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El Gordo Spices, LLC, a herbs, spices, and seafood repacking facility in Dallas, Texas, failed to comply with Seafood HACCP regulations (21 CFR Part 123) and Food Labeling requirements (21 CFR Part 101), resulting in their shelf-stable ready-to-eat Whole Dried Shrimp and Ground Dried Shrimp products being deemed adulterated due to preparation, packing, or storage under insanitary conditions. FDA investigators identified serious violations during a July 2022 inspection, including failure to develop and implement a compliant HACCP plan and labeling violations across six repacked products (Ground Dried Shrimp, Whole Dried Shrimp, Sesame Seeds, Textured Soybeans, Ground Cumin, and Whole Bay Leaves). The company had not responded to the Form FDA-483 inspectional observations issued at the conclusion of the inspection.