FDA 483 - Beckman Coulter, Inc. - December 13, 2024

Beckman Coulter, Inc. in Chaska, MN, was inspected regarding its manufacturing of immunoassays and immunoassay instruments. The inspection revealed significant deficiencies in the firm's risk analysis processes, including inadequate probability definitions and failure to follow internal protocols for expert review. Additionally, the firm's complaint handling procedures were found to be insufficient, particularly concerning the investigation of instrument malfunctions and the classification and reportability of complaints involving delayed assay results.