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Maruhachi Muramatsu Inc.'s Danchi Factory, a seafood processing facility in Japan, failed to comply with seafood HACCP regulations (21 CFR 123) during an FDA inspection in April 2024, resulting in their refrigerated reduced oxygen packaged (ROP) skipjack tuna soup base product being deemed adulterated. The company's HACCP plan was found to lack adequate critical limits as required by regulation, and their May 2024 corrective action response was deemed insufficient to address the violations. The FDA determined that the product may have been rendered injurious to health due to improper preparation, packing, or holding conditions resulting from non-compliant HACCP procedures.