FDA 483 - Fresenius Kabi USA, LLC - March 06, 2015

An FDA inspection of Fresenius Kabi USA, LLC in Grand Island, NY, revealed deficiencies in drug product manufacturing processes. Observations included a lack of established acceptable yield for bulk material and incomplete documentation of product loss, hindering process assessment. Additionally, the firm's environmental monitoring system in aseptic processing areas was found to be deficient, with re-testing performed without proper invalidation of original out-of-spec results.