FDA 483 - Fresenius Medical Care Holdings, Inc. - October 07, 2022

Fresenius Medical Care Holdings, Inc. in Ogden, UT, received a Form 483 with three observations during an FDA inspection. The firm's corrective and preventive action procedures were found inadequate, specifically lacking verification of effectiveness for changes made to address product issues. Additionally, a critical manufacturing process for bloodlines was not adequately validated, and complaint handling procedures failed to ensure proper evaluation for Medical Device Reporting requirements, even in cases involving patient death.