FDA WARNING_LETTER - Marumo Co., Ltd. - January 26, 2023

The FDA issued a warning letter to Marumo Co., Ltd., a seafood processing facility in Kagoshima, Japan, following an inspection conducted from January 25-26, 2023. The inspection revealed significant violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulations under 21 CFR Part 123. The primary issue identified was the inadequate HACCP plan for dried shaved skipjack tuna products, which failed to address the hazards of pathogenic bacteria and toxin formation, specifically Staphylococcus aureus and Clostridium botulinum, during rehydration and storage processes. The firm"s practices rendered the products adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act.

The FDA also noted insufficient monitoring of sanitation conditions, as evidenced by mold-like substances on equipment and damaged conveyor belts, which were not documented in the firm"s records. Marumo Co., Ltd. was required to revise its HACCP plan, provide five consecutive days of monitoring records, and ensure proper sanitation practices. The FDA requested a response within 15 working days detailing corrective actions, including documentation of changes and a revised HACCP plan. Failure to adequately address these issues could result in further regulatory actions.