Emprede S.A. – FDA Warning Letter, May 7, 2010

On August 11, 2010, the FDA issued a Warning Letter to Emprede S.A. following an inspection of their seafood processing facility in Guyaquil, Ecuador, from May 5-7, 2010. 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 regulation for foods (21 CFR Part 110).

The FDA determined that Emprede S.A.'s escolar, dorado, and histamine species fish were adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act, having been prepared, packed, or held under insanitary conditions.

Specific violations included: 1. **Inadequate HACCP Plans for Histamine Control:** The HACCP plans for Escolar and Dorado failed to list refrigerated storage as a critical control point for preventing histamine formation, as required by 21 CFR 123.6(a) and (c)(2). The FDA recommends specific temperature monitoring or ice/cooling media checks for histamine species fish. 2. **Insufficient Critical Limit for Histamine Testing:** The HACCP plans for Escolar and Dorado listed an inadequate critical limit of "No mas de 5 mg de histamine por cada 100g o 50 ppm del lots que se recibe"