FDA WARNING_LETTER - Kalloni S.A. - January 27, 2015

The FDA inspected Kalloni S.A.'s seafood processing facility in Kimmeria, Xanthi, Greece, on January 26-27, 2015, and found violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123). The firm's salted mackerel, anchovies, and sardines are deemed adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act.

Significant deviations include: 1. **Inadequate Hazard Analysis and HACCP Plan (21 CFR 123.6(a) and (c)(2)):** The revised HACCP plan for "Salted Fish (Anchovies, Sardines, Chub Mackerel)" dated February 12, 2015, lacks critical control points to control scombrotoxin (histamine) formation and pathogen growth/toxin formation due to time and temperature abuse. Specifically, it omits controls for refrigerated storage of incoming raw materials and storing fish in saturated brine and ice between deheading/gutting and salting steps. 2. **Inadequate Critical Limits (21 CFR 123.6(c)(3)):** * At "Receiving/Harvest Control/Transit Control," the plan lacks adequate critical limits for scombrotoxin formation onboard harvest vessels. While it lists (b)(4), it