FDA WARNING_LETTER - FACTORIA DEL LAGO C.A. - April 26, 2010

On April 22-26, 2010, an FDA inspection of Kingmar Seafood Corporation, a U.S. importer, revealed they were importing cooked crab meat from Factoria Del Lago C.A. The FDA collected Factoria Del Lago's HACCP plan for "Cooked Crab Meat," which showed serious deviations from 21 CFR Part 123, the seafood HACCP regulation. This renders their products adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act.

Specifically, the HACCP plan failed to list two critical control points: 1. Refrigerated storage after packing but before pasteurization to control pathogen growth (e.g., *Clostridium botulinum*, *Staphylococcus aureus*). 2. A critical control point for the cooling water during pasteurization to control pathogen introduction, with a suggested critical limit for residual chlorine or UV treatment.

Additionally, the corrective actions in the HACCP plan were deemed inappropriate: 1. Sampling a portion of product for pathogens at the "Pasteurization" critical control point is inadequate if the process fails to meet critical limits. 2. Corrective actions at processing critical control points (backing, picking, packing) did not address the cause of deviations.

Factoria Del Lago must respond in writing within fifteen working days, outlining specific corrections, including revised HACCP plans, five days of monitoring records