FDA WARNING_LETTER - Nicamex Seafood - February 15, 2022

On February 7-15, 2022, the FDA conducted a Foreign Remote Regulatory Assessment (FRRA) of Nicamex Seafood, a dried sea cucumber processing facility in Managua, Nicaragua. The assessment revealed serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123), rendering their dried sea cucumber products adulterated under 21 U.S.C. § 342(a)(4).

Key violations include: 1. **Inadequate HACCP Plan Critical Limit:** The HACCP plan for dried sea cucumber lacked an adequate critical limit to control pathogenic bacteria growth and toxin formation. Specifically, the listed critical limit “(b)(4)” at the (b)(4) critical control point does not ensure a maximum finished product water activity of 0.85 or below to control *Staphylococcus aureus* (S. aureus). The FDA recommends scientific validation for drying parameters and implementation of time and temperature controls (e.g., below 10°C or 50°F, or limited exposure to higher temperatures) to prevent S. aureus growth before achieving the target water activity. 2. **Failure to Implement Recordkeeping System:** The firm did not implement the recordkeeping system listed in its dried sea cucumber HACCP plan. Requested monitoring records for products shipped to the U.S. on June 30, 2021,