Fresenius Kabi Gets Warning Letter for Adulterated Devices, PCB Emissions, CAPA Lapses

The FDA has smacked Fresenius Kabi with a warning letter for selling adulterated devices that fail to conform to current good manufacturing practice (cGMP) requirements, following an inspection of the devicemaker’s Waltham, Mass., facility from June 26 to Aug. 2.

The agency noted it could not assess the adequacy of the company’s responses, dated Aug. 24 and Sept. 22, to an FDA Form 483 list of the inspectional observations because the devicemaker did not complete proposed corrective and preventive actions (CAPA) to address violations.

Fresenius Kabi did not take corrective action until almost two years after learning “of a potential issue impacting” hemodialysis machines that contain peroxide crosslinked silicone tubing,” read the warning letter. This, said the FDA, despite being notified on Dec. 3, 2020, of toxic, polychlorinated biphenyls (PCB) emissions that were “detected from the peroxide crosslinked silicone tubing component,” though the company did not open “CAPA 1100660 until June 15, 2022” while the devices were not recalled until Nov. 25, 2022.

Read the FDA warning letter here.

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