# FDA 483 - North Carolina Center for Reproductive Medicine Inc (NCCRM) - March 16, 2020

Source: https://www.keypedia.com/records/483/north-carolina-center-for-reproductive-medicine-inc-nccrm/f09dccd5-0b67-43c6-a312-ecafc2ec57f4

> FDA 483 for North Carolina Center for Reproductive Medicine Inc (NCCRM) on March 16, 2020. 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: 2020-03-16
- Product Type: biologics
- Office Name: Atlanta District Office
- Summary: The FDA inspected North Carolina Center for Reproductive Medicine Inc (NCCRM) in Cary, NC, a reproductive HCT/P facility. The inspection revealed deficiencies in donor screening and testing procedures for cryopreserved embryos, particularly concerning documentation for donors whose embryos were later used with gestational carriers. Additionally, the facility failed to adequately screen anonymous oocyte donors for communicable disease risk factors, including HIV, Vaccinia, and West Nile Virus.

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## 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