FDA WARNING_LETTER - HARBOR MARINE PRODUCT INC - March 27, 2025

The FDA issued a Warning Letter to Harbor Marine Product Inc. on November 28, 2025, following an inspection of their Vernon, CA, seafood processing and importer facility from March 5-27, 2025. The inspection revealed serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123).

A primary concern was the widespread presence of non-pathogenic Listeria species on various food contact surfaces during the processing of raw, ready-to-eat (RTE) salmon and tuna. This indicated insanitary conditions conducive to the growth of pathogenic Listeria monocytogenes, leading to the determination that their raw RTE fish products are adulterated under section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act. The company also failed to adequately monitor sanitation conditions and practices, as required by 21 CFR Part 117 Subpart B and 21 CFR 123.11(b). Additionally, as an importer, Harbor Marine Product Inc. did not ensure that imported fish products complied with U.S. regulatory standards (21 CFR 123.12).

The company"s responses to the FDA"s inspectional observations were found to be inadequate, lacking comprehensive corrective actions, effective environmental monitoring procedures, and a proper root cause analysis for the Listeria contamination. The FDA requires Harbor Marine Product Inc. to implement robust Listeria controls, develop and execute a compliant HACCP plan, enhance sanitation monitoring, and ensure all imported products meet U.S. regulatory requirements to prevent further adulteration and protect public health.