FDA 483 - Beckman Coulter, Inc. - October 16, 2017

An FDA inspection of Beckman Coulter, Inc. in Miami, FL, a medical device manufacturer, revealed significant deficiencies in their quality system. The firm failed to adequately establish and implement procedures for servicing activities, complaint handling, medical device reporting, and corrective and preventive actions. These failures led to a flow cytometry instrument misconfiguration, resulting in numerous erroneous patient results and delayed reporting of critical information to the FDA.