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Talk to a SpecialistTalk to a SpecialistPT. Winson Prima Sejahtera, an Indonesian seafood processor, was found to have serious violations of the Seafood HACCP regulation (21 CFR Part 123) during an FDA remote assessment in April 2023, rendering their wild, frozen, vacuum-packaged ready-to-eat yellowfin tuna adulterated. The facility failed to conduct a proper hazard analysis and develop a compliant HACCP plan identifying food safety hazards reasonably likely to occur in their products. The company's products were deemed to have been prepared and held under conditions whereby they may have been rendered injurious to health, and the firm had not responded to the discussion items raised by the FDA investigator at the time the warning letter was issued.