FDA WARNING_LETTER - Louisa Food Products Inc - April 22, 2014

On April 7-22, 2014, the FDA inspected Louisa Food Products, Inc.'s seafood processing facility, identifying serious violations of seafood HACCP (21 CFR Part 123) and GMP (21 CFR Part 110) regulations. These violations render their seafood products adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act.

Key violations include: 1. **Inadequate Hazard Analysis and HACCP Plans:** * Failure to identify *Clostridium botulinum* growth/toxin formation for raw, frozen, reduced-oxygen packaged fish/fishery ingredients in Lobster, Shrimp, and Scallops HACCP plan. * Failure to identify metal fragments as a hazard in Lobster, Shrimp, Scallops, and Salmon HACCP plans. * Failure to identify undeclared seafood allergens (fin fish, crustaceans, shellfish) in Lobster, Shrimp, Scallops, and Salmon HACCP plans. 2. **Missing Critical Limits:** * HACCP plans for lobster, shrimp, scallops, and salmon lack time elements for "Cooking (Heat Process)" critical limits to control microbiological pathogens, including *Listeria*. * HACCP plans for lobster, shrimp, scallops, and salmon lack sufficient critical limits for "Cooling of All Non-USDA" products to control *Cl