FDA WARNING_LETTER - Kakushime Matsuda Suisan - July 09, 2019

The FDA conducted an inspection of Kakushime Matsuda Suisan in Hakodate, Japan, on July 8-9, 2019, revealing serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123). Consequently, the firm's frozen, packaged salted and partially dried herring products are considered adulterated under section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act. The firm's submitted response and revised HACCP plan dated July 17, 2019, were deemed inadequate. Key deficiencies include the failure to conduct a proper hazard analysis and implement a HACCP plan that lists critical control points for scombrotoxin formation, pathogen growth, and Clostridium Botulinum in its herring products, as required by 21 CFR 123.6 and (c)(2). This includes missing CCPs for thawing, brining, drying, and labeling. Furthermore, the corrective actions outlined in their HACCP plan for critical control points were inappropriate, failing to ensure the root cause of deviations is corrected, violating 21 CFR 123.7(b). The FDA requires a written response within 15 working days detailing specific corrections, including a revised HACCP plan and five consecutive days of monitoring records. Failure to comply may lead to refusal of admission for products (DWPE) and re-inspection fees.