FDA WARNING_LETTER - Union Development Frozen Foods Co., Ltd

The FDA issued a Warning Letter to Union Development Frozen, Taiwan, following an evaluation of their HACCP plan for "Frozen Whole Gutted Salt Water Fish," dated May 3, 2010. This plan covers scombrotoxin-forming species like Yellowfin, Spanish Mackerel/King Fish, and Mahi Mahi. The FDA found serious deviations from the Seafood Hazard Analysis and Critical Control Point (HACCP) regulation, 21 CFR Part 123, rendering the firm's products adulterated under 21 USC § 342(a)(4).

Key violations include: 1. **Inadequate Monitoring Procedures (21 CFR 123.6(c)(4)):** * **Receiving CCP:** Insufficient sampling strategies for histamine testing (e.g., collecting only (b)(4) of fish or (b)(4) per batch is inadequate). Histamine sample collection procedures (e.g., sample size, grinding, aliquot) and analytical method verification were also deficient. The alignment of hazards, critical limits, and monitoring procedures was inconsistent. * **Thawing CCP:** Monitoring "Temp" by thermometer once/hour is insufficient as it doesn't specify the temperature value or ensure prevention of scombrotoxin formation throughout the fish, especially near the surface. Measuring only core temperature and a single fish is inadequate. * **Gutted CCP:** Monitoring "