FDA 483 - Fresenius Medical Care, North America - May 21, 2021

An FDA inspection of Fresenius Medical Care, North America in Ogden, UT, from May 19-21, 2021, revealed a significant deficiency in the firm's investigation processes. The company failed to conduct comprehensive investigations into numerous patient complaints regarding leakage of their Delflex Peritoneal Dialysis Sterile Solution bags. This indicates a serious lapse in quality control and root cause analysis for a critical medical product.