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483
•Children's Hospital of Orange County•April 29, 2026

Children's Hospital of Orange County – FDA 483, Apr 29, 2026

Record Details

An FDA inspection of Children's Hospital of Orange County's Blood Bank - Transfusion Services identified two observations related to donor screening procedures. The firm failed to provide educational material to a donor and did not obtain confirmation of a donor's contact address for eight weeks post-donation. These issues indicate non-compliance with established procedures for ensuring blood supply safety and donor traceability.

Company
Children's Hospital of Orange County
Inspection date
April 29, 2026
Product type
biologics
Office
Los Angeles District Office
Person
  • Maurine Fadlalla (FDA_PERSONNEL)
View Company Profile

ID · 62558965-255a-42b5-915e-bfd6bfae04a4

Other documents for Children's Hospital of Orange County
  • 483 - 2024-01-16January 16, 2024

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