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Myllan-ORA ehf, an Icelandic seafood processor, failed to comply with federal Hazard Analysis and Critical Control Point (HACCP) regulations for its ready-to-eat herring and refrigerated lumpfish caviar products. The company's HACCP plan did not identify necessary critical control points (CCPs) required to control food safety hazards, including the failure to establish receiving procedures with critical limits to prevent toxin formation from Clostridium botulinum and Staphylococcus aureus in refrigerated salted caviar. As a result, the FDA determined the products were adulterated and prepared under conditions that could render them injurious to health. The company had not responded to the FDA-483 Inspectional Observations issued at the conclusion of the May 2022 inspection.