483
Tri Tech Laboratories LLCTri Tech Laboratories LLC – FDA 483, Dec 19, 2023
Record Details
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.
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ID · 2dd4852e-0a6f-492f-9e70-2295c9560565
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