FDA 483 - Bloodworks - March 22, 2019

Bloodworks, a blood bank in Renton, WA, was cited for failing to follow its written standard operating procedures for the distribution of blood and blood components. Specifically, the firm distributed numerous units of unlicensed blood products in interstate commerce without the required Medical Director approval for urgent medical necessity. This indicates a serious lapse in adherence to internal policies and potentially regulatory requirements for blood product distribution.