FDA WARNING_LETTER - Nick & Katie's Inc. - February 13, 2008

On February 6, 7, and 13, 2008, the FDA inspected Nick & Katie's, Inc.'s seafood processing facility, identifying serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR 123) and Current Good Manufacturing Practice (21 CFR 110).

The firm's stuffed seafood products are deemed adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act due to insanitary conditions. Key violations include the absence of a HACCP plan for stuffed crabs, crab stuffed mushrooms, stuffed bell peppers, and crayfish stuffed portabella mushrooms to control pathogen survival, growth, toxin formation, and allergens (21 CFR 123.6(a) and (b)). Additionally, the firm failed to maintain sanitation monitoring records for water safety, food contact surfaces, cross-contamination prevention, hand washing facilities, protection from adulteration, proper labeling/storage of toxic compounds, employee health, and pest exclusion (21 CFR 123.11(c)).

The FDA acknowledged a voluntary recall of products with undeclared wheat, soy, and milk allergens. While corrected labels were received for Stuffed Italian Artichoke and Crab Stuffed Mushrooms, corrected labels for other products like Crayfish Stuffed Portabella Mushroom, Stuffed Crab, Stuffed Bell Pepper, Cocktail Muffaletta, Art