483
Sterling Regional Medical CenterSterling Regional Medical Center – FDA 483, Sep 19, 2024
Record Details
An FDA inspection of Sterling Regional MedCenter's Blood Bank in Sterling, CO, revealed significant deficiencies in record-keeping practices. The facility failed to ensure that quality control logs and maintenance records were properly reviewed by section heads and laboratory managers as required by their standard operating procedures. This indicates a lapse in oversight and documentation integrity for critical blood bank operations.
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