# FDA 483 - UNC Healthcare/Fertility - July 20, 2022

Source: https://www.keypedia.com/records/483/unc-healthcarefertility/745ee5f2-a7cb-475a-a3bb-c41f7fad3494

> FDA 483 for UNC Healthcare/Fertility on July 20, 2022. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: UNC Healthcare/Fertility
- Inspection Date: 2022-07-20
- Product Type: biologics
- Office Name: Atlanta District Office
- Summary: An FDA inspection of UNC Healthcare/Fertility in Raleigh, NC, identified a significant deficiency related to donor eligibility procedures for Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P). The firm failed to establish and maintain adequate procedures for screening and determining HCT/P donor eligibility, specifically lacking comprehensive steps, questionnaire guidance, and clarity on who can determine eligibility. This indicates a moderate severity issue concerning HCT/P donor screening practices.

## Related Officers

- [Marla A. Cassidy](https://www.keypedia.com/people/marla-a-cassidy/d2859ca5-e77b-4385-9a96-4c785f3ac4c6)

Company: https://www.keypedia.com/companies/unc-healthcarefertility/ea794b9c-ba60-4701-9daa-2c2092c57336

Office: https://www.keypedia.com/offices/atlanta-district-office/7586d99a-288e-49d1-8c3d-d88b7354b7a7