# FDA 483 - University of California Irvine Medical Center Campus Donor Center - May 15, 2024

Source: https://www.keypedia.com/records/483/university-of-california-irvine-medical-center-campus-donor-center/7d2d6a30-96c5-4ce0-be86-0a0b5fb4e3f2

> FDA 483 for University of California Irvine Medical Center Campus Donor Center on May 15, 2024. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: University of California Irvine Medical Center Campus Donor Center
- Inspection Date: 2024-05-15
- Product Type: biologics
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: The University of California Irvine Medical Center Campus Donor Center was cited for three observations during an FDA inspection. The firm failed to obtain complete donor contact information, did not thoroughly investigate discrepancies and documentation error trends, and did not adhere to its own standard operating procedures for collection equipment quality control. These issues indicate deficiencies in donor screening, incident investigation, and procedural compliance.

## Related Officers

- [FDA_PERSONNEL](https://www.keypedia.com/people/maurine-fadlalla/519e6e71-a50a-43b5-b41a-2249ec9afdd5)
- [Emily B. Camire](https://www.keypedia.com/people/emily-b-camire/dff5f4c6-bcbe-4ef1-ac0b-1b2701b311ef)

Company: https://www.keypedia.com/companies/university-of-california-irvine-medical-center-campus-donor-center/ab5fd5bc-26c8-44ed-b9c0-3ed45621bb5b

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