FDA WARNING_LETTER - Yakseon Food Agricultural Co. LTD - October 18, 2019

On February 11, 2020, the FDA issued a Warning Letter to a low-acid canned food (LACF) facility in South Korea following an October 17-18, 2019 inspection. The inspection revealed serious deviations from 21 CFR Part 113, Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers regulations. The firm's November 7, 2019, response was deemed inadequate.

Key violations include: 1. Failure to provide evidence that scheduled processes were established by a qualified person, specifically lacking temperature distribution, heat transfer rate, and heat distribution studies for their retort (21 CFR 113.83). The response lacked a timeframe or identified processing authority. 2. Failure to ensure the retort was operated to achieve commercial sterility, as critical parameters were not measured and recorded. The retort lacked a temperature-indicating device (TID), temperature recording chart, or mechanism to control the mixture (21 CFR 113.40(j)). The response lacked a timeframe or documentation of scheduled work. 3. Failure to measure and document the initial temperature of LACF products prior to processing (21 CFR 113.87(c), 21 CFR 113.100). The response lacked details on monitoring frequency or documentation. 4. Failure to conduct any container