FDA 483 - CareFusion 303, Inc. - September 06, 2018

CareFusion 303, Inc. in San Diego, CA, a Class-II medical device manufacturer, was inspected regarding its infusion pump products. The inspection revealed significant deficiencies in the firm's corrective and preventive action (CAPA) procedures, including inaccurate complaint data analysis and unverified battery conditioning methods. Additionally, the firm failed to adequately investigate device complaints and demonstrated insufficient design verification for critical pump changes.