FDA WARNING_LETTER - GuiLin SanYang Dietary Ecological Industry Co.Ltd. - September 24, 2019

On February 6, 2020, the FDA issued a Warning Letter to Mr. Qin Hui Yue, following a September 24, 2019, inspection of their low-acid canned food (LACF) and acidified food (AF) facility in Guilin, Guangxi, China. The inspection revealed serious deviations from 21 CFR Part 108 (Emergency Permit Control), 21 CFR Part 113 (Thermally Processed Low-Acid Foods), and 21 CFR Part 114 (Acidified Food).

Key violations include: 1. Lack of an accurate temperature-recording device on retort #2 (21 CFR 113.40(a)). The firm's response was inadequate, lacking documentation of the device's operability or supporting records for affected products. 2. Insufficient examination of pouch container closures for LACF rice noodles to ensure hermetic seals (21 CFR 113.60(a)(3)). The observed vacuum test frequency was inadequate, and no container integrity test records were maintained. The firm's response lacked implementation documentation. 3. Incomplete process and production information forms for LACF rice noodles, missing critical factors like flow rate or minimum come-up time (21 CFR 113.100(a)). The revised template was incomplete, and no supporting completed production records were provided.