CareFusion 303 FDA-483 Released

FDA has released the FDA-483 with eight inspection observations issued following a 3/2-4/6/20 inspection at CareFusion 303, a San Diego, CA, medical device manufacturer. The inspection observations were: 

•          failing to adequately establish procedures for corrective and preventive action;
•          failing to adequately establish procedures for receiving, reviewing, and evaluating complaints by a formally designated unit;
•          failing to evaluate and investigate where necessary complaints involving the possible failure of a device to meet any of its specifications;
•          failing to report to FDA a device that might present a risk to health;
•          failing to adequately establish procedures for design verification;
•          failing to implement written medical device reporting procedures;
•          failing to adequately establish procedures or instructions for performing servicing activities; and
•          validation of device software is incomplete.