FDA 483 - Fresenius Kabi USA, LLC - March 30, 2017

An FDA inspection of Fresenius Kabi USA, LLC in Grand Island, NY, revealed significant deficiencies in their manufacturing processes for sterile drug products. The firm failed to adequately prevent microbiological contamination, evidenced by a trend of out-of-specification bioburden results and an inadequate stopper sterilization process. Additionally, the environmental monitoring system for aseptic processing and sterilization filling lines was found to be deficient, with water observed on the floor in an ISO5 area.