Empacadora Diamante S.A. – FDA Warning Letter, Apr 4, 2013

On April 3-4, 2013, the FDA inspected Empacadora Diamante S.A. in Ecuador and found serious violations of the Seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR 123). The firm's histamine-forming fish products were deemed adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act.

Key violations include: 1. **Inadequate HACCP Plan (21 CFR 123.6(a) and (c)(2)):** The revised HACCP plan for scombrotoxin-forming fish lacked critical control points (CCPs) for post-processing storage and for processing steps (eviscerating, cutting, cleaning, classifying) to control histamine formation. 2. **Inadequate Critical Limits (21 CFR 123.6(c)(3)):** At the receiving CCP, critical limits for decomposition (more than 2 fish in a 118-fish sample showing decomposition) and internal temperature (40°F/4.4°C or below for fish held iced 24+ hours after death) were not adequate. 3. **Missing Monitoring Procedures/Frequency (21 CFR 123.6(c)(4)):** The HACCP plan lacked monitoring procedures and frequency for a specific critical limit at a CCP related