FDA 483 - Blood Bank Computer Systems, Inc. - June 30, 2023

An FDA inspection of Blood Bank Computer Systems, Inc. in Bonney Lake, WA, revealed three significant observations concerning their quality system for biological medical devices. The firm failed to include unique device identifiers (UDI) in device history records for their blood establishment computer software, did not perform quality audits at defined intervals, and lacked adequately established procedures for employee training and re-training. These issues indicate deficiencies in their quality management system.