Maui Seafoods LLC – FDA Warning Letter, May 16, 2025

The FDA issued a warning letter to Maui Seafood LLC following an inspection from April 28 to May 16, 2025, at their Las Vegas ready-to-eat (RTE) seafood processing facility. The inspection revealed serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123) and Current Good Manufacturing Practice (CGMP) requirements (21 CFR Part 117). A critical finding was the presence of Listeria monocytogenes (L. monocytogenes), a human pathogen, in environmental samples from the facility, including food contact surfaces. Whole genome sequencing linked these isolates to clinical cases, indicating a public health risk. The FDA determined that Maui Seafood LLC's RTE whole, raw, refrigerated fishery products, including tuna and salmon, are adulterated due to insanitary conditions. Main issues included inadequate sanitation monitoring, such as heavily worn and soiled cutting boards, filthy equipment, and widespread employee cross-contamination practices (e.g., handling drains and then RTE fish without changing gloves). Other problems involved the use of dirty towels for food contact, soiled aprons and curtains, improper storage of packaging on dirty floors, and condensation dripping onto products. Additionally, the company failed to implement its HACCP plan's monitoring procedures, did not ensure critical limits were adequate to control hazards like Clostridium botulinum, and failed to properly address consumer complaints by conducting food safety evaluations or documenting product disposition. Maui Seafood LLC must provide a written response within 15 working days detailing specific corrective actions, an explanation of how violations will be prevented from recurring, and supporting documentation. The FDA requires further evidence, including revised HACCP plans, environmental monitoring procedures, root cause analysis, cleaning records, and employee training, to demonstrate adequate control of pathogens and maintenance of a sanitary environment.