Regional West Medical CenterFebruary 9, 2023

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

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Record Details

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.

Company: Regional West Medical Center
Inspection Date: February 9, 2023
Product Type: Biologics
Office: Division of Human and Animal Food Operations - West II
Person: Ismael Olvera

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ID · 8c6f377e-35c1-4fb6-938b-5b85c8eb533c