FDA WARNING_LETTER - Winn Dixie Logistics, Inc. - January 26, 2012

The FDA inspected Winn Dixie Logistics, Inc.'s seafood processing facility in Miami, FL, from January 18-26, 2012, and found serious violations of seafood Hazard Analysis and Critical Control Point (HACCP) regulations (21 CFR Part 123) and Current Good Manufacturing Practice (21 CFR Part 110). These violations render their Smilin’ Bob’s Smoked Fish Dip, Beck’s Smoked Tuna Spread, and pasteurized crab meat products adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act.

Key violations include: 1. **Inadequate HACCP Plan (21 CFR 123.6(c)(1))**: The "Ready-to-Eat Seafood" HACCP plan failed to list histamine formation as a food safety hazard for products containing amberjack and tuna. 2. **Insufficient Critical Limits (21 CFR 123.6(c)(3))**: The "Ready-To-Eat-Seafood" HACCP plan's critical limit of "Product properly iced and in cooler" at the Storage CCP was inadequate to control pathogenic bacteria growth due to temperature abuse, lacking a specified refrigeration temperature. 3. **Failure to Implement Monitoring and Verification Procedures (21 CFR 123.6(b) and (c)(4))**: * The