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Talk to a SpecialistTalk to a SpecialistCoombe Castle International Ltd., a United Kingdom-based manufacturer of low-acid canned foods (LACF) destined for U.S. export, violated the Emergency Permit Control regulation (21 CFR Part 108) and the Thermally Processed Low-Acid Foods regulation (21 CFR Part 113) during an FDA inspection in October 2023. The company's responses to the FDA-483 observations issued at the conclusion of the inspection, submitted across three separate occasions through February 2024, were deemed inadequate to address the serious deviations identified. As a result, the FDA warned that the company's failure to comply with mandatory LACF processing requirements could trigger emergency permit control provisions and potential refusal of admission for the company's products into U.S. interstate commerce.