Vlazar Costa Caribe S.A. Warning Letter Details

Summary

Vlazar Costa Caribe S.A., a seafood processing facility in Nicaragua, was found to have serious violations of seafood Hazard Analysis and Critical Control Point (HACCP) regulations during an FDA inspection in April 2022, rendering their dried sea cucumber products adulterated. The company failed to conduct a required hazard analysis and develop a compliant HACCP plan that identified critical control points to prevent food safety hazards, in violation of 21 CFR Part 123. The FDA noted that the company had not responded to discussion items raised during the inspection as of the warning letter's issuance in August 2022.