FDA 483 - Yichang Jiayuan Foodstuffs Co., Ltd. - September 28, 2022

An FDA inspection of Yichang Jiayuan Foodstuffs Co., Ltd., conducted from September 26 to 28, 2022, identified significant concerns regarding the plant's design and sanitary operations. The inspection report, a Form FDA 483, highlighted that the facility was not adequately designed to facilitate proper maintenance and sanitation. A critical observation involved the use of a non-food grade grease/lubricant on mechanical chains and bearings. This lubricant was applied directly over and adjacent to the food contact surfaces of the exposed orange grading equipment. Investigators noted an excessive application of the grease, with it running over the edges of the components, thus posing a direct risk of contaminating food products. These findings were documented under Section 704(b) of the Federal Food, Drug and Cosmetic Act, which empowers the FDA to report conditions indicating potential food contamination or preparation under insanitary circumstances. As a result, Yichang Jiayuan Foodstuffs Co., Ltd. is required to promptly address these objectionable conditions and implement corrective actions. This typically involves revising plant maintenance procedures, ensuring only food-grade lubricants are used in processing areas, and re-evaluating the overall facility design to comply with food safety regulations and prevent future contamination risks.