# FDA WARNING_LETTER - uoya inc.  - July 09, 2015

Source: https://www.globalkeysolutions.net/records/warning_letter/uoya-inc/8a7dc320-2d62-40a2-bc39-f15ddee143ca

> FDA WARNING_LETTER for uoya inc.  on July 09, 2015. Product: Food. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: uoya inc. 
- Inspection Date: 2015-07-09
- Product Type: Food
- Office Name: New York District Office
- Summary: 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

## Related Officers

- [Program Director](https://www.globalkeysolutions.net/people/ronald-m-pace/a79d2af4-650e-4220-8de1-92bbd284457d)

Company: https://www.globalkeysolutions.net/companies/uoya-inc/e2f1ac2c-8885-4df6-af22-6489c18bf7ff

Office: https://www.globalkeysolutions.net/offices/new-york-district-office/9fa3d265-16ca-438d-8a6e-b47f60dc260d