# FDA 483 - Children's Hospital of Orange County - April 29, 2026

Source: https://www.keypedia.com/records/483/childrens-hospital-of-orange-county/62558965-255a-42b5-915e-bfd6bfae04a4

> FDA 483 for Children's Hospital of Orange County on April 29, 2026. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Children's Hospital of Orange County
- Inspection Date: 2026-04-29
- Product Type: biologics
- Office Name: Los Angeles District Office
- Summary: 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.

## Related Documents

- [483 - 2024-01-16](https://www.keypedia.com/records/483/childrens-hospital-of-orange-county/276ef377-4766-4ec5-82d8-971857807b03)

## Related Officers

- [FDA_PERSONNEL](https://www.keypedia.com/people/maurine-fadlalla/519e6e71-a50a-43b5-b41a-2249ec9afdd5)

Company: https://www.keypedia.com/companies/childrens-hospital-of-orange-county/7aeedbb4-de00-443f-b4a1-373d27a195f8

Office: https://www.keypedia.com/offices/los-angeles-district-office/edcf1dfe-596a-43b8-8df4-07d9cd94763b
