What happened
Original notice title
Ogura Shokuhin Co. Ltd. MARCS-CMS 676941, May 01, 2024
From the archived source record
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). 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. 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]. 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. 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.
What the official notice says to do
Check the original notice for the instructions that apply to the named product, company, and affected lots.
Read the official notice →Status and source details
- Status recorded in the archive
- No closeout listed in FDA table
- Source checked
- Jul 16, 2026
- Record revision
- 426660e2073b
This is a dated record. Its current status may have changed since the source was captured. A record applies to its stated scope; it is not a safety rating for every product from a company.
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