FDA 483 - William S. Middleton Memorial Veteran's Hospital - May 08, 2025

An FDA inspection of William S. Middleton Memorial Veteran's Hospital's Blood Bank revealed significant deficiencies. The facility failed to maintain proper temperatures for Red Blood Cells during shipment, leading to units being re-issued and transfused despite temperature excursions. Additionally, issues were noted with concurrent record-keeping for blood component storage and distribution, adherence to written standard operating procedures for product inspection, and the maintenance of quality control and general records for equipment.