kikkoman sales usa, Inc – FDA Warning Letter, Aug 3, 2012

The FDA inspected Sales USA, Inc.'s manufacturing facility in Gladewater, TX, from August 1-3, 2012, revealing serious violations of the juice Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 120) and Current Good Manufacturing Practice (CGMP) regulation (21 CFR Part 110). Consequently, the firm's lemon and lime juices are deemed adulterated due to insanitary conditions. Key violations include the failure to incorporate control measures in HACCP plans that consistently achieve a 5-log reduction of pertinent microorganisms, such as Listeria monocytogenes, in 100% lemon, lime, and key lime juices, as mandated by 21 CFR 120.24(a). The critical limits listed in the firm's HACCP plans were insufficient for this purpose. Additionally, the firm failed to adequately monitor sanitation conditions and practices to ensure CGMP compliance (21 CFR 120.6(b)), specifically regarding cross-contamination prevention. This was evidenced by uncleanable, rough, and pitted floors in the production area. While the firm provided a response dated August 29, 2012, it was deemed insufficient for addressing the 5-log reduction deficiency. The FDA requires prompt corrective action to address these violations and establish preventative procedures. The firm must respond in writing within fifteen working days, detailing specific corrections and providing supporting documentation. Failure to comply may result in re-inspection fees.