FDA 483 - Memorial Hospital - Gulfport - February 04, 2019

An FDA inspection of Memorial Hospital At Gulfport Blood Bank revealed inadequate quality control procedures for supplies and reagents used in pre-transfusion testing. The firm's standard operating procedures failed to adequately describe QC testing profiles and handling of indeterminate test results for their blood bank analyzers. This indicates a significant deficiency in ensuring the reliability of critical pre-transfusion testing.