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

The FDA inspected Xiyou Village's low-acid canned food (LACF) facility in China from March 11-13, 2024, identifying serious deviations from 21 CFR 108 (Emergency Permit Control) and 21 CFR 113 (Thermally Processed Low-Acid Foods). The firm manufactures 230g pouches of roasted gluten for U.S. export. Violations included failure to process LACF in conformity with the scheduled process (21 CFR 108.35(c)(3)(i)), specifically regarding retort loading patterns, potentially leading to under-processed batches. Additionally, the firm failed to ensure its horizontal still water spray retort achieved commercial sterility, as critical parameters like water flow rate and processing temperature were not measured and recorded at sufficient frequency (21 CFR 113.40(j)). The retort lacked a flow meter and a temperature recording device until recently, and temperature was only documented once per batch. Furthermore, the firm failed to conduct appropriate detailed inspections and tests for hermetic seal production at sufficient frequency (21 CFR 113.60(a)(2)), relying on visual examination without documenting discards and not performing destructive tests on pouches, despite receiving complaints of damaged seams. The firm's response outlined corrective actions, including new studies, installation of a flow meter and TRD, new record-keeping, and operator training. However, the FDA requires an evaluation by a Process Authority for all roasted gluten lots within shelf-life in the U.S. manufactured before March 30, 2024, to ensure commercial sterility. Failure to correct these violations may result in refusal of admission under section 801(a) of the Act and placement on Import Alert #99-38.