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Agustson A/S, a Danish acidified food manufacturer exporting to the United States, received a warning for serious deviations from the Emergency Permit Control regulation (21 CFR Part 108) and the Acidified Foods regulation (21 CFR Part 114) identified during an FDA inspection on March 4-5, 2024. The company failed to meet mandatory requirements including proper registration and filing of process information for thermally processed low-acid foods in hermetically sealed containers. The firm's written response to the inspection observations, submitted on March 25, 2024, was determined to be inadequate, leaving compliance gaps unresolved.