FDA WARNING_LETTER - Chongqing Tianrun Food Developmenet Co., Ltd. - April 19, 2024

The FDA issued a Warning Letter to a low-acid canned food (LACF) facility in Chongqing, China, following an April 2024 inspection. Serious deviations from Emergency Permit Control (21 CFR 108) and Thermally Processed Low-Acid Foods (21 CFR 113) regulations were found, rendering products adulterated. Violations included failure to register as a food canning establishment (FCE) and file scheduled processes before exporting to the U.S. The firm also lacked evidence that scheduled processes were established by a qualified expert (21 CFR 113.83). Critical factors like initial temperature, fill weight, and processing parameters were not measured or recorded, hindering deviation identification, and correlating with consumer complaints of swollen bags (21 CFR 113.40(b)(15)). Additionally, retort water levels were not monitored (21 CFR 113.40(b)(10)), and hermetic seal integrity checks were inadequate, despite reports of leaking bags (21 CFR 113.60(a)(3)). Finally, plant personnel lacked FDA-approved training in thermal processing (21 CFR 113.10). The firm's corrective action response was insufficient due to missing implementation records. The FDA demands a written response within 15 working days with detailed corrective actions and documentation. Non-compliance may lead to refusal of admission and detention without physical examination (DWPE) for imported products.