FDA 483 - Tacoma-Pierce County Blood Bank - May 26, 2023

The Tacoma-Pierce County Blood Bank received a Form 483 with two observations following an inspection from May 22-26, 2023. The observations highlight deficiencies in maintaining records for computer system validation and failing to perform routine calibration and alarm activation testing for critical blood component processing and storage equipment. These issues indicate a lack of adherence to established procedures for ensuring the reliability and proper functioning of systems and equipment used in blood banking operations.