FDA 483 - Day-Lee Foods Inc. - June 27, 2025

An FDA inspection conducted on June 26-27, 2025, at a seafood processor and multi-food warehouse in Union City, CA, identified several significant issues documented in an FDA Form 483. The facility, whose name is not explicitly provided in the document, received observations concerning its adherence to Current Good Manufacturing Practices (CGMPs) and the Seafood HACCP regulation (21 CFR 123).

Key violations included inadequate monitoring of sanitation conditions, specifically an employee cross-contaminating fresh salmon intended for sushi/sashimi after touching an unclean floor with the same gloved hands. The firm also failed to monitor the safety of water used for food contact and ice production. Furthermore, the firm's HACCP plan for fresh salmon was found deficient. It did not identify reasonably likely food safety hazards such as undeclared allergens (salmon) and potential metal inclusion from processing equipment. Monitoring frequencies for critical limits, such as cooler temperatures, were deemed insufficient to control pathogenic bacteria. Verification procedures within the HACCP plan were also inadequate, lacking periodic temperature measurements and timely reviews of records. The corrective action plan for temperature excursions was found insufficient, as it did not account for product temperature history. Finally, the firm failed to fully implement its own HACCP plan's monitoring and verification procedures, including reviewing supplier assurance letters and consistently monitoring cooler temperatures.

The firm is expected to respond to these observations with comprehensive corrective actions to ensure compliance with federal food safety regulations.