FDA 483 - Fuyang Fuchunjiang Canned Food Co.,Ltd. - March 13, 2024

During a U.S. Food and Drug Administration (FDA) inspection conducted from March 11-13, 2024, Fuyang Fuchunjiang Canned Food Co., Ltd., a low-acid canned food manufacturer in Hangzhou, China, received a Form FDA 483 citing significant observations regarding its manufacturing processes for roasted gluten products. The primary concerns revolved around critical deviations from established protocols. The firm was found to be processing significantly more product per retort cycle than what was validated by its heat penetration and distribution studies, which underpin its FDA-filed scheduled process. This practice raises serious questions about the product's commercial sterility. Furthermore, a critical factor for thermal processing, the water flow rate in their retort system, was neither measured nor recorded, despite being a specified requirement in their scheduled process. The retort lacked a flow meter, and the company confirmed no historical monitoring since 2019. The inspection also revealed inadequate temperature recording; the retort lacked a permanent temperature device for an extended period, and even after installation, records for certain batches shipped to the USA were missing. Finally, the identification codes on hermetically sealed containers were insufficient, failing to clearly identify the establishment, product, year, day, or period of packing in an accessible language. These observations highlight a need for immediate corrective actions by Fuyang Fuchunjiang Canned Food Co., Ltd. to ensure compliance with food safety regulations and the integrity of their low-acid canned food products.