FDA 483 - Kibun Foods Inc. Funabasi Factory - March 13, 2026

Between March 12 and March 13, 2026, the U.S. Food and Drug Administration (FDA) conducted an inspection of the Kibun Foods Inc. Funabasi Factory, located in Funabashi, Chiba, Japan. The facility specializes in the production of steamed and frozen processed egg products and fish-based surimi products. This inspection, conducted under the authority of Section 704(b) of the Federal Food, Drug, and Cosmetic (FD&C) Act, resulted in the issuance of a Form FDA 483. The primary violation identified involves deficiencies in the facility"s food safety plan regarding allergen management. Specifically, the FDA investigator observed that the company failed to establish a necessary preventive control for food allergens at the labeling stage of production. Although the factory"s hazard analysis correctly identified allergens as a potential risk during labeling, management did not implement specific controls to mitigate this risk. This oversight is significant because products exported to the United States—including mixed trays containing fish cake, seasoned kelp, and black soybeans—contain multiple major allergens such as wheat, fish, soy, and egg. To address these findings, Kibun Foods Inc. must review the observations and submit a formal response to the FDA. This response should detail the corrective actions taken or planned to resolve the identified labeling control issues. While the Form 483 documents the investigator"s observations, it does not represent a final agency determination regarding compliance.