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Talk to a SpecialistTalk to a SpecialistDalai Biotech Company Ltd, a Taiwan-based manufacturer of acidified and thermally processed canned foods for export to the U.S., failed to comply with the Emergency Permit Control regulation (21 CFR Part 108) and the Acidified Foods regulation (21 CFR Part 114), with serious deviations identified during an FDA inspection in May 2024. The company did not adequately fulfill mandatory requirements including product registration and filing of process information as required under 21 CFR 108.25. The firm's written response to the inspection findings, submitted in June 2024, was determined to be inadequate, placing the company at risk of emergency permit control enforcement under section 404 of the Federal Food Drug and Cosmetic Act.