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Fresenius Medical Care was cited for manufacturing adulterated dialysis systems and accessories, including the 2008 Series Hemodialysis Machine, that failed to comply with current good manufacturing practice requirements under FDA's Quality System Regulation (21 CFR Part 820). An FDA inspection of the company's Waltham, Massachusetts facility from June through August 2023 identified failures to establish and maintain procedures for implementing corrective and preventive actions, among other violations. The company's North American operations were found responsible for complaint handling, recall management, and quality system oversight of these medical devices, which are intended to treat disease through hemodialysis.