KP Pharmaceutical Technology – FDA 483, Feb 3, 2023

An FDA inspection of KF Pharmaceutical Technology in Bloomington, IN, revealed significant deficiencies in quality assurance procedures and equipment suitability. The firm failed to adequately manage visual inspection processes, environmental controls, and their water system, indicating potential risks to product quality and purity. These issues include lack of AQL testing, unqualified visual inspectors, inadequate particulate control, and insufficient documentation and testing of the water system.