Rey de los Camarones S. A. Warning Letter Details

Summary

Rey de los Camarones S.A., a seafood processing facility in Nicaragua, was cited for serious violations of seafood Hazard Analysis and Critical Control Point (HACCP) regulations during an FDA inspection in August 2024. The company failed to conduct a required hazard analysis and establish a compliant HACCP plan with identified critical control points as mandated by 21 CFR Part 123, rendering their dried and salted sea cucumber products adulterated. The FDA determined the products may have been prepared, packed, or held under unsafe conditions that could injure health, and the company had not responded to the inspection observations at the time the warning letter was issued.