Fresenius Medical Care Holdings, Inc. – FDA 483, Aug 2, 2023

Fresenius Medical Care Holdings, Inc. in Waltham, MA, received a Form FDA 483 for significant quality system deficiencies related to its hemodialysis and peritoneal dialysis machines. The inspection revealed inadequate corrective and preventive action procedures, including delayed investigations into PCB contamination and tubing leaks, and failures in supplier management and design validation. Additionally, the firm conducted an unreported field action to correct devices with PCB-leaching components, indicating a serious lack of regulatory compliance.