FDA WARNING_LETTER - NALMA, S.A. - February 01, 2013

On January 31 and February 1, 2013, the FDA inspected Nalma S.A.'s seafood processing facility in Aguadulce, Panama, finding serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR 123). Despite the firm's responses on February 15 and March 27, 2013, significant violations persisted, rendering their histamine-producing fish products adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act.

Key violations include: 1. **Inadequate Critical Limits:** The HACCP plan for histamine-producing fish lacks adequate critical limits for harvest vessel records at the receiving critical control point to control histamine formation. FDA recommends specifying parameters for time to icing or chilling to 40°F (4.4°C) or less, based on air/water temperatures and exposure time. 2. **Missing Critical Control Point:** The HACCP plan does not list receiving fish during transit from the wharf to the facility as a critical control point to control histamine formation, despite transit times up to (b)(4). Proper temperature control during transit is necessary. 3. **Inappropriate Corrective Actions:** Corrective action plans for histamine-producing fish at receiving and storage critical control points are insufficient. They do not ensure adulterated fish are kept out of commerce or that