FDA 483 - Beckman Coulter, Inc. - October 28, 2021

During an inspection, Beckman Coulter, Inc. in Miami, FL, was cited for significant deficiencies in its corrective and preventive action (CAPA) procedures and medical device reporting (MDR). The firm failed to adequately manage a Class I recall related to a manufacturing defect, including not updating CAPA records and servicing affected devices. Additionally, the company did not submit required MDR reports for device malfunctions that could cause serious injury or death.