FDA WARNING_LETTER - Sea One Enterprises, Inc. - July 03, 2012

The FDA inspected Sea One Enterprises, Inc.'s seafood processing facility from June 19 to July 3, 2012, and found serious violations of seafood Hazard Analysis and Critical Control Point (HACCP) regulations (21 CFR Part 123) and Current Good Manufacturing Practice (CGMP) regulations (21 CFR Part 110). These violations render their raw, ready-to-eat seafood products adulterated.

Key violations include: 1. **Lack of HACCP Plans:** The firm lacked HACCP plans for ready-to-eat salmon and rockfish to control pathogen growth and toxin formation (21 CFR 123.6(a) and (b)). 2. **Incomplete HACCP Plan:** The HACCP plan for raw, ready-to-eat yellowfin tuna failed to list pathogen growth and toxin formation as a reasonably likely food safety hazard (21 CFR 123.6(a) and (c)(1)). 3. **Insufficient Sanitation Monitoring:** The firm did not adequately monitor sanitation conditions, leading to cross-contamination (e.g., tuna on a pallet in pooled water, molded boxes above tuna, soiled doorway curtains), adulteration (e.g., tuna weighed on used Styrofoam, water splashing onto tuna), unclean food contact surfaces (gouged cutting boards, dirty ice scoop), and inadequate handwashing facilities (no soap/towels). Similar