutrition
Content current as of:
05/14/2024
Regulated Product(s)
Food & Beverages