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Talk to a SpecialistTalk to a SpecialistGondi S.A., a low-acid canned food (LACF) manufacturer in Ecuador, was cited for serious violations of FDA thermal processing regulations (21 CFR Parts 108 and 113) after laboratory analysis of their seafood products indicated under-processing that could allow spoilage organisms or pathogens to survive. The April 2023 inspection found the company had failed to comply with Emergency Permit Control regulations and requirements for thermally processed low-acid foods in hermetically sealed containers, creating potential food safety hazards in products destined for U.S. export. The violations were significant enough to warrant a formal Warning Letter despite the company's May 2023 response to the initial FDA-483 observations.