FDA 483 - CareFusion 303, Inc. - April 06, 2020

CareFusion 303, Inc. in San Diego, CA, a medical device manufacturer, was inspected by the FDA from March 2 to April 6, 2020. The inspection revealed significant deficiencies across multiple quality system areas, including inadequate corrective and preventive actions, complaint handling, medical device reporting, design verification, servicing procedures, and software validation. These issues were linked to numerous device malfunctions, some resulting in patient deaths or serious injuries, and included a failure to report a major field correction to the FDA.