FDA 483 - Regional West Medical Center - February 09, 2023

An FDA inspection of Regional West Medical Center, a hospital blood bank in Scottsbluff, NE, identified significant deficiencies in record-keeping practices. The firm failed to ensure records adequately identified personnel and provided a complete history of work performed. This included issues with unreviewed donor reaction reports, incomplete blood donor records, and unreviewed blood product disposition and supplier control records.