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483
•Regional West Medical Center•February 9, 2023

Regional West Medical Center – FDA 483, Feb 9, 2023

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
View Company Profile

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

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