FDA 483 - Fresenius Medical Care Holdings, Inc. - October 05, 2022

An FDA inspection of Fresenius Medical Care Holdings, Inc. in Waltham, MA, revealed significant deficiencies in the firm's quality system. Observations included inadequate corrective and preventive action procedures, unvalidated manufacturing processes, and failures in complaint handling. These issues indicate a lack of robust controls for ensuring device quality and patient safety, particularly concerning medical device reporting evaluations.