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Miyajima Shoyu Co., Ltd., a Japanese manufacturer of acidified foods exported to the United States, was found to have serious deviations from the Emergency Permit Control regulation (21 CFR Part 108) and the Acidified Foods regulation (21 CFR Part 114) during a May 2024 FDA inspection. The company failed to comply with mandatory requirements including proper registration and filing of process information as specified in 21 CFR 108.25 and Part 114 for processing acidified food products in hermetically sealed containers. The firm's written response to the inspection findings, submitted in June 2024, was deemed inadequate by the FDA.