FDA 483 - Fresenius Medical Care Holdings, Inc. - October 16, 2024

An FDA inspection of Fresenius Medical Care Holdings, Inc. in Waltham, MA, revealed significant deficiencies in their quality system, particularly concerning corrective and preventive actions, design change validation, risk analysis, and supplier management. The firm failed to adequately address repeat observations, properly assess CAPA impacts, validate critical device design changes, or appropriately analyze serious complaints, including one associated with a patient death. These findings indicate a high level of non-compliance with regulatory requirements for medical device manufacturing.