FDA 483 - Tacoma-Pierce County Blood Bank - September 09, 2021

An FDA inspection of Tacoma-Pierce County Blood Bank in Tacoma, WA, revealed multiple significant deficiencies in their blood component processing and quality control. Observations included failures to follow standard operating procedures for testing, inadequate investigations into product failures, uncalibrated equipment, and poor record-keeping. Additionally, the facility lacked proper quarantine space and did not consistently have CPR-certified personnel on-site during blood collections.