As part of its enforcement activities, the Food and Drug Administration sends warning letters to entities under its jurisdiction. Some letters are not posted for public view until weeks or months after they are sent. Business owners have 15 days to respond to FDA warning letters. Warning letters often are not issued until a company has been given months or years to correct problems. Generally, portions of the letters are redacted from public view.
Maui Seafood LLC
Las Vegas, NV
In a Dec. 10, 2025, warning letter, the Food and Drug Administration outlined serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation found during an inspection of Maui Seafood LLC’s ready-to-eat (RTE) seafood processing facility in Las Vegas, NV, from April 28 through May 16, 2025.
FDA investigators collected environmental swabs on April 30, 2025. Laboratory analysis of sample 1278716 confirmed Listeria monocytogenes (L. monocytogenes) on multiple surfaces, including food-contact surfaces. Positive findings included the top right of a salmon cutting board on table (redacted by FDA) (sub #(redacted by FDA)); top middle, metal crevice, and hose handle of another cutting board on table #(redacted by FDA) (sub #(redacted by FDA)); far right and left sides of strip curtains in the staging area that contacted RTE yellowfin tuna (subs #(redacted by FDA) and #(redacted by FDA)); and inside drain slots in the processing room and staging area (subs #(redacted by FDA), #(redacted by FDA), and #(redacted by FDA)).
Whole genome sequencing showed the strain matched a prior “smoked salmon” isolate and clinical isolates from 2017 and 2018, indicating potential to cause illness. Non-pathogenic Listeria innocua was also found on (redacted by FDA) swabs, including food-contact surfaces, signaling conditions suitable for Listeria monocytogenes survival and growth.
FDA determined the company’s ready-to-eat (RTE) whole, raw, refrigerated fishery products, including tuna and salmon, are adulterated because they were prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth or rendered injurious to health. Failure to implement a compliant HACCP plan renders seafood products adulterated.
At the inspection’s conclusion, the FDA issued a Form FDA 483. The company responded on May 16 and May 28, 2025. After review, FDA found the responses inadequate to demonstrate effective control of Listeria monocytogenes or sanitary conditions.
Key sanitation and HACCP violations and related current good manufacturing practice (CGMP):
- Inadequate cleaning of food-contact surfaces: Cutting boards were heavily worn, grooved, and soiled with brown, gray, and black filth, with some positive for Listeria monocytogenes. Ice scoop handle had filthy tape seams. Soiled aprons were used without cleaning between shifts.
- Cross-contamination and poor hygienic practices: Employees touched dirty floors/drains, then handled RTE products, hoses, curtains, and packaging without washing hands or changing gloves. Soiled towels wiped cutting boards, then RTE salmon and boxes. Boxes/lids stored on flooded floors near positive drains, then rinsed and used for RTE salmon.
- Condensate dripping: Condensers dripped onto RTE seafood boxes, wrapped loins, and racks for months; one had a broken, leaking pipe.
- Inadequate monitoring: Sanitation records falsely marked conditions “satisfactory.” HACCP monitoring for receiving and cooler temperatures was incomplete (e.g., only one fish temp per shipment, no data logger review, pre-filled logs).
- Inadequate critical limits: Storage/receiving limits did not ensure 38 degrees F or below to control Clostridium botulinum toxin formation.
The Southern Nevada Health District issued a cease-and-desist order May 16, 2025, and approved reopening May 22 after repairs and negative Listeria swabs. FDA acknowledged the action but remains concerned due to lack of documentation on long-term prevention, root cause analysis, environmental monitoring, revised HACCP plans, SSOPs, training records, and monitoring logs.
The violations are not all-inclusive. Failure to correct may result in seizure, injunction, or suspension of registration. The company must respond in writing within 15 working days with specific corrective steps and documentation.
The full warning letter can be viewed here.
Source: Food Safety News
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