# FDA 483 - North Carolina Center for Reproductive Medicine Inc (NCCRM) - January 26, 2023

Source: https://www.keypedia.com/records/483/north-carolina-center-for-reproductive-medicine-inc-nccrm/412e68db-5508-4b10-a3b1-889e13efe19a

> FDA 483 for North Carolina Center for Reproductive Medicine Inc (NCCRM) on January 26, 2023. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: North Carolina Center for Reproductive Medicine Inc (NCCRM)
- Inspection Date: 2023-01-26
- Product Type: biologics
- Office Name: Atlanta District Office
- Summary: An FDA inspection of North Carolina Center for Reproductive Medicine Inc (NCCRM) in Cary, NC, revealed significant deficiencies in determining HCT/P donor eligibility. The firm accepted multiple gamete donors despite incomplete health history screenings, positive risk factors, or lack of documentation regarding treatment or ineligibility. These practices raise concerns about the safety and suitability of the HCT/Ps processed by the facility.

## Related Documents

- [483 - 2020-03-16](https://www.keypedia.com/records/483/north-carolina-center-for-reproductive-medicine-inc-nccrm/f09dccd5-0b67-43c6-a312-ecafc2ec57f4)

## Related Officers

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

Company: https://www.keypedia.com/companies/north-carolina-center-for-reproductive-medicine-inc-nccrm/191c8f54-93b3-4389-9b15-c4e693cfdc96

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