FDA WARNING_LETTER - uoya inc. - July 09, 2015

The FDA inspected Uoya, Inc. dba Shintoku, Inc. & Apollo Fish Co. on July 6, 7, & 9, 2015, and found serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123). This renders their "Big Eye Tuna Loins," "Vacuum-Packaged Farmed Raw Yellowtail Fillets with time-temperature indicators," "Fresh Striped jack," and "Fresh Mackerel" adulterated.

Key violations include: 1. **Lack of HACCP Plans:** No HACCP plans for vacuum-packaged raw farmed yellowtail fillets (scombrotoxin, *Clostridium botulinum*, pathogenic bacteria), fresh mackerel (scombrotoxin, parasites, pathogenic bacteria for raw consumption), and fresh striped jack (scombrotoxin, parasites, pathogenic bacteria for raw consumption). 2. **Inadequate Tuna HACCP Plan - Critical Control Points:** The Tuna HACCP plan fails to list unrefrigerated processing (manual cutting, weighing, staging, packing) as a critical control point for scombrotoxin formation. 3. **Inadequate Tuna HACCP Plan - Monitoring Procedures:** Monitoring procedures for scombrotoxin control in Tuna are insufficient, not ensuring conformance with critical limits for time and temperature. FDA recommends continuous temperature recording and visual checks. 4. **Inappropriate Tuna HAC