CR Grupo Comercial Alvacora S.A. – FDA Warning Letter, Apr 22, 2022

The FDA conducted a Foreign Remote Regulatory Assessment of CR Grupo Comercial Alvacora S.A. from April 18-22, 2022, due to COVID-19 travel restrictions. The assessment revealed serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123), rendering their dry sea cucumber products adulterated under 21 U.S.C. § 342(a)(4).

Key violations include: 1. **Inadequate HACCP Plan Critical Limits:** The revised HACCP plan for dried sea cucumbers, dated January 2022, lists critical limits for drying at (b)(4)°C ((b)(4)°F) for (b)(4) days and a final weight of (b)(4)% of initial weight, which are insufficient to control pathogen growth and toxin formation. FDA recommends a target water activity of 0.85 or less in the finished product, or a minimum drying temperature of 57.2°C (135°F), or achieving 0.85 water activity within two hours. Monitoring procedures for final weight were also deemed inadequate in the HACCP plan, despite being in a record template. 2. **Inadequate Corrective Actions:** The HACCP plan's corrective action for the drying CCP, "(b)(4)," is insufficient to control pathogen growth and