FDA 483 - NCH Baker Hospital Downtown - February 26, 2020

NCH Baker Hospital Downtown, a blood bank establishment in Naples, FL, was inspected and cited for deficiencies in maintaining records for blood and blood component processing. Specifically, the firm failed to concurrently document visual inspections and temperatures for irradiated blood products in their "Blood Irradiation Logs." This indicates a significant lapse in record-keeping practices for critical steps in blood product handling.