Nicamex Seafood Warning Letter Details

Summary

Nicamex Seafood, a seafood processor in Nicaragua, failed to comply with FDA seafood Hazard Analysis and Critical Control Point (HACCP) regulations during a February 2022 inspection, resulting in their dried sea cucumber products being deemed adulterated. The facility's HACCP plan did not properly establish critical limits as required by 21 CFR 123.6(c)(3), which specify the maximum or minimum values for physical, biological, or chemical parameters at critical control points necessary to prevent food safety hazards. The company did not respond to discussion items or violations raised by the FDA investigator during the Foreign Remote Regulatory Assessment, and the facility's failure to implement a compliant HACCP plan rendered their products potentially injurious to health.