FDA WARNING_LETTER - Inversiones Peru Pacifico S.A - February 04, 2014

The FDA inspected Inversiones Peru Pacifico S.A.'s seafood processing facility in Sullana, Peru, on February 3-4, 2014, and found violations of the seafood Hazard Analysis Critical Control Point (HACCP) regulation (21 CFR 123). The firm's mahi-mahi products are deemed adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act.

Key violations include: 1. **Inadequate Critical Limits:** The revised HACCP plan's critical limit for scombrotoxin (histamine) formation at a specific critical control point is insufficient. FDA recommends sensory examination showing decomposition in less than 2.5% of fish. 2. **Inadequate Monitoring Procedures:** The revised HACCP plan's monitoring procedures for histamine control are inadequate. For internal temperature, it lacks specific guidance on the number and selection of fish to measure. For histamine analysis, it lacks specific guidance on the number and representative collection of fish to test. 3. **Inappropriate Corrective Actions:** The corrective action plan for scombrotoxin formation is inappropriate. In addition to rejecting a batch, FDA recommends discontinuing the supplier until harvesting and onboard practices improve.

The FDA also noted the absence of critical control points for unrefrigerated processing or in-process storage in the histamine fish HACCP plan.

The firm must respond within