CR Grupo Comercial Alvacora S.A. Warning Letter Details

Summary

CR Grupo Comercial Alvacora S.A., a seafood processing facility in Nicaragua, failed to establish and implement a compliant Hazard Analysis and Critical Control Point (HACCP) plan required under 21 CFR Part 123, rendering their dry sea cucumber products adulterated. The FDA conducted a remote assessment in April 2022 and identified serious violations including failure to establish critical limits as required by 21 CFR 123.6(c)(3), which define the maximum or minimum values for physical, biological, or chemical controls. The company's May 2022 response to FDA's findings was determined to be inadequate, leaving the violations unresolved.