FDA 483 - Oklahoma Blood Institute - June 07, 2019

An FDA inspection of Oklahoma Blood Institute - Sylvan N Goldman Center in Oklahoma City revealed significant deficiencies in quality control and record-keeping for blood and blood components. Observations included failures in documenting bacterial contamination testing, inadequate investigations of viral screening discrepancies, and improper donor medical history assessments. Additionally, issues were noted with maintaining concurrent records, performing required testing according to manufacturer instructions, and ensuring equipment was level and calibrated.