FDA 483 - Beckman Coulter, Inc. - December 11, 2023

An FDA inspection of Beckman Coulter, Inc. in Chaska, MN, revealed significant deficiencies in their quality management system. The firm's risk analysis procedures were found to be inadequate, with issues in defining qualitative risk levels and implementing post-launch risk assessments. Additionally, the inspection cited failures in establishing and implementing corrective and preventive actions, as well as insufficient control over nonconforming products and inadequately established design change procedures.