FDA 483 - Tri Tech Laboratories LLC dba KDC/One Columbus - December 19, 2023

Tri Tech Laboratories LLC dba KDC/One Columbus in New Albany, OH, was cited for significant deficiencies in quality control and laboratory practices during an FDA inspection. The observations highlight a systemic failure to adequately test raw materials and finished products, investigate out-of-specification results, maintain proper documentation, and control computer systems. These issues indicate a lack of robust quality assurance for their antibacterial hand gels and sanitizers.