# FDA 483 - Huntington Reproductive Center Medical Group - March 28, 2023

Source: https://www.keypedia.com/records/483/huntington-reproductive-center-medical-group/17add128-df50-4b8d-b3e9-532fc71c91dc

> FDA 483 for Huntington Reproductive Center Medical Group on March 28, 2023. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Huntington Reproductive Center Medical Group
- Inspection Date: 2023-03-28
- Product Type: biologics
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: An FDA inspection of Huntington Reproductive Center Medical Group in Newport Beach, CA, identified two significant issues regarding Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps). The firm failed to maintain donor anonymity by including identifying personal information on records for 31 anonymous oocyte donors. Additionally, donor eligibility was determined prematurely, prior to the completion of required screening and testing procedures.

## Related Documents

- [483 - 2024-10-29](https://www.keypedia.com/records/483/huntington-reproductive-center-medical-group/12919cce-d37a-4a7e-a206-1ecca9544d86)

## Related Officers

- [Creighton T. Tuzon](https://www.keypedia.com/people/creighton-t-tuzon/be0d09c0-59f4-48c3-9e3d-a1ceb2587e3e)

Company: https://www.keypedia.com/companies/huntington-reproductive-center-medical-group/1a33acf8-7b85-46f5-9985-dcb95991a8ca

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