Fresenius Medical Care Holdings, Inc. – FDA 483, Jun 3, 2026

Fresenius Medical Care Renal Therapies Group, LLC in Waltham, MA, received a Form 483 with six observations detailing significant deficiencies in their quality system for hemodialysis machines and related products. The inspection revealed inadequate risk management, design verification, and design validation, leading to potential patient harm and death. Furthermore, the firm failed to properly utilize feedback for risk management, implement effective corrective actions, and establish adequate supplier controls.