FDA 483 - I3 PHARMACEUTICALS LLC - December 21, 2018

I3 PHARMACEUTICALS LLC in Warminster, PA, a drug manufacturer, was cited for multiple deficiencies during an FDA inspection. Observations included inadequate routine inspection and control of manufacturing equipment, insufficient detail in cleaning and maintenance procedures, and analytical assay test procedures that failed to meet accuracy requirements. Additionally, the firm was cited for improper storage conditions for drug products, specifically regarding temperature and humidity monitoring.