# FDA 483 - Huntington Reproductive Center Medical Group - November 06, 2023

Source: https://www.keypedia.com/records/483/huntington-reproductive-center-medical-group/7f9f8ce8-2d32-41d8-a9f5-78746144d351

> FDA 483 for Huntington Reproductive Center Medical Group on November 06, 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: 2023-11-06
- Product Type: biologics
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: An FDA inspection of Huntington Reproductive Center Medical Group in Pasadena, CA, a reproductive fertility center, revealed significant deficiencies in their handling of HCT/Ps. The firm failed to properly determine donor eligibility, quarantine HCT/Ps, and apply appropriate warning labels for products from donors who were not adequately screened or had reactive test results for infectious substances. These issues indicate a failure to ensure the safety and proper processing of human cells and tissues.

## Related Officers

- [Celeta S. Coves](https://www.keypedia.com/people/celeta-s-coves/d0f63577-a6e4-4872-b06c-a024188a04ba)

Company: https://www.keypedia.com/companies/huntington-reproductive-center-medical-group/4fd12d3d-2f8b-4ea2-8e31-84d14841adec

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