FDA WARNING_LETTER - Brookshire Brothers Inc. - October 30, 2015

The FDA inspected Brookshire Brothers, Inc. (Lufkin, TX) from October 27-30, 2015, and found serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123). This renders their ready-to-eat Tuna Salad and Supreme Salad adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act.

Key violations include: 1. **Lack of HACCP Plan:** No HACCP plan for ready-to-eat Supreme Salad to control *Clostridium botulinum* toxin formation and pathogenic bacteria growth. 2. **Inadequate Hazard Analysis:** The HACCP plan for ready-to-eat Tuna Salad failed to list Undeclared Allergens at the Receiving critical control point and *Clostridium botulinum* toxin formation at Receiving and Storage critical control points. 3. **Inadequate Critical Limits:** The Tuna Salad HACCP plan's critical limits at Receiving were insufficient to control allergens, scombrotoxin, *Clostridium botulinum*, and pathogenic bacteria growth. Specifically, the temperature critical limit "(b)(4)" did not ensure product was maintained at or below 40°F throughout transit, and the allergen critical limit "(b)(4)" did not ensure proper allergen declarations on labels. 4. **Inadequate Monitoring Frequency:** The Tuna Salad