FDA WARNING_LETTER - Empresas Y-nuina, Inc. - July 06, 2010

On November 16, 2010, the FDA issued a Warning Letter to Empresas Y-Nuina, Inc. following an inspection from June 28 to July 6, 2010, at their seafood processing facility in Canóvanas, Puerto Rico. The inspection revealed serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123) and Current Good Manufacturing Practice (CGMP) regulation (21 CFR Part 110).

The firm's plantain fritters, mini plantain fritters, tacos, and mini tacos with crab meat were deemed adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act due to insanitary conditions and HACCP deficiencies. All other food products were also considered adulterated due to CGMP violations.

Key violations included: * **Seafood HACCP:** * Failure to list critical control points for thawing frozen crabmeat (pathogen growth/toxin formation) and cooler storage of cooked product (pathogen growth) in the HACCP plan for crabmeat products (21 CFR 123.6(a) and (c)(2)). * Failure to list "allergens" as a food safety hazard in the HACCP plan for crabmeat products, despite allergenic substances being present (21 CFR 12