FDA WARNING_LETTER - Ogura Shokuhin Co. Ltd. - November 16, 2023

On May 1, 2024, the FDA issued a Warning Letter to Ogura Shokuhin Co. Ltd. following a Foreign Remote Regulatory Assessment conducted from November 12-16, 2023. The assessment revealed serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123) and food/color additive regulations (21 CFR Parts 101, 74, 82).

The primary violation is the firm's failure to conduct a hazard analysis and implement a written HACCP plan for their dried reduced oxygen packaged (ROP) shelf-stable unrefrigerated sardines and dried ROP seasoned fish flakes and powder. These products, including "Niboshi Taberu Kozakana Dried Sardine," "Shirsu Chirimen Dried Prepared Sardine," "Denbu Sakura Seasoned Fish Flake," and "Denbu Sakura Seasoned Alaska Pollack Powder," are deemed adulterated under section 402(a)(4) of the Federal Food, Drug and Cosmetic Act (the Act) because they were prepared, packed, or held under conditions that may render them injurious to health, specifically concerning pathogen growth and toxin formation (e.g., Clostridium botulinum) and undeclared allergens.

Additional violations include: - **Adulterated Food:** "Denbu Sakura Seasoned Fish Flake" contains Red 106,