FDA WARNING_LETTER - Culinary Specialties - January 11, 2015

On March 31, 2015, the FDA issued a Warning Letter to Culinary Specialties, Inc. following an inspection from January 10-11, 2015, with additional records collected on March 13, 2015. The inspection revealed serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123) and the Current Good Manufacturing Practice (CGMP) regulation (21 CFR Part 110).

The FDA determined that the firm's seafood products, including brochettes, canapés, burritos, and other appetizers containing crab, tuna, shrimp, and lobster, were adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act) because they were prepared, packed, or held under insanitary conditions.

Key violations included: 1. **Inadequate Hazard Analysis and HACCP Plans (21 CFR 123.6(a) and (c)(1)):** The firm's HACCP plans failed to list reasonably likely food safety hazards such as histamine in ahi tuna, sulfites in shrimp, *C. botulinum* and pathogen growth in smoked salmon and crab, pathogen growth in lobster and scallops, and various allergen hazards (fish, crustacean shellfish, nut, milk, wheat, egg) across multiple products.