FDA 483 - Carefusion Corporation - September 28, 2018

CareFusion 2200, Inc. in Mannford, OK, a medical device manufacturer, was cited with two observations during an FDA inspection. The firm failed to adequately establish procedures for sampling methods, including statistical rationale for sample size changes and combining inspection lots. Additionally, the firm's complaint handling procedures were found to be inadequate, specifically regarding a complaint investigation that lacked a manufacturing records search and timely completion.