# FDA 483 - Children's Hospital of Orange County - January 16, 2024

Source: https://www.keypedia.com/records/483/childrens-hospital-of-orange-county/276ef377-4766-4ec5-82d8-971857807b03

> FDA 483 for Children's Hospital of Orange County on January 16, 2024. Product: biologics. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Children's Hospital of Orange County
- Inspection Date: 2024-01-16
- Product Type: biologics
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: Children's Hospital of Orange County in Orange, CA, received a Form 483 following an inspection of its Blood Bank - Transfusion Services. The inspection revealed deficiencies in establishing and maintaining written standard operating procedures for blood component processing, particularly regarding documentation of operating conditions. Additionally, the firm failed to concurrently maintain records for significant processing steps, leading to discrepancies in record modification verification.

## Related Officers

- [Eric Zhu](https://www.keypedia.com/people/eric-zhu/32919a8f-841a-441b-a489-8495f2e16993)
- [Creighton T. Tuzon](https://www.keypedia.com/people/creighton-t-tuzon/be0d09c0-59f4-48c3-9e3d-a1ceb2587e3e)

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

Office: https://www.keypedia.com/offices/division-of-pharmaceutical-quality-operations-iv/a2d2ff91-dc0f-433e-b91f-ca90ff8998b6