FDA WARNING_LETTER - Alimex Sa - September 16, 2011

On September 15-16, 2011, the FDA inspected Alimex S.A.'s seafood processing facility in Coronel, Chile, identifying serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123). The inspection resulted in an FDA 483, and the firm's September 30, 2011, response was deemed inadequate.

The FDA determined that Alimex S.A.'s canned salmon and frozen vacuum-packaged fish products are adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act, as they were prepared, packed, or held under insanitary conditions.

Specific violations include: 1. **Inadequate Hazard Analysis:** The HACCP plan for canned salmon did not list undeclared major food allergens and food intolerance substances as a reasonably likely food safety hazard. 2. **Inadequate HACCP Plan for Vacuum-Packaged Fish:** The HACCP plan for frozen vacuum-packaged fish did not list undeclared major food allergens and food intolerance substances, nor did it identify the hazard of *Clostridium botulinum*. The FDA recommends including a critical control point to ensure labels contain a "keep frozen" statement.

Alimex S.A. must respond in writing within thirty working days, outlining specific corrective actions, including revised HACCP plans