Tencho Food Co., Ltd. – FDA Warning Letter, Sep 7, 2012

On December 20, 2012, the FDA issued a Warning Letter to Tencho Food Co., Ltd. following an inspection of their acidified food facility in Japan on September 6-7, 2012. The inspection revealed serious deviations from acidified food regulations (21 CFR Part 108 and Part 114) and Current Good Manufacturing Practice (21 CFR Part 110), rendering their products adulterated.

Key violations include: * Failure to provide scheduled process information for eight acidified food products manufactured and distributed to the U.S., as required by 21 CFR 108.25(c)(2). * Failure to provide a process source document for "Amasu Ginger (Pickled Ginger)," the only scheduled process on file, as required by 21 CFR 108.25(c)(3)(ii). * Plant construction issues: floors in disrepair with cracks and missing concrete, and mold accumulation on walls and ceilings in the sterilizing room (21 CFR 110.20(b)(4)). * Non-corrosion-resistant food-contact surfaces: rust observed on vegetable slicing machine blades (21 CFR 110.40(a)). * Lack of backflow prevention devices on piping systems with threaded hoses, risking water supply contamination (21 CFR 110.