FDA 483 - CIL Isotope Separations, LLC - January 25, 2022

CIL Isotope Separations, LLC in Xenia, OH, a finished API manufacturer, was cited for significant deficiencies related to equipment and material suitability, environmental controls, and facility qualification during an FDA inspection. The inspection revealed issues including an unvalidated water system with high bioburden, inadequate differential pressure controls leading to air contamination, and an unqualified HVAC system, all impacting the production of Urea-13C. This is a repeat observation regarding equipment and material suitability.