# FDA 483 - UCLA Health Systems, Blood & Platelet Center - May 29, 2019

Source: https://www.keypedia.com/records/483/ucla-health-systems-blood-platelet-center/638f3c29-29a9-4af6-9e4b-1e0f840a6567

> FDA 483 for UCLA Health Systems, Blood & Platelet Center on May 29, 2019. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: UCLA Health Systems, Blood & Platelet Center
- Inspection Date: 2019-05-29
- Product Type: biologics
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: An FDA inspection of UCLA Health Systems, Blood & Platelet Center in Los Angeles, CA, revealed significant failures to follow written standard operating procedures. The firm did not adhere to its SOPs for managing adverse donor events, including timely follow-up with donors and completing required attempts for severe reactions. Additionally, compliance reviews for occurrence management reports were not completed within the specified timeframe, indicating systemic issues with recordkeeping and quality management.

## Related Officers

- [investigator](https://www.keypedia.com/people/brantley-s-collins/c806aac1-3d89-4427-8aeb-6d9db6dfc2f4)

Company: https://www.keypedia.com/companies/ucla-health-systems-blood-platelet-center/9c082828-14a2-4e8c-8765-b52302917d5d

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