FDA 483 - Fresenius Kabi USA, LLC - August 30, 2023

An FDA inspection of Fresenius Kabi USA, LLC, a medical device manufacturer in Grand Island, NY, revealed deficiencies in their corrective and preventive action (CAPA) procedures. The firm's CAPA process allows for actions to not include verification or validation of effectiveness under certain conditions, and two out of five reviewed CAPAs lacked this crucial step.