FDA 483 - Ascension Saint John Medical Center - May 09, 2025

Ascension Saint John Medical Center in Tulsa, OK, a hospital blood bank, received a Form 483 with two observations. The inspection revealed failures in reviewing records pertinent to irradiated blood products before release and a lack of thorough investigation and documentation of unexplained discrepancies during blood irradiation. These issues indicate deficiencies in quality control and record-keeping practices.