Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy. To check it, open FDA's record for this establishment, listed under FEI 3005017292.
Thai Union Group PLC's seafood processing facility in Thailand was found to have serious violations of seafood Hazard Analysis and Critical Control Point (HACCP) regulations under 21 CFR Part 123, rendering their frozen, pre-cooked tuna loin products adulterated. The facility failed to maintain a compliant HACCP plan that properly documented critical limits for controlling physical, biological, and chemical parameters at critical control points. The assessment was conducted remotely in January 2022 due to COVID-19 travel restrictions, and the company's subsequent responses in February and March 2022 did not adequately address the identified violations.
Thai Union Group PLC FDA Warning Letter, April 20, 2022
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