FDA WARNING_LETTER - Walker's Food Products Co. - June 17, 2014

On June 9-17, 2014, the FDA inspected Walker's Food Products Co.'s ready-to-eat salad manufacturing facility in North Kansas City, MO, finding serious deviations from seafood HACCP (21 CFR 123) and CGMP (21 CFR 110) regulations. These render products like Walker's Tuna Salad and Various Krab Salads adulterated under 21 U.S.C. § 342(a)(4).

Key violations include: 1. **HACCP Plan Deficiencies (21 CFR 123.6(c)(1)):** HACCP plans for "Various Krab Salads" and "Walker's Tuna Salad" failed to list hazards such as pathogenic bacteria growth-temperature abuse, *Clostridium botulinum* toxin formation, and allergen hazards. 2. **Critical Control Point Omissions (21 CFR 123.6(c)(2)):** The "Various Krab Salads" HACCP plan lacked a critical control point for thawing vacuum-packaged imitation crab meat to control pathogenic bacteria and *Clostridium botulinum*. Both Krab and Tuna Salad HACCP plans omitted "Weigh/Pack/Label" as a critical control point for allergen labeling. 3. **Sanitation Monitoring (21 CFR 123.11(b)):** An employee used