The Hazard Analysis was not complete since the hazard of pathogen growth, including Salmonella, which can pose risks in this situation, was not addressed.

The critical limits included in the HACCP Plan were not deemed adequate to prevent the formation of histamine, which can cause serious symptoms within minutes or hours of consumption. Histamine is a heat-stable toxic metabolite produced by certain bacteria found in some fish species that can be formed if the fish are not properly refrigerated. … Continue readingFDA Issues Warning Letter Through a Foreign Remote Regulatory Assessment