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Conservas Ortiz S.A., a Spanish seafood and low-acid canned food processor, failed to comply with Seafood HACCP regulations (21 CFR Part 123) during an FDA inspection in February 2022. The facility's canned tuna products were found to be adulterated because the company did not properly conduct hazard analysis or maintain a compliant HACCP plan with adequate critical control points as required by federal regulations. The company's March and April 2022 responses, which included updated HACCP documentation, were reviewed but found insufficient to address the serious violations identified during the inspection.