# FDA 483 - Cedars-Sinai Medical Center - August 26, 2022

Source: https://www.keypedia.com/records/483/cedars-sinai-medical-center/c7cc4d9e-00a2-40ee-a17b-47ccc9dbc327

> FDA 483 for Cedars-Sinai Medical Center on August 26, 2022. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Cedars-Sinai Medical Center
- Inspection Date: 2022-08-26
- Product Type: biologics
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: Cedars-Sinai Medical Center's blood bank in Los Angeles, CA, was cited for multiple significant deficiencies during an FDA inspection. The observations primarily concern failures in donor record management, investigation of discrepancies, notification of deferred donors, and the timely submission of biological product deviation reports. These issues indicate systemic problems with quality control and compliance in blood collection and processing.

## Related Documents

- [483 - 2022-08-26](https://www.keypedia.com/records/483/cedars-sinai-medical-center/d2f91a68-bd7e-4cb4-8e1c-a94a02f3bbeb)

## Related Officers

- [Dylan R. Jock](https://www.keypedia.com/people/dylan-r-jock/a083cb5e-95d7-491d-9c6d-8c36c5963ddf)
- [Emily B. Camire](https://www.keypedia.com/people/emily-b-camire/dff5f4c6-bcbe-4ef1-ac0b-1b2701b311ef)

Company: https://www.keypedia.com/companies/cedars-sinai-medical-center/0c040871-8a84-423c-ae2b-2a7748ab8111

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